Your company has received funding for a first-in-man trial of a novel oncology compound. The circumstances are typical: limited budget, uncomfortable timeline, a scarcity of skilled clinical trial professionals, and limited knowledge of regulatory hurdles to form a robust clinical strategy. And you recognize that the success of the drug — and possibly the company — depends on the outcome of this trial.
To complicate matters, your target is a newly validated mutated receptor present in a limited number of cancer patients, with no diagnostic test yet approved. You’re also using an antibody-like molecule that inhibits the receptor’s activity, but also stimulates a potent immune response. Neither the class of drug nor the target has ever been tested in a clinical trial, and much of the preclinical data suggests it will synergize with unapproved newer molecules that are now in later-stage trials.
Companies like yours, at the forefront of personalized medicine, are co-developing — at a very early stage — biomarkers and diagnostic kits to define those patients who will best respond to the therapy. These biomarkers and diagnostics also can yield noninvasive information about whether patients are getting the desired pharmacodynamic effect from the drug.
That’s a lot to consider, but you’re not alone. There are many highly skilled people and organizations to help plan and execute such studies. Some contract research organizations specialize in exactly this type of situation and can help you meet your goals, ideally getting involved immediately after (if not before) you meet critical funding milestones. You want to adopt a one-team approach and an agreed-on definition of attainable objectives, combined with a clinical development plan of engaging the agencies and execution of a high-quality, timely trial at a reasonable cost. This will improve the likelihood of meeting study objectives and establish continuity that aids in development of more advanced trials.
This webinar will highlight the many aspects a company must consider in planning and executing a trial, and how a CRO can help throughout the process. They include:
• Regulatory gap analysis leading to a clinical development plan
• Evaluating available data via a gap analysis
• Optimizing the regulatory pathway (accelerated, fast track, etc.)
• Incorporating regulatory feedback to develop a target product profile
• Defining the objectives of the initial trial
• Go/no-go criteria
• Objectives and adaptive designs in early oncology trials
• Proof of concept, mechanism, efficacy, and target
• Investigator and site identification
• Medical perspective
• Cohort management, site management, and eligibility review
• Safety and independent data monitoring committees
• Clinical efficacy endpoints
• Best practice case study
• Gap analysis and steering the clinical development plan
• Regulators and registration
• Optimization of operational key success drivers
- Driving Product Development and Finding the Fast Track in Early-Phase Oncology Programs: Webcast
- Tuesday, June 19, 2018
- 11am EDT | 10am CDT | 4pm BST | 5pm CEST
- 1 hour
- How regulatory gap analysis leads to a clinical development plan
- How to define the objectives of the initial trial
- The medical perspective of early-phase oncology trials
- Best practices for early-phase oncology trials
Vice President of Oncology, Clinical Development Services
Luke Gill has an extensive scientific background and more than 20 years of drug development experience. Specializing in oncology, he has led numerous global management teams and provided strategic clinical development assessment, management, and oversight.
Prior to joining Premier Research, Luke was has held several Senior Director Leadership roles building relationship with key opinion leaders and overseeing design and delivery of clinical development plans across multiple indications. Luke specialized in early-phase oncology trials overseeing a portfolio of CRO alliance programs with Genentech. He has held positions within the pharmaceutical sector which include Avenits, Pfizer, Parke Davis, Astra, and Glaxo
Luke holds a master’s degree in neuro and molecular pharmacology from the University of Bristol and an MBA focusing on strategy and international enterprise.
Executive Medical Director in Hematology-Oncology
Peter Larson, M.D., is the Executive Medical Director in 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 industry clinical development and medical affairs experience.
With a background spanning large pharma, startup biotech, and contract research, Dr. Larson has held Senior Medical positions in both large pharmaceutical organizations and small startup companies.
Dr. Larson has held faculty positions at the University of Pennsylvania/the Children’s Hospital of Philadelphia and University of North Carolina. Dr. Larson’s therapeutic expertise includes hematology, oncology, hemophilia, AML, ALL, multiple myeloma, GIST, infectious diseases.
He holds a Doctor of Medicine and a bachelor’s degree in biology from the University of North Carolina. He completed a residency in internal medicine and did fellowship training in transfusion medicine, blood banking, and hematology at University of North Carolina Hospitals.
Director, Regulatory Affairs
Dr. Hemsworth’s experience consists of multi-platform and therapeutic target drug regulatory, clinical and pharmacovigilance from over 30 years in the US pharmaceutical industry and 6 years of clinical-regulatory CRO experience at PPD. He has served as strategic executive leader and subject matter expert for regulatory affairs and pharmacovigilance at Otsuka Pharmaceuticals and Cardiokine and as operational leader in regulatory affairs, clinical development and quality assurance at Targacept, Carter-Wallace, Sterling Drug and Pfizer. In managing teams of 12-48 clinical, regulatory, pharmacovigilance and compliance professionals, Dr. Hemsworth experience includes more than 30 INDs/CTAs, including clinical development, new drug application defense and labeling negotiation, achieving approved adult and pediatric NDAs/sNDAs in the management of syndrome of inappropriate anti-diuretic hormone, congestive heart failure, inotrope therapy, schizophrenia, bipolar disease, epilepsy, seasonal and perennial allergic rhinitis, and intrathecal/intravascular contrast enhancement.
Dr. Hemsworth earned his Bachelor’s degree in biology and Master’s degree in microbiology at Rutgers University. His doctoral degree in microbiology and immunology was earned at Miami University of Ohio. He is also a United States Air Force veteran during which he managed a team of cryptographic national defense analysts providing critical intelligence analysis to NSA and the Federal Executive Branch.