Posted by: Audrey Erbes | December 8, 2013

FDA Issues Guidance for Mobile Medical Apps Plus Events and Jobs

Hi,

I had mentioned in earlier blog that I wondered what would happen to the many mobile medical apps which investors have embraced as being cheaper to develop. There’s a new guidance from the FDA which provides a distinct framework for this innovative sector. In the FDA’s mind, many apps that might qualify as medical devices “don’t warrant the time and resources necessary for active regulatory oversight owing to their relatively low risk status.” Latter quote was in article entitled” FDA Finally Releases Guidance on Mobile Medical Apps” by Bradley Merrill Thompson of Epstein Becker & Green in November 2013 issue of MD+DI. The FDA will exercise regulatory discretion for those apps perceived to be low risk. See full listing at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/MobileMedicalApplications/ucm368744.htm

This departure on part of FDA for these apps will be welcome news to many in this new space.

Highlights for This Coming Week’s Events

  • BioCentury This Week, See new program Webcast Starting Sunday, Dec. 8, 2013, 2013 www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; Topic: “Type 1 Diabetes: Hope on the Horizon?”Speakers: Cynthia Rice, SVP, JDRF; Dr. Ellen Leschek,  National Institute of Diabetes and Digestive and Kidney Diseases; Dr. Lisa Spain, National Institute of Diabetes and Digestive and  Kidney Diseases and with David Nexon of AdvaMed.
  • Bio2Device Group, Tuesday Evening, December 10, 2013; Topic: “Integrating High Level Diagnostics into Clinical Practice;” Speaker: Ted Snelgrove, CEO, CellScape Corporation
  • Foley and Lardner, LLP, Tuesday Noon, Dec. 10, 2013; Webinar Topic: “Overview of Changes to Imprement the Patent Law Treaty Act;” Courtenay Brinckerhoff is the Foley attorney responsible for the content of this program.
  • The RPM Report and The Pink Sheet, Wednesday and Thursday, Dec. 11-12, 2013; Event: “The FDA/CMS Summit for Biopharma Executives 2014: Crossroads or Turning Point?”
  • CACO Seminar Luncheon, Thursday Mid Day, Dec. 12, 2013; Topic: “Drug Delivery: Overcoming Big Obstacles with Tiny Particles;” Speaker: Professor Frank Szoka, UCSF
  • Palo Alto AWIS, Thursday Evening, Dec. 12, 2013; Topic: “The Secrets to Public Speaking;” Speaker: Chris Lipp, Professional Speech Coach at the Stanford Graduate School of Business
  • CACO Luncheon, Friday MidDay, Dec. 13, 2013; Topic: “Pharmacoeconomics: the Evolving Pharmaceutical Environment from the Managed Care Perspective;” Speaker: Elva Gao, PhD, MBA (Premara Blue Cross)

Spring Term Courses in New Professional Program in Life Science Business

UC Berkeley Extension has now posted the spring courses on their website so you can register for them. See the new tinyurl I posted for each of my spring courses.

UC Berkeley Extension, Thursday Evenings, Feb. 13-27, March 6-13 and 27

Course: “Life Science Product Marketing: It’s All in the Plan

Applies for credit toward Professional Program in Life Sciences Business (see flyer at http://extension.berkeley.edu/upload/lifesciences_business.pdf)

Instructor: Audrey S. Erbes, Ph.D., Principal, Erbes & Associates and http://www.AudreysNetwork.com

Guest Speakers:

  • Deb Donovan, Director of Marketing at Avantis Medical Systems
  • Stanley Skrzypczak, M.S., M.B.A., Senior Director, Commercial Development, Genomic Health
  • Charles Versaggi, President, Versaggi Biocommunications
  • Steven Wong, Senior Consultant, Plan A

Dates and Time: Thursdays, Feb. 13-27, March 6-13 and 27; 6:00 – 9:00 pm

Location: Downtown University of California, Berkeley Extension, 425 Market St., 8th Floor, San Francisco, CA 94105

Cost: (Fee to be announced in December 2013—$695 in 2013) Course identifier is BUS ADM X442.5.

See more details and register at http://tinyurl.com/k2aq8nr

UC Berkeley Extension Course, Thursday and Friday, April 10-11, 2014

Course: “Life Science Business and Marketing: Their Integral Role for Success

Applies for credit toward Professional Program in Life Sciences Business (see flyer at http://extension.berkeley.edu/upload/lifesciences_business.pdf)

Instructor: Audrey S. Erbes, Ph.D., Principal, Erbes & Associates and http://www.AudreysNetwork.com

Guest Speakers:

  • Joyce L Chiarenza, Chiarenza Consulting, L.L.C.
  • Linda L. Schock is the Director of Commercial Compliance & Government Programs at Compliance Implementation Services (CIS)
  • Bev Hudson, MBA, is Executive Director/SVP of Clinical Research, Oklahoma Foundation for Cardiovascular Research (OFCR)
  • Julie Tompkins, MBA, is Sr. Vice President at Timely Data Resources (TDR),

Dates and Time: Thursday and Friday, April 10-11, 2014; 8:30 am – 5:00 pm for classroom intensive and balance of term for working on term project

Location: Downtown University of California, Berkeley Extension, 425 Market St., 8th Floor, San Francisco, CA 94105

Cost: $795, course ID is BUS ADM x442.4

See more details and register now. You can locate course online and register at http://tinyurl.com/kqbu2rx

Find all the details for these upcoming events plus those through April 2014 in Audreys picks Dec. 8, 2013 You can also download the pdf of JobsThatCrossedMyDeskThrough Dec 8 ,2013 along with former document by right clicking on the highlighted titles. This latter list includes jobs I discovered this past week as well as the previous two weeks. I’ve attached both documents. You can always find my weekly blog and listings on my website www.audreysnetwork.com. Click on “blog.” Note that there are many sources—my list is not complete. I was looking for job sites and recent jobs in California companies.

Audrey

 

 

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Responses

  1. Hi Audrey, thanks for covering mobile medical apps.

    Feels like FDA is being pragmatic (2 questions later).

    I have a PhD biotech entrepreneur friend who produced a range of nutritional supplements based on Chinese plants. She took the extra un-required step of voluntarily paying for a Phase 3 trial (cost $150K for a 300 person trial done via Stanford as I recall). She felt this was good investment to back up the claims. I think she may have run a smaller ‘Phase 2 trial directly’. What do you think is good practice for mobile app makers:

    Where do we cross the line from a health diagnostic to medical diagnostic mobile app or online web app?

    Before out of controlled beta (say 300 folks) should all mobile apps go thru a ‘Phase 3 trial? (before say 30,000).

    I guess 300/30,000 numbers are scalable, if total market is 3 million sample should be prorated larger to.

    Thanks,
    Clive a student of Audrey’s, though more a C+ than an A student 😮


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