Ex head of European Medicines Agency (EMA) teams up with NDA
pharmafile | January 20, 2011 | Appointment | |
With new drug development costs soaring the NDA Group launches a new regulatory and market access business that aims to slash these rising costs and address the challenges of drug regulation and reimbursement, to ensure new medicines can get to patients faster. Dr. Thomas Lönngren, previously Executive Director of the European Medicines Agency (EMA), will take a strategic advisory role in the new business.
“The route to market is extremely complex and expensive and many products fail because companies do not fully address the needs to demonstrate the quality, safety and efficacy of their products and also adopting to the European regulatory and reimbursement systems,” said Tony Baker, vice president, the NDA Group. “Many new drug developments terminate before they even reach the regulators. And even if a product gains approval, the industry faces great challenges over pricing and reimbursement from regional agencies. This prevents many potential groundbreaking medicines from ever reaching patients in Europe and world wide.”
Integral to the new business (NDA Advisory Services Ltd) will be NDA’s Advisory Board, which will be expanded to include HTA and market access capabilities. Consisting of prominent ex-members of the EU regulatory committees and network and industry experts, the Advisory Board will include new specialists who will advise pharmaceutical companies how to best prove the value of their products to national agencies, such as NICE in the UK.
NDA already consults more than 400 drug development companies, comprising 90% of the world’s top twenty pharmaceutical companies. It provides advice on good drug development and also helps companies to cut poor development candidates before costs escalate, ultimately saving them money and resources.
Lönngren to realise vision for market access at NDA
Dr. Lönngren, who will play a fundamental role in the new market access business, will build on 30 years experience in the regulatory field including the last 10 years heading-up the EMA with extensive knowledge and understanding of the challenges which need to be overcome for a product to be able to reach patients. One of Lönngren’s key ambitions is to create a coordinated approach to Health Technology Assessment and improve the market access situation in Europe, which completely aligns with NDA’s new business goals.
“I’ve recognized for a long time that the whole area of market access needs new ideas and a new vision. I plan to further develop my ideas surrounding International Regulatory Strategies, coupled with pushing for a joined-up approach to HTA, to enable the best medicines to reach needy patients as efficiently as possible,” said Lönngren.
NDA CEO, Dr. Lars-Helge Strömquist, commented on the venture: “Thomas Lönngren has had a pivotal role within the European drug regulatory system and has been recognized internationally as a key influencer in the pharmaceutical sector. His reputation and vision will be a tremendous asset to NDA and to our customers.”
The new business will be based in the UK and will support European pharmaceutical businesses as well as global organizations looking to launch new medicines in Europe.
About NDA
NDA is an independent consulting group based in Germany, Sweden and the United Kingdom. It’s mission is to ensure that good medicines reach patients without unnecessary delay. It accomplishes this by providing the pharmaceutical industry with a comprehensive range of professional services within regulatory affairs, health technology assessment, pharmacovigilance and quality assurance. NDA’s team comprises more than 25% ex-regulators from major EU Agencies, plus a specialist Advisory Board, which consists of Europe’s leading regulatory experts, who are there to provide scientific advice to pharmaceutical companies supporting them in gaining fast and positive assessment of new drug approval applications from European regulatory agencies.
About Thomas Lönngren
Dr Lönngren finished his 10-year term as Executive Director on the 31 of December 2010. He is now joining NDA as Strategic Advisor to provide top level advice on a wide range of strategic drug development related topics, including regulatory strategy and Health Technology Assessment.
Lönngren is qualified as a pharmacist from the University of Uppsala, Sweden, in 1976 and holds an MSc in social and regulatory pharmacy.
He served with the Swedish National Board of Health and Welfare from 1978 to 1990, where his responsibilities included herbal medicines, cosmetics, medical devices, narcotics and contraceptives. After, Lönngren was appointed Director of Operations of the Swedish Medical Products Agency (MPA), of which he later became the Deputy Director General. During that time, Lönngren acted as senior pharmaceutical consultant for the Swedish International Development Agency’s health cooperation programme in Vietnam between 1982 and 1994.
He became an Honorary Member of the Royal Pharmaceutical Society of Great Britain in 2003 and was made an Honorary Fellow of the Royal College of Physicians in 2004. Lönngren was granted an Honorary Doctorate from the University of Uppsala in January 2008, and received the Drug Information Association’s Distinguished Career Award in March 2008.
