Archives: Speakers

As Head of Hospitality at Areen Design, Andrew is involved in, and monitors all aspects of a project: from initial client contact, brief and concept development through to documentation and site installation. His passion for delivering design solutions which add value, without compromising creative quality, is resolute.

Anca is serial entrepreneur and currently the CEO and Founder of Clinical Maestro. As an industry leader in clinical outsourcing, she hosted multiple webinars, spoken at leading industry conferences, authored multiple articles and white papers. Anca spent more than 20 years in the pharmaceutical industry, starting with founding an antimicrobial discovery biotech, managing M&A activities in the eClinical space for top CROs, and leading clinical outsourcing, R&D finance and strategic vendor management for top biotechs. She is passionate about accelerating and lowering the costs of conducting clinical trials through efficiencies in clinical business operations by leveraging modern technology, such as Artificial Intelligence and Machine Learning.

In his over 20-year career, Skip has had responsibility for formulating and executing strategies for drugs, vaccines, diagnostics and medical devices with broad global drug development knowledge including medical affairs, clinical trial design, pharmacovigilance, clinical operations, investigator site selection, patient advocacy and product commercialization. Skip most recently served as the Chief Medical Officer for Selecta Biosciences, a life sciences start-up headquartered in Watertown, Massachusetts, where he had responsibility for all clinical activities, including clinical strategy and development of drug candidates, clinical study designs, protocols, and CRO selection. He held a similar CMO role at Targacept, Inc. a biopharmaceutical company, and at Plasma Surgical, Inc., a medical device company. Prior to these roles, Skip held senior leadership roles including U.S. Head of R&D for Solvay Pharmaceuticals which was incorporated into Abbott Laboratories/AbbVie, as well as Procter and Gamble Pharmaceuticals. Skip started his career in Obstetrics/Gynecology in both the hospital and community setting and is a principal investigator himself.

Ellen Weiss joined PCM Trials in April 2019 as Vice President, Business Development. Ms. Weiss has worked to deliver patient-centric services to patients since 2014, including previous roles with CMed Clinical Services and Symphony Clinical Research. Additionally, she has driven the advancement of hospice services at Rainbow Hospice and Palliative Care, a non-profit hospice in Chicago, as both a board member and an on-staff patient advocate. She began her career in the financial services sector and has been an active volunteer for the Healthcare Businesswomen’s Association since 2005, where she works to foster communication across the healthcare industry

Business executive, advisor and entrepreneur Paul’s career includes nearly 20 years of leading companies, product development, global operations, design and adoption of technology in the most difficult of sectors: healthcare and drug development. As Senior Director Paul leads THREAD Consulting in ensuring customers are successful in the strategic design and deployment of technologies throughout the course of their clinical trials.

Claudia Berrón is Avantor’s Senior Vice President, Clinical Services. Claudia has over two decades of experience in B2B strategic marketing covering ideation, value proposition strategies, market segmentation, marketing and sales planning through product launch, and has been working with Avantor since 2015. She holds an MBA from the University of North Carolina Kenan-Flagler Business School in Chapel Hill, North Carolina, and a bachelor’s degree from Monterrey Institute of Technology in Mexico City.

Donald Kellerman is the Vice President of Clinical Development and Medical Affairs for Zosano Pharma. Dr. Kellerman has more than 30 years of experience working in several areas of the pharmaceutical industry, primarily clinical development. Dr. Kellerman has led registration trials in a number of therapeutic areas, including respiratory, allergy, ophthalmology, cardiovascular, and neurology. From 2008 to 2013, Dr. Kellerman served as Senior Vice President, Clinical Development and Medical Affairs at MAP Pharmaceuticals, Inc., where he led the development of Semprana for migraine. Prior to joining MAP, Dr. Kellerman held management positions at Inspire Pharmaceuticals, Inc. Glaxo Wellcome, plc, Sepracor, Inc., Ciba-GEIGY Corporation, and E.R. Squibb and Sons, Inc. He has served as project leader on multiple development teams including those working on Flovent,® Advair,® and Xopenex®. Dr. Kellerman received his Bachelor of Science and Doctor of Pharmacy from the College of Pharmacy at the University of Minnesota. He has authored major sections of eight NDAs, created labelling strategy for several pharmaceutical products, and has co-authored over 80 publications related to the results of clinical development activities.

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.