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Bert Spilker

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8004 Overhill Road
Bethesda, Maryland
20814-1145

Phone: 301-718-5150
Fax: 301-657-1403
E-mail: bas@bertspilker.com
Alt E-mail: bertspilker0@gmail.com


Brochures: (Acrobat)

  • Bert Spilker & Associates
  • "Enhancing Your Meetings with FDA"
  • . Media and Journal Articles

  • March 17, 2003: Bert Spilker, PhD, MD and Medifacts International Announce a Strategic Partnership That Will Shorten Drug & Device Development Time (press release)

    ROCKVILLE, MARYLAND - Medifacts International (Medifacts), a global Contract Research Organization (CRO) headquartered in Rockville, MD, announced today that the company has initiated a collaborative effort with Bert Spilker, PhD, MD; one of the foremost authorities on clinical trials, regulatory affairs, and drug development. As Senior Medical Consultant, Dr. Spilker will provide three unique and proprietary services designed to shorten drug and device development time - with guaranteed results. These services include:

    • Assisting pharmaceutical, biotech, and device companies in shortening development time through a proprietary system of on-site evaluations and discussions. Dr. Spilker will personally review development plans and activities and make recommendations on how to expedite the time to NDA, PLA, PMA, and other approvals.
    • Conducting drug development training for industry professionals at client sites. Several programs are offered to address each client¹s specific needs.
    • Addressing and solving regulatory, clinical, and development issues/problems.

    "This is a new opportunity for biotech and pharma companies to navigate the bureaucracy, challenges, and pitfalls of drug development. Both the length of time and the associated cost it takes for a new drug to reach those it will benefit have become a serious problem which is inhibiting the development of therapies that society sorely expects, needs, and demands," said Dr. Spilker, an independent consultant in Bethesda, Maryland, and former Senior Vice President of Scientific and Regulatory Affairs for the Pharmaceutical Research and Manufacturers of America.

    "Dr. Spilker's proven methodologies and notable expertise are considered the gold standard in improving clinical trial efficiency, ultimately resulting in shortened drug development time. Medifacts' clients will now have access to Dr. Spilker and his breadth of clinical study experience - an unbelievable advantage and a service not offered by any other CRO," said Sandra Garrett, PhD, President, CEO, and founder of Medifacts International.

    About Medifacts International

    Medifacts International is a global leader in the management of clinical development programs for the pharmaceutical, biotech, and medical device communities. The company provides a full range of consulting and clinical trial management services that include protocol design, project management, data management, clinical site monitoring, biostatistical analysis, and medical report writing. Medifacts is also a worldwide leader in non-invasive research services. Medifacts International is headquartered in Rockville, MD and has offices in Langenfeld, Germany, and Shanghai, China.

    About Dr. Spilker

    Bert Spilker, PhD, MD, FCP, FFPM, is an independent consultant who was most recently the Senior Vice President of Scientific and Regulatory Affairs for PhRMA (Pharmaceutical Research and Manufacturers of America) based in Washington, D.C. He was President and cofounder (in 1993) of Orphan Medical, Inc., a public pharmaceutical company that develops and markets important medical products for patients with uncommon diseases. He is well known as the author of 15 books on clinical trial methods and the processes of drug discovery and development. These books are considered by many as the standard references on clinical trials and drug development.

    He has worked at four major pharmaceutical companies for over 20 years (Pfizer, Philips-Duphar, Sterling-Winthrop, and Burroughs Wellcome) in medicine discovery, development, and management. He served on the Steering Committee for the International Conference on Harmonization (ICH) and has received numerous honors including the FDA Commissioner's Special Citation for work in the orphan medicine area.

    Contact

    Vincent Lagrotteria
    Executive Director, Sales & Marketing
    Medifacts International
    (301) 296-4738
    vlagrotteria@medifacts.com
    www.medifacts.com


  • January 3, 2003: (press release) National Bio-Pharmaceutical Forum Established at School of Public Health and Health Services, George Washington University

    Washington --The George Washington University today announced the formation of the National Bio-Pharmaceutical Forum within GW Medical Centerís School of Public Health and Health Services. The Forum, based at the School's Department of Health Policy, will focus its study and research activities on topics that affect the development and delivery of biological and pharmaceutical products.

    The Forum will be guided by a multi-disciplinary Advisory Board and will bring rigorous and impartial scrutiny to numerous critical topics in national prescription drug policy, including: Prescription drug safety; Biomedical research; Prescription drug discovery and development; Health outcomes from biological and pharmaceutical products

    The Forum will accomplish its objectives through special reports, an on-line forum, and consensus conferences. Funding comes from grants, gifts and a broad base of extramural support.

    "No health policy matter can be expected to receive greater attention during the 108th Congress than prescription drug coverage," said Professor Sara Rosenbaum, interim chair of the Department of Health Policy. "We are pleased that the Forum has selected us as its home."

    Bert Spilker, Ph.D., M.D., and Wayne Pines will serve as chair and president of the Forum, respectively. "This National Forum fills a need for an independent, objective voice in the policy debate over matters related to the pharmaceutical and biological product development and access," said Dr. Spilker. He recently served as the Senior Vice President of Scientific and Regulatory Affairs for PhRMA Pharmaceutical Research and Manufacturers of America). Dr. Spilker also served as President and cofounder of Orphan Medical, Inc., a public pharmaceutical company that develops and markets important medical products for patients with uncommon diseases. He is the author of 15 books on clinical trial methods and the processes of drug discovery and development.

    Mr. Pines served as Associate Commissioner for Public Affairs at the FDA. He has served in senior management positions in a number of leading public affairs and communications consultancies. "Pharmaceutical and biotechnology industries are central to the modern medical care system. This Forum and its affiliation with The George Washington University will bring an important new voice to these matters," he said.

    More information on the Forum is available at www.gwBioPharma.org or at 202-530-3922.


  • November 4, 2002: (Press release) "Bert Spilker & Associates, LLC Announces the Launch of The Spilker ReportTM - Unique Publication Focuses on Shortening Drug Development Time" [Full text - Acrobat]

    "Bethesda, MD - Both the length of time and the associated cost it takes for a new drug to reach those it will benefit have become a serious problem which is inhibiting the development of therapies that society sorely expects, needs and demands. Now, to tackle these issues, THE SPILKER REPORTTM, a new publication from one of the world's foremost authorities on drug development, addresses topics of import in the drug development arena."

  • September 12 2002: (Press release) "New Checklist Offered for IRBs & Ethical Committees to Prevent Fraud, Non-Compliance and Human Subject Harm in Clinical Trials" [Full text - Acrobat]

    "Boston, MA - September 12, 2002 - CenterWatch and Bert Spilker & Associates today announce a collaborative effort to publish a checklist designed to assist research professionals and institutional review boards (IRBs) and ethical committees (ECs) to best ensure the safety and ethical treatment of human subjects enrolled in clinical trials."


  • October 12, 2001: Dr. Bert Spilker to leave PhRMA


  • October 8, 2001: PhRMA Senior VP-Spilker to Retire in July


    Dr. Bert Spilker to leave PhRMA

    Dr. Bertram Spilker, senior vice-president for scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers of America (PhRMA), has announced that he is leaving the association in July 2002, to set up a consulting business. Dr. Spilker had succeeded Dr. John Beary at PhRMA in March 1998 (Scrip No 2321, p 28).

    The announcement was made 10 months in advance to allow PhRMA to find a successor, Dr. Spilker told Scrip. He noted that it took the association a year to replace Dr. Beary, who left in April 1997. Although PhRMA’s primary focus is lobbying members of Congress to enact — or defeat — critical legislation, its scientific and regulatory affairs functions have become increasingly important to an organisation that deals with the FDA every day and whose public face is "research".

    Dr. Spilker was uniquely qualified for the job. A physician and pharmacologist with more that 25 years’ experience in industry, he held scientific, medical and regulatory posts at Pfizer, Philips-Duphar, Sterling-Winthrop and Burroughs Wellcome before starting his own company, Orphan Medical, in 1993. He continues to hold faculty positions as clinical professor of pharmacy practice at the University of Minnesota and adjunct professor of medicine and pharmacy at the University of North Carolina in Chapel Hill.

    He is the author of 15 books on clinical trial methods and the processes of drug discovery and development. He serves on the steering committee for the International Conference on Harmonisation (ICH), and co-chairs ICH’s Global Cooperation Group.

    Bert Spilker Consultants will provide expertise and training for pharmaceutical companies in drug development, creation of strategies, and clinical trial methodologies; represent clients at meeting; and "mentor" newly appointed senior staff.

    Copyright www.pjbpubs.com/scrip SCRIP No 2686 October 12 th 2001 p 15. Reprinted by permission.


    PhRMA Senior VP-Scientific & Regulatory Affairs Spilker to Retire in July

    PhRMA is recruiting a new senior VP-scientific & regulatory affairs in anticipation of the retirement of Bert Spilker, MD/PhD, on July 1, 2002.

    Spilker, 60, announced his retirement from the Pharmaceutical Research & Manufacturers of America trade association Oct. 4. He plans to open a private consulting practice after he leaves the association and will serve as a consultant to PhRMA.

    PhRMA will have nine months to complete the search for a successor before Spilker’s retirement. The recruitment process that resulted in the hiring of Spilker in April 1998 took more than a year.

    Spilker succeeded John Beary, MD, who was the top medical and regulatory affairs exec at PhRMA for nine years. Beary joined Procter & Gamble in 1997.

    PhRMA has recently added two execs from other D.C. trade associations in the scientific and regulatory field. Associate VP-Regulatory Affairs Alan Goldhammer, PhD, joined PhRMA in 1999 from the Biotechnology Industry Organization, and VP-Science Policy & Technical Affairs Alice Till, PhD, joined from a generic drug trade association last year.

    Spilker will continue to oversee the negotiations with FDA over the reauthorization of the Prescription Drug User Fee Act, which sunsets in 2002. Goldhammer and PhRMA consultant William Kennedy are among the industry participants in those discussions.

    The departure of Spilker will complete a transition within the association among the first round of execs appointed by PhRMA President Alan Holmer after he joined in 1996. The other members of the initial group, including Exec VP Judith Bello, VP-Federal Affairs Barry Caldwell, VP-Policy Steve Cole and VP-Public Affairs Alixe Mattingly, have all departed. Mattingly and Bello are still consultants with PhRMA

    Spilker spent 25 years in the corporate sector before joining PhRMA, including 14 years with Burroughs Wellcome.

    His consulting practice will focus on traditional regulatory affairs work (including white papers, regulatory submissions, in-house courses, etc.), as well as staff mentoring, meeting coverage, public speaking engagements and organizational analysis)

    Copyright 2001 The Pink Sheet. Reprinted by permission.


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