An agenda and webinar recordings for "In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, and When" are provided below for the convenience of event attendees.

This two-day workshop was held May 21-22, 2019, at the University of Maryland School of Pharmacy, located at 20 N. Pine Street in Baltimore, Md.

Download a printer-friendly agenda here.

Conference Recordings:

Explore the links below to view webinar recordings filmed during "In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, and When."

Please note that each recording begins prior to speaker starting.

Conference Webinar Recordings
May 21
May 22

Conference Agenda:

Tuesday, May 21, 2019

Moderators: Dorys Diaz (Pfizer) and David LeBlond (CMCStats)

TimeActivity
8:30-8:35 a.m. Welcome and Logistics
James Polli, PhD
University of Maryland School of Pharmacy
8:35-8:50 a.m. Introduction and Objectives of the Workshop
Sandra Suarez, PhD
U.S. Food and Drug Administration
8:50-9:20 a.m. Keynote: The Value of Similarity Testing in Drug Product Development
Roger Nosal, PhD
Pfizer
9:20-9:50 a.m. F2 Similarity Testing, Performance and Limitations
Yi Tsong, PhD
U.S. Food and Drug Administration
9:50-10:20 a.m. Bootstrap Approach for Similarity Testing, Performance and Limitations
Leslie Van Alstine, MS
Pfizer
10:20-10:30 a.m. Break
10:30-11:00 a.m. Multivariate Statistical Distance Test (MSD) Performance and Limitations
Thomas Hoffelder
Boehringer-Ingelheim
11:00-11:30 a.m. Bayesian Approach for Similarity Testing, Performance and Limitations
Dave LeBlond, PhD
CMCStats
11:30 a.m. - Noon Weibull Model Approach for Similarity Testing, Performance and Limitations
Stan Altan, PhD
Johnson & Johnson
Noon – 12:45 p.m. Lunch
12:45-1:15 p.m. Rational Statistical Analysis Practice in Dissolution Profile Comparison: FDA Perspective
Haritha Mandula, PhD
U.S. Food and Drug Administration
1:15-1:45 p.m. Rational Statistical Analysis Practice in Dissolution Profile Comparison for Product Quality Assessment of Similarity through Real Case Studies: Industry Perspective
Yanbing Zheng, PhD
AbbVie
1:45-2:00 p.m. Introduction and Expectations of Breakout Sessions (BOs)
Dave LeBlond, PhD
CMCStats

BO Sessions, Background Topic: Advantages and Disadvantages of Available Statistical Approaches to Dissolution Profile Comparisons for Similarity Testing
2:00-2:15 p.m. Break and Transition to BOs
2:15-4:15 p.m. Breakout Sessions (Choose One to Attend)

BO Session A: Definition/Discussion of Similarity Terminology -- How Should "Similarity" Be Most Usefully Defined?
Moderators: Dave LeBlond (CMCStats), Thomas Hoffelder (Boehringer-Ingelheim)
Scribes: Haritha Mandula (FDA), Limin Zhang (BMS)
View Presentation Slides

BO Session B: Best Practices for Performing Dissolution Similarity for Regulatory Applications
Moderators: Elena Rantou (FDA), Krista Witkowski (Merck)
Scribes: Poonam Delvadia (FDA), Karin Rosenblatt (AbbVie)
View Presentation Slides

BO Session C: What is the Proper "Inference Space" for Similarity Studies? Addressing This is Key to Experimental Design
Moderators: Meiyu Shen (FDA), James Reynolds (AbbVie)
Scribes: David Lavrich (Merck), Ivelisse Colon-Rivera (Vertex)
View Presentation Slides

BO Session D: What Are the Advantages and Disadvantages of Currently Available "Statistical" Approaches for Dissolution
Moderators: Xiaoyu Cai (FDA), Kim E. Vukovinsky (Pfizer)
Scribes: Amy (Huizi) Zhang (GSK), Zachary Bergeron (Agios)
View Presentation Slides

4:15-4:45 p.m. Break (Moderators and Scribes to Convene)
4:45-5:30 p.m. Summary of Breakout Sessions
Lead Moderators
5:30-6:15 p.m. OC Members/Moderators/Scribes

Wednesday, May 22, 2019

Moderators: Andreas Abend (Merck), Poonam Delvadia (FDA), and Sandra Suarez (FDA)

TimeActivity
8:30-8:35 a.m. Welcome and Logistics
Poonam Delvadia, PhD
U.S. Food and Drug Administration
8:35-9:10 a.m. FDA's Current Practice and Challenges in the Evaluation of Dissolution Profile Comparisons in Support of Minor/Moderate Product Quality Changes: Case Studies
Om Anand, PhD
U.S. Food and Drug Administration
9:10-9:40 a.m. EMA's Current Practice and Challenges in the Evaluation of Dissolution Profile Comparisons in Support of Minor/Moderate Product Quality Changes: Case Studies
Evangelos Kotzagiorgis, MSc
European Medicines Agency
9:40-10:10 a.m. Dissolution Similarity Applications in New Drug Product Development -- Issues and Challenges: Case Studies
Limin Zhang, MS
Bristol-Myers Squibb
10:10-10:40 a.m. ANVISA's Current Practice and Challenges in the Evaluation of Dissolution Profile Comparisons in Support of Minor/Moderate Product Quality Changes: Case Studies
Victor Gomez Pereira, PhD
Anvisa
10:40-11:00 a.m. Break
11:00-11:30 a.m. Health Canada's Current Practice and Challenges in the Evaluation of Dissolution Profile Comparisons in Support of Minor/Moderate Product Quality Changes: Case Studies
Susan Lum, PhD
Health Canada
11:30 a.m. - Noon FDA's Current Challenges in the Use of Dissolution Similarity Testing for Demonstration of BE: Case Studies
Zhen Zhang, PhD
U.S. Food and Drug Administration
Noon - 12:30 p.m. Dissolution Similarity Applications in Generic Industry -- Issues and Challenges: Case Studies
Emilija Fredro-Kumbaradzi, PhD
Apotex
12:30-12:45 p.m. Introduction and Expectation of BO Sessions
Andreas Abend, PhD
Merck

BO Sessions, Background Topic: Dissolution Similarity Assessment, Requirements, and Global Expectations
12:45-1:30 p.m. Lunch
1:30-3:30 p.m. Breakout Sessions (Choose One to Attend)

BO Session A: The Value of Similarity Testing in Light of Clinically Relevant Specifications and Safe Space
Moderators: Sandra Suarez (FDA), Gregory Rullo (AZ)
Scribes: Elisabeth Kovacs, Andreas Abend (Merck)
View Presentation Slides

BO Session B: Dissolution Similarity Assessment, Requirements, and Global Expectations
Moderators: Johannes Kraemer (Disso-Science), Susan Lum (Health Canada)
Scribes: Amy Barker (Lilly), Kelly Kitchens (FDA), Xin Bu (BMS)
View Presentation Slides

BO Session C: How to Design a Robust Statistical Approach (e.g., Decision Tree) for the Assessment of Dissolution Profile Comparisons -- Part 1
Moderators: Yanbing Zheng (AbbVie), Meiyu Shen (FDA)
Scribes: Om Ananda (FDA), Ivelisse Colon-Rivera (Vertex)
View Presentation Slides

BO Session D: How to Design a Robust Approach (e.g., Decision Tree) Beyond Statistical Considerations for the Assessment of Dissolution Profile Comparisons -- Part 2
Moderators: Poonam Delvadia (FDA), David Lavrich (Merck), Amy (Huizi) Zhang (GSK)
Scribes: Dave LeBlond (CMCStats), Michael Cohen (Pfizer), Gao Yi (AbbVie)
View Presentation Slides
3:30-4:00 p.m. Break (Moderators/Scribes to Convene)
4:00-4:45 p.m. Summary of Breakout Sessions
Lead Moderators
4:55-5:15 p.m. Conclusion and Future Directions
Dorys Diaz, MBA
Pfizer