Pharma Leadership on New Thinking to Accelerate Clinical Development

Penny Carlson has 27+ years of experience in the pharmaceutical industry and is currently Head of Global Clinical Development Operations, which includes Clinical Program Leadership, Study Management, Business Operations and Partnership Health and Supplier Management. Prior to this, Penny held various roles of increasing responsibility across several disciplines and multiple therapeutic areas. She started her career working for a small Contract Research Organization supporting NIH sponsored Vaccine and Infectious Disease studies, followed by several years working for large pharma in various data management roles, eventually transitioning to clinical operations in the Oncology therapeutic area, where she stayed for a number of years. In 2011 Penny joined Takeda (previously Millennium) initially as a Clinical Program Manager and was later responsible for multiple assets in the early development space and was the Clinical Operations Lead for the Gastroenterology Therapeutic Area. For 5+ years, Penny has been an executive leader in the Global Development Organization, leading transformative initiatives for Takeda and focusing on clinical trial delivery, external partnerships and innovative ways of delivering medicines to patients.

Motivated each day by the opportunity to make a difference in the lives of patients, Christoph Koenen has extensive experience in leading development teams and organizations in all stages of development from first in human to late stage development. As a physician, his compassion for patients drives his interest in innovation in clinical trials. Dr Koenen understands that the greatest benefit of a successful launch will be patients’ access to a novel treatment. Dr Koenen is equally passionate about interacting with regulatory authorities globally as well as ensuring safety and access for patients on a local level. Dr Koenen is currently heading up Bayer's global Clinical Development and Operations where he oversees the clinical development of the entire portfolio including executing clinical studies globally. He joined Bayer from Otsuka where, as Chief Medical Officer, he oversaw the entire development organization including Clinical Pharmacology and Translational Medicine, Clinical Development and Operations, Drug Safety, Regulatory Affairs and Quality, Data Management and Analytics, Real World and Value Evidence, Technical Operations, Medical Affairs as well as portfolio and asset management. Before joining Otsuka in 2019, Dr Koenen was Head of Cardiovascular Medicine and Development at Bristol-Meyers Squibb (BMS), helping to develop its next generation of cardiovascular medicines. Prior to his role at BMS, Dr Koenen worked for Novo Nordisk in various medical and development functions in Europe, as well as in the US. Dr Koenen’s medical background has informed his ability to combine scientific innovation with a strategic approach to business development opportunities, regulatory navigation, and global patient access solutions. Dr Koenen received his medical degree from Ruprecht-Karls University School of Medicine in Heidelberg, Germany, in 1994. He also holds an MBA from Schiller International University, and is board certified in internal medicine and diabetology.

Andy Lee is Senior Vice President and Head, Global Clinical Trial Operations (GCTO). In this role, Mr Lee leads and manages GCTO, with particular focus on global, in-patient clinical trials, designed and executed to meet cost, speed and quality standards. Mr Lee is also responsible for the design and study/data management of clinical protocols in all regions and countries, as well as the tools, systems and processes to conduct Merck clinical trials.Mr Lee joined Merck in September 2014 from Sanofi, where he served as Senior Vice President and Deputy Head of Clinical Sciences and Operations (CSO) and Head of the CSO Clinical Operations Cluster. In addition to directing the CSO, Mr Lee led the integration of Sanofi with Genzyme, where he was Senior Vice President, Global Clinical Operations. Earlier in his career, he spent more than 16 years in a range of positions of increasing responsibility at Pfizer.Mr Lee holds leadership positions in a number of professional societies, including the role of Treasurer of TransCelerate Biopharma, Inc, a non-profit organization that comprises the world’s leading pharmaceutical and biotech companies. He also serves as a member of the TransCelerate Operating Committee. Mr Lee received his Masters in Bioenergetics and Physiology from Ball State University in Indiana and two undergraduate degrees from Rhodes University in South Africa.

Siân Ratcliffe, PhD, is currently SVP, Head of Quantitative Sciences & Development Operations at Biogen, where she leads large global teams accountable for the strategic planning, execution and analysis of clinical trials across all phases of development and therapeutic areas, ie MS/Immunology, Neuromuscular Disorders, Neurodegenerative Disorders and Therapeutics Development (Neurovascular therapies, Psychiatry, and Genetic Neurodevelopmental Disorders). Dr Ratcliffe is also the chair of the Technical Review Committee reviewing all protocols and protocol amendments for R&D. Prior to Biogen, Dr Ratcliffe spent 20+ years Pfizer, where she held senior leadership and group head roles in Clinical Development & Operations, Medical Writing, 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 and Vaccines). In that time, she directly led 17 NDA submissions, >70 INDs, >50 health authority interactions across multiple therapeutic areas, as well as functional line oversight of ~50+ NDA/sNDA/MAA submissions, including RTOR pathway and vaccine submissions. In addition, Dr Ratcliffe has co-led a number of cross-industry initiatives for TransCelerate and BIO to transform clinical trials and accelerate clinical development. Dr Ratcliffe has a PhD in Pharmacology from the University of Cambridge (1996). She is a recognized cross-industry expert in CNS clinical trial methodology, abuse potential and suicide risk assessment; she is also the Treasurer and Executive Committee member for International Society for CNS Clinical Trial Methodology and mentors new investigators involved in psychiatry and neurology research.

Rosemary is the ad interim Head of Global Clinical Operations at Novartis with  responsibility for over 4500 people in more than 60 countries delivering clinical trials. She is a member of the Development Leadership Team (DLT) and Innovation Management Board (IMB) of Novartis. Prior to this ad interim responsibility  Rosemary was Global Head of Novartis Study and Site Operations.She joined Novartis in 2001 and has a breadth of experience across the drug development continuum having held leadership roles in patient safety, medical, clinical, and global clinical operations, in addition to leading  several organizational transformations. She is passionate about the science and art of drug development.Rosemary studied medicine at the University of the Witwatersrand in South Africa, followed by a diploma in anesthetics and then practicing medicine in Johannesburg. She remains a member of the South African Medical Association and the College of Medicine of South Africa. Additionally, she has a Graduate Certificate in Pharmacoeconomics and completed the Certificate Course in Medicine and Law at the University of South Africa.Rosemary joined the pharmaceutical industry in South Africa, before moving to Switzerland with Novartis, and is now located in the USA with her husband and 2 children.