Bright and early

Creating a clear and consistent communications strategy around a development-stage product is often put off until phase III, but there are a number of ways that medical communications agencies and industry can combine much earlier in the process to help navigate the challenges during clinical development and prepare for a successful launch.

The healthcare conversation has many data points, many decision points and many stakeholders. And as our health system continues to evolve – with patient-driven decision-making, social networking and comparative effectiveness research dominating recent headlines – there is more at stake for pharmaceutical and biotechnology product-makers than ever before.

At the same time, fewer drugs are being approved by the Food and Drugs Administration (FDA) today than only a few years ago. And profit-driven manufacturers have been forced to scale back, or cut out entirely, some of the functions and internal personnel they had previously employed a decade ago.

Finally, as the ever-looming patent clock is counting down, pharma has many challenges and checkpoints during early-phase testing and clinical development. Against this clinical and regulatory backdrop, one must consider the litany of product development inputs and outputs that need to happen throughout clinical development, including:

• Protocol design
• Target product and patient profiles
• Market understanding and segmentation
• Intellectual property issues
• Mechanistic validation
• Positioning
• Branding
• Pricing and reimbursement
• Dissemination and publication of original research
• Communications strategy.

The result? The organisations and teams that shepherd products through all phases of clinical testing have to do more with less these days. Thus, it is imperative that medical affairs teams and their brand lead counterparts link up early on with a trusted medical communications agency.

What about trust?
The healthcare dialogue in today’s world is tightly regulated and fraught with mistrust. The lay press, the peer-reviewed publishing community, healthcare providers, government entities and, thus, patients share a healthy scepticism when it comes to pharmaceutical and biotechnology industry, due in large part to some of the past practices that are no longer in the mode.

However, the most important element in the communications mix – irrespective of whether the channel is scientific, educational or promotional – is to gain the trust of clinicians, scientists and patients.

What are the two most important factors in building trust and credibility in your communications plan?

1.    Presenting and publishing clinical trials results quickly, accurately and to the right audience. Yes, there are now legal obligations to be met with regard to the accuracy and timeliness with which data is disseminated. But there is a big difference between dissemination and publication; and reaching the appropriate audience can sometimes be equal parts art and science. Publications professionals – a discipline unto itself in the medical communications world – are expert in navigating these and other factors that are part of the decision matrix in our current publications climate.

2.    Facilitating a peer-to-peer dialogue. Physicians and other healthcare professionals rely on one another in their assessment of new therapeutic approaches. Leo Francis, PhD, President of the Publicis Medical Education Group, recently told MedAd News that ‘motivated healthcare professionals are great catalysts for engaging and educating their colleagues in a way that reinforces and facilitates consumption of critical information about new developments in healthcare’. Indeed, pharma can provide the appropriate data to support these peer-to-peer exchanges – and their medical communications agency partners can facilitate these discussions.

The common denominator for both publishing and peer-to-peer interaction is, of course, evidence. When there is an evidence-based foundation, there is integrity. And where there is integrity, we can regain trust.

How early is too early?
It’s never too early to begin planning or executing your communications plan and paving the path of trust. Each company and product situation is different, so there’s no universal approach. However, it is critically important to create a clear and consistent communications strategy – anchored by scientific and clinical evidence. Setting that strategy all too often happens in phase III, when it’s sometimes too late to execute against. Thus, the ideal scenario is for the agency to be brought on board between phase I and phase II. Tight budgets are often a rate-limiting factor at these earlier stages, but a team that uses partners early and wisely can be surprisingly effective in setting a clear strategy.

What are the ways in which medical communications agencies and industry can partner early in the product life cycle?

• Thought-leader (expert) identification and influence mapping
• Thought-leader engagement
• Publications planning and execution
• Facilitation of peer-to-peer exchange
• Depiction of mechanism of disease
• Scientific platform development
• Lexicon creation.

Agency selection
What should you look for when searching for the right agency partner? The following are considerations for assessing your potential agency partner:

1.    Proportion of in-house talent versus outsourced support. Most agencies employ a core set of senior and strategic personnel; not all companies employ a full complement of support staff (including digital strategists, graphic designers, editors and proofreaders); fewer still employ the content catalysts themselves: the medical writer. When looking at a potential agency, be sure to dig deep into the staff plan and understand the composition of the day-to-day team – who they are and by whom they are employed.

2.    Staff qualifications. Again, if talent drives content, you need to assess the qualifications of that talent. In addition to checking resumés, it is worthwhile to understand the educational backgrounds of the key staff, particularly on the medical or scientific teams. And if a professional certification is relevant – as it is for publications professionals, for instance – then this should be factored into the assessment.

3.    Digital expertise. While the pharmaceutical industry and FDA continue to wrestle with appropriate communications strategies that utilise today’s technologies, the agency world continues to innovate when it comes to employing digital media. Mobile platforms and smartphones, social media, augmented reality and two-dimensional bar codes (ie, Jagtags) are some of the channels and through which customers are engaging with content. Physicians are no longer the ‘late adopters’ of technology that they were half-a-dozen years ago. Agency digital personnel continue to define and refine the ways in which technology can be used for engaging the target audience.

4.    Demonstrated experience in the therapeutic category. A qualified, talented staff does not necessarily equate to therapeutic mastery. Yes, part of the agency’s job is to ramp up quickly. But it should also come to the table with a track record in the category that demonstrates a certain amount of understanding about the competitors, the experts, the meetings etc.

5.    Work samples. Before the agency can be hired, it’s a good idea to see similar work done for another client. The examples can be blinded to protect confidentiality. But the pharma team should have comfort that the agency is not doing something for the first time on its clock.

6.    References. You do reference checks before hiring an employee, right? Well, hiring an agency is no different. Speak with current clients, past clients, and (if possible) other teams within your own company who have worked with the agency before.

In summary, industry faces many challenges in the development of its products. Many of those are out of the team’s control. But one of the decisions that does rest in pharma’s hands is the choice to partner with a trusted medical communications agency early in the process. And a successful partner can provide the consultation and seamless integration that is needed to meet the team’s objectives – and bring the product to market.

The Author
J.R. Meloro, Executive Vice President and Managing Director, Medicus International New York, is a Certified Medical Publication Professional. He can be reached at (212) 448-6858 or at jr.meloro@medicusintny.com