Life-Science Panorama

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September 18th, 2008

Axendia to Chair “Entering the North American Market” Executive Workshop at Advamed 2008

FOR IMMEDIATE RELEASE

Yardley PA, and Washington DC, September 18, 2008- Axendia Inc., a trusted advisor to Life-Science Executives on Business, Technology and Regulatory strategies, and Advamed, the world’s largest association representing the medical technology industry, today announced that Daniel R. Matlis, Axendia’s President and Founder, will chair an Executive workshop on “Entering the North American Market” at the Advamed 2008 MedTech Conference.

Developed by industry, for industry, AdvaMed 2008 is the premier medical technology conference and exhibition for business leaders, policymakers, investors, news media, patient advocates, and industry stakeholders from around the world. The Conference is schedule from September 21st thought the 24th at the Marriott Wardman Park Hotel, in Washington DC.

“The executive workshop brings significant added value to both U.S. and international participants seeking to enter the North American markets,” said Ray Briscuso, Jr., producer of AdvaMed 2008.  Because the U.S. and Canada combined markets represent the most important commercial opportunity, it is essential to understand the unique and complex environments required to do business in each country. This workshop and other AdvaMed 2008 programs will dissect and explore the major issues and concerns that every MedTech company, small and large, needs to think about at every step of the product development and commercialization cycle.” added Briscuso.

“Bringing medical devices to the North American market requires a thorough understanding of Business environment, regulatory requirements and process, its participants and the timeframe for getting the job done,” commented Daniel R. Matlis, President and Founder of Axendia.  “Understanding these requirements and processes up-front, can greatly enhance a business ability to successfully market products in North America,” Matlis added.

Presented by a panel of distinguished speakers, the workshop will provide a roadmap for the path to successfully bringing medical devices to the North American market.

Topics to be covered in this Executive Session include:

• A roadmap to successfully bringing medical devices to the North American market
o Speaker:
Daniel R. Matlis, President & Founder, Axendia, Inc.

• Government Funding Opportunities
o Speakers:
Jo Anne Goodnight, NIH SBIR/STTR Program Coordinator
Don van Dyke, Ontario Ministry of Economic Development & Trade

• The “Soft Landing”: Finding Partners in the U.S. / Canada
o Speakers:
Jeanne R. O’Connor, Vice President & Chief Development Officer, Select Greater Philadelphia
Jordan Warshafsky, Partner, Ashton Tweed, Ltd.

• The Reimbursement Landscapes
o Speaker:
Stephen Chan, Executive Director, Boston Healthcare Associates

• Regulatory Landscapes
o Speakers:
Judy Meritz, Partner, Blank Rome LLP
Carole C. Carey, Director, International Relations and External Affairs Staff, Medical Devices Coordinator for Global HBD (Harmonization By Doing) Programs, U.S FDA Center for Devices and Radiological Health

The workshop will be held on Sunday, September 21, 2:00-6:00 p.m. at the Marriott Wardman Park Hotel, in Washington DC.

For detailed information about the session, visit: http://advamed2008.com/program/sunday.xhtml#Market

About Axendia:
Axendia Inc. is a leading analysis firm focused on the Life-Sciences and Healthcare markets. The firm provides trusted advice to Life-Science Executives on Business, Regulatory and Technology issues. Axendia’s unique perspective is a result or our focus on the Life-Sciences and Healthcare markets and a unique blend of industry experience and strategic vision. This approach enables us to successfully identify, create and execute strategies which provide lasting business value for our clients.  Additional information on Axendia’s can be found at http://www.axendia.com/

About AdvaMed 2008:
Designed by industry for industry, AdvaMed 2008 is the premier MedTech conference for business executives, policymakers, media, financiers, and service providers from around the world. In its inaugural year, AdvaMed 2007 attracted more than 400 organizations and 1,100 industry leaders – including 300+ CEOs, Presidents and C-level executives.

With more than 1,400 senior level attendees expected, AdvaMed 2008 is this year’s can’t miss event for networking; conducting partnering meetings; educating and influencing policymakers and the media; and participating in education sessions. Whether you need to finance, partner or license technology, AdvaMed 2008 introduces you to key decision-makers. Learn more at http://www.advamed2008.com/.

Editor’s Note: Media interested in attending this session or other presentations during AdvaMed 2008 are asked to preregister. Please do so by e-mailing Alicia@brightlinemedia.com to obtain a complimentary media registration code in advance of the conference. Questions? Call 410-991-7027. 

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September 11th, 2008

Please Do The Right Thing Even When No One is Looking

By Daniel R. Matlis

On September 15 2008, FDA’s final rule on “Current Good Manufacturing Practice and Investigational New Drugs Intended for Use in Clinical Trials” will become effective.

The Rule makes “early phase 1 clinical drug development safe and efficient by enabling a phased approach to complying with current good manufacturing practice (cGMP) statutes and FDA investigational requirements.”  Additional detail is available in the FDA’s Companion Guidance Document.

Phase 1 trials are used as the initial introduction of an investigational new drug into humans. These studies are closely monitored and may be conducted in patients, but are usually conducted in healthy volunteer subjects. These studies are designed to determine the metabolic and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. Phase 1 clinical trials, are often carried out in small-scale, academic environments, typically involving fewer than 80 subjects (many of them college students).

The rational for exempting most phase 1 investigational drugs from the requirements in 21 CFR § 211 (cGMP) is based on the premise that since most products do not proceed beyond the clinical trial phase of development, the burden of full compliance with cGMP at the phase 1 stage outweighs the benefits.

According to Rachel Behrman, M.D., associate commissioner for clinical programs and director of FDA’s Office of Critical Path Programs, “The new rule and guidance are intended to assure that manufacturers meet high standards for the safety of phase 1 drugs and biologics while removing unnecessary barriers that can slow the development of these potentially life-saving products.”

The FDA will continue to exercise oversight of the manufacture of these drugs under FDA’s general statutory CGMP authority and through review of investigational new drug (IND) applications.

I asked a friend, who is Director of R&D and product development at a large Pharma company in Central New Jersey, to review this article before publication. She commented that: “There may be a balance or even some good that this will do to expedite the process and invest the cost savings elsewhere, which may add value in the long run.  The entire drug development process is very costly and very unpredictable, but to your point, patient safety needs to be at the forefront.”

The fact is that bringing a new drug to market is a time consuming and expensive process. According to latest estimates it on average 12 to 15 years to bring a drug to market (See Figure)
The cost for bringing a new drug to market, that is from discovery to FDA approval, hovers around 1 Billion (yes with a B) dollars.

As we globalize and outsource development and manufacturing, it is critical to bear in mind that while mature sponsor organizations will often “do the right thing” even they are not obliged,   these expectation are not always met by operating practices at “less than mature companies or those in economies” (do Heparin and  Rambaxy ring a bell)

In the current drive to outsource, clinical manufacturing is a reasonable and viable development avenue. According to Jeffrey Meltzer, Director of Quality Management at Pharmaceutical Manufacturing Research Services Inc., “a key challenge of this approach is that some people and organizations think manufacturing outsourcing means that they are also outsourcing responsibility.” Meltzer added, “The implementation of this final rule makes it even more critical to partner with a mature, well established contract organization that has in place systems to confirm mutual expectations including contractor and sponsor responsibility.”

Failure to establish appropriate procedures and controls over Phase 1 manufacturing may in fact delay drug development and make it more costly. “Sure, you may get your Phase 1 done a bit faster and cheaper, but if the work is not well documented and well controlled, it increases the risk of incorrect development decisions” commented Meltzer.

My R&D Director friend at the Big Pharma Company (who shall remain nameless) pointed out that I seem pessimistic.  She is right I am a bit concerned about this rule, especially as we outsource to less mature markets. 

This concern stems from the experience that individual and organizational responses to regulatory compliance fall into four categories. (See Regulatory Compliance - Nature or Nurture?)

In my experience, many regulatory Zealots and Rationalist are in mature companies, for whom “Thou Shalt Do The Right Thing Even If Not Obliged” has been ingrained into the fabric of the organization. On the other hand, I have a sense that you would find many more Contrarians and Illusionned at less mature organizations.

Although the vast majority of Life-Science companies will do the right thing even if there is no regulatory requirement to oblige them. I am afraid that for some, aggressive development timelines and short term financial pressures may trump patient safety, especially where “doing the right thing” is not a core value.

This is one time when I hope I’m wrong. Because as the adage goes, there is never enough time to do it right, but there is always time to do it over.

In our industry, the consequences of a do-over can be life-threatening.

So please, do the right thing even when no one is looking.

September 4th, 2008

Interview on Closed-Loop Quality Execution and Continuous Innovation

By Daniel R. Matlis

During a recent interview, the folks at Camstar asked that I share my thoughts on the impact that Closed-Loop Quality Execution on Life Sciences Manufacturing in the “Age of Continuous Innovation”.

Hope you enjoy my first YouTube program.

Warning: with a face for radio and a voice for silent movies, I cannot be held responsible for any damage my likeness might cause to your system.

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