Immuno-modulating agents such as interleukin-2 and interferon have been used to treat some solid malignancies for years, but their use has generally been limited to cancers considered immunogenic – for example, melanoma and kidney cancers. Today, multiple immuno-oncology pathways are in development.
Promising approaches in immuno-oncology drug development include checkpoint inhibitors, antibody drug conjugates, autologous cellular immunotherapy, and oncolytic viruses. This webinar will explore each of these, along with challenges in researching these compounds and recommendations to improve your odds of success.
For instance, checkpoint inhibitors include monoclonal antibodies that target the cytotoxic T-lymphocyte associated antigen 4 (CTLA-4). Examples are ipilimumab – marketed as Yervoy – a drug that binds to the CTLA-4 on T cells and is indicated for treatment of unresectable metastatic melanoma, and programmed-death drugs such as pembrolizumab (Keytruda) that activate the immune system to attack tumors.
Clinical Trial Challenges
Response and efficacy of oncology agents is measured by RECIST (Response Evaluation Criteria in Solid Tumors), a set of published rules that define when cancer patients improve, stay the same, or worsen. This webinar will discuss why these criteria do not easily apply in immuno-oncology and how these realities gave rise to the immune-related response criteria – published rules that define when tumors respond, stabilize, or worsen.
Trial Planning Success Tips
Effective site training is essential when planning trials of immuno-oncology agents. In addition, combination studies should be planned early. This webinar will reveal how sufficient advance planning can reveal if a combination with a chemotherapy or other agent provides better efficacy without increasing toxicity.
Nina Balujam, Senior Medical Director, Medical Services, Premier Research
Nina Baluja performs medical and safety monitoring on clinical research projects and provides strategic guidance on protocol development, study design, regulatory filings, and study execution. She has more than 15 years of clinical research, medical marketing, and drug safety experience in the CRO and pharmaceutical fields.
Prior to joining Premier Research in 2017, Dr. Baluja was Senior Medical Director at PRA Health Services. Before that, she oversaw global regulatory consulting at PPD and worked extensively in the pharma sector in positions that included Medical Scientific Adviser at Boehringer-Ingelheim, Associate Medical Director at Wyeth Pharmaceuticals, and Trial Delivery Manager at AstraZeneca.
Dr. Balujas areas of specialty include oncology, hemato-oncology, and rare diseases. She has significant clinical development regulatory experience, having prepared and participated in numerous scientific meetings with the FDA, EMA, and Health Canada.
She holds an MBBS degree from Pune University in India and a masters in surgical oncology from Bombay University.
Luke Gill, Executive Director, Oncology, Strategic Development, 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 masters degree in neuro and molecular pharmacology from the University of Bristol, a bachelors 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 U.K.
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.