BOWDEN CONSULTING GROUP - Key Persons
Job Titles:
- Biostatistician
- Clinical Biostatistician
Greg Ginn is a Clinical Biostatistician with over 25 years' experience in the Medical Device, Pharmaceutical, Biotechnology and CRO industries. His experience also includes management of Biostatistics and Clinical Data Management groups. He has contributed to successful PMAs, NDAs, IPOs and Business Partnerships. Creating and developing successful in-house capabilities for biostatistics, SAS programming, data management (including EDC, IDC and DDC), and medical writing has been a primary focus at several organizations. Recruiting and retaining excellent staff is a key skill.
Jack Rogers is a consultant with more than 30 years of experience in regulatory affairs, quality systems, and product development for in vitro diagnostic (IVD), medical device, and pharmaceutical products. He has held roles with management responsibilities in regulatory affairs, quality systems compliance, and product development for global manufacturers ranging from start-ups to the world's largest and most respected companies.
Mr. Rogers has acquired a broad range of medical device and pharmaceutical product regulatory and quality systems expertise that has been repeatedly successfully realized in the IVD expanse including point of care systems used for heart disease and diabetes monitoring, immunoassay clinical chemistry diagnostic and therapeutic drug management systems, and ELISA-based autoimmune disease assays, as well as in the medical device area for electrosurgical and ultrasonic surgical devices, and also including combination devices for tissue repair and drug controlled release. He has been directly responsible for the successful U.S. FDA submission and clearance/approval of seventeen 510k's and a PMA. He has also achieved numerous worldwide marketing registrations/approvals for the same devices.
His pharmaceutical product knowledge and experience includes success and contributions in both human and animal domestic and international regulatory submissions and quality assurance activities for human oligonucleotide-based sterile active pharmaceutical ingredients (API) and drug products, veterinary generic animal drug sterile injectables, and both human and veterinary dental application controlled release sterile API, drug product, and combination devices. Mr. Roger's medical products scientific foundation was achieved early in his career as a research & development chemist where his role transitioned from the laboratory bench to the manufacturing rooms, to the regulatory and quality offices, helping to implement good science and good manufacturing practices and quality system principles. He has contributed to several scientific publications and is the co-inventor on three U.S. patents (5,077,049; 5,324,519; 5,324,520) for biodegradable polymer and controlled release systems.
Mr. Rogers has held regulatory affairs and quality systems positions with industry-leading companies including Beckman Coulter, Roche Diagnostics, Thermo Fisher Scientific, SIRNA Therapeutics (now Merck), and Valleylab (now Medtronics).
Mr. Rogers is Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professional Society (RAPS) since 1995. He received a Master of Science degree in geology from Colorado State University
Marco Casarin has over 20 years' international experience in the sales, service, marketing, quality and regulatory fields in medical devices, companion diagnostics, education and health care systems.
He has served in executive positions as Global COO at Vela Diagnostics where is was also co-founder, Senior Vice President at Roche Diagnostics Corporation and Senior Vice President for Professional Diagnostics and Applied Science at Roche Diagnostics Korea.Marco is an MBA graduate of the Open University and also holds an Electrical Engineering degree. Marco is interested in helping companies streamline and develop marketing, post-sales support
Marco is an MBA graduate of the Open University and also holds an Electrical Engineering degree. Marco is interested in helping companies streamline and develop marketing, post-sales support services and education, and change management, along with assisting in developing quality systems that meet FDA and global requirements.
Marco is also an educator and develops and delivers training in all areas of marketing, after sales support, and process and change management.
Job Titles:
- Advisor to GLG / Advisor to Epstein Becker Green
Job Titles:
- CEO
- President
- President of Samco & Associates, Inc
Sally Bowden is the President of Samco & Associates, Inc. Sally has over 20 years' experience in the quality and regulatory field in medical devices, companion diagnostics, education and health care systems. She has served in executive positions as Vice President of Quality Systems and Process Improvement at Ventana Medical Systems and as Vice President of Quality and Regulatory Compliance at Roche Diagnostics Corporation. She has served as an Associate Professor for School of Engineering and Technology where she developed the Quality Management Curriculum within the Mechanical Engineering Technology department. Sally is a graduate of Purdue University School of Engineering and has also achieved her MBA. Sally founded Samco & Associates, Inc in 2009 to provide consulting for companies interested in developing quality systems that meet FDA and global requirements and re-engineer them for efficient, effective compliance in the medical device field for all classes. In addition, Sally is helping to pioneer the Companion Diagnostic process in collaboration with pharmaceutical and diagnostic firms while building strong relationships with the applicable regulatory agencies. Sally is also an effective educator and develops and delivers training in all areas of regulatory, quality and process improvement, providing statistical guidance and analysis in all applicable areas of the quality system. In addition, she is very committed to delivering process improvements within the Health Care System and spent several years working to improve health care delivery at the Veterans Health Administration. Additionally, she sat on the Quality of Care Committee within the Community Health System