Michael L. Salgaller, PhD, has joined Biologics Consulting Group, Inc. in May 2009 as President and Chief Operating Officer. He has full operational responsibilities for the day-to-day activities of BCG, is primarily responsible for overseeing client activities and inquiries, and develops and executes business development activities. Dr. Salgaller, a medical researcher by training, brings over 20 years of experience in the biologics sector - including industry, venture capital, and at the National Institutes of Health (NIH). He has extensive expertise in the product development life-span, from inception/discovery through late-stage clinical trials. Dr. Salgaller works out of the firm's Virginia office.

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Michael Gross, Ph.D., RAC joined Biologics Consulting Group, Inc., as a Senior Consultant with expertise in combination products. He comes to BCG with over 25 years of experience in senior regulatory affairs, quality assurance and compliance roles in the pharmaceutical and medical device industries and the Food and Drug Administration. Michael is experienced in a variety of therapeutic areas including cardiovascular, neurological, pulmonary, urology, oncology, ophthalmology, dermatology, anti-infectives and blood products.

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The FDA Gamunex for Chronic Inflammatory Demyelinating Polyneuropathy Review Team
will be receiving a CBER Honors Award for advice on the development of and for reviewing the marketing application for the first product approved for the treatment of Chronic Inflammatory Demyelinating Polyneuropathy. Dr. Bryan was a clinical reviewer on this team during his tenure at FDA and has been with BCG for the last two years.

BCG representatives at the meeting will include:

Dr. David Lin who has expertise in CMC (quality), product development, and FDA submission requirements and served as an FDA reviewer at CDER for four years.

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Ms. Louise Johnson who has expertise in regulatory affairs for investigational and marketed small molecules and investigational biotechnology products. She has worked with small molecule, monoclonal antibody, and vaccine submissions and has experience with FDA, Health Canada's HPFB, and the UK's MHRA.

Contact Ms. Johnson

Dr. Anne Zurbay who has expertise in medical writing, clinical safety, product development, and in authoring the clinical sections of marketing applications. She has experience with global management of clinical trial safety data, from planning to review, coding, database reconciliation and query generation, and the training and supervision of clinical trial Investigators and Study Coordinators in the area of Clinical Safety.

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Please visit our booth

BCG consultants attend numerous conferences every year during which they are available to provide company information or consulting expertise. Below are some conferences that BCG consultants will be attending in the near future. Please feel free to contact the attending consultant either before, or during the conference for company information or to discuss a business opportunity.

Seton Hall Law School

Health Care Compliance Certification Program

"Advertising & Promotion of Medical Devices"

AAPS 2009 National Biotechnology Conference

"Phase I INDs for Biologics: How Much Data is Adequate"

Ron Marchesani
(speaker)

CMC Analytical, Comparability and Stability Studies for Biotechnology Products

"Current Expectations, Practical Considerations” 

Production & Manufacturing of Vaccines (part of the ImVacs Immunotherapeutics & Vaccine Summit)

"Essential Quality Considerations for Today’s Manufacturing of Vaccines: The Do’s and Don’ts for Successful Audits and Inspections"

National Non-Clinical Careers For Physicians

"Networking Your Way Into a Non-Clinical Career: Industry, Government & Consulting"