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Full Schedule

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Full Schedule

  • Wednesday, October 23, 2024
  • 7:30 AM – 8:30 AM MT
    Women in PharmSci Breakfast
  • 7:30 AM – 3:30 PM MT
    Speaker Ready Room
  • 8:00 AM – 2:30 PM MT
    Registration Hours
  • 8:00 AM – 7:00 PM MT
    Coat Check
  • 8:30 AM – 12:30 PM MT
    Free Professional Headshots
  • 8:30 AM – 12:30 PM MT
    LinkedIn Profile Critiques & Resume Reviews
  • 8:30 AM – 12:30 PM MT
    Mock Interviews
  • 8:30 AM – 1:30 PM MT
    Solution Center Hours & Poster Presentations
  • 9:00 AM – 10:00 AM MT
    Symbiotic Approaches for Rapid and Cost-Effective Manufacturing of Multiparticulate Formulations
    Partner Presentation Speaker: Nitin K. Swarnakar, PhD (he/him/his) – BASF Corp
    Partner Presentation Speaker: Ramesh Muttavarapu, MS – Thermo Fisher Scientific
    Formulation and Delivery
  • 9:00 AM – 10:30 AM MT
    Symposium: Advancing Vaccine Development: Utilizing the Power of Model-Based Approaches 1
    Moderator: Philip J. Kuehl, PhD – Lovelace Biomedical
    Preclinical, Clinical and Translational Sciences
  • 9:00 AM – 10:30 AM MT
    Symposium: Advancing Vaccine Development: Utilizing the Power of Model-Based Approaches 2
    Moderator: Christopher Rowbottom, BS – Moderna TX
    Preclinical, Clinical and Translational Sciences
  • 9:00 AM – 11:00 AM MT
    Symposium: Advanced Drug Delivery Technologies for Targeted Therapeutics
    Moderator: Alejandro J. Paredes, Ph.D. – Queen's University Belfast
    Formulation and Delivery
  • 9:00 AM – 11:00 AM MT
    Symposium: Challenges and Lessons Learned in Commercializing (Manufacturing and Product Quality Analysis) Novel Modalities 1
    Moderator: Thilak Mudalige, PhD (he/him/his) – US Food and Drug Administration
    Manufacturing & Analytical Characterization
  • 9:00 AM – 11:00 AM MT
    Symposium: Challenges and Lessons Learned in Commercializing (Manufacturing and Product Quality Analysis) Novel Modalities 2
    Moderator: Anuji Abraham, PhD – Bristol-Myers Squibb Company
    Manufacturing & Analytical Characterization
  • 9:00 AM – 11:00 AM MT
    Symposium: Innovative Approaches for Inhaled Delivery
    Moderator: Nitesh K. Kunda, PhD – St. John's University
    Formulation and Delivery
  • 9:00 AM – 11:00 AM MT
    Symposium: Innovative Methodologies for Advancing Therapeutics from Bench to Bedside
    Moderator: Rosalinde Masereeuw, PhD (she/her/hers) – Utrecht Institute for Pharmaceutical Sciences
    Discovery and Basic Research
  • 9:00 AM – 11:00 AM MT
    Symposium: Regulatory Implications for Bioanalysis 1
    Moderator: Manish Kumar, PhD (he/him/his) – Daiichi Sankyo
    Bioanalytics
  • 9:00 AM – 11:00 AM MT
    Symposium: Regulatory Implications for Bioanalysis 2
    Moderator: Darshana Jani, Ph.D. – Moderna Therapeutics
    Bioanalytics
  • 9:30 AM – 10:00 AM MT
    Coffee Break in the Solution Center
  • 9:30 AM – 10:25 AM MT
    Special Poster Collection
  • 9:30 AM – 10:30 AM MT
    Mitigating Nitrosamine Risks: An In-Silico Approach to Identifying NDSRIs and Evaluating API-Excipient Interactions
    Partner Presentation Speaker: Rainer Dobrawa, PhD (he/him/his) – BASF Pharma Solutions
    Partner Presentation Speaker: Sandip Tiwari, PhD (he/him/his) – BASF Corporation
    Formulation and Delivery
  • 9:30 AM – 10:30 AM MT
    Speed to Market: The Power of Controlled Release Formulated Systems
    Partner Presentation Speaker: Lawrence Martin, BS – Colorcon
    Partner Presentation Speaker: Ali Rajabi-Siahboomi – Colorcon
    Formulation and Delivery
  • 10:00 AM – 10:45 AM MT
    Advancements in Oral Drug Delivery via Drug Pelleting
    Chalk Talk Presenter: Lauren G. Petraglia, BS – LCI Corporation
    Formulation and Delivery
  • 10:00 AM – 11:00 AM MT
    Hot Topic: Beyond the Hype: The Realities of AI in Drug Discovery
    Hot Topic Speaker: Eric Luellen, Msc, MPH (he/him/his) – Turing Biosciences LLC
    Hot Topic Moderator: Md Masud Parvez, PhD (he/him/his) – AbbVie Inc.
    Discovery and Basic Research
  • 10:00 AM – 11:00 AM MT
    Speaker Spotlight: Optimizing CAR T Cell Trials: Guidance on Developing and Validating Flow Cytometry Assays for Pharmacokinetics in Clinical Trials
    Spotlight Speaker: Kevin Lang, PhD (he/him/his) – PPD, part of Thermo Fisher Scientific
    Moderator: Long Yuan, PhD – Biogen Inc.
    Bioanalytics
  • 10:00 AM – 11:00 AM MT
    Speaker Spotlight: Overcoming Challenges in Manufacturing and Scale-up of CGT (Cell and Gene Therapy)
    Spotlight Speaker: Raghu Malapaka, PhD – AGC Biologics
    Moderator: Sai Chamarthy
    Manufacturing & Analytical Characterization
  • 10:30 AM – 11:30 AM MT
    Analytical Method Advances in Measuring Nitrites in Pharmaceutical Excipients
    Partner Presentation Speaker: Koudi Zhu, MS – IFF Pharma Solutions
    Manufacturing & Analytical Characterization
  • 10:30 AM – 11:30 AM MT
    Evaluation of Solid Self-Emulsifying Drug Delivery System by Fluid-Bed Technology
    Partner Presentation Speaker: Tasneem Gandhi, n/a – Glatt Group - Pharmaceutical Services CDMO Unlimited
    Formulation and Delivery
  • 10:30 AM – 11:30 AM MT
    How to Negotiate Contracts Like a Pro
    Career Center Speaker: Prabu Nambiar, PhD MBA FRAPS (he/him/his) – Syner-G Biopharma Group
    Career Center Speaker: Ashok Dang, PhD – Perkin Elmer
    Career Center Speaker: Kim Huynh-Ba, M.S., PMP, FAAPS – Pharmalytik
    Career Development
  • 11:00 AM – 1:30 PM MT
    Dedicated Solution Center Hours
  • 11:30 AM – 12:25 PM MT
    Special Poster Collection
  • 11:30 AM – 12:30 PM MT
    Speaker Spotlight: Omics-Driven Drug Delivery: Pioneering Precision Medicine
    Spotlight Speaker: Robert Arnold, PhD (he/him/his) – Auburn University
    Moderator: Sibylle Neuhoff, PhD (she/her/hers) – Certara Predictive Technologies
    Preclinical, Clinical and Translational Sciences
  • 11:30 AM – 12:30 PM MT
    Speaker Spotlight: Patient-Focused Drug Development: CMC Considerations
    Spotlight Speaker: Hong Cai, PhD (she/her/hers) – U.S. Food and Drug Administration
    Moderator: Josephine Aimiuwu, PhD – U.S. Food and Drug Administration
    Formulation and Delivery
  • 11:30 AM – 12:30 PM MT
    Speaker Spotlight: Synthesis and Characterization of Dual-Payload Antibody-Drug Conjugates
    Spotlight Speaker: Shawn Owen, PhD (he/him/his) – University of Utah
    Moderator: Abhisheak Sharma, Ph.D. – University of Florida
    Discovery and Basic Research
  • 12:00 PM – 1:00 PM MT
    Empowering Success:Developing Transferable Skills for Graduate Students and Postdoctoral Fellows
    Career Center Speaker: Sudip K. Das, PhD (he/him/his) – Butler University, College of Pharmacy & Health Sciences
    Career Center Speaker: Bo Tokarski, PhD, MBA – Charles River Laboratories Ashland LLC
    Career Center Moderator: Sudip K. Das, PhD (he/him/his) – Butler University, College of Pharmacy & Health Sciences
    Career Development
  • 12:30 PM – 1:25 PM MT
    Special Poster Collection
  • 1:30 PM – 2:30 PM MT
    Keynote: Impact of Immunogenicity on Gene Therapy Development – Science, Regulatory and Patients
    Keynote Speaker: Jim McNally, PhD – BioAgilytix
    Moderator: Maria Jadhav, PhD – Novartis Institutes for BioMedical Research, Inc.
    Bioanalytics
  • 1:30 PM – 2:30 PM MT
    Keynote: Challenges with New Modalities: Hitting the Stride from Day 1
    Keynote Speaker: Jennifer Chadwick, PhD – Jennifer Chadwick
    Moderator: Anuji Abraham, PhD – Bristol-Myers Squibb Company
    Manufacturing & Analytical Characterization
  • 1:30 PM – 2:30 PM MT
    Keynote: Effective Drug Development Requires Rationales, Not Rules – Rethinking Guidance for Industry
    Keynote Speaker: Lauren Stevenson, PhD (she/her/hers) – Immunologix Laboratories
    Moderator: Chad J. Briscoe, PhD (he/him/his) – Celerion
    Bioanalytics
  • 1:30 PM – 2:30 PM MT
    Keynote: Innovation Through Advanced Manufacturing: What We Can Learn From the Future
    Keynote Speaker: Xiaoming Xu, PhD (he/him/his) – US Food and Drug Administration
    Moderator: Thilak Mudalige, PhD (he/him/his) – US Food and Drug Administration
    Manufacturing & Analytical Characterization
  • 1:30 PM – 2:30 PM MT
    Keynote: Materials and Protein Engineering to Counter Inflammation and Autoimmunity
    Keynote Speaker: Jeffrey A. Hubbell, PhD (he/him/his) – University of Chicago
    Moderator: Shijie Cao
    Formulation and Delivery
  • 1:30 PM – 2:30 PM MT
    Keynote: Model Informed Vaccine Development (MIVD) – Challenges and Opportunities
    Keynote Speaker: Mindy Magee, PharmD (she/her/hers) – Clinical Pharmacology Modeling & Simulation, Infectious Diseases and Vaccines, Precision Medicine, GlaxoSmithKline
    Moderator: Vaishali Sahasrabudhe, PhD (she/her/hers) – Pfizer Inc.
    Preclinical, Clinical and Translational Sciences
  • 1:30 PM – 2:30 PM MT
    Keynote: Modelling Prion Neurodegeneration in Human Brain Organoids; Can We Increase the Possibility of Therapeutic Success?
    Keynote Speaker: Cathryn Haigh, PhD – NIAID, NIH
    Moderator: Rosalinde Masereeuw, PhD (she/her/hers) – Utrecht Institute for Pharmaceutical Sciences
    Discovery and Basic Research
  • 1:30 PM – 8:00 PM MT
    Exhibitor Move-Out
  • 3:00 PM – 3:45 PM MT
    Rapid Fires: Challenges and Lessons Learned in Commercializing (Manufacturing and Product Quality Analysis) Novel Modalities 2
    Rapid Fire Moderator: Li Tian, PhD (she/her/hers) – US Food and Drug Administration
    Manufacturing & Analytical Characterization
  • 3:00 PM – 4:00 PM MT
    Hot Topic: PK/PD and Translational Considerations for LNP Delivered Gene Editing Products
    Hot Topic Speaker: Bahru Habtemariam, Pharm.D. – Beam Therapeutics
    Hot Topic Moderator: Salvatore Iovino
    Preclinical, Clinical and Translational Sciences
  • 3:00 PM – 4:00 PM MT
    Hot Topic: Trends in Utility of Animal Studies in Oral Drug Development
    Hot Topic Speaker: Bart Hens, PharmD, PhD (he/him/his) – Pfizer
    Hot Topic Speaker: Filippos Kesisoglou, Ph.D. (he/him/his) – Merck & Co., Inc.
    Hot Topic Speaker: Stephen D. Stamatis, PhD – Eli Lilly and Company
    Hot Topic Moderator: Siddhi S. Hate, PhD – Eli Lilly and Company
    Hot Topic Speaker: Nikoletta Fotaki, PhD – University of Bath
    Formulation and Delivery
  • 3:00 PM – 4:00 PM MT
    Rapid Fires: Advanced Drug Delivery Technologies for Targeted Therapeutics 1
    Rapid Fire Moderator: Jing Ling, Ph.D. – Merck & Co., Inc.
    Formulation and Delivery
  • 3:00 PM – 4:00 PM MT
    Rapid Fires: Advanced Drug Delivery Technologies for Targeted Therapeutics 2
    Rapid Fire Moderator: Nitesh K. Kunda, PhD – St. John's University
    Formulation and Delivery
  • 3:00 PM – 4:00 PM MT
    Rapid Fires: Advancing Vaccine Development: Utilizing the Power of Model-Based Approaches 1
    Rapid Fire Moderator: Zhiyi Cui, PhD (she/her/hers) – GSK
    Preclinical, Clinical and Translational Sciences
  • 3:00 PM – 4:00 PM MT
    Rapid Fires: Advancing Vaccine Development: Utilizing the Power of Model-Based Approaches 2
    Rapid Fire Moderator: Punit Marathe, PhD – Agios Pharmaceuticals
    Preclinical, Clinical and Translational Sciences
  • 3:00 PM – 4:00 PM MT
    Rapid Fires: Challenges and Lessons Learned in Commercializing (Manufacturing and Product Quality Analysis) Novel Modalities 1
    Rapid Fire Moderator: Kevin Gurney, Ph.D. (he/him/his) – Merck & Co., Inc.
    Manufacturing & Analytical Characterization
  • 3:00 PM – 4:00 PM MT
    Rapid Fires: Innovative Methodologies for Advancing Therapeutics from Bench to Bedside
    Rapid Fire Moderator: Li Di, PhD (she/her/hers) – Recursion
    Discovery and Basic Research
  • 3:00 PM – 4:00 PM MT
    Rapid Fires: Regulatory Implications for Bioanalysis 1
    Rapid Fire Moderator: Jim X. Shen, PhD (he/him/his) – Bristol-Myers Squibb
    Bioanalytics
  • 3:00 PM – 4:00 PM MT
    Rapid Fires: Regulatory Implications for Bioanalysis 2
    Rapid Fire Moderator: Mahadevan (Maha) Lakshminarasimhan, PhD (he/him/his) – Merck & Co., Inc.
    Bioanalytics
  • 4:15 PM – 5:30 PM MT
    Closing Plenary: AI and AI-assisted Approaches in Pharmaceutical Discovery and Development
    Plenary Speaker: Piet H. van der Graaf, Pharm.D., Ph.D. – Certara
  • 5:30 PM – 6:30 PM MT
    Closing Reception