The science and technology of drug and biologics development is moving faster than at almost any time in modern history, and the FDA is struggling to keep pace.
It must adapt a regulatory framework designed for conventional pharmaceuticals to the new world of gene therapy, personalized medicine and much more. And by hook or by crook, it’s doing so.
The questions you face are: How? How soon? And what impact on your profits?
Come to Washington for the answers. It’s an all-day conference with one of the Capital’s top FDA lawyers, Christina (Chris) Markus Esq. of King & Spalding LLP. Over the course of a full day in K&S’s well-appointed K Street offices, she’ll spell out the novel issues and the regulatory revolution they’re triggering … and help you develop a coping strategy. You’ll discover:
- Red flags: Product characteristics that raise regulatory classification and evaluation challenges
- Novel products: Why they may not fit into current regulatory regimes
- How precedent applies: Recent laws, FDA guidances and review precedents
- FDA interpretations: How the agency is adapting existing precedents to novel products
- Informed consent: How it may change to enable research use of biospecimens, including recent amendments and practical risks associated with consent
- Product approvals: How recent regulatory actions may affect them
- Tricks of competitors: Approval strategies that are working for others
- Capitalizing on incentives: Incentives exist for product development and may facilitate regulatory interactions
- Practical take-home strategies: Tips for getting what you need from the FDA
- And MUCH more!
Plan on making time for networking. Your fellow attendees will be drug, biotech, combination product makers, lenders and investors eager to discover your solutions and share theirs.
Unable to get to Washington? No sweat! The full day will be livestreamed for your convenience. Register for livestreaming for just $797, with a $200 Early Bird discount for registrations by Aug. 24.
The conference takes place in the heart of the Nation’s Capital with fine dining, shopping and world-class museums in walking distance. Consider adding on a day or a long weekend to enjoy all that Washington has to offer.
Drug development science, technology and manufacturing techniques are moving at a breakneck pace. The FDA is playing catch-up, but playing hard. You live in a tightly regulated world where going by the rules pays off in big dollars. So learn the rules — as they stand, as they’re evolving, where they could wind up.