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By Daniel R. Matlis

During the last Microsoft Health and Life-Science Conference, I had the privilege to participate in an enlightening discussion with stakeholders (or special interest groups, depending or the news network you watch) in Healthcare Reform.

The panel represented a board spectrum of constituents and included (in alphabetical order):

• Jeff Brown - Director IT, Partners Healthcare
• Deighton Liverpool - Director,  IT , American Association for Cancer Research
• Okey Okuzu - Director -  US Managed Markets Strategy & Innovation, Novartis Pharmaceuticals Corporation
• Arman Ozgun – Managing Partner, Netsoft USA
• Chad Pomeroy - VP Innovation & eBusiness, WellPoint

The session provided ample opportunity to discuss and highlight key challenges and opportunities of the US healthcare system.

In my opinion, the underlying problem with the current Healthcare system is misaligned incentives.  That is, each stakeholder is incentivized and compensated based on different and often conflicting benchmarks.

For example:

• Research institutions seek public and private funding to conduct focused research
• Life-Science companies seek to recoup and profit for the high risks and costs associated with bringing new products to market
• Health Insurers seek to manage and lower healthcare costs and make profit
• Healthcare providers seek to improve patient outcomes and reduce costs while minimizing litigation risks
• Technology companies offer enabling platform to automate and “smart-up”  healthcare

What if we found a way to align incentives and gain synergies from all these stakeholders? 

Imagine, if you would, a model where each stakeholder is a link in the healthcare chain, and gets benefits from others in the ecosystem.

In this environment:

• Research institutions could partner with Life-Science companies early in the discovery process and feed new compounds to Pharma R&D. 
• Another benefit is looking blockbusters from the trash bin.  In other words finding new uses for compounds that did not show promise with the initial target (Rogaine and Viagra were side effects)
• Hospitals could provide de-personalized patient information to build better models toward the road to virtual clinical trials and targeted “personalized medicine”
• Insurance companies could lower costs and make better treatment decisions based on appropriate diagnostic tools and “pay for outcome” model (Geisinger already offers Heart Surgery warranty which has lowered costs as well as 30-day readmission rate 44%) 

These do not even take into considerations the benefits associated with bringing medical records to the electronic age or applying Lean and Six Sigma techniques to a very inefficient Healthcare model.

According to a recent reports, patients in the American Healthcare system received the recommended care only 54.9% of the time. By contrast, your car, phone and PC are built to meet requirements 99.997%. 

In my opinion, aligning incentives for healthcare stakeholder would yield lower healthcare costs and improved patient outcomes.

By Daniel R. Matlis

To determine the industry’s adoption of a Total Product Life Cycle approach, as advocated by FDA, Axendia, in cooperation with Cambashi and FDAnews recently conducted a major research project on this subject.

A total of 212 industry insiders from a wide range of medical device and diagnostic companies participated in this research.

The research is now complete and the full findings are available in a new report entitled, “Total Product Lifecycle Management: Lowering Costs while Increasing Quality.”

We hope this research will serve as an aid to enable Medical Device companies in their transformation to a holistic end-to-end Total Product Lifecycle (TPLC) strategy.

• Read the Executive Summary
• Download a copy of the report
• Read the Press Release 

 

The research is co-sponsored by five companies - all of which are active in the Medical Device industry. These companies provide deep and diverse expertise in medical devices practices and provide design, product lifecycle management, production, quality, and related software and services to the industry as well as management consulting services to leverage applications appropriately. Working together, these underwriting sponsors hope to increase the medical device market’s understanding of how to reduce risks and improve compliance and profitability.

Research Sponsors for the study are: management and technology consulting firm PricewaterhouseCoopers LLP (www.pwc.com/pharma), enterprise manufacturing and quality software provider Camstar Systems (www.camstar.com ), product lifecycle management (PLM) software innovator Dassault Systèmes Enovia (www.3ds.com) with its medical device industry PLM partner Integware (www.integware.com), and PLM and enterprise content management software provider PTC (www.ptc.com).

The analysis and report was prepared by Axendia and Cambashi, which retain full editorial control.

By Daniel R. Matlis

Innovation is the lifeblood of the medical device industry. Managing the Total Product Life Cycle (TPLC) could enable medical device manufactures to lower costs while increasing quality. 

To determine the industry’s adoption of a Total Product Life Cycle approach, as advocated by FDA, Axendia ™ , in cooperation with Cambashi and FDAnews launched a major research project.
This study entitled, Managing the Total Product Lifecycle: Lowering Costs While Increasing Quality, will examine the transformation from waterfall processes to more concurrent and collaborative processes. 

This study will:

• identify major challenges associated with managing the Total Product Lifecycle
• uncover the transitional issues facing medical device organizations and their ecosystem, including globally distributed production, outsourced operations, suppliers, distributors and trading partners
• describe innovative strategies, best practices, and technologies that medical device companies should consider to achieve quality and cost benefits
• characterize the current state of the medical device industry and provide insight into how industry leaders are meeting today’s challenges

 To be a part of this important industry research and share your perspectives on Medical Device trends, complete the survey by clicking on the link below:

http://www.surveymethods.com/EndUser.aspx?E6C2AEB0E0A6B0BD  The survey will be open from April 2 until April 14th. 

Note: Individual responses will remain strictly confidential.

Survey respondents will receive the final report as an aid to enable their transformation from disconnected “silo” processes to holistic end-to-end product approaches, plus valuable related reports. 

The results of this survey will be released at the Sixth Annual Medical Device Quality Congress June 3-5 in Cambridge, MA in a special session on the research, Managing the Total Product Lifecycle:  Lowering Costs while Increasing Quality.  This research ties in closely with this year’s conference theme, “Leading the Way to Better Performance With Quality Systems Compliance”. 

To learn more about this research visit: http://axendia.com/blog/managing-the-tplc/

The research is co-sponsored by five companies – all of which are active in the Medical Device industry.  These companies provide deep and diverse expertise in medical devices practices and provide design, product lifecycle management, production, quality, and related software and services to the industry as well as management consulting services to leverage applications appropriately.  Working together, these underwriting sponsors hope to increase the medical device market’s understanding of how to reduce risks and improve compliance and profitability. 

Research Sponsors for the study are: management and technology consulting firm BearingPoint (www.bearingpoint.com), enterprise manufacturing and quality software provider Camstar Systems (www.camstar.com ), product lifecycle management (PLM) software innovator Dassault Systèmes Enovia (www.3ds.com) with its medical device industry PLM partner Integware (www.integware.com), and PLM and enterprise content management software provider PTC (www.ptc.com).

The analysis and report will be prepared by Axendia and Cambashi, which retain full editorial control.

Issues for the Supreme Court to Consider - Part II

 By:Iana DeSouza, Esq. and Judith Meritz, Esq.

On November 3rd 2008, counsel for Wyeth Pharmaceuticals and for Vermont resident Diane Levine presented oral arguments to the Supreme Court of the United States. 

In Part One of this series, we covered the key issues the Supreme Court will need to consider in this case. Specifically, whether the FDA or a Jury should determine Drug Safety Standards? 

Part Two of the Wyeth v. Levine series covers issues the Supreme Court may consider in light of the election of President-elect Obama and the state of the US economy.

The Obama Paradigm of Information and Patient Safety

On January 20, 2009, President-Elect Barack Obama will be sworn in and will focus on using technology to manage information, requiring full transparency regarding quality of care and promoting patient safety.  According to Obama’s plan to lower health care costs for Americans, the Obama administration is expected to spend $10 billion dollars over the next 5 years on Health Care Information Technology.

Preparing for this Obama paradigm of information and patient safety, the Court may decide that Wyeth did not do all that it could have to utilize available information regarding the drug’s risks to ensure patient safety. The Court may decide to hold Wyeth out as an example, to the community of  pharmaceutical and health care providers of a company that failed to adequately protect patients due to its delinquent  use of information. As  Levine argued in her brief, possibly, Wyeth knew of the serious risks and could have added a stronger warning or instruction against the IV-push injection method even after the drug was approved by FDA. If the Court agrees that Wyeth had access to greater specific information about Phenergan and the IV push method than the FDA, then the Court may find Wyeth responsible for Levine’s amputated arm. Moreover, since Wyeth is responsible for drafting the label on the drug, the Court could also decide that ultimately it was Wyeth’s responsibility to strengthen the warning even absent a mandate from the FDA to do so.

However, the Court may instead accept Wyeth’s response that it complied with all of the laws and regulations by disclosing to the FDA all of the information in its possession. Moreover, Wyeth relied on the FDA’s concurrence that the warnings were adequate. Wyeth complied with FDA’s instructions to include prominent warnings that IV administration required extreme care or gangrene requiring amputation was likely to follow. The Court may find that Wyeth did all it was required to do to prevent patients from suffering any harm. The Court may agree that it would be unreasonable to expect Wyeth to go above and beyond the required FDA standard safety warnings since the FDA, currently, is the ultimate standard for drug approvals.

Can the Current U.S. Economy Afford More State Claims?

Moreover, as Levine’s counsel asserted in their brief, permitting state actions would incentivize drug manufacturers to stay abreast of all potential injuries stemming from their products. However, how much would this cost? If Wyeth was responsible to protect against every potential harm that could result from its drug, how much more would that cost the drug companies to research, manufacture and market these drugs? How much more would Medicare and Medicaid have to pay for these drugs? And at the bottom line, how much more would that cost middle America, already barely able to afford the cost of drug prescriptions?

As America stands today in a slowing economy with many Americans who struggle to purchase their medications, a Court decision permitting state actions against drug manufacturers may continue to drive this economy into a deeper hole. If every patient who suffered any side effect or harm from a drug sued the drug manufacturer, would these companies be able to afford to research and develop the next new drug? Ultimately, a decision in favor of state actions, might also affect the development of our pipeline of medications available to the American public. Is permitting state actions against drug companies truly in the best interest of this country and should this enter into the Court’s analysis?

As we await a decision from the Court, these are just a few of the issues that the Court may consider in its adjudication.  Ultimately, the Court will decide whether the FDA’s approval of a drug should preempt state tort actions brought against a drug manufacturer based on an unintended side effect suffered by one patient which was caused by a drug that has helped millions of patients.

The views expressed in this article are those of the authors and do not necessarily represent those of Life-Science Panorama, its editor or Axendia, Inc.

Iana DeSouza Esq. is an associate in the Health Law Practice Group at Blank Rome LLP. She concentrates her practice on healthcare with a focus on FDA compliance, licensure, certification, accreditation, contract drafting and negotiation, fraud and abuse, and corporate transactions.

Ms. DeSouza provides counsel to clients regarding due diligence for new acquisitions, business ventures, and strategic partnerships. She also advises clients on all aspects of regulatory affairs and governmental compliance including quality assurance, product labeling, registrations, recalls, the handling of adverse events, security breach and consumer notifications. Prior to this position, she obtained pharmaceutical industry experience while working for a global drug manufacturer.

Judith K. Meritz, Esq. is a partner in the Health Law Practice Group at Blank Rome LLP.  She concentrates her practice in FDA compliance counseling in the areas of drugs, devices and biologics. She also offers regulatory expertise in the areas of DEA, OSHA, DOT and EPA.

Judith Meritz served as Assistant General Counsel for the American Red Cross responsible for regulatory affairs.  In this capacity, she was the chief counsel to the Biomedical Services group providing guidance to ARC headquarters staff, as well as field blood regions and national testing labs, with particular emphasis on compliance with FDA regulations and the FDA Amended Consent Decree. 

Issues for the Supreme Court to Consider on Wyeth v. Levine Case

By: Iana DeSouza, Esq. and Judith Meritz, Esq.

On November 3, 2008, while most of America anxiously awaited Election Day to cast their vote, counsel for Wyeth Pharmaceuticals and for Vermont resident Diane Levine presented oral arguments to the Supreme Court of the United States on this issue.  This two part article will cover the key issues the Court may need to consider on the Wyeth v. Levine case.

“Intra-Venous (IV) administration requires extreme care or gangrene requiring amputation will likely follow.”

Is this an adequate warning? Should the Food and Drug Administration (“FDA”) or a state jury determine the adequacy of the warning?

FDA approved a drug label for a Wyeth Pharmaceuticals Inc., drug named Phenergan. Diana Levine, was injected with Phenergan to treat nausea. Levine experienced an unintended side effect that led to the amputation of her arm. Levine sued Wyeth on a tort state claim. The Vermont Supreme Court upheld the lower courts verdict for the plaintiff and Wyeth appealed and brought the matter to the U.S. Supreme Court (the “Court”). The Court will soon decide this issue in the Wyeth Pharmaceuticals Inc. versus Diana Levine suit.

When the FDA has determined a drug to be safe and efficacious, and authorizes a drug manufacturer to sell and distribute that drug, should individuals, such as Diana Levine who lost her arm due to an unintended effect of the drug’s IV push administration, have recourse to sue the drug manufacturer under state law when the drug does not perform as it was expected? This is the question in front of the Highest Court of the U.S. Judiciary system.

Counsel for Wyeth urged the Court to overturn the $7 million dollar state verdict and rule that state tort claims against Wyeth are preempted by federal law. Levine’s counsel argued that individuals should be able to sue drug manufactures in spite of the drug’s approval by the FDA. The Supreme Court is asked to decide this question which could significantly change the landscape of the drug industry.

If the Supreme Court decides that federal law preempts the state claims and that FDA approval is a sufficient standard, patients will not be able to assert state tort claims against manufacturers of FDA approved drugs. However, if the Supreme Court decides to permit state claims, then drug manufactures could be exposed to potential suits brought by patients from every state. These drug companies might then need to significantly increase their budget and their efforts to anticipate and avoid all drug risks. Perhaps the Court will render a decision that will consider both the interests of patients who have been harmed by a drug and yet still protect drug manufacturers from excessive risk of state claims.

The Court might decide this case on one or more of several sub-issues.

Who Is Better Suited to Determine Drug Safety Standards?

Is the FDA or a state jury better suited to decide drug manufacturer’s drug safety standards? Wyeth argues that the FDA is better suited to decide which product label warning standards are required. Wyeth asserts that the FDA’s expertise enables it to possess the training and experience necessary to properly decide which drug warnings are necessary on a drug label. Thus, Wyeth’s briefs argued that Wyeth was justified in relying on the FDA’s approval of the drug’s labeling as adequate and safe to distribute in the market.  Levine’s counsels point of view prefers to substitute lay jurors opinions’ of a single victim’s injury, gathered during the time of the trial, as adequate perspective on the overall pharmaceutical system. Wyeth’s counsel asserts that this process is not optimum in order to decide the adequacy or inadequacy of a drug label.

However, a jury that has heard the arguments delineating that the drug manufacturer complied with FDA regulation and utilized best efforts to warn of drug risks and has also witnessed how the patient was harmed, may be able to make the best decision as to which drug safety standard is adequate. For example, in one state claim case, a jury might find that a drug manufacturer did do everything it could have done to prevent the patient harm and thus the drug manufacturer should not be liable. However, in another state claim case, a jury might find that the warnings were not adequate in light for the risks associated with that drug.

Risks and Benefits of Federal Pre-Emption

The Supreme Court could resort to a risks-benefits analysis to assess whether or not to permit FDA’s drug approval to pre-empt state tort claims. If plaintiffs were prohibited from bringing suit against drug companies for FDA approved drugs, the risks would include the following possibilities: 1) drug manufacturers may become less concerned with safety if there was no risk of state tort claims; 2) the FDA may realize it is the final judge on product safety and might become ultra conservative in reaching drug approval determinations; and 3) people harmed by a drug may not adequately financially recover for  harm suffered from a drug’s unintended effect if the drug companies are protected from lawsuits.

Possible benefits of preempting state claims and allowing the FDA to be the final authority on drug labels include:

1. drug manufacturers would avoid drug labeling requirements from the various states;
2. drug manufacturers would not be subject to juries focused solely on the harm caused by the drug and not on the benefit;
3. plaintiffs may be forced to shift liability  to other parties, such as the hospital or physicians, who may have had more control over the administration of the drug; and
4. maintain a national, uniform regulation of drug labels.

After weighing the risks and benefits of preempting state claims, the Court could decide that the benefits of preempting state claims justify the risks and thus preemption is necessary. This would mean that state claims would be prohibited from being brought once the FDA has approved a drug and its labeling. However, the Court might also decide that the risks of preempting state claims do not justify the benefits of preemption and thus disallow preemption as it relates to state tort claims. Plaintiffs would still be able to file state claims contesting an FDA approved drug label.

Part Two of this article will cover issues the Supreme Court may consider in light of the election of President-elect Obama and the state of the US economy.

The views expressed in this article are those of the authors and do not necessarily represent those of Life-Science Panorama, its editor or Axendia, Inc.

Iana DeSouza Esq. is an associate in the Health Law Practice Group at Blank Rome LLP. She concentrates her practice on healthcare with a focus on FDA compliance, licensure, certification, accreditation, contract drafting and negotiation, fraud and abuse, and corporate transactions.

Ms. DeSouza provides counsel to clients regarding due diligence for new acquisitions, business ventures, and strategic partnerships. She also advises clients on all aspects of regulatory affairs and governmental compliance including quality assurance, product labeling, registrations, recalls, the handling of adverse events, security breach and consumer notifications. Prior to this position, she obtained pharmaceutical industry experience while working for a global drug manufacturer.

Judith K. Meritz, Esq. is a partner in the Health Law Practice Group at Blank Rome LLP.  She concentrates her practice in FDA compliance counseling in the areas of drugs, devices and biologics. She also offers regulatory expertise in the areas of DEA, OSHA, DOT and EPA.

Judith Meritz served as Assistant General Counsel for the American Red Cross responsible for regulatory affairs.  In this capacity, she was the chief counsel to the Biomedical Services group providing guidance to ARC headquarters staff, as well as field blood regions and national testing labs, with particular emphasis on compliance with FDA regulations and the FDA Amended Consent Decree.  

By Daniel R. Matlis

Although Senators McCain and Obama (listed in alphabetical order) are looking to address many of the same problems, they have very different approaches.

The Presidential candidates don’t agree on many things, from the economy to energy, healthcare to taxes, even Joe the Plumber.

One thing they both agree on: Drug Re-importation.

“John McCain will look to bring greater competition to our drug markets through safe re-importation of drugs and faster introduction of generic drugs.”

“Barack Obama and Joe Biden will allow Americans to buy their medicines from other developed countries if the drugs are safe and prices are lower outside the U.S.”

I thought it would be worth discussing some facts about drug re-importation:

FACT: You can buy many pharmaceutical drugs abroad for a lower price.
FACT: Some of these drugs are made by the same company at same plant, to the same standards as those sold in the US.

So why is a 30 day supply of 20mg Lipitor available for $60.78 on CanadaDrugs.com while Drugstore.com offers the same product and dose for $119.99?

The answer is good American capitalism.  No, not in the way you think. Pharmaceutical Companies are not charging more in the US simply because they can.

Pharma Companies are obliged to charge less for the same product in every “G-7″ (Group of 7) industrialized nation countries (Canada, France, Germany, Italy, Japan, the United Kingdom) except for the United States (see Table for examples).

Drug Pricing in Canada
In Canada, the Patent Medicine Prices Review Board establishes and enforces guidelines that determine the maximum prices at which manufacturers can sell brand name drugs. The Canadian pricing system results in brand name drug prices that are an average of 38% lower than prices in the US

Drug Pricing in France
The French pricing system allows pharmaceutical companies to sell their products at any price. However, if these companies want the national health care system to reimburse patients for the cost of the drug, the companies must agree to a lower, negotiated price. The French pricing system results in brand name drug prices that are an average of 45% lower than prices in the US

Drug Pricing in Italy
Italy’s national health care system allows manufacturers to sell their drugs at any price.
However, if these drugs are to be eligible for reimbursement under the national health care system, pharmaceutical companies must set the price of the drug at a cost that does not exceed a twelve country European average price. The Italian pricing system results in brand name drug prices that are an average of 48% lower than prices in the US.

Drug Pricing in the United Kingdom
Drug companies in the United Kingdom are free to establish their own prices for individual drugs. However, under the country’s pharmaceutical laws, the maximum profit that drug manufacturers can earn on sales in the United Kingdom is limited. The pricing system in the United Kingdom results in brand name drug prices that are an average of 31% lower than prices in the US.

Reference: http://oversight.house.gov/documents/20040629103247-74022.pdf

The fact is that price controls in 6 of the G7 nations places an undue strain on the US consumer.

To put it in simple terms, the US (about 300 million people) subsidize R&D for the other six G7 countries (about 425 million people). That doesn’t seem fair to me.

Having been born and raised in what we now call a “Developing Economy” (we used to be known as 3rd world counties), I recognize that adjustments must be made to factor economic conditions.  However, industrialized nations should be able to equitably share in the development of life-saving therapies.

Unfortunately, drug re-importation proposals by both Presidential candidates seek to address the symptom, not the cause.

Forcing Pharmaceutical companies to artificially lower the cost of drugs in the US will have a negative impact on their ability to bring new and life-changing products to market.  And that hurts us all. 

In my opinion, we should seek to address the root cause of higher prescription drug costs in the US.  To this end, every G7 nation should equitably share in the cost of R&D for pharmaceutical drugs. That would bring prices down in the US, while supporting the development of new and innovative Pharmaceutical therapies.

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.

By Daniel R. Matlis

This article does not intend to take a position for or against regulation, bigger of smaller government.  We are all entitled to our opinions and that issue is best addressed in front of a voting machine (paper, electronic or otherwise). So, on November 4th, VOTE.

Opinions notwithstanding, we operate in a regulated industry with rule books we must follow. This article offers a commentary on individual and organizational responses to existing regulations.

I recently attended the worldwide conference of one of the largest global technology companies (whose identity shall remain confidential) where I heard a senior executive touting the benefits of using technology to facilitate regulatory compliance.

As you know, I advocate the use of technology to address business challenges in a regulatory compliant manner.  Technology can be a very useful tool to enable compliance by enforcing business and regulatory policies, sequencing activities to prevent opportunities for non-conformances and even predicting trends before they require corrective actions.

Nevertheless, the expression this executive used got me thinking about different philosophies on regulatory compliance.  She said that technology can help companies comply “against” regulations. 

At that moment I had an epiphany. I realized that individual and organizational responses to regulatory compliance fall into one of these categories.

• The Contrarian, who complies “Against the Regulations”:
  These people look at regulations as rules to be worked around, seeking every loophole and every way to avoid complying with the regulation. For example, citing on the “typewriter rule” to avoid compliance with audit rail requirements of 21CFR§11.  The logic might go something like this:” Our System is no different than a typewriter. We print every batch record at the end of each run, and we use paper as the official record, so why do we need audit trail functionality?

• The Zealot, who goes “Above and Beyond Regulations”:
  These are the regulatory zealots. They over interpret regulations and seek to build fences around them to ensure the organization exceeds compliance requirements so that even if you miss the target, you have room because you aimed high. They go beyond “mistake-proofing” procedures with the goal of eliminating opportunities for error. In the process they often break Einstein’s rule on simplicity: everything should be made as simple as possible, but no simpler. The zeal to over document often leads to one of the top 483 findings; not following approved procedures -because they often cannot be followed.

• The Rationalist, who “Complies With Regulations”:
  These people tend to look at a common sense approach to compliance. We look at regulations with a rational approach and take the opportunity to develop best practices where compliance is a byproduct of running a well governed, effective and streamlined business.

• The Illusionned, who seeks the “Regulatory Magic Box”:
  Can you validate this for me? I don’t know what I don’t know.  The Illusionned are looking for transfer of liability, if you do it, then you are liable for it (never mind that the FDA enforcement trends do not support this theory). They are often in search of a magic box that can create all the documentation required to validate a process or system with the wave of a wand (or a few magic keystrokes).

Whether our individual approach to regulatory compliance is coded into our DNA or learned, nurture or nature, I will leave to geneticists, psychologist and organizational behavioralists to address.

The great philosopher “GI Joe” said “knowing is half the battle.” Understanding an individual’s tendency toward regulatory compliance can help you choose the best approach to presenting and addressing compliance issues.

So, are you a Contrarian, a Zealot, a Rationalist or Illusionned?

YARDLEY, Pa. and WOBURN, Mass., July 9, 2008  — Axendia Inc., a trusted advisor to Life-Science Executives on Business, Technology and Regulatory strategies, and CBI Research Inc., a provider of live and electronic conferences for senior-level executives in the pharmaceutical and biotech industries, today announced that Daniel R. Matlis President and Founder of Axendia, will chair CBI’s “3rd Annual Manufacturing Execution Systems for Life Sciences Congress” to be held on August 5 - 6, 2008 in Philadelphia, PA.

Over 500 pharmaceutical, biotech and medical device executives have benefited from the Manufacturing Execution Systems (MES) Conference. The 3rd Annual meeting convenes manufacturing decision-makers from the pharmaceutical, biotech and medical device communities.

“We are delighted to have Dan Matlis join us as Chairman of this year’s 3rd Annual MES for Life Sciences Congress,” commented Sharon Langan, Senior Program Manager for The Center for Business Intelligence. “This is the premier event for lean manufacturing and manufacturing execution systems in the pharmaceutical, biotech and medical device industries. Dan brings a very exciting perspective to this annual meeting, having worked extensively on projects spanning R&D, Engineering, Operations, Regulatory, Business Development and IT. He will add tremendous value to this important meeting,” added Langan.

“Life-Science Executives are facing some of the most difficult challenges ever encountered in the industry,” commented Daniel R. Matlis, President and Founder of Axendia. “This meeting offers an outstanding opportunity for industry executives to exchange ideas and solutions for next-generation manufacturing IT infrastructures,” Matlis added.

Constituents at the congress discuss current plant-level IT needs and discover the latest and best ways to implement a MES system for future success.

For detailed information about the 3rd Annual MES for Life Sciences Congress visit www.cbinet.com/mes

About Axendia Inc. 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 of 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 www.Axendia.com

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By Daniel R. Matlis

Sterile Manufacturing facilities are often, well sterile.  They are typically comprised of drab clean-rooms where the color palette is limited to stainless steel and shades of grey.

For this installment of our “2008 Learning from Success” series, I had the privilege of speaking with Dr. Ralf Pfirmann, Managing Director of IDT Biologika’s site in Dessau-Rosslau, Germany.  IDT’s new vaccine manufacturing site received the 2008 Facility of the Year Award for Operational Excellence.

IDT new 4.700 m² vaccine production facility is changing the perception of sterile manufacturing. Its innovative use of color and transparency suggests a new way of thinking in designing workplace environments.

Clean-rooms with glass walls, glass doors in material locks, and passageways of glass, allow for clear visibility across the entire building.  In addition, the facility uses color to create a better working environment. This trend-setting approach allows IDT to meet the most rigorous hygiene standards for aseptic production conditions.

The IDT vaccine production facility features two contained manufacturing lines that allow segregated operations for preparation of cells, virus propagation and virus purification using highly efficient technical systems such as fermenters and robotic systems. In-process control areas, offices and storage areas complement the manufacturing plant. The building was constructed within 19 months and provides capacities for development and manufacturing of vaccines for clinical trials, Phase I though III, as well as for commercial supply.

Key challenges in building this facility included preventing cross-contamination in the multipurpose structure as well as minimizing expensive lead time between manufacturing campaigns.

To meet these challenges, IDT chose to extensively use disposable technologies, to save time and simplify compliance and validate steps.  Pre-sterilized, single use technologies enabled IDT to streamline room sterilization procedures and provide transparency of operations and process flows.

Although counterintuitive, disposable technologies offer environmental benefits, as they reduced the use of sterilization agents and large amounts steam used often used to prevent cross contamination.
 
Since we are not in real estate, pretty colors and open floor plans don’t, by themselves, provide business value.  
So in addition to “brightening the sterile manufacturing facility” here are a few more benefits from IDT’s approach:

1. Clear makes it is easier to keep squeaky clean
  Glass is easier, faster and cheaper to keep clean in a sterile environment

2. Create a better working environment 
   Productivity increases when people are in an appealing and comfortable setting

3. Streamline site inspections and audits
  Complete visibility into the sterile suite enables thorough walkthroughs with out the need to gown up

4. Disposing can be cheaper that cleaning
   Disposable technologies save time, add flexibility and simplify regulatory compliance

5. Advanced technology can limit human exposure and improve efficiencies
  IDT uses automated laser techniques and isolators to open and process incubated eggs without breaking the shell membrane, keeping the egg sterile while opened

As a result of the successes IDT has achieved in the vaccine production facility, the company plans a further investment of 24 million Euros in a new filling plant utilizing similar facility design principles.

IDT is working in cooperation with international organizations, biotechnological as well as pharmaceutical companies, to manufacture vaccines against dangerous infectious diseases, such as Tuberculosis, Malaria, AIDS and Rotavirus.