Shilpa Rai Airy, M.S., has 15 years of research experience in protein chemistry and global clinical program management for both large cap pharma and biotech start-up companies. Shilpa has managed 14 global phase II-IV clinical drug trials to successful completion in a variety of indications and actively participated in three NDA/BLA filings resulting in FDA approvals. Shilpa has a B.S. in Biochemistry from Rutgers University, and an M.S. in Biochemistry from Columbia University. Shilpa works as a Consultant in Clinical Operations to several biotech and pharma companies in San Francisco and New York City.
Fabio De Martino is currently Senior Manager in the Global Quality function at Genentech where he manages continuous improvements global projects and programs. Prior to this role he was a Manufacturing Engineer at Novartis Vaccines and Diagnostics where he led critical projects and investigations in compliance with FDA regulations and international quality standards, managing continuous improvement initiatives across Europe, Asia and US. Fabio holds a Bachelor's degree in Chemical Engineering from the University of Salerno and a Master's degree in Chemical Engineering from Pisa University, Italy. Fabio is a licensed/registered engineer (Italy), a certified Lean Manufacturing Six-Sigma Black Belt and a Project Management Professional (PMP).
He is the President-elect of the local Parenteral Drug Association (PDA) Chapter and a PMP Instructor for the San Francisco Bay Area PMI Chapter.
Bruno Gagnon, B.Pharm., M.Sc., is the Vice-President of Clinical Operations at BioMarin Pharmaceutical Inc. He is an opinion leader in the field of Clinical Operations. He has more than 20 years of drug development experience. He has held positions in big pharma, CRO, biotech and diagnostics companies.
Prior to his current position, Bruno was heading the Clinical Operations group at Roche Molecular Systems, Inc. Functional areas under his responsibility have included: Clinical Trial Management, Medical Writing, Outsourcing and Contracts, Supply Chain Management, Clinical Data Management, Clinical Systems, Document Management and Training. He has a bachelor's degree from the School of Pharmacy, Laval University and a Master's in Pharmaceutical Sciences from University of Montreal, both in Quebec, Canada.
Michelle Gray, M.H.S., has more than 20 years of research experience with development of biologics and small molecules. She has worked on US and international studies in all phases of trials for private and public organizations, and taught clinical trials classes at the university level. Michelle's focus has been on clinical operations and program management and has been part of several IND and NDA submissions. Michelle is Senior Director of Clinical Operations at a small start-up company focused on neurological diseases. Michelle received her master's at John Hopkins University School of Public Health.
Ron Lillie is currently Director, Drug Safety Data Analytics at Exelixis, Inc. a biopharmaceutical company based in South San Francisco, which markets oncology products. In his current role he supports the Signal & Risk Management and Drug Safety Operations groups through overseeing the development of interactive software applications based on the Tableau analytics platform. In additional current roles, he manages software and process related projects in vendor selection, and is responsible for vendor management. Ron is a graduate of the University of Toronto with a Bachelor’s of Science in Human Biology, and is currently enrolled in an M.S. program in Technical and Innovation Management at Johns Hopkins University. He brings over 20 years of experience within the pharmaceutical industry in Clinical Development and Software Applications.
Peter Shabe, M.S., is President of Advance Research Associates, Inc., a contract research organization (CRO) providing data management and biostatistical services to medical device, biotech and pharmaceutical industries. Prior to starting ARA, he worked as a biostatistician for several pharmaceutical and CRO companies and taught statistics courses at several universities.
Siu Po Sit, M.S., Ph.D., serves as Vice President, Clinical Affairs, for Penumbra Inc. and has worked in clinical trials for more than 20 years. His work includes oversight of clinical trials of a wide variety of drugs, devices and pharmaceuticals. He is widely published and has taught at Harvard Medical School and Gwynedd-Mercy College. His advanced degrees are from Michigan State University.
Thomas Tremblay has more than 18 years experience in industry-based clinical operations including the ethical design and implementation of Phase 1 though Phase 3 clinical trials and is a registered nurse with experience in intensive/coronary care medicine, emergency/trauma, HIV, oncology and investigational site-based clinical research. Thomas has worked for large as well as start-up pharmaceutical companies recently as the Senior Director of Clinical Operations for a local bay area company and is currently an independent clinical operations consultant.
Bethany Van Veen has been involved in drug safety and pharmacovigilance (PV) within the pharmaceutical industry for more than 15 years including 13 years in PV management and leadership in both large and small companies. She recently began a consulting business providing strategic PV advice to Bay Area pharmaceutical companies. Prior to this, Bethany was the Sr. Director of Safety Operations with the Drug Safety Risk Management team at InterMune, Inc. where she was responsible for drug safety case management, vendor and global affiliate management, quality management, and drug safety informatics.
Abigail Waite, CCRA, MBA, has over 15 years experience in Clinical Research working in both Clinical Operations and Medical Affairs supporting cardiovascular medical device studies as well as global post-marking and drug development studies for ultra-rare genetic diseases. Abigail is currently a Senior Clinical Program manager at Ultragenyx Pharmaceuticals focusing on neurological diseases. Abigail received her Master's Degree at University of Phoenix and a Clinical Research Certification from Association of Clinical Research Professionals.