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
Co-Founder & Chief Executive Officer
With such extensive experience and based on long-time networking in the pharmaceutical industry, Claudia co-founded Arensia Exploratory Medicine in Düsseldorf, Germany with the purpose of contributing innovative strategies to the acceleration of the drug development process. Arensia runs its own network of modern Phase 1 units in Eastern Europe which are specialized to perform sophisticated Phase 1b/2a/Proof-of-Concept trials with extraordinary recruitment speed across most therapeutic areas.09:30 -10:00 Innovative approaches to achieve Proof of Concept results in record time Claudia HesselmannCo-Founder & Managing Director, ARENSIA EXPLORATORY MEDICINE GmbH
ARENSIA Exploratory Medicine
Director Clinical Operations
Dr. Angela Bischoff received her master of Biology from the University of Bochum in 1992 and obtained PhD at University of Essen in 1996. Angela was Lecturer and Tutor in Pharmacology in Essen and Bochum between 1996 – 2000. She has published 26 scientifc papers. Since year 2000 Angela has acquired a vast experience in early phase drug development, particularly project management and quality assurance responsibilities for Phase I /II clinical trials involving both healthy volunteers and patients. Her expertise includes pharmacological and logistics overview of more than 500 early stage development clinical trials. Angela has been part of ARENSIA Exploratory Medicine since its foundation, where she holds the position of Director Clinical Operations. In her role Angela is supervising the medical activities at ARENSIA, ensuring standardized performance of protocols by coordinating training activities, as well as learning and synergies of the medical teams/investigators across all ARENSIA Phase I unitsTatiana 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.
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 scientifc 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
Clinical Operations Strategy Meeting US 2016,
The Westin Boston Waterfront
425 Summer Street Boston, MA, 02210 USA