Seeking Clinical Utility

Change in Process for FDA Medical Device Advisory Committees

2010-04-27T09:55:55-07:00

The FDA announced several changes in process yesterday that will affect the way that business is conducted in their Medical Device Advisory Committees, effective May 1, 2010. The press release notes that the changes have been prompted by an increased volume of reviews and panel activity.

FDA Center for Devices and Radiological Health (CDRH) Director, Jeffrey Shuren, M.D., stated, "These changes are expected to empower the agency to make more effective decisions that are informed by more clear and focused discussion by panel experts." The changes appear to be intended to make sure that final approvability votes more accurately reflect the content of panel discussions with respect to safety, effectiveness, and the balance of risk versus benefit for a given device.

We've compiled a brief summary of the changes here:

1. Rather than voting on approvability of premarket approval (PMA) applications, panels will vote on the safety and effectiveness of the device and its risk versus benefit. Dr. Shuren stated, "By making this change in voting procedure, panel members will address key scientific issues during their discussions, which will be reflected in their votes. The change also will allow panel members to address issues related to their area of expertise instead of regulatory issues that may be unfamiliar to them." Panels will also no longer vote on conditions of approvability.

2. Panel votes will now be conducted by ballot, rather than a simultaneous show of hands. This seems to be intended to allow members to vote their conscience without undue influence from their peers votes. Panel votes will still be publicly tallied so that it will be possible to determine later how individual panel members voted.

3. FDA presentations to the panels will no longer include comments on approvability. They will continue to include reviews of data analysis conducted by the agency.

4. The FDA medical device reviewers will present the committees with data and analysis that reflects the range of scientific opinion amongst the reviewers. This is a change from the agency reviewers' historical tendency to prevent a consensus analysis with a unified front. The FDA notes in the press release that this is intended to encourage more in-depth analysis and discussion related to the safety/effectiveness and risk/benefit balance of the device being considered.

5. Regarding the Advisory Committee Staff, the Designated Federal Officers were recently centralized by CDRH and a staff of six full-time employees has been hired. The FDA notes that this is intended to improve continuity across CDRH.

The FDA's press release regarding these changes is available by clicking here.

The FDA's summary of the changes to CDRH's advisory committee process is available here.

The CDRH Advisory Committee Tentative 2010 calendar is available here.

FDA Medical Devices Advisory Commitees

The following is quoted from the FDA website:

"The Center for Devices and Radiological Health has established advisory committees to provide independent, professional expertise and technical assistance on the development, safety and effectiveness, and regulation of medical devices and electronic products that produce radiation. Each committee consists of experts with recognized expertise and judgment in a specific field. Members have the training and experience necessary to evaluate information objectively and to interpret its significance. These persons are not regular employees of FDA, but are paid as 'special government employees' for the days they participate as members of a panel. This is time they take from their daily occupations to provide their professional skills to FDA. The committees are advisory--they provide their expertise and recommendations--but final decisions are made by FDA."

"The Center has four advisory committees, including a Medical Devices Advisory Committee which consists of 18 panels that cover the medical specialty areas."

Myriad Breast Cancer Gene Patent Controversy: Upcoming Genetic Alliance Webinar

2010-04-26T11:34:10-07:00

Recently, we discussed the ongoing controversy over the invalidation of some of Myriad Genetics' breast cancer gene patents. The controversy continues to rage in both traditional media and the blogosphere.

One thing that seems quite clear is the impressive polarization of opinions supporting either side in this case, which likely will end up in the Supreme Court eventually.

For those who are still seeking to understand the perspective of one side or the other in this case, Genetic Alliance is presenting a webinar this Friday, April 30, which should be well worth your time:

Genetic Alliance Webinar

The Myriad Gene Patent Case - What Does it Mean, and Why Does it Matter?

Friday, April 30, 2010, 12:00pm - 1:30pm Eastern Time

Presenters

John Conley - Professor of Law, University of North Carolina - Chapel Hill

Joshua Sarnoff - Professor & Associate Director, Glushko-Samuelson Intellectual Property Law Clinic, Washington College of Law, American University

Hans Sauer - Associate General Counsel for Intellectual Property, BIO

Ann Waldo - Senior Counsel, Genetic Alliance

The webinar is free. Click here to register for it at the Genetic Alliance website. It should be a very interesting discussion.

New Hereditary Breast and Ovarian Cancer Gene: RAD51C

2010-04-20T12:35:35-07:00

In a paper published online over the weekend in Nature Genetics, Alfons Meindl and colleagues demonstrated that rare monoallelic mutations in the gene RAD51C (which is also newly implicated in Fanconi anemia-like disorder when biallelic mutations are present) confer increased risk for breast and ovarian cancer. It's too early to really know for sure, but it appears that mutations in this gene may behave somewhat similarly to those in BRCA2 (in terms of high penetrance, the Fanconi anemia pathway connection, etc.).

Upcoming San Francisco Bay Area Biotech and Digital Health Events - April to June

2010-04-17T16:26:46-07:00

Monday-Tuesday, April 12-13, 2010:

Q1 Productions, Partnerships in Personalized Medicine Conference, San Mateo
Q1 Productions, 2nd Annual Intellectual Property for the Medical Device Industry Conference, San Mateo

Tuesday, April 13, 2010:

Bio2Device Group, A Serial Entrepreneur's Journey - How a Physicist Became a Leading Device Innovator, 6:00pm, Palo Alto
Industry Roundtable: Expanding Life Science Careers, Palo Alto

Tuesday-Thursday, April 13-15, 2010:

Risk Based Solutions for FDA Compliance Including Agile Software Development, San Mateo

Thursday, April 15, 2010:

BayBioNEST, Venture Spotlight: A Tailor Made Approach: Personalized Medicine, 8-10am, Menlo Park

Monday, April 19, 2010:

FountainBlue Life Science Forum, Physician's Panel: Partnering with Entrepreneurs to Better Address Patient Needs, 5:30-7:30pm, Palo Alto

Tuesday, April 20, 2010:

Bio2Device Group, Biotech Start-ups from the Inside Out - An Unconventional Story of 3 Decades in the World of Emerging Companies, 8:30am, Sunnyvale

Wednesday, April 21, 2010:

BioScience Forum, Dr. Jean Deleage, Biotechnology Investing from 1976 to the Present: Successes and Lessons Learned, 6-9pm, Millbrae
Stanford Dept. of Medicine Grand Rounds, Dr. Peter Singer, Global Health - Can Biotechnology Save the World?, 8-9am, Stanford

Thursday, April 22, 2010:

BayBio Therapeutic Breakfast Series, Preparing for Coverage & Reimbursement: Demonstrating Value, 8-10am, Redwood City
San Jose BioCenter, Meet with...Amgen, 9am-5pm, San Jose
VC Taskforce, The Life Sciences VC Connection, 6:00pm-8:30pm, Palo Alto

Friday, April 23, 2010:

CSB Seminar, Dr. Thomas Hermann, RNA as a Drug Target, 12-1pm, Stanford

Monday, April 26, 2010:

LES Silicon Valley Chapter,Commercializing Technology Through the Power of IP Licensing, 8:30am-6:30pm, Stanford
Informatics in Industry Seminar Series, Dr. David Johnson, Gene Security Network, 12:15-1:05pm, Stanford

Monday - Tuesday, April 26-27, 2010:

Optimal Approaches to Oncology Clinical Trial Design and Analysis, San Francisco
UCSF Brecher Lecture, Dr. Stephen Baylin, Reversing the Abnormal Cancer Epigenome - The Therapeutic Promise for Leukemia and Other Cancers, 4-5pm, San Francisco

Tuesday, April 27, 2010:

San Jose BioCenter, Startup Strategies: How to Maximize the Value of Your BioPharma IP, 8:30am-11:45am, Palo Alto
Bio2Device Group,Launching a Consumer Medical Start-up: the Aardvark Medical Experience, 8:30am, Sunnyvale

Wednesday, April 28, 2010:

Life Sciences Financing Seminar, You Survived 2009--Now What?, 8am-10am, Palo Alto

Thursday, April 29, 2010:

Frontiers in Gene and Molecular Therapies, Dr. Eric Nestler, New Insight Into the Neurobiology and Treatment of Depression, 3-4pm, Stanford

Monday, May 3, 2010:

Informatics in Industry Seminar Series, Dr. John Sninsky, Celera, 12:15-1:05pm, Stanford

Tuesday, May 4, 2010:

Bio2Device Group, Have You Considered Consulting? 8:30am, Sunnyvale

Wednesday, May 5, 2010:

Stanford Dept. of Medicine Grand Rounds,Dr. Timothy Quill, Health Policy, 8-9am, Stanford

Friday, May 7, 2010:

CIRGE/CLB Conference, The Coming Revolution in Prenatal Genetic Testing? Scientific, Ethical, Social, and Policy Responses to Maternal Serum-Free Fetal DNA Testing, 8am-6:30pm, Stanford

Monday, May 10, 2010:

Informatics in Industry Seminar, West Shell III, Chairman and CEO, Healthline, 12:15-1:05pm, Stanford

Tuesday, May 11, 2010:

BayBio Medical Device Breakfast Series, How the FDA's 510(k) Programs Are Changing, 8-10am, Palo Alto
Dr. Thomas Stossel, The Pathophysiology and Recommended Management of "Conflict of Interest" Policies, 12-1pm, Stanford

Wednesday, May 12, 2010:

BayBio Executive Series, Managing the Board, 5:30-7:30pm, Redwood City
Frontiers in Biology, Dr. Stephen Quake, Is the Genome Useful in Medicine?, 4-5pm, Stanford

Friday - Saturday, May 14-15, 2010:

TiEcon 2010: It's in Your DNA, Santa Clara

Sunday - Wednesday, May 16-19, 2010:

2010 AAPS National Biotechnology Conference, San Francisco

Monday, May 17, 2010:

Informatics in Industry Seminar, Dr. Andrew Kasarkis, Sage Bionetworks, 12:15-1:05pm, Stanford

Wednesday, May 19, 2010:

California Life Sciences Day at the State Capitol, Sacramento

Monday, May 24, 2010:

Informatics in Industry Seminar, Ilya Kuperschmidt, NextBio, 12:15-1:05pm, Stanford

Tuesday - Thursday, May 25-27, 2010:

The 12th Annual C21 BioVentures Conference, Napa

Thursday, May 27, 2010:

BayBio Therapeutic Breakfast Series, Alternative Partnering and Financing Approaches for Emerging Companies, 8-10am, Redwood City

Wednesday, June 2, 2010:

San Jose BioCenter, BioCenter Open House Tour, 2:30-3:30pm, San Jose

Thursday, June 3, 2010:

San Jose BioCenter, Financing Alternatives: Where's the Money?, 3:00pm-6:30pm, Menlo Park

Wednesday, June 23, 2010:

San Jose BioCenter, Meet with...Gilead, 9am-5pm

BayBio 2010 Conference Panel on Next Generation Sequencing - April 7, 2010

2010-04-05T16:00:30-07:00

I have really enjoyed having an opportunity to help organize the upcoming BayBio 2010 conference (via the BayBio 2010 Advisory Board and the BayBio 2010 Company Presentations Advisory Board). It will be held on Wed., April 7, 2010 in Burlingame, CA, so I'm putting one last plug in to try to reach those who might be thinking about attending.

In particular, I'm looking forward to having a chance to moderate what should be a fun (and hopefully very useful) panel in the conference's innovation track on the implications of emerging next generation sequencing technologies for the Bay Area biotech industry.

Here's the lineup:

Moderator

Matt Mealiffe, MD - Founder/Principal, Clinical Utility Consulting

Panelists

Rade Drmanac, PhD - Co-Founder and Chief Scientific Officer, Complete Genomics, Inc.
Omead Ostadan - Vice President, Marketing, Illumina, Inc.
Eric Schadt, PhD - Chief Scientific Officer, Pacific Biosciences, Inc.
Daixing Zhou, PhD - Director, Business Development, Life Technologies, Inc.

Hope to see you there!