From the desk of
Robert Greenberg, MD, PhD
SoCalBio Board Member
&
President and CEO
Second Sight Medical Products
www.2-sight.com
August 15, 2008
SoCalBio Members and Friends:
On August 7, the California Life Science Industry Alliance -- a
partnership between California's regional trade associations SoCalBio, BIOCOM
and BayBio -- hosted a meeting with Mr. Tevi
Troy (photo right), Deputy Secretary of the U.S. Department of Health and Human Services,
for an informal discussion regarding issues affecting our industry
including device user fee, reimbursement, comparative effectiveness, and medical
device pre-emption.
This meeting was held at BIOCOM's office in San Diego and
included about 15 Southern California participants. In addition to myself
as the representative of the SoCalBio Board of Directors, a number of Los
Angeles/Orange County companies, such as Tensormed and Verity Associates, were
in attendance.
Mr. Troy gave an update of his view of the future of medicine which,
he believed, centered around
personalized health care. He told us about a report regarding this issue
published by HHS in September of 2007. You can access this report online at: http://www.hhs.gov/myhealthcare/news/phc-report.pdf.
The gist of this approach is that genotyping is expected to take a more central role in determining which treatments are appropriate for an
individual patient.
Mr. Troy called on industry to help educate the public that it was not possible to produce drugs or devices
with 100% safety profile. He blamed congress' pressure for 'perfectly safe' drugs for the record low FDA drug approvals
and felt that industry could play a larger role in helping to educate the public
in this regard.
The meeting also raised a number of issues centered around biotech deals not getting done because of the high level of uncertainty with FDA
and CMS. Participants asked for greater guidance from the agencies specifying requirements for approval to decrease the risks associated with unknown
regulatory and reimbursement hurdles.
This meeting was -- in summary -- an intimate discussion with a very senior government official
that I'm sure was just the beginning of the kind of relationships SoCalBio's new partnership
with the California sister organizations, BIOCOM and BayBIO, will bring to the
life science community in our region.
If you are not a member of SoCalBio, we urge
you to join
our organization to support its advocacy efforts.
Please let us know your comments by blogging
at the newly created "SoCalBio Community of Innovators"
Bulletin Board at: http://www.socalbio.org/community/
We hope to see you at the
SoCalBio Investor Conference on September 19: http://www.socalbio.org/SoCalBio2008/home08.htm
Sincerely,
Rob
--
Robert Greenberg
bobg@2-sight.com
