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At a GLANCE
This special Year in Preview issue provides insights into the trends that will impact the industry in the coming year and beyond. Below are some highlights from the sectors covered in the following pages. Focus on specialty markets David Avitabile President JFK Communications Inc. Last year, I predicted that during 2008, the focus on specialty markets was going to increase as more companies recognized the wisdom of developing strength in key therapeutic areas. This year, major pharmaceutical companies have bought into this strategy in a big way —witness the acquisitions of specialty pharmaceutical companies by major pharma companies. Novartis acquired Speedel Laboratories to strengthen its focus on cardiovascular and metabolic diseases. Eli Lilly acquired ImClone to build on its strengths in the oncology market. Takeda acquired Millennium to give the Japanese company a significant foothold in oncology. Big pharma is spending less time trying to develop blockbusters and more time looking for deals that add to their pipelines and reduce overall R&D costs. Specialty pharmaceutical and biotech companies are finding ways to maximize R&D efficiencies and maintain their focus on significant unmet medical needs. JFK Communications, Princeton, N.J., is a healthcare public relations firm that partners with specialty pharmaceutical, biotechnology, and medical technology companies. For more information, visit jfkhealth.com. Editor’s Note: To read more about new development models, please turn to page 64. Welcome to the party Dan Berman CEO PharmaCentra LLC Social media networks have proven themselves as essential and valuable marketing channels, despite lagging participation from pharmaceutical companies. Progressive marketers have made forays into social media through third-party sponsorships, essentially piggybacking onto the momentum of established groups. In 2009, my prediction is that pharmaceutical companies will evaluate their participation in social media networks against that of brands in other industries — and that self-examination will drive them to join the party. PharmaCentra, Atlanta, creates marketing programs that help pharmaceutical companies communicate with physicians and patients who depend on their brands. For more information, visit pharmacentra.com. Editor’s Note: To read more about social networks, please turn to page 90. Postmarketing Studies Richard Gliklich, M.D. CEO Outcome As I predicted last year, 2008 has seen a tremendous rise in postmarket safety registry requirements pushed forward in large part by the passage of FDAAA and Risk Evaluation and Mitigation Strategies (REMS). This has become a tremendous part of what clients are seeking help with. In 2009, expect this trend to continue to grow nationally and internationally. Also, expect to see more attention being paid to comparative effectiveness — or how one product compares with other treatment options in real-world use. There is currently work under way (GRACE Principles — graceprinciples.org) to set principles to guide comparative effectiveness research. Outcome, Cambridge, Mass., is a provider of patient registries, postapproval studies, quality improvement programs, and integrated technologies for evaluating real-world outcomes. For more information, visit outcome.com. Editor’s Note: To read more about postmarketing safety, please turn to page 64. Assessing the Value of Medicines David Harrell President and CEO OptimizeRx With the 20%-plus growth in the number of consumers and physicians seeking specific healthcare information, treatment choices, and healthcare purchase transactions via the Internet and other digital media, pharmaceutical manufacturers will need to do a better job addressing their value propositions directly to patients, including the economics associated with increased out-of-pocket costs for their brands. This is especially important for specialized and chronic medications. OptimizerRx, Rochester, Mich., provides platforms to help patients better afford and comply with their medicines and healthcare products, while offering pharmaceutical and healthcare companies effective ways to expand patient awareness, access, and adherence to their brands. For more information, visit optimizerx.com. Editor’s Note: To read more about new communications media, please turn to page 90. Acquistion strategies Nicholas Landekic President ,CEO, and Founder PolyMedix Inc. There will be more acquisitions of small- and medium-sized biotech companies by big pharma and big pharma wannabe companies (big biotech). There is a direct correlation between company size and the emptiness of product pipelines. In the near term, companies will try to buy their way out of the desert by acquiring companies with earlier-stage pipelines. There will be more attempts to find uses for failed compounds. One thing the industry has no shortage of is compounds that have failed clinical trials. There will continue to be greater efforts to unlock these investments and find new uses for, and ways to commercialize, these compounds, some attempts legitimate, others pure fantasy. Breakthrough products will be in increasingly short supply, at any stage of development. With viable late-stage products all but dried up, and with few companies willing to invest in early-stage discovery, there will be increasingly fewer products with major market opportunities. PolyMedix Inc., Radnor, Pa., focuses on developing novel high-value therapeutic drug products for serious, life-threatening acute disorders. For more information, visit polymedix.com. Editor’s Note: To read more about early-stage research, please turn to page 58. A specialist role Beth A. Price Executive VP The Medical Affairs Company The MSL role is evolving from a generalist to a specialist role based on a host of factors: life-cycle management, product complexity, market dynamics, and stakeholder needs. Clinical trial liaisons engage in scientific exchanges with sites and physicians to differentiate clinical trials and aid enrollment. Clinical specialists have emerged to provide key local physicians with targeted, clinical presentations. Field-based outcomes research managers target healthcare policy, government, MCOs, and payer organizations with value-based economic modeling weighing the clinical advantages of using more costly therapies. The advent of a new hybrid MSL function, the clinical specialist, is a response to salesforce reductions. Traditional MSL teams engage in scientific exchanges with national and regional KOLs. In response to increasing demand by key local physicians for disease state and clinical data, companies are deploying healthcare-degreed liaisons at the local level to provide educational support directly to these physicians, an area once reserved as the purview of sales teams. Contrary to industry downsizing trends, the expansion of the classic MSL role to now include more specialized functions will result in an influx of field-based medical opportunities. MSLs will have opportunities to become therapeutic specialists as well as functional experts who possess in-depth knowledge targeted to specific stakeholder groups, for example managed-care decision makers. The Medical Affairs Company (TMAC), Kennesaw, Ga., provides pharmaceutical, biotechnology, and medical-device industries with a complete array of strategic and tactical medical affairs solutions, including: contract and consultative MSL programs, MSL knowledge management solutions, and medical communications services. For more information, visit themedicalaffairscompany.com. Editor’s Note: To read more about the changing salesforce model, please turn to page 82. Improving the Dialogue Tammy Smalls Senior Director Consumer Marketing AstraZeneca Our goal is to help the right patient get the right medicine at the right time. Our programs are designed with the intent to ensure that our communications encourage conversations between patients and their doctors, ultimately resulting in positive patient outcomes. We have several programs that are effective at accomplishing this. For example, our Crestor 360 program is an outstanding example of a cross-customer, cross-channel integrated campaign; it promotes and impacts the dialogue between these audiences, enhancing the campaign’s overall effectiveness. Both physicians and consumers are efficiently pulled through awareness, to interest, to preference, via the enhanced dialogue that the campaign makes possible. AstraZeneca also offers patient materials to assist healthcare providers in their ability to provide resources to patients. For example, The AsthmaKidCare (AKC) program was developed to help grow Pulmicort Respules volume and give moms the support they need to better care for their young children who have asthma. The program teaches them the importance of recognizing and treating uncontrolled asthma. AKC also serves as an invaluable platform to help meet and overcome the challenges surrounding nebulizing by providing better understanding about asthma and the medicines used to treat the disease. The program was publicized in DTC print and through physician offices. AstraZeneca, Wilmington, Del., discovers new medicines that are designed to improve the health and quality of life of patients around the world. For more information, visit astrazeneca.com. Editor’s Note: To read more about patient education, please turn to page 98. a different kind of hybrid Robin Winter-Sperry, M.D. President and CEO Science Oriented Solutions and Scientific Advantage LLC The MSL position is more universally accepted as a role and as a vital part of the industry. There are more hybrid teams — mixed backgrounds — the majority of whom have doctoral-level scientific degrees. This is especially true for emerging companies whose resources are limited and need to have their MSLs wear different hats — ranging from research support to commercialization and beyond. Although the role and responsibilities are different from other field-based teams such as sales representatives, increased industry regulation and decreasing access make the role of the MSL and his or her unique ability to engage in a peer-to-peer scientific exchange with healthcare providers even more important. Serving as a field-based medical resource is critical as new therapeutic agents become more complex and personalized medicine continues to evolve. Healthcare providers need access to a timely, data-driven, fair-balanced scientific information exchange, and MSLs are a conduit of scientific information between providers and their companies. Science Oriented Solutions, Kennesaw, Ga., and Scientific Advantage, Bernardsville, N.J., in strategic partnership, provide global medical affairs and MSL resources. For more information, visit scienceorientedsolutions.com and scientificadvantage.com. Editor’s Note: To read more about personalized medicine, please turn to page 72. F PharmaVOICE welcomes comments about this article. E-mail us at firstname.lastname@example.org. November/December 2008 PharmaVOICE