Archives: Speakers

Dr. Greene is a seasoned pharmaceutical research professional with success both in large pharmaceutical companies and in CROs. He has a PhD and post-doctoral training in psychology and neuroscience, with a focus on the neuroanatomical and neurochemical bases of learning and memory. His career has spanned the full range of clinical development from preclinical pharmacology through late-stage clinical development, successful NDA and MAA submissions, and post approval commitments and label extensions. Dr. Greene has published numerous manuscripts and over thirty abstracts, all focused in CNS research from the bench to clinical work. With over 25 years of experience in the pharmaceutical industry, first as a Lilly Fellow at the Universitè Louis Pasteur in Strasbourg, France, Paul has obtained roles of progressing responsibility at major pharmaceutical companies and CROs. He has experience across a range of CNS disease states with very deep concentrations in mood disorders and schizophrenia. He has worked extensively in pediatric and elderly populations including special institutional environments. At GlaxoSmithKline Dr. Greene led the clinical team through the creation and execution of a clinical development plan for a major marketed product for bipolar disorder. He also led the submission team for a successful NDA and MAA for that product and wrote the Integrated Summary of Efficacy and the Integrated Summary of Benefits and Risks. Having led global project management teams, a rater training enterprise, and large customer relationships at Syneos Health, Dr. Greene brings scientific, operational, and partnership expertise to the relationships in his remit. Paul is Senior Vice President, Global Client Solutions at Syneos Health.

Thomas is a registered nurse with both clinical and over 30 years pharmaceutical development experience. His pharmaceutical development experience includes clinical operations, clinical science, clinical development, drug safety and quality. He is currently Vice President of Clinical Development at Trefoil Therapeutics and adjunct faculty at San Francisco State University.

Dave is an entrepreneur and technology innovator. He is known for pioneering the fields of A.I.-based medical decision-support, Training Analytics, and Virtual Patient Simulation (VPS). Dave’s last company, TheraSim, launched the world’s first successful online VPS system for physicians and trained over 500,000 doctors in every country on Earth. TheraSim built the world’s largest network of computer-based clinical simulation sites in Africa in support of the USAID and the CDC’s HIV-treatment effort. TheraSim was acquired by WebMD in 2014. Since then, he has focused his passion for technological innovation and learning systems in the field of clinical trials, helping sponsors make their studies more accurate and efficient through finding the right technology mix such as virtualization, performance management and applied behavioral sciences to produce the most effective, lasting, and engaging results for clinical trials. Dave has always valued the interconnectedness of our vastly changing world, and has traveled to over 70 countries for his global health work and for cultural development outreach through music.

Tara Safakish is a Software Engineer with over 15 years of experience in different roles such as Software Developer, Software Quality Engineer and Quality Computer System Validation specialist in medical device and biotechnology/pharmaceutical industries. She is also a Certified Medical Device Auditor (CMDA) and Six Sigma Green Belt (CSSGB).

She started her career as a software developer and after a few years found her passion in software quality engineering field. She worked for several medical device and biotechnology companies in North America including, CryoCath, enLabel Global Services, Sciex, Avalanche Biotechnologies. Presently, Tara is the Associate Director, QA Computer System Validation at Ultragenyx Pharmaceutical Inc. where she has worked for over 5 years.

The combination of her education and experience as a software quality engineer involved in all aspects of software development life cycle, including risk management, gives her a unique perspective to identify and assess data integrity risks through its life cycle.

Jacqueline Lee has been working in the clinical research industry for over 30 years. She brings a unique perspective in that she has worked in several different capacities, including at the site level, the CRO level, and the Sponsor side of this industry. For the past 17 years, Jacqueline has been working at Cytokinetics, a biopharmaceutical company located in South San Francisco, California. She is currently the Senior Director of Clinical Operations and has provided strategic planning, leadership, and oversight for over 35 clinical trials, the majority of which were conducted internationally.

Jeff Lewis is the Sr. Director of QA Computer Systems & Data Integrity for Ultragenyx Pharmaceutical, which focuses on bringing life-changing medications to patients with rare and ultra-rare genetic diseases. Prior to Ultragenyx, Jeff consulted for more than fifteen years for a wide range of life sciences companies, where he provided quality systems, computer system validation, software development and data integration services. Jeff served on the ISPE Data Integrity Special Interest Group, which produced a series of GAMP Data Integrity Good Practices Guides. He lives in Oakland with his wife and three children.

Amy is the Sr. Director and lead for Information Technology (IT) Research and Development (R&D) at Ultragenyx Pharmaceutical. Amy leads teams as they build IT strategies, develop innovative and efficient technology portfolios, implement best in class and emerging technologies, and enable business capabilities through technology enablement. She has promoted technology advancements across the Life Sciences, from building the nation’s most successful private health insurance exchange platforms, to improving state Medicare & Medicaid technology solutions, and growing the technology portfolios of both biotechnology and pharmaceutical companies. Amy promotes strong partnership and collaboration across IT and functional stakeholders, as it has proven to promote speed and efficiency in pre-clinical drug development and clinical trial execution. With experience in IT consulting at the nation’s leading strategy consulting firm, as well as a background in International Public Health, Amy combines deep analytical approaches with a desire to save the world one patient at a time. Amy spends her free time learning about new cultures as she travels across the globe, with her knitting needles always along for the ride.

Andy Lipetz has 19 years of experience in clinical research including time at PPD and IQVIA where he held a broad range of roles across operations, sales, analytics, and strategy. Andy is now the head of CRO Partnerships at Castor where he collaborates with customers to build long-term relationships and to deliver decentralized and hybrid clinical trials. Andy holds an economics degree from UCLA and an MBA from UNC Chapel Hill.

Aryana Hosseinkhani is the Director of Patient Cloud at Medidata, a Dassault Systemes Company. She completed her education at University of California, Davis in Genetics and shortly after began working as a bench scientist in stem cell research. Aryana began her clinical research career at Science 37 around 7 years ago, as the third employee and a founding partner. At Medidata she focuses on product and patient communications in patient facing technologies. She believes that when sponsors, sites, and patients have optimized experiences, drug development timelines can be expedited and clinical research can become an option for more people. Aryana is passionate about the value of research and seeing it through from the bench to the real world. Over her career, she has focused on disruptive and innovative technologies that can simplify clinical trials for patients, sites and sponsors.