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Full Schedule

Full Schedule

  • 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