Hopkins Biotech Network Holds Regulatory Affairs Discussion
On April 8, members of the biotechnology community gathered on campus for a discussion of trends and perspectives on biotech regulatory affairs, focusing on one of today’s regulatory hot topics: biosimilar products.
The discussion included presentations by:
• Dr. Mukesh Kumar, Senior Director of Regulatory Affairs and Quality Assurance at Amarex Clinical Research, speaking about the current regulatory path a drug/biologic takes to market, along with giving and overview into the globalization process
• Dr. Kadriye Ciftci, Senior Director, Drug Delivery, for ICON Development Solutions, speaking about biologic regulation in the United States and European Union (EU).
The evening concluded with a presentation by Chris Holloway, President, ERA Consulting, on the innovative science of biosimilar products (similar biological medicinal products) and why “there can be no generic biologics, only biosimilars.”
Holloway compared regulations in both the US and EU, provided a historical overview, and presented case studies on biosimilar products. He explained how the two governments’ different approaches to this innovative science have caused very distinct paths when it comes to the regulatory process a product must face prior to entering the market. Holloway concluded with a look at today’s regulatory trends and where the future of biosimilars is heading.
“This was a great event — not only for regulatory professionals but also for those seeking to manage or maximize mature biologic franchises,” said Lauren Nelson, Vice President, Industry, Hopkins Biotech Network. “It was great to see representatives from industry, FDA employees, and students come together for a very interesting discussion.”
This event was co-sponsored by the Global Alliance of Indian Biomedical Professionals (GAIBP) and the Regulatory Affairs Professional Society (RAPS).
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