Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review; Public Workshop, October 2 - 3, 2017

Summary:

The Food and Drug Administration is announcing a public workshop entitled “Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review.” The workshop is free to attend and open to the public--register online now!

Modeling and simulation have been increasingly used in drug development, providing a framework for synthesizing information and extrapolating beyond what has been studied. Model-informed drug development (MIDD) approaches can be applied to both brand and generic drug products. MIDD includes pharmacokinetic/pharmacodynamics (PK/PD) models, physiologically-based pharmacokinetic (PBPK) or absorption models, systems pharmacology, quantitative risk modeling, and emergent machine learning tools. These application areas can leverage the large pharmaceutical data sets (big data) available to the FDA and other organizations to improve development and regulatory decision making. Quantitative approaches have been used to address critical scientific and regulatory issues in all phases of the product lifecycle: from pre-investigational new drug applications (INDs) through NDAs, ANDAs, and post-approval evaluation of new and generic drugs. Given the broad applications of modeling and simulation through the entire lifecycle of a product, there is a need to identify best practices to improve the routine use and acceptance of modeling and simulation for regulatory decision making for generic drugs.

The purposes of the workshop are to:

Engage global stakeholders and share experience and vision on using quantitative approaches in regulatory decision making for generic drug development and product lifecycle management;
Identify and prioritize potential areas for global harmonization for tools to inform regulatory decision making;
Share the current state of knowledge and practice in utilizing quantitative methods and modeling for generic drug development and review by case demonstrations and by integrating experience and lessons learned from new drug development and reviews;
Identify opportunities for complex and locally acting product development and discuss approaches and principles in using quantitative methods and modeling to aid product-specific guidance development, pre-ANDA interactions between FDA and prospective applicants, ANDA reviews, and postmarket performance monitoring; and
Discuss next generation quantitative method and modeling toolsets, future directions, and application areas.

Dates & Times: October 2 (8 a.m. - 4:30 p.m.)

October 3, 2017 (8 a.m. - 4:00 p.m.)

Location:    FDA White Oak Campus
                    10903 New Hampshire Avenue
                    Bldg. 31 Conference Center
                    Section B and C of the Great Room (Rm. 1503)
                    Silver Spring, MD 20993
                    Public Meetings at FDA White Oak Campus

Visitors attending public meetings in the Building 31 Great Room must enter through Building 1 where they will undergo the routine security check procedures for building entry. A visitor badge and escort are not required to attend a public meeting in the Great Room. Please allocate 15 - 30 min for arrival and security checks. Driving and parking information for visitors to the FDA, along with a campus map, can be found at: FDA White Oak Campus Visitor Information.

Registration: You may attend in person or via the Webcast. Seating will be limited, so early registration is recommended. Registration is free and will be on a first-come, first-served basis. Please register by To Register, go to: Quantitative Methods and Modeling Workshop Registration on or before September 25, 2017. Registration on the day of the public workshop will be provided on a space available basis beginning at 7:30 a.m.

Webcast Link for Online Attendees: https://collaboration.fda.gov/dqmm1017/. Please log-in as guests.

Meeting Materials: Agenda (PDF - 65 KB)

Remarks by Scott Gottlieb, M.D.

Comments: Will be added once FR notice is posted and docket is created.

For Further Information Contact:

Lanyan (Lucy) Fang Ph.D. or Liang Zhao Ph.D.,
CDER Office of Generic Drugs, Division of Quantitative Methods and Modeling
Email: CDER-OGD-OfficeofResearchandStandardsAnnouncement@fda.hhs.gov

Meeting Recordings

Day 1:

Day 2:

Meeting Presentations

Leveraging Quantative Methods & Modeling to Modernize Generic Drug Development & Review Introduction & Workshop Objectives (PDF - 655 KB)
Kathleen "Cook" Uhl, M.D. Director, Office of Generic Drugs FDA/CDER
Science and Generic Drugs (PDF - 705 KB)
John R. Peters, M.D. Deputy Director, Office of Generic Drugs FDA/CDER
ICH for Generic Drugs – The FDA’s Perspective (PDF - 228 KB)
Zili Li, M.D., M.P.H. Associate Director for Global Affairs, Office of Generic Drug FDA/CDER
Partial AUCs 2.0 – Improved Metrics for Assessing Bioequivalence on Mixed Release Mode (IR/ER) Drug Products (PDF - 198 KB)
Charles E. DiLiberti, Montclair Bioequivalence Services, LLC
Considerations for bioequivalence evaluation of nano-particulate/molecular medicine (PDF - 843 KB)
Jessie L.-S. Au, Optimum Therapeutics LLC
Model-based Approaches as Guidance to Bioequivalence Decision Making: Design and Analysis Considerations (PDF - 13 MB)
Andrew C. Hooker, Uppsala University
Strengths and Weaknesses of Population PK Analyses for the Assessment of Bioequivalence of Complex and Locally Acting Products (PDF - 927 KB)
Murray P. Ducharme, Learn and Confirm Inc.
Toward Consensus on Definitions of PD and Synergy for Claims in Drug Regulatory Decisions
Ting-Chao Chou, PD Science, LLC (PDF - 406 KB)
Is there a Potential to Apply the Bayesian Approach in Generic Drug Development and Approval
Carl Peck, UNCF (PDF - 338 KB)
Pharmacometric Approach To Define Narrow Therapeutic Index (NTI) Drugs & Evaluate Bioequivalence (BE) Criteria for NTI Drugs (PDF - 2 MB)
Elyes Dahmane, Joga Gobburu and Vijay Ivaturi, University of Maryland
Challenges in Maintaining Competition in Small Generic Drug Markets (PDF - 979 KB)
Ernst R. Berndt, MIT Sloan School and NBER
Challenges in Maintaining Competition in Small Generic Drug Markets II
Rena M. Conti, University of Chicago (PDF -861 PDF)
A Model- and Systems-Based Approach to Efficacy and Safety Questions Related to Generic Substitution (PDF - 1.5 MB)
Stephan Schmidt, University of Florida
Real World Pragmatic Studies: Pharma Perspective and a Recent Example (PDF - 451 KB)
Cynthia Haung Barlett, Pfizer Oncology
Using the Sentinel System to Assess Generic Drug Safety in the Post-Approval Setting (PDF - 1 MB)
D. Tyler Coyle, MD, MS, Office of Surveillance and Epidemiology, FDA/CDER
Use of Regulatory Science Research to Support Post-marketing Surveillance of Generic Drug Products (PDF -684 KB)
Sarah Ducher, PhD, Office of Generic Drugs, FDA/CDER
Generic drug regulations and regulatory convergence (PDF - 217 KB)
Chandrashekar Ranga, CDSCO
CFDA Reform and ICH Membership (PDF - 1.3 MB)
Weng Xinyu, CFDA
Quantitative Methods and Generic Drugs: Current Approaches and Future Directions in Health Canada (PDF - 400 KB)
Danika Painter, Health Canada
Generic Industry Voice for Regulatory Convergence and Harmonization (PDF - 269 KB)
Nicholas Cappuccino, IGBA
Initiatives and Progress Towards Harmonization (PDF - 680 KB)
Antony Fake, WHO
Using Quantitative Methods and Modeling to Transform Generic Drug Development and Review (PDF - 509 KB)
Robert Lionberger, Director, Office of Research and Standards, FDA/CDER/OGD
Leveraging Quantitative Methods in Reviewing Complex/Locally Acting Products (PDF - 843 KB)
Lanyan (Lucy) Fang, Ph.D., Office of Research and Standards, FDA/CDER/OGD
Prediction of the first ANDA submission for NCEs utilizing machine learning methodology (PDF - 927 KB)
Meng Hu, Ph.D., Office of Research and Standards, FDA/CDER/OGD