Medical Affairs Role(presence) In Pharmaceutical Industry

By Author: Lydia Daisy
Total Articles: 13
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The Medical affairs is a growing vital sector in today's bio pharmaceutical industry in providing hospital consultants, key opinion leaders (KOL's), regulatory agencies and healthcare professionals with scientific and medical information relating to the value and correct usage of products.

The Medical Affairs team consists of experienced physicians assisted by pharmacologists who have an expertise in nearly all most all the therapeutic areas of medicine. Every member of the team must be aware of the strict safety regulations and posses the ability to implement safety concepts into product designs. Team includes professionals from the core medical affairs areas like - Medical Science Liaisons (MSL), Medical Communications/Publications, Medical Education, and Medical Information.

The role of the Medical Affairs (MA) function is to educate stakeholders through the delivery of accurate, complete, and unbiased information that supports a product. MA activities must comply with federal, industry, and company regulatory ...
... policy and are not designed to "promote" a product or substitute for Sales and Marketing practices. All materials distributed through the activities of MA should be reviewed for compliance with existing regulatory policies.

Pharmaceutical companies spend tremendous resources for the development of new drugs. A great deal of their time is spent in conducting research on potential medical products and medicines. Often the commitment is over many years followed by filing for marketing approvals on the researched indication. These indications are obtained in relatively small-sized markets and expansion is planned to post approval larger sized markets. While considering the differences between post marketing studies and clinical registration trials, medical affairs can fill the need for the studies conducted post approval. This is yet another place where medical affairs have a significant role to play. Sales groups may be ill-positioned to accurately present the new product to physicians and often need help in making more expert presentations. Medical affairs groups can assist in developing appropriate positioning for new products and help to leverage the newer indications to come.

Medical Affairs Role in Functional Areas:

Medical Affairs acts as the central focal point for different therapeutic areas for sales, marketing and research. Medical Affairs work closely with various functional departments such as:

Medical Writing:

Medical Affairs is responsible for the following:

•Scientific Development and Reviewing of Product profiles, monographs, package insert/ patient's information leaflet, pharmacology and toxicology sections of registration dossiers with ongoing updates.

•Preparation of Clinical Development Plan

•Providing therapeutic and scientific content for development of study protocol

•Designing and implementation of pharmacoeconomic studies

•Reviewing and approval of regulatory reports, manuscripts, abstracts, posters and other scientific documents

Medical Monitoring:

Medical affairs are the Primary medical contact to the sponsor, investigative sites, and project team.

•Medical Affairs supports the planning, conduct and evaluation of clinical studies and involves ongoing data maintenance and management.

•Involves in discussion on study feasibility with Key Opinion Leaders and other potential investigators regarding possible logistical requirements of the study protocol and responds to subject eligibility and withdrawal questions.

•A Medical affairs team is also responsible for ongoing clinical trials Protocol and study related training for Investigators and site staff.

Pharmacovigilance:

Medical Affairs work with Pharmacovigilance team for Medical Monitoring and Safety Management on reported SAE's and other pharmacovigilance data of current drugs on the market and also preliminary data for drugs in development. Medical Affairs coordinates with the Sponsor, Investigation Sites and Project Management team for any medical or safety related issues on an ongoing basis through:

•Preparation and maintenance of Medical and Safety related SOPs

•Receiving, processing and archiving of SAE information including CIOMS reports

•Set up and maintenance of a safety database

•Medical support for Serious Adverse Events reconciliation

•Medical review of CRFs

•Review and approval of medical coding using MedDRA

•Review of safety parameters and alert reports

•Medical review and assessment of serious adverse event reports

•Resolving queries about the product from prescribers and other stakeholders

Medico Marketing:

During Pre launch phase of drug the Medical Affairs team will develop a KOL strategy associated with the product based upon prescriber's interest in research and education for the given indication. Then MA departments will target potential KOLs and interact with them regarding the science behind the new product, ongoing trials including the balanced information of both positive and negative results. Also discuss the key data from medical meetings and summaries of changes to practice guidelines. In addition MA will conduct external education activities to Sales/Marketing people to raise awareness of the disease state, current therapeutics, and current gaps in patient care. Further, the interests of the KOLs will be assessed during discussions to determine appropriate scientific exchange and any potential opportunities for future investigator-initiated trials (IITs).

At the time of product launch Medical Affairs is responsible in ensuring clear understanding on use of the product by the prescribers. They exchange scientific information regarding compound-specific attributes and physician perceptions of the drug profile. During this period MA will review IIT proposals that would generate a Phase IV strategy which can further differentiate the product post-marketing.

During the Post-launch period of a drug, MA seeks feedback from KOLs and resolves the queries about the product ensuring that they know exactly how to use the product. MA maintains the collection of information regarding the acceptance of the product among prescribers and issues being faced with the drug. These valuable data will help to update marketing efforts as deemed necessary. Further discussions on clinical practice guidelines and potential additional indications with KOL's facilitate the commencement of IITs and Phase IV studies. Medico Marketing involves in various functions such as:

Medical Information:

Medical information is responsible for the following:

•Dissemination of technical information regarding current products to regulatory agencies and healthcare professionals. Responsible for the training of sales force with regards to technical information and also the dissemination of information internally.

•Providing updated, balanced, technical & scientific information, medical education about drugs, diseases & therapeutic areas and pharmacoeconomic data.

•Executing medical training, produce scientific seminars, collaborate in arranging and supervising Continuous Medical Education (CME) programs to healthcare professionals.

•Ensuring that internal colleagues, healthcare providers and authorities are provided with accurate, updated and useful scientific information. Also, to review and approve the scientific content of post-marketing programs and materials.

•Establishing peer-to-peer scientific relationships with healthcare decision makers.

•Involving in a broad range of scientific exchange activities, KOL interaction, phase IV planning, product launch support, sales training, and medical information preparation.

•Providing information on pipeline drugs and the development plans for those drugs to KOPLs that could benefit their research interests.

Medical Communication:

Medical communication offers a unique scientific perspective in all new product Pre-launch activities by:

•Serving in different liaison and communication roles for various concerned departments to ensure sufficient and mutual interaction across them.

•Getting involved in the different phases of product development as scientific advisory and advocacy for product development, life cycle planning, presentation and launching.

•Coordinating company's response on external customers (i.e. authorities, policy maker, healthcare professionals, patient and principal investigator) comments or complaints on new product.

Conclusion:

Medical Affairs is most credible link with external stakeholders and also play an increasingly important role in communicating the product value message to physicians in an objective and ethical manner. They help in dissemination of technical information regarding current products to regulatory agencies and healthcare professionals. Thus Medical Affairs play an important role in developing appropriate positioning for new products and help to leverage the newer indications to come. In common word medical affairs represents the heart of the organization.

Resource Box:

This is an informative article explains the importance of Medical Affairs. MakroCare’s expertise in medical affairs, coupled with our experience in clinical development and commercialization can be very valuable, particularly in complex specialty markets.