Risk Management in Drug Development

Announcement posted by marcus evans, summits division 19 May 2010

Paul Beninger, a speaker at the marcus evans Evolution Summit 2010, shares his thoughts on the future of drug development.

Interview with: Paul Beninger, Vice President – Pharmacovigilance, Genzyme

Miami, FL, May 18, 2010 - FOR IMMEDIATE RELEASE

While risk management in the drug development industry has shifted from a post-marketing activity to the clinical trial stage, risks are still not managed in a prospective way but as a reaction to a problem, according to Paul Beninger, Vice President – Pharmacovigilance at Genzyme. The specific set of skills and expertise required has meant that risk management is only selectively employed. A speaker at the marcus evans Evolution Summit 2010 taking place in Florida, May 10-12, 2010, Beninger discusses the need for appropriate risk management, the opportunities Chief Medical Officers can utilize and his projections for the future of drug development.

What are your thoughts on risk management?

Paul Beninger: Risk management is a practice that we are only just learning how to do. Europeans are much better at it than we are in the US. We have to learn how to manage risks in a prospective way and not just be reactive to the next problem. The types of measures that Europe have put in place that anticipate problems - looking ahead to what the concerns might be and putting the appropriate monitoring measures in place are not very exciting, but it is the kind of daily work that can keep the next catastrophe from happening.

Over the years, risk management has been thought of primarily as a part of the post-marketing realm. Now, it is increasingly playing a more important role earlier in the product development process. Moving risk management into the clinical trial environment and understanding the profile of an agent, beginning with animal studies, has been a big step. Thus the types of skills and expertise that safety managers need have moved from a strictly post-marketing realm, all the way through to clinical studies and now potentially into what is essentially veterinary medicine. The very widely encompassing skill set that is required has meant that risk management is still only selectively employed because few professionals possess these skills.

What are some of the opportunities that Medical Officers can take advantage of?

Paul Beninger: There are new trial designs that are showing promise with regard to shortening the time frame. The proposition that we can conduct studies that are less detailed needs to be looked at more closely, but I think it is clear that a lot of studies are conducted with more information than is actually needed; therefore, stripped down models of studies have increasingly greater potential for use in the future.

There are also adaptive design models that allow adjustments to the dosing, frequency or eligibility criteria of the trial, mid-stream, as opposed to completing the study with the existing design and then starting a new one. It is that ramping down one study and ramping up the next study that consumes a great deal of time. If that can be minimized by actually changing the design of the study while it is still ongoing and with the appropriate protections and measures in place, it is possible to shorten the time frame of a study and learn a great deal more about what is necessary to move the development program forward.

What are your projections for the next 10 years?

Paul Beninger: There are two things I would like to highlight. Firstly, the direction of really being global in how studies are being conducted; we are at the front end of that experience and on the steep part of the learning curve. Secondly, personalized medicine, learning how to identify the proper patient for the proper drug which is the Holy Grail of the pharmaceutical industry. So many patients now receive a drug, particularly in certain areas such as cancers, without any hope of benefiting from it. We do not yet have the appropriate biomarkers to show that these drugs are suited for patients with specific deficiencies or concerns. We are at the beginning of this process and have years before we really learn how to do it well.

What are some of the international hurdles CMOs need to overcome?

Paul Beninger: The first concern has to be understanding the culture; many companies are going into third world countries to conduct studies, primarily because of cost issues, and not being particularly sensitive enough to the cultural issues. They need to have the appropriate institutional review board or ethics committees in place, and endpoint review and executive committees for those local environments.

There was an incident in the recent past where a company had to go back and conduct a multi-thousand patient study again, as European authorities had found ethical breaches in the conduct of the study. That set the company back two or three years. Therefore, it is critical to take the cultural issues, and how medicine is practiced in that country, into account.

Contact: Sarin Kouyoumdjian-Gurunlian, Press Manager, marcus evans, Summits Division

Tel: + 357 22 849 313

Email: press@marcusevanscy.com

About the Evolution Summit 2010

This unique forum will take place at the Doral Golf Resort & Spa, Miami, Florida, May 10-12, 2010. Offering much more than any conference, exhibition or trade show, this exclusive meeting will bring together esteemed industry thought leaders and solution providers to a highly focused and interactive networking event. The summit includes presentations on the future of drug development, developing a culture of safety and maximizing return on investment.

For more information please send an email to info@marcusevanscy.comor visit the event website at http://www.evolutionsummit.com/PaulBeningerInterview

Please note that the summit is a closed business event and the number of participants strictly limited.

About marcus evans Summits

marcus evans Summits are high level business forums for the world’s leading decision-makers to meet, learn and discuss strategies and solutions. Held at exclusive locations around the world, these events provide attendees with a unique opportunity to individually tailor their schedules of keynote presentations, think tanks, seminars and one-on-one business meetings. For more information, please visithttp://www.marcusevans.com