ePharma Summit 2011: Consumer health and guidance

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KEYNOTE: What's New, What's Coming and How it Will Change Everything
David Pogue, The New York Times, CBS News

Pogue’s presentation begins with a simple question: can the iPhone save your life? Yes, it in fact can. It’s a greater object than the middle line between a cell phone and a cell phone. The iPhone is a new category of electronics (does your laptop have a compass?)
What are the coolest medical apps Pogue has to show us?

For patients:

• Jet Lag Rx – Develops eating, sleeping regiment to avoid jet lag
• uHear – Instant hearing aid
• SoundAMP
• LoseIt! – keeps people constantly thinking about weight loss, it’s fun

For doctors:

• Osirex – tap in to hospital database to see scans wherever you are.
• Epocrates – database of drugs, includes interactions, pill identifier – different levels available
• AirStrip OB – Monitor baby heartrate from anywhere in town
• AllsCRIPTS Remote
• Lifescan Bluetooth Wireless Glucose Monitor

Augmented reality – screenshots of people to identify ways to get to public transit, look at a building and see who is using Twitter, look at others and see what social networks they’re working on.

This all results in consumers taking care of their health. There is technology that isn’t even available on your computer.


KEYNOTE: Addressing Internal Regulatory and Legal Concerns and Challenges
• Lucy Rose, Lucy Rose & Associates • Tom Casola, Shire Pharmaceuticals • Cynthia Phillips, Millennium • Bill Aprea, Merck • Bryant Lim, ViroPharma • Paul Savidge, Bristol-Myers Squibb

FDA has carved out special guidance for television. Why can’t they do this for the Internet medium?

The regulations and guidances document in 1999 goes to more of changing requirements, but reflecting on the medium and how they can reflect the requirements already set. Television has its 60 seconds time limit. With the Internet, it’s unlimited and uncontrolled. How do you set guidances for something so vast?

What do we know?
The use of patient experience/celebrity spokes people. Advantage: People can hear from other patients. If the patient experience is presented, it must be done in an accurate way. Between patient groups it’s fine, but on a Pharma site, they have to control them. In terms of safety – basic principle of brand name and disease – almost always trigger risk information.