FDA Experts to Address 'Hot Topic' Therapeutic Equivalence in School of Pharmacy Workshop

By Cynthia McMullen

The Virginia Commonwealth University School of Pharmacy announces its first in a series of annual pharmaceutical sciences workshops thanks to the efforts of its recently formed Pharmaceutical Sciences Graduate Advisory Board.

“Therapeutic Equivalence: Legislative, Regulatory and Scientific Issues in Drug Product Development” will feature presentations by Food and Drug Administration scientists Dale P. Conner, Barbara M. Davit, John Z. Duan and Mehul Mehta, as well as Eric Mittleberg of Sandoz and Leon Shargel of Applied Biopharmaceutics LLC.

The workshop will take place April 18 from 9 a.m. to 5:30 p.m. at the Jonah Larrick Student Center, 900 Turpin St., in Richmond.

Bioequivalence-related topics range from in vitro methodology to modified-release products. According to workshop moderator Chandra Chaurasia, Conner, a counterpart in the Office of Generic Drugs’ Division of Bioequivalence I, will specifically address nasal and inhalation products. Many generics are being developed in the inhalation arena now that their complexities are better understood.

“This has been a hot topic in the industry for some years and is going to remain a hot topic,” said Chaurasia, who is a team leader for the FDA’s Division of Bioequivalence II, Office of Generic Drugs. “More than 70 percent of prescriptions being filled now are generic, and bioequivalence plays a very important role in establishing safety and efficacy.”

Jurgen Venitz, M.D., Ph.D., associate professor in the Department of Pharmaceutics, notes that the workshop is targeting pharmaceutical scientists interested in the most current science and regulatory decision-making in this area. Venitz, a member of the workshop planning committee, has worked extensively with the FDA.

Graduate Advisory Board member Eugenio Cefali of EA Cefali Pharmaceutical Consulting LLC, said the overall goal of the workshop series, as the idea evolved, was to have academic, industrial and regulatory leaders present and discuss relevant pharmaceutical issues on a graduate /postdoctoral level. The series is open to pharmaceutical sciences students, residents, faculty, governmental employees and others in the industry.

Therapeutic Equivalence will open at 9 a.m. with coffee and a continental breakfast and close with a 5:30 p.m. reception.

To register for the Therapeutic Equivalence workshop or to see the workshop brochure, please visit www.pharmacy.vcu.edu/workshop. For more information, Call 804-828-3016 or email emleverich@vcu.edu.