Scope: Increasingly, medical product development, authorization, marketing, promotion, production and transport have become more complex and more globalized. The U.S. Food & Drug Administration is authorized to enter into memoranda of understanding and confidentiality commitments on the sharing of non-public information with foreign government officials. The FDA has acknowledged the need for such coordination to avoid duplication of costs and regulations, particularly where a majority of new products (or portions of a product) originate in foreign countries.
In the field of pharmaceutical and biopharmaceutical products, service providers offer contract services that cover the full life product life cycle. At the early stages, service providers conduct research and formulation of new products (“new drug applications,” or “NDA’s”), analytical testing and clinical testing. At the more mature stages, service providers engage in contract manufacturing, packaging, distribution and logistics management. At certain inflection points, third parties can help with product recalls, publicity and brand management. Outsourcers include clinical investigators (“CI’s”), contract research organizations (“CRO’s”), project monitors, and contract development and manufacturing organizations (“CDMO’s”).
Technical Requirements: Beyond technical expertise in biopharma and process management, the most important technical qualifications in pharm-sourcing are confidentiality, secrecy and protection of proprietary rights from wrongful disclosure and unfair competition. Pharma companies need the information technology for secure communications. The legal frameworks in the service delivery centers need to conform to global standards in all markets. Contract service providers must also comply with applicable regulations including
- “good laboratory practices” (“GLP”);
- “good clinical practices” (“GCP”); and
- “good manufacturing practices” (“GMP”).
Pharm-sourcers should have the capacity to assist pharma companies with safety signal detection and drug risk evaluation relating to the post-marketing safety of drugs, which may include “pharmacovigilance” functions such as identification of relevant information for disclosure to the public, risk-minimization action plans (“RMAP’s”) or risk-management plans (“RMP’s”).
Benefits: Outsourcing of product formulation, research and development, as well as clinical trials, can greatly reduce time to market, as well as reducing costs and risks. Finding and contracting with the right contract manufacturer can also achieve guaranteed product quality, reduced processing costs for smaller batches and for volume sales, access to current manufacturing technologies, equipment and processes from “best in class” providers, and experience and “best practices” (“good manufacturing practices”, or “GMP”) in meeting stringent regulatory standards. Outsourcing can help expand market shares for generics and improve market penetration for new and improved drugs.