Navigation Links
Laureate Pharma Launches New Regulatory Affairs Services and Appoints Robert G. Burford, Ph.D., as Vice President

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

For more information, contact: Imara Charles, Ph.D., Director of Project Management, Laureate Pharma, at (609) 919-3367, or or visit or Jennifer Vollaro at Integrated Marketing Services at (609) 683.9055 ext. 247, or

SOURCE Laureate Pharma, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Laureate Pharma Announces New Development and Manufacturing Agreement to Produce AVEO Pharmaceuticals Antibody Therapeutic
2. Elsevier Celebrates Nine 2010 Nobel Laureates and Honors Achievements With Freely Available Prize-Winning Research
3. Laureate Pharma Secures $20 Million to Enhance and Grow Biopharmaceutical Contract Manufacturing Business
4. Laureate Pharma Appoints Steven R. Johnson as Vice President, Business Development
5. Thomson Reuters Predicts Nobel Laureates
6. Laureate Pharma Announces Signing New Biopharmaceutical Development & Manufacturing Agreement
7. Nobel Laureate Dr. Gunter Blobel to Speak at Florida Atlantic University
8. Aires Pharmaceuticals, Inc. Completes $20M Equity Financing and Signs an Option Agreement with a Major Pharmaceutical Company
9. Access Pharmaceuticals Presents CobOral™ Insulin Research at 10th Annual Diabetes Technology Meeting on November 11-13, 2010
10. Optimer Pharmaceuticals to Host Investor and Analyst Event on November 18
11. DUSA Pharmaceuticals to Present at the 4th Annual Maxim Group Growth Conference
Post Your Comments:
(Date:11/24/2015)... , Nov. 24, 2015  In the pharmaceutical ... in an effort to quickly uncover new insights, tactics ... --> --> However, organizations ... market research project and ensure that all rules and ... industry standards. Another major barrier to efficiently launching market ...
(Date:11/24/2015)... NEWPORT NEWS, Va. , Nov. 24, 2015 /PRNewswire/ ... that they have signed an agreement for DILON to ... select geographies across the globe. The signing of this distribution ... GE,s Discovery NM750b Molecular Breast Imaging system and is ... ways to provide better healthcare solutions for clinicians and ...
(Date:11/24/2015)... 24, 2015   HeartWare International, Inc . (NASDAQ: ... circulatory support technologies that are revolutionizing the treatment of ... Executive Officer Doug Godshall is scheduled to ... Healthcare Conference on December 1, 2015 at 3:00 p.m. ... New York . ...
Breaking Medicine Technology:
(Date:11/24/2015)... , ... November 24, 2015 , ... DMG Productions announced ... Begley Jr., airing first quarter 2016 via Discovery Channel. Dates and show times TBA. ... Province, and is in the business of producing and supplying medical marijuana pursuant to ...
(Date:11/24/2015)... ... November 24, 2015 , ... ... Reactor System. Brillouin is the developer of renewable energy technologies capable of producing ... reactions (“LENR”), announced today that its WET™ and HHT™ Boiler System reactor core ...
(Date:11/24/2015)... ... November 24, 2015 , ... American Family Care (AFC), the nation’s ... a holiday pop-up clinic located in Metro Atlanta’s North Point Mall. The clinic is ... different way. The location is scheduled to operate through Dec. 24. , Holiday Pop-Up ...
(Date:11/24/2015)... ... November 24, 2015 , ... ... designated an Aetna Institute of Quality® Bariatric Surgery Facility for treating individuals living ... cost of health care services available to its members to help them make ...
(Date:11/24/2015)... ... November 24, 2015 , ... Bibliomotion is thrilled to announce ... about Reinvention and Diversity by Nancy M. Schlichting, Chief Executive Officer of ... to adequately address the needs of patients and their families, shaped my desire to ...
Breaking Medicine News(10 mins):