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Survey Finds Key Barriers to Pharmaceutical Innovation
Nearly 400 industry professionals share the challenges and opportunities for innovation.
3 Min Read
Survey participants noted two key barriers to pharmaceutical innovation.gorodenkoff / iStock / Getty Images Plus via Getty Images
The International Society for Pharmaceutical Engineering recently surveyed nearly 400 pharmaceutical professionals in order to uncover and address the barriers to pharmaceutical innovation.
They weigh in on challenges and opportunities with introducing technological innovation, citing economic factors and regulatory concerns as key barriers.
The ISPE released a report on its survey, “Enabling Global Pharmaceutical Innovation: Delivering for Patients,” which includes insights from 391 respondents from the pharmaceutical industry with a mix of large to small manufacturers, contract and development organizations, suppliers, facilities, software service providers, and more, from multiple countries and reflecting multiple product modalities. The majority of responses came from brand name companies.
Survey participants also included the types of products they were responsible for including large molecules, small molecules, combination products and vaccines, medical devices, companion diagnostics, as well as manufacturing and analytical equipment/components/facilities, digital software, process materials, and reagents.
Top Challenges and Factors Impacting Innovation
In general, economic factors were the primary drivers determining the cost/benefit for capital investment in innovative technology
The current regulatory environment poses a significant challenge to implementing continual improvement and innovative technologies
Regulatory challenges were reported by nearly half the respondents (48%) as the most significant or significantly greater than other factors in terms of influencing decisions to develop innovative technology
The top concerns with regulators accepting innovative technology were around challenges during application reviews and a lack of globally harmonized regulations
When the level of uncertainty associated with divergent regulatory expectations is relatively high, the potential value of an innovation relative to its return on investment becomes difficult to estimate and justify. Subsequently, according to many respondents, innovative approaches are often postponed or even terminated until after the regulatory environment is deemed to be more favorable
The regulatory environment is complex. As this report indicates, regulatory harmonization will be a critical component to enabling innovation in the pharmaceutical industry. ISPE strives to facilitate industry-wide clarity surrounding regulations. Survey reports like this one, which provide statistically significant data points drawing from insights shared by hundreds of professionals, will enable us to advance efforts between the industry and regulators and ultimately help to shape the future of the pharmaceutical industry – Thomas B. Hartman, ISPE President & CEO
Top Recommendations for Pharmaceutical Regulators & the Industry
Establish an efficient system that connects regulatory authorities with the industry and fosters opportunities for companies and vendors to propose and establish innovations for global consideration, acceptance, and implementation
Align application review/assessment processes that cultivate a convergent approach to evaluate the merits of innovative technologies and produce a combined list of queries from global regulatory authorities
Adopt a single or limited GMP inspection schedule for assessing the implementation of innovative technologies per manufacturing facility (when required) in accordance with global inspection standard
Initiate global regulatory authority approvals that rely on mutual reliance/recognition
Establish a predictable global regulatory authority review/assessment/inspection and approval schedule that ensures global supply chain reliability and patient access
Introduce a globally harmonized regulatory process to support review, inspection, and approval of platform technologies, which may apply to multiple products
ISPE is planning to present proposals to multiple regulatory agencies intended to promote practical incentives for the industry and regulatory authorities to address specific challenges to innovation and continual improvement initiatives.
Additionally, the ISPE team will work with pharmaceutical industry and equipment suppliers to understand the steps needed to introduce innovative technologies and develop a “points to consider document” with key considerations about how to address specific challenges to innovation and continual process improvement.
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