Our experts have proven track records in strategy and implementation. We bring the rare ability to integrate understanding of board level business objectives with technician level execution. Our experts have direct operating experience with every phase of product and company development. A list of consultants and resumes are available upon request.
Seraphim Founders
Gary Gamerman MS, JD, President
Gary’s background covers management, regulatory and legal fields. Prior to co-founding Seraphim, he was the EVP of Iatros Bio/Pharma Inc. Previously, he was a FDA/CBER reviewer, and an attorney in the FDA/Life Sciences practices of two leading international law firms, where he counseled leading companies and venture firms in the development, licensing and regulation of biologics, pharmaceuticals, and medical devices.
Maureen Costello PhD, RAC, Vice President–North America
Maureen is a recognized leader in bioproduction and regulation, with extensive expertise in recombinant proteins, monoclonal antibodies and gene therapy. She has held senior management positions at SmithKline Beecham, Hoffman-La Roche and BioResponse where she was responsible for developing outsourcing programs for raw materials and APIs, technology transfer, analytical and QA/QC programs and CMC & regulatory strategy for biopharmaceuticals in all development phases.
Seraphim Affiliate Consultants
Seraphim has over 30 Senior Affiliate Consultants providing the expertise and knowledge that comes from decades of hands-on experience in industry and at regulatory authorities. A few of our available experts are listed here.
John Budzinski, Ph.D., Manufacturing/Outsourcing
Over 28 years of management, technical and business experience in R&D, Administration and Manufacturing covering all aspects of drug manufacturing outsourcing, including 9 years as the Senior Director, Strategic Sourcing for DuPont Pharma. Broadly networked with other pharmaceutical professionals to outsource finished dosage, quality and packaging. Strong knowledge of outsourcing processes and vendor capabilities with many industry contacts.
Christina Chew, MBA, Business Development
Christina spent the last 15 years working at a wide variety of organizations, such as not-for-profits, start-ups, mid-cap and large corporations in various capacities. Specific industry sectors include molecular diagnostics, medical device and biotech/pharmaceutical. Functional skills include new product development and launch, IP assessment and valuation, traditional and innovative marketing planning and execution, sophisticated scenario-based financial modeling, business/strategic planning, competitive and market research, and physician and sales force education.
John McCloskey, Ph.D., Manufacturing/Outsourcing
Over 30 years of experience focusing on all aspects of pharmaceutical technology transfer, outsourcing and project management, including over 10 years at DuPont Pharma as the Senior Director New Product Planning and Package Engineering . Broadly networked with other pharmaceutical professionals to outsource finished dosage, quality and packaging. Strong knowledge of outsourcing processes and vendor capabilities with many industry contacts.
Bill Gannon Jr., MD, MBA, Clinical
Bill has spent the last 20 years in the development, regulatory – NDA, BLA, ANDA, IND, IDE, PMA and 510K FDA submissions and approvals, commercialization, marketing and management of products and technologies for the healthcare, medical devices, allied health and pharmaceutical industries. He is also well versed with the European (ISO 9000), Canadian and Japanese regulatory environments, and with IBC AHA and JCAHO regulatory affairs processes.
Gary Lightfoot, Clinical Outsourcing
Gary has been involved in healthcare and clinical research for 36 years. He has held a wide variety of position including: Hospital Pharmacist, Hospital Administrator, Sales Manager, International Product Manager, Marketing Director, VP of Sales and Marketing World Wide, President and CEO. He managed the field resources for Eli Lilly in Clinical Research and was one of the first Outsourcing Managers in the Industry. After retiring from Lilly he held several VP level positions with Pharmaco and PPD including VP Global Business Development and VP Strategic Development. He became the first CEO for ACRP in 1999 and formed the ACRP Foundation.
Marlo A. Mravec
A qualified auditor (ASQ CQA) and Clinical Research Associate (CCRA), Ms. Mravec brings valuable clinical trial experience, along with knowledge in FDA regulations, CE mark Certification & IVDD Requirements to the product design process. Recent work has focused on assisting foreign companies with FDA guidances. A skilled auditor, Ms. Mravec integrates real life experience gained from FDA audits into the cGMP auditing process. She has worked for companies such as Bayer, Baxter Healthcare and MonoGen. Her work has received national recognition from Children With Diabetes magazine. Ms. Mravec specializes in quality system and design control for PMA devices and has a passion for integrating user needs into product design.
Eugene J. McNally, Ph.D. CM&C, Product Development/Outsourcing
Dr. McNally has over 20 years of experience in small molecule and biologics product development having led numerous product development teams responsible for both API and finished product production. Most recently Dr. McNally was Vice President and General Manager for Gala Biotech a Catalent Pharma Solutions Company where he was responsible for all site operations encompassing Biotech Development and Clinical Manufacturing. Prior to joining Gala, he was Vice President of R&D at Cardinal Health’s oral drug development facility in Somerset, New Jersey. Previous to his CMO experiences with Cardinal Health/Catalent, Dr. McNally spent many years with Boehringer Ingelheim Pharmaceuticals Inc., in roles of increasing responsibility within their drug development organization. His areas of research interest have included the characterization of protein instability, protein conjugation and macromolecule drug delivery. The author or co-author of a number of professional publications, abstracts and scientific presentations, he is a member of the American Association of Pharmaceutical Scientists.
