David L. Chesney
David L. Chesney, MSJ, is the Principal and General Manager for DL Chesney Consulting, LLC, providing GMP and GCP compliance consulting and training services to clients world wide. He served for over 20 years as Vice President, Strategic Compliance Services for PAREXEL Consulting. Prior to joining PAREXEL Consulting, he served 23 years with the FDA as an Investigator, Supervisory Investigator, Director of Investigations and ultimately as District Director in San Francisco, managing all FDA operations in Northern California, Nevada and Hawaii.
Robert G. Miotke
Robert G. Miotke is the Founder of Advantage Pharma Solutions LLC, a consultancy firm that assists biopharmaceutical companies, CROs/CMOs, Private Equity/Venture Capital firms, and Nutraceutical companies in Strategic Planning, Technology Development/Positioning, Supply Chain Outsourcing Strategies, M&A, and Business Development/Intelligence projects. Mr. Miotke has 30+ years’ experience on executive teams managing contract manufacturing organizations with major customers such as GlaxoSmithKline, Pfizer, Merck, Bristol Myers Sq0uibb, Schering-Plough, Warner Lambert, Astra Zeneca and Lilly. As VP General Manager of a new start-up called Aerojet Fine Chemicals LLC, he led the design, development, and launch of a new $110M manufacturing complex, and later, the creation of joint venture NextPharma where, as the North American President, he helped identify and negotiate the acquisition of 7 companies in both US and European markets over an intense 18-month period.