September 14, 2021

The Center for Research on Complex Generics (CRCG), the collaborative center jointly established by the University of Maryland School of Pharmacy and the University of Michigan College of Pharmacy, recently hosted its first public workshop, which drew more than 2,500 virtual attendees. CRCG was established in 2020 and is funded by the US Food and Drug Administration (FDA).

Participants from 70 countries attended the virtual workshop on "In Vitro Release Test (IVRT) and In Vitro Permeation Test (IVPT) Methods: Best Practices and Scientific Considerations for ANDA Submissions" on Aug. 18-20, 2021.

The mission of the CRCG is to increase access to safe and effective generic drugs through collaborative research, training, and information exchange. To that end, the first event addressed a very important topic in generic drug development — IVRT and IVPT methods, and their use to support a demonstration of bioequivalence. The program content and panel discussions facilitated necessary discussions on IVRT and IVPT method development, validation, and the scientific and regulatory use of these test methods – with extensive input from (and deliberation amongst) numerous stakeholders in the generic drug industry.

“The IVRT/IVPT workshop was a wonderful inaugural CRCG event,” says James Polli, PhD, the Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics at the University of Maryland School of Pharmacy and co-director of the CRCG. “It was rewarding to collaborate with industrial scientists, particularly those who conduct IVRT/IVPT studies, and to see their contributions to workshop planning, presentations, training videos, and question-and-answer panels.”

“One of the greatest challenges to the development of complex generics, as reported to the FDA from generic industry stakeholders, is an uncertainty about how to implement scientific insights from generic drug research in a manner consistent with the FDA’s regulatory expectations,” says Sam Raney, PhD, Associate Director for Science in FDA’s Office of Generic Drugs, Office of Research and Standards. “This includes the development of suitable test procedures, study designs, model integrated evidence or other matters impacting generic drug applications. This workshop was the first in a series of practical workshops that engaged industry and the FDA experts to explore these challenges by deliberating about the scientific considerations, illustrating best practices and discussing how research-based methodologies can be incorporated into generic drug applications.”

Those who joined the public workshop, and those who spoke or presented, have a wide variety of roles in the generic drug industry. Attendees included students, academicians, drug development professionals, FDA regulators and scientists, and senior pharmaceutical industry executives working in drug development and regulatory affairs, as well as others.

“From our conversations with those working in the generic drug industry, we realized topical products are a very important category of complex generics,” says Anna Schwendeman, PhD, William I Higuchi Collegiate Professor of Pharmacy at the University of Michigan College of Pharmacy and co-director of the CRCG. “Multiple companies are working on the development of these products, yet many questions remain about how to correctly conduct IVRT/IVPT studies, interpret the data, and perform statistical analysis. We made this conference very interactive — to address all these specific questions with the goal of having many safe and effective topical generic products approved in the future.”

"I was honored to be a speaker and panelist at this extremely well-orchestrated CRCG 3-day event,” says Audra Stinchcomb, PhD, professor of pharmaceutical sciences at the University of Maryland School of Pharmacy. “This conference highlighted the regulatory science progress made in IVRT and IVPT over the last several years and helped to pinpoint some aspects that still need clarification. This conference was the apogee of IVRT/IVPT method development and utility."

The Center will hold additional free virtual public workshops Sept. 30 - Oct. 1 and Nov. 30, 2021. To learn more about the events and register, visit: complexgenerics.org/events.

For more information on the Center’s activities to advance generic drug development and future educational events, sign up for updates from the CRCG, and follow its Twitter and LinkedIn pages.