Regulatory pressures are adding layers of complexity to business decisions, pharma companies are increasingly leaning on biotechs to supplement their R&D functions, and global market dynamics are shifting. Together, these factors will challenge the ability of biotechs to bring new and innovative therapies to market. The success of today’s biotechs will depend on their approach when addressing these factors, which could ultimately affect the vitality of the life sciences industry.
Across the life sciences industry, evolving regulatory and compliance requirements are necessary and expected, though their implications are not always foreseeable. Along with the various global and domestic regulations, and grey areas involving regenerative therapies and personalized technologies, there are particular regulatory forces that biotechs need to consider. While the impact may be greater if commercialization is the strategy, these regulations will largely affect how therapies are marketed to potential partners, payers, and consumers.
The Innovation Act bill (H.R. 3309) may impact how biotechs defend their patents. Intended to help reduce frivolous, lengthy and costly patent disputes, the Innovation Act raises many concerns among biotechs that start-ups and innovators will not be adequately protected. The Biotech Industry Organization (BIO), the largest biotechnology trade association, published its concerns about the act,1 and also identified amendments2 that could help address those concerns. Biotechs should stay abreast of the legislation, preparing for the long-term effects it may have on IP protection and innovation in the industry.
Drug Quality and Security Act
In the U.S. and internationally, there are growing concerns around the safety of the medical supply chain, which has led to increased legislation. In the U.S., the Drug Quality and Security Act was recently signed into law, and provides clear guidance for all products distributed in the U.S.; paper Across the life sciences industry, evolving regulatory and compliance requirements are necessary and expected, though their implications are not always foreseeable.
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