The research, development, manufacturing, and regulatory approval of new biotechnology and biopharmaceutical products often presents novel challenges for which a background in conventional pharmaceuticals offers little guidance.
To bridge this gap between academic instruction and the real-world complexities of research, development, validation, regulations, processing, and manufacturing, we provide practical, specialized training by industry experts. With ever-changing scientific understanding and government regulations, it’s critical that you have the most current information possible – training with COBBLESTONE ensures you will.
Dr. Jayasree (Jay) M. Srinivasan
Dr. Jayasree (Jay) M. Srinivasan is a Research Scientist in the R&D laboratory at Simtra BioPharma Solutions in Bloomington, IN. She received her BSc from the University of Madras (India), her MS in Synthetic Organic Chemistry from the University of Houston, and her PhD in Synthetic Organic Chemistry from Indiana University. Her areas of focus… Continue reading Dr. Jayasree (Jay) M. Srinivasan
Read MoreDavid E. Wiggins
David E. Wiggins is an Analytical/Stability Consultant within the pharmaceutical industry with a focus on pre-market stability, analytical method validation, and method transfer. Mr. Wiggins was previously Sr. Associate Director of Analytical Development for Bayer Consumer Care. Prior to joining Bayer, Mr. Wiggins worked for Schering-Plough and Merck with responsibility for method optimization, method validation,… Continue reading David E. Wiggins
Read MoreKhurshid Iqbal, Ph.D.
Dr. Iqbal has over 25 years of domestic and international experience in pharmaceutical product development. He has worked within the leading multinational pharmaceutical organizations, R.W. Johnson Pharmaceutical Research Institute, Hoffmann-La Roche, and E.R. Squibb & Sons, and lastly as Sr. Vice President and CSO at KBI Biopharma, Inc. Dr. Iqbal earned his Ph.D. in Pharmaceutics… Continue reading Khurshid Iqbal, Ph.D.
Read MoreDavid Long
David Long worked for Rhône Poulenc Health Division (now Sanofi-Aventis) in Quality Assurance (QA) for over twenty years, where he gained considerable experience in all three Good Practice disciplines: GLP, GCP, and GMP. When he left Rhône-Poulenc, he was Senior Director of R&D worldwide for Quality and Process Improvement. Mr. Long has since worked for… Continue reading David Long
Read MoreJoy McElroy
Joy McElroy has 10 years of experience as a consultant and over 20 years of total experience in the pharmaceutical and biotech industries. Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, and equipment qualification. She has written and executed equipment qualification and validation protocols for numerous companies. Ms. McElroy specializes… Continue reading Joy McElroy
Read MoreLucia Mokres
Dr. Lucia Mokres is a Biotechnology Entrepreneurial Consultant based in the Bay Area, specializing in helping early-stage companies with novel technology gain traction and develop an investable technology and business model, and helping later-stage companies work through regulatory and clinical challenges. Prior to establishing her consultancy, she was the Chief Medical Officer of EpiBiome, Inc.,… Continue reading Lucia Mokres
Read MoreRachel Monsef
Rachel Monsef is a consultant to the biopharmaceutical and pharmaceutical industries for analytical and quality control. She has 19 years of experience working with many types of assays for all stages of drug development. Ms. Monsef has been responsible for method development, method qualification, method validation, assay transfers, characterization work, and stability studies. She has… Continue reading Rachel Monsef
Read MoreDr. Marie-Eve Beaulieu
Dr. Marie-Eve Beaulieu is co-founder and Chief Scientific Officer of Peptomyc S.L. Dr. Beaulieu has a strong background in R&D project management and coordinates the scientific team at Peptomyc. Her experience in biochemistry and peptide and protein structure and production has enabled her to manage the in-house and outsourced scientific activities at Peptomyc since 2014. Marie-Eve… Continue reading Dr. Marie-Eve Beaulieu
Read MoreDanielle DeLucy, M.S.
Danielle DeLucy, M.S., is the owner of ASA Training and Consulting, LLC, which provides pharmaceutical and biologics-based companies with training and quality systems assistance in order to meet regulatory compliance. Prior to this role, Danielle has been in the industry for 23 years, serving in numerous Quality Management Roles, such as the Director of Product… Continue reading Danielle DeLucy, M.S.
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