How to Address and Reverse Clinical Protocol Complexity

With over 30 years of international leadership and accountability in the biopharmaceutical industry, Elspeth Carnan is an accomplished global executive, specialized in clinical development, implementing strategy and operational execution of a portfolio of pre-clinical and clinical stage programs, across a variety of therapeutic areas, including, oncology, immunology, and rare disease. In her roles at Alkermes and Regeneron, as SVP and VP of clinical operations, Carnan was accountable for driving global clinical trials, improving efficiency and consistency of performance as well as implementing an improved delivery of risk based strategic monitoring. At Merck KgA/ EMD Serono, Carnan drove the R&D Strategic Sourcing & Vendor management function being accountable for global outsourcing strategy for clinical development, developing and negotiating strategic alliance partnerships, critical issue management and executive governance. While at Amgen (2005 to 2015), Carnan was instrumental in shaping the Amgen clinical monitoring platform; first successfully driving the global implementation of the Functional Service Provider, with 12 providers and across 56 countries. With her wealth of clinical operations experience, she was instrumental in the design and support of the centralized monitoring initiative. During her Amgen tenure, she made a significant impact in shaping Amgen’s approach to innovation. Through her commitment to driving Operational Efficiency and supporting the scoping of the Streamline Clinical Trials initiative, Carnan ensured a focus on transforming the approach to clinical trial execution, most notably in study design and study start up. Her dedication to the establishment of the R&D Global Network framework to enhance end to end process development added value to Amgen’s approach to knowledge sharing. Carnan holds a PhD in Physiology from University Newcastle Medical School and a Bachelor of Science (Physiology) from University of Glasgow. Carnan lives in Lexington MA, an ‘empty nester’ as her twins attend the University of Toronto. 

Kenneth A. Getz, MBA, is the Executive Director and Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he conducts research focusing on drug development management and operating strategies and tactics; protocol design practices; and global outsourcing, investigative site and patient recruitment practices and policies. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise. A well-known speaker at conferences, symposia, universities, investor meetings and corporations, Mr Getz has published extensively in peer-review journals, books and in the trade press and writes a bi-monthly column nominated for a Neal Award in Applied Clinical Trials. He holds a number of board appointments in the private and public sectors including WCG and ORA and serves on the editorial boards of Pharmaceutical Medicine and Therapeutic Innovation and Regulatory Science. Mr Getz received an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University. Mr Getz is the founder of CenterWatch, a leading publisher in the clinical trials industry.

Jill Kearney has worked in Clinical Development for 30 years.She is currently the Head of Trial Strategy and Delivery at Genmab. In this role, Jill provides strategic and operational leadership to drive the implementation of clinical development strategies across all phases of the Genmab Development portfolio. Jill leads a global team of clinical trial professionals, fostering high-quality planning and execution of clinical trials, including strategic partnership with Clinical Research Organizations, and inspection readiness across the portfolio.Before her current role, Jill worked as a Global Operations Head of Oncology at Johnson & Johnson Innovative Medicine focused on the strategy, execution, and delivery of the Oncology Early Development portfolio. Before that, she was the Director of Licensing & Acquisitions leading integrations and strategic Due Diligence in support of Collaboration & Licensing deals, Mergers & Acquisitions (M&A), and Out-licensing/Divestiture opportunities. In the past as a Global Development Program Leader, Jill was responsible for building a top-line, cohesive Portfolio Delivery Operations team and for shaping clinical trial execution at Janssen.Prior to J&J, Jill worked in many roles overseeing the development of several early and late-stage Oncology assets. She has worked as a CRA, Global Trial Leader, Clinical Program Manager, and Clinical Scientist. She has managed a variety of clinical trials from large international registrational programs, and complicated adaptive trial designs, to First in Human trials. Jill has lead several initiatives to improve the efficiency of oncology trial start-up and execution.Jill holds a Bachelor of Science Degree in Biology and a Master of Business Administration with a focus in Healthcare.

Liz Thompson is a Global Development Leader and R&D Excellence Execution Lead at Roche Products Ltd, with over 30 years of experience in drug development. At Roche, she spearheads the Study Design and Protocol Optimization initiative, leading to significant cost and time savings. Thompson has been instrumental in developing numerous new medicines, including treatments for rheumatoid arthritis and COVID-19. Her career includes leadership roles in biostatistics and clinical development at Roche, GlaxoSmithKline, and AstraZeneca.

Siân is currently SVP, Head of Quantitative Sciences & Development Operations (QSDO) at Biogen, where she leads a global team accountable for the strategic planning, execution and analysis of clinical trials across all phases of development and therapeutic areas, ie MS/Immunology, Rare Disease (Neuromuscular Disorders, Genetic Neurodevelopmental Disorders) and Neuroscience (Alzheimer’s Disease, Movement Disorders, Psychiatry). Siân and her team are driving numerous innovation projects to transform clinical trials and accelerate clinical development. Prior to Biogen, Siân spent 20+ years Pfizer, where she held senior leadership and group head roles in Clinical Operations, Medical Writing, Clinical Development, Preclinical Safety (Toxicology and Safety Pharmacology), Safety Risk Management and Regulatory Strategy, managing projects throughout development stages from research to post-approval in multiple therapeutic areas (including Oncology, Neurology, Psychiatry, Pain, Rare Disease, Immunology, Internal Medicine, Women’s Health and Vaccines). In addition, Siân has co-led a number of cross-industry initiatives for TransCelerate, BIO, ICH and public-private partnerships to advance clinical trial innovation approaches, precision medicine drug development and translational sciences. Siân has a PhD in Pharmacology from the University of Cambridge where she also held post-doctoral research and academic posts. Siân also serves on the Executive Committee as Treasurer for the International Society for CNS Clinical Trials Methodology (ISCTM), co-leads the ISCTM CNS Clinical Trial Diversity Working Group and mentors new investigators involved in psychiatry and neurology research.