Clinical Trials Design and Management Faculty

Important Notice

This program is on hiatus. Please contact program lead Afitap Boz with questions.

Wajiha Ali has more than 10 years of experience in pharmaceutical, biotech and CRO environments, with extensive experience as a regional clinical research associate focusing on site management, implementation and monitoring of clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines. She has expertise in the following therapeutic areas including oncology, neurology, immunology, gastroenterology, virology and vaccines focusing on phase I, II, III studies. Also, she has been involved in several initiatives including streamlining clinical trials and development of effective monitoring tools. Wajiha has a passion for making lives better through clinical research. Prior to clinical research, she also worked in the pre-clinical area including in-vitro and in-vivo studies. She is an enthusiastic and empathetic mentor/trainer who is eager to invest in others with the willingness to commit the time needed to build and maintain a productive relationship.

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.

Ron Lillie is currently Director, Drug Safety Data Analytics at Exelixis, Inc. an Alameda CA based biopharmaceutical company, 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 Johns Hopkins University with an M.S. in Technical Management (Innovation focus), and the University of Toronto with a BSc in Human Biology and is currently enrolled in the Doctoral program in Regulatory Sciences at the University of Southern California. He brings over 20 years of experience within the pharmaceutical industry in Clinical Development and Software Applications.

Dr. Lequina Myles, DRSc, MS, MBA, RAC, PMP, PMI-ACP, has over ten years of experience within the pharmaceutical and biotechnology industries. Currently, Lequina works as a Senior Director of Quality Assurance and Regulatory Affairs, responsible for global oversight for regulatory strategy and quality compliance.

Lequina holds a B.S. in Biochemistry from the University of California, Los Angeles (UCLA) and a Master of Business Administration (MBA) with an emphasis in Project Management from Mount Saint Mary's University. Lequina also obtained a Master of Regulatory Science and Doctor of Regulatory Science (DRSc) from the University of Southern California. Lequina is a certified Project Management Professional (PMP) and holds a Regulatory Affairs Certification (RAC) in both drugs and devices.

Tenea Nelson, PhD, ensured the safety of biologics and pharmaceuticals as a toxicologist at Genentech and Gilead Sciences. She has taught Natural Sciences and Environmental Management with the University of Maryland Global College, and has degrees from Mary Baldwin University and the University of Rochester. Dr. Nelson has also worked in STEM diversity and inclusion at Stanford University, and is currently an independent consultant.

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.

Dr. Sit has extensive clinical trial experience with employments at Johnson and Johnson, Baxter Healthcare, and Boston Scientific where he conducted clinical trials in hypertension, congestive heart failure, cerebral atherosclerosis, acute ischemic stroke, cerebral aneurysms, and peripheral vascular diseases. His last position was with Penumbra Inc., as Vice President of Clinical Affairs. He received his degree from Michigan State University, and completed his postdoctoral training at the Brigham and Women’s Hospital and Harvard Medical School. Dr. Sit is retired but remained active as a consultant and lecturer.

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, CPCC, MBA, has 20 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. Currently, Abigail is an Associate Director in Commercial Learning and Development at BioMarin Pharmaceutical, and a certified professional life coach. She received her Master's Degree at University of Phoenix, coaching certification from the Coaches Training Institute, and a Clinical Research Certification from Association of Clinical Research Professionals.

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