Approximately 300 million people worldwide are living with a rare disease. Due to the limited patient population, clinical trials for these conditions present unique considerations, particularly around recruitment and retention.
Cross-border patient participation, allowing for a broader patient pool, is a necessity. This approach can lead to additional complexities if not well-considered in advance and/or without practical experience. Key considerations include site selection, patient transportation, language and cultural barriers, differing legislation between countries, managing patient care and patient education – each of which is critical for the success of rare disease clinical trials.
In this webinar, the expert speakers will explore strategies for cross-border patient participation, drawing on lessons learned from years of experience running these trials. They will share key cross-border enrollment and retention factors for conducting these trials, covering regulatory intelligence, operational considerations and methods for enhancing patient experience.
Register for this webinar today to gain insights and strategies for success in rare disease clinical trials without boundaries.
Speakers
Michelle Petersen, MS, Vice-President, Clinical Trial Management, Medpace
Michelle Petersen brings over 16 years of experience in clinical operations. She has expertise overseeing global rare/ultra-rare disease trials and pediatric disorders and has been part of several programs that have received market approval. Michelle also co-chairs Medpace’s cross-functional Rare Disease Consortium and has a special interest in cell and gene therapies.
Message Presenter
James Thomas, BSc (Hons), MA, Senior Director, Regulatory Submissions, Medpace
James Thomas has a combined scientific (biomedical sciences, BSc), legal (masters in biotechnological law and ethics) and ethical background to conduct and oversee submissions and approvals in over 65 countries from Phase 0 to IV over the last 20 years.
His additional interactions are with regulatory authorities, government policy stakeholders across the spectrum of therapeutic indications and trial types. He specializes in operationally complex and innovative trials, including supporting both intra-country and inter-country movement in rare diseases.
Message Presenter
Beate Hess, PhD, Sr. Clinical Trial Manager/Sr. Associate Director, Medpace
Dr. Beate Hess brings over 30 years of experience in preclinical and clinical research with over 20 years in the pharmaceutical industry and 16 years in clinical project management. She has global multi-therapeutic experience across Phase I to IV studies and post-marketing safety surveillances, including preclinical safety, imaging, study group, sponsor as well as CRO experience. Amongst others, she managed studies of metabolic rare diseases, pediatrics, oncology, cardiology, nephrology, immunology, dermatology, endocrinology, gastroenterology, neuroscience, musculoskeletal and infectious diseases.
Message Presenter
Carly Wolnitzek, Sr. Patient Recruitment Coordinator, Medpace
Carly Wolnitzek brings over seven years of experience in clinical development with patient and caregiver focused support and over five years of experience in patient recruitment and retention activities. She provides management and oversight of the Medpace Patient Concierge Services Team, which she was instrumental in establishing within the company. She has experience across a variety of therapeutic areas and expertise in managing global travel and payment services in over 30 countries.
Message PresenterWho Should Attend?
This webinar will appeal to VPs, Directors, Managers and Department Heads working within:
- Clinical affairs
- Clinical research
- Clinical pharmacology
- Clinical outsourcing
- Project management
- Regulatory affairs
- Medical affairs
What You Will Learn
Attendees will learn about:
- How to effectively recruit and retain rare disease patients across international borders
- How to address logistical and operational hurdles and manage cross-border patient care
- Navigating international regulatory frameworks and utilizing regulatory intelligence to streamline cross-border enrollment process in rare disease trials
Xtalks Partner
Medpace
Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach that leverages local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system and anti-viral and anti-infective.
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