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 Michael CasoBiopharmaceutical companies pride themselves on conducting comprehensive research activities. These research initiatives 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 here 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. Opportunities for Targeting: Disease States and Geography Disease States Disparities in healthcare are evident in the diagnosis and treatment of specific health conditions, in the utilization of preventive services and in health outcomes. These disparities may be caused by unique reactions to medicines, cultural or social factors. In fact, the majority of published research indicates that minorities are less likely than whites to receive needed services. In Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care, the Institute of Medicine (IOM) of the National Academies, reports: African-Americans and Hispanics tend to receive a lower quality of healthcare across a range of disease areas; disparities are found across a range of clinical settings; and the disparities in care are associated with higher mortality among minorities. Any institution that impacts public health — academia, medicine and social services, etc. — has a role to play in reducing disparities in healthcare; pharmaceutical companies are no exception. It would be challenging to find a pharmaceutical company without a product in at least one of the core six disease states identified by the U.S. Department of Health and Human Services (HHS) Office of Minority Health (OHM), in which racial and ethnic minorities experience serious disparities in health access and outcomes, as well as other diseases which differentially impact minority populations:
In addition, the following diseases and conditions disproportionately impact racial and ethnic minorities: Disease Disparities Mental health
While providing a tremendous service by addressing critical unmet medical needs, pharmaceutical companies will expand business opportunities by reaching minority populations. Analyzing and communicating data about these markets can improve pharmaceutical company efforts in improving outcomes and delivering assistance to the healthcare system through improved population management. The improved outcomes and population health management assistance will increase product demand, enhance relationships with growing physician and patient populations, and lead to networking opportunities within governmental health agencies, ethnic medical associations and community-based organizations. Geography While a focus on specific disease states is critical, so too is the ability to impact specific population bases. In this manner, it is more likely that limited resources can have a significant and measurable impact that can then be duplicated in other areas of need. Historically, significant minority population bases exist in major metropolitan areas. Wikipedia, as well as government census reports provide listings of cities for black, Hispanic and Asian populations and these tables can be used for creating an initiative for a single population. However, if your goal is to have a comprehensive initiative across all three of these minority groups, a comparative analysis of metropolitan areas would be required. A suggested list of targeted cities for initiatives impacting black, Hispanic, and Asian populations would include the following:
Developing a Plan for Engagement and Collaboration Now that we have addressed the why, what and where, let’s review options for how. The development of any plan for engaging minority physicians and patients should exhibit a number of key characteristics:
Proposed Strategies and Tactics Having provided the characteristics listed above, the following are suggested strategies along with associated tactics:
As the U.S. population demographics shift, so too must the focus of the pharmaceutical industry. As stated previously in this publication, there exists here a nexus of needs and opportunities with minority populations, where a focus on a medical need can result in a healthier population and a healthier bottom line. 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. |
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