NDA Partners Guides Clinical Development For Biopharmaceutical And Medical Device Companies
Consultancy Offers Long-term, Comprehensive Strategic Advisory Services Through Teams of Internationally Recognized Experts
FALLS CHURCH, Va., April 13 /PRNewswire/ -- NDA Partners LLC, a product development consultancy to the biopharmaceutical and medical device industries, today announces the deployment of a comprehensive set of services for mid-stage companies that are moving products from discovery into clinical development. Established to address the need for experienced, high-level individuals to provide strategic guidance to venture capital funded companies with limited internal resources, NDA Partners aims to dramatically improve the success rate and development speed of new biopharmaceutical discoveries and medical devices.
Under the leadership of Dr. Carl Peck, former head of the U.S. Food and Drug Administration's Center for Drug Evaluation and Research, the company was founded by 10 individuals with a collective 200 years of experience gained from industry, regulatory agencies and academics. The founders have served as senior global clinical, drug development and regulatory executives, offering a broad base of advisory expertise.
"NDA Partners brings a depth of relevant knowledge and experience far beyond that which any entrepreneurial biotech company could have on its own staff or afford on a full-time basis," commented Steve Burrill, chief executive officer at Burrill & Company, the San Francisco-based merchant banking company. "Their availability as strategic advisors to guide a company's development programs offers a new and important strategic alternative for drug development in emerging biopharmaceutical companies."
"We enter into board-level relationships with a focus on achieving shorter development times, lower overall costs, and a greater percentage of FDA approvals," commented Earle Martin, NDA Partners chief executive officer. "The reaction from the investor community has been very positive, and we initiated a number of client relationships shortly after founding the company."
One of NDA Partners' premiere clients, Vanda Pharmaceuticals, focuses on repositioning compounds that failed in phase II or phase III trials due to undifferentiated efficacy. At the request of Care Capital, Vanda Pharmaceutical's principal investor, NDA Partners works with company management to identify and assess potential in-licensing candidates.
"We made the decision to align ourselves with NDA Partners in late 2003 to utilize their brain trust to assess product candidates and accelerate our development programs," said Dr. Mihael Polymeropoulos, chief executive officer of Vanda Pharmaceuticals. "NDA Partners' experience is proving invaluable in advancing our programs toward marketability."
NDA Partners assists investors with due diligence, development program assessments and similar services. It helps biopharmaceutical companies evaluate technology and identify products in the discovery pipeline with the greatest probability for success, advises in the preparation of pre-clinical and clinical strategy plans, and provides guidance in product development program design and execution.
The founding partners are augmented by a roster of senior consultants, each a nationally-recognized expert in their field, lending expertise to project teams, advisory boards, and other committees formed to provide clinical, scientific, regulatory, and program management support.
About NDA Partners
NDA Partners is a provider of strategic advisory services for mid-stage biopharmaceutical and medical device companies undertaking initial product development programs. Company founders include internationally recognized experts who have been instrumental in shaping the course of drug development during the past several decades. NDA Partners offers emerging companies a unique combination of drug development and regulatory expertise, strategic advice, and proven clinical development and management practices that lead to rapid, efficient and economical product development and commercialization. For more information, visit www.NDApartners.com or call toll-free 888-823-2412.
Founders:
* Fritz Buhler, M.D., director of European Center of Pharmaceutical Medicine and former Head, Worldwide Clinical R&D, Hoffman-LaRoche
* Alexander Cross, Ph.D., DSc, FRSC, formerly president and chief executive officer of Zoecon Corporation, vice president of Research at Syntex Corporation, president of Syntex Scientific Systems, and president of Syntex International Pharmaceuticals.
* Dennis Fisher, M.D., founder of the "P-Less-Than" Company, a clinical pharmacology and pharmacometrics consultancy and former professor, Anesthesia and Pediatrics, UCSF
* Malcolm Rowland, Ph.D., research professor of Pharmacy and former dean, School of Pharmacy and Pharmaceutical Sciences, University of Manchester and founder and former director, Medeval Ltd. (a CRO)
* David Savello, Ph.D., executive vice president of quality, regulatory and chief scientific officer at Cardinal Health and former vice president regulatory affairs, Glaxo Inc.
* George Schwartz, MBA, former chairman of Aircraft Services International Group, Inc., founder of Tioga Capital Corporation, and former senior vice president of Corporate Finance at Drexel Burnham Lambert
* Lewis Sheiner, M.D., professor of Clinical Pharmacology in the Departments of Laboratory Medicine and Biopharmaceutical Sciences, UCSF
* Carl Peck, M.D., founder and director, Georgetown University Center for Drug Development Science and former director of FDA's Center for Drug Evaluation & Research
* Earle Martin, founder and former chairman and chief executive officer, PRA International (an international clinical CRO)
* Charles Grudzinskas, Ph.D., adjunct professor, Georgetown CDDS and former executive at G.D. Searle & Co., Lederle Laboratories and NIH/NIDA
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Source: NDA Partners LLC