Seasoned life science executives, Mel Walker, Ph.D. and Yngve Mikkelsen, M.D. have joined NDA Group bringing their unique and considerable experience to strengthen and expand the breadth of HTA advice provided by NDA Advisory Board.
Kurt Stoeckli, President NDA Advisory Board, comments:
“Both Mel and Yngve understand today’s multi-stakeholder environment for innovative medicines. They excel at providing unique support to our clients at the convergence of medical innovation, commercial value and public health. They bring a unique mix of professional experience and strategic insights is an area of growing need and impact. Such input will continue to play a crucial role for next generation innovations to find the most effective ways to global markets and demonstrating value, so as to bring help to all patients in need. I am excited to welcome them as new members of the Advisory Board”.
Mel utilizes his extensive experience in strategy development to enable companies to achieve success by integrating commercial and patient access requirements at earlier phases of drug development, including Advanced Therapy Medicinal Products (ATMP). His areas of expertise include deep knowledge of European Payer and HTA systems and strategies that optimize value proposition, pricing, reimbursement, patient access and product uptake.
His experience allows him to support clients to better understand their strategic HTA options from TPP development to post-authorisation phase.
Mel, who has held senior leadership roles at Roche, GSK and Otsuka during his 20+ years in the industry says, “NDA are a very well-respected brand in the regulatory field, and I am excited about further developing the HTA aspect of their advisory capabilities and the considerable impact that can be delivered for small companies that lack these capabilities.”
He adds “I am also looking forward to learning from the deep expertise of the other advisors, many of whom have held senior roles in key agencies around the world”.
Yngve excels at advising companies on their development strategies identifying the optimal connection between products and market, facilitating the generation of evidence essential for market access and price optimization and communication of product value to stakeholders. He has experience from 50+ HTAs within various pharmaceuticals, biotechnology, and medical devices across different therapeutic areas. Yngve’s expertise in the use of real-world evidence (RWE) for the novel design of clinical trials has proven to be of increasing importance to clients.
Yngve, who has held senior positions at Biogen and Pfizer in Europe and joins NDA from his position as executive vice president at LINK Medical Research, says, “I am excited to engage with the NDA group because the sole purpose is to ensure the best medicines get to the market without delay to help patients in need. I am intrigued by the high quality of talent at NDA, and I look forward to collaborating and learning from this excellent pool of knowledge and skills “.
The NDA Advisory Board comprises some of the most well-known names in the industry, many of whom have been involved in designing the regulatory and HTA systems in place today. Together, they provide strategic advice and unbiased second opinions to pharmaceutical clients during part of, or the complete end-to-end drug development life cycle. This also includes support and advice during interaction with regulatory agencies, be it at scientific advice, during review of a marketing authorisation application or at any stage post-authorisation.
Johan Strömquist, CEO of NDA Group, commented on the appointment:
“The NDA Advisory Board is one of a kind – no other professional body comes as close to reflecting the current opinions and practices of the world’s regulatory and reimbursement agencies. I am delighted to welcome Mel and Yngve to our team. I very much look forward to working with them to help bring more good medicines to people all over the world.”