DefinedHealth

Jeffrey M. Bockman, PhD.

Potential remedies for the well-vetted Pharma innovation gap exist in the pipelines of many biotechnology companies, but some of these opportunities are not oral tablets or large molecule biologicals — they are complex, multi-component, macromolecular therapeutics such as cell-based therapies and gene therapies that in many cases will require autologous processing of patient materials and depend on some type of process and service component. Pharma has yet to grapple seriously with how these approaches might be developed into viable commercial “products.”

Please join Defined Health and a group of your industry peers as we explore this fascinating topic at our next Insight Series executive briefing, Complex Therapeutics: Therapeutic Vaccines, Cell and Gene Therapy - Will Pharma Deliver When the Product Is Not Off-the-Shelf?

Defined Health will first recap from a clinical, regulatory and commercial perspective Pharma’s historical resistance to what at the time were considered complex therapies, whether inhaled devices for respiratory diseases or injectable recombinant proteins. Case studies will include a range of examples, from the early days of monoclonals, to Tysabri, from ex vivo stem cell processing for bone marrow transplants to tissue engineering products such as Carticel. The focus of our presentation and discussion will then turn toward the future, looking at what role (and to what extent) Pharma will play in this space as even more complicated products (e.g., dendritic vaccines for cancer or stem cell infusions for heart disease — both requiring autologous cell processing) move through clinical development.