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Regulatory Compliance/FDA product and clinical development plans." THE VAST ROLES OF RI If a company plans to submit an application to the FDA for marketing approval of a biosimilar, the RI staff members' job would be to provide the agency with detailed information about the safety and efficacy of the biosimilar products that have been on the market in Europe. "The FDA loves data," Buehler noted. The EMEA, which has given marketing approval for biosimilar products since 2006, is now the largest biosimilar market worldwide. Biopharmaceutical companies also love data, particularly when considering in-licensing a ment the work of RI staff. But, even if consultants are hired, RI leaders should continue to keep abreast of regulatory agencies by, for example, attending open-to-the-public FDA sessions. Attending these meetings and paying attention to thought leaders such as Dr. Temple are among the best of the "best practices" to impact the company's bottom line. Experience makes a world of difference. "Global regulatory drug development is more complex than ever before." Gary Buehler, VP of global regulatory intelligence and policy, Teva Pharmaceuticals new compound, a merger and acquisition, or a strategic alliance and partnership with another company. "RI is often employed as part of a due diligence team in looking at existing and/or emerging products that a company may want to partner on or acquire," he said. "The RI team will review the potential asset to help formulate a regulatory benefit/risk that is factored into the comprehensive due diligence efforts." RI is typically separate from but collaborative with the competitive intelligence (CI) function at biopharmaceutical companies. "CI focuses more on the financial side of the business, looking at market shares, sales, and pricing," he said. There are points of overlap, for example in claims and promotion, in which RI and CI should work together to provide a comprehensive picture to guide the company. To guide the regulatory decisions of the company's leaders, RI staff must develop systematic procedures to review, document, and summarize massive amounts of data. "The leaders of all affected functions at the company should be trained or informed in a timely manner," Buehler said. Biopharmaceutical companies often turn to specialized external consultants to supple- Ash Stevens has been providing the Life Sciences industry with contract pharmaceutical manufacturing services for more than 50 years. s s s s s s Process research, development, and scale-up Early-stage to commercial API manufacturing Highly potent drug substance development and cGMP manufacturing Analytical development and validation Comprehensive regulatory support Preparation of documentation for submission (IND, NDA, DMF, CTD) To see how our experience can help your drug development program succeed, call or click today. 734-282-3370 ashstevens.com Visit Ash Stevens at BIO Booth # 5243 April 2013 LifeScienceLeader.com 53