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:
| Time | Activity |
|---|---|
| 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
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:
| Time | Activity |
|---|---|
| 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:
| Time | Activity |
|---|---|
| 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 |
| 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 |