With coronavirus inhibiting the traditional approach to clinical trials, many companies are adopting the decentralized trial approach. And decentralized trials were on-the-rise even before the pandemic, boasting higher recruitment and retention rates for patients who prefer trials without the logistical challenges of in-clinic attendance. But adopting the decentralized trial approach introduces new challenges for those companies hoping to ramp up an early phase trial or keep later stage studies going during the pandemic. Strengthening the direct-to-patient supply chain is crucial in ensuring the decentralized trial process goes smoothly for patient and company alike. We'll discuss the challenges posed by direct-to-patient supply with decentralized trial experts, whose experience poses solutions for common roadblocks.
Nicole Gray is currently Director, Strategic Supply Solutions for Catalent Clinical Supply Services, responsible for developing the Direct to Patient business and other new strategic service offerings. She has been in the Pharmaceutical industry for 18 years and has held multiple roles in clinical supplies project management. Prior to moving to her current role in August 2018, Nicole spent 6 years as the Director of Project Management for the Catalent Philadelphia site, responsible for a team of 45 Project Coordinators, Project Managers, and Sr. Project Managers. Prior to moving to Catalent Philadelphia, Nicole was responsible for the Mt. Laurel and Allendale Project Management teams (previously Aptuit).
Prior to joining Catalent, Nicole held various project management, communications and marketing coordination roles at Omnicare Clinical Research, GE Financial Assurance, and the United States House of Representatives.
Nicole is an active member of the Global Clinical Supplies Group (GCSG) and is currently the Board Secretary.
Deb Jamieson is the Head of Global Clinical Supply Chain within Research & Development at Takeda Pharmaceutical Company Ltd. Her career spans 30 years in the pharmaceutical industry with extensive experience in Clinical and Commercial Manufacturing Operations and Supply Chain.
Deb provides leadership and oversight for the Clinical Supply Chain function which includes the planning and supply strategy for development projects at the program and study level, logistics management, operational execution, business process management, as well as vendor management and oversight.
Prior to Takeda, she held several leadership positions at AstraZeneca, BioVest, Organogenesis, and Cellcor where she was accountable for building, developing, and leading teams responsible for the manufacturing, packaging, and distribution of several technically diverse products including parenteral products, biologics, autologous cell therapy, tissue engineered products, and an autologous cancer vaccine.
Deb received her B.S. in biology from Stonehill College and M.Ed. in health promotion from Bridgewater State College.
Rasmus Hogreffe, MSc.Med., MBA is considered as a Virtual Clinical Trials expert. His main goal is to improve treatment for patients by making trials better and faster than ever before, using digital and remote innovations.
He holds an Executive MBA and a Master in Medical Science (MSc. Medicine) and has, since 2010, been working in the healthcare industry in various positions within clinical research & development.
Rasmus has extensive experience in the pharmaceutical industry and has been involved in more than 60 clinical trials, giving him a broad knowledge regarding every aspect of clinical research.
Furthermore, Rasmus is a serial entrepreneur and has a successful record of starting and selling companies within his broad scope of interests: Digitalization of clinical trials, Patient recruitment, Real World Data, and Health innovation.
In addition, as an external lecturer and supervisor at Aalborg University, Rasmus has developed and given courses and workshops on management of clinical studies on topics such as the development of recruitment and retention strategies, site-optimization, site-selection and patient engagement to sponsors, investigators and study teams at leading medical centers.
His innovative approach within the field of digital health, Patient Recruitment, and Virtual Clinical Trials make him a frequently used chairman and speaker.
Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.