This webinar aims to shed light on three challenging aspects of clinical trials in oncology:
- The need for innovative study design for novel therapies,
- Patient access and diversity, and
- Navigating the ever-changing regulatory landscape.
These topics have become increasingly important as the continued development of precision medicines has led to smaller study populations associated with higher uncertainty on the evidence-base for approval and reimbursement decision-making, while at the same time broad patient access and the external validity of the data need to be ensured. This force-field warrants clever thinking about study design and making adequate use of the evolving regulatory environment.
Protocol design for new and novel therapies:
Developing robust and efficient protocols is crucial for successfully evaluating the safety and efficacy of emerging treatments. Speakers will discuss innovative methodologies, adaptive trial designs and data-driven approaches that optimize trial outcomes while ensuring patient safety. The audience will gain insights into the key considerations for designing oncology trials that account for the unique characteristics of oncology therapies, including personalized medicine, immunotherapies and targeted treatments. Case studies will highlight the impact of optimized protocols on trial efficiency, patient recruitment and overall trial success.
Patient access and diversity:
Navigating the changing regulatory landscape:
In oncology trials it is not uncommon to use surrogate or intermediate endpoints as primary efficacy analysis necessitating sponsors to provide confirmatory evidence post-approval. While on the one hand this approach may have sped up the approval of targeted medicinal products, it is all but certain that it has overall led to earlier access of such products for patients. As this type of medicine development is here to stay, a need for innovative trial design has been identified, which is reflected in various US Food and Drug Administration (FDA) and European Medicines Agency (EMA) programs to stimulate use of alternative sources/analysis methods of efficacy and safety data as the basis for marketing authorization. Within this context and emphasizing the essential considerations for conducting clinical trials in oncology, the speakers will discuss the latest updates in regulatory guidance and proposed EU legislation.
Register for this webinar on innovation in oncology trials to gain valuable insights optimizing trial design, into overcoming barriers and adhering to the evolving regulatory landscape. Ultimately, this knowledge will contribute to equitable access to innovative treatments, improved trial efficiency and enhanced patient outcomes.
Robert Rachford, Vice President, Biostatistics and Programming, ProPharma
Robert Rachford (Bobbie) has 10+ years of experience leading biostatistics, programming and data management teams in both sponsor and CRO settings for pharmaceuticals and medical devices. Bobbie has a master’s degree in biostatistics and several years of SAS experience programming both TLF output and CDISC compliant datasets (SDTM and ADaM). He has extensive experience utilizing a large variety of EDC systems plans and oversees the movement of clinical data from design and capture to manipulation and final delivery.
Kimberly Futch, Director, Clinical Operations Strategy, ProPharma
Kimberly Futch has 20+ years of clinical experience and more than 18 years dedicated to drug development in oncology. Kim’s background includes program and project management, operational execution, client relationship management and strategy formulation.
She has Phase I–IV trial experience ranging from first-in-human trials through successful NDS submissions in large pharma, biotechs and CROs. Additional areas of therapeutic experience include CNS, immunology, infectious disease and rare disease.
Shelby Stillwagon, Sr Director, Decentralized Clinical Trials, ProPharma
Shelby Stillwagon has 10+ years of experience with the past eight years focused on decentralized clinical trials, primarily home visits. Shelby began her career in academic research in neuroscience then moved to the clinical site environment working in oncology. Within DCT, she has supported hundreds of trials, providing expert guidance on home visit design and logistics. Her therapeutic areas of expertise include rare disease, pediatrics, oncology, neurology and gene therapy. In addition, Shelby is an expert in collaborating with involved stakeholders (Sponsor, CRO, vendors, etc.) to build and maintain study-specific, quality-focused processes that support simple to complex decentralized clinical trials.
Paula van Hennik, Clinical Group Head, Regulatory Sciences, ProPharma
Paula van Hennik has 10+ years of experience in regulatory affairs, including serving as an alternate CHMP member on behalf of the Dutch Medicines Evaluation Board and a Senior Clinical Assessor at the Dutch Medicines Evaluation Board. Prior to that, she spent several years in research as a postdoc and research group leader in The Netherlands studying molecular mechanisms of hematopoietic (stem) cell migration and was awarded several competitive public research grants. Paula has a PhD in hematology on in vivo and in vitro hematopoietic stem cells assays from Erasmus University in Rotterdam, The Netherlands.
Who Should Attend?
- Clinical researchers, investigators and regulatory professionals working in the oncology space
- Pharma/biotech/medical device professionals interested in advancing the development and accessibility of innovative therapies for cancer patients worldwide
What You Will Learn
Attendees will gain:
- Insights into protocol design for new and novel therapies in oncology, including adaptive trial designs and data-driven approaches to optimize trial outcomes and patient safety
- Strategies for improving patient access and diversity in oncology clinical trials, including initiatives to address barriers and engage underserved populations
- An understanding of the implications of the changing regulatory landscape for oncology clinical trials
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.