Determining the optimal dose, dosing regimen and, in a growing number of trials, the right combination treatment partner for a key Phase II clinical trial, is essential to developing an oncology therapeutic. Phase I/II oncology clinical trial designs must take into account the latest information about emerging therapies, biomarkers, and clinical trial methodology, along with evolving regulations, to achieve the optimal design to determine dose, schedule, and combination treatment regimen.
This webinar will review these and other factors important to planning and executing early-phase oncology clinical trials in preparation for a decision-making Phase II trial. This is important since most failures of oncology therapeutics result from poor outcomes in Phase II studies.
Beginning with the end in mind, we will:
- Identify what is meant by the “right” dose, regimen, and potential combination treatment for a Phase II clinical trial
- Describe current regulatory and scientific/clinical factors impacting dose and regimen selection
- Consider how to define starting dose, regimen, combination, and potential biomarkers and pharmacodynamic measurements from nonclinical and clinical data on your compound or those with a similar mechanism of action
- Describe early-phase trial designs, such as 3+3, the continual reassessment method, and Bayesian designs, that determine the minimum effective dose and/or maximum tolerated dose
- Explore use of adaptive design approaches in phase I/II trials
Paul Hallenbeck, Ph.D., Executive Director, Strategic Development, Oncology, Premier Research
Dr. Hallenbeck is a senior biopharmaceutical research and development executive with international experience. He is also a multiple award-winning passionate scientist and results-driven cancer therapeutics research and development leader. Dr. Hallenbeck has 23 years of experience covering all phases of oncology drug discovery, development, and translation to and through various phases of clinical trials. His expertise covers the discovery and development of numerous novel therapeutics (e.g. antibody and antibody-like molecules, gene therapy, immunotherapy, nanoparticles, oncolytic viruses, peptides, pro-drug, proteins, RNA/DNA, and small molecules) alone and in combination.
Dr. Hallenbeck is currently Executive Director, Strategic Development, Oncology at Premier Research. He serves as the principal strategist who advises, consults, plans and directs the design and strategy of new business opportunities (RFPs) and provides his expertise in the conduct of clinical trials. He is also responsible for developing strong relationships with existing and potential clients, clinical sites, and key opinion leaders.
Dr. Hallenbeck joined Premier Research in 2015 after a tenure with a variety of biopharmaceutical companies, from start-up to large pharma, all of which were focused on the discovery and development of novel compounds for the treatment of cancer and other unmet medical needs. His leadership include positions as Senior Project Leader, Senior Fellow, CSO, CEO, and President. In his last position at a small international biopharmaceutical company, Paul was CSO and led a global team that was responsible for all facets from selecting early stage small molecule compounds for development and shepherding them through all phases of preclinical and early clinical development planning and execution. For his accomplishments he won a National Distinguished Expert award.
Prior to that, Dr. Hallenbeck was the sole founder of a cancer therapeutics/technology start-up with a novel early stage immunotherapeutic in-licensed from Novartis. He built and led a team that successfully performed all preclinical testing required for IND approval, discovered key biomarkers and incorporated them into the Phase I/II clinical trial, and filed a successful IND. He further co-led the team through a Phase IIb clinical trial in SCLC and an additional Phase I in pediatric oncology. Through this work, he formed major collaborations with top Key Opinion Leaders (KOLs) in oncology research at major institutions such as Baylor, Harvard, Johns Hopkins, and NCI. For his accomplishments, he won the Ernst and Young Entrepreneur of the year award and Frost and Sullivan product innovation of the year.
Dr. Hallenbeck was also a key leader at a large pharmaceutical company focused on the discovery and development of novel therapeutic compounds to treat cancer. Paul played a major role in the discovery through early clinical development of several novel compounds, including those that induced systemic immunotherapeutic effects. While there, he also played a major role in establishing, developing, and managing key areas of research (e.g. targeting, immunotherapy, drug delivery, predictive preclinical models, non-invasive imaging, angiogenesis, gene therapy, and functional genomics), resulting in significant Novartis investment and leadership in these areas. He also served as a representative of the division he co-led on several international clinical development teams. For his accomplishments, he received a lifetime achievement award.
Dr. Hallenbeck earned a PhD and MS in Microbiology from the University of Illinois and a BS in Chemistry from Siena College. He also had significant postdoctoral training at NIH being selected as a National Academy of Science Fellow. He is a published author, multiple award winner, patent holder, and articulate public speaker with more than 30 publications, 35 patents/patent applications, and 150 scientific and regulatory reports. Paul is a current member of the American Association for Clinical Oncology and American Association for Cancer Research. He is the recipient of numerous awards including the National Distinguished Expert Award from China, U.S. Frost & Sullivan Award for Product Innovation of the Year, Ernst & Young’s Life Sciences Entrepreneur of the Year for Greater Philadelphia Region, and Novartis Leading Scientist and Lifetime Achievement VIVA Award.
Peter Larson, M.D., Senior Medical Director, Hematology-Oncology, Premier Research
Peter Larson, M.D., is Senior Medical Director for Hematology-Oncology. Dr. Larson supports the drug development work of the innovative biotech companies that comprise most of Premier Research’s customer base, bringing to the role extensive clinical and medical affairs experience.
With a background spanning large pharma, startup biotech, and contract research, Dr. Larson was Senior Director of Clinical Research at pharmaceutical start-up Chimerix Inc. before joining Premier Research in 2016. Prior to that, he was Senior Director of Oncology Global Medical Affairs at Novartis Pharmaceutical Corporation.
Dr. Larson also held senior positions at F. Hoffmann-La Roche AG, where he led the company’s global virology franchise, and Bayer Corporation, where he was head of global clinical strategy. He was also Assistant Professor of Pediatrics at the University of Pennsylvania. Dr. Larson’s therapeutic expertise includes hematology, oncology, hemophilia, mastocytosis, AML, ALL, multiple myeloma, GIST, and virology.
He holds a Doctor of Medicine and a bachelor’s degree in biology from the University of North Carolina and is a fellow in transfusion medicine, blood banking, and hematology at University of North Carolina Hospitals.
Gabriele Accetta, Principal Biostatistician, Premier Research
Prior to joining Premier Research, Mr. Accetta was lead statistician for a thrombosis research institute in London. Most of his work as a statistician and consultant has dealt with real-world evidence, observation studies, epidemiology, and health technology assessment.
Mr. Accetta teaches statistics at the University of Pisa and previously taught medical statistics at the University of Florence. He is the author of more than 40 papers in peer-reviewed international journals.
He holds a doctorate in applied statistics from the University of Florence and graduated laurea cum laude from Sapienza University of Rome with a degree in statistics and demography.
Who Should Attend?
VPs, Directors, Managers, Department Heads, Scientists and Researchers working within:
- Clinical Affairs
- Clinical R&D
- Clinical Research
- Clinical Pharmacology
- Clinical Operations
- Project Management
- Regulatory Affairs
- Medical Affairs
for pharmaceutical, biotechnology companies
Premier Research is a leading CRO serving highly innovative biotech, pharmaceutical and medical device companies. The company has a wealth of experience in rare disease and pediatric research having managed about 100 projects in each area in the last five years alone. Its services include clinical research and regulatory outsourcing in the areas of analgesia; neurology; infectious, cardiovascular, and respiratory disease; dermatology; oncology; and medical devices.
Premier Research and operates in 84 countries. It employs 1,000+ clinical professionals dedicated first and foremost to fulfilling each customer’s requirements in a timely, accurate, and cost-effective manner. This includes a strong international network of monitors and project management professionals combined with regulatory, data management, statistical, scientific, and medical experts, and staff at its well-established network of dedicated clinical sites.