Study Group: Pharmaceutical Regulation and FDA Experts: Lawyers

Council Members in this Study Group: 48

This study group may include professors, attorneys, former regulatory officers, and consultants knowledgeable on topics such as law and litigation issues, lobbying, policy and government, elections, antitrust, immigration, intellectual property, and legislation, among others.

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Leading Experts in this Study Group

Stephen Bent

Partner
FOLEY & LARDNER LLP

Stephen A. Bent is Partner and former co-leader of the Life Sciences Industry Team at Foley & Lardner in Washington, DC. He is also a member of the Biotechnology & Pharmaceutical Practice Group and the Health Care and Nanotechnology Industry Teams. Mr....

Thomas Saunders

Of Counsel
RISSMAN HENDRICKS & OLIVERIO, LLP

Thomas Saunders is an Of Counsel at Rissman Hendricks & Oliverio. He specializes in representing emerging medical technology, biotechnology/genetic engineering and pharmaceutical concerns, particularly as to patent prosecution, patent strategy, IP licensing...

James O'Reilly

Volunteer Professor of Law
University of Cincinnati - CC

James O'Reilly is a Volunteer Professor of Law at University of Cincinnati. He counsels large and small drug, biotech, device and food firms. Prof. O'Reilly's 41 books and 175 articles have been widely cited, and as an FDA expert over many years, he has...

Marc Scheineson

Partner & Chair, Food and Drug Practice
ALSTON & BIRD LLP

Marc Scheineson is a Partner with Alston & Bird where he heads the firm's Food and Drug Law Practice. He has practiced food and drug law, health care law and administrative law for over 20 years in national law firms and at the FDA. His practice focuses...

Gregory Glover

Partner
Pharmaceutical Law Group PC

Greg Glover is Principal at Pharmaceutical Law Group in Washington, DC, where his practice focuses on providing advice on the strategic interaction of Food and Drug Administration (FDA) regulations, intellectual property law, and technology licensing....

GLG News^SM Analyses by this Study Group's Leading Experts (?)

Opinions and analyses expressed in GLG News are solely those of the author. See the Terms of Use for details.

No Company is Bullet-Proof Against Federal Contractor Risks

June 10, 2008

Analysis by:James O'Reilly, Volunteer Professor of Law,

Analysis of:U.S. sues Honeywell over bullet-proof vests | www.latimes.com

Product liability exposure of new materials makers can be severe, especially with fatal consequences of failures Internal memos re product problems can shoot company in the foot; prudent firms have a plan for controlling open-ended speculative memos in an instant-message environment Major PR and govt. contract risk of "getting it wrong" with new materials under expected stressful conditions makes this a good warning to upstream materials suppliers.

Controversy Bred By Under-Regulation: Are Genes Too Casual?

February 4, 2008

Analysis by:James O'Reilly, Volunteer Professor of Law,

Analysis of:Growth of Genetic Tests Concerns Federal Panel | www.nytimes.com

Recent reports by a federal study panel, addressed in stories in the NY Times and other sources, highlight one more gap between expectations and reality in the resource-starved federal safety net for consumers. Much less is being done to oversee Gene Test kits than consumers may expect; eventually there will be a public outcry when some real harm is documented. This Administration has prided itself on responsiveness to industry's preferences, yet choices to not regulate leave open the federal agencies as well as the industry to a backlash when future harms occur.

RIPENING INHIBITORS: ROSY FUTURE OR BRUISED FRUIT?

December 21, 2007

Analysis by:Thomas Saunders, Of Counsel,

Analysis of:Current and Potential Commercial Applicationsof the Suppression of Ethylene Action by 1-MCP in Plants | www.rohmhaas.com

Product shelf-life is a major economic concern for the agricultural industry. The biological mechanism for regulating the ripening of fruits is mediated by ethylene. Ethylene management is addressed in three ways: 1) Ethylene absorption 2) Inhibition of ethylene biosynthesis and 3) Prevention of ethylene receptor signaling. In the ripening control patent landscape novel cyclopropene compounds function as ethylene receptor blockers. Of the 60 U.S. patents that have issued, approximately 15 are related to cyclopropenes, while the remaining 45 are more or less evenly distributed between about 20 different ethylene management technologies. AgroFresh Inc., a Rohm and Haas subsidiary, has staked out a significant position in ethylene receptor blocking technology by claiming a wide range of cyclopropene derivatives

Paint Industry Needs Global Lead Settlement Quickly

May 9, 2007

Analysis by:James O'Reilly, Volunteer Professor of Law,

Analysis of:Lead paint industry on the defensive | www.lawyersweeklyusa.com

"Son of Asbestos" claims may sound extreme; but the lead paint makers would be prudent to collectively negotiate and fund a 50-state settlement that follow the tobacco companies' model and avoids the bankruptcy model of the asbestos-using firms. Lead injury awareness has increased and demands for public protection will escalate. Paint and related product industries knew of risks long before the warnings and bans, so their parallels to asbestos defendants are likely to bring juries to similar sized awards. Lobbyists can buy time but not buy peaceful continued business operations. As author of studies on building safety, toxic torts and on product warnings liabilities, I see only a matter of a few years before asbestos-like liabilities will inevitably crush those who don't choose a global settlement of the lead legacy.

Defending Knock-Offs: Head-to-head With Brand Names in Trademark, Copyright, and Internet Marketing

March 1, 2007

Analysis by:Thomas Saunders, Of Counsel,

Analysis of:Defending Knock-Offs: Head-to-head With Brand Names in Trademark, Copyright, and Internet Marketing | www.iptoday.com

-Name Brands vs, Knock-Offs: Strategies and Counter-Strategies

-Vulnerabilities of Name Brand Copyrights

-Why the internet Knock-Off market will always exist

View All GLG News by members of this Study Group

Members in this Study Group include these company types:

Law Firm (general practice/large)
Law Firm (Boutique / Specialized)
Pharmaceuticals Manufacturer

Members in this Study Group often have these job titles:

Partner

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FDA Medical Device Experts: Lawyers	29
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FDA Medical Device Regulations Experts: Legal, Economic, and Regulatory Affairs	52
Biotechnology Patent Experts: Lawyers (US)	99
Medical Device Patent Experts: Lawyers (US)	77
Medical Device Experts	317
Council Members in the U.S. who are Familiar with Regulations Pertaining to Andrx Corporation's Form 483	18