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| Kenneth I. Kaitin a keynote speaker at the marcus evans Evolution Summit 2015, on the challenge of clinical development and how companies are addressing it. |
NEW YORK, N.Y., Aug 20, 2015 - (ACN Newswire) - "There is often misunderstanding and lack of appreciation by the public about the value of clinical trial participation. The industry should continue its efforts to educate people on the importance of clinical studies in supporting medical research and in the development of critical new medicines," advises Kenneth I. Kaitin, Professor and Director, Tufts Center for the Study of Drug Development, Tufts University School of Medicine.
Kaitin is a keynote speaker at the marcus evans Evolution Summit 2015 taking place in Las Vegas, Nevada, September 20-22.
- What are the complexities of bringing new drugs to market in the pharmaceutical industry today?
Our studies have shown that the current cost of bringing a single new drug to market, including the cost of failures, has skyrocketed to USD 2.6 billion, which represents a 145 percent increase from our previous study in 2003. High drug development costs are a significant obstacle for developers, with important public health consequences in terms of finding new treatments for unmet medical needs.
The most significant factor contributing to these high costs is not the considerable time it takes to develop a new drug, but rather the exceedingly low success rates of compounds entering clinical development. Our recent analysis indicates that overall clinical success rates have fallen from 22 percent in the early 2000s to less than 12 percent today. In some therapeutic areas, success rates are alarming low; for example, for neuropsychiatric drugs, less than five percent of drugs entering clinical trials are likely to reach the market.
The decrease in clinical success rates is due in part to increasing complexity built into clinical trials. There has been a steady rise in procedures done and protocol amendments filed during clinical development, which ultimately have made it harder to recruit and retain patients for clinical studies, prolonging study times and raising trial costs.
- What are companies doing to address these complexities?
Pharmaceutical companies, academic institutions, teaching hospitals, patient groups and government agencies are collaborating through consortia and integrated alliances to find better biomarkers and tools for determining what drugs are likely to succeed in clinical development.
Not long ago, many of the large legacy pharmaceutical companies took great pride in the fact that they alone could take a compound from the laboratory bench all the way to the marketplace. Now those same companies promote the fact that they actively partner with other organizations in the discovery and research phase, and that they have preferred-provider relationships with contract research organizations. Through these relationships, companies are able to contain research and development (R&D) costs, "de-risk" the development process, and increase the likelihood of success. The bottom line is that the era of the self-sufficient, fully-integrated pharmaceutical company is over. Companies are now engaging in partnerships and integrated alliances to reduce overall R&D spend and boost productivity.
- What would improve the quality of decision-making in clinical trials?
The clinical trial process has remained virtually unchanged for the past 50-plus years. Many companies have legacy systems in place that are not easily changed, made more difficult by the fact that product development times can last ten to 15 years. In response, some companies are developing new governance mechanisms for reviewing clinical protocols and the design of clinical studies to weed out inefficiencies in drug development programs. In some cases, companies have chosen to move the decision-making process outside the company, to get an objective efficiency assessment, rather than relying on individuals within the company, who may have a vested interest in keeping products alive.
The era of the self-sufficient, fully-integrated pharmaceutical company is over.
About the Evolution Summit 2015
The 9th Evolution Summit is the premium forum bringing clinical trial experts from leading drug development companies and solution providers together. The Summit offers an intimate environment for a focused discussion of key new drivers shaping drug development. Taking place at Red Rock Resort & Spa, Las Vegas, Nevada, September 20-22, the Summit includes presentations on shaping the industry's future, viewing CROs as strategic business partners, analyzing the benefits of patient-centered drug development and patient recruitment and retention.
For more information please send an email to press@marcusevanscy.com or visit the event website at www.evolutionsummit.com/Kaitin_Interview
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Please note that the Summit is a closed business event and the number of participants strictly limited.
Contact:
Luzdary Hammad
Press Manager, marcus evans, Summits Division
Tel: +357 22 849 385
Email: press@marcusevanscy.com
Topic: Trade Show or Conference
Source: marcus evans Summits
Sectors: Daily Finance, Daily News
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