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
10:15-11:00 a.m. Use of Bio-Predictive Methods During Early Formulation Screening with Case Studies
Jesse Kuiper, PhD
Principal Scientist
Merck
11:00-12:00 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
12:00-12:50 p.m. Lunch
12:50-1:35 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
1:35-2:15 p.m. Status and Challenges of Dissolution Models for Real Time Release Testing
Hanlin Li, PhD
Associate Director
Vertex

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

Speakers:
Dorys Argelia Diaz, MBA, Associate Director, Pfizer, and Pramod Kotwal, PhD, Director, Merck
Facilitators:
Cindy Buhse, PhD, Director, FDA; Angelica Dorantes, PhD, Acting Branch Chief, FDA; Johannes Kraemer, PhD, CEO, Phast GmbH; Dorys Argelia Diaz, MBA, Associate Director, Pfizer; Pramod Kotwal, PhD, Director, Merck; and Haiyan Grady, Associate Director, Takeda
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, GlaxoSmithKline, and Yiqing Lin, PhD, Senior Scientist, Biogen
Facilitators:
Erika Stippler, PhD, Director, USP; Kimberly Raines, PhD, Acting Branch Chief, FDA; and Danna Mattocks, PhD, Senior Manager, TherapeuticsMD; Yiqing Lin, PhD, Senior Scientist, Biogen; David Curran, PhD, Scientist, GSK; Banu Zolnik, PhD, Biopharmaceutics Reviewer, FDA
Questions for Discussion:
(TBD)
4:30-5:00 p.m. Summary of Breakout Discussions
5:15-6:15 p.m. Speaker/Facilitator/Note Takers Day 1 Close-out

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)
8:35-9:05 a.m. Challenges and Strategies in Establishing an in vitro-in vivo Link
Paul Seo, PhD
Division Director
CDER/FDA
9:05-9:35 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
9:35-10:10 a.m. Development of Canaglifiozin: Mechanistic Absorption Modeling During Late-Stage Formulation and Process Optimization
Nico Holmstock, PhD
Scientist, Preformulation and Biopharmaceutics
Janssen R&D, Johnson and Johnson
10:10-10:25 a.m. Break
10:25-11:00 a.m. Application of Stochastic Deconvolution in IVIVC Development
Maziar Kakhi, PhD
Staff Fellow
CDER/FDA
11:00-11:35 a.m. PBPK Absorption Modeling Challenges in Predicting Clinical Outcomes Across BCS/BDDCS Classes (PPI Effects, Formulation Assessments, Food Effects): Case Studies from Industry Perspective
Tycho Heimbach, PhD
Director
Novartis
11:35-12:10 p.m. Case Studies of Mechanistic Absorption Modeling and IVIVC Used in Development Projects
Andres Olivares-Morales, PhD
Project Leader, M&S Scientist
Roche
12:10-1:00 p.m. Lunch
1:00-2:10 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
2:10-2:45 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)
10-20 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

Speakers: Xavier Pepin, PhD, Principal Scientist, Biopharmacy, AstraZeneca, and Carrie Coutant, PhD, Principal Research Scientist, Eli Lilly
Facilitators: Marilyn Martinez, PhD, Senior Biomedical Research Scientist, FDA; Xavier Pepin, AstraZeneca; and Carrie Coutant, PhD, Eli Lilly; and HoPi Lin, PhD, FDA
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

Speakers: Nikunjkumar Patel, PhD, Senior Research Scientist (M&S), Certara, and Denise Morris, PhD, Assistant Director, SimulationsPlus
Facilitators: Ping Zhao, PhD, Lead, PBPK Program, FDA; Tycho Heimbach, Novartis; Filippos Kesisoglou, Merck; Min Li, FDA, Amitava Mitra, PhD, Associate Director, Sandoz
Questions for Discussion: (TBD)
5:00-5:30 p.m. Summary of Breakout Discussions
5:45-6:30 p.m. Speaker/Facilitators/Note Takes Day 2 Close-out

Wednesday, May 17:

TimeActivity
8:00-8:30 a.m. Registration
8:30-8:35 a.m. Welcome and Logistics
Sandra Suarez Sharp, 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

Speakers: Nagesh Bandi, PhD, Executive Director, Merck, and Michael Cohen, Pfizer
Facilitators: Evangelos Kotzagiorgis, EMA; Sandra Suarez, FDA; Andreas Abend, Merck; Poonam Delvadia, PhD, Acting Biopharmaceutics Lead, FDA; and Nagesh Bandi, 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

Speakers: Erik Sjogren, PhD, Associate Professor in Biopharmaceutics, Uppsala University, and Barbara Davit, Merck
Facilitators: Paul Seo, PhD, Director, FDA; Shereeni Veerasingham, PhD, Assessment Officer, Health Canada; Erik Sjogren, Uppsala University; Xinyuan (Susie) Zhang, PhD, Clinical Pharmacology Reviewers, FDA; and Shinichi Kijima, MSc, Clinical Pharmacology Reviewer, PMDA
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
4:15-5:15 p.m. Speaker/Faciliator/Note Takers Day 3 Close-out