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Full Schedule

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Full Schedule

  • Friday, October 14, 2022
  • 12:00 PM – 5:00 PM ET
    Registration Hours
  • 1:00 PM – 5:00 PM ET
    Exhibitor Move-In (Booths 300 SF or larger)
  • Saturday, October 15, 2022
  • 7:30 AM – 5:00 PM ET
    Registration Hours
  • 8:00 AM – 5:00 PM ET
    Exhibitor Move-In
  • Sunday, October 16, 2022
  • 7:00 AM – 7:00 PM ET
    Registration Hours
  • 8:00 AM – 5:00 PM ET
    Exhibitor Move-In
  • 9:00 AM – 1:00 PM ET
    Business Development Advisory Board (by invitation only)
  • 12:00 PM – 4:00 PM ET
    Speaker Ready Room
  • 5:00 PM – 6:30 PM ET
    Opening Plenary with Tim Urban & Awards Celebration

    Plenary Speaker: Tim Urban – Wait But Why

  • 6:30 PM – 8:00 PM ET
    Welcome Reception
  • 8:00 PM – 9:30 PM ET
    ASIPS (American Society of Iranian Pharmaceutical Scientists) Annual Meeting
  • Monday, October 17, 2022
  • 7:00 AM – 8:30 AM ET
    Exploring funding opportunities and considerations within current capital markets
  • 7:30 AM – 8:30 AM ET
    The Journals of AAPS Editorial Board Breakfast (by invitation only)
  • 7:30 AM – 5:00 PM ET
    Registration Hours
  • 7:30 AM – 5:00 PM ET
    Speaker Ready Room
  • 8:30 AM – 9:00 AM ET
    Prologue: An Evolving Biologics Landscape Driving Innovation and Optimization

    Prologue Speaker: Robert S. Foti, PhD – Merck

    Preclinical Development – Biomolecular

  • 8:30 AM – 9:00 AM ET
    Prologue: Analytical Challenges for Biomolecules

    Prologue Speaker: Paul Logan Walsh, PhD – AbbVie

    Manufacturing & Analytical Characterization – Biomolecular

  • 8:30 AM – 9:00 AM ET
    Prologue: Can Computers Accelerate the Discovery of New Drugs? Comments From a Sarcastic but Optimistic Computational Chemist

    Prologue Speaker: Alexander Tropsha, PhD – University of North Carolina

    Discovery and Basic Research

  • 8:30 AM – 9:00 AM ET
    Prologue: Challenges and Opportunities During COVID-19 Pandemic and its Impact on Clinical Trials: A Clinical Pharmacology Perspective

    Prologue Speaker: Sandhya Girish, M.Pharm, PhD – Gilead Sciences

    Clinical Pharmacology – Chemical

  • 8:30 AM – 9:00 AM ET
    Prologue: Immunogenicity of AAV Vectors in Gene Therapy

    Government Speaker: Ronit Mazor, Ph.D. – U.S. Food and Drug Administration

    Bioanalytics – Biomolecular

  • 8:30 AM – 9:00 AM ET
    Prologue: Modeling and Predictive Design in Pharmaceutical Development

    Prologue Speaker: Sayantan Chattoraj, Ph.D. – GSK

    Manufacturing & Analytical Characterization – Chemical

  • 8:30 AM – 9:00 AM ET
    Prologue: Pharmacokinetics and Interaction Implications for LNP Therapy

    Prologue Speaker: Douglas Burdette, Ph.D. – Moderna Therapeutics

    Formulation and Delivery – Biomolecular

  • 8:30 AM – 9:00 AM ET
    Prologue: PRiME: A Vision for Accelerating Academic Drug Discovery

    Prologue Speaker: Carolyn Cummins, Ph.D. – University of Toronto

    Preclinical Development – Chemical

  • 8:30 AM – 9:00 AM ET
    Prologue: Smaliobiotideocules: Where Do Small Molecules End and Large Molecules Start?

    Prologue Speaker: Shane Needham, Ph.D. – Veloxity Labs, LLC

    Bioanalytics – Chemical

  • 8:30 AM – 9:00 AM ET
    Prologue: Systems and Clinical Pharmacology of Covid-19 Therapeutic Candidates: A Clinical and Translational Medicine Perspective

    Prologue Speaker: Simone Perazzolo, PhD – University of Washington

    Clinical Pharmacology – Biomolecular

  • 8:30 AM – 9:00 AM ET
    Prologue: The Elimination of Biochemical and Immunological Barriers in the Tumor Microenvironment to Improve Cancer Immunotherapy

    Prologue Speaker: Stephen Hatfield, PhD – Northeastern University

    Discovery and Basic Research

  • 8:30 AM – 4:00 PM ET
    Guest Tour: The North Shore of Boston (additional fee required)
  • 8:30 AM – 4:30 PM ET
    Coffee Station
  • 8:30 AM – 4:30 PM ET
    Free Professional Headshots
  • 8:30 AM – 4:30 PM ET
    LinkedIn Profile Critiques & Resume Reviews
  • 8:30 AM – 5:00 PM ET
    Solution Center Hours & Poster Presentations
  • 9:00 AM – 10:00 AM ET
    Hot Topic: Current Learnings From Diverse Global Immune Responses to COVID-19 Vaccines

    Hot Topic Speaker: Sharon Vijayanand, B. Pharm – Mercer University

    Hot Topic Speaker: Smital R. Patil, Bachelor of Pharmacy – Mercer University College of Pharmacy

    Hot Topic Moderator: Satish Singh – Moderna Therapeutics

    Discovery and Basic Research

  • 9:00 AM – 10:00 AM ET
    The Skills You Need to be a Pharmaceutical Consultant

    Career Center Moderator: Suzanne Minton, PhD – Certara

    Career Center Moderator: Mark Lovern, PhD – Certara

    Career Center Speaker: Dave Mitchell, PhD – Certara

    Career Center Speaker: Jill Fiedler-Kelly, MS, FISoP – Simulations Plus, Inc., Cognigen division

    Career Center Speaker: Alexander Berg, PharmD, PhD, FCP – Simulations Plus

    Career Center Speaker: Ben Suttle, PhD – qPharmetra

    Career Development

  • 9:00 AM – 10:00 AM ET
    Understanding Formulation Challenges Early to Accelerate Timelines for FIH Trials

    Partner Presentation Speaker: Russell Scammell – Charles River Laboratories

    Partner Presentation Speaker: Darren Matthews – Charles River Laboratories

    Preclinical Development

  • 9:00 AM – 10:30 AM ET
    Symposium: Analytical and Predictive Approaches in Drug Development and Manufacturing (CE)

    Moderator: Sayantan Chattoraj, Ph.D. – GSK

    Manufacturing & Analytical Characterization – Chemical

  • 9:00 AM – 10:30 AM ET
    Symposium: COVID Pandemic and Beyond: Role of Clinical Pharmacology in Development of Non-COVID and COVID Drugs (BM)

    Clinical Pharmacology – Biomolecular

  • 9:00 AM – 10:30 AM ET
    Symposium: COVID Pandemic and Beyond: Role of Clinical Pharmacology in Development of Non-COVID and COVID Drugs (CE)

    Moderator: Sandhya Girish, M.Pharm, PhD – Gilead Sciences

    Clinical Pharmacology – Chemical

  • 9:00 AM – 10:30 AM ET
    Symposium: Recent Development in Prophylactic Therapies and Vaccines (BM)

    Moderator: Douglas Burdette, Ph.D. – Moderna Therapeutics

    Formulation and Delivery – Biomolecular

  • 9:00 AM – 11:00 AM ET
    Symposium: Analytical and Predictive Approaches in Drug Development and Manufacturing (BM)

    Moderator: Paul Logan Walsh, PhD – AbbVie

    Manufacturing & Analytical Characterization – Biomolecular

  • 9:00 AM – 11:00 AM ET
    Symposium: Beyond Legacy Therapeutics - Navigating the Path Less Traveled (BM)

    Moderator: Lynn Kamen, PhD – BioAgilytix Labs

    Bioanalytics – Biomolecular

  • 9:00 AM – 11:00 AM ET
    Symposium: Beyond Legacy Therapeutics - Navigating the Path Less Traveled (CE)

    Moderator: Jian Chen, PhD – Bristol-Myers Squibb

    Bioanalytics – Chemical

  • 9:00 AM – 11:00 AM ET
    Symposium: Bridging The Cross-Functional Silos To Expedite Compound Progression Into The Clinic (BM)

    Moderator: Morgan B. Giles, PhD – Merck & Co. Inc

    Preclinical Development – Biomolecular

  • 9:00 AM – 11:00 AM ET
    Symposium: Bridging The Cross-Functional Silos To Expedite Compound Progression Into The Clinic (CE)

    Moderator: Sarah Cash – University of Toronto

    Preclinical Development – Chemical

  • 9:00 AM – 11:00 AM ET
    Symposium: Oncotargets: Challenges & Opportunities

    Moderator: Stephen Hatfield, PhD – Northeastern University

    Discovery and Basic Research

  • 9:00 AM – 11:00 AM ET
    Symposium: Rapid Discovery of Therapeutics: Past Experience and Computational Approaches

    Moderator: Alexander Tropsha, PhD – University of North Carolina

    Discovery and Basic Research

  • 9:00 AM – 11:00 AM ET
    Symposium: Recent Development in Prophylactic Therapies and Vaccines (CE)

    Moderator: Rodrigo Cristofoletti, PhD – University of Florida

    Formulation and Delivery – Chemical

  • 9:30 AM – 10:00 AM ET
    Coffee Break in the Solution Center
  • 9:30 AM – 10:30 AM ET
    Evaluation of Advanced Container Surface Technologies for Sensitive Drugs Products

    Formulation and Delivery

  • 9:30 AM – 10:30 AM ET
    Speaker Spotlight: Advances in Co-Processed APIs,  Transformative Technologies to Optimize Physicochemical Properties

    Spotlight Speaker: Luke Schenck – Merck & Co., Inc.

    Moderator: Maria Cruanes, PhD Chemistry (she/her/hers) – Organon

    Manufacturing & Analytical Characterization

  • 9:30 AM – 10:30 AM ET
    Speaker Spotlight: The Intersection of Hepatic Transporters and Drug-Induced Liver Injury: Preclinical Tools to Advance Mechanistic Understanding and Precision Medicine

    Spotlight Speaker: Kim L.R Brouwer, PharmD, PhD – UNC Eshelman School of Pharmacy The University of North Carolina at Chapel Hill

    Moderator: Mattie Hartauer – University of North Carolina - Chapel Hill

    Preclinical Development

  • 9:30 AM – 10:30 AM ET
    Speaker Spotlight: Translational Biomarkers for Rare Disease Gene Therapies, Limitations and Opportunities

    Spotlight Speaker: Mohamed Hassanein, PhD – Pfizer

    Moderator: Shazia Baig, PhD (she/her/hers) – BioAgilytix

    Clinical Pharmacology – Biomolecular

  • 9:30 AM – 10:30 AM ET
    Successful Collaboration Delivering Impactful Solutions to Novel Challenges in Pharma

    Partner Presentation Speaker: Paulina Pinedo-Gonzalez, PhD – SGS Health Science

    Partner Presentation Speaker: Simon Szwandt, PhD (he/him/his) – Thermo Fisher Scientific

    Manufacturing & Analytical Characterization

  • 10:00 AM – 11:00 AM ET
    Hot Topic: Careers in Biopharmaceutics Related Fields: A Career Development Panel Discussion

    Hot Topic Moderator: Siddhi S. Hate, PhD – Eli Lilly and Company

    Hot Topic Speaker: David C. Sperry, PhD – Eli Lilly and Company

    Hot Topic Speaker: Andre Hermans, PhD – Merck & Co., Inc.

    Hot Topic Speaker: Nikoletta Fotaki, PhD – University of Bath

    Government Speaker: Paul Seo, PhD – US Food and Drug Administration, Invited

    Formulation and Delivery – Chemical

  • 10:00 AM – 11:00 AM ET
    Meet The Employers: Hosted by Certara
  • 10:30 AM – 11:30 AM ET
    Nose to Brain Delivery: possibility or a pipedream?

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

    Partner Presentation Speaker: Julie D. Suman, PhD – Aptar Pharma

    Preclinical Development

  • 10:30 AM – 11:30 AM ET
    Special Poster Collection - 2022 PharmSci 360 Best Posters
  • 10:30 AM – 11:30 AM ET
    Strategically Design Your Path to Career Success

    Career Center Speaker: Nicole Buist, PhD – Merck & Co.

    Career Center Speaker: Ronald L. Smith, PhD, FAAPS – Pharmawyze

    Career Center Speaker: Anthony Leone, PhD – BMS

    Career Center Speaker: Tapan Das, PhD, FAAPS – Bristol Myers Squibb

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

    Career Development

  • 11:00 AM – 12:00 PM ET
    A toxicologist’s viewpoint on the safe manufacturing of oncology drugs

    Partner Presentation Speaker: Joe Galati, PhD – Thermo Fisher Scientific

    Manufacturing & Analytical Characterization

  • 11:00 AM – 12:00 PM ET
    Patient Centric Sampling to Enable Decentralization of Clinical Trials

    Partner Presentation Speaker: Stephanie Cape, PhD (she/her/hers) – Labcorp

    Bioanalytics

  • 11:00 AM – 1:30 PM ET
    Dedicated Solution Center Hours
  • 11:15 AM – 12:00 PM ET
    Characterization of Dextran/Heparin via GPC/SEC Advanced detection with 21-CFR11-Compliant software

    Chalk Talk Presenter: Derek Lohmann, PhD – PSS USA Inc

    Chalk Talk Presenter: Lorena Lopez, BSc / MBA – Agilent Technologies

    Manufacturing & Analytical Characterization

  • 11:15 AM – 12:00 PM ET
    Nitrosamine Risk Management and Analytical Testing

    Chalk Talk Presenter: Caddy Hobbs, PhD (she/her/hers) – Cambrex

    Manufacturing & Analytical Characterization

  • 11:15 AM – 12:00 PM ET
    Supporting R&D with Nondilutive Federal Funding

    Chalk Talk Presenter: Stephen Morris, PhD – EverGlade Consulting

    Discovery and Basic Research

  • 11:45 AM – 1:30 PM ET
    AAPS Student Meet Up
  • 12:00 PM – 1:00 PM ET
    Developing Sustainable Environments for DE&I Across a Global Workplace

    Career Center Speaker: Stephanie Barrett, PhD – Merck & Co., Inc.

    Career Center Speaker: Neil Strotman, PhD – Merck & Co., Inc.

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

    Career Center Speaker: Alita Miller, MS – Oral Formulation Sciences, Merck & Co., Inc.

    Career Development

  • 12:00 PM – 1:00 PM ET
    Mass spectrometry Based Characterization of Oligonucleotides

    Partner Presentation Speaker: Michael Knierman – Agilent Technologies

    Manufacturing & Analytical Characterization

  • 12:00 PM – 2:00 PM ET
    The AAPS Journal Editor Strategy Meeting (by invitation only)
  • 12:30 PM – 1:15 PM ET
    AAPS Regulatory Sciences Community Membership Meeting

    Community Leader: Raja B. Velagapudi, PhD – Tolmar, Inc.

  • 12:30 PM – 1:15 PM ET
    NextGen – CMC. Innovation, Digitization, Contextualization, and Analytics of Manufacturing Data

    Chalk Talk Presenter: Vishal Prasad – Mareana, Inc.

    Manufacturing & Analytical Characterization

  • 12:30 PM – 1:15 PM ET
    Sprinkle Formulations: A Convenient Dosing Platform for Special Populations

    Chalk Talk Presenter: Srinivasan Shanmugam, PhD – Adare Pharma Solutions

    Formulation and Delivery

  • 12:30 PM – 1:30 PM ET
    FDA Modernization ACT: What's the Future of Current Test Systems

    Partner Presentation Speaker: Jake McDonald, PhD – Lovelace Biomedical

    Partner Presentation Speaker: Jim McKim, PhD, DABT – LifeNet Health

    Partner Presentation Speaker: Lorna Ewart, PhD – Emulate

    Preclinical Development

  • 12:30 PM – 1:30 PM ET
    Mutagenic Impurities Analysis: Response Factor Variation on Quantitative Accuracy

    Partner Presentation Speaker: Adam Eason, MSc (he/him/his) – Jordi Labs

    Manufacturing & Analytical Characterization

  • 12:30 PM – 1:30 PM ET
    Special Poster Collection
  • 1:30 PM – 2:30 PM ET
    Equip yourself for independence!

    Career Center Speaker: Prathap Nagaraja Shastri, PhD – Johnson and Johnson

    Career Center Moderator: Pankajini Mallick, PhD – Neurocrine Biosciences

    Career Center Speaker: Nimita Dave, PhD – Nimbus Therapeutics

    Career Development

  • 1:30 PM – 2:30 PM ET
    Keynote: COVID-19: A Disruptive Force Transforming Clinical Pharmacology and Medicines Development

    Keynote Speaker: Brian Corrigan, PhD – Pfizer

    Moderator: Vaishali Sahasrabudhe, PhD (she/her/hers) – Pfizer Inc.

    Clinical Pharmacology

  • 1:30 PM – 2:30 PM ET
    Keynote: Designing Function-Selective Kinase Inhibitors: Taking an Idea to Clinical Trials

    Keynote Speaker: Paul Shapiro, PhD – University of Maryland School of Pharmacy

    Moderator: Alexander Tropsha, PhD – University of North Carolina

    Discovery and Basic Research

  • 1:30 PM – 2:30 PM ET
    Keynote: Development of mRNA based Covid Vaccine

    Keynote Speaker: Nicholas Warne, PhD – Pfizer Inc.

    Moderator: Shuhua Bai, PhD – Husson University

    Formulation and Delivery – Biomolecular

  • 1:30 PM – 2:30 PM ET
    Keynote: Dragons and Invisible Helicopters: Evolution of Analytical Technologies

    Keynote Speaker: Ian Mangion, PhD – Merck

    Moderator: Paul Logan Walsh, PhD – AbbVie

    Manufacturing & Analytical Characterization – Biomolecular

  • 1:30 PM – 2:30 PM ET
    Keynote: Integrated Risk/Benefit Assessment to Inform Decision Making in Drug Discovery 

    Preclinical Development – Chemical

  • 1:30 PM – 2:30 PM ET
    Keynote: Keynote: A Vision for Accelerating Oral Solid Dosage Drug Product Development Using Material Science and Simulation

    Manufacturing & Analytical Characterization – Chemical

  • 1:30 PM – 2:30 PM ET
    Keynote: Oligonucleotides, Where We Started, Where We Stand, and Where We Would Like Go

    Keynote Speaker: Troy Voelker, PhD – Pyxant Labs Inc.

    Moderator: Matthew S. Halquist, PhD – Virginia Commonwealth University

    Bioanalytics – Chemical

  • 1:30 PM – 2:30 PM ET
    Keynote: Opportunities and Challenges in Translating Novel Discoveries into Biologic Drugs in R&D: From Oncology to Neurology

    Keynote Speaker: Sara Kenkare-Mitra, PhD – Alector

    Moderator: Adrian Fretland, PhD – Repare Therapeutics

    Preclinical Development – Biomolecular

  • 1:30 PM – 2:30 PM ET
    Keynote: Prophylactic Therapies in Global Health Applications?

    Keynote Speaker: Niya Bowers, PhD – Bill & Melinda Gates Foundation

    Moderator: Nikoletta Fotaki, PhD – University of Bath

    Formulation and Delivery – Chemical

  • 1:30 PM – 2:30 PM ET
    Keynote: Redox Biology and Cancer Therapeutics

    Keynote Speaker: Kenneth Tew, PHD, DSc, FASPET – Medical University of South Carolina

    Moderator: Tamer E. Fandy, PhD, BCGP, FCP – University of Charleston

    Discovery and Basic Research

  • 1:30 PM – 2:30 PM ET
    Keynote: The Future of Medicine is Here. Are We (Bioanalytically) Ready?

    Keynote Speaker: Boris Gorovits, PhD – Sana Biotechnology

    Moderator: Lynn Kamen, PhD – BioAgilytix Labs

    Bioanalytics – Biomolecular

  • 1:30 PM – 2:30 PM ET
    Long Acting Injectables- Predictive approaches in drug development and manufacturing

    Manufacturing & Analytical Characterization

  • 2:00 PM – 3:00 PM ET
    Co-processed HPMC–mannitol: A directly compressible excipient for controlled release

    Tech Spotlight Speaker: Talles Ernica, MS – Roquette America Inc.

    Formulation and Delivery

  • 2:00 PM – 3:00 PM ET
    Meet The Employers: Hosted by AstraZeneca
  • 2:00 PM – 3:00 PM ET
    Serial Two-Photon Plus: Translating Ex Vivo to In Vivo Imaging

    Tech Spotlight Speaker: Stefan Linehan, MS – TissueVision Inc.

    Preclinical Development

  • 2:30 PM – 3:00 PM ET
    Coffee Break in the Solution Center
  • 2:30 PM – 3:30 PM ET
    Hot Topic: Emerging Use of Real World Data to Address Data Gaps in Clinical Pharmacology: Opportunities & Challenges

    Hot Topic Moderator: Simon Dagenais, PhD, MSc – Pfizer

    Hot Topic Speaker: Abie Ekangaki, PhD – Premier Research

    Hot Topic Speaker: Marc Gastonguay, PhD – Metrum Research Group

    Hot Topic Speaker: Simon Dagenais, PhD, MSc – Pfizer

    Clinical Pharmacology

  • 2:30 PM – 3:30 PM ET
    Speaker Spotlight: Complex Generics

    Government Speaker: Sam Raney, PhD – US Food and Drug Adminstration

    Moderator: Jaymin C. Shah, PhD – Pfizer Worldwide Research and Development

    Formulation and Delivery

  • 2:30 PM – 3:30 PM ET
    Speaker Spotlight: Understanding Clinical Immunogenicity Impact for a Bispecific Antibody Agonist

    Spotlight Speaker: Yanqiu (Emma) Liu, PhD – Genentech

    Moderator: William Hallet, PhD (he/him/his) – Janssen R&D / J&J

    Bioanalytics – Biomolecular

  • 2:30 PM – 3:30 PM ET
    Special Poster Collection
  • 3:00 PM – 3:45 PM ET
    Rapid Fire: Analytical and Predictive Approaches in Drug Development and Manufacturing (BM)

    Rapid Fire Moderator: Jianmei D. Kochling, PhD, MBA – Sanofi

    Manufacturing & Analytical Characterization – Biomolecular

  • 3:00 PM – 3:45 PM ET
    Rapid Fire: Bridging The Cross-Functional Silos To Expedite Compound Progression Into The Clinic (BM)

    Rapid Fire Moderator: HaiAn Zheng, PhD – Albany College of Pharmacy and Health Sciences

    Preclinical Development – Biomolecular

  • 3:00 PM – 3:45 PM ET
    Rapid Fire: Oncotargets: Challenges & Opportunities

    Rapid Fire Moderator: Muhammad D. Hussain, PhD (he/him/his) – Husson University

    Discovery and Basic Research

  • 3:00 PM – 3:45 PM ET
    Rapid Fire: Recent Development in Prophylactic Therapies and Vaccines (BM)

    Rapid Fire Moderator: Jayachandra Babu Ramapuram, PhD (he/him/his) – Auburn University

    Formulation and Delivery – Biomolecular

  • 3:00 PM – 4:00 PM ET
    A Look into the Future of Bioanalytics

    Partner Presentation Speaker: Barry Jones, PhD – Q2 Solutions

    Partner Presentation Speaker: Todd Lusk (he/him/his) – Q2 Solutions

    Bioanalytics

  • 3:00 PM – 4:00 PM ET
    Career Transitions Between Academia Industry and Regulatory Agency

    Career Center Moderator: Hiten J. Gutka, PhD – BMS

    Career Center Speaker: Deborah S. Goldberg, PhD – Department of Chemical and Biomolecular Engineering University of Maryland

    Government Speaker: Rohit Kolhatkar

    Career Center Speaker: Sachin Lohani, PhD – Merck

    Career Development

  • 3:00 PM – 4:00 PM ET
    Happy Hour Sponsored by Alturas Analytics
  • 3:00 PM – 4:00 PM ET
    Happy Hour Sponsored by CoreRx
  • 3:00 PM – 4:00 PM ET
    Happy Hour Sponsored by Gattefossé Corporation
  • 3:00 PM – 4:00 PM ET
    Meet The Employers: Hosted by AbbVie
  • 3:00 PM – 4:00 PM ET
    Rapid Fire: Analytical and Predictive Approaches in Drug Development and Manufacturing (CE)

    Rapid Fire Moderator: Rosalind Ang, PhD – Merck & Co., Inc.

    Manufacturing & Analytical Characterization – Chemical

  • 3:00 PM – 4:00 PM ET
    Rapid Fire: Beyond Legacy Therapeutics - Navigating the Path Less Traveled (BM)

    Rapid Fire Moderator: Chad J. Briscoe, PhD – BioAgilytix Labs

    Bioanalytics – Biomolecular

  • 3:00 PM – 4:00 PM ET
    Rapid Fire: Beyond Legacy Therapeutics - Navigating the Path Less Traveled (CE)

    Rapid Fire Moderator: Amanda Hays, Ph.D. – BioAgilytix

    Bioanalytics – Chemical

  • 3:00 PM – 4:00 PM ET
    Rapid Fire: Bridging The Cross-Functional Silos To Expedite Compound Progression Into The Clinic (CE)

    Rapid Fire Moderator: Haiqing Wang, PhD – Takeda

    Preclinical Development – Chemical

  • 3:00 PM – 4:00 PM ET
    Rapid Fire: COVID Pandemic and Beyond: Role of Clinical Pharmacology in Development of Non-COVID and COVID Drugs (BM)

    Rapid Fire Moderator: Hardik Mody, PhD – Johnson and Johnson

    Clinical Pharmacology – Biomolecular

  • 3:00 PM – 4:00 PM ET
    Rapid Fire: COVID Pandemic and Beyond: Role of Clinical Pharmacology in Development of Non-COVID and COVID Drugs (CE)

    Rapid Fire Moderator: Punit Marathe, PhD – Agios Pharmaceuticals

    Clinical Pharmacology – Chemical

  • 3:00 PM – 4:00 PM ET
    Rapid Fire: Rapid Discovery of Therapeutics: Past Experience and Computational Approaches

    Rapid Fire Moderator: Ryan Polli, PhD – Novartis Institutes for Biomedical Research

    Discovery and Basic Research

  • 3:00 PM – 4:00 PM ET
    Rapid Fire: Recent Development in Prophylactic Therapies and Vaccines (CE)

    Rapid Fire Moderator: Suman A. Luthra, PhD – Merck & Co., Inc.

    Formulation and Delivery – Chemical

  • 3:00 PM – 4:00 PM ET
    Start-up Pavilion Meet & Greet and New England Brewery Tour
  • 3:30 PM – 4:30 PM ET
    A Patient Centric Solution for Development of Oral Dosage Forms

    Partner Presentation Speaker: Karunakar Sukuru, PhD – Catalent, Inc.

    Formulation and Delivery

  • 3:30 PM – 4:30 PM ET
    Happy Hour Sponsored by WuXi AppTec
  • 3:30 PM – 4:30 PM ET
    Hot Topic: Learnings From Managing Immunogenicity Risks to Protein Based Therapeutics; Need to Pivot for Cell and Gene Therapies or 1 Size Fits All?

    Hot Topic Moderator: Amy S. Rosenberg, MD – Epivax

    Preclinical Development – Biomolecular

  • 3:30 PM – 4:30 PM ET
    Special Poster Collection
  • 3:30 PM – 4:30 PM ET
    Using HME for Low-Cost, High-Volume, Excipient-Enabled Antimalarials for Underserved Populations

    Partner Presentation Speaker: Gavin P. Andrews, PhD (he/him/his) – Queen’s University Belfast

    Partner Presentation Speaker: Victoire de Margerie, PhD – Rondol Industrie

    Partner Presentation Speaker: Lindsay M. Johnson, PhD – BASF Corporation

    Formulation and Delivery

  • 3:45 PM – 4:45 PM ET
    Happy Hour Sponsored by Adare Pharma Solutions
  • 3:45 PM – 4:45 PM ET
    Happy Hour Sponsored by Boston Analytical
  • 4:00 PM – 5:00 PM ET
    AAPS Pharmacometrics Community Membership Meeting

    Community Leader: Dipti Pawaskar

  • 4:00 PM – 5:00 PM ET
    AAPS Women in Pharmaceutical Science Community Membership Meeting

    Community Leader: Amy Lavelle, PhD (she/her/hers) – PPD Laboratories

  • 5:00 PM – 6:00 PM ET
    AAPS Biomarkers & Precision Medicine Community Membership Meeting

    Community Leader: Amanda Hays, Ph.D. – BioAgilytix

  • 5:00 PM – 6:00 PM ET
    AAPS Gene & Cell Therapy Products Community Membership Meeting

    Community Leader: Prathap Nagaraja Shastri, PhD – Johnson and Johnson

  • 5:00 PM – 6:00 PM ET
    AAPS Global Health Community Membership Meeting

    Community Leader: Joleen T. White, PhD – Bill & Melinda Gates Medical Research Institute

  • 5:00 PM – 6:00 PM ET
    AAPS In Vitro Release & Dissolution Testing Community Membership Meeting

    Community Leader: Andre Hermans, PhD – Merck & Co., Inc.

  • 5:00 PM – 6:00 PM ET
    AAPS Inhalation & Nasal Community Membership Meeting

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

  • 5:00 PM – 6:00 PM ET
    AAPS Oral Biopharmaceutics & Absorption Modeling Community Membership Meeting

    Community Leader: Nikoletta Fotaki, PhD – University of Bath

  • 5:00 PM – 6:00 PM ET
    AAPS Protein Purification, Storage, Transportation, and Drug-Device Combination Community Membership Meeting

    Community Leader: Mary E. Krause, Ph.D. – Drug Product Development / Bristol Myers Squibb

  • 5:00 PM – 6:00 PM ET
    AAPS Stability Community Membership Meeting
  • 5:00 PM – 6:00 PM ET
    AAPS Sterile Products Community Membership Meeting

    Community Leader: Smeet Deshmukh, Ph.D. – Merck & Co., Inc.,

  • 5:00 PM – 6:00 PM ET
    AAPS Therapeutic Product Immunogenicity Community Membership Meeting

    Community Leader: Yi Wen, PhD – Eli Lilly and Company

  • 5:00 PM – 7:00 PM ET
    University of Kansas Pharmaceutical Chemistry Alumni Reception (Invitation Only)
  • 5:00 PM – 7:00 PM ET
    University of Michigan College of Pharmacy Alumni and Friends Reception
  • 5:30 PM – 7:30 PM ET
    Minnesota Alumni Reception
  • 5:30 PM – 7:30 PM ET
    University at Buffalo, School of Pharmacy and Pharmaceutical Sciences, Alumni Reception
  • 5:30 PM – 7:30 PM ET
    University of Texas - Austin, College of Pharmacy Alumni & Friends Reception
  • 5:30 PM – 7:30 PM ET
    University of Wisconsin-Madison Alumni & Friends Reception
  • 5:30 PM – 8:00 PM ET
    University of Utah Pharmaceutics & Pharmaceutical Chemistry/Molecular Pharmaceutics Alumni Event
  • 6:00 PM – 8:00 PM ET
    2022 AAPS OSU Alumni and Friends Reception (Invitation Only)
  • 6:00 PM – 8:00 PM ET
    Purdue University College of Pharmacy Alumni and Friends Reception
  • 6:00 PM – 8:00 PM ET
    St. John's College of Pharmacy and Health Sciences
  • 6:00 PM – 9:00 PM ET
    Vietnamese Association of Pharmaceutical Scientists
  • 7:00 PM – 9:00 PM ET
    President's Reception (by invitation only)
  • Tuesday, October 18, 2022
  • 7:00 AM – 8:30 AM ET
    Mentoring Breakfast
  • 7:30 AM – 5:00 PM ET
    Registration Hours
  • 7:30 AM – 5:00 PM ET
    Speaker Ready Room
  • 8:30 AM – 9:00 AM ET
    Prologue: Advancements in Translational PK/PD Approaches Towards Novel Biologic Modalities

    Prologue Speaker: Prathap Nagaraja Shastri, PhD – Johnson and Johnson

    Preclinical Development – Biomolecular

  • 8:30 AM – 9:00 AM ET
    Prologue: Application of PBPK Modeling to Support Dose Selection in Underrepresented Populations

    Prologue Speaker: Rodrigo Cristofoletti, PhD – University of Florida

    Clinical Pharmacology – Biomolecular

  • 8:30 AM – 9:00 AM ET
    Prologue: Current Status and Gaps in Predicting the Food Effect

    Prologue Speaker: Xinyuan Zhang, PhD – Daiichi Sankyo, Inc.

    Preclinical Development – Chemical

  • 8:30 AM – 9:00 AM ET
    Prologue: Developmental Challenges with Antibody-Drug Conjugates

    Prologue Speaker: Manoj Charati, PhD – Merck

    Manufacturing & Analytical Characterization – Biomolecular

  • 8:30 AM – 9:00 AM ET
    Prologue: Patient Centric Bioanalysis: Where We’ve Been and Where We’re Going

    Prologue Speaker: Joleen T. White, PhD – Bill & Melinda Gates Medical Research Institute

    Bioanalytics – Chemical

  • 8:30 AM – 9:00 AM ET
    Prologue: PBPK/PBBM to Inform the Bioequivalence Safe Space, Food Effects, and pH-Mediated DDIs

    Prologue Speaker: Tycho Heimbach, PhD – Pharmaceutical Sciences, Merck & Co., Inc., Rahway, NJ USA

    Clinical Pharmacology – Chemical

  • 8:30 AM – 9:00 AM ET
    Prologue: Practical Considerations for Implementing Biomarkers in Clinical Trials, Challenges and Opportunities

    Prologue Speaker: Lakshmi Amaravadi, PhD – Dewpoint Therapeutics

    Bioanalytics – Biomolecular

  • 8:30 AM – 9:00 AM ET
    Prologue: Regulation of Cannabinoids for Histone Modification in Resistant Breast Cancer

    Prologue Speaker: Mandip S. Sachdeva, PhD – Florida A&M University

    Discovery and Basic Research

  • 8:30 AM – 9:00 AM ET
    Prologue: Rethinking ASD Particle Architecture and Performance Utilizing Advances in Engineering Technologies

    Prologue Speaker: Luke Schenck – Merck & Co., Inc.

    Formulation and Delivery – Chemical

  • 8:30 AM – 9:00 AM ET
    Prologue: Science-Based Formulation and Process Development of Biologicals: Physical Chemical and Analytical Aspects

    Prologue Speaker: Evgenyi Shalaev, PhD – Abbvie

    Formulation and Delivery – Biomolecular

  • 8:30 AM – 9:00 AM ET
    Prologue: The Microbiome in Pharmaceutical Development and Disease

    Prologue Speaker: Matthew Henke, PhD – University of Illinois Chicago

    Discovery and Basic Research

  • 8:30 AM – 4:30 PM ET
    Coffee Station
  • 8:30 AM – 4:30 PM ET
    Free Professional Headshots
  • 8:30 AM – 4:30 PM ET
    LinkedIn Profile Critiques & Resume Reviews
  • 8:30 AM – 5:00 PM ET
    Solution Center Hours & Poster Presentations
  • 9:00 AM – 10:00 AM ET
    Hot Topic: Phase Appropriate Design Controls for Combination Products during Clinical Development

    Hot Topic Speaker: Kim Huynh-Ba, MS, PMP, FAAPS – Pharmalytik

    Hot Topic Speaker: Jiaying Shen, PhD – Merck & Co., Inc.

    Hot Topic Speaker: Gretchen Vandal, MS, MBA – Takeda

    Hot Topic Moderator: Shrinivas (Cheenu) Murti, PhD, MBA – Takeda Pharmaceutical Company Limited

    Manufacturing & Analytical Characterization – Chemical

  • 9:00 AM – 10:00 AM ET
    Overcoming Today's Pharmaceutical Formulation Challenges with Aprecia's In-Blister Manufacturing

    Formulation and Delivery

  • 9:00 AM – 10:00 AM ET
    Promoting Yourself and Increasing Your Visibility in the Workplace

    Career Center Moderator: Mustafa Bookwala, M.S. – Duquesne University

    Career Center Moderator: Stacey Axler – AAPS

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

    Career Center Speaker: Lauren Stevenson, PhD – Immunologix Laboratories

    Career Development

  • 9:00 AM – 10:30 AM ET
    Symposium: Epigenetic Drug Targets and Epigenetic Modifiers

    Moderator: Mandip S. Sachdeva, PhD – Florida A&M University

    Discovery and Basic Research

  • 9:00 AM – 10:30 AM ET
    Symposium: Microbiome: Impact in Pharmaceutical Development and Disease

    Moderator: Matthew Henke, PhD – University of Illinois Chicago

    Discovery and Basic Research

  • 9:00 AM – 10:30 AM ET
    Symposium: Novel Manufacturing Approaches in Pharmaceuticals and Biopharmaceuticals (BM)

    Moderator: Manoj Charati, PhD – Merck

    Manufacturing & Analytical Characterization – Biomolecular

  • 9:00 AM – 10:30 AM ET
    Symposium: Novel Manufacturing Approaches in Pharmaceuticals and Biopharmaceuticals (CE)

    Moderator: Maria Cruanes, PhD Chemistry (she/her/hers) – Organon

    Manufacturing & Analytical Characterization – Chemical

  • 9:00 AM – 11:00 AM ET
    Symposium: Advances in Engineering Technologies for Drug Substance and Enabling Drug Product (BM)

    Moderator: Evgenyi Shalaev, PhD – Abbvie

    Formulation and Delivery – Biomolecular

  • 9:00 AM – 11:00 AM ET
    Symposium: Advances in Engineering Technologies for Drug Substance and Enabling Drug Product (CE)

    Moderator: Luke Schenck – Merck & Co., Inc.

    Formulation and Delivery – Chemical

  • 9:00 AM – 11:00 AM ET
    Symposium: Breaking Through Barriers in Preclinical Development To Improve Clinical Translation (BM)

    Moderator: Nagendra V. Chemuturi, GDMPK – Takeda

    Preclinical Development – Biomolecular

  • 9:00 AM – 11:00 AM ET
    Symposium: Breaking Through Barriers in Preclinical Development To Improve Clinical Translation (CE)

    Moderator: Yasuhiro Tsume, PhD – Merck & Co., Inc.

    Preclinical Development – Chemical

  • 9:00 AM – 11:00 AM ET
    Symposium: Model Informed Drug Development (MIDD): Role in Dose Selection, Vulnerable Populations, and Biowaivers (BM)

    Clinical Pharmacology – Biomolecular

  • 9:00 AM – 11:00 AM ET
    Symposium: Model Informed Drug Development (MIDD): Role in Dose Selection, Vulnerable Populations, and Biowaivers (CE)

    Clinical Pharmacology – Chemical

  • 9:00 AM – 11:00 AM ET
    Symposium: Sample Challenges, Yet Opportunities (BM)

    Moderator: Christian Braithwaite, M.S. – BioAgilytix

    Bioanalytics – Biomolecular

  • 9:00 AM – 11:00 AM ET
    Symposium: Sample Challenges, Yet Opportunities (CE)

    Moderator: Matthew S. Halquist, PhD – Virginia Commonwealth University

    Bioanalytics – Chemical

  • 9:00 AM – 4:00 PM ET
    Career Fair
  • 9:30 AM – 10:00 AM ET
    Coffee Break in the Solution Center
  • 9:30 AM – 10:30 AM ET
    Platform Usage to Support Advanced Drug Modalities

    Partner Presentation Speaker: Jim McNally, PhD – BioAgilytix

    Bioanalytics

  • 9:30 AM – 10:30 AM ET
    Speaker Spotlight: Gene Therapy Delivery Using Recombinant Adeno-Associated Virus

    Spotlight Speaker: Dan Wang, PhD – UMass Chan Medical School

    Moderator: Tianzhi Yang, PhD – Husson University

    Formulation and Delivery

  • 9:30 AM – 10:30 AM ET
    Speaker Spotlight: New Tools for Pharmaceutical Research Based on Tetrazine Ligation

    Moderator: Zhenzhen Dong, PhD (she/her/hers) – Adesis Inc.

    Spotlight Speaker: Joseph Fox, PhD – University of Delaware

    Discovery and Basic Research

  • 9:30 AM – 10:30 AM ET
    Speaker Spotlight: Post-Pandemic Configurations for Regulated Bioanalysis

    Moderator: HsinPin Ho, PhD – Bristol Myers Squibb

    Bioanalytics

  • 9:30 AM – 10:30 AM ET
    The Evolution of Separations and Sample Preparation Technologies for Biopharma

    Partner Presentation Speaker: John C. Gebler, PhD – Phenomenex

    Bioanalytics

  • 10:30 AM – 11:30 AM ET
    Design Your Career Board of Directors

    Career Center Speaker: Susan Morris, M.Ed., CPCC, ACC – Susan Morris Coaching

    Career Development

  • 10:30 AM – 11:30 AM ET
    Exploring Protein Degrader Drug Delivery Challenges

    Partner Presentation Speaker: Nathan Bennette, M.S. – Catalent

    Preclinical Development

  • 10:30 AM – 11:30 AM ET
    Special Poster Collection
  • 11:00 AM – 12:00 PM ET
    New functional polyvinyl alcohol grade for optimized amorphous solid dispersions

    Partner Presentation Speaker: Thomas Kipping, PhD – MilliporeSigma

    Formulation and Delivery

  • 11:00 AM – 12:00 PM ET
    Working with a CDMO to accelerate Lead to FIH journey

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

    Formulation and Delivery

  • 11:00 AM – 1:30 PM ET
    Dedicated Solution Center Hours
  • 11:15 AM – 12:00 PM ET
    AAPS Excipients Community Membership Meeting

    Community Leader: Allison E. Radwick, PhD – Symbiotix

  • 11:15 AM – 12:00 PM ET
    Combined In-Silico & Experimental Approach for Solid Form Crystallization Development

    Chalk Talk Presenter: Yuriy Abramov, PhD – J-Star Research Inc.

    Chalk Talk Presenter: Harsh Shah, PhD – J-Star Research Inc.

    Formulation and Delivery

  • 11:15 AM – 12:00 PM ET
    Improving oral absorption to rapidly advance early phase compounds

    Chalk Talk Presenter: Deanna M. Mudie, PhD – Lonza Small Molecules

    Formulation and Delivery

  • 12:00 PM – 1:00 PM ET
    Exploring Ways to Maintain your Network and Keep It Alive

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

    Career Center Speaker: Jianmei D. Kochling, PhD, MBA – Sanofi

    Career Center Moderator: Kim Huynh-Ba, MS, PMP, FAAPS – Pharmalytik

    Career Development

  • 12:00 PM – 1:00 PM ET
    Online Amino Acid Analysis for Spend Media Control

    Partner Presentation Speaker: Lorena Lopez, BSc / MBA – Agilent Technologies

    Manufacturing & Analytical Characterization

  • 12:30 PM – 1:15 PM ET
    AAPS Topical and Transdermal Community Membership Meeting

    Community Leader: Lakshmi Raghavan, PhD – Solaris Pharma Corporation

  • 12:30 PM – 1:15 PM ET
    Liposome formulation in cancer immunotherapy and challenges on early-stage development

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

    Formulation and Delivery

  • 12:30 PM – 1:15 PM ET
    Speaker Spotlight: Ask A Regulator

    Spotlight Speaker: Brian Booth, PhD – FDA

    Bioanalytics

  • 12:30 PM – 1:30 PM ET
    Oligonucleotide Analysis: How You Can Go Faster and Further?

    Partner Presentation Speaker: Andrew Argo, MSc (he/him/his) – Waters Corp.

    Manufacturing & Analytical Characterization

  • 12:30 PM – 1:30 PM ET
    Solubility Enhancement Technology to Develop Particle-Engineered Free-Flowing Amorphous Solid Dispersion

    Partner Presentation Speaker: Mohammed Irfan Syed, M.S. – Evonik Corporation

    Formulation and Delivery

  • 12:30 PM – 1:30 PM ET
    Special Poster Collection
  • 1:30 PM – 2:30 PM ET
    Keynote: Applications of MIDD for Dose Selection, Specific Populations, and Beyond: The Advantages of Bracketing

    Keynote Speaker: Julie Bullock, PharmD – Certara

    Moderator: Vaishali Sahasrabudhe, PhD (she/her/hers) – Pfizer Inc.

    Clinical Pharmacology

  • 1:30 PM – 2:30 PM ET
    Keynote: Challenges and Opportunities in the ADC Manufacturing

    Keynote Speaker: Sreedhara Alavattam, PhD (he/him/his) – Genentech, Inc.

    Moderator: Manoj Charati, PhD – Merck

    Manufacturing & Analytical Characterization – Biomolecular

  • 1:30 PM – 2:30 PM ET
    Keynote: Fluidic Processes for Bottom-Up Engineering of Particles to Enable Drug Product Performance

    Keynote Speaker: Patrick Doyle, PhD – MIT

    Moderator: Jaymin C. Shah, PhD – Pfizer Worldwide Research and Development

    Formulation and Delivery – Chemical

  • 1:30 PM – 2:30 PM ET
    Keynote: From preclinical to clinical drug product development- a path for smooth transition

    Keynote Speaker: Sandra Suarez-Sharp, PhD – Simulations Plus, Inc.

    Moderator: Christine Bowman, PhD – Genentech

    Preclinical Development – Biomolecular

  • 1:30 PM – 2:30 PM ET
    Keynote: Gut Bugs and Fecal Transplants: Experience Over a Decade of Clinical Microbiome Research

    Keynote Speaker: Colleen R. Kelly, MD – Lifespan Physician Group

    Moderator: Richard A. Gemeinhart, PhD (he/him/his) – University of Illinois Chicago

    Discovery and Basic Research

  • 1:30 PM – 2:30 PM ET
    Keynote: How Lyndra Is Working to 'Reinvent Medicine for a Healthier World

    Moderator: Maria Cruanes, PhD Chemistry (she/her/hers) – Organon

    Keynote Speaker: Patricia Hurter, PhD (she/her/hers) – Lyndra Therapeutics Inc.

    Manufacturing & Analytical Characterization – Chemical

  • 1:30 PM – 2:30 PM ET
    Keynote: Keys to Improving Clinical Predictability via Preclinical Development

    Keynote Speaker: Leslie Z. Benet, PhD – UCSF School of Pharmacy

    Moderator: Jae H. Chang, PhD – Exelixis

    Preclinical Development – Chemical

  • 1:30 PM – 2:30 PM ET
    Keynote: Preparing for the Renaissance of the Dried Microsample: Lessons Learned in Newborn Screening

    Bioanalytics – Chemical

  • 1:30 PM – 2:30 PM ET
    Keynote: Surrogate Matrices – A Creative Solution to Scarcity, or Simply Sound Science?

    Keynote Speaker: Lauren Stevenson, PhD – Immunologix Laboratories

    Moderator: Amanda Hays, Ph.D. – BioAgilytix

    Bioanalytics – Biomolecular

  • 1:30 PM – 2:30 PM ET
    Keynote: Targeting Epigenetic Regulator Mutations in Cancer

    Keynote Speaker: Keith D. Robertson, PhD – Mayo Clinic

    Moderator: Tamer E. Fandy, PhD, BCGP, FCP – University of Charleston

    Discovery and Basic Research

  • 1:30 PM – 2:30 PM ET
    Quality attributes and characterization of gene vectors using light scattering

    Partner Presentation Speaker: John Champagne, PhD – Wyatt Technology

    Bioanalytics

  • 1:30 PM – 2:30 PM ET
    Strategies for a Successful Job Interview

    Career Center Moderator: Nimita Dave, PhD – Nimbus Therapeutics

    Career Center Speaker: Jay Chapman, BS – Hughes and Associates

    Career Center Speaker: Patrick J. Marroum, PhD – AbbVie, Inc.

    Career Development

  • 2:00 PM – 3:00 PM ET
    Design and Manufacturing of Polymeric Long-Acting Injectable Products

    Partner Presentation Speaker: Tom Tice, PhD – Evonik

    Formulation and Delivery

  • 2:00 PM – 3:00 PM ET
    Exponentially Expanding Science: Regulatory Acceptance and Use Cases for PBPK

    Preclinical Development

  • 2:30 PM – 3:00 PM ET
    Coffee Break in the Solution Center
  • 2:30 PM – 3:30 PM ET
    Hot Topic: The Potential Dark Side of AI for Drug Discovery

    Hot Topic Speaker: Sean Ekins, PhD, DSc – Collaborations Pharmaceuticals, Inc.

    Hot Topic Moderator: Tamer E. Fandy, PhD, BCGP, FCP – University of Charleston

    Discovery and Basic Research

  • 2:30 PM – 3:30 PM ET
    Speaker Spotlight: Addressing the Gaps in Human PK and DDI Prediction

    Spotlight Speaker: Li Di, PhD – Pfizer Inc

    Moderator: Naveen Thakral, PhD – Schrodinger, Inc. USA

    Preclinical Development

  • 2:30 PM – 3:30 PM ET
    Speaker Spotlight: Extrapolating Efficacy from Adults to Pediatrics

    Spotlight Speaker: Joga Gobburu, PhD, MBA – University of Maryland

    Moderator: Raja B. Velagapudi, PhD – Tolmar, Inc.

    Clinical Pharmacology – Chemical

  • 2:30 PM – 3:30 PM ET
    Speaker Spotlight: Phase Appropriate Design Controls for Combination Products During Clinical Development

    Spotlight Speaker: Shrinivas (Cheenu) Murti, PhD, MBA – Takeda Pharmaceutical Company Limited

    Moderator: Kim Huynh-Ba, MS, PMP, FAAPS – Pharmalytik

    Manufacturing & Analytical Characterization – Chemical

  • 2:30 PM – 3:30 PM ET
    Taste of Boston: Food Tour
  • 3:00 PM – 3:45 PM ET
    Rapid Fire: Advances in Engineering Technologies For Drug Substance and Enabling Drug Product (BM)

    Rapid Fire Moderator: Suman A. Luthra, PhD – Merck & Co., Inc.

    Formulation and Delivery – Biomolecular

  • 3:00 PM – 3:45 PM ET
    Rapid Fire: Microbiome: Impact in Pharmaceutical Development and Disease

    Rapid Fire Moderator: Maya Lipert, PhD – AbbVie

    Discovery and Basic Research

  • 3:00 PM – 3:45 PM ET
    Rapid Fire: Novel Manufacturing Approaches in Pharmaceuticals and Biopharmaceuticals (BM)

    Rapid Fire Moderator: Jay Jukyung Kang, PhD – Pfizer

    Manufacturing & Analytical Characterization – Biomolecular

  • 3:00 PM – 4:00 PM ET
    Early CMC Development Strategies to Support Late-Stage Success

    Partner Presentation Speaker: Neha Shah, Ph.D. – Societal CDMO

    Partner Presentation Speaker: Kiran Pedada, Ph.D. – Societal CDMO

    Manufacturing & Analytical Characterization

  • 3:00 PM – 4:00 PM ET
    Happy Hour Sponsored by Flow Sciences, Inc.
  • 3:00 PM – 4:00 PM ET
    Happy Hour Sponsored by Prolytix
  • 3:00 PM – 4:00 PM ET
    Rapid Fire: Advances in Engineering Technologies For Drug Substance and Enabling Drug Product (CE)

    Rapid Fire Moderator: Ashish Punia, PhD – Merck & Co., Inc.

    Formulation and Delivery – Chemical

  • 3:00 PM – 4:00 PM ET
    Rapid Fire: Breaking Through Barriers in Preclinical Development To Improve Clinical Translation (BM)

    Rapid Fire Moderator: Nirav Shah, PhD – Janssen Research and Development, LLC

    Preclinical Development – Biomolecular

  • 3:00 PM – 4:00 PM ET
    Rapid Fire: Breaking Through Barriers in Preclinical Development To Improve Clinical Translation (CE)

    Rapid Fire Moderator: Steven W. Louie, M.S. – Novartis

    Preclinical Development – Chemical

  • 3:00 PM – 4:00 PM ET
    Rapid Fire: Epigenetic Drug Targets and Epigenetic Modifiers

    Rapid Fire Moderator: Kevin Litwiler, PhD (he/him/his) – OnKure Therapeutics

    Discovery and Basic Research

  • 3:00 PM – 4:00 PM ET
    Rapid Fire: Model Informed Drug Development (MIDD): Role in Dose Selection, Vulnerable Populations, and Biowaivers (BM)

    Rapid Fire Moderator: Amitava Mitra, PhD – Kura Oncology

    Clinical Pharmacology – Biomolecular

  • 3:00 PM – 4:00 PM ET
    Rapid Fire: Model Informed Drug Development (MIDD): Role in Dose Selection, Vulnerable Populations, and Biowaivers (CE)

    Rapid Fire Moderator: Punit Marathe, PhD – Agios Pharmaceuticals

    Clinical Pharmacology – Chemical

  • 3:00 PM – 4:00 PM ET
    Rapid Fire: Novel Manufacturing Approaches in Pharmaceuticals and Biopharmaceuticals (CE)

    Rapid Fire Moderator: Praveen Kandi, PhD – Karuna Therapeutics Inc.

    Manufacturing & Analytical Characterization – Chemical

  • 3:00 PM – 4:00 PM ET
    Rapid Fire: Sample Challenges, Yet Opportunities (BM)

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

    Bioanalytics – Biomolecular

  • 3:00 PM – 4:00 PM ET
    Rapid Fire: Sample Challenges, Yet Opportunities (CE)

    Rapid Fire Moderator: Wenkui Li, Ph.D – Novartis

    Bioanalytics – Chemical

  • 3:00 PM – 4:00 PM ET
    Scientist to Executive - Transition beyond PhD and 1st job,

    Career Center Moderator: Prasad N. Tata – Sandoz, Inc.

    Career Center Speaker: Vijendra Nalamothu, PhD – Tergus Pharma, LLC

    Career Center Speaker: Kurt Nielsen, PhD (he/him/his) – Longview Leader Corp

    Career Development

  • 3:30 PM – 4:30 PM ET
    Elimination of Titanium Dioxide from Film Coating-Challenges and Opportunities

    Partner Presentation Speaker: Manish Ghimire, PhD – ColorCon

    Partner Presentation Speaker: Laura Scattergood (she/her/hers) – Colorcon

    Manufacturing & Analytical Characterization

  • 3:30 PM – 4:30 PM ET
    Happy Hour Sponsored by Luminex
  • 3:30 PM – 4:30 PM ET
    Hot Topic: Novel-Approaches to Accelerate Access of Complex Locally-Acting Products to Patients

    Government Speaker: Priyanka Ghosh, PhD – US Food and Drug Adminstration

    Preclinical Development – Chemical

  • 3:30 PM – 4:30 PM ET
    Important Role of UGTs in Drug Metabolism and Drug-Drug Interactions

    Partner Presentation Speaker: Maciej Czerwinski, PhD – Sekisui XenoTech, LLC

    Preclinical Development

  • 3:30 PM – 4:30 PM ET
    Special Poster Collection
  • 3:45 PM – 4:45 PM ET
    Happy Hour Sponsored by Agilent Technologies
  • 3:45 PM – 4:45 PM ET
    Happy Hour Sponsored by COREALIS Pharma Inc.
  • 5:00 PM – 6:00 PM ET
    AAPS Bioanalytical Community Membership Meeting

    Community Leader: Stephanie Cape, PhD (she/her/hers) – Labcorp

  • 5:00 PM – 6:00 PM ET
    AAPS Bioequivalence and Bioavailability Science Community Membership Meeting

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

  • 5:00 PM – 6:00 PM ET
    AAPS Chemistry, Manufacturing, & Controls (CMC) Membership Meeting

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

  • 5:00 PM – 6:00 PM ET
    AAPS Nanotechnology Community Membership Meeting

    Community Leader: Mandip S. Sachdeva, PhD – Florida A&M University

  • 5:00 PM – 6:00 PM ET
    AAPS Pharmaceutical Discovery & Preclinical Development Community Membership Meeting

    Community Leader: Vibha Jawa, PhD – Bristol Myers Squibb

  • 5:00 PM – 6:00 PM ET
    AAPS Pharmacokinetics, Pharmacodynamics, & Drug Metabolism Community Membership Meeting

    Community Leader: Nimita Dave, PhD – Nimbus Therapeutics

  • 5:00 PM – 7:00 PM ET
    PhRMA Foundation (Invitation Only)
  • 5:30 PM – 7:00 PM ET
    Sustaining Sponsor Reception
  • 6:00 PM – 9:00 PM ET
    2022 Simulations Plus Annual User Forum (Invitation Only)
  • 6:00 PM – 9:30 PM ET
    American Association of Indian Pharmaceutical Scientist (AAiPS)-Annual Meeting
  • Wednesday, October 19, 2022
  • 7:30 AM – 8:30 AM ET
    Women in PharmSci Breakfast
  • 7:30 AM – 2:30 PM ET
    Registration Hours
  • 7:30 AM – 5:00 PM ET
    Speaker Ready Room
  • 8:30 AM – 9:00 AM ET
    Prologue: Biomarkers in Cancer Immunotherapy – a Clinical Pharmacology Perspective

    Government Speaker: Xiaofei Wang, PhD – U.S. Food and Drug Administration

    Clinical Pharmacology – Biomolecular

  • 8:30 AM – 9:00 AM ET
    Prologue: Biomarkers in Drug Development: Overview, Progress and Challenges

    Prologue Speaker: Gurunadh Chichili, PhD – Astellas

    Clinical Pharmacology – Chemical

  • 8:30 AM – 9:00 AM ET
    Prologue: Cell-Inspired Strategies for Precision Therapy and Drug Delivery

    Prologue Speaker: Zongmin Zhao, PhD – University of Illinois Chicago

    Discovery and Basic Research

  • 8:30 AM – 9:00 AM ET
    Prologue: Challenges and Opportunities for Worldwide Analytical Procedure Management

    Prologue Speaker: Christine M V Moore, PhD – Organon

    Manufacturing & Analytical Characterization – Biomolecular

  • 8:30 AM – 9:00 AM ET
    Prologue: Complexities in Defining/Designing Bioanalytical Strategies to Characterize Pharmacokinetics for CGT

    Bioanalytics – Biomolecular

  • 8:30 AM – 9:00 AM ET
    Prologue: Drug Hunters as Project Champions

    Prologue Speaker: Dennis X. Hu, PhD – Drug Hunter Inc.

    Preclinical Development – Chemical

  • 8:30 AM – 9:00 AM ET
    Prologue: Industry Perspectives in Continuous Manufacturing

    Prologue Speaker: Robert F. Meyer, PhD – Merck & Co., Inc.

    Manufacturing & Analytical Characterization

  • 8:30 AM – 9:00 AM ET
    Prologue: Modulation of Tumor Microenvironment for Immunotherapy: Focused on Lipid Nanoparticle-Based Gene Delivery Strategies

    Prologue Speaker: Yun Liu, PhD – Spark Therapeutics

    Formulation and Delivery – Biomolecular

  • 8:30 AM – 9:00 AM ET
    Prologue: Overcoming Pitfalls in Moving Compounds From Preclinical Development to the Clinic: Examples From Bench to Bedside

    Prologue Speaker: Weirong Wang, PhD – Janssen R&D

    Preclinical Development – Biomolecular

  • 8:30 AM – 9:00 AM ET
    Prologue: Patient-Centric Drug Formulation and Delivery

    Prologue Speaker: Rene Holm, PhD – University of Southern Denmark

    Formulation and Delivery – Chemical

  • 8:30 AM – 9:00 AM ET
    Prologue: Recent Progress in Protein Degradation

    Prologue Speaker: Adam M. Gilbert, PhD – Pfizer

    Discovery and Basic Research

  • 8:30 AM – 9:00 AM ET
    Prologue: Rising to the Challenge: Advances in Mass Spectrometry Enabling the Future of Biomarker and Biotherapeutic Analysis

    Prologue Speaker: Chad J. Briscoe, PhD – BioAgilytix Labs

    Bioanalytics – Chemical

  • 8:30 AM – 1:00 PM ET
    Free Professional Headshots
  • 8:30 AM – 1:00 PM ET
    LinkedIn Profile Critiques & Resume Reviews
  • 8:30 AM – 1:30 PM ET
    Solution Center Hours & Poster Presentations
  • 9:00 AM – 10:00 AM ET
    Development of robust, sensitive LC-MS/MS workflows for metabolites and oligonucleotides

    Tech Spotlight Speaker: Remco van Soest, MS – SCIEX

    Partner Presentation Speaker: Rahul Baghla, M.Pharm, MBA (he/him/his) – Sciex

    Discovery and Basic Research

  • 9:00 AM – 10:00 AM ET
    Hot Topic: PBPK Modeling: Exponentially Expanding Science

    Moderator: Raja B. Velagapudi, PhD – Tolmar, Inc.

    Clinical Pharmacology – Chemical

  • 9:00 AM – 10:00 AM ET
    Symposium: Cross-Modality and Modality Agnostic Approaches to Development and Manufacturing 2

    Moderator: Robert F. Meyer, PhD – Merck & Co., Inc.

    Manufacturing & Analytical Characterization

  • 9:00 AM – 10:00 AM ET
    The Science of Belonging for STEM Women

    Career Center Speaker: Susan Morris, M.Ed., CPCC, ACC – Susan Morris Coaching

    Career Center Speaker: Lara S. Kallander, PhD, MAPP, ACC – Thriving Though Adversity Coaching

    Career Development

  • 9:00 AM – 10:30 AM ET
    Symposium: Overcoming Pitfalls in Moving Compounds From Preclinical Development to the Clinic: Examples From Bench to Bedside (CE)

    Moderator: Dennis X. Hu, PhD – Drug Hunter Inc.

    Preclinical Development – Chemical

  • 9:00 AM – 10:30 AM ET
    Symposium: Targeted Drug Discovery and Molecular Pharmacology

    Moderator: Adam M. Gilbert, PhD – Pfizer

    Discovery and Basic Research

  • 9:00 AM – 11:00 AM ET
    Symposium: A Look Into the Future of Bioanalytics (BM)

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

    Bioanalytics – Biomolecular

  • 9:00 AM – 11:00 AM ET
    Symposium: A Look Into the Future of Bioanalytics (CE)

    Moderator: Amanda Hays, Ph.D. – BioAgilytix

    Bioanalytics – Chemical

  • 9:00 AM – 11:00 AM ET
    Symposium: Cells as Carriers of Therapy: From Factories to Hitchhiking

    Moderator: Zongmin Zhao, PhD – University of Illinois Chicago

    Discovery and Basic Research

  • 9:00 AM – 11:00 AM ET
    Symposium: Cross-Modality and Modality Agnostic Approaches to Development and Manufacturing 1

    Moderator: Isabelle Vu Trieu, MA, Chemistry; MS, Chemical Engineering – Waters Corporation

    Manufacturing & Analytical Characterization

  • 9:00 AM – 11:00 AM ET
    Symposium: Evolution in Patient-Centric Drug Formulation and Delivery (BM)

    Formulation and Delivery – Biomolecular

  • 9:00 AM – 11:00 AM ET
    Symposium: Evolution in Patient-Centric Drug Formulation and Delivery (CE)

    Moderator: Rene Holm, PhD – University of Southern Denmark

    Formulation and Delivery – Chemical

  • 9:00 AM – 11:00 AM ET
    Symposium: Overcoming Pitfalls in Moving Compounds From Preclinical Development to the Clinic: Examples From Bench to Bedside (BM)

    Moderator: Weiwei Tan, PhD – Pfizer Inc

    Preclinical Development – Biomolecular

  • 9:00 AM – 11:00 AM ET
    Symposium: Translational Biomarkers: From Bench to Bedside (BM)

    Clinical Pharmacology – Biomolecular

  • 9:00 AM – 11:00 AM ET
    Symposium: Translational Biomarkers: From Bench to Bedside (CE)

    Moderator: Gurunadh Chichili, PhD – Astellas

    Clinical Pharmacology – Chemical

  • 9:30 AM – 10:00 AM ET
    Coffee Break in the Solution Center
  • 9:30 AM – 10:30 AM ET
    Novel Plasma Fractionation Process to Produce Intravenous Immunoglobulin (IVIG)

    Tech Spotlight Speaker: Matthew Whelihan, PhD (he/him/his) – Prolytix

    Manufacturing & Analytical Characterization

  • 9:30 AM – 10:30 AM ET
    Speaker Spotlight: Lessons Learned from Prodrug Design- Lactone Stabilized Camptothecin From Comprehensive Preclinical Pharmacokinetics Translating to Clinical Trial

    Spotlight Speaker: Diana S-L Chow, PhD – University of Houston

    Moderator: Jaymin C. Shah, PhD – Pfizer Worldwide Research and Development

    Formulation and Delivery

  • 9:30 AM – 10:30 AM ET
    Speaker Spotlight: Monitoring CAR-T Persistence by Droplet Digital PCR

    Moderator: Kate B. Herr, M.S. – Janssen R&D/ Johnson & Johnson

    Spotlight Speaker: Shian-Jiun Shih, PhD – Tessa Therapeutics

    Bioanalytics

  • 10:00 AM – 11:00 AM ET
    Hot Topic: Manufacturing and Analytical Characterization

    Hot Topic Moderator: Sayantan Chattoraj, Ph.D. – GSK

    Manufacturing & Analytical Characterization

  • 10:30 AM – 11:30 AM ET
    How reducing protein viscosity can improve formulation and process economics

    Partner Presentation Speaker: Tobias Rosenkranz, PhD – MilliporeSigma

    Formulation and Delivery

  • 10:30 AM – 11:30 AM ET
    Is Entrepreneurship in your Pharmaceutical Career Crystal Ball?

    Career Center Speaker: Nurulain T. Zaveri, PhD, FAAPS – Astraea Therapeutics, LLC

    Career Center Moderator: Annette Bak, PhD, MBA, FAAPS (she/her/hers) – AstraZeneca

    Career Center Speaker: Gregory Verdine, PhD (he/him/his) – Harvard University

    Career Center Speaker: PRABU NAMBIAR, PhD MBA – SynerG BioPharma Group, LLC

    Career Development

  • 10:30 AM – 11:30 AM ET
    Special Poster Collection
  • 11:00 AM – 12:00 PM ET
    Brace for (Regulatory) Impact: Proactive TiO2 Removal from Film Coatings

    Partner Presentation Speaker: Allison Labriola (she/her/hers) – JRS PHARMA LP

    Formulation and Delivery

  • 11:00 AM – 12:00 PM ET
    Transforming Drug Loads in Injectable Hydrogels, the Power of Small Particles

    Partner Presentation Speaker: Christopher Worrall, PhD – University of Manchester, UK

    Formulation and Delivery

  • 11:00 AM – 1:30 PM ET
    Dedicated Solution Center Hours
  • 11:30 AM – 12:30 PM ET
    Speaker Spotlight: Addressing Issues of Metabolism-Mediated Toxicity During Drug Development

    Spotlight Speaker: William Humphreys, PhD – Aranmore Pharma Consulting

    Moderator: Yasuhiro Tsume, PhD – Merck & Co., Inc.

    Preclinical Development

  • 11:30 AM – 12:30 PM ET
    Speaker Spotlight: Integrating Clinical Biomarkers in QSP Models: Applications in Drug Development

    Spotlight Speaker: Kapil Gadkar, PhD – Denali Therapeutics

    Moderator: Nimita Dave, PhD – Nimbus Therapeutics

    Clinical Pharmacology

  • 11:30 AM – 12:30 PM ET
    Speaker Spotlight: Long Acting Implants

    Spotlight Speaker: Stephanie Barrett, PhD – Merck & Co., Inc.

    Moderator: Maria Cruanes, PhD Chemistry (she/her/hers) – Organon

    Manufacturing & Analytical Characterization

  • 11:30 AM – 12:30 PM ET
    Special Poster Collection
  • 12:00 PM – 1:00 PM ET
    Career in Pharma: Uncountable Roads, Several Bends and Steering Right

    Career Center Speaker: Russ Weiner – Takeda

    Career Center Speaker: Marta Miles – M2 Consulting

    Career Center Moderator: Ashley Lay-Fortenbery, PhD – Merck & Co., Inc.

    Career Center Moderator: Vivek Gupta, PhD – St. John's University

    Career Development

  • 12:00 PM – 1:30 PM ET
    Phoenix Lunch and Learn

    Partner Presentation Speaker: Michael Clifton – Certara

    Partner Presentation Speaker: Christopher Mehl, M.S – Certara

  • 1:30 PM – 2:30 PM ET
    Keynote: A Shared Goal to Support Drug Development Utilizing Clinical Biomarkers: Tales of a Public-Private Partnership (PPP) Enthusiast

    Government Speaker: Joseph P. Menetski, PhD (he/him/his) – Foundation for the NIH

    Moderator: Mohamed Hassanein, PhD – Pfizer

    Clinical Pharmacology

  • 1:30 PM – 2:30 PM ET
    Keynote: Advanced Spectroscopic and ML Approaches in Analytical Characterization

    Keynote Speaker: Karl Booksh

    Moderator: Isabelle Vu Trieu, MA, Chemistry; MS, Chemical Engineering – Waters Corporation

    Manufacturing & Analytical Characterization – Biomolecular

  • 1:30 PM – 2:30 PM ET
    Keynote: Bioanalytics Future State: Precise, Personal and Predictive

    Bioanalytics – Chemical

  • 1:30 PM – 2:30 PM ET
    Keynote: Cell Mediated Delivery of Therapeutics

    Keynote Speaker: Samir Mitragotri, Professor – Harvard University

    Moderator: Richard A. Gemeinhart, PhD (he/him/his) – University of Illinois Chicago

    Discovery and Basic Research

  • 1:30 PM – 2:30 PM ET
    Keynote: Continuous Manufacture of Active Pharmaceutical Ingredients: Current Status, Future Prospects

    Keynote Speaker: Allan S. Myerson, PhD – Massachusetts Institute of Technology

    Moderator: Robert F. Meyer, PhD – Merck & Co., Inc.

    Manufacturing & Analytical Characterization

  • 1:30 PM – 2:30 PM ET
    Keynote: Drugging the Undruggable: Induced Proximity Medicines as the Next Wave of Drug Discovery

    Keynote Speaker: Ryan Potts, PhD – Amgen

    Moderator: Adam M. Gilbert, PhD – Pfizer

    Discovery and Basic Research

  • 1:30 PM – 2:30 PM ET
    Keynote: Evolving FDA Quality Assessment Journey

    Government Speaker: Lawrence Yu – FDA

    Moderator: Maya Lipert, PhD – AbbVie

    Preclinical Development – Chemical

  • 1:30 PM – 2:30 PM ET
    Keynote: Intra-Target Microdosing (ITM) - A Novel Drug Development Approach - Enabling Safe,  Human-Specific, and Rapid Preclinical Candidate Selection and Translation of Novel Drug Compounds

    Keynote Speaker: Tal Burt, MD – Phase-0/Microdosing Network

    Moderator: Naveen Thakral, PhD – Schrodinger, Inc. USA

    Preclinical Development – Biomolecular

  • 1:30 PM – 2:30 PM ET
    Keynote: Opportunities and Challenges with Long Acting Injectable Formulations

    Keynote Speaker: Manish Gupta, PhD – GSK

    Moderator: Jaymin C. Shah, PhD – Pfizer Worldwide Research and Development

    Formulation and Delivery – Chemical

  • 1:30 PM – 2:30 PM ET
    Keynote: qPCR Application in Cell and Gene Therapies

    Moderator: William Hallet, PhD (he/him/his) – Janssen R&D / J&J

    Keynote Speaker: Kate B. Herr, M.S. – Janssen R&D/ Johnson & Johnson

    Bioanalytics – Biomolecular

  • 1:30 PM – 8:00 PM ET
    Exhibitor Move-Out
  • 3:00 PM – 3:45 PM ET
    Rapid Fire: A Look Into the Future of Bioanalytics (CE)

    Rapid Fire Moderator: Tuo Meng, PhD – Merck

    Bioanalytics – Chemical

  • 3:00 PM – 3:45 PM ET
    Rapid Fire: Advances in Engineering Technologies For Drug Substance and Enabling Drug Product (BM)
  • 3:00 PM – 3:45 PM ET
    Rapid Fire: Translational Biomarkers: From Bench to Bedside (CE)

    Rapid Fire Moderator: Punit Marathe, PhD – Agios Pharmaceuticals

    Clinical Pharmacology – Chemical

  • 3:00 PM – 4:00 PM ET
    Hot Topic: Classification Systems in Formulation Development Strategies

    Hot Topic Moderator: Shriram M. Pathak, PhD – Quotient Sciences, UK

    Hot Topic Moderator: James E. Polli, Ph.D., FAAPS – University of Maryland School of Pharmacy

    Formulation and Delivery – Chemical

  • 3:00 PM – 4:00 PM ET
    Hot Topic: Fit-For-Purpose

    Hot Topic Moderator: Faye Vazvaei, M.S. – Merck & Co. Inc.

    Bioanalytics – Chemical

  • 3:00 PM – 4:00 PM ET
    Rapid Fire: A Look Into the Future of Bioanalytics (BM)

    Rapid Fire Moderator: Ran Ye

    Bioanalytics – Biomolecular

  • 3:00 PM – 4:00 PM ET
    Rapid Fire: Cells as Carriers of Therapy: From Factories to Hitchhiking

    Discovery and Basic Research

  • 3:00 PM – 4:00 PM ET
    Rapid Fire: Cross-Modality and Modality Agnostic Approaches to Development and Manufacturing (BM)

    Rapid Fire Moderator: Kaizhu Guo, PhD – Merck

    Manufacturing & Analytical Characterization – Biomolecular

  • 3:00 PM – 4:00 PM ET
    Rapid Fire: Cross-Modality and Modality Agnostic Approaches to Development and Manufacturing (CE)

    Rapid Fire Moderator: Xiaolong Zhu, PhD – Merck Co & Inc

    Manufacturing & Analytical Characterization – Chemical

  • 3:00 PM – 4:00 PM ET
    Rapid Fire: Evolution in Patient-Centric Drug Formulation and Delivery (BM)

    Rapid Fire Moderator: Xin Oliver Tong, PhD – Merck & Co., Inc.

    Formulation and Delivery – Biomolecular

  • 3:00 PM – 4:00 PM ET
    Rapid Fire: Evolution in Patient-Centric Drug Formulation and Delivery (CE)

    Rapid Fire Moderator: Ashish Punia, PhD – Merck & Co., Inc.

    Formulation and Delivery – Chemical

  • 3:00 PM – 4:00 PM ET
    Rapid Fire: Overcoming Pitfalls in Moving Compounds From Preclinical Development to the Clinic: Examples From Bench to Bedside (BM)

    Rapid Fire Moderator: Suman A. Luthra, PhD – Merck & Co., Inc.

    Preclinical Development – Biomolecular

  • 3:00 PM – 4:00 PM ET
    Rapid Fire: Overcoming Pitfalls in Moving Compounds From Preclinical Development to the Clinic: Examples From Bench to Bedside (CE)

    Rapid Fire Moderator: Daniel Bow, PhD – AbbVie

    Preclinical Development – Chemical

  • 3:00 PM – 4:00 PM ET
    Rapid Fire: Targeted Drug Discovery and Molecular Pharmacology

    Rapid Fire Moderator: Mark E. Arnold, PhD, FAAPS – Labcorp Drug Development

    Discovery and Basic Research

  • 3:00 PM – 4:00 PM ET
    Rapid Fire: Translational Biomarkers: From Bench to Bedside

    Rapid Fire Moderator: Hardik Mody, PhD – Johnson and Johnson

    Clinical Pharmacology

  • 4:15 PM – 5:30 PM ET
    Closing Plenary with Dr. Udit Batra

    Plenary Speaker: Udit Batra, Ph.D. – Waters Corporation

  • 5:30 PM – 6:30 PM ET
    Closing Reception
  • Thursday, October 20, 2022
  • 8:00 AM – 12:00 PM ET
    Exhibitor Move-Out