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).
The business case for early adoption of product lifecycle management
The business case for new drug development is both difficult and risky, but the effective use of product lifecycle management
strategies can reduce risk and increase opportunities for innovator companies of all sizes. For product lifecycle management
to be most successful, the groundwork must be integrated early in the drug development process, as opposed to added on a few
years before a patent expires. A diverse, cross-functional team working at the clinical stage enables companies to:
- select the optimal therapeutic indication;
- develop effective formulation strategies;
- manage intellectual property;
- gather competitive intelligence;
- understand payer policies;
- develop marketing messages;
- develop proactive regulatory strategies;
- use lifecycle management tactics to expand beyond the base indication of the initial product launch (2, 7).
