Windhover Information proudly presents:

Medical Devices: Surviving the New World of Government Investigation, Enforcement and Settlements

Get a head start in understanding the new rules



For more information on Windhover products and conferences, visit us at www.windhover.com,
or

send an email to conferences@windhover.com.
10 Hoyt St., Norwalk, CT 06851
* Tel: +1 (203) 838-4401 x 113
* Fax: +1 (203) 838-3214


Wednesday, March 12, 2008 • 12 PM ET / 9 AM PT • 90 minutes

About the eventKey topicsSpeakersWho should attendBenefitsRegister

Featuring
Windhover's
David Cassak
and
Stephen Levin

and

Brien O’Connor
Partner / Ropes & Gray

Bruce S. Manheim
Partner / Ropes & Gray

Registration for the live webinar: $399
Registration for live webinar plus complete audio recording: $499

FREE to clients of Ropes & Gray!

REGISTER NOW!

We're all aware of the high-profile government enforcement actions against major pharmaceutical companies like Bristol-Myers Squibb and Schering-Plough Corp. The device industry plays by different rules than the pharmaceutical industry, but the government is increasingly focusing on the medical device industry. Lately, the US Department of Justice effectively concluded the ongoing investigation of financial relationships with physicians under the federal anti-kickback statute.

Physicians are critical to the design and development of devices and work closely with device companies from an earlier stage. How critical are state and federal prosecutors going to be of device manufacturer/physician relationships?

The discussion is backed by proprietary Windhover data, delivered in a convenient audio conference format, and capped off with an interactive Q&A round.

So join us, in the convenience of your own office, for a thought-provoking analysis by Windhover's expert editorial team and the government enforcement team from Ropes & Gray. Grab your team (or several teams), a conference room at your office, a phone and a computer with Web access (that last one's optional). No travel required.

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Key discussion highlights include:

  • Manufacturer / physician relationships
  • Trends and forecasts in device enforcement actions
  • Defrauding the FDA: Preventing misleading information in your 510K submissions
  • Off-label promotion investigations in the device space: Mindset of US Attorney’s Offices and Main Justice going into investigations
  • Prosecutor views of conflicts of interest
  • The role of whistleblowers
  • Conduct that will trigger investigations, or support liability
  • Recommendations regarding compliance activity
  • Investigative processes
  • Corporate Integrity Agreements

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David Cassak
Managing Partner
Windhover Information

David Cassak is a Managing Partner of Windhover Information and has been involved with the health care industry for more than 20 years. He writes extensively on the medical device and hospital supply industries for Windhover’s IN VIVO and Start-Up, and is a frequent speaker before various companies and industry trade groups.

Cassak began his career as an expert analyst, writer and speaker on these industries during the 1980s, before joining The Wilkerson Group, a health care consulting company, in 1988, as an editor of IN VIVO: The Business & Medicine Report.™

In 1989, Cassak, along with partner Roger Longman, led a buyout of the publications business of The Wilkerson Group, forming Windhover Information Inc. Cassak and Longman, recognizing the demand for health care business investment information, created various other monthly health care industry journals. In addition to IN VIVO, widely recognized as the premier provider of business intelligence in the health care industry, Windhover’s publications include Start-Up: Emerging Medical Ventures,™ and The RPM Report: Regulation • Policy • Market Access.™ In 2005, Windhover also acquired Medtech Insight Inc., and now publishes Medtech Insight: Medical Technology Market Intelligence.™

Cassak and Longman also created Windhover’s renowned Strategic Intelligence Systems, a web-based suite of databases, featuring the most comprehensive and detailed source of industry alliances, acquisitions and financings. SIS, which is unique among databases in providing expert commentary and analysis along with data, was developed to provide top health care executives and analysts with the vital intelligence they need to make decision quickly and confidently. Now known as Windhover’s Strategic Transactions Database, it provides all Windhover subscribers with instant, online access to all of Windhover’s content. Windhover recently unveiled a limited version of Strategic Transactions, Transaction Tracker, which offers a snapshot of recent deal activity to active dealmakers.

Windhover also produces numerous influential conferences every year and is well-known for, among others, its Pharmaceutical Strategic Alliances, Euro-Biotech and BIO-Windhover meetings. Since the acquisition of Medtech Insight, Windhover also hosts that company’s respected Investment in Innovation (In3) partnering conferences around the world.

Cassak earned a BA from Drew University and did graduate work at Columbia and Princeton, earning an MA with honors from the former, before joining Cassak Publications Inc., a family-run business that published trade journals for the hospital and alternate site distribution industries.


 

Stephen Levin
Executive Editor
Windhover Information Inc.

Stephen Levin joined Windhover Information in 1997, specializing in medical devices and distribution and legal issues. Prior to joining Windhover, Levin was senior counsel to the U.S. Senate Permanent Subcommittee on Investigations, where he directed Senate investigations into a wide variety of areas including health care fraud and abuse, international organized crime and corruption in federal contracting programs.

Before joining the Subcommittee, Levin held various positions in Washington including working for the Federal Election Commission and the Department of Justice, and was an editor of Health Industry Today.

The Association of Health Care Journalists recently named Levin a winner in its inaugural awards for Excellence in Health Care Journalism.



Brien O'Connor
Partner
Ropes & Gray

Brien T. O’Connor is a partner in the Boston office of Ropes & Gray who specializes in defending corporations and their directors, officers and employees in government enforcement matters and related complex litigation.

Mr. O’Connor has led the defense of entities involved in criminal and civil health care enforcement matters, both federal and state, and complex private party litigation. Mr. O'Connor's experience includes representing numerous pharmaceutical and medical device manufacturers, as well as one of the country's largest pharmacy benefit managers, in matters involving alleged illegal promotional activities, various forms of illegal pricing, Anti-Kickback Statute violations, the suppression and non-disclosure of clinical trial and adverse event information, and other alledged illegality. He also conducts internal investigations for health care industry clients on issues potentially implicating federal and state criminal laws, as well as civil statutes and regulations.

Mr. O'Connor is a former Chief of the Public Corruption and Special Prosecutions Unit in the U.S. Attorney’s Office in Boston (1996-1999), and a recipient of the Department of Justice’s top trial award, the John Marshall Award for Trial of Litigation (1996) and several other awards for federal prosecutions. He has 10 years of experience prosecuting health care, public corruption, securities, tax, racketeering and other white collar cases in the District of Massachusetts.

Mr. O’Connor is a graduate of Yale University (1981) and the University of Pennsylvania Law School (1985). He was a law clerk for a former Chief Judge of the United States District Court for the District of Massachusetts, the Honorable Andrew A. Caffrey (1985-1986).


Bruce S. Manheim
Partner
Ropes & Gray

Bruce Manheim is a partner in the Washington, D.C. office of Ropes & Gray. He specializes in representing pharmaceutical, biotechnology and medical device clients on a variety of regulatory issues and has been deeply involved in counseling clients on internal investigations and government enforcement actions.

With a graduate degree in biology, Mr. Manheim brings a specialized scientific background to the firm. He has assisted clients on numerous complex issues involving compliance with FDA regulatory requirements governing medical devices, biologics and drug products. Those issues include enforcement by FDA and the Justice Department of provisions governing off-label promotion of medical devices and drug products. Mr. Manheim has also served as lead counsel in litigation involving approval of pharmaceutical products. Mr. Manheim formerly worked on public health issues as a senior scientist-attorney for the Environmental Defense Fund in Washington, D.C..

Mr. Manheim is a graduate of Georgetown University Law Center (1988) and obtained his undergraduate degree from Pomona College (1977). He also earned graduate degrees in biology and public policy from Claremont Graduate School and Vermont Law School, respectively.

  • Senior executives at medical device companies
  • Government affairs and regulatory groups
  • Venture capitalists and angel investor groups
  • Consulting, legal and other service providers involved in health care product development

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What does registration get me?
  • One (1) phone line, for you alone, or around which to gather your team(s). Toll-free in the U.S. only.
  • One (1) password to a website on which you'll be taken through the presenter's slides as they speak to them.
  • An interactive Q&A round with speakers: Type your questions on the website during the presentation, for the speakers to address afterward.
  • Online access to the audio and slides of the entire event if you can't attend the webinar live, and still want to hear the content.
  • The insight you've come to expect and respect from Windhover and our guest speakers.
What are the unique benefits of a webinar?
  • Lower cost and, therefore, higher value. Your entire team can listen in one room.
  • No travel required. You just have to walk to your conference room.
  • A team approach. You've often wanted to have everyone on your team getting the same knowledge and insight you derive from physical conferences. Now you can.
  • Interactivity. You're remote, but not removed. Our webinars let you ask the important, burning, controversial questions of our speakers that you'd be able to pose at a physical conference.
  • Flexibility. Want to be able to review what you learn? No problem ... just register for the live webinar PLUS a digital copy of the entire event to listen to at your convenience. Interested in the topic but have a scheduling conflict? Don't worry — the recording is available for purchase at any time!

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  • Register online: Click here for the live webinar
  • Register online: Click here for the live webinar PLUS recording
  • Buy the recording online: Click here for just the recorded webinar
  • Register by email: ariley@windhover.com
  • Register by phone: Alexandria Riley / 203-838-440, X1
Ropes & Gray clients must register by email or phone
to get this webinar FREE.

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