Webinar: Innovation in Oncology Clinical Trials

Navigating Regulatory Challenges, Optimizing Protocols and Breaking Access Barriers

In this webinar, learn from our regulatory and clinical research experts how personalized medicine and other innovative strategies have 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.

Our expert speakers discuss three challenging aspects of oncology clinical trials, including navigating the ever-changing regulatory landscape, key types of innovative study design for novel therapies, and patient access and diversity.

Watch now to gain valuable insights into how to optimize trial design, overcome barriers and adhere to the evolving regulatory landscape. Ultimately, this knowledge will contribute to equitable access to innovative treatments, improved trial efficiency, and enhanced patient outcomes.

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Meet the Speakers

Paula van Hennik

Vice President, Clinical, Regulatory Sciences - Development

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Robert Rachford

Vice President, Biostatistics and Programming

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Kimberly Futch

Director, Clinical Operations Strategy
Shelby Stillwagon

Vice President, Decentralized Clinical Trials

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Paula van Hennik

After finalising her PhD in Hematology in 2001 and spending almost 11 years conducting fundamental research on hematopoietic cell migration, Paula joined the Dutch Medicines Evaluation Board early 2012. Initially as clinical assessor, later as senior clinical assessor, with focus on products for oncology, hemato-oncology and hematology. From August 2016 up to February 2023 she was alternate CHMP (Committee for Medicinal Products for Human Use) member representing the Netherlands in this committee. In this committee, deciding on amongst others the benefit/risk of (extensions of) European marketing authorization applications, the oncology, haemato-oncology, part of the benign hematology, female reproductive and osteoporosis products were at the center of her portfolio. These included biologicals, small molecules and advanced (gene and cell) therapy products.

In early 2023 she has started to work at ProPharma, initially as Group Head Clinical and later as Vice President, Clinical, providing procedural support and expert advice to clients with human medical products in various stages of development with the focus on the EU regulatory system.

Robert Rachford

Robert Rachford (Bobbie) has 15 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).

Kimberly Futch

Shelby Stillwagon

Shelby started her career in academic research, then moved to the clinical site environment, working in oncology, and has spent the past 11 years focused on supporting and operationalizing Decentralized Clinical Trials. Since 2013, Shelby has worked with numerous sponsors across hundreds of clinical trials, where she has provided expert guidance on decentralized visit design and logistics. She has held multiple oversight roles, supporting global teams across a wide variety of therapeutic areas including rare disease, pediatrics, oncology, neurology, and infectious diseases. Her expertise lies in collaborating with involved stakeholders to build and maintain study-specific, quality-focused processes that support complex decentralized clinical trials.