• Facilitators Linda Judge and Alan Schwartz Ocio, DLA Piper
• Panelist Anar Kotadia, MSS Consulting and Chair San Francisco Bay Area Chapter, Regulatory Affairs Professionals Society, formerly with Johnson & Johnson, (with a medical device perspective), RAPS
• PanelistAlan Jacobs, Acorn Biomedical (early stage clinical development)
• Panelist Geetha Rao (with a medical device perspective )
• Panelist Rick Srigley, CEO & President of Aragen Bioscience (with pharma perspective)

As life science entrepreneurs, we know that the company life cycle is much longer for our companies than for high tech entrepreneurs, due to product development, regulatory issues, and other factors related to the nature of the industry. Below are notes from the conversation for your reference.

Ideas for funding product development and navigating government regulations:

• SBIR, small business innovation research grants, up to 100K for phase 1, more for phase 2 http://www.sbirworld.com
  • Must have less than 500 people in the company to qualify
  • Principle investigator must be an employee
  • Non-diluted funding, but government owns the research and may ask you to share the results
  • This would impact likelihood of getting institutional funding

• Drug vs. Biologic approval process
  • Drugs: approvals focused on clinical effects rather than the process
  • Biologics: Pay attention to the process/the process may be the product - vaccines, blood products, etc.,
• Advice for navigating government regulations
  • Find out who will be evaluating your product/process and build a relationship with them first.
  • Agree on protocols and end points up front, the earlier the better
  • Stick to what you agreed to do. Communicate your progress.
  • Label your product and process with care. The regulatory officials will evaluate your product or process based on the labels you agree on.
  • When looking for an approval for a medical device, consider the class of the device and work with standards organizations (ISO, IEC) standards.
  • Show proof that your product has less risk than currently accepted products.
  • For combination devices, consider the best category of fit. Try to categorize it as a medical device if appropriate.
  • Plan during and following the approval process. Document before, during and after the process.