Showcase Reveals Strategic Steps to Clinical and Regulatory Success
Hosted on the fifth floor of Bridgeside, current and new Pittsburgh chapter members of Women In Bio (WIB) came together to network over drinks and small bites while enjoying a presentation by organization sponsor, Clinical Research Strategies, about the lifecycle of products in healthcare.
Featuring Clinical Research Strategies employees Julie Cramer, PhD, MS, Director of Clinical and Regulatory Affairs and Parul Nisha, PhD, Senior Director, Clinical and Regulatory Affairs, the life sciences consulting firm specializes in the following, making them a great source of insight for our community:
Innovation
Regulatory sciences
Policy and reform in the US and EU
Quality, clinical, regulatory, and safety over the life cycle of a product
Helping a device or drug navigate through the proper FDA, EU, or Rest of the World (ROW) regulations to bring it to market
The evening started with attendees noshing and networking over complimentary catering from Community Kitchen Pgh (who is also hosting an event in early November!) on the beautiful outdoor patio before the two WIB sponsors took the mic.
Dr. Cramer and Dr. Nisha dove right in, recognizing first that not all innovators or companies have the same needs that apply to medical devices and drugs/biologics. For instance, some companies may be in search of the right regulatory strategy for a medical device while others are focused on a drug or biologic that needs regulatory-clinical trial lifecycle management. Despite these differences, there are clinical and regulatory strategies that can be tailored to meet any objective, and they shared a few examples of how these strategies were implemented. Lastly, they touched on the many roles needed to support the various stages of development and also shared personal stories and experiences:
“We are very involved in our community here in Pittsburgh and across the region. We know it takes a village to have Pittsburgh rise up in the life sciences industry and we pride ourselves on being involved in the community.”
Following the presentations, the evening concluded with questions from the audience and additional networking opportunities.