A successful drug discovery and development in the pharmaceutical industry is a long, expensive and complicated process. The product development model included 2 main pillars: an R & D organization for drug manufacturing and commercial organization for marketing and selling of product. Thus, Medical Affairs has become more complex, moreover a separate medical organization that works on product launch activities and has both the scientific and clinical expertise for product commercialization.
Launching a new pharmaceutical product to market is a unique process based on great amount of research work in drug chemistry, manufacturing, controls, pre-clinical science and clinical trials. Medical Affairs play an important role in coordinating internal /company stakeholders (including commercial, market access, regulatory, clinical development and drug safety) which fulfill the requirements of external stakeholders. It caters to pharmaceutical, medical device, cosmetic and complementary medicine industries. Medical Affairs function need to be coordinated in today’s competitive and regulated marketplace and set of activities for product launch divided into following time frames; early market, pre-launch, launch and post launch.
Early market includes time period greater than 24 months prior to launch and it also includes market planning. Pre-launch includes activities from educating department members, customer questions are addressed. During the launch period, Medical Affairs ensure that physicians have a clear and complete understanding of the use of drug including its safety, efficacy, dosing and administration. During the post launch period, Medical Affairs make sure that prescriber inquiries are answered and they provide informational services to healthcare centers. The activities can be divided into three broad categories: Medical Communication and Publications, Medical Science Liaisons (MSLs), Medical Information services.
Medical communication team needs to communicate data in a medical affair group that directs all drug-related publications such as abstracts, posters and manuscripts to support commercial products. Another key role for medical communication team is developing data in an accurate, complete and unbiased way to deliver maximum value to a company. A publication plan must be carefully coordinated before they are made available to serve the public health. Medical science Liaisons (MSLs) plays an important role in the success of a company. The first responsibility of an MSL is to maintain peer-to-peer relationships with leading doctors who influences other doctor’s and physicians. These influential doctors are referred as Key Opinion leaders (KOLs). KOLs are an extremely valuable & necessary component for markets and medical staff throughout the life-cycle process of a specific drug or product. At the time of launch, medical information services including the medical staff responds to question about the commercial drug products.
WorkSure™ Medical Affairs organization mission is to provide the consulting services to sales & marketing, clinical trials, pharmacovigilance, regulatory and legal departments. We at WorkSure are proactive at all levels, identify novel approaches and establish dedicated boundary-spanning teams for different companies. We work at all stages in the life cycle of a biopharmaceutical product/device which is paramount for a successful, timely and cost efficient drug development process. The various Medical Affairs functions that we offer are: Medical strategy and business support, Medico-marketing launch collaterals, Medical Communication/Publications, KOL management & interfacing responsibilities, Medical Education & training. Medical education activities include CMEs, seminars, small group meetings, updates and conferences etc. We create and deliver effective and successful training programs for clinical, scientific, marketing and sales personnel.
WorkSure, Medical Information System Management Software provides highest quality communication that flows from medical & marketing via other stakeholders & comes back to them as information. This provides key support for a product as it enters the marketplace and transitions through the product lifecycle.