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ISPE measures impact of biotechnology and globalization on personalized medicine.
Mike Arnold, board chair of the International Society for Pharmaceutical Engineering (ISPE), discusses how the introduction of biotechnology has pushed the industry in the direction of personalized medicine.
PharmTech: How has the pharmaceutical industry evolved since ISPE was founded in 1980?
Arnold (ISPE): In the 1980s, the advent of biotechnology marked the beginning of the industry’s transformation. Biotechnology has contributed to the discovery and manufacture of large-molecule pharmaceutical drugs, and the development of biosimilars. Today, biotech commands significant market share and is driving the development of modern pharmaceutical manufacturing technologies and practices.
Equally significant has been the impact of globalization on the industry, including the ability to reach greater numbers of patients. The resulting market and supply-chain complexities have accentuated the need for development of global standards in regulation and quality, as well as the need for greater transparency and quality oversight.
PharmTech: What do you foresee for the next 10 years in pharma innovations?
Arnold (ISPE): Medicine will become more personalized as biotechnology evolves; patients will reap the benefits of technological innovation. Enter the world of ‘Patient Centricity’. The world will become more ‘flat’ and regulatory operations will become more harmonized.
Biotechnology will have hit its stride and with it modern pharmaceutical manufacturing technologies and practices. It is easy to imagine that pharmaceutical manufacturing professionals will move away from treatments and progress more toward cures.
PharmTech: How has your organization changed over the years?
Arnold (ISPE): In 1980, a few North American engineers who believed the industry needed an organization that would deal with practical applications of science and technology for technical professionals founded ISPE. Almost four decades later, membership is global, and has expanded beyond engineering to include broad representation from pharmaceutical professionals and regulatory agencies. ISPE’s mandate has evolved. Our solutions help members manufacture quality medicines for patients, by providing rapid access to information, driving efficient manufacturing operations, and shaping issues of local and regional relevance. On the regulatory front, we focus on facility licensing, manufacturing processes, quality operations, and supply chain sustainability.
PharmTech: How has your organization influenced the pharma industry?
Arnold (ISPE): ISPE is a collaborative organization that pursues knowledge on behalf of its members. Knowledge sharing and collaboration are its goals. ISPE’s conference program and Training Institute offer participants access to the best and most innovative thinkers, teachers, and trainers. ISPE executives work with regulatory agencies and industry organizations to research, and understand drug shortages, quality metrics, quality culture, data integrity, and assist in the drive toward harmonized global regulatory expectations.
Through our relationships with members, regulatory agencies, and life-science professionals around the world, we hope to influence progress in all facets of modern pharmaceutical manufacturing practice.
PharmTech: How is your organization planning to grow and affect the industry in the next 10 years?
Arnold (ISPE): ISPE recognizes that helping the industry involves more than training and tooling its people in the basics of facilities and equipment, production systems, and quality systems. We intend to strengthen our position as the go-to organization for knowledge regarding designing, building, and operating pharmaceutical plants across all technology platforms. We will continue to respond head-on to evolving industry challenges by fostering knowledge exchange and related professional development that is focused on achieving results. Through our efforts, we will improve the quality of life for patients worldwide.
Vol. 41, No. 7
When referring to this article, please cite it as PharmTech, “Perspective: Biotechnology Moves Industry Toward Personalized Medicine,” Pharmaceutical Technology 41 (7) 2017.