GRx+Biosims 2024 Presentations

Monday, October 21, 2024

OGD Keynote Address

• Iilun Murphy, M.D.
  Director, Office of Generic Drugs (OGD), CDER, FDA

Interchangeability

• Jessica Greenbaum, J.D.
  Director, Regulatory Affairs Policy U.S., Sandoz
• Arlene Wolny, PhD
  Global Head of Regulatory Affairs, Biocon Biologics Ltd.

ANDA Deficiency Trends: Common Issues to Improve ANDA Submission Quality

• Bhupesh Singh Bisht, MPharm
  Director, Regulatory Affairs U.S., Apotex
• Darby Kozak, PhD
  Deputy Director, OGD, CDER, FDA
• Anand Saxena, M.Sc.
  Director, Regulatory Affairs, Cipla LTD
• CDR Geoffrey Wu, PhD, PMP, CPH
  Acting Office Director, OPQA I, OPQ, CDER, FDA

Streamlining Biosimilars Development

• Stacey Ricci, Meng, ScD
  Director, Scientific Review Staff, OTBB, OND, CDER, FDA
• Martin Schiestl, PhD
  Global Head Regulatory Affairs Policy, Sandoz
• Cory Wohlbach
  Global VP, Biosimilars Regulatory Affairs, Teva Pharmaceuticals
• Elena Wolf-Holz, M.D., PhD
  Global Head Clinical Development, Biocon Biologics Ltd.

Drug shortages: An Agency Perspective

• Janie Gwinn
  Vice President, Regulatory Affairs, Amneal Pharmaceuticals
• Christina Mazzella, MSc
  VP Quality Compliance, Teva Pharmaceuticals
• Adam Steinberg, PharmD
  Associate Director, Regulatory Affairs, Apotex
• CDR Emily Thakur, RPh
  Team Leader, Drug Shortage Staff, OCD, CDER, FDA
• CDR Silvia Wanis, PharmD, MS, BCPPS
  Senior Regulatory Officer, Incidents, Recalls and Shortages Branch, Office of Drug Security, Integrity, and Response (ODSIR), OC, CDER, FDA

Nitrosamines and Harmonization

• Sanjeeva Chinnakadoori, PhD
  Senior Research Scientist/Associate Director, Analytical R&D, Amneal Pharmaceuticals
• Vijaya Iyer, M.S.
  Senior Director, Global Regulatory Affairs PLCM & Regulatory Compliance, Apotex
• Nalin Karkra
  General Manager, Sun Pharmaceuticals
• John “JD” Derstine
  Senior Director, Generics Regulatory Affairs, Teva Pharmaceuticals

Legal Overview of the BIOSECURE Act

• Aaron Cummings, JD
  Partner, Crowell & Moring LLP

Device Requirements for Biosimilars and Interchangeable Biosimilars

• Amith Belavadi
  Director, Technical Program Management, Project & Portfolio Management, Amneal Pharmaceuticals
• Johannes Keuschnigg, PhD
  Regulatory Devices Portfolio Head, Sandoz
• Maria Burkholder, MHA
  Senior Director, Regulatory Affairs Global Biosimilars, Teva Pharmaceuticals

Best Practices for Securing Timely Approvals of ANDAs

• Rashmi V. Shetty, MSc.
  Director, Regulatory Affairs, Cipla LTD
• CAPT Stacy Barley RN, MSN, MHA
  Lead REMS Coordinator, Division of Clinical Safety and Surveillance (DCSS), OSCE, OGD, CDER, FDA
• Jayani Perera, PhD
  Senior Chemist, Division of Product Quality Assessment XIX, OPQA III, OPQ, CDER, FDA
• Diana Vivian, PhD
  Associate Director, Division of Bioequivalence II (DB II), OB, OGD, CDER, FDA

Updates on Electronic Submissions

• Heather Crandall
  Operations Research Analyst, DDMSS, OBI, OSP, CDER, FDA
• Seyoum Senay
  Supervisory Operations Research, DDMSS, OBI, OSP, CDER, FDA
• Jonathan Resnick, PMP
  Project Management Officer, DDMSS, OBI, OSP, CDER, FDA
• Megan Boals MPH, MS, CSM, CSPO, A-CSPO
  Operations Research Analyst, DDQCSS, OBI, OSP, CDER, FDA

USP Excipient Nomenclature and Advanced Analytical Procedures for Characterization of Polymeric Excipients

• Hong Wang
  Senior Manager, Science & Standards Excipients, USP

Tuesday, October 22, 2024

OII Keynote Address

• Michael Rogers, MS
  Associate Commissioner for Inspections and Investigations, Office of Inspections and Investigations (OII), FDA

OII Medical Products Inspectorate Keynote Address

• Elizabeth Miller, PharmD
  Deputy Associate Commissioner Medical Products, OII, FDA

Multi-attribute Method and Non-clinical Immunogenicity Studies

• Diane McCarthy, PhD
  Senior Director, Science and Standards, Global Biologics, USP
• Andrew Graves, M.S., SCYM
  Director, Immunogenicity Assessment, Teva Pharmaceuticals
• Anita Krishnan, PhD
  Associate Vice President and Head of Analytical Sciences, Biocon Biologics Ltd.
• Sarah Rogstad, PhD
  Senior Scientific Advisor, Office of Pharmaceutical Quality Research, OPQ, CDER, FDA

Generic Drug-Device Combination Products – Evaluating Generic Combination Products and Navigating Differences

• Sharon Ahluwalia, M.D.
  Physician, Division of Clinical Review (DCR), OSCE, CDER, FDA
• Andrew Clerman, M.D., PhD
  Acting Lead Physician, Division of Therapeutic Performance I (DTP I), ORS, OGD, CDER, FDA
• Aparna Dagar, PhD, RAC
  Senior Director, Regulatory Affairs, Fresenius Kabi USA, LLC
• Chris Lamanna, PhD
  Head Regulatory Devices, Sandoz

Product & Quality Threats and Opportunities: Extractables/Leachables

• Vince Crowley, PhD
  Senior Pharmacologist, Division of Pharmacology/Toxicology Review (DPTR), OSCE, OGD, CDER, FDA
• Priti Jagani
  Senior Director, Pharma R&D, Amneal Pharmaceuticals
• Edwin Jao, PhD
  Director, Division of Pharmaceutical Manufacturing Assessment IV, OPMA, OPQ, CDER, FDA
• Alan Thompson
  Director, Inhalation Regulatory Affairs, Teva Pharmaceuticals

Regulatory Science Challenges for Complex Generics

• Tarun Goswami, PhD
  Senior Director, Complex Product Development, Amneal Pharmaceuticals
• Vasiliy Korotchenko, PhD
  Chemist, Division of Product Quality Assessment IV, OPQA I, OPQ, CDER, FDA
• Keduo Qian, PhD
  Chemist, Division of Product Quality Assessment XIX, OPQA III, OPQ, CDER, FDA
• Kalpana Vanam, MBA
  Senior Vice President, Regulatory Affairs, Lupin Pharmaceuticals
• Yan Wang, PhD
  Acting Deputy Director, Division of Therapeutic Performance I (DTPI), ORS, OGD, CDER, FDA

Best Practices for Post-Approval Changes

• Andy Aguanno, BSc.
  Manager, Global Regulatory Affairs, Liquids & Specialty Dosage, Apotex Inc.
• David Awotwe-Otoo, PhD
  Senior Pharmaceutical Quality Assessor, Division of Product Quality Assessment III, OPQA I, OPQ, CDER, FDA
• Hongling Zhang, PhD
  Director, Division of Bioequivalence II, OB, OGD, CDER, Food and Drug Administration
• Mayank Nagar
  Vice President, Technical Services & New Product Launches (North America), Dr. Reddy’s Laboratories Inc.

Humira Biosimilar Adoption: Hints of Progress or Signs of Doom?

• Nick Adolph
  Principal, US Market Access Strategy Consulting, IQVIA

GRx+Biosims Exposition

• Per- and polyfluoroalkyl substances (PFAS)
• Get to know Generic Drug Structured Assessment – Bioequivalence (GDSA-BE)
• OGD Regulatory and Labeling Project Managers
• Get to know OGD’s Office of Safety and Clinical Evaluation
• Office of Therapeutic Biologics and Biosimilars (OTBB)
• Comparative Use Human Factors Studies (CUHFS): An Alternative Approach
• OGD: What GDUFA Research Can Do For You!
• OGD: Driving Efficiency of Pre-ANDA Communications

Wednesday, October 23, 2024

CDER Keynote Address

• Jacqueline Corrigan-Curay, JD, M.D.
  Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER), FDA