Former EMA chief Lonngren teams up with NDA Group, which launches new unit; Almirall names R&D chief

With new drug development costs soaring, the NDA Group has launched 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. Thomas Lonngren, 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 adapting to the European reimbursement systems,” said Tony Baker, vice president of the NDA Group, which has operations in Germany, Sweden and the UK. “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,” he added.

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 European Union 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 the National Institute of Health and Clinical Excellence (NICE) in the UK.