PRINCETON, N.J., Nov. 11, 2010 /PRNewswire/ -- Laureate Pharma, Inc., a full-service biopharmaceutical contract development and manufacturing organization, today announced the establishment of a Regulatory Affairs group and the appointment of Robert G. Burford, Ph.D. FACA as Vice President, Regulatory Affairs. Dr. Burford will establish and expand regulatory affairs services to support Laureate clients' clinical programs.
"This group will initially focus on the creation and delivery of critical electronic Common Technical Document (eCTD) regulatory submissions for clients as required for global drug product approvals. Over time it will expand to provide a full range of regulatory support services including innovative drug and biologic development strategies to achieve our clients' corporate objectives," said Michael A. Griffith, Chief Executive Officer of Laureate. "We have already initiated our first eCTD project for a new client."
The new regulatory affairs service offerings will include: (i) Expert advice regarding preclinical and clinical strategies for development of new drug products; (ii) Expert guidance, preparation and review of electronic regulatory submissions; (iii) Strategies and protocols for implementing process improvements or upgrades for clinical-stage or commercial products; (iv) Comprehensive management and oversight of our client's regulatory affairs needs; (v) Accompanying clients to meetings with regulatory authorities to represent them or to provide impartial expertise; and (vi) Regulatory and quality due diligence for in-licensing opportunities.
"The regulatory process is a critical element of any drug development program," said Robert G. Burford, Laureate's newly appointed Vice President, Regulatory Affairs. "Laureate's regulatory affairs programs will complement a 30-year track record of successfully developing and manufacturing monoclonal antibodies and other drug products. We will provide our clients with a broad range of solutions for development of their new drug products that will help achieve clinical development timelines."
Dr. Burford comes to Laureate with a distinguished and productive career in the pharmaceutical industry. Prior to joining Laureate, he has been the President of the American Clinical Research Consultants Inc. for the past 16 years, where he has provided expert advice and counsel in preclinical toxicology and clinical development of new drug products and medical devices. He has represented both domestic and foreign clients before the FDA and HPB, being thoroughly familiar with the regulatory requirements of medical product approval in the US, Europe and Canada. Prior to this Dr. Burford held positions of increasing responsibility in the pharmaceutical industry in clinical research and regulatory affairs. He is a past President of the Society of Toxicology, Canada, Secretary General of the International Union of Toxicology and is a member of the American Society for Clinical Pharmacology and Therapeutics. Dr. Burford also holds a Ph.D. in pharmacology/toxicology from the University of Western Ontario, Canada.
About Laureate Pharma
Laureate Pharma is a full-service biopharmaceutical contract development and manufacturing organization. Laureate's scientists are expert in process development and cGMP production of therapeutic proteins including monoclonal antibodies and Fc-fusion proteins. In addition, the company's portfolio of services includes aseptic filling, cell line development, analytical and stability testing and regulatory support. Laureate has served a global client base from its Princeton, New Jersey facility since 1981 and is a portfolio company of Saints Capital, LLC.
About Saints Capital, LLC
Saints Capital is a leading direct secondary acquirer of venture capital and private equity investments in emerging growth companies around the globe. It also makes traditional direct venture capital investments on a primary basis and in special situations in technology, healthcare, consumer and industrial companies in the United States. Founded in 2000, Saints provides liquidity for private investors in such markets as investment and commercial banks, buyouts, corporate venture capital and hedge funds. Saints has more than $1 billion of committed capital under management, over 50 completed portfolio transactions and investments in more than 200 companies. For more information, please visit www.saintsvc.com.
For more information, contact: Imara Charles, Ph.D., Director of Project Management, Laureate Pharma, at (609) 919-3367, or firstname.lastname@example.org or visit www.laureatepharma.com or Jennifer Vollaro at Integrated Marketing Services at (609) 683.9055 ext. 247, or email@example.com.
|SOURCE Laureate Pharma, Inc.|
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