The COVID-19 pandemic has led the public to become more aware of and familiar with the names of regulators and regulatory agencies (e.g., FDA, EMA) inside the pharmaceutical and biotech sector and the balance they need to find between benefit and risk. Defining this balance has become more complex as technology has moved from small-molecule medicine to biologics and monoclonal antibodies and now cell and gene therapies with companion diagnostics to devices and digital applications. At the same time, society is seeking greater transparency on these decisions. Taken together, this has created today’s ecosystem of healthcare partners (patients, academics, physicians, payers) who regulators need to engage and to which the regulatory frameworks need to adapt.
New technologies have meant new demands and challenges for the regulators. Novel technology, methods, and data sources have meant a review across the full span of their remit:
Regulatory and legislative frameworks still differ between regions despite more than 20 years of international harmonization. Furthermore, to meet the challenges previously noted, many of these frameworks are being reviewed or refreshed for their ability and agility to address the modern pace of change. Some examples of this include:
The first FDA approvals for cell and gene therapies occurred in 2017, and while the pace of registration has not been as fast as originally anticipated, the European regulators are estimating 10 reviews per year by 2025. Many of these programs are in rare or ultra-rare settings, and we are seeing the truest test as to whether more regulatory agility is needed. Regulators from across the globe express wanting communication early and often (e.g., FDA INTERACT meeting) and to have this be part of a multistakeholder dialogue (e.g., EMA-HTA, UK ILAP).
Medical and clinical regulations are evolving to be agile and responsive to the changing needs of society. Medicine at large can only benefit from these newer proactive and interactive communications between academics, investigators, and regulators.
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Precision for Medicine is part of the Precision Medicine Group, an integrated team of experts that extends Precision for Medicine’s therapeutic development capabilities beyond approval and into launch strategies, marketing communication, and payer insights. As one company, the Precision Medicine Group helps pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.
