We reached out to the Medical Affairs people at pharma and medical device companies, as well as people at agencies, to get the keys to forming a long-lasting relationship with the medical and scientific communities, learn how to find the right people, and discover what changes are on the horizon.

The opinions expressed by the authors in the Think Tank section are their own and do not necessarily reflect those of their affiliated companies or organizations.

KEVIN APPARETI

Global Director, Medical Science Liaison
Office of Medical and Health Affairs
Philips Healthcare
kevin.appareti@philips.com

We have successfully established a variety of relationships with key stakeholders in the scientific and medical community across our businesses using a simple model. Typically, the initiation of our relationships is dependent on the objectives and the timing within our idea-to-product timeline. The key is identifying the right person and the right interaction at the right time. For example, we establish strong scientific relationships in the early stages of idea generation and solution design. This leads to collaborations with basic and clinical researchers at various institutions that support this intense discovery process.

As ideas develop and get crafted into products and solutions we engage with a new set of key scientific and clinical colleagues who have the expertise in translational and clinical medicine. They are often different individuals from our partners in research as we seek different characteristics in this next phase. Later, when products and solutions go to market we reach out to yet another segment of the clinical community for evidence support, advocacy and education. At each stage along the development path we choose specific types of individuals and work with them to accomplish specific goals. This proactive process of segmenting whom we work with and how augments our success.

The intended consequence of this focused approach to interaction design is that the relationships become strong, long- lasting, efficient and highly valuable. The process of matching individuals with unique skills to the specific type of interaction at an appropriate time ensures you meet expectations and goals. Nurturing these types of relationships becomes easy to accomplish when you have common goals between clinicians and vendors. Then you are set up to easily collaborate and reach successes together. Growing these relationships is no different from other types of relationships. Communication, respect, trust, openness, sharing ideas, etc., are all part of the relationship-building process that makes both parties more successful than if they were on their own.

FAITH DIBIASI, M(ASCP), CMPP

Associate Director, Medical Affairs
Knowledge Management
Human Genome Sciences, Inc.
Faith_DiBiasi@hgsi.com

One aspect of the industry and scientific/medical community relationship that cannot be ignored is scientific communications. These peer-reviewed abstracts and articles play a critical role in the drug development process. They update the progress of new discoveries, aid in the understanding of a new mechanism of action for drugs in development, provide the foundation for decision-making in the medical community, inform best practices for future scientific discovery, and even provide valuable lessons from failed studies on what not to do or how to design better trials that include patients who can benefit the most from a particular drug.

When developing scientific communications, especially those from clinical studies, they need to be accurate, timely, transparent and compliant. Work with authors (both company and external) that are intimately involved in the trials from concept to final interpretation along with other key experts in the specific scientific area. Managing scientific communications in this manner provides the credible evidence needed for a new drug or device to be accepted in the market. Peer-reviewed articles and abstracts are essential to the success of a development program, which is why all of these programs should include plans to publish their results starting at the earliest stages and continuing throughout the entire development process. In today’s environment you cannot over publish as long as you are legitimately adding to the body of scientific knowledge and not just grabbing the proverbial “share of voice” in the market. Don’t forget that all clinical trial results must be disclosed under FDAAA guidelines and the timelines are very tight. A Certified Medical Publication Professional can be a valuable asset to a development team to help educate authors on best practices, navigate all of the guidelines, and manage the critical timelines and documentation required to have a compliant scientific communications program.

MARIA BAVISHI

Vice President, Scientific Services
Discovery Chicago
maria.bavishi@discoverychicago.com

Like any long-lasting relationship, a successful affiliation between members of the medical community and pharma must be built on a foundation of trust, commitment and communication. Building evolving relationships that endure throughout a brand’s lifecycle begins with identifying the right partners. Engaging top medical leaders is important—but expanding that connection to include influential HCPs creates the most mutually beneficial working environment for goal-oriented collaborations.

Top medical leaders are easily identified by cachet. No effective partnerships are possible without the input of those who have national visibility as a result of clear contributions to disease-state knowledge and current treatment paradigms. However, it is also essential to unearth those most likely to inspire peers. This network expansion is accomplished through careful assessment of strategically targeted professional characteristics at the regional and local levels. With this kind of multilayer cultivation, a thriving network of potential partners is established—each of whom has the ability to become an effective advocate who truly believes in the brand. Engaging potential advocates in this setting begins with defining a shared belief—that the brand fills an unmet patient need. The brand team must demonstrate its commitment to providing a product that unequivocally improves patient lives.

Trust building starts prior to product launch by engaging identified national, regional and local medical partners in a variety of advisory-level activities and touchpoints. These encounters provide an opportunity for cross-fertilization, giving brand teams valuable expert feedback while encouraging potential partners to weigh in on unmet needs as well as future clinical development plans and brand communications.

This approach lays the groundwork for industry to establish supportive, collaborative, and committed partnerships within the medical community. This fosters connections not only among advocates who believe in the drug—based on study outcomes and their now collective clinical expertise—but who also want to share their opinions as to why this brand is a highly credible treatment option.

ALAN H COHEN, MD, FAAP, FCCP

Senior Vice President, Medical Affairs
InterMune, Inc.   

acohen@intermune.com

When attempting to bring a novel drug substance through the clinical stages all the way to approval it is never too early to begin working closely and engaging with the best and brightest minds in the scientific community. Chances are there has already been some degree of dialogue through the usual channels, such as abstract or platform presentations at academic meetings and articles in peer-reviewed publications. Being aware of who is similarly invested in your particular area of interest, and how each party may be able to further advance the other’s work is the very nature of the scientific method and the value of early engagement. It isn’t too often that the same clinicians who are working with and caring for the patient population(s) we ultimately hope to serve are the same cutting-edge scientists advancing the pre-clinical work—but if and when that happens it is undoubtedly to the benefit of both the patients and the drug developers.

For instance, consider idiopathic pulmonary fibrosis (IPF), which is a poorly understood, rare, and unfortunately lethal condition. The worldwide IPF experts consist of a small community of dedicated pulmonologists, molecular biologists, and geneticists working tirelessly to better understand this terrible disorder and to help advance therapies (such as Esbriet, which is now approved in the EU and being studied in a Phase III trial in the U.S.). By meeting and working with leaders in the field, we are better able to help advance the science through collaboration, supporting scholarly independent research and publishing our own findings. Clinical trials, academic and medical communities, government agencies, and patient advocacy groups are all critical elements for the future benefit of those patients and families touched by IPF.

LANCE HILL

CEO
 Within3
lhill@within3.com

The advancement of social technologies offers a new way to strengthen the relationship between the industry and the medical and scientific communities. Pharmaceutical companies can leverage virtual work environments to promote scientific information exchange and shared clinical insights on a broad range of healthcare or disease-state topics. While the technology behind a virtual platform is essential, understanding how healthcare professionals (HCPs) work and communicate is equally important. Research has shown that ease-of-use is paramount to success and HCPs value the peer-to-peer collaboration and interactive dialogue that the virtual environment offers. In addition, communication can be exchanged freely since the group is invitation-only and the platform is safe and secure.

By the nature of its design, a virtual environment is more convenient and accessible—available 24/7 for HCPs to participate more frequently and form deeper clinical partnerships. A robust set of resources, such as member profiles, photos, background and specialty information, and authored publications reinforce collaboration and a sense of community. Additionally, because a virtual environment transcends the barriers of time and geography, interactions can flow seamlessly as people are connected across the globe. Breaking through these barriers facilitates the increased sharing of knowledge and improves the ability to obtain up-to-date information, allowing pharmaceutical companies to respond more quickly to market changes.

Virtual work environments open new and expanded ways to address business challenges. No longer encumbered by the limitations of time and space, pharmaceutical companies are free to think differently about their objectives and to access the wealth of knowledge and experience an HCP brings to the discussion. As many organizations rethink their internal processes for drug development, launch preparation, and overall lifecycle management, social technologies will increasingly be included in their strategic plans to foster deeper clinical discussions and improve outcomes.

EDIO ZAMPAGLIONE, MD


Vice President, US Medical Affairs
General Medicine and Diagnostic Imaging
Bayer HealthCare Pharmaceuticals
Edio.Zampaglione@bayer.com
Interactions with the medical and scientific community should begin as early as possible, usually once a compound makes it through the early stages of development and is beginning Phase II. If a compound is truly novel in that it has a unique mechanism of action or is the first in a new class, then the interactions may begin even sooner. Scientific opinion leaders such as biochemists and pharmacologists can be an invaluable resource in these instances. How to pick the right opinion leaders can be a bit more challenging. Most companies follow similar profiling strategies such as looking into publications, top academic centers, areas of research interest and medical specialty, and speaking engagements at congresses. However, the best way to find out who the right opinion leaders are is to network within the medical and scientific community and to form appropriate relationships. Medical Science Liaisons are usually best equipped to forge these relationships.

Once these relationships are formed, advisory boards or experts meetings are common venues used to interact with opinion leaders. These meetings are most often face-to-face at a suitable hotel or conference center. However, as technology and online communications continue to evolve, companies are starting to consider virtual meetings as a novel way to interact without having to deal with the usual scheduling and logistical constraints. The most important objective of early engagements is to develop a product that will meet the needs of the medical and scientific communities. The interactions will also help the company better understand where its product fits into the treatment options and management of a disease. This will allow development of appropriate educational tools and information for both patients and HCPs. Once a product is mature, the advice sought is more focused around life-cycle management such as potential additional indications or different formulations.

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