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.

Flore Nouvel is a Strategy and Operations Senior Manager on the Data Strategy & Solutions team at Vertex Pharmaceuticals. She drives strategy of data solutions supporting Global Clinical Operations, including solutions for patient / HCP / site identification scalable across disease areas. She is an experienced data translator and change management agent working with business partners and technical teams to drive adoption of data / advanced analytics / data science to inform decision making and generate value for the business. She has led various initiatives to pilot and measure the deployment of data solutions informing site selection, patient recruitment and referrals. Flore also worked in economic consulting at Charles River Associates leading and conducting analytics of Real World Data (RWD) to inform competitive / antitrust disputes across healthcare payors and providers. Flore earned a BA in Economics, Statistics, and Computer Science from Swarthmore College and an MBA from MIT Sloan with business analytics and healthcare certificates.

Felix has over 20 years in strategy and innovation building new business offerings, partnerships, investments, products and services, inside and outside healthcare, across geographies, companies and functions.

He was most recently heading the medical development of digital healthcare for Sanofi US, pioneering medical strategy, evidence generation, stakeholder engagement and capability building for digital health solutions that empower self-management in people living with chronic conditions to improve outcomes.

Over the past 9 years his focus has been in pharmaceutical innovation across the lifecycle continuum, and in recent years, digital health, behavior change and of late, the meaningful applications of real-world data and development of organizational capabilities fit for the future of health.

Felix began his career as a pharmacist in the UK, earned his MBA from the Warwick Business School and is a Fellow of the Chartered Institute of Management Accountants.

Robert Roberson is the Manager of the Enterprise Shared Service Center (eSSC) at Merck, where he has been contributing since 2022. Before joining Merck, Mr Roberson spent 17 years working in the Laboratory Animal Resource field at the University of Pennsylvania and Temple University. He began his career as an animal laboratory technician and, through his strong work ethic, commitment to excellence, and the guidance of his mentors, quickly advanced to the roles of supervisor and, eventually, manager. This progression showcases Mr Roberson’s dedication and capability in his field, leading to his current leadership position at Merck.

Mr Roberson’s journey in the animal laboratory resource field has allowed him to grow as a leader. However, he remains deeply influenced by the strong family structure he grew up with and the life lessons imparted by his father, who always believed in him. These early lessons instilled in Mr Roberson the importance of seizing the moment and never taking anything for granted. Alongside the mentorship he has received throughout his career, the wisdom of his father and the challenges he has faced remind him of the significance of investing in others, particularly those from his own community. Mr Roberson feels a profound obligation to pay it forward.

He finds great satisfaction in mentoring others and sharing the wisdom passed down from his father. His passion for helping others and creating inclusive environments where individuals can be their authentic selves drives his commitment to continuous learning, development, and growth. Mr Roberson aims to use his experiences and knowledge to support and uplift anyone God places in his life, whether for a moment, a season, or a lifetime. He firmly believes that every encounter is meaningful and can significantly impact both his own future and the future of the person he interacts with.

Laszlo Vasko’s career of leading technology enabled innovation in drug development spans over twenty five years, having worked at Wyeth, AstraZeneca, and now Johnson & Johnson Innovative Medicines. Throughout his career, Mr Vasko seized opportunities to engage drug development leaders to accelerate the delivery of new medicines with technology capabilities to get the right data, to the right person, at the right time in order to improve clinical trial design, digitalize advanced therapy development, and streamline information flows. Mr Vasko’s current responsibilities, as Product Group Leader, Therapeutic Area Enabling Innovation, are enabling advanced therapies such as CAR-T, innovation in workflow and decision enablement, as well as continuing to pioneer Research in Clinical Care – ways to leverage healthcare platforms for clinical trial execution.

Mr Vasko earned Master’s degrees in both Clinical Research Operations Management and Information Science from Drexel and Penn State respectively.

Mr Vasko’s offices are in Cambridge MA and outside of work he’s active in the aviation community as a private pilot.

Uli Broedl, MD, is Corporate Senior Vice President and Head of Global Clinical Development & Operations at Boehringer Ingelheim. Dr Broedl is passionate about research, development and digital innovation to improve patient access and care. He steers Boehringer Ingelheim’s global Medicine Excellence Transformation to accelerate Clinical Development timelines and to create holistic Clinical Development stakeholder (regulator-payer-patient) evidence, a comprehensive global approach integrating people culture, digital and business transformation initiatives.

Dr Broedl held various leadership roles at Boehringer Ingelheim over the last 14 years, including Global Head of Late Clinical Development of Boehringer Ingelheim’s diabetes portfolio (with successful development and approval of the SGLT2 inhibitor empagliflozin (Jardiance) to improve glycemic control and to reduce the risk of cardiovascular death in patients with type 2 diabetes mellitus), Country Medical Director Canada, and Head of Global Clinical Operations.

Dr Broedl is adjunct Professor of Medicine at the University of Munich, Germany, and holds a Doctorate of Medicine degree from the University of Munich. He completed a Postdoctoral Fellowship in Dr Daniel J. Rader ́s lab, Institute for Translational Medicine and Therapeutics, University of Pennsylvania School of Medicine, Philadelphia, USA, and completed his training in Internal Medicine, Endocrinology and Metabolism at the Medical Center of the University of Munich. He published more than 100 scientific articles in peer-reviewed journals with >30000 citations (google scholar) and an h-index of 56 (Scopus).

Susanne Witzke is heading up the Clinical Operations Office, part of the Clinical Operations Center of Expertise at Novo Nordisk A/S. The team is driving process optimization initiatives, facilitating alignment across the clinical organization as well as enabling communication and efficient way of working within the global clinical organization.

Ms Witzke joined Novo Nordisk in 2015 and has 25 years of experience from various clinical operations roles in global pharma companies. Prior to joining Novo Nordisk, she has worked for Janssen-Cilag and Merck.

Ms Witzke is from Denmark and holds a MSc in Pharmacy.

Dr Abby Levine leads product strategy for Evidation’s Consumer platform, focusing on solutions for enterprise partners. Her product initiatives at Evidation include FluSmart, a digital flu monitoring program powered by machine learning. Dr Levine has a background in Anthropology, and holds a BA and MA from Stanford University, and a PhD from UCLA.

Randy Krauss is the Head & Executive Director of Metrics, Analytics, and Performance within Global Clinical Trial Operations at Merck. In this role, his group supports the optimization activities of planned studies, as well oversight of the portfolio, studies, and processes.

Prior to joining Merck in 2016, Randy worked in similar roles at other pharmaceutical/biotech companies including Genzyme (Sanofi), Shire & Alexion. At Genzyme, he served in various roles from R&D Portfolio Management to Clinical Operations, where he developed and maintained an enterprise-wide tool to track global development plans to identifying and maintaining KPIs and other metrics to ensure operational success and compliance.

Randy also spent four years at the BU School of Medicine as an Instructor of Biochemistry. Randy received his B.S. from the SUNY Fredonia and his Ph.D. in Microbiology from the University of Alabama at Birmingham. He completed his post-doctoral Fellowship at the University of Massachusetts Medical Center in Worcester.

Joe Lengfellner is a dedicated digital health innovator with a passion for applying technology strategies in clinical research. He strives to enhance the experiences of patients, clinicians, and research teams by implementing cutting-edge solutions that streamline processes, bolster communication, and optimize data management.

As the Senior Director of Clinical Research Informatics and Technology at Memorial Sloan Kettering Cancer Center (MSK), Mr Lengfellner has spearheaded numerous large-scale research technology initiatives, such as the implementation of MSK's Clinical Trial Management System (CTMS), the development and deployment of eConsent for research, the management of the Electronic Data Capture (EDC) ecosystem, and leading the implementation of Epic for research at MSK.

Mr Lengfellner is deeply interested in streamlining clinical data pipelines from EHR systems to research platforms, aiming to reduce the data management workload on sites and simultaneously enhance data quality while also lowering costs for both sites and sponsors.

A strong advocate for collaboration, he believes in forging partnerships among clinical research sites, technology vendors, and industry sponsors to develop clinical trial technology solutions that benefit all stakeholders and ultimately accelerate the pace of clinical trial execution.

In addition to his role at MSK, Mr Lengfellner leads the Clinical Research Innovation Consortium, a group designed to spearhead innovation within the clinical research industry. Under his leadership, the consortium works to foster collaboration and drive forward-thinking solutions that address the evolving challenges in clinical research. Through his work with the consortium, Mr Lengfellner is committed to shaping the future of clinical research by promoting innovation and excellence across the industry.

TBA

David Levitz, MD, is an attending physician and Assistant Professor at Montefiore Einstein. Dr. Levitz’s clinical focus is in classical hematology, diagnosing and treating a diverse range of disorders such as sickle cell disease, thrombosis, anemias, bleeding disorders, hemoglobin disorders, thalassemia, autoimmune hematologic diseases, and other rare diseases. He also has interests in phase I clinical trial drug development.

After receiving his Bachelor of Science at University of Connecticut in 2013, Dr. Levitz came to Einstein to obtain his Doctor of Medicine, earning it in 2017. He pursued postgraduate training at Tufts Medical Center, completing his internal medicine residency in 2020. Dr. Levitz then returned to Montefiore to complete his hematology/oncology fellowship, taking on the role of Chief Fellow in his final year.

Dr. Levitz’s research focus is in translational drug development for solid oncology and malignant hematology. He has shared his work through peer-reviewed journals and poster presentations.

Dr. Levitz is board certified in Internal Medicine and Hematology and Oncology. He is a member of the American Society of Hematology and the American Society of Clinical Oncology.