Your company has received funding for a first-in-man oncology trial of a novel compound. The circumstances are typical: limited budget, uncomfortable timeline, a scarcity of skilled clinical trial professionals, and limited knowledge of short-term clinical strategy. And you recognize that the success of the compound — and possibly the company — depends on the outcome of this trial.
To complicate matters, your target is a newly validated mutated receptor present in only 15 percent of pancreatic cancer patients, with no diagnostic test yet approved. You’re also using an antibody-like molecule with the unique property of not only inhibiting the receptors’ activity, but also stimulating a potent immune response. Neither the class of drug nor the target has ever been tested in a clinical trial. In addition, much of the preclinical data suggests it will synergize with unapproved newer molecules that are now in later-stage trials.
It’s reassuring to know that almost 25 percent of drugs now used to treat patients are targeted and novel like yours and had similar beginnings. Companies like yours are at the very forefront of personalized medicine, and many are co-developing, at a very early stage, biomarkers and diagnostic kits to define those patients who will best respond to the therapy — or yield non-invasive 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 objectives, 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 proper planning and execution of a high-quality, timely trial. 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:
- ·Developing a strategy
- Determining your short- and long-term strategies
- Beginning with the end in mind and using a strategic planning tool called a Target Product Profile
- Translational medicine considerations
- How to maximize the potential for developing a predictive biomarker
- PK, PD
- Defining the objectives of the initial trial
- Go/no-go criteria
- Objectives and adaptive designs in early oncology trials
- Proof of concept, mechanism, efficacy, target
- Safety, clinical endpoints
- Operational considerations
- Choosing the right CRO for your company
Paul Hallenbeck, Executive Director, Drug Development Strategy, Oncology, Premier Research
Paul Hallenbeck, Executive Director-Oncology, Strategic Development Department, Premier Research
Paul Hallenbeck has more than 20 years of experience in the biotech industry spanning all phases of drug discovery and development. He has pioneered and overseen clinical development of numerous innovative therapeutic compounds.
Dr. Hallenbeck joined Premier Research after working for a variety of bioPharmaceutical companies, from start-ups to big pharma. He most recently served as Chief Scientific Officer for oncology therapeutics specialist Hangzhou Bensheng Pharmaceuticals, and prior to that, founded Synbody Biotechnology Inc., serving as the company’s President and CEO and leading development of antibody-like technologies and compounds.
He has played a major role in the discovery of several novel compounds, including those that induce systemic immunotherapeutic effects.
Dr. Hallenbeck holds a doctorate in microbiology from the University of Illinois and a bachelor’s degree in chemistry from Siena College. He holds 35 patents and applications, and his work has appeared in more than 30 publications and 150 scientific and regulatory reports.
Luke Gill, Executive Director Clinical Development Planning, Premier Research
Luke Gill, MSc,MBA, Executive Director – Oncology,Strategic Development Department, Premier Research
Luke Gill has an extensive scientific background and more than 20 years of drug development experience. Specializing in oncology, he has led numerous global CRO management teams and provided strategic assessment, management, and oversight of study enrollment and program metrics.
Prior to joining Premier Research in 2015, Mr. Gill was Director of Global Project Management for Hematology and Oncology at PPD, overseeing design and delivery of clinical development plans across multiple indications and specializing in early-phase oncology. He also served as Assistant Project Management Director at PPD, was CRO alliance program director for Merck Serono, and has held positions at Pfizer/Parke Davis, Astra, and Glaxo.
Mr. Gill holds a master’s degree in neuro and molecular pharmacology from the University of Bristol, a bachelor’s degree in biological sciences from the University of the West of England, and an MBA specializing in strategy and international enterprise from the Open University in the UK.
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 and medical device 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.