FDA and the Center for Research on Complex Generics (CRCG) will host a free virtual public workshop on November 30, 2021: Establishing the Suitability of Model-Integrated Evidence to Demonstrate Bioequivalence for Long-Acting Injectable and Implantable Drug Products.
The slides and recordings from the workshop will be available for viewing soon. If you registered for the event, you will receive an email when they are available. Please follow us on LinkedIn for an update on when the materials are posted on this website.
About the Event:
Model integrated approaches are being increasingly applied by the drug industry to support and demonstrate bioequivalence (BE), especially for complex generic products (e.g., long-acting injectable drug products) for which in vivo BE studies are challenging to conduct. These challenges are due, in part, to lengthy BE studies that use patient populations and often require multiple doses, potentially taking months for each patient to reach steady state. Model-integrated approaches have the potential to overcome some of these challenges and result in more efficient study designs to demonstrate BE.
This workshop engages experts in the field of modeling and simulation in the generic and new drug industries, academia, and relevant stakeholders to explore, identify and recommend best practices for the development and assessment of model integrated approaches for BE assessment of long-acting injectables and implants. The workshop will focus on how model-integrated approaches support innovative study designs and data analyses and how they can be validated and verified. A collaborative development of best practices will contribute to the availability of more long-acting injectable and implantable generic drug products for the American public.
FDA and the Center for Research on Complex Generics—which is a collaboration between the University of Maryland School of Pharmacy and the University of Michigan College of Pharmacy—are dedicated to advancing programs that stimulate scientific dialogue, disseminate current insights about complex generics, and generate new knowledge in support of FDA’s mission to promote and protect the public health by increasing access to safe and effective generic medicines.
Workshop Recordings:
2021 LAI Workshop Welcome and Opening Remarks
2021 LAI Workshop Session 1 Presentations
2021 LAI Workshop Session 2 Presentations
2021 LAI Workshop Session 3 Presentations
2021 LAI Workshop Panel Discussion 1
2021 LAI workshop Panel Discussion 2, Summation and Closing Remarks
Workshop Slides:
CRCG Welcome Remarks
James Polli, PhD Co-Director, CRCG
Anna Schwendeman, PhD Co-Director, CRCG
Opening Remarks
Robert Lionberger, PhD Director, ORS, OGD, CDER, FDA
Session 1: Challenges in Life Cycle Management of Long-Acting Injectable and Implantable Drug Products
Model-Integrated Evidence for Bioequivalence Assessment of LAIs – From a Generic Drug Perspective
Miyoung Yoon, PhD Acting Team Lead, DQMM, ORS, OGD, CDER, FDA
Modeling and Simulation to Support Appropriate Use of Long-Acting Antipsychotics
Hao Zhu, PhD Acting Director, DPM, OCP, OTS, CDER, FDA
Industry Perspective: Regulatory Challenges in Development of Generic Long-Acting Injectables
Ameya Kohojkar, MS, RAC Associate Director, Regulatory Affairs, Generics, TEVA Pharmaceuticals
Industry Perspective: Incorporation of BE Modeling and LAI Development Challenges
Michael Fitzgerald, PhD Head of Injectable Formulation Development, Viatris
Session 2: Current Status of The Model-Integrated Bioequivalence for Long-Acting Injectable and Implantable Drug Products
Model-Integrated Methods and Innovative Study Designs for Generic LAI Product Development and Regulatory Assessment
Andrew Hooker, PhD Prof., Dept. of Pharmacy, Uppsala Univ.
Model-Integrated BE Approaches for Long-Acting Injectables
Murray Ducharme, PharmD, FCCP, FCP President & CEO, Learn and Confirm Inc./Prof. Associé, Pharmacie, Univ. of Montreal
Session 3: Examples of Model-Integrated Bioequivalence for Long-Acting Injectable and Implantable Drug Products – Focus on Best Practice Development
Accelerating LAI Generic Development Using Model-Integrated Bioequivalence
Joga Gobburu, PhD Prof. & Director, Center for Translational Medicine, Univ. of Maryland Baltimore
Novel Model-Integrated Designs for Bioequivalence Studies of LAI Products: A Complete Framework with the MonolixSuite
Géraldine Ayral, PhD VP Application, Simulations Plus, Lixoft Division
A Model-Integrated Pathway to Explore Bioequivalence of LAI Products: Studies Using Paliperidone Palmitate
Parmesh Gajjar, BA (Hons), MMath, PhD Principal Scientist, Seda Pharmaceutical Development Services
Session 4: Live Panel Discussion
Live Panel Discussion Part 1: Response to Speakers
Moderator: Lanyan (Lucy) Fang, PhD Deputy Director, DQMM, ORS, OGD, CDER, FDA
Panelists: Robert Lionberger, PhD Director, ORS, OGD, CDER, FDA
Anna Schwendeman, PhD Co-Director, CRCG
Miyoung Yoon, PhD Acting Team Lead, DQMM, ORS, OGD, CDER, FDA
Hao Zhu, PhD Acting Director, DPM, OCP, OTS, CDER, FDA
Ameya Kohojkar, MS, RAC Associate Director, Regulatory Affairs, Generics, TEVA Pharmaceuticals
Michael Fitzgerald, PhD Head of Injectable Formulation Development, Viatris
Andrew Hooker, PhD Prof., Dept. of Pharmacy, Uppsala Univ.
Murray Ducharme, PharmD, FCCP, FCP President & CEO, Learn and Confirm Inc./Prof. Associé, Pharmacie, Univ. of Montreal
Joga Gobburu, PhD Prof. & Director, Center for Translational Medicine, Univ. of Maryland Baltimore
Géraldine Ayral, PhD VP Application, Simulations Plus, Lixoft Division
Parmesh Gajjar, BA (Hons), MMath, PhD Principal Scientist, Seda Pharmaceutical Development Services
Bing Li, PhD Associate Director for Scientific Innovation, OB, OGD, CDER, FDA
Liang Zhao, PhD Director, DQMM, ORS, OGD, CDER, FDA
Raja Velagapudi, PhD Executive Director for Clinical Development, Sandoz Inc.
Yu Chung Tsang, PhD CSO, Biopharmaceutics & Biostatistics, Apotex
Live Panel Discussion Part 2: In Depth Discussion of Model-Integrated Evidence Approach and Audience Q & A
Moderator: Same as Part 1
Panelists: Same as Part 1
Workshop Summation and Closing Remarks
Liang Zhao, PhD Director, DQMM, ORS, OGD, CDER, FDA
Topics:
- Current challenges in development and assessment of generic long-acting injectables and implantable drug products
- Recent research on the development of model-integrated bioequivalence approaches – innovative study designs and data analysis for bioequivalence assessment
- Application of model-integrated approaches to long-acting injectable and implantable drug products using population pharmacokinetic modeling
- Validation and verification for model-integrated bioequivalence approaches
- Building consensus on best practices for model-integrated bioequivalence approaches
Audience:
Generic and new drug industries, academia, and other involved stakeholders with a particular interest in the field of modeling and simulation.
For More Information:
If you have any questions about this workshop please contact complexgenerics@rx.umaryland.edu.
Employment Opportunities:
Junior/Senior Reviewer, Quantitative Clinical Pharmacology
Oak Ridge Institute for Science (ORISE) Fellows
