Medicine and Product Development: the Critical Role of the Industry Physician

The key to the rapid adoption of new products, whether pharmaceuticals, biologics or medical devices, lies essentially in how closely these new products address medical needs. As a Medical Doctor, the industry physician can play a critical role in assessing these needs and how best they should be addressed. He should have a leading role in planning clinical development, ensuring its perfect execution, and of course, be a major contributor to all regulatory decisions. Ultimately, the future of any new therapy depends on the quality and relevance of the data that clinical research generates for its validation. The industry physician should be empowered to make this happen and be accountable for the successful execution of the necessary research.

Current trends, in health care and in the drug and device manufacturing industry, call for defining very precisely the role of physicians, thus achieving cost savings by curtailing them to a few core responsibilities. Many of their traditional functions are now performed by less costly surrogate workers. An undesirable consequence is an increasing isolation of physicians from a number of functions critical to the well being of the products.

This trend affects virtually all areas of product development. The assessment of medical needs is often performed by marketing experts with limited or no medical background. Regulatory strategies are developed with a focus on the rules of regulations but little regard to their purpose, i.e. establishing a clear, accurate and objective efficacy and safety profile for the new therapy. As conceived, regulations and related guidance are mostly medical in nature, as they aim at protecting the public and at ensuring its well being. Companies request that adverse events be reported to ensure compliance with regulatory requirement. Compliance should rather start by demonstrating that careful attention is given, in a documented and systematic manner, to the significance of the adverse events from a medical point of view. Investigators, study coordinators and site monitors pay much less attention to ensuring the reports are medically relevant, succinct, precise, and accurate. Coding may be performed by personnel oblivious to the medical significance of the effort. The resulting terms may have little relevance relative to the actual event. Statistical analysis plans may address all the aspects foreseen in the study protocols and yet give little regard to the experience gained by the Medical Monitor (or Study Clinician, for some companies) while supervising the trial. Examples of significant disconnect between medicine and product development are so numerous that surely, readers can related very easily. Industry “Best Practices” should recognize how critical expanding the role of the Industry Physician is to ensure full and prompt success.

Strategy Building

New products should be designed to address clear medical needs, which are defined by the medical conditions of the patients and the corresponding therapeutic requirements defined by their physicians. It should be only natural for industry physicians to lead their company in understanding the needs of the patients and of their physicians, and in translating this information into defining a product profile that is relevant to the needs of the patients and of their physicians. Once launched, new products need to be nurtured to optimize their development and over time, the management of their life cycle, by addressing changing medical needs and related scientific questions timely and accurately.

Based on a medically-sound product profile, a number of actions of business relevance can be executed in a pertinent manner, including market assessment, product feasibility assessment, regulatory and clinical development planning, as well as time and resource budgeting. Even seasoned industry physicians do not have all the skills that are required to address each area fully; only accomplished cross-functional teams actually do. However, none of the challenges that must be addressed to commercialize a new product to its full potential can be addressed optimally without significant contributions from physicians. Whether the new product is relevant, usable, its design optimal, its market defined realistically and the penetration strategy optimized are all questions that cannot be addressed without active physician involvement. External advisors often provide some of the necessary input on a consulting basis. This advice is most often excellent. However, unlike top industry physicians, they are not available around the clock, on demand, and are not an integral part of the process as a whole (or of the product development team, for that matter). In addition, most lack the critical skill set that is proper to the business side of the industry.

We see on a regular basis companies that attempt to conceive the development of their products independent of industry physicians. Compared to companies where physicians are integral to the development process, companies that rely solely on non-physicians or on external advisors generate sub-optimal development plans, face more difficult regulatory negotiations and significantly slower market adoption.

Execution

Regulations require that a physician be involved in any study involving human subjects. This requirement is pretty clear to most firms, although some, at time sizeable, seem still not to understand the requirement in its full scope. Regulations are not specific in defining what this requirement implies. Good Clinical Practice Guidance (ICH E6) calls for the sponsor designating “appropriately qualified personnel … to advise on trial-related medical questions or problems” (section 5.3), and specifies under section 5.4 (trial design) that physicians be utilized “throughout all stages of the trial process”. The Guidance continues to specify that “all stages” means protocol and CRF design, planning the analyses and issuing interim and final reports.

Some companies comply fully with the letter and the spirit of the regulation by assigning properly qualified physicians in sufficient numbers to the clinical development team. Unfortunately, these instances remain relatively rare. Indeed, although it is virtually the rule in established pharmaceutical companies, this practice remains less than universal, especially among start-ups and device companies. Medical device companies in particular appear to carry over past practices, where data requirements were relatively modest and clinical research consequently rather limited when compared to the requirements related to manufacturing and controls. Developments over the last few years, both scientific and regulatory, are bound to change this state of affairs. We believe that companies that embrace this change now will emerge with significant competitive advantage in the short term.

It is critical at all stages of the clinical development process to pay close medical attention to clinical data as near to real time as possible. Industry physicians must understand fully the meaning of such commitment and make this commitment completely and genuinely. In return, companies should enable their physicians, whether employees or consultants, to play their function thoroughly. To this end, companies should foster a culture that focuses on the purpose of their products from the standpoint of the patients’ benefits and medical needs, thus helping integrate physicians firmly in the necessary cross functional teams. This approach is fundamental in optimizing development programs of global relevance. Indeed, it provides the basis for conceiving clinical development plans that are consistent with the agreed-upon strategy in both nature and priorities. Next, it ensures that study protocols actually address the product development needs in a scientifically and ethically sound manner, and that the data that are collected are meaningful and reliable. This approach also helps ensure that upcoming safety signals are detected and managed without bias while studies are ongoing. Likewise, it helps assure that the analysis of the data and the publication of the results is executed properly, and that all the information that was sought per the study protocol is obtained, analyzed and disclosed.

Conclusion

This is not to say that MDs on their own perform miracles! It takes a whole team to build a product to its potential. Like any team member, MDs must learn to contribute by first listening and understanding the issues faced by the team, and by understanding clearly exactly what they are expected to bring. An important condition for the successful integration of MDs into a product development team is that the MDs must learn enough to master the numerous concepts related to the clinical development of a given product and how they best apply. These include regulatory requirements, principles of protocol design and statistics (including ground-breaking innovations such as adaptive designs), data management, fundamentals of risk and safety management, and core promotional requirements.

Another condition is for physicians to understand that by joining the industry, they are not getting a 9 to 5 job with few responsibilities. Industry physicians should be reachable, constantly available to their co-workers and to the study teams on a 24 / 7 basis. They should also be clear with the fact that, although industry physicians do not take responsibility for the care of specific patients, one at a time, their responsibilities are in reality of a much greater scope. By ensuring that safe and effective therapies are made available to all who need them, industry physicians make critical decisions that affect millions of patients every day, as well as society as a whole, thus going well beyond the obvious duties that they have toward their employers

We believe that becoming an industry physician is akin to learning a new specialty altogether, yet there is no such curriculum available today. It takes time and dedication to acquire the necessary knowledge and attitude. For companies interested in capitalizing on the contributions of industry physicians as suggested here, the resources are available, in house or on a consulting basis, ready to boost new therapies to new heights at launch and through their life cycle! It is time for the industry to value the knowledge and skills of physicians fully, so that new products perform globally to the maximum of their potential.

About Paul-André de Lame

Paul-André de Lame, M.D. is President and CEO of Anabase International Corp. He has more than 20 years of industry experience and a broad knowledge of product development, clinical research, and related regulatory issues. He made critical contribution to a number new product launches while organizing multiple research projects at the domestic and international levels. His team-based approach to global project management has proven extremely efficient in organizing complex projects with short- and long-term business relevance. Building on this industry experience, Dr. de Lame and Dr. Lemaire co-founded Anabase International Corp. in 1996. Anabase is dedicated to providing strategic consulting, clinical research services, regulatory affair support, and information management systems to the Pharmaceutical, Medical Device and Health Care Industries. Prior to founding Anabase, Dr. de Lame obtained his M.D. degree from the Catholic University of Louvain (Belgium) with a specialization in anesthesiology and intensive care medicine. He spent several years as Head of Intensive Care in a private hospital in Brussels (Belgium) before joining Merck Sharp & Dohme, Belgium. He then joined Warner Lambert Parke-Davis, where he was a critical contributor to the successful launch of atorvastatin.

About the company

Anabase International Corp. provides consulting services for clinical development and regulatory strategies, medical and safety monitoring, integrated study and data management systems and processes. Information regarding Anabase International Corp. can be found on the web at www.anabase.com.