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Full Schedule

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Full Schedule

  • Pre-Recorded
  • Prologue: AI Solutions for Dose and Dosage Form Selection in Drug Clinical Development
    Prologue Speaker: Sruthi Sarvepalli (she/her/hers) – St. John's University
    From Bench to Bedside: Bioanalysis and Translational Science
  • Prologue: A New Era in Preclinical to Human Translation for Novel Modalities: Evolution of ADME, PKPD and Clinical Pharmacology
    Prologue Speaker: Nagendra Chemuturi
    From Bench to Bedside: Bioanalysis and Translational Science
  • Prologue: Complex Biologics Attempt to Stymie Bioanalysts… Challenge Accepted
    Prologue Speaker: Jennifer Cunliffe, PhD (she/her/hers) – Novartis Institutes for BioMedical Research, Inc.
    From Bench to Bedside: Bioanalysis and Translational Science
  • Prologue: Intravitreal Drug Delivery: Overcoming Formulation and Device Challenges
    Prologue Speaker: Andrea Allmendinger, Prof Dr (she/her/hers) – ten23 health AG
    Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
  • Prologue: TBD 1
    Prologue Speaker: Amardeep Bhalla, Ph.D. – Regeneron Pharmaceuticals
    Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
  • Prologue: TBD 2
    Prologue Speaker: Parag Kolhe, Ph.D. – Pfizer Inc.
    Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
  • Sunday, May 4, 2025
  • 7:30 AM – 6:00 PM ET
    Registration Hours
  • 8:00 AM – 3:00 PM ET
    Exhibitor Move-In
  • 12:00 PM – 4:00 PM ET
    Speaker Ready Room
  • 3:00 PM – 4:30 PM ET
    Opening Plenary
  • 4:30 PM – 6:00 PM ET
    Welcome Reception in the Solution Center
  • Monday, May 5, 2025
  • 7:30 AM – 3:30 PM ET
    Registration Hours
  • 8:00 AM – 9:30 AM ET
    Executive Track: Developability and Due Diligence: How to Assess, Draw, and Sometimes End the Road(map) for New and Unusual Modalities
  • 8:30 AM – 3:30 PM ET
    Speaker Ready Room
  • 9:30 AM – 11:00 AM ET
    Symposium: Accelerating Novel Formulation Development of Biologics for Newer and Established Modalities
    Moderator: Rikhav Gala
    Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
  • 9:30 AM – 11:00 AM ET
    Symposium: Breaking Barriers: Bioanalytical Innovation for Complex Biologics
    From Bench to Bedside: Bioanalysis and Translational Science
  • 10:00 AM – 11:00 AM ET
    Coffee Break in the Solution Center
  • 10:00 AM – 11:00 AM ET
    Hot Topic: Progress in mRNA LNP Understanding to Enable Refrigerated Long-Term Storage
    Hot Topic Speaker: Himanshu Bhattacharjee, PhD – GlaxoSmithKline
    Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
  • 10:00 AM – 4:30 PM ET
    Coffee Station
  • 10:00 AM – 4:30 PM ET
    Solution Center Hours & Poster Presentations
  • 11:00 AM – 1:00 PM ET
    Dedicated Solution Center Hours
  • 11:30 AM – 1:00 PM ET
    Lunch in the Solution Center
  • 1:00 PM – 2:00 PM ET
    Keynote: Challenges in Characterization and Comparability of Advanced Therapies
    Keynote Speaker: Phillip Ramsey, MS, MBA – Sangamo Therapeutics
    Moderator: Vivek Agrahari, PhD (he/him/his) – CONRAD
    Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
  • 1:00 PM – 2:00 PM ET
    Keynote: Delivering Biotherapeutics to the CNS via Different Routes of Administration: State-of-the-Art
    Keynote Speaker: Robert G. Thorne, PhD (he/him/his) – Denali Therapeutics & University of Minnesota
    Moderator: Steven W. Louie, M.S. (he/him/his)
    From Bench to Bedside: Bioanalysis and Translational Science
  • 2:00 PM – 2:30 PM ET
    Coffee Break in the Solution Center
  • 2:30 PM – 3:30 PM ET
    Rapid Fire: Accelerating Novel Formulation Development of Biologics for Newer and Established Modalities
    Rapid Fire Moderator: Jing Ling, Ph.D. – Merck & Co., Inc.
    Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
  • 2:30 PM – 3:30 PM ET
    Rapid Fire: Breaking Barriers: Bioanalytical Innovation for Complex Biologics
    Rapid Fire Moderator: Francis Wolenski
    From Bench to Bedside: Bioanalysis and Translational Science
  • 3:00 PM – 4:00 PM ET
    Hot Topic: Panel Discussion on Neutralizing Antibody Sample Testing and Report Harmonization
    Hot Topic Speaker: Darshana Jani, Ph.D. – Moderna
    Hot Topic Speaker: Daniela Verthelyi, Ph.D. – US Food and Drug Administration
    Hot Topic Speaker: Jason Pennucci, MS (he/him/his) – Moderna Therapeutics
    Hot Topic Speaker: Susan Irvin, PhD (she/her/hers) – Regeneron Pharmaceuticals
    Hot Topic Moderator: Varun Ramani, Master of Science, PMP (he/him/his) – Inhibrx, Inc.
    From Bench to Bedside: Bioanalysis and Translational Science
  • 5:00 PM – 6:30 PM ET
    Sustaining Partner Reception (by invitation only)
  • Tuesday, May 6, 2025
  • 7:30 AM – 3:30 PM ET
    Registration Hours
  • 8:30 AM – 3:30 PM ET
    Speaker Ready Room
  • 9:30 AM – 11:00 AM ET
    Symposium: Bioprocessing, Characterization & Comparability for Complex Biologics
    Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
  • 9:30 AM – 11:00 AM ET
    Symposium: Managing Global Clinical Trials and Crises in Sample Logistics
    From Bench to Bedside: Bioanalysis and Translational Science
  • 10:00 AM – 11:00 AM ET
    Coffee Break in the Solution Center
  • 10:00 AM – 11:00 AM ET
    Hot Topic: Industry Discussions on Companion Diagnostics for AAV-Mediated Gene Therapy
  • 10:00 AM – 4:30 PM ET
    Coffee Station
  • 10:00 AM – 4:30 PM ET
    Solution Center Hours & Poster Presentations
  • 11:00 AM – 1:00 PM ET
    Dedicated Solution Center Hours
  • 11:30 AM – 1:00 PM ET
    Lunch in the Solution Center
  • 1:00 PM – 2:00 PM ET
    Keynote: Harnessing Bioinspiration for the Delivery of Protein and Nucleic Acid-Based Biotherapeutics
    Keynote Speaker: Stephen T. Buckley, PhD (he/him/his) – Novo Nordisk A/S
    Moderator: Jing Ling, Ph.D. – Merck & Co., Inc.
    Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
  • 1:00 PM – 2:00 PM ET
    Keynote: Where the Patients Are: Bioanalytical Strategies Enabling Global Clinical Trials
    Keynote Speaker: Joleen T. White, PhD (she/her/hers) – Gates Medical Research Institute
    Moderator: Steven W. Louie, M.S. (he/him/his)
    From Bench to Bedside: Bioanalysis and Translational Science
  • 2:00 PM – 2:30 PM ET
    Coffee Break in the Solution Center
  • 2:30 PM – 3:30 PM ET
    Rapid Fire: Bioprocessing, Characterization & Comparability for Complex Biologics
    Rapid Fire Moderator: Vivek Agrahari, PhD (he/him/his) – CONRAD
    Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
  • 2:30 PM – 3:30 PM ET
    Rapid Fire: Managing Global Clinical Trials and Crises in Sample Logistics
    From Bench to Bedside: Bioanalysis and Translational Science
  • 3:00 PM – 4:00 PM ET
    Hot Topic: AI/ML + FDA: Best Practices, Themes & Considerations for Regulatory Success in Drugs, Diagnostics, & Devices
    Hot Topic Moderator: Rikhav Gala
    Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
  • 4:30 PM – 8:00 PM ET
    Exhibitor Move-Out
  • 5:00 PM – 6:30 PM ET
    Women in Biotech Reception
  • Wednesday, May 7, 2025
  • 8:30 AM – 2:00 PM ET
    Registration Hours
  • 8:30 AM – 2:00 PM ET
    Speaker Ready Room
  • 9:30 AM – 11:00 AM ET
    Symposium: Patient-Centric Product Design and Precision Medicine
    Moderator: Jing Ling, Ph.D. – Merck & Co., Inc.
    Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
  • 9:30 AM – 11:00 AM ET
    Symposium: Preclinical and Clinical PK/PD, Safety Translation of Newer Modalities
    Moderator: Rodrigo Cristofoletti, Ph.D. – University of Florida
    From Bench to Bedside: Bioanalysis and Translational Science
  • 10:00 AM – 11:00 AM ET
    Hot Topic: Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
    Hot Topic Moderator: Vivek Agrahari, PhD (he/him/his) – CONRAD
    Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
  • 11:00 AM – 12:30 PM ET
    Networking Lunch
  • 12:30 PM – 1:30 PM ET
    Keynote: Bench to Bedside Translation of Newer Modalities Using Quantitative Models: State-of-the-Art
    Keynote Speaker: Dhaval K. Shah, PhD (he/him/his) – University at Buffalo
    Moderator: Rodrigo Cristofoletti, Ph.D. – University of Florida
    From Bench to Bedside: Bioanalysis and Translational Science
  • 12:30 PM – 1:30 PM ET
    Keynote: Predict and Overcome Developability Challenges in High-Concentration Formulations Through Machine Learning
    Keynote Speaker: Pin-Kuang Lai, PhD (he/him/his) – Stevens Institute of Technology
    Moderator: Yongchao Su, PhD – Merck & Co, Inc.
    Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
  • 2:00 PM – 3:00 PM ET
    Hot Topic: Role of Model-Informed Drug Development in Cell and Gene Therapies
    Hot Topic Moderator: Rodrigo Cristofoletti, Ph.D. – University of Florida
    From Bench to Bedside: Bioanalysis and Translational Science
  • 2:00 PM – 3:00 PM ET
    Rapid Fire: Patient-Centric Product Design and Precision Medicine
    Rapid Fire Moderator: Sheetal S. Pai-Wechsung, PhD (she/her/hers) – Pfizer Inc
    Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
  • 2:00 PM – 3:00 PM ET
    Rapid Fire: Preclinical and Clinical PK/PD, Safety Translation of Newer Modalities
    From Bench to Bedside: Bioanalysis and Translational Science
  • 3:00 PM – 4:00 PM ET
    Closing Plenary