By Michael CasoBackground and Objectives
The rationale and benefits of having a scientific platform and subsequent publication plan for a new drug entity are well established in the biopharmaceutical industry. The ability to disseminate clinical concepts and research results to as wide an audience as possible has demonstrated significant value to biopharmaceutical organizations. It is true that we have successfully developed a comprehensive set of strategies and tactics designed to identify market gaps and key scientific communications, as well as research appropriate publication and presentation venues. However, simply planning a publication placement does not maximize the value of that article. Publishing the scientific data that our preclinical research and clinical development teams have worked hard to produce validates or disproves the original scientific hypothesis. So why do we think that simply publishing the content is all that needs to happen? Biopharmaceutical content dissemination needs to catch up with the approaches taken in other industries, proactively expanding the audience and digitally presenting key messages to reach a larger range of key targets through currently available electronic communication vehicles. So yes, while the terms “marketing” and publication planning are not normally used in the same sentence, there are ways to accomplish a myriad of product objectives at pre-publication, publication launch and post-publication timeframes. At Omni Healthcare Communications (Omni-HC) we believe all publications should:
Concept Overview As stated previously, the development of a product’s scientific platform forms the foundation upon which all communications activities can be developed. Key to the early awareness and long-term success of a product are the:
Scientific Platform Stakeholder Expansion The mission of a truly comprehensive scientific platform should be to Educate, Empower, and Engage all key stakeholders, including providers, payers and patients. On the other hand, Medical Affairs teams don’t have as strong a relationship with all stakeholders that allows the ability to publish data once and all will see it, especially if published in a journal behind a pay access wall. In the digital age, traditional publications and the underlying communication plan can be enhanced, not just by more publications, but also by using electronic means to enhance and disseminate key information. Key Issues to Address
Key Opportunities for Action Pre-publication communications Creating awareness of upcoming publications is a productive way to prepare targeted audiences for your soon-to-be-published manuscript. Many journals are now providing services designed to alert subscriber targeted audiences to upcoming publications. Specific opportunities are outlined on publisher websites and should be considered into the publication plan. Enhancing awareness at publication The use of social media tactics commonly used in reaching consumer audiences has now reached the medical communications industry. A well-developed plan of action for a publication plan would include the following:
Post-publication follow-through In the current medical communications environment, we are all being required to demonstrate value for the services we provide. This is also the case for publication planning. Simply submitting a publication to a journal is not sufficient. What are potential opportunities to capitalize on manuscripts in print, as well as show an impact of our publication planning recommendations?
Scientific publications have been the archive of scientific evidence for over a century. Within the scientific archive, it is estimated there are almost 50 million scientific papers have been published and the number of papers published each year is increasing. Although simply publishing the data gives a reference point for future use, much like anything else, the more stakeholders are exposed to the data and message the better the scientific exchange. All these areas mentioned above help to broaden the audience for the scientific communication and increase the value of the effort to the company. At Omni-HC, we actively consider all the various ways that publications and other communications may be enhanced to generate the maximum value from the company effort. We strive to not only efficiently develop communications for the various key audiences, but also to expand the audience for that communication and message.
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By Steve CaseyEarly-stage companies commonly focus solely on investors and regulatory stakeholders and overlook other stakeholders who are critical in optimizing the later development-commercialization pathway. Addressing these other stakeholders maximizes the “downstream” value of any product. Such stakeholders are gatekeepers critical to life-cycle areas such as market access, reimbursement, and medical education. Even investors in early-stage companies are now considering the impact the “downstream” stakeholders have on their ability to secure financial exits. Today’s newly minted healthcare-product companies are frequently being asked to demonstrate both regulatory viability and commercial potential at the earliest stages. Long gone are the days when a product would “sell itself” and companies could count on guaranteed reimbursement and rapt attention from healthcare providers. Rather, today’s stakeholders are focused on specific therapies with defined risks and demonstrated healthcare benefit. As a result of these changes, a broader definition of product success must be established during early development to generate a rational basis and plan of action for both product approval and commercial success.
Engineer the Product Value It has long been understood that an evaluation of commercial potential during the early stages of clinical development in parallel with a well-developed regulatory strategy can greatly increase the value of a product. The integration of market forecasting, health economics, reimbursement and anticipated medical practice input leads to a development strategy that engineers more value and is more cohesive than a traditional staged approach. While commonplace in large pharmaceutical companies, this integration can be difficult for smaller companies where resources are limited, information is incomplete, and, frankly, product commercialization is viewed as the job of whatever company decides to license the product. While many legitimate limitations exist in the ability to describe a product’s potential completely at an early-development stage, future success will be determined by how well companies are able to structure integrated development programs to meet the needs of all stakeholders. How to Get There from Here Fortunately, it doesn’t require armies of healthcare professionals, scientists, and MBAs to develop an integrated clinical, regulatory, and commercial development plan. If a company takes a structured approach to establishing the program goals, much of the information is common to all perspectives. It has been said that the value of a product is driven by its product label; this is true if the commercial aspects of a healthcare product’s business are limited to communicating only what is in the label. To help guide development programs the FDA has provided a good starting point for drug developers with the Target Product Profile (TPP). The FDA TPP template follows the major categories of a package insert, allowing developers to forecast the desired target product attributes and track progress against this profile. The TPP tool is well understood and should always be used by companies developing new therapies. However, the TPP is focused primarily on regulatory approval and is not sufficient to describe fully the commercial attributes of a successful therapeutic. In parallel to the development of the TPP, companies should also consider creating a value hypothesis. The Value Hypothesis A value hypothesis considers the desired global commercial attributes for the therapeutic. As with the TPP, for early-stage programs the value hypothesis will be more general and aspirational in nature, but the real value of the hypothesis for an early-stage development program is in its creation. The development of the hypothesis, the identification of unknowns, and the specific questions that are generated as a result of the analysis, will all guide where early-stage candidates may warrant additional commercialization diligence. While all items will be important eventually, prioritizing where a company should focus limited resources in the value hypothesis is an important decision. A Value Hypothesis The importance of intellectual property (IP) protection in the biopharma industry dictates that IP strategy should be the top priority. Although many companies have competent legal staff handling their IP strategy, many early-stage programs stop with IP and provide limited focus to the other important elements that define commercial value of an early-stage therapeutic (ie. clinical differentiation, pricing/reimbursement, and demand forecasting). An exhaustive analysis of these commercial components is not practical or necessary at the early stages of product development; however, any company seeking to invest $10M or more in getting to a Phase 1 clinical study should have a clear understanding of the commercial assumptions for their product. But a value-hypothesis analysis is extremely valuable and better informs clinical decisions. Starting with a value hypothesis, therapeutic developers will improve clarity of the development/commercialization pathway, enhance confidence in the clinical program, and create a solid understanding to address stakeholder needs. This integration of regulatory and commercial factors will be critically important for product success in the new healthcare-market dynamics. The senior staff at Omni Healthcare Communications have extensive expertise in creating value hypotheses for developmental agents during their experiences while working at pharma companies and as proactive agency partners. Omni welcomes the opportunity to bring an unparalleled depth and breadth of experience to maximize the benefit and value that your product can achieve. by Michael Caso Biopharmaceutical companies pride themselves on conducting comprehensive research activities. These could be clinical programs to determine the viability of a new chemical entity to satisfy an unmet medical need, market access programs, or more recently, patient-centric needs of targeted populations. Why then have these same companies virtually ignored the medical, social and cultural needs of the fastest growing segment of the U.S. population? Ethnic and racial minorities currently comprise over 30 percent of the U.S. population and will grow to 50 percent by 2050. In fact, in many geographical areas, minority populations represent an “emergent majority” — a collective majority of minorities. Additionally, this population can have unique responses to medications and are differentially impacted by a number of common disease states for which they are diagnosed later and have poorer control or survival rates than majority populations. It would appear that there exists a nexus of needs and opportunities that should appeal to the biopharmaceutical industry, where a focus on a medical need can result in a healthier population and a healthier bottom line. This is the first of a three-part posting that will provide supportive data that identifies the need, demonstrates targeting opportunities, and provides specific strategies and tactics designed to positively impact complementary health disparity reduction and business goals. By Dana Randall, PharmD and Kevin D. Pawley Academic scientists share a mantra: “Publish or perish.” The cornerstone of the scientific process—and the accurate record of it—is peer-review publication of studies in scientific journals. Without publications in such reputable journals, flawed studies and their results may gain impact and real scientific advances may be lost. The continual practice of holding scientific developments up to peer review and documenting by publication the scientific process from concept through completion guarantees those continual developments. Similarly, publications in reputable peer-review medical journals guarantee continual development in the world of medicine. But in the world of medicine, lives may be at stake…making the rapid publication of important medical developments vital. Today’s highly regulated world creates challenges to rapid publication, but my tenet remains, Physicians like data, but they don’t like “data on file.” Thus, the challenge for pharmaceutical companies is to engage the peer-review and publication process efficiently or risk significant delays and roadblocks in a product’s reaching its full benefit and potential. To overcome that challenge—to engage the process efficiently—pharmaceutical companies regularly develop publication plans: planning and disseminating scientific and clinical data on a drug to healthcare professionals (HCPs) by presentation at medical congress/society meetings and publication in peer-review journals. Such planning accounts for a number of variables affecting:
1. Benefit to your product by maximizing the reach and clarity of your clinical data. Plainly stated, clinical data define a product—its use, dosage, benefits, risks, appropriate patient selection…it is the heart and soul of a product. It underwrites the new drug application; it defines clinical use; it creates perceived value. Thus how the drug is introduced, used, and perceived will be based (certainly at launch) on the quality, scope, and scale of the published clinical data. It falls to the owners of the data to create a plan for comprehensive and cohesive disclosure of data to those who need it most—prescribing clinicians. But publication also satisfies legal, ethical, and industry obligations:
2. Benefit to the market by placing your product “in context” within the current therapeutic area. Development of a publication plan is a process of thorough analysis of existing literature about the full therapeutic area, the disease and its diagnosis, as well as treatment options and practices. Additionally, an important element of the process is a “gap” analysis—finding things that aren’t yet well-defined, finding gaps where new clinical data or expanded expert opinion may enhance clinical understanding and practice. If a product is first-in-class, a comprehensive publication plan is particularly important, for example, to introduce a new mechanism of action or define where the drug fits in the clinical picture: Will it be used as a first-line agent? Second-line agent? Concomitant with other drugs? After other therapies fail? Publication of new clinical data expands the existing literature and expands the foundation of evidence-based decision-making. Timely publication of clinical data positions your product to be included in new or updated treatment guidelines. Planned publications that account for the full context of a therapeutic area—diagnosis and treatment—can help place your product in a clearly defined position at launch. 3. Benefit to prescribing HCPs by fostering consistent delivery of scientific communication points across all media. By planning and carefully executing publications, a consistent scientific foundation is established to support the product—consistent language describing mechanism of action, product features, and clinical efficacy and safety. This published body of evidence supports all future product communications, from press releases to promotional materials to patient- and HCP-education materials. 4. Benefit to all members of the product development team with a systematic dissemination of all data. A publication plan provides a roadmap and systematic approach to data dissemination for all product stakeholders—drug discovery, clinical development, health economics and outcomes research (HEOR), regulatory affairs. Naturally, each aspect of drug development contributes to the product’s comprehensive profile and clinical use. Publication planning keeps everyone aware, coordinated, and consistent throughout the life of the product. 5. Benefit to all members of the treatment team by delivering key data to key audiences…who needs to hear what and when. A publication plan should address the varying information needs of HCPs across the spectrum of care—specialist and general physicians, nurses, nurse practitioners, physician assistants. Different audiences may need to understand preclinical data versus clinical trial data versus HEOR data. For products with multiple indications, the publication plan should target multiple specialties or multiple types of prescribers; for other products, specialists may be the chief prescribers and thus the main audience; but primary care physicians and allied health professionals need appropriate information, too. 6. Benefit to regulatory bodies and payors by providing clinical context for safety and efficacy, establishing evidence-based value for a product. In a single peer-reviewed publication, authors provide a clinical context and a rational for the trial, and the clinical significance of results. But with today’s escalating healthcare costs and growing demands to control them, regulatory bodies and payors compile data across published studies to establish an evidence-based “value” of a product (ie, AMCP Dossier, Global Value Dossier). A publication plan coordinated across clinical trials ensures a peer-reviewed source for establishing a product’s value in the context of existing medical literature and usual clinical practice. 7. Benefit to the patient by clarifying and addressing all issues that may affect acceptance and appropriate use—even optimal use—of the product. Clinical trial-based data form the core of a publication plan, but additional types of publications may enhance acceptance of your product and directly benefit patients’ understanding of their therapy, ie, a publication describing how an injectable’s unique delivery system improves medication adherence compared with existing delivery systems. HEOR data are increasingly important for acceptance of a new agent in a crowded market, ie, a cost-effectiveness analysis that demonstrates a lower annual cost of your product compared with a well-established competitor or long-term outcomes data demonstrating a reduction in hospitalizations or improved quality of life among patients receiving your product versus a competitor. After a product has been on the market, feedback from the field (eg, medical science liaisons, sales representatives) may inform additional analyses and publications that could provide prescribers with additional patient-centric data. 8. Benefit to the world of medical science by advancing and enriching peer-reviewed medical literature. The peer-reviewed publication process serves a medical/scientific need to validate the data within the medical/scientific community. The medical literature included in PubMed (the US National Library of Medicine and National Institutes of Health online library), includes more than 27 million studies—a phenomenal collection of the progress of mankind’s knowledge and understanding. Where once many illnesses had no name, now they are well-defined and treatable, even curable. Where once disease processes and treatment mechanisms were unknown, now they are clearly understood. For example, over the decades the discussion of autoimmune diseases has moved from inflammation to immune response, from anti-inflammatories to immunomodulation and biologics. Effective publication planning creates a path for advancing and enriching our knowledge. Publications and the publication plan are the core of a pharmaceutical product’s entry to the market and to its acceptance in clinical practice. Thus, publication planning should begin early in the product life cycle, anticipate change, and be adaptable as additional data become available and as the market evolves…because the goal is to provide benefits across the spectrum. |
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