New consultancy to the biopharmaceutical and medical device industries, announces a comprehensive set of services for mid-stage companies
NDA Partners, a product development consultancy to the biopharmaceutical and medical device industries, 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 Carl Peck, former head of the US Food and Drug Administration's centre for drug evaluation and research, the company was founded by ten 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 and Co, a San Francisco-based merchant banking company. "Their availability as strategic advisors to guide a company's development programmes 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's 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 utilise their brain trust to assess product candidates and accelerate our development programs," said Mihael Polymeropoulos, chief executive officer of Vanda Pharmaceuticals. "NDA Partners's experience is proving invaluable in advancing our programmes toward marketability".
NDA Partners assists investors with due diligence, development programme 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 programme design and execution.
The founding partners are augmented by a roster of senior consultants, each a nationally-recognised expert in their field, lending expertise to project teams, advisory boards, and other committees formed to provide clinical, scientific, regulatory, and programme management support.
