A schedule of events for Dissolution and Translational Modeling Strategies Enabling Patient-Centric Product Development is provided below for the convenience of conference attendees.

This multi-day conference scheduled for May 15-17, 2017, will be held at the University of Maryland School of Pharmacy, located at 20 N. Pine Street in Baltimore, Md.

For a printable version of the conference agenda, please download this document‌.

Monday, May 15:

TimeActivity
8:00-8:30 a.m. Registration
8:30-8:35 a.m. Welcome and Logistics
James Polli, PhD
Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics
Department of Pharmaceutical Sciences
University of Maryland School of Pharmacy

Sandra Suarez Sharp, PhD
Master Biopharmaceutics Reviewer
CDER/FDA
8:35-8:45 a.m. Opening Remarks
Lawrence Yu, PhD
Deputy Office Director
CDER/FDA
8:45-9:00 a.m. Introduction and Objectives of the Workshop
Andreas Abend, PhD
Director
Merck

Rob Ju, PhD
Head, Dissolution Sciences
AbbVie
  The Role of Dissolution Testing in Drug Product Development
Challenges and Opportunities in Developing in vitro Methods to Successfully Guide Product Development and Justification of QC Method Conditions and Acceptance Criteria
9:00-9:30 a.m. The Future of Dissolution Testing: Key Element for the Need of Patient-Centric Assessment of Quality -- Regulatory Perspective
Sarah Pope Miksinski, PhD
Office Director
CDER/FDA
9:30-10:00 a.m. Industry Perspective on the Current Status and Future of Dissolution Testing for Product Development and Quality Control
Rob Ju, PhD
Head, Dissolution Sciences
AbbVie

Haiyan Grady, PhD
Associate Scientific Director
Takeda Pharmaceuticals
10:00-10:15 a.m. Break
10:15-11:10 a.m. Use of Bio-Predictive Methods During Early Formulation Screening with Case Studies
Jesse Kuiper, PhD
Principal Scientist
Merck
11:10-12:10 p.m. Dissolution Methodologies from Biorelevant to Quality Control: Challenges and Gaps
Xujin Lu, PhD
Senior Principal Scientist
Bristol-Myers Squibb

Jian-Hwa Han, PhD
Section Manager
AbbVie

Danna Mattocks, PhD
Senior CMC Project Manager
TherapeuticsMD
12:10-1:00 p.m. Lunch
1:00-1:45 p.m. The Use of Surrogates for Dissolution Testing for IR Formulation: When Is It Feasible? -- Case Studies
Limin Zhang
Senior Research Scientist
Bristol-Myers Squibb

Andre Hermans, PhD
Principal Scientist
Merck
1:45-2:15 p.m. Status and Challenges of Dissolution Models for Real Time Release Testing
Hanlin Li, PhD
Associate Director
Vertex

German Drazer
Rutgers University
  Breakout Sessions (Choose One)
10-Minute Presentation Followed by Discussion on Pre-Selected Questions
2:20-4:30 p.m. Definition/Discussion of Terminologies (e.g., QC vs. Physiologically Relevant vs. Clinically Relevant vs. Bio-Predictive vs. Discriminating Dissolution Testing

Speaker:
Dorys Diaz, PhD, Associate Director at Pfizer
Facilitators:
Angelica Dorantes, PhD, Acting Branch Chief, CDER/FDA; Johannes Kraemer, CEO, Phast GmbH; and Dorys Diaz, PhD, Associate Director, Pfizer
Questions for Discussion:
(TBD)

Bridging Bio-Predictive --> QC Methods: Framework, Approaches, and Information Suggested to Reach Following Scenarios
  1. Scenario Where QC Methods Can Be Bio-Predictive
  2. Scenario Where It Is Challenging for QC Methods to Be Bio-Predictive (Parallel R&D Bio-Predictive and QC Methods)
Speaker: David Curran, Scientist at GlaxoSmithKline
Facilitators:
Erika Stippler, Director, USP; Kimberly Raines, PhD, Acting Branch Chief, CDER/FDA; and Danna Mattocks, PhD, TherapeuticsMD
Questions for Discussion:
(TBD)
4:30-5:00 p.m. Summary of Breakout Discussions

Tuesday, May 16:

TimeActivity
8:00-8:30 a.m. Registration
8:30-8:35 a.m. Welcome and Logistics
Tycho Heimbach, PhD
Director
Novartis

Rob Ju, PhD
Head, Dissolution Science
AbbVie
  The Need for Establishing in vitro-in vivo Link
Novel Approaches and in silico Tools in the Development of Bio-Predictive Dissolution and Permeability Testing (BCS 2/4)
8:35-9:15 a.m. Challenges and Strategies in Establishing an in vitro-in vivo Link
Paul Seo, PhD
Division Director
CDER/FDA
9:15-9:45 a.m. Novel Approaches in Human PK Study Design (e.g., Stable Isotopes Technique) to Overcome the Challenges in the Conduct of Dedicated BA/BE Studies (Case Studies)
Timothy H. Montague, PhD
Clinical Statistics ADD TA Head
GSK
9:45-10:30 a.m. Development of Canagliflozin: Mechanistic Absorption Modeling During Late-Stage Formulation and Process Optimization
Nico Holmstock, PhD
Scientist, Preformulation and Biopharmaceutics
Janssen
10:30-10:45 a.m. Break
10:45-11:30 a.m. Conventional IVIVC and Recent Development in Modeling/Simulation: Case Studies from Regulatory Perspective
Maziar Kakhi, PhD
Staff Fellow
CDER/FDA
11:30-12:00 p.m. PBPK Absorption Modeling Challenges in Predicting Clinical Outcomes Across BCS/BDDCS Classes (PPI Effects, Virtual Trial BE vs. Conventional BE for MR): Case Studies from Industry Perspective
Tycho Heimbach, PhD
Director
Novartis
12:00-1:00 p.m. Lunch
1:00-1:45 p.m. The Utility of in silico PBPK Absorption Modeling and Simulation as a Tool to Increase the Success of Developing Bio-Predictive Dissolution Methods: Success and Limitations (Case Studies from Regulatory Perspective)
HoPi Lin, PhD
Biopharmaceutics Reviewer
CDER/FDA

Liang Zhao, PhD
Division Director
CDER/FDA
1:45-2:15 p.m. Case Studies of Mechanistic Absorption Modeling and IVIVC Used in Development Projects
Andres Olivares-Morales, PhD
Project Leader, M&S Scientist
Roche
2:15-2:45 p.m. Applications of PBPK Modeling for the Development of Biorelevant Dissolution Methods with Case Studies -- Industry Perspective
Xavier Pepin, PhD
Principal Scientist, Biopharmacy
AstraZeneca
  Breakout Sessions (Choose One)
10-Minute Presentation Followed by Discussion on Pre-Selected Questions
3:00-5:00 p.m. Gaps in Knowledge to Increase the Confidence in the Use of in silico PBPK Absorption Models for Regulatory Decision Making: Space of API and Formulation Attributes Where in silico PBPK May Have Limited Utility

Speaker: Xavier Pepin, PhD, Principal Scientist, Biopharmacy, AstraZeneca
Facilitators: Marilyn Martinez, PhD, Senior Biomedical Research Scientist, CVM/FDA; Dave Sperry, Eli Lilly; Xavier Pepin, AstraZeneca; and Carrie Coutant, PhD, Principal Research Scientist, Eli Lilly
Questions for Discussion: (TBD)

Which Data Should be Submitted to Support the Validation/Verification of in silico PBPK Absorption Models for Regulatory Decision Making? What Are the Recommended Validation Acceptance Criteria for PBPK M&S

Speaker: Ping Zhao, PhD, Lead, PBPK Program, CDER/FDA
Facilitators: Ping Zhao, PhD, Lead, PBPK Program, CDER/FDA; Tycho Heimbach, Novartis; and Handan He, Novartis
Questions for Discussion: (TBD)
5:00-5:30 p.m. Summary of Breakout Discussions

Wednesday, May 17:

TimeActivity
8:00-8:30 a.m. Registration
8:30-8:35 a.m. Welcome and Logistics
Sandra Suarez, PhD
Master Biopharmaceutics Reviewer
CDER/FDA

Evangelos Kotzagiorgis, MSc
Scientific Administrator
European Medicines Agency
  Regulatory Applications of Bio-Predictive Dissolution Testing
8:35-9:35 a.m. Framework of Setting Clinically Relevant Specifications: Approach, Information Needed, and Criteria
Sandra Suarez Sharp, PhD
Master Biopharmaceutics Reviewer
CDER/FDA

Evangelos Kotzagiorgis, MSc
Scientific Administrator
European Medicines Agency

Andreas Abend, PhD
Director
Merck
9:35-10:05 a.m. The Role of Bio-Predictive Dissolution Method in the Selection of CMA, CPPS, and Verification of Design Space(s): Case Studies
Mike Cohen, PhD
Research Fellow
Pfizer
10:05-10:20 a.m. Break
10:20-11:00 a.m.

The Role of Bio-Predictive Dissolution Testing in Increasing the Success Rate of IVIVR/IVIVC: Key Approach in Support of Major Post-Approval Changes (Biowaivers) in Reference to Regulatory Guidelines
Min Li, PhD
Acting Biopharmaceutics Lead
CDER/FDA

Anna Nordmark, PhD
Pharmacokinetic Assessor at MPA
European Medicines Agency

11:00-11:25 a.m. The Utility of On Level C IVIVC for Setting Clinically Relevant Specifications: Case Studies and Implications
Filippos Kesisoglou, PhD
Senior Principal Scientist
Merck
11:25-12:10 p.m. Establishing Clinical Relevant Specifications During Product Life Cycle: Case Studies
Barbara Davit, PhD, JD
Distinguished Scientist
Merck

Patrick Marroum, PhD
Senior Research Fellow
AbbVie
12:10-1:00 p.m. Lunch
  Breakout Sessions (Choose One)
10-Minute Presentation Followed by Discussion on Pre-Selected Questions
1:00-3:00 p.m. Similarities, Differences, and Shared Challenges in the EMS and U.S. FDA: Recommended Approaches to Setting Clinically Relevant Drug Product Specifications

Speaker: Paul Dickinson, PhD, Director, SEDA Pharmaceutical Development Services
Facilitators: Evangelos Kotzagiorgis, EMA; Sandra Suarez, FDA; and Andreas Abend, Merck
Questions for Discussion: (TBD)

Similarities, Differences, and Shared Challenges in the EMA and U.S. FDA: Recommended Use of in silico PBPK Absorption M&S in Regulatory Decision Making in Relation to Biowaivers

Speaker: TBD
Facilitators: Paul Seo, PhD, Division Director, CDER/FDA
Questions for Discussion: (TBD)
3:00-3:30 p.m. Summary of Breakout Discussions
3:30-4:00 p.m. Meeting Wrap-Up and Follow-Up Actions