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Affilliate Event

Sunday, Oct 22nd

8:00 PM – 9:30 PM ET

American Society of Iranian Pharmaceutical Scientists

Location: Challenger 41-42, Hyatt Regency Orlando

Monday, Oct 23rd

5:00 PM – 7:00 PM ET

University of Kansas Department of Pharmaceutical Chemistry Alumni Reception (by invitation only)

Location: Challenger 38-39, Hyatt Regency Orlando

Monday, Oct 23rd

5:00 PM – 7:00 PM ET

University of Michigan College of Pharmacy Alumni and Friends Reception

Location: Orlando L, Hyatt Regency Orlando

Monday, Oct 23rd

5:30 PM – 6:30 PM ET

Minnesota Alumni Reception

Location: Discovery 48, Hyatt Regency Orlando

Monday, Oct 23rd

5:30 PM – 7:30 PM ET

University of Wisconsin-Madison School of Pharmacy Reception

Location: Challenger 41-42, Hyatt Regency Orlando

Monday, Oct 23rd

5:30 PM – 7:30 PM ET

UT Austin College of Pharmacy Alumni and Friends Reception

Location: Plaza K Ballroom, Hyatt Regency Orlando

Monday, Oct 23rd

5:30 PM – 6:30 PM ET

University at Buffalo Alumni & Friends Reception

Location: Plaza I Ballroom, Hyatt Regency Orlando

Monday, Oct 23rd

5:30 PM – 8:00 PM ET

University of Utah - Department of Molecular Pharmaceutics Reception

Location: Plaza F Ballroom, Hyatt Regency Orlando

Monday, Oct 23rd

6:00 PM – 8:00 PM ET

St. John's University Alumni & Friends Reception

Location: Plaza D Ballroom, Hyatt Regency Orlando

Monday, Oct 23rd

6:00 PM – 8:00 PM ET

University of Florida College of Pharmacy Meet the Dean

Location: Cafe Tu Tu Tango

Monday, Oct 23rd

7:00 PM – 9:00 PM ET

UConn School of Pharmacy Alumni Reception

Location: The Pub - Orlando

Tuesday, Oct 24th

7:00 AM – 9:00 AM ET

Quotient Sciences Breakfast Seminar - How To Accelerate Drug Product Optimization: Integrated Program Delivery Using Translational Pharmaceutics® (by invitation only, pre-registration required))

Location: Plaza K Ballroom, Hyatt Regency Orlando

Tuesday, Oct 24th

5:00 PM – 6:00 PM ET

Handbook of Pharmaceutical Excipients: Next Grand Challenges Continued (Invited guests only)

Location: Challenger 41-42, Hyatt Regency Orlando

Tuesday, Oct 24th

5:00 PM – 6:30 PM ET

The University of Mississippi, School of Pharmacy Alumni & Friends Reception (by invitation only)

Location: Plaza F Ballroom, Hyatt Regency Orlando

Tuesday, Oct 24th

5:00 PM – 7:00 PM ET

The National Institute for Pharmaceutical Technology & Education (NIPTE)

Location: Plaza D Ballroom, Hyatt Regency Orlando

Tuesday, Oct 24th

5:30 PM – 8:30 PM ET

Rutgers University Alumni & Friends Reception

Location: Orlando L Ballroom, Hyatt Regency Orlando

Tuesday, Oct 24th

5:30 PM – 9:30 PM ET

American Association of Indian Pharmaceutical Scientists (AAiPS) Annual Banquet Meeting

Location: Tabla Restaurant (5847 Grand National Drive)

Tuesday, Oct 24th

6:00 PM – 8:00 PM ET

Purdue University College of Pharmacy Reception

Location: Del Frisco's Double Eagle Steakhouse, Orlando Florida

Tuesday, Oct 24th

6:00 PM – 10:00 PM ET

IPEC Foundation 2023 Awards Ceremony (by invitation only)

Location: Orlando N Ballroom, Hyatt Regency Orlando

Tuesday, Oct 24th

6:30 PM – 9:00 PM ET

University of Iowa Alumni Dinner at AAPS PharmSci 360 (by invitation only)

Location: The Pub - Orlando

Career Development

Monday, Oct 23rd

8:30 AM – 4:30 PM ET

Free Professional Headshots

Location: Careers 360, Exhibit Hall West A4-B3

Career Development

Sponsored By Agilent

Monday, Oct 23rd

8:30 AM – 4:30 PM ET

LinkedIn Profile Critiques & Resume Reviews

Location: Careers 360, Exhibit Hall West A4-B3

Career Development

Sponsored By

Monday, Oct 23rd

8:30 AM – 4:30 PM ET

Mock Interviews

Location: Careers 360, Exhibit Hall West A4-B3

Career Development

Sponsored By

Monday, Oct 23rd

9:00 AM – 10:00 AM ET

Developing Critical Thinking Skills Needed for Your Job

Location: 360 Stage #3 Exhibit Hall West A4-B3

Career Center Speaker: Kim Huynh-Ba, MS, PMP, FAAPS – Pharmalytik Consulting & Training

Career Development

Monday, Oct 23rd

10:00 AM – 11:00 AM ET

Career Conversations: Hosted by Merck

Location: Careers 360, Exhibit Hall West A4-B3

Career Development

Sponsored By

Monday, Oct 23rd

10:30 AM – 11:30 AM ET

Catalyze Your Success: Developing Business Acumen and Leadership

Location: 360 Stage #3 Exhibit Hall West A4-B3

Career Center Moderator: Pankajini Mallick, PhD (she/her/hers) – Neurocrine

Career Center Speaker: Annette Bak, Ph.D, M.B.A., FAAPS (she/her/hers) – Astra Zeneca

Career Center Speaker: Venus Huang, PhD (she/her/hers) – TriLink Biotechnologies

Career Development

Monday, Oct 23rd

11:00 AM – 12:00 PM ET

Career Conversations: Hosted by GSK

Location: Careers 360, Exhibit Hall West A4-B3

Career Development

Sponsored By:

Monday, Oct 23rd

12:00 PM – 1:00 PM ET

How to Win a (Small Business) Grant

Location: 360 Stage #3 Exhibit Hall West A4-B3

Career Center Speaker: Sean Ekins, PhD, DSc – Collaborations Pharmaceuticals, Inc.

Career Development

Monday, Oct 23rd

1:00 PM – 1:30 PM ET

Sean Ekins, Ph.D, Ds, Author of “Winning Grants”, Book Signing and Meet and Greet

Location: Careers 360, Exhibit Hall West A4-B3

Author: Sean Ekins, PhD, DSc – Collaborations Pharmaceuticals, Inc.

Career Development

Monday, Oct 23rd

1:00 PM – 2:00 PM ET

Career Conversation: Hosted by AstraZeneca

Location: Careers 360, Exhibit Hall West A4-B3

Career Development

Sponsored By

Monday, Oct 23rd

1:30 PM – 2:30 PM ET

Employing Psychological Safety Approaches to Promote Inclusion and Innovation

Location: 360 Stage #3 Exhibit Hall West A4-B3

Career Center Moderator: Gayle A. Brazeau, PhD (she/her/hers) – Marshall University School of Pharmacy

Career Center Speaker: Cynthia A. Jones, PhD (she/her/hers) – Marshall University School of Pharmacy

Career Center Speaker: Evan T. Robinson, RPh, PhD – Creighton University School of Pharmacy and Health Professions

Career Development

Monday, Oct 23rd

3:00 PM – 4:00 PM ET

Job Offers 101: What to Expect Across Different Career Stages

Location: 360 Stage #3 Exhibit Hall West A4-B3

Career Center Moderator: Maya Lipert, PhD – AbbVie Inc.

Career Center Speaker: Anna Schwendeman, PhD (she/her/hers) – University of Michigan

Career Center Speaker: Amy C. Doty, PhD (she/her/hers) – Sage Therapeutics

Career Center Speaker: Elizabeth Joshi, PhD, MBA (she/her/hers) – Investigative ADME/Toxicology & Bioanalytical Research/Eli Lilly & Company

Career Center Speaker: Jane Kenny, PhD (she/her/hers) – Genentech

Career Development

Tuesday, Oct 24th

7:00 AM – 8:30 AM ET

Mentor Breakfast

Location: Florida AB, Hyatt Regency Orlando

Career Development

Sponsored By Merck

Tuesday, Oct 24th

8:30 AM – 4:30 PM ET

Free Professional Headshots

Location: Careers 360, Exhibit Hall West A4-B3

Career Development

Sponsored By Agilent

Tuesday, Oct 24th

8:30 AM – 4:30 PM ET

LinkedIn Profile Critiques & Resume Reviews

Location: Careers 360, Exhibit Hall West A4-B3

Career Development

Sponsored By

Tuesday, Oct 24th

8:30 AM – 4:30 PM ET

Mock Interviews

Location: Careers 360, Exhibit Hall West A4-B3

Career Development

Sponsored By

Tuesday, Oct 24th

9:00 AM – 10:00 AM ET

The Science of Story Telling: Mastering Your Presentation

Location: 360 Stage #3 Exhibit Hall West A4-B3

Career Center Speaker: Erica Schlesinger, PhD (she/her/hers) – Seran Biosciences, LLC

Career Development

Tuesday, Oct 24th

9:00 AM – 4:00 PM ET

Career Fair

Location: Careers 360, Exhibit Hall West A4-B3

Career Development

Tuesday, Oct 24th

10:30 AM – 11:30 AM ET

Three Communication Skills You Must Build to Lead a Team

Location: 360 Stage #3 Exhibit Hall West A4-B3

Career Center Speaker: David P. Otey, MA, MBA (he/him/his) – Speaking of Solutions, LLC

Career Development

Tuesday, Oct 24th

11:30 AM – 12:00 PM ET

David P. Otey, MA, MBA, Book Signing and Meet and Greet

Location: Careers 360, Exhibit Hall West A4-B3

Author: David P. Otey, MA, MBA (he/him/his) – Speaking of Solutions, LLC

Career Development

Tuesday, Oct 24th

12:00 PM – 1:00 PM ET

How Professionals Keep Work-Life Balance and What is Work-Culture?

Location: 360 Stage #3 Exhibit Hall West A4-B3

Career Center Speaker: Yasuhiro Tsume, PhD – Merck

Career Center Speaker: Michael Callahan (he/him/his) – Charles River Laboratories

Career Center Speaker: Catherine A. Fromen, PhD (she/her/hers) – University of Delaware

Career Center Speaker: Corinne B. Jankovsky, PhD – Boehringer-Ingelheim

Career Development

Tuesday, Oct 24th

1:30 PM – 2:30 PM ET

Work-Life Harmony for Women: Strategies for Supporting Each Other

Location: 360 Stage #3 Exhibit Hall West A4-B3

Career Center Speaker: Meena Subramanyam, PhD (she/her/hers) – Takeda

Career Center Moderator: Nivedita Shetty, PhD (she/her/hers) – Genentech

Career Center Speaker: Priya Muralidharan, MS, PhD (she/her/hers) – AstraZeneca

Career Center Speaker: Wendy O. Adamowicz, MS (she/her/hers) – PPD Clinical Research, Thermo Fisher Scientific

Career Development

Tuesday, Oct 24th

3:00 PM – 4:00 PM ET

How to Thrive in the Workplace Without Sacrificing Mental Health

Location: 360 Stage #3 Exhibit Hall West A4-B3

Career Center Speaker: Adeola O. Coker, PhD (she/her/hers) – University of the Incarnate Word

Career Center Moderator: Mustafa Bookwala, MS (he/him/his) – Duquesne University

Career Development

Tuesday, Oct 24th

4:15 PM – 5:00 PM ET

AAPS Student Chapters Awards Ceremony

Location: 360 Stage #3 Exhibit Hall West A4-B3

Speaker: Dawn Klinefelter – American Association of Pharmaceutical Scientists (AAPS)

Wednesday, Oct 25th

8:30 AM – 12:30 PM ET

Free Professional Headshots

Location: Careers 360, Exhibit Hall West A4-B3

Career Development

Sponsored By Agilent

Wednesday, Oct 25th

8:30 AM – 12:30 PM ET

LinkedIn Profile Critiques & Resume Reviews

Location: Careers 360, Exhibit Hall West A4-B3

Career Development

Sponsored By

Wednesday, Oct 25th

8:30 AM – 12:30 PM ET

Mock Interviews

Location: Careers 360, Exhibit Hall West A4-B3

Career Development

Sponsored By

Wednesday, Oct 25th

9:00 AM – 10:00 AM ET

Global Leadership: Inclusivity and Empathy for Multicultural Team

Location: 360 Stage #3 Exhibit Hall West A4-B3

Career Center Speaker: Binodh S. DeSilva, PhD – Bristol-Myers Squibb

Career Center Speaker: Meena Subramanyam, PhD (she/her/hers) – Takeda

Career Center Speaker: Tina S. Morris, PhD – AAPS

Career Center Speaker: Cesar Compadre, Ph.D. – Department of Pharmaceutical Sciences, College of Pharmacy, University of Arkansas for Medical Sciences, Little Rock, AR 72205, Tocol Pharmaceuticals, LLC, Little Rock, AR 77205, USA

Career Center Moderator: Annette Bak, Ph.D, M.B.A., FAAPS (she/her/hers) – Astra Zeneca

Career Development

Wednesday, Oct 25th

10:30 AM – 11:30 AM ET

Understanding a Multigenerational Workforce

Location: 360 Stage #3 Exhibit Hall West A4-B3

Career Center Speaker: Kim Huynh-Ba, MS, PMP, FAAPS – Pharmalytik Consulting & Training

Career Center Speaker: Yan Wu, PhD – Merck Sharp & Dohme

Career Development

Chalk Talk Spotlight

Monday, Oct 23rd

9:30 AM – 10:30 AM ET

Overcoming Formulation Challenges with Binder Jetting 3D Printing Platforms

Location: Spotlight Stage C Exhibit Hall West A4-B3

Chalk Talk Presenter: Michael Gosselin, PhD – Aprecia Pharmaceuticals

Formulation and Delivery

Presented By

Monday, Oct 23rd

11:15 AM – 12:00 PM ET

Accelerating Immunogenicity Analysis: From IgG- to AAV-based Therapies

Location: Spotlight Stage B Exhibit Hall West A4-B3

Chalk Talk Presenter: Eric Feeley, Ph.D. – Gyros Protein Technologies

Preclinical and Translational Sciences

Presented By

Monday, Oct 23rd

11:15 AM – 12:00 PM ET

Advances in Targeting Ion Channels with Biologics and Small Molecules

Location: Spotlight Stage A Exhibit Hall West A4-B3

Chalk Talk Presenter: Doug Krafte, PhD (he/him/his) – OmniAb, Inc.

Discovery and Basic Research

Presented By

Monday, Oct 23rd

11:15 AM – 12:00 PM ET

Microcrystalline cellulose with innovative and unique particle morphologies

Location: Spotlight Stage C Exhibit Hall West A4-B3

Chalk Talk Presenter: Raxit Mehta – Asahi Kasei America

Formulation and Delivery

Presented By

Monday, Oct 23rd

12:30 PM – 1:15 PM ET

Application of Accurate Mass Spectrometry for Nitrosamine Impurities in Metformin

Location: Spotlight Stage B Exhibit Hall West A4-B3

Chalk Talk Presenter: Dan Safarpour, PhD (he/him/his) – Symbiotic Research, LLC

Bioanalytics

Sponsored By

Monday, Oct 23rd

12:30 PM – 1:15 PM ET

Calcium Carbonate as Alternative to Titanium Dioxide in Coatings

Location: Spotlight Stage C Exhibit Hall West A4-B3

Chalk Talk Presenter: Giovanni Raspantini, PharmD (he/him/his) – MilliporeSigma a Business of Merck KGaA

Formulation and Delivery

Presented By

Monday, Oct 23rd

12:30 PM – 1:15 PM ET

Challenges and Opportunities for Bioanalytical Support of New Drug Modalities

Location: Spotlight Stage A Exhibit Hall West A4-B3

Chalk Talk Presenter: Daniel Sikkema, PhD – Labcorp

Bioanalytics

Presented By Labcorp

Tuesday, Oct 24th

9:30 AM – 10:30 AM ET

Challenges in Analytical Aerosol Methods for High Payload Inhalation Products

Location: Spotlight Stage C Exhibit Hall West A4-B3

Chalk Talk Presenter: Blaine Bueche, PhD – Kindeva Drug Delivery

Formulation and Delivery

Presented By

Tuesday, Oct 24th

11:15 AM – 12:00 PM ET

AI for Subvisible Particle Image Analysis Delivers Actionable Data

Manufacturing and Analytical Characterization

Partner Presentation-Manufacturing & Bioprocessing

Location: Spotlight Stage A Exhibit Hall West A4-B3

Chalk Talk Presenter: Eric Gottlieb, BSc, MBA – SentrySciences, Inc.

Manufacturing & Analytical Characterization

Presented By

Tuesday, Oct 24th

11:15 AM – 12:00 PM ET

Liposomal formulations in advanced-cancer therapies and challenges in early-stage development

Location: Spotlight Stage C Exhibit Hall West A4-B3

Chalk Talk Presenter: Naoki Yamada, MS – FUJIFILM Pharmaceutical U.S.A., Inc.

Formulation and Delivery

Presented By

Tuesday, Oct 24th

11:15 AM – 12:00 PM ET

Revolutionize Critical Reagent Development with Rabbit Single B-Cell Technology

Location: Spotlight Stage B Exhibit Hall West A4-B3

Chalk Talk Presenter: Hao Cheng, PhD (he/him/his) – Yurogen Biosystems

Bioanalytics

Presented By

Tuesday, Oct 24th

12:30 PM – 1:15 PM ET

Considerations in the Development of Potency Assays for ATMPs

Location: Spotlight Stage B Exhibit Hall West A4-B3

Chalk Talk Presenter: Jeff Patrick, PhD (he/him/his) – BioAgilytix - Durham, NC

Manufacturing & Analytical Characterization

Presented By

Tuesday, Oct 24th

12:30 PM – 1:15 PM ET

Designing Pharmaceutical Materials for Extrusion Enabled Continuous Manufacturing

Location: Spotlight Stage A Exhibit Hall West A4-B3

Chalk Talk Presenter: Thomas Dürig, PhD – Ashland

Formulation and Delivery

Presented By

Tuesday, Oct 24th

12:30 PM – 1:15 PM ET

Hyaluronic Nanogel: Facile Fabrication for Solubilization, SR and Vaccine Applications

Location: Spotlight Stage C Exhibit Hall West A4-B3

Chalk Talk Presenter: Takero Kurosawa, M.S. – Asahi Kasei

Formulation and Delivery

Presented By

Wednesday, Oct 25th

10:00 AM – 11:00 AM ET

Development of Multiarticulate Formulations Using Innovative Excipients Through Algorithm-Based Tools

Location: Spotlight Stage C Exhibit Hall West A4-B3

Chalk Talk Presenter: Nitin K. Swarnakar, PhD (he/him/his) – BASF Corporation

Chalk Talk Presenter: Ramesh Muttavarapu, M.S (Pharma), MBA – Patheon, by Thermo Fisher Scientific

Formulation and Delivery

Presented By

Committee Meeting

Sunday, Oct 22nd

9:00 AM – 1:00 PM ET

Business Development Advisory Board (by invitation only)

Location: Manatee Spring, Hyatt Regency Orlando

Monday, Oct 23rd

12:00 PM – 1:00 PM ET

AAPS Committee Chairs Discussion (by invitation only)

Location: Florida C, Hyatt Regency Orlando

Community Event

Monday, Oct 23rd

4:00 PM – 5:00 PM ET

AAPS Biomarkers & Precision Medicine Community Membership Meeting

Location: Spotlight Stage C Exhibit Hall West A4-B3

Community Leader: Amanda L. Hays, Ph.D. – BioAgilytix Labs, LLC

Monday, Oct 23rd

4:00 PM – 5:00 PM ET

AAPS Gene & Cell Therapy Products Community Membership Meeting

Location: Spotlight Stage A Exhibit Hall West A4-B3

Community Leader: Vittal Shivva, PhD – Genentech, Inc.

Monday, Oct 23rd

4:00 PM – 5:00 PM ET

AAPS Global Health Community Membership Meeting

Location: Spotlight Stage B Exhibit Hall West A4-B3

Community Leader: Sudip Das, PhD (he/him/his) – Butler University

Monday, Oct 23rd

5:00 PM – 6:00 PM ET

AAPS Chemistry, Manufacturing, & Controls (CMC) Community Membership Meeting

Location: 205 AB West

Community Leader: Shrinivas (Cheenu) Murti, PhD, MBA – Takeda Pharmaceutical Company Limited

Monday, Oct 23rd

5:00 PM – 6:00 PM ET

AAPS Drug Transport Community Membership Meeting

Location: 311 AB West

Community Leader: Wei Yue, PhD (she/her/hers) – University of Oklahoma Health Sciences Center

Monday, Oct 23rd

5:00 PM – 6:00 PM ET

AAPS In Vitro Release & Dissolution Testing Community Membership Meeting

Location: 311 EF West

Community Leader: Jie Shen, PhD (she/her/hers) – Northeastern University

Monday, Oct 23rd

5:00 PM – 6:00 PM ET

AAPS Inhalation & Nasal Community Membership Meeting

Location: 206 AB West

Community Leader: Vivek Gupta, PhD – St. John's University

Monday, Oct 23rd

5:00 PM – 6:00 PM ET

AAPS Ocular Drug Delivery & Disposition Community Membership Meeting

Location: 308 CD West

Community Leader: Chun-Wan Yen, PhD (she/her/hers) – Genentech, Inc.

Monday, Oct 23rd

5:00 PM – 6:00 PM ET

AAPS Preformulation & Formulation Design/Development Community Membership Meeting

Location: 311 GH West

Community Leader: Deepak Bahl, PhD – Bristol-Myers Squibb Company

Monday, Oct 23rd

5:00 PM – 6:00 PM ET

AAPS Protein Purification, Storage, Transportation, and Drug-Device Combination Community Membership Meeting

Location: 208 AB West

Community Leader: Yuan Cheng, PhD (he/him/his) – Regeneron Pharmaceuticals

Monday, Oct 23rd

5:00 PM – 6:00 PM ET

AAPS Regulatory Sciences Community Membership Meeting

Location: 309 AB West

Community Leader: Raja B. Velagapudi, PhD (he/him/his) – Tolmar Inc

Monday, Oct 23rd

5:00 PM – 6:00 PM ET

AAPS Stability Community Membership Meeting

Location: 308 AB West

Community Leader: Kim Huynh-Ba, MS, PMP, FAAPS – Pharmalytik Consulting & Training

Community Leader: Lori McCaig, PhD (she/her/hers) – Seagen Inc.

Monday, Oct 23rd

5:00 PM – 6:00 PM ET

AAPS Topical & Transdermal Community Membership Meeting

Location: 311 CD West

Community Leader: Nisarg N. Modi, PhD (he/him/his) – Transdermal Research Pharm Laboratories LLC

Tuesday, Oct 24th

4:00 PM – 5:00 PM ET

AAPS Excipients Community Membership Meeting

Location: Spotlight Stage A Exhibit Hall West A4-B3

Community Leader: Haichen Nie, PhD – Teva Pharmaceuticals

Tuesday, Oct 24th

4:00 PM – 5:00 PM ET

AAPS Lipid-Based Drug Delivery Systems Community Membership Meeting

Location: Spotlight Stage C Exhibit Hall West A4-B3

Community Leader: Masumi Dave, PhD (she/her/hers) – Gattefosse USA

Tuesday, Oct 24th

4:00 PM – 5:00 PM ET

AAPS Manufacturing Science & Engineering Community Membership Meeting

Location: Spotlight Stage B Exhibit Hall West A4-B3

Community Leader: Rajesh Dave, PhD (he/him/his) – NJIT

Tuesday, Oct 24th

5:00 PM – 6:00 PM ET

AAPS Bioanalytical Community Membership Meeting

Location: 311 EF West

Community Leader: Robert Dodge, PhD – Novartis

Community Leader: Chad J. Briscoe, PhD – Celerion

Tuesday, Oct 24th

5:00 PM – 6:00 PM ET

AAPS Bioequivalence and Bioavailability Science Community Membership Meeting

Location: 311 GH West

Community Leader: Prasad N. Tata – Sandoz, Inc.

Tuesday, Oct 24th

5:00 PM – 6:00 PM ET

AAPS Nanotechnology Community Membership Meeting

Location: 311 CD West

Community Leader: Mandip Singh Sachdeva, PhD, FAAPS – Florida A & M University

Community Leader: Ryan Pearson, PhD – University of Maryland Baltimore

Tuesday, Oct 24th

5:00 PM – 6:00 PM ET

AAPS Pharmacokinetics, Pharmacodynamics, & Drug Metabolism Community Membership Meeting

Location: 309 AB West

Community Leader: Abhisheak Sharma, PhD – University of Florida

Wednesday, Oct 25th

7:30 AM – 8:30 AM ET

Women in PharmSci Breakfast

Location: Florida AB, Hyatt Regency Orlando

Sponsored By Genentech

Executive

Monday, Oct 23rd

7:00 AM – 9:00 AM ET

The Integration of Clinical Trials and Clinical Care: A Revolution in the Participant and Sponsor Experience or an Implementation Nightmare? Or Both?

Location: 308 AB West

Executive Education Speaker: Jeanne Hecht, MBA, PMP (she/her/hers) – JTH Consulting & Associates

Executive Education Speaker: Gerald E. Finken, R.Ph., M.S. (he/him/his) – RxE2 Inc.

Executive Track

Happy Hour

Monday, Oct 23rd

3:00 PM – 4:00 PM ET

Happy Hour Sponsored by Porton

Location: Booth #2942, Exhibit Hall West A4-B3

Sponsored By

Monday, Oct 23rd

3:30 PM – 4:30 PM ET

Happy Hour Sponsored by Alturas Analytics, Inc.

Location: Booth #2522, Exhibit Hall West A4-B3

Sponsored By

Monday, Oct 23rd

3:30 PM – 4:30 PM ET

Happy Hour Sponsored by GlobePharma, Inc.

Location: Booth #3215, Exhibit Hall West A4-B3

Sponsored By

Monday, Oct 23rd

4:00 PM – 5:00 PM ET

Happy Hour Sponsored by Neopharm Labs

Location: Booth#2356, Exhibit Hall A4-B3

Sponsored By Neopharm Labs

Monday, Oct 23rd

4:00 PM – 5:00 PM ET

Happy Hour Sponsored by SENTRYSCIENCES, INC

Location: Booth #2347, Exhibit Hall West A4-B3

Sponsored By

Monday, Oct 23rd

4:00 PM – 5:00 PM ET

Start-Up Pavilion Happy Hour

Location: Start-Up Pavilion (Aisle 2000), Exhibit Hall West A4-B3

Tuesday, Oct 24th

3:00 PM – 4:00 PM ET

Happy Hour Sponsored by ROQUETTE

Location: Booth #2542, Exhibit Hall West A4-B3

Sponsored By

Tuesday, Oct 24th

3:30 PM – 4:30 PM ET

Happy Hour Sponsored by COREALIS Pharma Inc.

Location: Booth #2500, Exhibit Hall West A4-B3

Sponsored By COREALIS Pharma

Tuesday, Oct 24th

3:30 PM – 4:30 PM ET

Happy Hour Sponsored by IDBS

Location: Back of aisle 3200 near the AAPS Media Booth, Exhibit Hall West A4-B3

Sponsored By IDBS

Tuesday, Oct 24th

3:30 PM – 4:30 PM ET

Happy Hour Sponsored by Syngene International Limited

Location: Booth #3307, Exhibit Hall West A4-B3

Sponsored By

Tuesday, Oct 24th

4:00 PM – 5:00 PM ET

Happy Hour Sponsored by Agilent Technologies

Location: Booth #2413, Exhibit Hall West A4-B3

Sponsored By

Tuesday, Oct 24th

4:00 PM – 5:00 PM ET

Happy Hour Sponsored by Certara

Location: Booth #2615, Exhibit Hall West A4-B3

Sponsored By Certara

Tuesday, Oct 24th

4:00 PM – 5:00 PM ET

Happy Hour Sponsored by Infinity Laboratories

Location: Booth #3346, Exhibit Halls A4-B3

Sponsored By

Tuesday, Oct 24th

4:00 PM – 5:00 PM ET

Happy Hour Sponsored by Prolytix

Location: Booth #2401, Exhibit Hall WA4-B3

Sponsored By Prolytix

Hot Topic

Monday, Oct 23rd

9:00 AM – 10:00 AM ET

Hot Topic: Rethinking the Immunogenicity Testing Paradigm for 21st Century Modalities

Location: 308 CD West

Hot Topic Speaker: Lauren Stevenson, PhD (she/her/hers) – Immunologix Laboratories

Hot Topic Speaker: Jenny Valentine, PhD (she/her/hers) – Regeneron Pharmaceuticals

Hot Topic Speaker: Laura I. Salazar-Fontana, PhD (she/her/hers) – LAIZ Regulatory Science Consulting

Hot Topic Moderator: Michael Partridge, PhD – Regeneron

Hot Topic Speaker: Kyra J. Cowan, PhD – Merck KGaA

Bioanalytics – Biomolecular

Monday, Oct 23rd

10:00 AM – 11:00 AM ET

Hot Topic: Drug Delivery Technology: Quo Vadis?

Location: 308 AB West

Hot Topic Speaker: Kinam Park, PhD (he/him/his) – Purdue University

Hot Topic Speaker: Richard H. Guy, PhD, FAAPS – University of Bath

Hot Topic Speaker: Robert Lionberger, PhD – U.S. Food & Drug Administration

Hot Topic Moderator: Richard H. Guy, PhD, FAAPS – University of Bath

Hot Topic Speaker: Randall Mrsny, Ph.D. (he/him/his) – University of Bath

Formulation and Delivery – Chemical

Monday, Oct 23rd

2:30 PM – 3:30 PM ET

Hot Topic: Inhalable Aerosol Immune Engineering

Location: 308 CD West

Hot Topic Speaker: Catherine A. Fromen, PhD (she/her/hers) – University of Delaware

Hot Topic Moderator: Sumanta Goswami

Discovery and Basic Research

Monday, Oct 23rd

3:30 PM – 4:30 PM ET

Hot Topic: Product and Process Design for Long Acting Injectable (LAI) Formulations

Location: 308 AB West

Hot Topic Speaker: Sujatha Sonti, Dr – GSK

Hot Topic Moderator: Diane J. Burgess, Ph.D. (she/her/hers) – University of Connecticut

Manufacturing & Analytical Characterization

Tuesday, Oct 24th

10:00 AM – 11:00 AM ET

Hot Topic: Regulatory Challenges and Considerations for Orally Inhaled Drug Product

Location: 308 AB West

Hot Topic Speaker: Adrian Goodey, PhD – Merck

Hot Topic Speaker: Sue Holmes, MS – GSK

Hot Topic Moderator: Parind Desai, PhD – GlaxoSmithKline

Manufacturing & Analytical Characterization – Chemical

Tuesday, Oct 24th

2:30 PM – 3:30 PM ET

Hot Topic: Engineering Human Organoids and Organs-on-Chips for Disease Modeling, Drug Development and Personalized Medicine

Location: 308 AB West

Hot Topic Moderator: Yurong Lai, PhD (he/him/his) – Gilead Sciences, Inc.

Hot Topic Speaker: Rodrigo Cristofoletti, Ph.D. (he/him/his) – University of Florida

Preclinical and Translational Sciences

Tuesday, Oct 24th

3:30 PM – 4:30 PM ET

Hot Topic: ICH M10 Bioanalytical Method Validation Guidance-1 year Later

Location: 308 CD West

Hot Topic Speaker: Eric Joel Woolf, PhD, FAAPS (he/him/his) – Merck and Co Inc

Hot Topic Speaker: Faye Vazvaei-Smith, M.S. – Merck & Co.

Hot Topic Speaker: Chongwoo Yu, Ph.D. – US Food and Drug Administration

Hot Topic Speaker: Enaksha Wickremsinhe, PhD (he/him/his) – Bill and Melinda Gates Medical Research Institute

Hot Topic Moderator: Eric Joel Woolf, PhD, FAAPS (he/him/his) – Merck and Co Inc

Bioanalytics

Wednesday, Oct 25th

10:00 AM – 11:00 AM ET

Hot Topic: Challenges and Opportunities of in vitro Assays and Organ-On-A-Chip

Location: 308 CD West

Hot Topic Speaker: Seyoum Ayehunie, PhD – Mattek

Hot Topic Moderator: Twinkle R. Christian – Amgen

Hot Topic Speaker: Lorna Ewart, PhD – Emulate

Hot Topic Speaker: Annie Hamel, MSc (she/her/hers) – Charles River Laboratories

Hot Topic Speaker: James R. Gosset (he/him/his) – Pfizer Inc

Discovery and Basic Research

Wednesday, Oct 25th

3:00 PM – 4:00 PM ET

Hot Topic: Novel Excipients in Biopharma: Balancing Innovation, Risk, and Need

Location: 308 AB West

Hot Topic Speaker: Joshua Katz, PhD – International Flavors and Fragrances Inc.

Hot Topic Speaker: Mary E. Krause, PhD – BMS

Hot Topic Moderator: Joshua Katz, PhD – International Flavors and Fragrances Inc.

Hot Topic Speaker: Andrea Hawe, PhD (she/her/hers) – Coriolis Pharma

Hot Topic Speaker: Can Araman, PhD – MilliporeSigma

Formulation and Delivery

Wednesday, Oct 25th

3:00 PM – 4:00 PM ET

Hot Topic: Understanding Data Needs for AI/ML Approaches During Preclinical Development

Location: 308 CD West

Hot Topic Speaker: Vibha Jawa, PhD, FAAPS – Bristol Myers Squibb

Hot Topic Moderator: Fei Hua, PhD – Applied BioMath

Hot Topic Speaker: Anant Madabhushi, PhD (he/him/his) – Emory University

Hot Topic Speaker: Michelle Graham, PhD (she/her/hers) – AbbVie

Hot Topic Speaker: Narendra Chirmule, Dr. (he/him/his) – SymphonyTech Biologucs

Preclinical and Translational Sciences

Journal Meeting

Monday, Oct 23rd

7:30 AM – 8:30 AM ET

AAPS Joint Editorial Board Breakfast (by invitation only)

Location: Florida A, Hyatt Regency Orlando

Keynote

Monday, Oct 23rd

1:30 PM – 2:30 PM ET

Keynote: Apply Endogenous Biomarkers to Detect DDIs

Location: 311 AB West

Keynote Speaker: Hiroyuki Kusuhara, PhD (he/him/his) – Graduate School of Pharmaceutical Sciences, the University of Tokyo

Moderator: Yurong Lai, PhD (he/him/his) – Gilead Sciences, Inc.

Preclinical and Translational Sciences

Monday, Oct 23rd

1:30 PM – 2:30 PM ET

Keynote: Biomarker Selection and Utility in Clinical Drug Development Today: Workhorses and Unicorns

Location: 311 CD West

Keynote Speaker: Lindsay Ewan King, Ph.D. (he/him/his) – Pfizer Inc

Moderator: Jaya Vaidyanathan, PhD – Division of Cardiometabolic and Endocrine Pharmacology, OCP/OTS/CDER/US Food and Drug Administration

Preclinical and Translational Sciences

Monday, Oct 23rd

1:30 PM – 2:30 PM ET

Keynote: Crossing Modalities: Analytical Adventures at the Interface of Small and Large Molecules

Location: 206 AB West

Keynote Speaker: Narayan Variankaval, PhD – Merck & Co

Moderator: Jason Rodriguez, PhD – US Food and Drug Administration

Manufacturing & Analytical Characterization

Monday, Oct 23rd

1:30 PM – 2:30 PM ET

Keynote: Crystal and Particle Engineering Strategies in Pharmaceutical Product Development and Manufacturing

Location: 205 AB West

Keynote Speaker: Jukka Rantanen, PhD (he/him/his) – University of Copenhagen

Moderator: Sushrut Marathe, PhD (he/him/his) – GSK

Manufacturing & Analytical Characterization

Monday, Oct 23rd

1:30 PM – 2:30 PM ET

Keynote: Engineering and Characterizing Large Molecule Delivery to the Brain: Taking Antibodies, Enzymes, and Other Proteins to the Final Frontier

Location: 309 AB West

Keynote Speaker: Robert G. Thorne, PhD (he/him/his) – Denali Therapeutics & University of Minnesota

Moderator: Steven W. Louie, MS (he/him/his) – Moderna

Discovery and Basic Research

Monday, Oct 23rd

1:30 PM – 2:30 PM ET

Keynote: Patient Centricity: One Blood Draw at a Time

Location: 311 EF West

Keynote Speaker: Enaksha Wickremsinhe, PhD (he/him/his) – Bill and Melinda Gates Medical Research Institute

Moderator: Catherine L. Brockus, PhD (she/her/hers) – Eli Lilly and Company

Bioanalytics

Monday, Oct 23rd

1:30 PM – 2:30 PM ET

Keynote: Predicting Formulation Performance: Learning from Generic Drugs

Location: 208 AB West

Keynote Speaker: Robert Lionberger, PhD – U.S. Food & Drug Administration

Moderator: Yan Wang, PhD (she/her/hers) – U.S. Food and Drug Administration

Formulation and Delivery

Monday, Oct 23rd

1:30 PM – 2:30 PM ET

Keynote: Shrinking Time to Market Through the Targeted Integration of Technology, Modeling, and Patient Centricity

Location: 209 AB West

Keynote Speaker: Bikash Chatterjee (he/him/his) – Pharmatech Associates

Moderator: Stephanie Gaulding, CPGP, CQA (she/her/hers) – Pharmatech Associates

Formulation and Delivery

Monday, Oct 23rd

1:30 PM – 2:30 PM ET

Keynote: The Bioanalytical Program: From Strategy to Implementation –Current State and Additional Considerations

Location: 311 GH West

Keynote Speaker: Jad Zoghbi, MS – Biogen

Moderator: Catherine Vrentas, PhD – PPD, A ThermoFisher Company

Bioanalytics

Tuesday, Oct 24th

1:30 PM – 2:30 PM ET

Keynote: Excipient Taxonomy for the 21st Century: A Grand Challenge for the Pharmaceutical Sciences Community

Location: 209 AB West

Keynote Speaker: Bruno Hancock, PhD (he/him/his) – Pfizer Inc.

Moderator: Haichen Nie, PhD – Teva Pharmaceuticals

Formulation and Delivery

Tuesday, Oct 24th

1:30 PM – 2:30 PM ET

Keynote: Genetic (Nano) Medicine: State of the Art, Frontiers and Current Research

Location: 311 GH West

Keynote Speaker: Michelle Lynn Hall, PhD (she/her/hers) – Eli Lilly

Moderator: Yan G. Ni, PhD – Passage Bio

Bioanalytics

Tuesday, Oct 24th

1:30 PM – 2:30 PM ET

Keynote: Health Disparities in Basic Science: Implications for Pharmacological Research

Location: 311 AB West

Keynote Speaker: Kathleen Giacomini, PhD (she/her/hers) – University of California, San Francisco

Moderator: Wei Yue, PhD (she/her/hers) – University of Oklahoma Health Sciences Center

Discovery and Basic Research

Tuesday, Oct 24th

1:30 PM – 2:30 PM ET

Keynote: In Vitro In Vivo Correlation (IVIVC) for Long Acting Injectable (LAI) Formulations

Location: 205 AB West

Keynote Speaker: Diane J. Burgess, Ph.D. (she/her/hers) – University of Connecticut

Moderator: Thilak Mudalige, Ph.D. (he/him/his) – US Food and Drug Administration

Manufacturing & Analytical Characterization

Tuesday, Oct 24th

1:30 PM – 2:30 PM ET

Keynote: Navigating Project Optimus: Use of Modeling and Simulation to Inform Dosing Strategies in Oncology

Location: 311 CD West

Moderator: Fei Hua, PhD – Applied BioMath

Keynote Speaker: Dean Bottino, PhD (he/him/his) – Takeda Pharmaceuticals

Preclinical and Translational Sciences

Tuesday, Oct 24th

1:30 PM – 2:30 PM ET

Keynote: New Era of Bioanalysis Post Covid-19 Pandemic

Location: 311 EF West

Keynote Speaker: Qin Ji, PhD – AbbVie

Moderator: Long Yuan, PhD – Biogen Inc.

Bioanalytics

Tuesday, Oct 24th

1:30 PM – 2:30 PM ET

Keynote: Novel Nanotechnology-Based Approaches to Improving the Effectiveness of Anticancer Vaccines

Location: 208 AB West

Keynote Speaker: Jayanth Panyam, PhD (he/him/his) – University of Washington

Moderator: Anette Mullertz, PhD, FAAPS – University of Copenhagen

Formulation and Delivery

Tuesday, Oct 24th

1:30 PM – 2:30 PM ET

Keynote: Process Modelling and Digital Twin Development for Bioprocessing of mAbs

Location: 206 AB West

Keynote Speaker: Marianthi Ierapetritou, PhD (she/her/hers) – University of Delaware

Moderator: Ou Yang, PhD – GSK

Manufacturing & Analytical Characterization

Tuesday, Oct 24th

1:30 PM – 2:30 PM ET

Keynote: Towards Development of Translational PBPK Models for Biologics

Location: 309 AB West

Keynote Speaker: Dhaval K. Shah, PhD (he/him/his) – University at Buffalo

Moderator: Jaya Vaidyanathan, PhD – Division of Cardiometabolic and Endocrine Pharmacology, OCP/OTS/CDER/US Food and Drug Administration

Preclinical and Translational Sciences

Wednesday, Oct 25th

1:30 PM – 2:30 PM ET

Keynote: Advancing Clinical Translation: An Automated Platform for Massively Scalable Preclinical Human Testing

Location: 311 GH West

Keynote Speaker: Anthony Bahinski, MBA, PhD – Vivodyne, Inc.

Moderator: Amanda L. Hays, Ph.D. – BioAgilytix Labs, LLC

Bioanalytics

Wednesday, Oct 25th

1:30 PM – 2:30 PM ET

Keynote: High Resolution Analytical Tools to Enhance Regulatory Science

Location: 205 AB West

Keynote Speaker: Jason Rodriguez, PhD – US Food and Drug Administration

Moderator: Thilak Mudalige, Ph.D. (he/him/his) – US Food and Drug Administration

Manufacturing & Analytical Characterization

Wednesday, Oct 25th

1:30 PM – 2:30 PM ET

Keynote: Novel NK and CAR-NK Expansion Platforms (Feeder Cells vs. No Feeder Cells)

Location: 206 AB West

Keynote Speaker: Dongfang Liu, MD/PhD (he/him/his) – Rutgers University-New Jersey Medical School

Moderator: Sayantan Chattoraj, PhD – GSK

Manufacturing & Analytical Characterization

Wednesday, Oct 25th

1:30 PM – 2:30 PM ET

Keynote: Novel Tools and Insights into Predicting Systemic and Tissue Drug Concentrations in Humans Including Special Populations

Location: 309 AB West

Keynote Speaker: Jashvant D. Unadkat, PhD – University of Washington

Moderator: Yurong Lai, PhD (he/him/his) – Gilead Sciences, Inc.

Preclinical and Translational Sciences

Wednesday, Oct 25th

1:30 PM – 2:30 PM ET

Keynote: Patient Centric Drug Formulation and Delivery: Lessons from FDA Approved and Pharmacy Compounded Products

Location: 209 AB West

Keynote Speaker: Robert B. MacArthur, PharmD, MS, BCSCP (he/him/his) – Rockefeller University Hospital

Moderator: Robin H. Bogner, PhD (she/her/hers) – University of Connecticut

Formulation and Delivery

Wednesday, Oct 25th

1:30 PM – 2:30 PM ET

Keynote: Patient Centric Product Design-Not a Fad but an Imperative

Location: 208 AB West

Keynote Speaker: Rao V. Mantri, PhD, MBA – Bristol Myers Squibb

Moderator: Mary E. Krause, PhD – BMS

Formulation and Delivery

Wednesday, Oct 25th

1:30 PM – 2:30 PM ET

Keynote: Predictive Drug Discovery Platforms

Location: 311 CD West

Keynote Speaker: James R. Gosset (he/him/his) – Pfizer Inc

Moderator: Fei Hua, PhD – Applied BioMath

Preclinical and Translational Sciences

Wednesday, Oct 25th

1:30 PM – 2:30 PM ET

Keynote: State-of-The-Art Microfluidic Methodologies for Development of Micro- and Nanoparticles: Application to Drug Delivery Technologies

Location: 311 AB West

Keynote Speaker: Helder Santos (he/him/his) – University Medical Center Groningen

Moderator: Sudip Das, PhD (he/him/his) – Butler University

Discovery and Basic Research

Wednesday, Oct 25th

1:30 PM – 2:30 PM ET

Keynote: When Companion Diagnostics Met Bioanalysis: The Roles of Companion Diagnosis and Bioanalysis in Guiding Treatment Selection and Monitoring Drug Response

Location: 311 EF West

Keynote Speaker: Mark Ma, MD (he/him/his) – Biotech

Moderator: Catherine Vrentas, PhD – PPD, A ThermoFisher Company

Bioanalytics

Networking

Monday, Oct 23rd

8:00 AM – 9:00 AM ET

Coffee and Conversation With the Fellows Communications Task Force (Fellows Only)

Location: 312 A West

Committee Chair: Dale Eric Wurster, Ph.D., FAAPS – University of Iowa

Monday, Oct 23rd

8:30 AM – 2:00 PM ET

Guest Tour: Space Coast River Tour (additional fee required)

Location: Meet at the Hyatt Regency Orlando at 8:30 am

Monday, Oct 23rd

8:30 AM – 4:30 PM ET

Coffee Station

Location: Booth #2335, Exhibit Hall West A4-B3

Sponsored By

Monday, Oct 23rd

8:30 AM – 5:00 PM ET

Solution Center Hours & Poster Presentations

Location: Exhibit Hall West A4-B3

Monday, Oct 23rd

9:30 AM – 10:00 AM ET

Coffee Break in the Solution Center

Location: Exhibit Hall West A4-B3

Monday, Oct 23rd

11:00 AM – 1:30 PM ET

Dedicated Solution Center Hours

Location: Exhibit Hall West A4-B3

Monday, Oct 23rd

2:30 PM – 3:00 PM ET

Coffee and Conversation With the Fellows Communications Task Force (Fellows Only)

Location: 312 A West

Committee Chair: Dale Eric Wurster, Ph.D., FAAPS – University of Iowa

Monday, Oct 23rd

2:30 PM – 3:00 PM ET

Coffee Break in the Solution Center

Location: Exhibit Hall West A4-B3

Tuesday, Oct 24th

8:30 AM – 4:30 PM ET

Coffee Station

Location: Booth #2335, Exhibit Hall West A4-B3

Sponsored By

Tuesday, Oct 24th

8:30 AM – 5:00 PM ET

Solution Center Hours & Poster Presentations

Location: Exhibit Hall West A4-B3

Tuesday, Oct 24th

9:30 AM – 10:00 AM ET

Coffee Break in the Solution Center

Location: Exhibit Hall West A4-B3

Tuesday, Oct 24th

10:00 AM – 12:00 PM ET

Taste of Orlando Smoothie Station Sponsored by Eurofins

Location: Booth #2234/2236

Sponsored By

Tuesday, Oct 24th

11:00 AM – 1:30 PM ET

Dedicated Solution Center Hours

Location: Exhibit Hall West A4-B3

Tuesday, Oct 24th

2:30 PM – 3:00 PM ET

Coffee Break in the Solution Center

Location: Exhibit Hall West A4-B3

Wednesday, Oct 25th

8:30 AM – 1:30 PM ET

Solution Center Hours & Poster Presentations

Location: Exhibit Hall West A4-B3

Wednesday, Oct 25th

9:30 AM – 10:00 AM ET

Coffee Break in the Solution Center

Location: Exhibit Hall West A4-B3

Wednesday, Oct 25th

11:00 AM – 1:30 PM ET

Dedicated Solution Center Hours

Location: Exhibit Hall West A4-B3

Partner Presentation

Monday, Oct 23rd

9:00 AM – 10:00 AM ET

Overcome Capping Challenges and Increase Tableting Speed in Direct Compression

Location: 360 Stage #1 Exhibit Hall West A4-B3

Partner Presentation Speaker: Talles Ernica, MD – Roquette America Inc.

Formulation and Delivery

Presented By

Monday, Oct 23rd

9:30 AM – 10:30 AM ET

From Concept to Clinic: Navigating RNA-Lipid Nanoparticle Development

Location: 360 Stage #2 Exhibit Hall West A4-B3

Partner Presentation Speaker: Jagbir Singh, PhD – Precision NanoSystems

Formulation and Delivery

Presented By

Monday, Oct 23rd

9:30 AM – 10:30 AM ET

Lipidomic Applications to Support Pharmaceutical Early Discovery and Safety Assessment

Location: 360 Stage #4 Exhibit Hall West A4-B3

Partner Presentation Speaker: Andrea Coates, MRes PhD (she/her/hers) – Charles River

Discovery and Basic Research

Presented By

Monday, Oct 23rd

10:30 AM – 11:30 AM ET

Precision Microspheres: Then and Now

Location: 360 Stage #1 Exhibit Hall West A4-B3

Partner Presentation Speaker: Nathan Dormer, PhD (he/him/his) – Adare Pharma Solutions

Formulation and Delivery

Presented By

Monday, Oct 23rd

11:00 AM – 12:00 PM ET

Inhalation Pharmacokinetics and Toxicity of CBD and other Cannabinoids

Location: 360 Stage #4 Exhibit Hall West A4-B3

Partner Presentation Speaker: Philip J. Kuehl, PhD – Lovelace Biomedical Research Institute

Preclinical and Translational Sciences

Presented By

Monday, Oct 23rd

11:00 AM – 12:00 PM ET

Unleash Small and Large Molecule Solutions for Biologics and Gene-Therapy

Location: 360 Stage #2 Exhibit Hall West A4-B3

Partner Presentation Speaker: Andre Mueller, PhD (he/him/his) – Unchained Labs

Partner Presentation Speaker: Del Ray Jackson, PhD – Unchained Labs

Partner Presentation Speaker: Ben Knappett, PhD – Unchained Labs

Bioanalytics

Presented By

Monday, Oct 23rd

12:30 PM – 1:30 PM ET

Leveraging Advanced Raman and UV-Vis Techniques in Pharmaceutical Manufacturing Processes

Location: 360 Stage #4 Exhibit Hall West A4-B3

Partner Presentation Speaker: Yanqia Wang, PhD – Agilent

Manufacturing & Analytical Characterization

Presented By

Monday, Oct 23rd

12:30 PM – 1:30 PM ET

The Viscosity Reduction Platform: Enabling High-concentration and Low-viscosity Protein Formulations

Location: 360 Stage #2 Exhibit Hall West A4-B3

Partner Presentation Speaker: Can Araman, PhD – MilliporeSigma

Formulation and Delivery

Presented By

Monday, Oct 23rd

2:00 PM – 3:00 PM ET

Leveraging Lipid-Based Formulations for Bioavailability, Compliance, and Scalability from Preclinical to Commercial

Location: 360 Stage #2 Exhibit Hall West A4-B3

Partner Presentation Speaker: Karunakar Sukuru, R.Ph., PhD, – Catalent

Formulation and Delivery

Presented By

Monday, Oct 23rd

2:00 PM – 4:00 PM ET

Challenges and Opportunities of Protein-long Active Injectables

Location: 360 Stage #4 Exhibit Hall West A4-B3

Partner Presentation Speaker: Karolina Dziemidowicz, PhD, MPharm (she/her/hers) – UCL School of Pharmacy

Partner Presentation Speaker: Aiva Simaite, PhD – InnoCore Pharmaceuticals

Partner Presentation Speaker: Puneet Tyagi, Ph.D. – Dosage Form Design and Development,

Formulation and Delivery

Presented By

Monday, Oct 23rd

3:00 PM – 4:00 PM ET

Exploring Chromatography Methods for the Analysis of Oligonucleotide Therapeutics

Location: 360 Stage #1 Exhibit Hall West A4-B3

Partner Presentation Speaker: Sandeep kondaveeti, PhD (he/him/his) – Agilent

Manufacturing & Analytical Characterization

Presented By

Monday, Oct 23rd

3:30 PM – 4:30 PM ET

Customization of Functional Capsules: An Enteric Delivery Case Study

Location: 360 Stage #2 Exhibit Hall West A4-B3

Partner Presentation Speaker: Vincent Jannin, PhD (he/him/his) – Lonza

Manufacturing & Analytical Characterization

Presented By

Tuesday, Oct 24th

9:00 AM – 10:00 AM ET

Recent Advances in Improving Patient Wellbeing Through Long-acting Injectable Formulations

Location: 360 Stage #1 Exhibit Hall West A4-B3

Partner Presentation Speaker: Purushottam Singnurkar, PhD (he/him/his) – Syngene International Ltd

Formulation and Delivery

Presented By

Tuesday, Oct 24th

9:30 AM – 10:30 AM ET

Leverage Bioanalysis Outsourcing Partnerships to Support Complex Clinical Trials

Location: 360 Stage #2 Exhibit Hall West A4-B3

Partner Presentation Speaker: Joe Marino (he/him/his) – LabConnect

Bioanalytics

Presented By

Tuesday, Oct 24th

9:30 AM – 10:30 AM ET

Next-Generation Bioprocessing Strategies to Improve Speed, Cost and Tech Transfer

Location: 360 Stage #4 Exhibit Hall West A4-B3

Partner Presentation Speaker: Shendi Lu – IDBS

Manufacturing & Analytical Characterization

Presented By

Tuesday, Oct 24th

10:30 AM – 11:30 AM ET

New Generation of Digital Self-Serve Platforms Boost R&D Productivity

Location: 360 Stage #1 Exhibit Hall West A4-B3

Partner Presentation Speaker: Shahrzad Missaghi, PhD – Colorcon

Partner Presentation Speaker: Jo Varshney, PhD – VeriSIM Life

Formulation and Delivery

Presented By

Tuesday, Oct 24th

11:00 AM – 12:00 PM ET

Improvements to PS80 Determination in Drug Product Formulations

Location: 360 Stage #4 Exhibit Hall West A4-B3

Partner Presentation Speaker: Joseph P. Campbell, PhD (he/him/his) – Prolytix - Essex Junction, VT

Manufacturing & Analytical Characterization

Presented By

Tuesday, Oct 24th

11:00 AM – 12:00 PM ET

Safely Handling Potent APIs to Protect Workers/Product Protection at CMOs/CDMOs/CROs

Location: 360 Stage #2 Exhibit Hall West A4-B3

Partner Presentation Speaker: Robert G. Sussman, PhD, DABT (he/him/his) – SafeBridge Regulatory & Life Sciences Group

Manufacturing & Analytical Characterization

Presented By

Tuesday, Oct 24th

12:00 PM – 1:00 PM ET

Purification of Oligonucleotides Using Prep-LC MS/UV with Improved IP-RPLC Chromatography

Location: 360 Stage #1 Exhibit Hall West A4-B3

Partner Presentation Speaker: Olof Torsten Stålberg, Sr., PhD (he/him/his) – Agilent

Discovery and Basic Research

Presented By

Tuesday, Oct 24th

12:30 PM – 1:30 PM ET

Impurity/Degradation Products: Time to Move Beyond Standard ICHQ3 Qualification Studies?

Location: 360 Stage #2 Exhibit Hall West A4-B3

Partner Presentation Speaker: Jim Herman, PhD, DABT (1992-2022) – Certara

Preclinical and Translational Sciences

Presented By

Tuesday, Oct 24th

12:30 PM – 1:30 PM ET

Subvisible Particle Analysis Using Flow Imaging Microscopy and Light Obscuration

Location: 360 Stage #4 Exhibit Hall West A4-B3

Partner Presentation Speaker: Austin Daniels, PhD (he/him/his) – Yokogawa Fluid Imaging Technologies

Manufacturing & Analytical Characterization

Presented By

Tuesday, Oct 24th

1:30 PM – 2:30 PM ET

Strategies to Reduce Nitrosamine Contamination of Drug Products

Location: 360 Stage #1 Exhibit Hall West A4-B3

Partner Presentation Speaker: Andreas Sauer – Shin-Etsu

Formulation and Delivery

Presented By

Tuesday, Oct 24th

2:00 PM – 3:00 PM ET

A Paradigm Shift in Processing Amorphous Solid Dispersions (ASDs)

Location: 360 Stage #4 Exhibit Hall West A4-B3

Partner Presentation Speaker: Zafar Iqbal, PhD, RPh, MBA – Glatt Air Techniques, Inc. - Ramsey, NJ

Formulation and Delivery

Presented By

Tuesday, Oct 24th

2:00 PM – 3:00 PM ET

Extractable Leachable Analysis from Sample Preparation to Compound Identification

Location: 360 Stage #2 Exhibit Hall West A4-B3

Partner Presentation Speaker: David A. Weil, PhD (he/him/his) – Agilent

Manufacturing & Analytical Characterization

Presented By

Tuesday, Oct 24th

3:00 PM – 4:00 PM ET

Microdosing– Powder in Capsule Technology Pathway from Development to Commercialization

Location: 360 Stage #1 Exhibit Hall West A4-B3

Partner Presentation Speaker: Mark Cappucci – Lonza

Partner Presentation Speaker: Benito G. Graniela – Lonza

Formulation and Delivery

Presented By

Tuesday, Oct 24th

3:30 PM – 4:30 PM ET

A Formulators Guide to Crossing the Valley of Death

Location: 360 Stage #2 Exhibit Hall West A4-B3

Partner Presentation Speaker: Darren Matthews, PhD – Charles River

Partner Presentation Speaker: Dolly Jacob, PhD – Quotient Sciences

Preclinical and Translational Sciences

Presented By

Tuesday, Oct 24th

3:30 PM – 4:30 PM ET

Immunogenicity Assessment and Functional Testing of Candidate Therapeutics

Location: 360 Stage #4 Exhibit Hall West A4-B3

Partner Presentation Speaker: Chloe Ackaert, PhD (she/her/hers) – ImmunXperts, a Q2 Solutions Company

Preclinical and Translational Sciences

Presented By

Wednesday, Oct 25th

9:00 AM – 10:00 AM ET

Overcoming the Unique Challenges in Today’s Early Stage Drug Development

Location: 360 Stage #1 Exhibit Hall West A4-B3

Partner Presentation Speaker: Nan Zhao, Ph.D – WuXi

Partner Presentation Speaker: Santipharp Panmai, Ph.D. – WuXi STA, a subsidiary of WuXi AppTec

Discovery and Basic Research

Presented By

Wednesday, Oct 25th

9:30 AM – 10:30 AM ET

Characterization of Polymer Molecules by Automated Viscosity Measurement

Location: 360 Stage #4 Exhibit Hall West A4-B3

Partner Presentation Speaker: David Trowbridge, PhD, MS – Cannon Instrument Company

Manufacturing & Analytical Characterization

Presented By

Wednesday, Oct 25th

10:30 AM – 11:30 AM ET

How to Mitigate Risks to Pharmaceutical Quality? Role of Reference Standards

Location: 360 Stage #1 Exhibit Hall West A4-B3

Partner Presentation Speaker: Yu Tang, PhD (she/her/hers) – United States Pharmacopeial Convention

Manufacturing & Analytical Characterization

Presented By

Wednesday, Oct 25th

11:00 AM – 12:00 PM ET

Advancements in Oral Solid Dose Technologies for Potent Treatments

Location: 360 Stage #2 Exhibit Hall West A4-B3

Partner Presentation Speaker: Anshul Gupte, PhD – Catalent

Manufacturing & Analytical Characterization

Presented By

Wednesday, Oct 25th

11:00 AM – 12:00 PM ET

U.S. Government Contracts & Grants: Non-Dilutive Funding for Life Sciences

Location: 360 Stage #4 Exhibit Hall West A4-B3

Partner Presentation Speaker: Laura Powell, PhD – EverGlade Consulting

Partner Presentation Speaker: Steve Morris, PhD – EverGlade Consulting

Preclinical and Translational Sciences

Presented By

Wednesday, Oct 25th

12:00 PM – 1:00 PM ET

New Considerations for LC-Based Characterization and Quantitation of Oligonucleotide Therapeutics

Location: 360 Stage #1 Exhibit Hall West A4-B3

Partner Presentation Speaker: Matthew Lauber, PhD – Waters Corporation

Bioanalytics

Presented By

Wednesday, Oct 25th

12:30 PM – 1:30 PM ET

Co-processing: A Multifaceted Approach for Enhancing Density & Powder Flow

Location: 360 Stage #2 Exhibit Hall West A4-B3

Partner Presentation Speaker: San Kiang, PhD – Porton USA

Formulation and Delivery

Presented By

Wednesday, Oct 25th

12:30 PM – 1:30 PM ET

Getting Your Research Right with Open Source Visual Programming

Location: 360 Stage #4 Exhibit Hall West A4-B3

Partner Presentation Speaker: Martyna Pawletta, MA – KNIME

Partner Presentation Speaker: Corey Weisinger – KNIME

Bioanalytics

Presented By

Plenary Session

Sunday, Oct 22nd

5:00 PM – 6:30 PM ET

Opening Plenary with Dr. Thomas Hartung

Location: Chapin Theater

Plenary Speaker: Thomas Hartung, MD, PhD – Johns Hopkins University

Wednesday, Oct 25th

4:15 PM – 5:30 PM ET

Closing Plenary with Dr. Julie DeMartino

Location: Chapin Theater

Plenary Speaker: Julie DeMartino, Ph.D. – AcheneRx LLC

Prologue

ON DEMAND

Prologue: A Physiologically Based Pharmacokinetic Framework to Develop Predictive Endogenous Biomarkers

Location: On Demand

Prologue Speaker: Sibylle Neuhoff, PhD – Certara UK Limited, Simcyp Division

Preclinical and Translational Sciences

ON DEMAND

Prologue: Advancing Analytical Capabilities to Enable Cross Modality Pharmaceutical and Vaccine Innovations

Location: On Demand

Prologue Speaker: Wei Xu, PhD (she/her/hers) – Merck

Manufacturing & Analytical Characterization

ON DEMAND

Prologue: Alternative Methods to Animal Studies: Artificial Tissue to Artificial Intelligence

Location: On Demand

Prologue Speaker: Ketan D. Patel, PhD (he/him/his) – St. John's University

Preclinical and Translational Science - Biomolecular

ON DEMAND

Prologue: An End-to-End Biomarker Strategy to Accelerate Drug Development: Current Landscape and Future Prospects

Location: On Demand

Prologue Speaker: Kelly A. Fader, PhD (she/her/hers) – Pfizer Inc.

Preclinical and Translational Sciences

ON DEMAND

Prologue: Biomarker and Omics Approaches

Location: On Demand

Prologue Speaker: Robert Dodge, PhD – Novartis

Bioanalytics

ON DEMAND

Prologue: Biomarker Assays Are Not PK Assays: Prologue on Biomarker Assays

Location: On Demand

Prologue Speaker: Lauren Stevenson, PhD (she/her/hers) – Immunologix Laboratories

Bioanalytics – Biomolecular

ON DEMAND

Prologue: Brevican-Targeting Peptide for Therapeutic Delivery to Glioblastoma: Tools for Drug Discovery

Location: On Demand

Prologue Speaker: Choi-Fong Cho, PhD – Brigham and Women's Hospital, Harvard Medical School

Discovery and Basic Research

ON DEMAND

Prologue: Current Status of Transporter-Mediated Drug Delivery

Location: On Demand

Prologue Speaker: Elena Puris, PhD (she/her/hers) – Institute of Pharmacy and Molecular Biotechnology/Heidelberg University

Discovery and Basic Research

ON DEMAND

Prologue: Current Trends and Research Opportunities for Collaboration in Pediatric Formulation Development

Location: On Demand

Prologue Speaker: Stephen W. Hoag, PhD, FAAPS – University of Maryland, Baltimore

Formulation and Delivery – Biomolecular

ON DEMAND

Prologue: Drug Delivery Alternatives to Injectables For Systemic Availability

Location: On Demand

Prologue Speaker: Jaap Wieling, PhD (he/him/his) – PureIMS BV

Formulation and Delivery – Chemical

ON DEMAND

Prologue: Embracing Innovation: Harnessing Emerging Technologies for Enhanced Pharmaceutical Quality

Location: On Demand

Prologue Speaker: Geng Tian, PhD (he/him/his) – US FDA

Manufacturing & Analytical Characterization

ON DEMAND

Prologue: Emerging Applications of Data Driven and Hybrid Modelling in Pharmaceutical Manufacturing

Location: On Demand

Prologue Speaker: Gabriele Bano, PhD (he/him/his) – GSK

Manufacturing & Analytical Characterization

ON DEMAND

Prologue: Emerging Trends in Continuous Manufacturing of Pharmaceuticals

Location: On Demand

Prologue Speaker: Lawrence De Belder, MSc (he/him/his) – Pharmatech Associates Inc.

Manufacturing & Analytical Characterization

ON DEMAND

Prologue: Excipients: It's Complicated

Location: On Demand

Prologue Speaker: Chris Moreton, PhD (he/him/his) – FinnBritt Consulting

Formulation and Delivery

ON DEMAND

Prologue: From Modality-Specific to Boundaryless Analytics – Delivering the Pipeline of Tomorrow

Location: On Demand

Prologue Speaker: Jason Cheung, PhD – Merck

Manufacturing & Analytical Characterization

ON DEMAND

Prologue: Health Disparities Research: How Basic Science can Inform Clinical Practice

Location: On Demand

Prologue Speaker: Julie Armin, PhD (she/her/hers) – The University of Arizona

Discovery and Basic Research

ON DEMAND

Prologue: Immunogenicity and Regulatory Considerations

Location: On Demand

Prologue Speaker: Karen Liao, MD (she/her/hers) – Merck & Co.

Bioanalytics – Biomolecular

ON DEMAND

Prologue: LC-MS Approaches and Advances

Location: On Demand

Prologue Speaker: Brendan Powers, PhD (he/him/his) – LabCorp Drug Development - Bioanalytical Services

Bioanalytics – Biomolecular

ON DEMAND

Prologue: Modelling and Predictive Design in Pharmaceutical Development

Location: On Demand

Prologue Speaker: Simeone Zomer, DR – GSK

Manufacturing & Analytical Characterization

ON DEMAND

Prologue: Patient Centric Sampling: Tips and Tricks for Bioanalysis

Location: On Demand

Prologue Speaker: Shane Needham, PhD – Veloxity Labs, LLC

Bioanalytics – Chemical

ON DEMAND

Prologue: The CGT Landscape

Location: On Demand

Prologue Speaker: Catherine Vrentas, PhD – PPD, A ThermoFisher Company

Bioanalytics – Biomolecular

ON DEMAND

Prologue: "Grades" of Ancillary, Raw and Starting Materials and Excipients

Location: On Demand

Prologue Speaker: Allison Elizabeth Radwick, PhD (she/her/hers) – USP

Formulation and Delivery – Chemical

ON DEMAND

Prologue: Breaking Barriers for bRo5 Molecules: Formulation Strategies for Next-Generation Therapeutics

Location: On Demand

Prologue Speaker: Ketan D. Patel, PhD (he/him/his) – St. John's University

Formulation and Delivery – Chemical

ON DEMAND

Prologue: Preformulation and Biopharmaceutical Support for Drug Delivery

Location: On Demand

Prologue Speaker: Andrei Blasko, PhD, FRSC – Clearview Pharma Solutions LLC

Formulation and Delivery – Chemical

ON DEMAND

Prologue: Role of Biomarkers in Rare Disease Drug Development and Regulatory Approval

Location: On Demand

Prologue Speaker: Lakshmi Amaravadi, PhD – Kojin Therapeutics

Preclinical and Translational Sciences

ON DEMAND

Prologue: Use of Artificial Intelligence and Machine Learning in Regulatory Submissions

Location: On Demand

Prologue Speaker: Raja B. Velagapudi, PhD (he/him/his) – Tolmar Inc

Preclinical and Translational Science - Chemical

Rapid Fire

Monday, Oct 23rd

3:00 PM – 4:00 PM ET

Rapid Fires: Accelerating the Drug Development Process through Formulation and Delivery Strategies 1

Location: 208 AB West

Rapid Fire Moderator: Michael Danquah, PhD – Chicago State University College of Pharmacy

Formulation and Delivery

Monday, Oct 23rd

3:00 PM – 4:00 PM ET

Rapid Fires: Accelerating the Drug Development Process through Formulation and Delivery Strategies 2

Location: 209 AB West

Rapid Fire Speaker: Tzichi Ju, Ph.D. – AbbVie Inc.

Formulation and Delivery

Monday, Oct 23rd

3:00 PM – 4:00 PM ET

Rapid Fires: Advanced Manufacturing and Emerging Technologies in Pharmaceuticals and Biopharmaceuticals 1

Rapid Fire Manufacturing & Bioprocessing

Location: 205 AB West

Rapid Fire Moderator: Xiaoqing Hua, PhD (she/her/hers) – Merck & Co, Inc

Manufacturing & Analytical Characterization

Monday, Oct 23rd

3:00 PM – 4:00 PM ET

Rapid Fires: Advanced Manufacturing and Emerging Technologies in Pharmaceuticals and Biopharmaceuticals 2

Location: 206 AB West

Rapid Fire Moderator: Natalia Subelzu, Ph.D. (she/her/hers) – Merck & Co., Inc.

Manufacturing & Analytical Characterization

Monday, Oct 23rd

3:00 PM – 4:00 PM ET

Rapid Fires: Advancing Therapeutic Discovery and Development: Mechanistic Considerations for Drug Delivery

Location: 309 AB West

Rapid Fire Moderator: Xiaoshu Pan, PhD – University of Florida College of Pharmacy

Discovery and Basic Research

Monday, Oct 23rd

3:00 PM – 4:00 PM ET

Rapid Fires: Predictive Biomarker Strategies to De-Risk Drug Development 1

Location: 311 AB West

Rapid Fire Moderator: Mahmoud Salama Ahmed, PhD (he/him/his) – Texas Tech University Health Sciences Center

Preclinical and Translational Sciences

Monday, Oct 23rd

3:00 PM – 4:00 PM ET

Rapid Fires: Predictive Biomarker Strategies to De-Risk Drug Developments 2

Location: 311 CD West

Rapid Fire Moderator: F. Yushra Thanzeel, PhD – Merck & Co., Inc.

Preclinical and Translational Sciences

Monday, Oct 23rd

3:00 PM – 4:00 PM ET

Rapid Fires: Setting up for Success -- Considerations for Study Design in the Context of Bioanalysis 1

Location: 311 EF West

Rapid Fire Moderator: Linlin Luo, Ph.D. – Merck & Co., Inc.

Bioanalytics

Monday, Oct 23rd

3:00 PM – 4:00 PM ET

Rapid Fires: Setting up for Success -- Considerations for Study Design in the Context of Bioanalysis 2

Location: 311 GH West

Rapid Fire Moderator: Jennifer A. Vance, PhD (she/her/hers) – Recursion Pharmaceuticals

Bioanalytics

Monday, Oct 23rd

3:00 PM – 3:15 PM ET

ADA and NAb Assays with Distinct Formats Determined by Biologics

Location: 311 EF West

Rapid Fire Speaker: Yongzhong Zhao, PhD – Frontage Laboratories, Inc.

Bioanalytics

Monday, Oct 23rd

3:00 PM – 3:15 PM ET

Atmospheric Freeze Drying – Towards a More Sustainable Lyophilization Process

Location: 205 AB West

Rapid Fire Speaker: Alf Lamprecht – University of Bonn

Manufacturing & Analytical Characterization

Monday, Oct 23rd

3:00 PM – 3:15 PM ET

Deciphering Molecular Insights of Meis1 and Hoxb13 for Cardiac Regeneration

Location: 311 AB West

Rapid Fire Speaker: Mahmoud Salama Ahmed, PhD (he/him/his) – Texas Tech University Health Sciences Center

Preclinical and Translational Science - Chemical

Monday, Oct 23rd

3:00 PM – 3:15 PM ET

FDA in vitro Studies on Sunscreen Formulations to Support Safety

Location: 209 AB West

Rapid Fire Speaker: Yang Yang, PhD – US Food and Drug Administration

Formulation and Delivery

Monday, Oct 23rd

3:00 PM – 3:15 PM ET

Investigation of Compound-A Rat Exposure Bias Observed in Toxicological Studies

Location: 311 GH West

Rapid Fire Speaker: Rajesh B. Desai, M.S. – Merck and Co Inc

Bioanalytics

Monday, Oct 23rd

3:00 PM – 3:15 PM ET

New Approach for Extracellular Vesicle Cargo Loading and Drug Delivery

Location: 309 AB West

Rapid Fire Speaker: Zuo Ding, PhD – University of Florida College of Pharmacy

Discovery and Basic Research

Monday, Oct 23rd

3:00 PM – 3:15 PM ET

Spatial Biomarker to Inform Biological Context Drug Response

Location: 311 CD West

Rapid Fire Speaker: Corinne Ramos (she/her/hers) – Aliri

Preclinical and Translational Sciences

Monday, Oct 23rd

3:00 PM – 3:15 PM ET

The Potential for a Ban on TiO2 (E171) Use in Pharmaceuticals and the Impact on Patients and the Industry

Location: 208 AB West

Rapid Fire Speaker: David R. Schoneker, M.S. (he/him/his) – Black Diamond Regulatory Consulting/IPEC-Americas

Formulation and Delivery

Monday, Oct 23rd

3:00 PM – 3:15 PM ET

The Risks Triggering FDA’s Pre-Approval Inspection for a Manufacturing Facility

Location: 206 AB West

Rapid Fire Speaker: MD ABDULLAH A. MAHMUD, Doctor of Philosophy in Pharmaceutical Sciences (he/him/his) – US Food and Drug Administration

Manufacturing & Analytical Characterization

Monday, Oct 23rd

3:15 PM – 3:30 PM ET

Ambient Temperature Preservation of Biomolecules Using Capillary-Mediated Vitrification Process

Location: 205 AB West

Rapid Fire Speaker: Sankar Renu, PhD (he/him/his) – Upkara, Inc

Manufacturing & Analytical Characterization

Monday, Oct 23rd

3:15 PM – 3:30 PM ET

Bead-Based NAb Assay with High Drug Tolerance for A Bispecific

Location: 311 EF West

Rapid Fire Speaker: Megan Schnarr, MS – Janssen

Bioanalytics

Monday, Oct 23rd

3:15 PM – 3:30 PM ET

FAP Inhibitor Enabled Inhalable Nano-Theranostics for Treating Pulmonary Fibrotic Complications

Location: 311 AB West

Rapid Fire Speaker: Mukti Vats, PhD (she/her/hers) – St. John's University

Preclinical and Translational Science - Biomolecular

Monday, Oct 23rd

3:15 PM – 3:30 PM ET

How Twin-Screw Wet Granulation Factors Impact Granules and Tablets Attributes

Location: 206 AB West

Rapid Fire Speaker: Piero Piccinni, MSc (he/him/his) – Aptuit (an Evotec Company)

Manufacturing & Analytical Characterization

Monday, Oct 23rd

3:15 PM – 3:30 PM ET

Leveraging Microgravity to Achieve Elusive Drug Solid-State Objectives

Location: 209 AB West

Rapid Fire Speaker: Dom Hebrault, PhD Organic Chemistry – Varda Space Industries

Formulation and Delivery

Monday, Oct 23rd

3:15 PM – 3:30 PM ET

Machine-Learning Prediction of Antibody Aggregation and Viscosity in Formulation Development

Location: 208 AB West

Rapid Fire Speaker: Neil Mody – AstraZeneca

Formulation and Delivery

Monday, Oct 23rd

3:15 PM – 3:30 PM ET

Stability & Compatibility of Peptides for Oral Drug Delivery

Location: 311 CD West

Rapid Fire Speaker: F. Yushra Thanzeel, PhD – Merck & Co., Inc.

Preclinical and Translational Sciences

Monday, Oct 23rd

3:15 PM – 3:30 PM ET

The Combination of miRNA-Loaded Nanobubbles and Ultrasound for Cancer Therapy

Location: 309 AB West

Rapid Fire Speaker: Taiki Yamaguchi – Tokyo University of Pharmacy and Life Sciences

Discovery and Basic Research

Monday, Oct 23rd

3:15 PM – 3:30 PM ET

Use of AI to Guide Immunoassay Development

Location: 311 GH West

Rapid Fire Speaker: Mark Ma, MD (he/him/his) – Biotech

Bioanalytics

Monday, Oct 23rd

3:25 PM – 3:45 PM ET

Microglia-Derived Exosomes As A Drug Delivery Tool In Alzheimer's Disease

Location: 309 AB West

Rapid Fire Speaker: Terjahna Richards, PhD – St John's University

Discovery and Basic Research

Monday, Oct 23rd

3:30 PM – 3:45 PM ET

Cisplatin/Hyaluronan film for Loco-Regional Chemotherapy: Technology and Preclinical Evidence of Activity

Location: 208 AB West

Rapid Fire Speaker: Sabrina Banella – University of Ferrara

Formulation and Delivery

Monday, Oct 23rd

3:30 PM – 3:45 PM ET

Comprehensive LC-MS/MS Analysis of VSV-GP Lipidome

Location: 311 CD West

Rapid Fire Speaker: Yuecheng Xi, PhD (she/her/hers) – Boehringer Ingelheim

Preclinical and Translational Sciences

Monday, Oct 23rd

3:30 PM – 3:45 PM ET

Experiment Design Considerations in the Development of Dermal Absorption Models

Location: 209 AB West

Rapid Fire Speaker: Abdullah Hamadeh, PhD – University of Waterloo

Formulation and Delivery

Monday, Oct 23rd

3:30 PM – 3:45 PM ET

Layered Microneedles for Protein Delivery from Coacervate

Location: 205 AB West

Rapid Fire Speaker: Nathaniel S. Wright, M.S. – Cornell University

Manufacturing & Analytical Characterization

Monday, Oct 23rd

3:30 PM – 3:45 PM ET

Novel Approaches and Troubleshooting for Developing High-Throughput Oligonucleotide LC-MS Method

Location: 311 GH West

Rapid Fire Speaker: Changhong Yun, PhD – Merck & Co.

Bioanalytics

Monday, Oct 23rd

3:30 PM – 3:45 PM ET

PD-L1/PD-1 Targeting in Immunotherapy with NK-EVs in Resistant Lung Cancer

Location: 311 AB West

Rapid Fire Speaker: Aakash Nathani, MS (he/him/his) – Florida A&M University

Preclinical and Translational Science - Biomolecular

Monday, Oct 23rd

3:30 PM – 3:45 PM ET

Personalized Pediatric Dosing Enabled by 3D Printing- A Case Study

Location: 206 AB West

Rapid Fire Speaker: Jayeeta Sengupta, PhD (she/her/hers) – TNO

Manufacturing & Analytical Characterization

Monday, Oct 23rd

3:30 PM – 3:45 PM ET

Utilization of Quality-by-Design/Design-of-Experiment(s) for Optimization of Flow Cytometric Wet-Lab Methods

Location: 311 EF West

Rapid Fire Speaker: Stefanie Biedermann, MS (she/her/hers) – Miltenyi Biotec B.V. & Co. KG

Bioanalytics

Monday, Oct 23rd

3:45 PM – 4:00 PM ET

Development of Immunoactive Polymeric Nanocomplex to Activate Innate Immune Response for Cancer Immunotherapy

Location: 311 AB West

Rapid Fire Speaker: Fanfei Meng, PhD (he/him/his) – University of Mass-Lowell

Preclinical and Translational Sciences

Monday, Oct 23rd

3:45 PM – 4:00 PM ET

High Concentration Protein Suspensions: Optimizing the Suspension Vehicle

Location: 208 AB West

Rapid Fire Speaker: Cindy Chung, PhD (she/her/hers) – Serán Bioscience, LLC

Formulation and Delivery

Monday, Oct 23rd

3:45 PM – 4:00 PM ET

Novel Strategies for Process-Related Impurity Clearance during Biologics Manufacturing

Location: 205 AB West

Rapid Fire Speaker: Aba Acquaah, BS (she/her/hers) – Merck Research Laboratories

Manufacturing & Analytical Characterization

Monday, Oct 23rd

3:45 PM – 4:00 PM ET

Pharma 4.0: Digital Manufacturing of Advanced Continuous Pharmaceutical Tablet Manufacturing

Location: 206 AB West

Rapid Fire Speaker: Ravendra Singh (he/him/his) – Rutgers University

Manufacturing & Analytical Characterization

Monday, Oct 23rd

3:45 PM – 4:00 PM ET

Platform Methods: Universal Immunoaffinity-LCMS Bioanalytical Methods for Drug Development Platforms

Location: 311 GH West

Rapid Fire Speaker: Ben Nie, PhD (he/him/his) – BioAgilytix

Bioanalytics

Monday, Oct 23rd

3:45 PM – 4:00 PM ET

Quantification of mRNA from mRNA-LNP Therapeutics by RT-qPCR

Location: 311 EF West

Rapid Fire Speaker: Suresh Peddigari, PhD (he/him/his) – Moderna Therapeutics

Bioanalytics

Monday, Oct 23rd

3:45 PM – 4:00 PM ET

Strategy for Assessing Stability in Multiplexed Cytokine Panels

Location: 311 CD West

Rapid Fire Speaker: Christian Braithwaite, M.S. – BioAgilytix

Preclinical and Translational Sciences

Monday, Oct 23rd

3:45 PM – 4:00 PM ET

Therapeutic Delivery of Proteolysis Targeting Chimeras Loaded Extracellular Vesicles

Location: 309 AB West

Rapid Fire Speaker: Nina Erwin (she/her/hers) – University of Florida

Discovery and Basic Research

Monday, Oct 23rd

3:45 PM – 4:00 PM ET

Using DyGIST to Predict PK Performance of Immediate Release Products

Location: 209 AB West

Rapid Fire Speaker: Anette Mullertz

Formulation and Delivery

Monday, Oct 23rd

4:15 PM – 4:30 PM ET

Rapid Fire: Nurturing Unity: Integrating New Graduates into the Pharmaceutical Industry Workspace

Location: 360 Stage #3 Exhibit Hall West A4-B3

Rapid Fire Speaker: Yoon Sik Jung (he/him/his) – University of Southern California

Career Development

Tuesday, Oct 24th

9:00 AM – 9:30 AM ET

2023 AAPS High Impact Manuscript Award Rapid Fire Presentations

Location: 308 CD West

Rapid Fire Moderator: Robert O. Williams, III, PhD (he/him/his) – University of Texas at Austin

Tuesday, Oct 24th

9:00 AM – 9:15 AM ET

Integrating Biomarkers in PD-1/PD-L1 Antibody Therapy for Personalized Cancer Treatment

Location: 308 CD West

Rapid Fire Speaker: Baolin Zhang, PhD (he/him/his) – Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)

Tuesday, Oct 24th

9:15 AM – 9:30 AM ET

Polyvinyl Alcohol/Chitosan Single-Layered and Polyvinyl Alcohol/Chitosan/Eudragit RL100 Multi-layered Electrospun Nanofibers as an Ocular Matrix for the Controlled Release of Ofloxacin: an In Vitro and In Vivo Evaluation

Location: 308 CD West

Rapid Fire Speaker: Ali Nokhodchi, PhD (he/him/his) – University of Sussex

Tuesday, Oct 24th

3:00 PM – 4:00 PM ET

Rapid Fires: Addressing Health Disparities in Basic Science Research

Location: 311 AB West

Rapid Fire Moderator: Veeran Kadajji

Discovery and Basic Research

Tuesday, Oct 24th

3:00 PM – 4:00 PM ET

Rapid Fires: Advanced Modelling and Predictive Approaches in Drug Development, Manufacturing and Analysis 1

Location: 205 AB West

Rapid Fire Moderator: MD ABDULLAH A. MAHMUD, Doctor of Philosophy in Pharmaceutical Sciences (he/him/his) – US Food and Drug Administration

Manufacturing & Analytical Characterization

Tuesday, Oct 24th

3:00 PM – 4:00 PM ET

Rapid Fires: Advanced Modelling and Predictive Approaches in Drug Development, Manufacturing and Analysis 2

Location: 206 AB West

Rapid Fire Moderator: Diaa Shakleya, PhD – US Food and Drug Administration

Manufacturing & Analytical Characterization

Tuesday, Oct 24th

3:00 PM – 4:00 PM ET

Rapid Fires: Advancing Innovation in In Silico Translational Approaches 1

Location: 309 AB West

Rapid Fire Moderator: Sean Ekins, PhD, DSc – Collaborations Pharmaceuticals, Inc.

Preclinical and Translational Sciences

Tuesday, Oct 24th

3:00 PM – 4:00 PM ET

Rapid Fires: Advancing Innovation in In Silico Translational Approaches 2

Location: 311 CD West

Rapid Fire Moderator: Cheng Chang, PhD – Pfizer Inc.

Preclinical and Translational Sciences

Tuesday, Oct 24th

3:00 PM – 4:00 PM ET

Rapid Fires: Approaches for Emerging Modalities and Complex Studies 1

Location: 311 EF West

Rapid Fire Moderator: Heather A. Myler, PhD – Takeda

Bioanalytics

Tuesday, Oct 24th

3:00 PM – 4:00 PM ET

Rapid Fires: Approaches for Emerging Modalities and Complex Studies 2

Location: 311 GH West

Rapid Fire Moderator: Sanjeev Bhardwaj, PhD – Janssen BioTherapeutics

Bioanalytics

Tuesday, Oct 24th

3:00 PM – 4:00 PM ET

Rapid Fires: Enabling Excipients and Approaches for Advancing Formulation and Delivery 1

Location: 208 AB West

Rapid Fire Moderator: Tzichi Ju, Ph.D. – AbbVie Inc.

Formulation and Delivery

Tuesday, Oct 24th

3:00 PM – 4:00 PM ET

Rapid Fires: Enabling Excipients and Approaches for Advancing Formulation and Delivery 2

Location: 209 AB West

Rapid Fire Moderator: Michael Danquah, PhD – Chicago State University College of Pharmacy

Formulation and Delivery

Tuesday, Oct 24th

3:00 PM – 3:15 PM ET

Amorphous Solid Dispersion Physical Stability: Historical Examples and Shelf-Life Assessment

Location: 206 AB West

Rapid Fire Speaker: Anura Indulkar, PhD – AbbVie

Manufacturing & Analytical Characterization

Tuesday, Oct 24th

3:00 PM – 3:15 PM ET

Clinical Bioanalysis of AMG 133, a Bispecific Molecule for Obesity

Location: 311 GH West

Rapid Fire Speaker: Omar S. Barnaby, PhD (he/him/his) – Amgen

Bioanalytics

Tuesday, Oct 24th

3:00 PM – 3:15 PM ET

Impact of Pneumatic Tube System Transportation on Biopharmaceutical Product Quality

Location: 209 AB West

Rapid Fire Speaker: Kashappa Goud Desai, PhD – GSK

Formulation and Delivery

Tuesday, Oct 24th

3:00 PM – 3:15 PM ET

Large Language Models for Predicting ADME/Tox

Location: 309 AB West

Rapid Fire Speaker: Sean Ekins, PhD, DSc – Collaborations Pharmaceuticals, Inc.

Preclinical and Translational Science - Chemical

Tuesday, Oct 24th

3:00 PM – 3:15 PM ET

Measuring and Understanding the Relevance of Cellular-Immune Responses to CAR-T-Cells

Location: 311 EF West

Rapid Fire Speaker: Madhan Masilamani, PhD – Bristol Myers Squibb

Bioanalytics

Tuesday, Oct 24th

3:00 PM – 3:15 PM ET

ORODS: a Novel Expandable Platform for in situ Drug Delivery

Location: 208 AB West

Rapid Fire Speaker: Matteo Cerea, PhD (he/him/his) – Universita' degli Studi di Milano

Formulation and Delivery

Tuesday, Oct 24th

3:00 PM – 3:15 PM ET

PAT to Support Continuous Manufacturing: from Development to Commercialization

Location: 205 AB West

Rapid Fire Speaker: Xiaoqing Hua, PhD (she/her/hers) – Merck & Co, Inc

Manufacturing & Analytical Characterization

Tuesday, Oct 24th

3:00 PM – 3:15 PM ET

SARS-CoV-2 Infection Affects Drug Metabolizing Enzymes and Membrane Transporters

Location: 311 AB West

Rapid Fire Speaker: Chukwunonso Kingsley Nwabufo, MSc, MBA – University of Toronto

Discovery and Basic Research

Tuesday, Oct 24th

3:00 PM – 3:15 PM ET

The Estimates for Absorption Rate Constant in Pharmacokinetics/Pharmacometrics Are Wrong (Focus On Finite Absorption Time)

Location: 311 CD West

Rapid Fire Speaker: Panos Macheras, Ph.D., FAAPS – University of Athens

Preclinical and Translational Science - Biomolecular

Tuesday, Oct 24th

3:15 PM – 3:30 PM ET

A Translational Minimal Physiologically Based Pharmacokinetic Model (mPBPK) for CRISPR-Cas Gene Therapy

Location: 311 CD West

Rapid Fire Speaker: Devam A. Desai, MS – University of Florida

Preclinical and Translational Science - Chemical

Tuesday, Oct 24th

3:15 PM – 3:30 PM ET

Innovative Immunogenicity Strategies for New Modalities

Location: 311 EF West

Rapid Fire Speaker: Heather A. Myler, PhD – Takeda

Bioanalytics

Tuesday, Oct 24th

3:15 PM – 3:30 PM ET

Long-Acting Biodurable Implants: Fundamental Transport Properties to Complex Release Mechanisms

Location: 209 AB West

Rapid Fire Speaker: Angela Ren, BS (she/her/hers) – University of Texas At Austin

Formulation and Delivery

Tuesday, Oct 24th

3:15 PM – 3:30 PM ET

Mechanistic Modelling of pH-Dependent Drug-Drug Interactions

Location: 309 AB West

Rapid Fire Speaker: Sebastian Polak, PhD – Certara UK / Simcyp

Preclinical and Translational Science - Chemical

Tuesday, Oct 24th

3:15 PM – 3:30 PM ET

Novel Artemisinin-Containing Nanodrug for Leukemia Treatment

Location: 208 AB West

Rapid Fire Speaker: Noha A. Ghonim, Pharm.B., PhD Candidate (she/her/hers) – University of Maryland Baltimore

Formulation and Delivery

Tuesday, Oct 24th

3:15 PM – 3:30 PM ET

Sex Differences in Steady-State Pharmacokinetic Studies of Mitragynine

Location: 311 AB West

Rapid Fire Speaker: Yi-Hua Chiang, MS (she/her/hers) – University of Florida

Discovery and Basic Research

Tuesday, Oct 24th

3:15 PM – 3:30 PM ET

Simulation and Troubleshooting of Mixing Systems for Secondary Biopharm Manufacture

Location: 205 AB West

Rapid Fire Speaker: Elaheh Ardalani, PhD (she/her/hers) – GSK

Manufacturing & Analytical Characterization

Tuesday, Oct 24th

3:15 PM – 3:30 PM ET

The Bioanalytical Profile for a DARPin Therapeutic: Pharmacokinetics and Immunogenicity.

Location: 311 GH West

Rapid Fire Speaker: Robert Dodge, PhD – Novartis

Bioanalytics

Tuesday, Oct 24th

3:15 PM – 3:30 PM ET

Using Surface Dissolution Imaging to Understand Weakly Basic Drug Dissolution

Location: 206 AB West

Rapid Fire Speaker: Devin Swiner, PhD (she/her/hers) – Merck & Co., Inc

Manufacturing & Analytical Characterization

Tuesday, Oct 24th

3:30 PM – 3:45 PM ET

ADA Strategies to Address Potential Target Interference in Support of a FIH Study Sprays

Location: 311 EF West

Rapid Fire Speaker: Linlin Luo, Ph.D. – Merck & Co., Inc.

Bioanalytics

Tuesday, Oct 24th

3:30 PM – 3:45 PM ET

Concentrations and Causal Confounding: Choosing Exposure Measures with Care

Location: 311 CD West

Rapid Fire Speaker: Rena Byrne, PhD – Metrum Research Group

Preclinical and Translational Science - Biomolecular

Tuesday, Oct 24th

3:30 PM – 3:45 PM ET

Expanding the Extracellular Vesicle Pancreatic Cancer Biomarker Space With Peptide-Based Capture-and-Release

Location: 311 AB West

Rapid Fire Speaker: Zachary Greenberg, MS (he/him/his) – University of Florida

Discovery and Basic Research

Tuesday, Oct 24th

3:30 PM – 3:45 PM ET

Exploring Role of Lipidic and Phospholipidic Excipients for Dry-Powder Inhalers

Location: 208 AB West

Rapid Fire Speaker: Nivedita Shetty, PhD (she/her/hers) – Genentech

Formulation and Delivery

Tuesday, Oct 24th

3:30 PM – 3:45 PM ET

Formulating Biologics for Oral Delivery – Considerations and Challenges

Location: 209 AB West

Rapid Fire Speaker: True Rogers, PhD (he/him/his) – IFF

Formulation and Delivery

Tuesday, Oct 24th

3:30 PM – 3:45 PM ET

Hybridization LC-MS/MS for Oligonucleotide Quantification: When Specificity Meets Sensitivity

Location: 311 GH West

Rapid Fire Speaker: Kevork Mekhssian, MSc – Altasciences

Bioanalytics

Tuesday, Oct 24th

3:30 PM – 3:45 PM ET

In-Depth Characterization of Polysorbate 80 Degradation in Biologics Drug Products

Location: 205 AB West

Rapid Fire Speaker: Rong-Sheng Yang, M.S. (he/him/his) – Merck & Co., Inc.

Manufacturing & Analytical Characterization

Tuesday, Oct 24th

3:30 PM – 3:45 PM ET

Nitrosamines Mitigation Strategies in Drug Product

Location: 206 AB West

Rapid Fire Speaker: Diaa Shakleya, PhD – US Food and Drug Administration

Manufacturing & Analytical Characterization

Tuesday, Oct 24th

3:30 PM – 3:45 PM ET

Physiologically Based Pharmacokinetic Modeling for Nanomedicines: Resolving Parameter Gaps

Location: 309 AB West

Rapid Fire Speaker: Amy Alston, PharmD, MS – CSL Vifor

Preclinical and Translational Science - Biomolecular

Tuesday, Oct 24th

3:45 PM – 4:00 PM ET

AI-Based Discovery and IND-Enabling of BMX Inhibitors for Cancer-Therapeutics Development

Location: 309 AB West

Rapid Fire Speaker: Ahmed Abu Fayyad, PhD, R.Ph. – Long Island University

Preclinical and Translational Science - Chemical

Tuesday, Oct 24th

3:45 PM – 4:00 PM ET

Amorphous Dispersion Speciation: Impact of Polymer Chemistry and Molecular Weight

Location: 208 AB West

Rapid Fire Speaker: Wesley K. Tatum, PhD – Serán Bioscience

Formulation and Delivery

Tuesday, Oct 24th

3:45 PM – 4:00 PM ET

Extracellular Vesicles for Developing Targeted Therapeutics to the Inner Ear

Location: 311 AB West

Rapid Fire Speaker: Xiaoshu Pan, PhD – University of Florida College of Pharmacy

Discovery and Basic Research

Tuesday, Oct 24th

3:45 PM – 4:00 PM ET

Immunocapture-LC/MS Investigation of a mAb Glycosylation Pattern in Human Plasma

Location: 311 GH West

Rapid Fire Speaker: Wei Wei, PhD (she/her/hers) – Boehringer Ingelheim

Bioanalytics

Tuesday, Oct 24th

3:45 PM – 4:00 PM ET

Risk-Based Bioanalytical Strategy for AAV Gene Therapy for Cardiac Delivery

Location: 311 EF West

Rapid Fire Speaker: Kun Yang, PhD – Bristol Myers Squibb

Bioanalytics

Tuesday, Oct 24th

3:45 PM – 4:00 PM ET

Strategic Modular Approaches to Continuous Manufacturing

Location: 205 AB West

Rapid Fire Speaker: Andrew Birkmire – GEA Pharma Systems

Manufacturing & Analytical Characterization

Tuesday, Oct 24th

3:45 PM – 4:00 PM ET

The Role of Saccharide Excipient Chemistry on Protein Particle Engineering

Location: 209 AB West

Rapid Fire Speaker: Amrit Paudel, PhD – Graz University of Technology

Formulation and Delivery

Tuesday, Oct 24th

3:45 PM – 4:00 PM ET

Translational Analysis Across Formulations/Populations to Support a Pediatric Formulation Approval

Location: 311 CD West

Rapid Fire Speaker: Cheng Chang, PhD – Pfizer Inc.

Preclinical and Translational Science - Chemical

Tuesday, Oct 24th

3:45 PM – 4:00 PM ET

Ultra-High-Resolution Optical Coherence Tomography for Investigating Very Thin Pharmaceutical Coatings

Location: 206 AB West

Rapid Fire Speaker: Moaaz Abdelhamid, M.Sc. – RCPE GmbH

Manufacturing & Analytical Characterization

Wednesday, Oct 25th

3:00 PM – 4:00 PM ET

Rapid Fires: Formulation and Delivery for Patient Centric Product Development 1

Location: 208 AB West

Rapid Fire Moderator: Tzichi Ju, Ph.D. – AbbVie Inc.

Formulation and Delivery

Wednesday, Oct 25th

3:00 PM – 4:00 PM ET

Rapid Fires: Formulation and Delivery for Patient Centric Product Development 2

Location: 209 AB West

Rapid Fire Moderator: Michael Danquah, PhD – Chicago State University College of Pharmacy

Formulation and Delivery

Wednesday, Oct 25th

3:00 PM – 4:00 PM ET

Rapid Fires: Novel Modalities and Cross-Modality Considerations in Manufacturing and Analysis 1

Location: 205 AB West

Rapid Fire Moderator: Devin Swiner, PhD (she/her/hers) – Merck & Co., Inc

Manufacturing & Analytical Characterization

Wednesday, Oct 25th

3:00 PM – 4:00 PM ET

Rapid Fires: Novel Modalities and Cross-Modality Considerations in Manufacturing and Analysis 2

Location: 206 AB West

Rapid Fire Moderator: Nahid S. Kamal, PhD (she/her/hers) – US Food and Drug Administration

Manufacturing & Analytical Characterization

Wednesday, Oct 25th

3:00 PM – 4:00 PM ET

Rapid Fires: Novel Predictive Preclinical Models for Efficacy and Toxicology 1

Location: 309 AB West

Rapid Fire Moderator: Claudio M. Marzo, PhD (he/him/his) – Evotec SE

Preclinical and Translational Sciences

Wednesday, Oct 25th

3:00 PM – 4:00 PM ET

Rapid Fires: Novel Predictive Preclinical Models for Efficacy and Toxicology 2

Location: 311 CD West

Rapid Fire Moderator: Bill R. Thelin, PhD (he/him/his) – Altis Biosystems

Preclinical and Translational Sciences

Wednesday, Oct 25th

3:00 PM – 4:00 PM ET

Rapid Fires: State-of-the-Art Tools for Basic Research and Early-Stage Drug Discovery

Location: 311 AB West

Rapid Fire Moderator: Somnath Singh, Ph.D. – Creighton University

Discovery and Basic Research

Wednesday, Oct 25th

3:00 PM – 4:00 PM ET

Rapid Fires: The Bioanalytical Lab of the Future 1

Location: 311 EF West

Rapid Fire Moderator: Robert Dodge, PhD – Novartis

Bioanalytics

Wednesday, Oct 25th

3:00 PM – 4:00 PM ET

Rapid Fires: The Bioanalytical Lab of the Future 2

Location: 311 GH West

Rapid Fire Moderator: Jim Shen, PhD (he/him/his) – Bristol Myers Squibb/Head of Regulated Bioanalysis & Operations

Bioanalytics

Wednesday, Oct 25th

3:00 PM – 3:15 PM ET

Applications of Human-Based Intestinal Cell Models in Preclinical Drug Development

Location: 311 CD West

Rapid Fire Speaker: Bill R. Thelin, PhD (he/him/his) – Altis Biosystems

Preclinical and Translational Science - Biomolecular

Wednesday, Oct 25th

3:00 PM – 3:15 PM ET

Bioanalysis and Pharmacokinetic-Modelling Considerations for Antisense Oligonucleotides Targeting CNS Diseases

Location: 311 GH West

Rapid Fire Speaker: Susovan Mohapatra, PhD (he/him/his) – Stoke Therapeutics, Inc.

Bioanalytics

Wednesday, Oct 25th

3:00 PM – 3:15 PM ET

BIONDD Capsule for Effective Oral Delivery of Biopharmaceuticals

Location: 209 AB West

Rapid Fire Speaker: Nina Mertz, PhD (she/her/hers) – Biograil ApS

Formulation and Delivery

Wednesday, Oct 25th

3:00 PM – 3:15 PM ET

Coating Platform to Taste Mask Bitter Drugs in Pediatric Microtablets

Location: 208 AB West

Rapid Fire Speaker: Biplob Mitra, PhD – Bristol-Myers Squibb Company

Formulation and Delivery

Wednesday, Oct 25th

3:00 PM – 3:15 PM ET

Collagen Based Organoids-on-a-Chip: Preclinical Drug Efficacy & Toxicity Evaluation

Location: 311 AB West

Rapid Fire Speaker: Samantha S. Ali, MS – University of Florida

Discovery and Basic Research

Wednesday, Oct 25th

3:00 PM – 3:15 PM ET

Mitochondrial Biogenesis and Mitophagy: Novel Predictive Target in Diabetic Neuropathy

Location: 309 AB West

Rapid Fire Speaker: ISLAUDDIN KHAN (he/him/his) – Florida A&M UniversityCollege Of Pharmacy & Pharmaceutical Sciences

Preclinical and Translational Science - Biomolecular

Wednesday, Oct 25th

3:00 PM – 3:15 PM ET

Non-Compendial Small Volume Dissolution for Early-Stage Formulation Model Development

Location: 206 AB West

Rapid Fire Speaker: Ishai Nir (he/him/his) – Distek, Inc.

Manufacturing & Analytical Characterization

Wednesday, Oct 25th

3:00 PM – 3:15 PM ET

The Impact of ICH Q12 and Established Conditions

Location: 205 AB West

Rapid Fire Speaker: Diane Goll, MS – US Food and Drug Administration

Manufacturing & Analytical Characterization

Wednesday, Oct 25th

3:00 PM – 3:15 PM ET

Therapeutic Drug Monitoring: Opportunities and Technical Considerations

Location: 311 EF West

Rapid Fire Speaker: Michael Partridge, PhD – Regeneron

Bioanalytics

Wednesday, Oct 25th

3:15 PM – 3:30 PM ET

A Gut-on-a-Chip Model to Predict Oral Bioavailability of Developing Drugs

Location: 311 AB West

Rapid Fire Speaker: Whitney Shin Yi Ong, PhD (she/her/hers) – Merck & Co., Inc.

Discovery and Basic Research

Wednesday, Oct 25th

3:15 PM – 3:30 PM ET

Acid-Induced Post-Inhalation Cough in a Guinea Pig Animal Model

Location: 309 AB West

Rapid Fire Speaker: Andrei Blasko, PhD, FRSC – Clearview Pharma Solutions LLC

Preclinical and Translational Science - Chemical

Wednesday, Oct 25th

3:15 PM – 3:30 PM ET

Characterization of Inhalation Drug Products Containing Spray-Dried Phospholipid Porous Particles

Location: 208 AB West

Rapid Fire Speaker: Yang Yang, PhD – US Food and Drug Administration

Formulation and Delivery

Wednesday, Oct 25th

3:15 PM – 3:30 PM ET

Delivery of IL-10 and ATRA For Psoriasis Treatment

Location: 209 AB West

Rapid Fire Speaker: Nathaniel S. Wright, M.S. – Cornell University

Formulation and Delivery

Wednesday, Oct 25th

3:15 PM – 3:30 PM ET

Epitope Specific Concentration Analysis of Recombinant Calibrators for Biomarker LBAs

Location: 311 EF West

Rapid Fire Speaker: Jonathan R. Haulenbeek, PhD – Bristol-Myers Squibb/Translational Sciences

Bioanalytics

Wednesday, Oct 25th

3:15 PM – 3:30 PM ET

Evaluation of Biocompatibility of 3D-Printed Materials

Location: 311 CD West

Rapid Fire Speaker: Krishna Veerubhotla (he/him/his) – University of Missouri-Kansas City

Preclinical and Translational Science - Chemical

Wednesday, Oct 25th

3:15 PM – 3:30 PM ET

Formulation Variables Affecting CQAs of Dissolvable Microneedles

Location: 206 AB West

Rapid Fire Speaker: Nahid S. Kamal, PhD (she/her/hers) – US Food and Drug Administration

Manufacturing & Analytical Characterization

Wednesday, Oct 25th

3:15 PM – 3:30 PM ET

Hierarchical Approach to Raw Material Variability in Drug Product Lifecycle

Location: 205 AB West

Rapid Fire Speaker: David J. Goldfarb, PhD – Merck & Co, Inc

Manufacturing & Analytical Characterization

Wednesday, Oct 25th

3:15 PM – 3:30 PM ET

Physiologically Based Pharmacokinetic Modeling of Naloxone Hydrochloride Nasal Sprays

Location: 311 GH West

Rapid Fire Speaker: Steven Chopski, PhD (he/him/his) – US Food and Drug Administration

Bioanalytics

Wednesday, Oct 25th

3:30 PM – 3:45 PM ET

A Supramolecular Scaffold for Guided Assembly of Fibroblastic Reticular Cells

Location: 311 AB West

Rapid Fire Speaker: Ketki Velankar, MS (she/her/hers) – Duquesne University - Graduate School of Pharmaceutical Sciences

Discovery and Basic Research

Wednesday, Oct 25th

3:30 PM – 3:45 PM ET

Biomarker Challenges: Dilution Linearity or Parallelism?

Location: 311 EF West

Rapid Fire Speaker: Marc-Olivier Pepin, BSc – Charles River Laboratories

Bioanalytics

Wednesday, Oct 25th

3:30 PM – 3:45 PM ET

Cannabinoids in Combination with Terpenes to Overcome Cancer Resistance

Location: 311 CD West

Rapid Fire Speaker: Breana Boirie, Pharm.D. (she/her/hers) – Florida A&M University

Preclinical and Translational Science - Biomolecular

Wednesday, Oct 25th

3:30 PM – 3:45 PM ET

Characterization of In Situ Forming Implants Using CT Imaging

Location: 208 AB West

Rapid Fire Speaker: Xinhao Lin – University of Connecticut

Formulation and Delivery

Wednesday, Oct 25th

3:30 PM – 3:45 PM ET

Engineering Injectable Hydrogels with Programmable Vaccine Release Kinetics

Location: 209 AB West

Rapid Fire Speaker: Wenting Shi, BS (she/her/hers) – Georgia Institute of Technology

Formulation and Delivery

Wednesday, Oct 25th

3:30 PM – 3:45 PM ET

Monoclonal Antibody Blood Bioanalysis - Keeping the Goal in Mind

Location: 311 GH West

Rapid Fire Speaker: James Huleatt, PhD (he/him/his) – Bill & Melinda Gates Medical Research Institute

Bioanalytics

Wednesday, Oct 25th

3:30 PM – 3:45 PM ET

Non-Sterile Drug Product Manufacturing: Recent FDA Focus on Controlling BCC

Location: 206 AB West

Rapid Fire Speaker: Jason Carbol – Dow Development Labs

Manufacturing & Analytical Characterization

Wednesday, Oct 25th

3:30 PM – 3:45 PM ET

Short-Term Immunosuppressants Induces Long-Term Tolerance to Human Antibody in Rats

Location: 309 AB West

Rapid Fire Speaker: PARIDHI GUPTA, BS – University of Tennessee health science center

Preclinical and Translational Science - Biomolecular

Wednesday, Oct 25th

3:30 PM – 3:45 PM ET

USP’s Iterative Approach on Modern Analytical Methods for Polymeric Excipients

Location: 205 AB West

Rapid Fire Speaker: Peng Zhang, PhD (he/him/his) – United States Pharmacopeia (USP)

Manufacturing & Analytical Characterization

Wednesday, Oct 25th

3:45 PM – 4:00 PM ET

BATA to Evaluate Drug Unpleasant Taste and Select Masking Strategy

Location: 309 AB West

Rapid Fire Speaker: Claudio M. Marzo, PhD (he/him/his) – Evotec SE

Preclinical and Translational Science - Chemical

Wednesday, Oct 25th

3:45 PM – 4:00 PM ET

Closed System Transfer Devices for Dose Preparation of Low-Dose Biologics

Location: 209 AB West

Rapid Fire Speaker: Elissa Grzincic, PhD (she/her/hers) – Abbvie

Formulation and Delivery

Wednesday, Oct 25th

3:45 PM – 4:00 PM ET

Evaluation of Predicting Long-Term Release Rate of the Islatravir Implant

Location: 205 AB West

Rapid Fire Speaker: Hyunho Kang, PhD – Merck & Co, Inc - Rahway, NJ

Manufacturing & Analytical Characterization

Wednesday, Oct 25th

3:45 PM – 4:00 PM ET

Microsampling Device Considerations and Workflows Supporting Regulated Bioanalysis

Location: 311 GH West

Rapid Fire Speaker: Jeff Plomley, M.Sc. – Altasciences Clinical Research

Bioanalytics

Wednesday, Oct 25th

3:45 PM – 4:00 PM ET

Model-Based Approach to Facilitate Regulatory Approval of Topical Dermatological Products

Location: 311 CD West

Rapid Fire Speaker: Seeprarani P. Rath, BPharm, MPharm, PhD – University of Toronto, Toronto, Canada

Preclinical and Translational Science - Chemical

Wednesday, Oct 25th

3:45 PM – 4:00 PM ET

Parallelism for Biomarker Assays Best Practice

Location: 311 EF West

Rapid Fire Speaker: Lindsay Ewan King, Ph.D. (he/him/his) – Pfizer Inc

Bioanalytics

Wednesday, Oct 25th

3:45 PM – 4:00 PM ET

Putting Lipids on the Map of 3D-Printable Filaments!

Location: 208 AB West

Rapid Fire Speaker: Moaaz Abdelhamid, M.Sc. – RCPE GmbH

Formulation and Delivery

Wednesday, Oct 25th

3:45 PM – 4:00 PM ET

Targeting Hypoxia and Adenosine Mediated Immunosuppression to Improve Cancer Therapy

Location: 311 AB West

Rapid Fire Speaker: Stephen Hatfield, PhD – Northeastern University

Discovery and Basic Research

Wednesday, Oct 25th

3:45 PM – 4:00 PM ET

Ultra-Precise Control of Active Ingredient Content Using a Novel Process

Location: 206 AB West

Rapid Fire Speaker: Eva Pontrelli (she/her/hers) – University of Michigan

Manufacturing & Analytical Characterization

Reception

Sunday, Oct 22nd

6:30 PM – 8:00 PM ET

Welcome Reception

Location: Plaza Ballroom, Hyatt Regency Orlando

Sponsored By Merck & Co Inc., Regeneron Pharmaceuticals

Monday, Oct 23rd

7:00 PM – 9:00 PM ET

President's Reception (by invitation only)

Location: Discovery Cove

Tuesday, Oct 24th

5:30 PM – 7:00 PM ET

Fellows Networking Reception (by invitation only)

Location: Florida C, Hyatt Regency Orlando

Sponsored By

Tuesday, Oct 24th

5:30 PM – 7:00 PM ET

Sustaining Sponsor Reception (by invitation only)

Location: Orchid / Verandah, Hyatt Regency Orlando

Wednesday, Oct 25th

5:30 PM – 6:30 PM ET

Closing Reception

Location: Upper Pool Deck (4th Floor), Hyatt Regency Orlando

Speaker Spotlight

Monday, Oct 23rd

9:30 AM – 10:30 AM ET

Speaker Spotlight: Surveying the Landscape of Extracellular Vesicles as Drug Delivery Agents

Location: Spotlight Stage A Exhibit Hall West A4-B3

Moderator: Sudip Das, PhD (he/him/his) – Butler University

Spotlight Speaker: Thomas Schmittgen, PhD (he/him/his) – University of Florida

Discovery and Basic Research

Monday, Oct 23rd

9:30 AM – 10:30 AM ET

Speaker Spotlight: The Path to Peak Performance: PAT Solutions for Advanced Process Control in Continuous Pharmaceutical Manufacturing

Location: Spotlight Stage B Exhibit Hall West A4-B3

Spotlight Speaker: Thomas De Beer, PhD (he/him/his) – Ghent University

Manufacturing & Analytical Characterization

Monday, Oct 23rd

2:30 PM – 3:30 PM ET

Speaker Spotlight: Advances in Predictive Biomarkers for DDIs

Location: Spotlight Stage B Exhibit Hall West A4-B3

Spotlight Speaker: Manthena V. Varma, PhD – Pfizer Inc

Moderator: Fei Hua, PhD – Applied BioMath

Preclinical and Translational Sciences

Monday, Oct 23rd

2:30 PM – 3:30 PM ET

Speaker Spotlight: Accelerating Drug Development: Past, Present and Future

Location: Spotlight Stage C Exhibit Hall West A4-B3

Spotlight Speaker: Steve Byrn, PhD – Purdue University

Moderator: Vadim J. Gurvich, PhD – University of Minnesota

Formulation and Delivery

Monday, Oct 23rd

2:30 PM – 3:30 PM ET

Speaker Spotlight: Single-Cell Multi-Omics for Cell and Gene Therapies

Location: Spotlight Stage A Exhibit Hall West A4-B3

Spotlight Speaker: Priya S. Chockalingam, PhD (she/her/hers) – Beam Therapeutics

Moderator: Karen J. Quadrini, PhD – Passage Bio, Inc

Bioanalytics

Tuesday, Oct 24th

9:30 AM – 10:30 AM ET

Speaker Spotlight: Evolving Clinical Pharmacology and Translational PK/PD Approaches for New Modalities

Location: Spotlight Stage B Exhibit Hall West A4-B3

Spotlight Speaker: Joshua F. Apgar, PhD (he/him/his) – Applied BioMath, LLC

Moderator: Fei Hua, PhD – Applied BioMath

Preclinical and Translational Sciences

Tuesday, Oct 24th

9:30 AM – 10:30 AM ET

Speaker Spotlight: Targeted vs Untargeted Workflows to Quantify Oligonucleotide Therapeutics by High Resolution Mass Spectrometry

Location: Spotlight Stage A Exhibit Hall West A4-B3

Spotlight Speaker: Ryan Hill (he/him/his) – Drug Disposition/ADME/Eli Lilly and Company

Moderator: Enaksha Wickremsinhe, PhD (he/him/his) – Bill and Melinda Gates Medical Research Institute

Bioanalytics

Tuesday, Oct 24th

2:30 PM – 3:30 PM ET

Speaker Spotlight: Analytical Testing Access and Capabilities Low-Income and Middle-Income Countries

Location: Spotlight Stage A Exhibit Hall West A4-B3

Moderator: Abhisheak Sharma, PhD – University of Florida

Spotlight Speaker: Chaitanya Koduri, MTech (he/him/his) – US Pharmacopeia

Discovery and Basic Research

Tuesday, Oct 24th

2:30 PM – 3:30 PM ET

Speaker Spotlight: Achieving Scientific Agility in a Rigid Matrix

Location: Spotlight Stage B Exhibit Hall West A4-B3

Spotlight Speaker: Selen Stromgren, PhD (she/her/hers) – FDA/Office of Regulatory Affairs

Moderator: Fengqiang Wang, PhD (he/him/his) – Merck and Co Inc

Manufacturing & Analytical Characterization

Tuesday, Oct 24th

2:30 PM – 3:30 PM ET

Speaker Spotlight: The Value of USP Standards for Excipients Used in Medicines: Current and Future State

Location: Spotlight Stage C Exhibit Hall West A4-B3

Spotlight Speaker: Catherine Sheehan, DRSc. MS. MS. – U.S. Pharmacopeia (USP)

Moderator: Chris Moreton, PhD (he/him/his) – FinnBritt Consulting

Formulation and Delivery

Wednesday, Oct 25th

10:00 AM – 11:00 AM ET

Speaker Spotlight: Emerging Trends and Future Outlook for Advanced Manufacturing

Location: Spotlight Stage B Exhibit Hall West A4-B3

Spotlight Speaker: Fernando Muzzio, Ph.D. – Rutgers - The State University of New Jersey

Moderator: Sushrut Marathe, PhD (he/him/his) – GSK

Manufacturing & Analytical Characterization

Wednesday, Oct 25th

10:00 AM – 11:00 AM ET

Speaker Spotlight: The Power of Hybrid LC-MS/MS: Case Studies from Simple to More Complex Biotherapeutic Modalities

Location: Spotlight Stage A Exhibit Hall West A4-B3

Moderator: James Huleatt, PhD (he/him/his) – Bill & Melinda Gates Medical Research Institute

Spotlight Speaker: Dawn Dufield, PhD – KCAS

Bioanalytics

Wednesday, Oct 25th

11:30 AM – 12:30 PM ET

Speaker Spotlight: Innovative PK-PD is Helping Informed-Decision in Neuro-Oncology

Location: Spotlight Stage B Exhibit Hall West A4-B3

Moderator: Pankaj B. Desai, PhD (he/him/his) – University of Cincinnati

Spotlight Speaker: Nader Sanai, MD (he/him/his) – Ivy Brain Tumor Center at Barrow Neurological Institute

Preclinical and Translational Sciences

Wednesday, Oct 25th

11:30 AM – 12:30 PM ET

Speaker Spotlight: Barriers and Disparities for Pediatric Drug Delivery

Location: Spotlight Stage C Exhibit Hall West A4-B3

Spotlight Speaker: Tulio Valdez, MD (he/him/his) – Stanford University

Moderator: Xiuling Lu, PhD (she/her/hers) – University of Connecticut

Formulation and Delivery

Wednesday, Oct 25th

11:30 AM – 12:30 PM ET

Speaker Spotlight: ECCS Class 3A: Interaction of Gabapentin and its Analogues with Transporters: A Love-Hate Relationship

Location: Spotlight Stage A Exhibit Hall West A4-B3

Spotlight Speaker: Ayman El-Kattan, PhD (he/him/his) – IFM

Moderator: Md Masud Parvez, PhD (he/him/his) – AbbVie Inc.

Discovery and Basic Research

Special Poster Collection

Monday, Oct 23rd

9:30 AM – 10:30 AM ET

Special Poster Collection

Location: Poster Forum #7; Exhibit Hall West A4-B3

Poster Collection Host: Patrick J. Sinko, Ph.D. – Rutgers University

Monday, Oct 23rd

10:30 AM – 11:30 AM ET

Special Poster Collection - Best Poster Award Winners

Location: Poster Forum #7; Exhibit Hall West A4-B3

Poster Collection Host: Carsten Ehrhardt, Ph.D. – Trinity College Dublin

Monday, Oct 23rd

11:30 AM – 12:30 PM ET

Special Poster Collection

Location: Poster Forum #7; Exhibit Hall West A4-B3

Poster Collection Host: Aliasger K. Salem – University of Iowa

Monday, Oct 23rd

12:30 PM – 1:30 PM ET

Special Poster Collection

Location: Poster Forum #7; Exhibit Hall West A4-B3

Poster Collection Host: David Cipolla – Insmed

Monday, Oct 23rd

1:30 PM – 2:30 PM ET

Special Poster Collection

Location: Poster Forum #7; Exhibit Hall West A4-B3

Poster Collection Host: Amit Desai, Ph.D. – Astellas Pharma

Monday, Oct 23rd

2:30 PM – 3:30 PM ET

Special Poster Collection

Location: Poster Forum #7; Exhibit Hall West A4-B3

Poster Collection Host: Daniel A. Norris, Ph.D. – Ionis Pharmaceuticals

Monday, Oct 23rd

3:30 PM – 4:30 PM ET

Special Poster Collection

Location: Poster Forum #7; Exhibit Hall West A4-B3

Poster Collection Host: Russ S. Weiner, Ph.D., FAAPS – Takeda

Tuesday, Oct 24th

9:30 AM – 10:30 AM ET

Special Poster Collection

Location: Poster Forum #7; Exhibit Hall West A4-B3

Poster Collection Host: Gopi Shankar, Ph.D., M.B.A., FAAPS – Larimartx

Tuesday, Oct 24th

10:30 AM – 11:30 AM ET

Special Poster Collection

Location: Poster Forum #7; Exhibit Hall West A4-B3

Poster Collection Host: Amanda L. Hays, Ph.D. – BioAgilytix Labs, LLC

Tuesday, Oct 24th

11:30 AM – 12:30 PM ET

Special Poster Collection

Location: Poster Forum #7; Exhibit Hall West A4-B3

Poster Collection Host: Lynn Kamen, Ph.D. – BioAgilytix

Tuesday, Oct 24th

12:30 PM – 1:30 PM ET

Special Poster Collection

Location: Poster Forum #7; Exhibit Hall West A4-B3

Poster Collection Host: Kevin Litwiler, Ph.D. (he/him/his) – OnKure Therapeutics

Tuesday, Oct 24th

1:30 PM – 2:30 PM ET

Special Poster Collection

Location: Poster Forum #7; Exhibit Hall West A4-B3

Poster Collection Host: Annette Bak, Ph.D, M.B.A., FAAPS (she/her/hers) – Astra Zeneca

Poster Collection Host: Silvia Sonzini, Ph.D. (she/her/hers) – AstraZeneca

Tuesday, Oct 24th

2:30 PM – 3:30 PM ET

Special Poster Collection

Location: Poster Forum #7; Exhibit Hall West A4-B3

Poster Collection Host: Carl Allenspach – Bristol-Myers Squibb Company

Tuesday, Oct 24th

3:30 PM – 4:30 PM ET

Special Poster Collection

Location: Poster Forum #7; Exhibit Hall West A4-B3

Poster Collection Host: Otilia M. Koo, Ph.D., FAAPS (she/her/hers) – Bristol Myers Squibb

Wednesday, Oct 25th

10:30 AM – 11:30 AM ET

Special Poster Collection

Location: Poster Forum #7; Exhibit Hall West A4-B3

Poster Collection Host: Shanghao Li, Ph.D. – WuXi AppTec

Wednesday, Oct 25th

12:30 PM – 1:30 PM ET

Special Poster Collection

Location: Poster Forum #7; Exhibit Hall West A4-B3

Poster Collection Host: Carsten Ehrhardt, Ph.D. – Trinity College Dublin

Symposium

Monday, Oct 23rd

9:00 AM – 10:30 AM ET

Symposium: Advances in Predictive Biomarkers For Drug Development

Location: 311 CD West

Moderator: Manthena V. Varma, PhD – Pfizer Inc

Preclinical and Translational Sciences

Monday, Oct 23rd

9:00 AM – 9:30 AM ET

Pharmacodynamic Biomarkers Evidentiary Considerations for Biosimilar Development and Approval

Location: 311 CD West

Speaker: Lakshmi Manasa S. Chekka, PharmD, PhD – U.S. FDA

Preclinical and Translational Sciences

Monday, Oct 23rd

9:30 AM – 10:00 AM ET

Leveraging Biomarkers in Establishing PK/PD Models

Location: 311 CD West

Speaker: Donald E. Mager, PharmD, PhD – University at Buffalo, SUNY/Enhanced Pharmacodynamics, LLC

Preclinical and Translational Sciences

Monday, Oct 23rd

10:00 AM – 10:30 AM ET

Metabolomics: a Powerful and Efficient Tool for Drug Discovery and Development

Location: 311 CD West

Speaker: Thomas P. Roddy, PhD (he/him/his) – Atavistik Bio

Preclinical and Translational Sciences

Monday, Oct 23rd

9:00 AM – 11:00 AM ET

Symposium: Accelerating the Drug Development Process through Formulation and Delivery Strategies 1

Location: 208 AB West

Moderator: Jing Ling, PhD – Merck & Co., Inc.

Formulation and Delivery

Monday, Oct 23rd

9:00 AM – 11:00 AM ET

Symposium: Accelerating the Drug Development Process through Formulation and Delivery Strategies 2

Location: 209 AB West

Moderator: Na Li, Ph.D. (she/her/hers) – University of Connecticut

Formulation and Delivery

Monday, Oct 23rd

9:00 AM – 11:00 AM ET

Symposium: Advanced Manufacturing and Emerging Technologies in Pharmaceuticals and Biopharmaceuticals 1

Location: 205 AB West

Moderator: Jason Rodriguez, PhD – US Food and Drug Administration

Manufacturing & Analytical Characterization

Monday, Oct 23rd

9:00 AM – 11:00 AM ET

Symposium: Advanced Manufacturing and Emerging Technologies in Pharmaceuticals and Biopharmaceuticals 2

Location: 206 AB West

Moderator: Jukka Rantanen, PhD (he/him/his) – University of Copenhagen

Manufacturing & Analytical Characterization

Monday, Oct 23rd

9:00 AM – 11:00 AM ET

Symposium: Advancing Therapeutic Discovery and Development: Mechanistic Considerations for Drug Delivery

Location: 309 AB West

Moderator: Patrick Ronaldson, PhD – University of Arizona

Discovery and Basic Research

Monday, Oct 23rd

9:00 AM – 11:00 AM ET

Symposium: PD Biomarkers As Evidence in Rare Disease

Location: 311 AB West

Moderator: Lakshmi Amaravadi, PhD – Kojin Therapeutics

Preclinical and Translational Sciences

Monday, Oct 23rd

9:00 AM – 11:00 AM ET

Symposium: Setting up for Success: Considerations for Study Design in the Context of Bioanalysis

Location: 311 EF West

Moderator: Shefali Patel, BSc., MLT – Janssen Research and Development, LLC

Bioanalytics

Monday, Oct 23rd

9:00 AM – 11:00 AM ET

Symposium: Setting up for Success: Considerations for Study Design in the Context of Bioanalysis 2

Location: 311 GH West

Moderator: Jurre J. Kamphorst, PhD (he/him/his) – Olaris, Inc.

Bioanalytics

Monday, Oct 23rd

9:00 AM – 9:30 AM ET

Advancing Nanoparticle-Based Delivery Systems with Novel Assessment Approaches

Location: 209 AB West

Speaker: Xiaoming Xu, PhD (he/him/his) – FDA

Formulation and Delivery

Monday, Oct 23rd

9:00 AM – 9:30 AM ET

API Co-Processing for Enhanced Solid Oral Dosages

Location: 205 AB West

Speaker: Rajesh Dave, PhD (he/him/his) – NJIT

Manufacturing & Analytical Characterization

Monday, Oct 23rd

9:00 AM – 9:30 AM ET

Impact of Raw Materials Variation On Continuous Feeders Performance

Location: 206 AB West

Speaker: Sara Fathollahi, PhD – DFE Pharma

Manufacturing & Analytical Characterization

Monday, Oct 23rd

9:00 AM – 9:30 AM ET

Low Volume Sampling Technologies Versus Venipuncture in a Clinical Study

Location: 311 EF West

Speaker: Saloumeh K. Fischer, PhD – Genentech Inc

Bioanalytics

Monday, Oct 23rd

9:00 AM – 9:30 AM ET

Metabolomics in Drug Discovery & Precision Diagnostics, and the Importance of Context-of-Use

Location: 311 GH West

Speaker: Jurre J. Kamphorst, PhD (he/him/his) – Olaris, Inc.

Bioanalytics

Monday, Oct 23rd

9:00 AM – 9:30 AM ET

Regulatory Considerations for Demonstrating Pharmaceutical Equivalence and Bioequivalence of Complex PLGA Based LAI Products

Location: 208 AB West

Speaker: Yan Wang, PhD (she/her/hers) – U.S. Food and Drug Administration

Formulation and Delivery

Monday, Oct 23rd

9:00 AM – 9:30 AM ET

Supporting Rare Disease Drug Development and Use of Biomarkers: Ravulizumab Case Study

Location: 311 AB West

Speaker: Mark Ma, MD (he/him/his) – Biotech

Preclinical and Translational Sciences

Monday, Oct 23rd

9:00 AM – 9:30 AM ET

The Shift From Passive To Active Targeting Drug Delivery

Location: 309 AB West

Speaker: Silvia Sonzini, Ph.D. (she/her/hers) – AstraZeneca

Discovery and Basic Research

Monday, Oct 23rd

9:30 AM – 10:00 AM ET

Critical Path for Rare Neurodegenerative Diseases Initiative for Drug Development

Location: 311 AB West

Speaker: Colin Hovinga – C-Path Institute

Preclinical and Translational Sciences

Monday, Oct 23rd

9:30 AM – 10:00 AM ET

Long-Acting Injectables: Advances in In Vitro Equivalence Testing

Location: 208 AB West

Speaker: Bin Qin, PhD – U.S. FDA

Formulation and Delivery

Monday, Oct 23rd

9:30 AM – 10:00 AM ET

Mitigation Strategies for Batch-Effects in Biomarker Data in Long-Term Studies

Location: 311 GH West

Speaker: Jihee Sohn, PhD (she/her/hers) – Biogen

Bioanalytics

Monday, Oct 23rd

9:30 AM – 10:00 AM ET

Mixing Systems for Floating and Settling Particles for Sterile Drug Products

Location: 205 AB West

Speaker: Parind Desai, PhD – GlaxoSmithKline

Manufacturing & Analytical Characterization

Monday, Oct 23rd

9:30 AM – 10:00 AM ET

Multi-Omics Microsampling for Dynamic Health Monitoring and Biomarker Discovery

Location: 311 EF West

Speaker: Michael Snyder – Stanford University

Bioanalytics

Monday, Oct 23rd

9:30 AM – 10:00 AM ET

NanoLipoSome Technology: a Toolbox for the Oral Delivery of Peptides

Location: 209 AB West

Speaker: Ansgar Bögershausen, PhD (he/him/his) – Losan Pharma

Formulation and Delivery

Monday, Oct 23rd

9:30 AM – 10:00 AM ET

Regulatory Pathways of Folate Delivery To The Brain

Location: 309 AB West

Speaker: Reina Bendayan, PharmD, FAAPS, FCSPS, FCAHS – University of Toronto

Discovery and Basic Research

Monday, Oct 23rd

9:30 AM – 10:00 AM ET

Troubleshooting Difficult Formulations For Continuous Twin-Screw Wet Granulation

Location: 206 AB West

Speaker: Michael R. Thompson, PhD (he/him/his) – McMaster University

Manufacturing & Analytical Characterization

Monday, Oct 23rd

10:00 AM – 10:30 AM ET

A Novel Method to Overcome ADA Interference in PK Assay

Location: 311 GH West

Speaker: Saleem Shaik, PhD – Takeda Pharmaceuticals

Bioanalytics

Monday, Oct 23rd

10:00 AM – 10:30 AM ET

Advance Clinical Studies with Patient Centric Sampling: Opportunities and Challenges

Location: 311 EF West

Speaker: Zhuo Chen, PhD (he/him/his) – GSK

Bioanalytics

Monday, Oct 23rd

10:00 AM – 10:30 AM ET

Development and Control Strategy for a Semi-Continuous Granulation Process

Location: 206 AB West

Speaker: Yasmin Suessenbach, PhD (she/her/hers) – Bayer AG

Manufacturing & Analytical Characterization

Monday, Oct 23rd

10:00 AM – 10:30 AM ET

Neurodegenerative Rare Diseases: Biomarkers in Drug Development and Regulatory Decisions

Location: 311 AB West

Speaker: Bilal AbuAsal, PhD – US FDA

Preclinical and Translational Sciences

Monday, Oct 23rd

10:00 AM – 10:30 AM ET

Novel 3D Printing Techniques to Assess Adhesion Testing for Patches

Location: 205 AB West

Speaker: Mandip Singh Sachdeva, PhD, FAAPS – Florida A & M University

Manufacturing & Analytical Characterization

Monday, Oct 23rd

10:00 AM – 10:30 AM ET

Novel Analytical Imaging and Dissolution Modeling

Location: 208 AB West

Speaker: Shawn Zhang, PhD – DigiM Solution LLC

Formulation and Delivery

Monday, Oct 23rd

10:00 AM – 10:30 AM ET

Particle Engineering for High Concentration Protein Suspensions

Location: 209 AB West

Speaker: Erica Schlesinger, PhD (she/her/hers) – Seran Biosciences, LLC

Formulation and Delivery

Monday, Oct 23rd

10:00 AM – 10:30 AM ET

Recent Advances in the In Vitro and In Vivo Methods to Assess Impact of P-gp and BCRP in Drug Intestinal Absorption and Brain Penetration

Location: 309 AB West

Speaker: Hong Shen, PhD – Bristol Myers Squibb Company

Discovery and Basic Research

Monday, Oct 23rd

10:30 AM – 11:00 AM ET

Advancing Delivery of mAbs and RNA Through Drug-Eluting Implants

Location: 208 AB West

Speaker: Harsh Patel, PhD (he/him/his) – Celanese

Formulation and Delivery

Monday, Oct 23rd

10:30 AM – 11:00 AM ET

Bioanalytical Strategies for the Determination of Peptide-Conjugated Phosphorodiamidate Morpholino Oligonucleotides

Location: 309 AB West

Speaker: Pallavi Lonkar, Post Graduate – PepGen

Discovery and Basic Research

Monday, Oct 23rd

10:30 AM – 11:00 AM ET

Development and Scale-Up of HDAd Process Using iCELLis® Bioreactor Platform

Location: 205 AB West

Speaker: Jyoti Amatya, MS (she/her/hers) – Cytiva

Manufacturing & Analytical Characterization

Monday, Oct 23rd

10:30 AM – 11:00 AM ET

Investigation of Patient Centric Sampling Solutions for Routine Clinical Measurements

Location: 311 EF West

Speaker: Bradley Collier, PhD – Labcorp

Bioanalytics

Monday, Oct 23rd

10:30 AM – 11:00 AM ET

Optimization of Design Space for Continuous Manufacturing of Extended-Release Tablets

Location: 206 AB West

Speaker: Ahmed S. Zidan, Ph.D – US Food and Drug Administration

Manufacturing & Analytical Characterization

Monday, Oct 23rd

10:30 AM – 11:00 AM ET

Pharmacodynamic Biomarkers as Confirmatory Evidence in Rare Disease Drug Development

Location: 311 AB West

Speaker: Nayeem Hossain, PhD – US FDA

Preclinical and Translational Sciences

Monday, Oct 23rd

10:30 AM – 11:00 AM ET

Post-Production Processes for Cell Therapy Products

Location: 209 AB West

Speaker: Patrick Hanley, PhD – Children's National Hospital

Formulation and Delivery

Monday, Oct 23rd

10:30 AM – 11:00 AM ET

Stability and Method Performance Considerations for Bioanalytical Enzymatic Activity Assays

Location: 311 GH West

Speaker: Christian Duke, MBA (he/him/his) – PPD, part of Thermo Fisher Scientific

Bioanalytics

Tuesday, Oct 24th

9:00 AM – 11:00 AM ET

Symposium: Addressing Health Disparities in Basic Science Research

Location: 311 AB West

Moderator: Melanie Felmlee, Ph.D. (she/her/hers) – University of the Pacific

Discovery and Basic Research

Tuesday, Oct 24th

9:00 AM – 11:00 AM ET

Symposium: Advanced Modelling and Predictive Approaches in Drug Development, Manufacturing and Analysis 1

Location: 205 AB West

Moderator: Sayantan Chattoraj, PhD – GSK

Manufacturing & Analytical Characterization

Tuesday, Oct 24th

9:00 AM – 11:00 AM ET

Symposium: Approaches for Emerging Modalities and Complex Studies 1

Location: 311 EF West

Moderator: HsinPin Ho, Ph.D. – Bristol Myers Squibb Company

Bioanalytics

Tuesday, Oct 24th

9:00 AM – 11:00 AM ET

Symposium: Approaches for Emerging Modalities and Complex Studies 2

Location: 311 GH West

Moderator: Troy Voelker, PhD – Aliri Bioanalysis

Bioanalytics

Tuesday, Oct 24th

9:00 AM – 11:00 AM ET

Symposium: Enabling Excipients and Approaches for Advancing Formulation and Delivery 1

Location: 208 AB West

Moderator: Anette Mullertz, PhD, FAAPS – University of Copenhagen

Formulation and Delivery

Tuesday, Oct 24th

9:00 AM – 11:00 AM ET

Symposium: Enabling Excipients and Approaches for Advancing Formulation and Delivery 2

Location: 209 AB West

Moderator: Haichen Nie, PhD – Teva Pharmaceuticals

Formulation and Delivery

Tuesday, Oct 24th

9:00 AM – 11:00 AM ET

Symposium: Evolving Clinical Pharmacology and Translational PK/PD Approaches For New Modalities

Location: 309 AB West

Moderator: Hardik Mody, PhD – Genetech

Preclinical and Translational Sciences

Tuesday, Oct 24th

9:00 AM – 11:00 AM ET

Symposium: Harnessing The Power of AI/ML in Drug Development

Location: 311 CD West

Moderator: Raja B. Velagapudi, PhD (he/him/his) – Tolmar Inc

Preclinical and Translational Sciences

Tuesday, Oct 24th

9:00 AM – 11:00 AM ET

Symposium: Advanced Modelling and Predictive Approaches in Drug Development, Manufacturing and Analysis 2

Location: 206 AB West

Moderator: Thomas De Beer, PhD (he/him/his) – Ghent University

Manufacturing & Analytical Characterization

Tuesday, Oct 24th

9:00 AM – 9:30 AM ET

A Hybridization Approach to Oligonucleotide Sample Extraction and LC/MS Analysis

Location: 311 GH West

Speaker: Troy Voelker, PhD – Aliri Bioanalysis

Bioanalytics

Tuesday, Oct 24th

9:00 AM – 9:30 AM ET

Advances in Regulated Bioanalytical Strategies Supporting Quantitation of Protein Degraders

Location: 311 EF West

Speaker: Jim Shen, PhD (he/him/his) – Bristol Myers Squibb/Head of Regulated Bioanalysis & Operations

Bioanalytics

Tuesday, Oct 24th

9:00 AM – 9:30 AM ET

Application of Mechanistic Physiologically Based Pharmacokinetic Models to Oligonucleotides

Location: 309 AB West

Speaker: Felix Stader, PhD (he/him/his) – Certara UK Limited

Preclinical and Translational Sciences

Tuesday, Oct 24th

9:00 AM – 9:30 AM ET

Enabling Oral Absorption of Peptides By Self-Nanoemulsifying Drug Delivery Systems

Location: 208 AB West

Speaker: Anette Mullertz, PhD, FAAPS – University of Copenhagen

Formulation and Delivery

Tuesday, Oct 24th

9:00 AM – 9:30 AM ET

Harnessing Machine Learning and Protein Structure to Characterize SLC Structure and Function

Location: 311 AB West

Speaker: Avner Schlessinger

Discovery and Basic Research

Tuesday, Oct 24th

9:00 AM – 9:30 AM ET

Recent Advances in Machine Learning for Characterizing Subvisible Particles

Location: 206 AB West

Speaker: Chris P. Calderon, PhD – Ursa Analytics

Manufacturing & Analytical Characterization

Tuesday, Oct 24th

9:00 AM – 9:30 AM ET

Small Molecule Drug In Silico Crystal Structure and Property Predictions

Location: 205 AB West

Speaker: John C. Shelley, PhD – Schrodinger, LLC

Manufacturing & Analytical Characterization

Tuesday, Oct 24th

9:00 AM – 9:30 AM ET

Strategic Overview of Complex Excipients in US Pharmacopeia With a Focus on Polysorbates and LG Polymer

Location: 209 AB West

Speaker: Otilia M. Koo, Ph.D., FAAPS (she/her/hers) – Bristol Myers Squibb

Formulation and Delivery

Tuesday, Oct 24th

9:00 AM – 9:30 AM ET

Understand the Regulatory Environment for AI and Machine Learning

Location: 311 CD West

Speaker: Kim Huynh-Ba, MS, PMP, FAAPS – Pharmalytik Consulting & Training

Preclinical and Translational Sciences

Tuesday, Oct 24th

9:30 AM – 10:00 AM ET

Amplicon-Based Next-Generation Sequencing Nonclinical Assay Validation

Location: 311 GH West

Speaker: Kelly S. Colletti, PhD, MBA (she/her/hers) – Beam Therapeutics

Bioanalytics

Tuesday, Oct 24th

9:30 AM – 10:00 AM ET

Computational Approaches to Salt Screening: Case of Aripiprazole Salts Crystallization

Location: 205 AB West

Speaker: Yuriy Abramov, PhD – J-Star Research | Porton

Manufacturing & Analytical Characterization

Tuesday, Oct 24th

9:30 AM – 10:00 AM ET

Deciphering Genetic Causes for Sex Differences in Human Health Through Drug Metabolism and Transporter Genes

Location: 311 AB West

Speaker: R. Stephanie Huang, PhD (she/her/hers) – University of Minnesota

Discovery and Basic Research

Tuesday, Oct 24th

9:30 AM – 10:00 AM ET

Deep Learning Models to Reduce False Rejects in Pharmaceutical manufacturing

Location: 206 AB West

Speaker: Vijay Yadav – Merck & Co., Inc.

Manufacturing & Analytical Characterization

Tuesday, Oct 24th

9:30 AM – 10:00 AM ET

Environmentally-Responsive Hydrogel Excipient Broadly Enhances Oral Bioavailability of Insoluble Drugs

Location: 208 AB West

Speaker: Doug Godfrin, PhD – VeraMorph

Formulation and Delivery

Tuesday, Oct 24th

9:30 AM – 10:00 AM ET

Mechanistic Insights on Fogging in Lyophilized Formulations

Location: 209 AB West

Speaker: Navpreet Kaur, PhD (she/her/hers) – Sanofi

Formulation and Delivery

Tuesday, Oct 24th

9:30 AM – 10:00 AM ET

PK/PD Modeling of Bispecific T Cell Engagers for Clinical Translation

Location: 309 AB West

Speaker: Yanguang (Carter) Cao, PH.D – University of North Carolina at Chapel Hill

Preclinical and Translational Sciences

Tuesday, Oct 24th

9:30 AM – 10:00 AM ET

Quantitation of Oligonucleotides – LC-HRMS or LC-MS/MS, Which is Better?

Location: 311 EF West

Speaker: Zamas Lam, PhD (he/him/his) – QPS

Bioanalytics

Tuesday, Oct 24th

9:30 AM – 10:00 AM ET

The Use of Machine Learning in the Development of Scoring Rule for the Identification of Adult Patients Under the Emergency Use Authorization for Anakinra for Treatment of COVID-19 in the United States

Location: 311 CD West

Speaker: Ruihao Huang, PhD (he/him/his) – U.S. Food and Drug Administration

Preclinical and Translational Sciences

Tuesday, Oct 24th

10:00 AM – 10:30 AM ET

Clinical Pharmacology Considerations for Allogeneic Cell Therapies

Location: 309 AB West

Speaker: Dhruvitkumar Sutaria, PhD (he/him/his) – Genentech

Preclinical and Translational Sciences

Tuesday, Oct 24th

10:00 AM – 10:30 AM ET

Continuous Manufacturing: Optimizing Quality and Efficiency Improvement Using AI

Location: 206 AB West

Speaker: Rupesh Malhotra, MS – Vertex Pharmaceuticals

Manufacturing & Analytical Characterization

Tuesday, Oct 24th

10:00 AM – 10:30 AM ET

High Content Biomarkers: Application of High Parameter Flow Cytometry for Single-Cell Analysis in Clinical Trials

Location: 311 GH West

Speaker: Michelle Graham, PhD (she/her/hers) – AbbVie

Bioanalytics

Tuesday, Oct 24th

10:00 AM – 10:30 AM ET

High-Throughput Screening Workflow for Amorphous Solubility and Excipient Performance

Location: 208 AB West

Speaker: Yuchen Fan, PhD – Genentech Inc.

Formulation and Delivery

Tuesday, Oct 24th

10:00 AM – 10:30 AM ET

Hybridization LC-MS/MS Bioanalysis of Oligonucleotides to Support PET Imaging Study

Location: 311 EF West

Speaker: Di Jiang, PhD (she/her/hers) – Biogen Inc.

Bioanalytics

Tuesday, Oct 24th

10:00 AM – 10:30 AM ET

Integrating Machine Learning and Systems Pharmacology to Predict Clinical Outcomes to CAR-T Therapies

Location: 311 CD West

Speaker: Avisek Deyati, PhD (he/him/his) – Notch Therapeutics

Preclinical and Translational Sciences

Tuesday, Oct 24th

10:00 AM – 10:30 AM ET

Leveraging Power of Quantitative Omics Tools and Biorepositories to Address Health Disparity in Basic and Translational Research

Location: 311 AB West

Speaker: Bhagwat Prasad, Ph.D – Washington State University

Discovery and Basic Research

Tuesday, Oct 24th

10:00 AM – 10:30 AM ET

Next Generation Lab-Scale Transport Validation: Fluid Behavior and Quality Impacts

Location: 205 AB West

Speaker: Florian Rosenthal, MSc ETH (he/him/his) – F. Hoffman - La Roche Ltd.

Manufacturing & Analytical Characterization

Tuesday, Oct 24th

10:00 AM – 10:30 AM ET

Revisiting the Crucial Role of Amino Acids as Excipients in Protein-Based Drug Product Development

Location: 209 AB West

Speaker: Haichen Nie, PhD – Teva Pharmaceuticals

Formulation and Delivery

Tuesday, Oct 24th

10:30 AM – 11:00 AM ET

A Novel Digital Twin of End-to-End Continuous Manufacturing of Injectable

Location: 205 AB West

Speaker: Ravendra Singh (he/him/his) – Rutgers University

Manufacturing & Analytical Characterization

Tuesday, Oct 24th

10:30 AM – 11:00 AM ET

A Quantitative Systems Pharmacology Model to Characterize the PKPD Relationship Following Treatment with IL-15R Agonists

Location: 309 AB West

Speaker: Louis Joslyn, PhD – Genentech

Preclinical and Translational Sciences

Tuesday, Oct 24th

10:30 AM – 11:00 AM ET

Developing a Semi-Quantitative LBA LC-MS Assay for Anti-Drug Antibody Isotypes

Location: 311 EF West

Speaker: Paige A. Malec, PhD (she/her/hers) – Labcorp Drug Development

Bioanalytics

Tuesday, Oct 24th

10:30 AM – 11:00 AM ET

Role of Excipients in Frozen and Freeze-Dried Protein Formulations

Location: 209 AB West

Speaker: Raj Suryanarayanan, PhD, MPharm, MSc – College of Pharmacy/University of Minnesota

Formulation and Delivery

Tuesday, Oct 24th

10:30 AM – 11:00 AM ET

Scale-Down Modeling of Bioreactor Operations for Monoclonal Antibody Production

Location: 206 AB West

Speaker: Ou Yang, PhD – GSK

Manufacturing & Analytical Characterization

Tuesday, Oct 24th

10:30 AM – 11:00 AM ET

Scientific Challenges Developing Bioanalytical Assays for Novel Modalities: Car-T

Location: 311 GH West

Speaker: Mark Blimline, MS (he/him/his) – Navigate Biopharma

Bioanalytics

Tuesday, Oct 24th

10:30 AM – 11:00 AM ET

Understanding Surfactant-Protein Interactions in Mitigating Interface-Induced Protein Particle Formation in Biotherapeutic Solutions Subjected to Interfacial Stresses

Location: 208 AB West

Speaker: Prajnaparamita Dhar, PhD (she/her/hers) – The University of Kansas

Formulation and Delivery

Tuesday, Oct 24th

10:30 AM – 11:00 AM ET

Understanding the Impact of Ancestral and Demographic Diversity On -Omics Data is Essential For Biomedical Research: Case Studies

Location: 311 AB West

Speaker: Joseph Daniel Szustakowski, PhD – Bristol Myers Squibb

Discovery and Basic Research

Tuesday, Oct 24th

10:30 AM – 11:00 AM ET

When Modeling & Simulation Meets GPT

Location: 311 CD West

Speaker: Liang Zhao, PhD – US Food and Drug Administration

Preclinical and Translational Sciences

Wednesday, Oct 25th

9:00 AM – 10:30 AM ET

Symposium: Alternative Approach to Animal Studies

Location: 309 AB West

Moderator: Ketan D. Patel, PhD (he/him/his) – St. John's University

Preclinical and Translational Sciences

Wednesday, Oct 25th

9:00 AM – 9:30 AM ET

Application of (Q)SAR Modeling to the Safety Assessment of Pharmaceuticals

Location: 309 AB West

Speaker: Naomi Kruhlak, PhD (she/her/hers) – US Food and Drug Administration

Preclinical and Translational Sciences

Wednesday, Oct 25th

9:30 AM – 10:00 AM ET

A Novel in vitro Hepatocyte Culture System (icHep) for Biliary Drug Excretion Analysis Using Permeation Assay

Location: 309 AB West

Speaker: Ikumi Tamai, Ph.D (he/him/his) – Kanazawa University

Preclinical and Translational Sciences

Wednesday, Oct 25th

10:00 AM – 10:30 AM ET

SafetAI Initiative: AI Based Prediction Initiative For Predicting Toxicity End-Points

Location: 309 AB West

Speaker: Shraddha Thakkar, MSc, M.S., PhD – US FDA/CDER/OTS/OCS

Preclinical and Translational Sciences

Wednesday, Oct 25th

9:00 AM – 11:00 AM ET

Symposium: Formulation and Delivery for Patient Centric Product Development 1

Location: 208 AB West

Moderator: Jaap Wieling, PhD (he/him/his) – PureIMS BV

Formulation and Delivery

Wednesday, Oct 25th

9:00 AM – 11:00 AM ET

Symposium: Formulation and Delivery for Patient Centric Product Development 2

Location: 209 AB West

Moderator: Stephen W. Hoag, PhD, FAAPS – University of Maryland, Baltimore

Formulation and Delivery

Wednesday, Oct 25th

9:00 AM – 11:00 AM ET

Symposium: Methodologies to Expedite Drug Development

Location: 311 CD West

Moderator: Aniruddha S. Karve, PhD – University of Cincinnati

Preclinical and Translational Sciences

Wednesday, Oct 25th

9:00 AM – 11:00 AM ET

Symposium: Novel Modalities and Cross-Modality Considerations in Manufacturing and Analysis 1

Location: 205 AB West

Moderator: Selen Stromgren, PhD (she/her/hers) – FDA/Office of Regulatory Affairs

Manufacturing & Analytical Characterization

Wednesday, Oct 25th

9:00 AM – 11:00 AM ET

Symposium: Novel Modalities and Cross-Modality Considerations in Manufacturing and Analysis 2

Location: 206 AB West

Moderator: Caitlin Wood, Ph.D. (she/her/hers) – Merck & Co., Inc.

Manufacturing & Analytical Characterization

Wednesday, Oct 25th

9:00 AM – 11:00 AM ET

Symposium: State-of-the-Art Tools for Basic Research and Early-Stage Drug Discovery

Location: 311 AB West

Moderator: Carsten Ehrhardt, Ph.D. – Trinity College Dublin

Discovery and Basic Research

Wednesday, Oct 25th

9:00 AM – 11:00 AM ET

Symposium: The Bioanalytical Lab of the Future 1

Location: 311 EF West

Moderator: Nanda Balasubramanian, MSc, PhD (he/him/his) – Bristol Myers Squibb

Bioanalytics

Wednesday, Oct 25th

9:00 AM – 11:00 AM ET

Symposium: The Bioanalytical Lab of the Future 2

Location: 311 GH West

Moderator: Robert Dodge, PhD – Novartis

Bioanalytics

Wednesday, Oct 25th

9:00 AM – 9:30 AM ET

Analytical Quality-by-Design: Analytical Comparability Assessment and Bioanalysis of Biosimilars by LC-MS Approaches

Location: 311 EF West

Speaker: Jinhui Zhang, PhD (he/him/his) – US Food and Drug Administration

Bioanalytics

Wednesday, Oct 25th

9:00 AM – 9:30 AM ET

Automated Analysis of Organoid Culture Development

Location: 311 AB West

Speaker: James A. Corson, PhD (he/him/his) – Enthought

Discovery and Basic Research

Wednesday, Oct 25th

9:00 AM – 9:30 AM ET

Drug and Device Development for Patient Empowering Organ Specific Delivery

Location: 208 AB West

Speaker: Stan C. Kwok, PhD – AstraZeneca, Biologics Pharmaceutical Development, Dosage Form Design

Formulation and Delivery

Wednesday, Oct 25th

9:00 AM – 9:30 AM ET

Industrial Perspective on Recent Advances in Pediatric Formulation and Delivery Systems

Location: 209 AB West

Speaker: Robert L. Ternik, PhD (he/him/his) – Rolara Medaka Consulting

Formulation and Delivery

Wednesday, Oct 25th

9:00 AM – 9:30 AM ET

Metabolomics in the Clinic: Technical Hurdles and Success Stories

Location: 311 GH West

Speaker: Anne M. Evans, PhD (she/her/hers) – Metabolon

Bioanalytics

Wednesday, Oct 25th

9:00 AM – 9:30 AM ET

Predictive Analytics in the Design and Development of Long Acting Injectable (LAI) Drug Products

Location: 205 AB West

Speaker: Sayantan Chattoraj, PhD – GSK

Manufacturing & Analytical Characterization

Wednesday, Oct 25th

9:00 AM – 9:30 AM ET

Submicron Particles in Injectable Biologics: Risks and Measurement Techniques

Location: 206 AB West

Speaker: Dennis Yang, PhD (he/him/his) – Eli Lilly and Company

Manufacturing & Analytical Characterization

Wednesday, Oct 25th

9:00 AM – 9:30 AM ET

Translational Studies and Phase 0/1 Clinical Trial to Accelerate Repurposing Letrozole for the Treatment of Recurrent GBM

Location: 311 CD West

Speaker: Pankaj B. Desai, PhD (he/him/his) – University of Cincinnati

Preclinical and Translational Science - Chemical

Wednesday, Oct 25th

9:30 AM – 10:00 AM ET

Advancing Drug Development Through Data-Independent Acquisition Mass Spectrometry for Biomarker Discovery and Development

Location: 311 GH West

Speaker: Veronica Anania, PhD – Genentech

Bioanalytics

Wednesday, Oct 25th

9:30 AM – 10:00 AM ET

Application of Quantitative Modelling in the Development of Respiratory Medicines

Location: 311 AB West

Speaker: Hochhaus Guenther, PhD – University of Florida College of Pharmacy

Discovery and Basic Research

Wednesday, Oct 25th

9:30 AM – 10:00 AM ET

Future of Vaccination With Novel Microarray Patch (MAP) Technology

Location: 209 AB West

Speaker: Sarika Namjoshi, PhD – Vaxxas Pty Ltd

Formulation and Delivery

Wednesday, Oct 25th

9:30 AM – 10:00 AM ET

Impact of Molecular Mobility on ADCs Degradation in Lyophiles

Location: 206 AB West

Speaker: Ehab Moussa, PhD – AbbVie Inc.

Manufacturing & Analytical Characterization

Wednesday, Oct 25th

9:30 AM – 10:00 AM ET

Integrated Immunogenicity Strategies Support Value-Driven Clinical Development

Location: 311 EF West

Speaker: Devangi Mehta, PhD – Immunologix Laboratories

Bioanalytics

Wednesday, Oct 25th

9:30 AM – 10:00 AM ET

Intercompany Perspective on Studies to Enable Administration of Biopharmaceutical Products

Location: 208 AB West

Speaker: George Crotts, PhD, RpH – GSK

Formulation and Delivery

Wednesday, Oct 25th

9:30 AM – 10:00 AM ET

Promises and Pitfalls of Phase 0/1 Clinical Trials

Location: 311 CD West

Speaker: David M. Peereboom, MD – Cleveland Clinic Burkhardt Brain Tumor and Neuro-oncology Center

Preclinical and Translational Sciences

Wednesday, Oct 25th

9:30 AM – 10:00 AM ET

Regulatory Expectations in Extractables and Leachables Testing of Combination Products

Location: 205 AB West

Speaker: Dujuan Lu, PhD – SGS Health Sciences

Manufacturing & Analytical Characterization

Wednesday, Oct 25th

10:00 AM – 10:30 AM ET

A Novel Control Strategy for PS-80 Degradation in Citrate Buffer Based on An Iron-Catalyzed Oxidation Study

Location: 205 AB West

Speaker: Chengbei Li, PhD (she/her/hers) – Merck & Co., Inc.

Manufacturing & Analytical Characterization

Wednesday, Oct 25th

10:00 AM – 10:30 AM ET

Blocking the Bitter Taste of Medicines

Location: 209 AB West

Speaker: Peihua Jiang, PhD – Monell Chemical Senses Center

Formulation and Delivery

Wednesday, Oct 25th

10:00 AM – 10:30 AM ET

Bridging the Gap: Preclinical Modeling for Effective PK/PD-Driven Clinical Trials

Location: 311 CD West

Speaker: Shwetal Mehta, PhD – Ivy Brain Tumor Center / Barrow Neurological Institute

Preclinical and Translational Sciences

Wednesday, Oct 25th

10:00 AM – 10:30 AM ET

Cross Modality Considerations for Host Cell Protein Controls

Location: 206 AB West

Speaker: Fengqiang Wang, PhD (he/him/his) – Merck and Co Inc

Manufacturing & Analytical Characterization

Wednesday, Oct 25th

10:00 AM – 10:30 AM ET

Establishing Drug Product Compatibility in New, Unique, and Difficult Devices

Location: 208 AB West

Speaker: Iriny Ekladious, PhD – Merck & Co, Inc

Formulation and Delivery

Wednesday, Oct 25th

10:00 AM – 10:30 AM ET

Novel Technical Breakthrough: qPCR Sensitivity LLOQ of 8 Copies/ug DNA

Location: 311 GH West

Speaker: Bin Xu, PhD (he/him/his) – Accurant Biotech

Bioanalytics

Wednesday, Oct 25th

10:00 AM – 10:30 AM ET

qPCR and dPCR Assay Validations for Cell and Gene Therapies

Location: 311 EF West

Speaker: Wendy O. Adamowicz, MS (she/her/hers) – PPD Clinical Research, Thermo Fisher Scientific

Bioanalytics

Wednesday, Oct 25th

10:00 AM – 10:30 AM ET

Real Time Imaging for Developing and Assessing Complex Pharmaceuticals

Location: 311 AB West

Speaker: Xiuling Lu, PhD (she/her/hers) – University of Connecticut

Discovery and Basic Research

Wednesday, Oct 25th

10:30 AM – 11:00 AM ET

3D Cell Culture Models For Efficacy Determination Of Nanotherapeutics

Location: 311 AB West

Speaker: Vivek Gupta, PhD – St. John's University

Discovery and Basic Research

Wednesday, Oct 25th

10:30 AM – 11:00 AM ET

Application of Asymmetric Flow Field-Flow Fractionation (AFFF) and Capillary Electrophoresis (CE) for the Characterization of Liposomal Formulations

Location: 206 AB West

Speaker: Thilak Mudalige, Ph.D. (he/him/his) – US Food and Drug Administration

Manufacturing & Analytical Characterization

Wednesday, Oct 25th

10:30 AM – 11:00 AM ET

Current Resources and Opportunities to Collaborate for Pediatric Formulation Development

Location: 209 AB West

Speaker: James E. Cummins, Jr., PhD (he/him/his) – Division of AIDS/NIH

Formulation and Delivery

Wednesday, Oct 25th

10:30 AM – 11:00 AM ET

LCMS Approaches for Discovery and Quantitation of Biomarkers for Target Engagement and Pathway Modulation

Location: 311 GH West

Speaker: Faizan Zubair, PhD – Takeda Pharmaceuticals

Bioanalytics

Wednesday, Oct 25th

10:30 AM – 11:00 AM ET

Leveraging Statistical Methods Across the Analytical Procedure Lifecycle

Location: 205 AB West

Speaker: Tara Scherder, MS – SynoloStats

Manufacturing & Analytical Characterization

Wednesday, Oct 25th

10:30 AM – 11:00 AM ET

Marker Molecules to Measure BBB Permeability in and Around Brain Tumors

Location: 311 CD West

Speaker: William F. elmquist, PhD (he/him/his) – University of Minnesota

Preclinical and Translational Sciences

Wednesday, Oct 25th

10:30 AM – 11:00 AM ET

Patient Centric Science Risk-based Stability Strategy to Accelerate Product Development

Location: 208 AB West

Speaker: Yan Wu, PhD – Merck Sharp & Dohme

Formulation and Delivery

Wednesday, Oct 25th

10:30 AM – 11:00 AM ET

Utility of TAb vs.NAb Assays as Prescreen for Gene-Therapy Trials

Location: 311 EF West

Speaker: Renuka Pillutla, PhD (she/her/hers) – SparkTx

Bioanalytics

User Group Meeting

Monday, Oct 23rd

12:00 PM – 2:00 PM ET

User Group Meeting: The Power of Phoenix Tools Analyzing PK Data

Location: 360 Stage #1 Exhibit Hall West A4-B3

Tech Spotlight Speaker: Ana Henry, M.S., Biomathematics – Certara

Tech Spotlight Speaker: Chris Mehl, M.S – Certara

Tech Spotlight Speaker: Fred Mahakian (he/him/his) – Certara

Tech Spotlight Speaker: Michael Clifton, BS – Certara

Preclinical and Translational Sciences

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