In today’s fast-changing world, to stay competitive means to be innovative and open to embrace new approaches. Industry is facing time-pressing competition when fast movement through exploratory clinical phase is posing great challenges. Early go/no-go decisions have become critical. This is in contrast to dropping efficiency of clinical operations, constantly increasing complexity of study protocols and skyrocketing costs.
Industry thought leaders will gather for a one-day series of round table discussions to exchange their vision of paradigm shifts in early clinical development that are already underway and yet to happen. The focus will be on practical aspects of implementation of innovative approaches to achieve Proof of Concept results in record time. We will share best practices and real-life case studies, exploring them from different perspectives – regulatory, sponsor, clinical site and patient.
Attendees will be able to address these issues and leave the day better informed on how to:
- Develop an efficient strategy to Proof of Concept ( First-in-Man -> First-in-Patient): classical approach vs. “umbrella” protocols
- Overcome challenges in execution of exploratory protocols: from feasibility stage to successful patient enrolment in Phase 1b/2a studies. Case studies from oncology, immunology and infectious diseases.
- Balance scientific/business interests & regulatory requirements
- Navigate in the new EMA legislation on Phase 1 clinical trials following the incident in France
Aminex Therapeutics, Inc.
Senior Vice President of Drug Development & Chairman Scientific Advisory Board
Atea Pharmaceuticals, Inc.
Vice President, Clinical Operations and Project Management
Claudia Hesselmann, chemist by training with PhD in molecular biology, has over 15 years of expertise in the early phases of drug development. This includes co-founding and holding management positions in various CROs with activities in Western and Eastern Europe, Japan and Middle East. With such extensive experience and based on long-time networking in the pharmaceutical industry, Claudia has co-founded ARENSIA Exploratory Medicine in Düsseldorf, Germany, with the purpose of contributing with innovative strategies to the acceleration of the drug development process. ARENSIA runs its own network of modern Phase I units, located in large hospitals in Eastern Europe. The units are specialized to perform sophisticated Phase Ib/IIa/Proof-of- Concept trials in PATIENTS, with extraordinary recruitment speed across most therapeutic areas.Claudia HesselmannCo-Founder & Managing Director, ARENSIA EXPLORATORY MEDICINE GmbH
Tatiana Eidus received her master degree in Biophysics from Moscow State University. Entering the industry almost a decade ago, Tatiana has accumulated wide expertise in all operational aspects of setting up and managing Phase I-III trials across Europe and US. Prior to joining ARENSIA Exploratory Medicine, Tatiana worked for GSK and Merck. Primarily focused on early stage exploratory programs, she conducted trials in various disease areas. In her current role as Director Corporate Development Tatiana supports ARENSIA’s partners in the US, supervising cross-functional coordination throughout study planning, start-up and execution.Tatiana EidusDirector Corporate Development, ARENSIA EXPLORATORY MEDICINE GmbH
Dr. Zhou is currently Executive Vice President of early development at Atea Pharmaceuticals in Boston. Prior to joining Atea, he was the head of clinical pharmacology & early medical development at Idenix Pharmaceuticals. Dr. Zhou has designed and successfully conducted more than 50 early phase clinical studies including integrated FIM/POC trials allowing rapid evaluation of dose/exposure-response critical to decision making during early clinical development. Dr. Zhou received his PhD in Pharmacology from the Université de la Mediterranée (Aix-Marseille II) in France. He has authored/co-authored over 60 peer-reviewed papers and numerous conference presentations.Xiao-Jian Zhou, Ph.D.Executive Vice President, Early-Stage Development, Atea Pharmaceuticals, Inc.
Dr Michael Palfreyman has more than four decades of successful drug discovery and development experience with two major pharmaceutical companies and several biotechnology companies. He is currently the chief scientific officer at Amorsa Therapeutics, a director of Oculogics, and scientific advisor to Jasco Pharmaceuticals, and he is responsible for research and development diligence at Torrey Pines Investment Ventures. Previously he was chairman of Amakem Therapeutics and Opthakem, vice president of drug development and program management at EnVivo (now Forum) Pharmaceuticals, and senior vice president of research and development at Scriptgen (now Anadys) Pharmaceuticals. Michael also held executive positions at Marion Merrell Dow (MMD) Research Institute (now Sanofi), including vice president of research (North America), and was a key member of the team that developed DFMO (eflornithine). Prior to MMD, Michael was the head of biochemical pharmacology at Beecham Pharmaceuticals (now GlaxoSmithKline). He received his BPharm, MRPharmS, PhD, and DSc from the University of Nottingham. He is co-inventor on 45 US and European patents and three pending patents, and has coauthored over 150 scientific articles and book chapters.Michael PalfreymanSenior Vice President of Drug Development & Chairman Scientific Advisory Board, Aminex Therapeutics, Inc.
Keith Pietropaolo has over 17 years of global drug development experience across multiple
therapeutic areas. He is currently the VP of Clinical Operations and Project Management at
Atea Pharmaceuticals, Inc. in Boston. Prior to joining Atea, Keith has held numerous scientific
and operational clinical positions at Alnylam, Sideris, Idenix and Averion, where he has led
clinical development programs and project teams for both early and late phase drug candidates.
He spent over 10 years at Idenix Pharmaceuticals, where he managed a portfolio of global
phase I-III clinical trials across multiple antiviral programs.
Patricia joined Arbutus in 2015 as part of the clinical team to lead the siRNA program for HBV. She has more than 10 years of experience in clinical development and medical affairs, she has been part of multiples approvals in Hepatitis C; initially with Boceprevir at Schering-Plough Research Institute/MERCK follow by DaKlinza and Asunaprevir at BMS. During her last position at BMS; she was appointed as a Global Medical Virology Lead, leading the medical teams and activities in preparation to the Daklinza and Asunaprevir launches across markets.
Patricia received her MD degree in Bogota Colombia. Following graduation Patricia trained in Internal Medicine, Gastroenterology and Hepatology at Joseph Hospital and Jackson Memorial Hospital at the University of Rosario and the University of Miami.
Ingeborg Heirman currently holds a position of Senior Director Clinical Research at MSD. She has over 10 years of experience in early phase drug development, i.e. First-in-Human trials through Proof-of-Concept in patients, as well as trials designed to validate technologies (e.g. mobile health, MRI, echocardiography) and biomarkers (imaging and molecular biomarkers) for use in early clinical development.
Ingeborg Heirman holds a master in Biomedical Sciences from the Free University of Brussels (Be) and a PhD in Biotechnology from the Ghent University (Be). In addition, Ingeborg has also held a position as Sr Business Development Manager role within VIB, an excellence-based Belgian entrepreneurial institute focusing on basic research and translating scientific results into pharmaceutical, agricultural and industrial applications, resulting in an understanding licensing strategies within pharma/biotech.
Clinical Operations Strategy Meeting US 2016,
The Westin Boston Waterfront
425 Summer Street Boston, MA, 02210 USA