Bridging the gap between R&D and marketing

European pharma launches are more challenging than ever and the early launch window is critical to long-term success. 'Evidence is everything' so it is vital for companies to align R&D and marketing functions toward common data goals. Yet, all too often these functions are far from symphonic.

When a chasm exists between marketing and R&D, typically it reflects a difference in priorities. The clinical development team is focused on regulatory approval, while the marketing unit seeks 'value added' evidence that will give them an edge in differentiating the brand. How can pharma address this chasm, and how can service providers help bridge clinical and commercial priorities? By a strong 'multi-stakeholder' approach in key areas of development and commercialisation.

Brand vision
An effective target product profile (TPP) takes a 360° view of the clinical and health technology assessment (HTA) hurdles that must be overcome for a product to be competitive and viable. In October 2009, Tebbey and Rink described a Strategic Evaluation Framework (SEF) that augments the traditional TPP with the vision for the brand and the prevailing needs of the marketplace. In other words, the additional information needed to assess fully the product's market potential.

Service providers with integrated clinical, regulatory, market access and strategic marketing expertise can help characterise unmet medical needs, segment the target market populations, anticipate the data required for HTA and contribute to the definition of endpoints, giving a product an 'edge'.

Bridging clinical and commercial priorities
 Strategic evaluation framework

Investigators
Investigator communications offer tremendous potential for a pharma sponsor, supported by a specialist clinical communications team, to gain valuable interaction with sites about the disease, patient profiles, educational needs etc.

Mutually beneficial interactions between sponsors and study sites help to foster trust and understanding – two important building blocks for advocacy. Successful companies tend to align their teams, communication structures and service providers to ensure collaboration internally, and maximise engagement externally with study sites.

Market access
In today's healthcare environment, where governments increasingly determine price and availability of drugs to patients through formulary designation, market access has been termed the "fourth hurdle" (after safety, efficacy and quality) in bringing a drug to market.

Some service providers offer expertise in reimbursement and market access. This can help clients to define which endpoints they must address during late-phase development, to allow government bodies to appraise their new product more easily.

Communication teams now increasingly include market access consultants, scientific strategists and medical writers, together with creative teams, social media experts and medical event specialists. Such integrated data dissemination expertise helps support accurate, compelling positioning for the product and appropriate advocacy development. It also ensures that data are conveyed to all target audiences in a professional and compliant manner.

A team approach
Successful commercialisation is no longer just about gaining regulatory approval. It is about meeting the needs of a growing number of stakeholders, including physicians, patients, governments and payers. Success requires integrated pharma team working, including the right external expertise where needed, to bridge the traditional silos of R&D, marketing and regulatory, and focus on common goals. This multi-stakeholder approach will ensure your drug gets the best possible chance to succeed in the all-important launch window – and beyond.

The Author
Trevor Fitzpatrick is VP marketing & customer strategy at PAREXEL Medical Communications
Email him at: trevor.fitzpatrick@parexel.com

This article was first published in PME May/June 2010 as part of the Thought Leader series.

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