Scientific advice is gaining momentum around the world and many processes are evolving
Mapi offers Integrated Scientific Advice (ISA) training workshops and consulting services to support manufacturers in optimizing their product development programs to generate evidence that is relevant to regulators, HTA bodies, and payers for timely patient access.
A shift in the regulatory/HTA paradigm is occurring, driven by affordability concerns, efficacy-effectiveness gaps, patient centricity, and early access
to important medicines. The value of early integrated scientific advice is
to support navigating this paradigm shift, manage uncertainty and de-risk, manage evidence complexity in HTA submissions, and promote company collaboration to eliminate the “silo effect”. The most important reason for seeking integrated scientific advice is to provide support for timely access to innovative medicines.
Transformational medicines may be made available to patients up to 4 years earlier through the Early Access to Medicines Scheme (EAMS) in the UK, Compassionate Access programs or expanded access studies. Obtaining this designation will require integrated early dialogue between the regulatory authorities, payers, and HTA agencies to support these new changes to align the regulatory and HTA bodies earlier.
Today, we’ll discuss the considerations from the regulatory, payer, and HTA perspectives with respect to the overlap and synergies in the consideration of the definition of population, study design and comparators, outcomes, and subgroups. The importance of the value proposition is emphasized in the development of a robust briefing book to provide a framework to develop “value added” questions for the agencies. Additionally, the importance of patient involvement in these early engagements will be discussed to support early alignment of all stakeholders to optimize the clinical development plan and identify potential gaps.
- Dr. Matthew Bending
- Rory Graham
- Dr. Amina Udechuku
- Dr. Sabine Latour
- Dr. Jacoline Bouvy
Dr. Matthew BendingDirector, Head of HTA, Strategy & Communication, Real World Strategy & Analytics, Mapi Group
Dr. Matthew Bending, a Director of Real World Strategy & Analytics, is a health economist with 10+ years of consulting experience. He heads projects for HTA submissions, scientific advice, market access, literature reviews, economic modeling, payer advisory boards, and global value dossiers. Before joining Mapi, Dr. Bending was a Senior Consultant for York Health Economics Consortium. He earned a PhD in Health Sciences from the University of York; his thesis explored the use of HTA in international reimbursement decision-making. He has an MSc and BSc (Hon.) in Economics from the University of Warwick.
Rory GrahamSenior Director, EU Regulatory Services, Mapi Group
Mr. Graham has facilitated numerous aspects of drug and medical device development during his 25 year career in the pharmaceutical, biotechnology and device industries. Mr. Graham has held senior positions in the area of regulatory a airs in companies in Europe and Asia-Pacific. He has arranged and directly participated in meetings with many global agencies including FDA, EMA, PMDA, TGA and European National Agencies. He has experience in various therapeutic areas including CNS, Oncology, Hematology, Immunology, Diabetes, Analgesia and Wound-Care. He has achieved orphan designations for pharmaceutical products in the EU, US and Australia. Mr. Graham leads a talented team of regulatory professionals that produce client-specific regulatory and development strategies, as well as solutions for global and local market needs.
Dr. Amina UdechukuSenior Research Manager, Real World Strategy & Analytics, Mapi Group
Dr. Udechuku is an evidence-based pricing and market access consultant with over 9 years of expertise in HTA engagements in both healthcare academia and strategic consulting. Amina has experience with a wide variety of health economics and outcome research (HEOR) projects for pharmaceutical, vaccine, and medical device companies. Amina specialises in Health Technology Assessment (HTA) submissions, integrated scientific advice engagements with HTA and regulatory agencies, and value communication strategy and methods. Amina provides leadership on projects in antimicrobials, oncology, neurological disorders, mental health disorders, cardiology and various orphan diseases.
Dr. Sabine LatourGlobal Market Access Director, Debiopharm
Dr. Sabine Latour is a physician with diverse pharmaceutical experience through her work for major pharma, medical device companies, and start-ups. Specializing in value identiﬁcation, as well as clinical and economic evidence generation, Dr. Latour earned her medical degree and completed courses in Pharmaceutical Medicine and Health Economics. She leads international, strategic discussions with regulatory and reimbursement authorities, and payer bodies, both individually, with country HTA entities (GBA, NICE, TLV, AIFA, HAS), and also through joint scientiﬁc council with EMA and HTA entities
Dr. Jacoline BouvyScientific Adviser, NICE
Dr. Jacoline Bouvy is a Health Economist specialising in the interface between marketing authorisation and health technology assessment (HTA) of medicines. She works at the National Institute for Health and Care Excellence (NICE) in London within the Science, Policy & Research team for several research projects on topics such as adaptive pathways and big data for better outcomes in Alzheimer’s disease. Before joining NICE, Jacoline worked at the European Medicines Agency where she was involved in the EMA registries initiative. Before that, she held postdoctoral positions at Erasmus University Rotterdam and Utrecht University in the Netherlands where she worked on various drug regulatory science and health economics topics.
Welcome and value of multi-stakeholder scientific advice
The evolution of the regulatory scientific advice landscape
Integrated (regulatory and HTA) scientific advice in the context of the adaptive pathways approach
Overview of integrated HTA and regulatory processes and the key considerations
Industry learnings from seeking integrated scientific advice
Roundtable discussion panel on multi-stakeholder integrated scientific advice