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Outsourcing Reformulation and Life Cycle Management: The Expanding Role of CROs

Michelle Hughes is a section head, Formulation Development, at MDS Pharma Services, and Kim Black-Washington is a product manager, Pharmaceutics, Biopharmaceuticals and Pharmacology, MDS Pharma Services, tel. 425.487.8282, kim.black-washington@mdsps.com

Recent industry discussion has focused on moving contract research organizations (CROs) from the traditional role of supplemental capacity supplier to strategic and collaborative partner with pharmaceutical companies. Increasing needs to maximize the value of existing products as well as a rise in poor clinical-trial results attributable to formulation have led to redefined CRO–sponsor relationships and a greater reliance on CRO expertise in product reformulation and lifecycle management. Traditional pharmaceutical, specialty pharmaceutical, and biopharmaceutical companies must now shift their attention to product lifecycle management tactics from as early as preclinical development throughout market life (1, 2). Forward-thinking CROs provide strong evidence for the new dynamic by offering innovative solutions to product reformulation challenges for a variety of pharmaceutical dosage forms and by working to identify and execute strategies that are closely tied to client needs at every phase of the product lifecycle. Exploring the CRO advantage Industry trends depict an increasing percentage of strategic outsourcing by traditional Big Pharma companies—which are well regarded as experts in integrated brand-defense strategies—electing to rely on external expertise for complex formulations and product reformulation while retaining internal core competencies such as drug discovery and product commercialization (1, 3). Small and medium specialty pharmaceutical companies as well as some biopharmaceutical companies rely on CRO expertise as a survival strategy in all aspects of product lifecycle management. CROs that have successfully aligned their capabilities to match increasingly complex client demands are positioned to provide sponsors with a competitive edge. Beginning as early as preclinical development, these CROs offer strategies for accelerating drug development such as expedited formulation and direct-fill of active pharmaceutical ingredient (API) into capsules for early clinical proof-of-concept studies. During prelaunch and the patent exclusivity period, CROs can work with sponsors to build prelaunch awareness and develop a product launch strategy that enables sponsors to maximize initial sales and product profitability through line extensions, product reformulation, and identification of new active ingredient forms. Finally, CROs can gather competitive intelligence and work with sponsors to develop a strategic plan for extending the patent exclusivity period through product reformulation, new dosing regimens, or novel delivery mechanisms. Lifecycle management: no longer an option Diminishing product pipelines, soaring drug development costs, strict regulatory requirements, and a competitive environment characterized by increasing generic competition define the current situation faced by pharmaceutical companies. Pharmaceutical companies must engage in product lifecycle management to exploit the full commercial potential of existing molecules and minimize the effect of generic competition. Fortunately, product reformulation and lifecycle management often increases benefits to consumers. To extend exclusivity, new products from existing branded products must show a clear, improved clinical benefit over existing products while ensuring safety and efficacy. These advantages may include enhanced kinetics, improved patient compliance, preferred dosing regimens, novel delivery systems enabling more accurate dosing or higher efficacies, improved safety profiles, new indications, or alternative dosage choices (1, 2). Understanding that few blockbuster products achieve top sales based solely on initial formulations and indications, pharmaceutical companies have developed systematic brand management strategies to prolong marketability and maximize product revenue and have engaged in portfolio management to deliver maximum return on investments. A recent report states that 43% of global brand teams begin lifecycle management planning as early as Phase I development. Early planning has proven most beneficial in retaining market share, defending patents, and anticipating competitive threats. Strategies for the most active pharmaceutical brands target a new product launch every year after the initial product launch, which can result in as many as 10 product formulations or indications (4–6). (continued)