Posted by: Audrey Erbes | February 9, 2014

Celebrate FDA Flexibility Plus Events and Jobs

Margaret Hamburg, M.D., Commissioner of FDA, responded to a recent AMA article challenging thoroughness of reaching drug approvals in her Feb. 6 blog.  The AMA found that between 2005 and 2012 the FDA used a range of clinical trial evidence in supporting their approval of 188 new drugs for 208 uses. Dr. Hamburg notes that the results are entirely consistent with the FDA’s mandate. “We believe varying approaches to clinical studies to support drug approval is good news, not bad.”

The article’s authors were concerned that more than a third of the drugs were approved based on just one pivotal trial and other some trials involved small groups of patients for shorter durations. Fortunately, the FDA doesn’t use a one-size-fits-all approach. Today’s serious disease and cancer patients without alternatives can’t wait for 10-15 years for a drug to be marketed in the traditional approach for drug development. Of course, there need to be safeguards to track these fast developed critical drugs after marketing but patients are willing to take a trade-off to have access to life-saving drugs earlier. Past patient demand for HIV as well as cancer drugs sooner support this FDA flexibility.

“Increased flexibility does not mean abandoning standards, and it certainly does not mean abandoning science. Just the opposite. We need to employ the best science in ways that will increase efficience, productivity and our shared ability to find creative solutions to the challenges that confront us.” Cheers to an enlightened FDA which seems to be moving in direction to enable personalized medicine and reasonably priced but safe drug development. This consistency of management without an empty commissioner seat over years as experienced in the past allows for progress in the regulatory process that all stakeholders should welcome.

Upcoming Events for Week of Feb. 9, 2014

It’s not too late to sign up for my upcoming Life Science Product Marketing starting Thursday which will be held for 6 Thursday evenings over 7 week period at the downtown campus of UC Berkeley Extension on corner of Market and Fremont. In seven weeks you will be able to develop a preliminary product marketing plan with your team for your selected life science sector product. See highlight below and details at

  • BioCentury This Week, See new program Webcast Starting Sunday, Feb. 9, 2014,, Available anytime starting at 9:00 a.m. EDT; Topic: “Chronic Challenges: Multiple Diseases;” Speakers: Dr. Anand Parekh, deputy assistant secretary for health at HHS; Dr. Robert Temple, deputy director of FDA’s Center for Drug Evaluation and Research; and  Myrl Weinberg, CEO of the National Health Council, a patient advocacy organization
  • Bio2Device Group, Tuesday Evening, Feb. 11, 2014; Topic: Magellan Robotics, Catheter System; Speaker: Francis Macnamara, Hansen Medical
  • SF AWIS, Wednesday Evening, Feb. 12, 2014; Topic: “Science and Entrepreneurship;” Speaker: Akhila Satish, CEO of CyberDoctor
  • UC Berkeley Extension, Thursday Evenings, Feb. 13-27, March 6-13 and 27; Topic: “Life Science Product Marketing: It’s All in the Plan;” See more details and register at;Instructor: Audrey S. Erbes, Ph.D.;  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 and Steven Wong, Senior Consultant, Plan A; and  John M. York, Pharm.D.; Principal and CEO, Akita Biomedical and Associate Editor, Cancer Control
  • HBA, Thursday Evening, Feb. 13, 2014; Topic: “Regulatory and clinical challenges and opportunities in orphan drug development;” Speakers: Michelle Rohrer. Vice president regulatory – Genentech Inc.; Jeffrey Siegel, Senior group medical director -Genentech Inc.; Jorge Tavel, Medical director – Genentech Inc.

Find all the details for these upcoming events plus those through June 2014 in Audreys Picks Feb. 9, 2014. You can also download the pdf of JobsThatCrossedMyDeskThroughFeb. 9, 2014 along with Audrey’s Picks by right clicking the highlighted titles. This latter list includes the latest three weeks of positions.

You can always find my weekly blog and listings on my website Select “blog” and then right click on blog title to link to the WordPress site.


Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s


%d bloggers like this: