The Evolving Role of Medical Affairs
"The primary purpose of medical affairs is twofold: (1) educate and communicate scientific information to healthcare providers in an objective unbiased manner and (2) generate new data for the medical community or for the purpose of enhancing a product's on-label indication (typically in a post-marketing setting via investigator-initiated studies (IIS) or Phase IIIb/IV studies)." --Understanding Medical Affairs in Pharma, Accreditation Council for Medical Affairs (ACMA)
X KEY MEDICAL AFFAIRS AREAS
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SCIENTIFIC COMMUNICATIONS
- Strategic Publication Planning
- Execution and Management of Continuing Medical Education submissions
CORE SLIDE LIBRARIES
When faced with an upcoming presentation, give your team the gift of being able to draw slides directly from an already-approved, up-to-date core slide library complete with speaker's note and background annotated references and data for each of your products and disease states.
SCIENTIFIC COMMUNICATION PLATFORMS (SCPs)
- Development
- Not just the plan but also SOPs and Work Instructions to update (with deadline)
- Implementation and rollout
- Bring cross-functional areas together
- Develop metrics, such as product and key product features in the medical literature; terminology use; questions and responses given by medical information and field-based medical team
- Deliverables
- Scientific symposia and advisory board integration
- Updated standard response and congress FAQ documents
- Develop training program, communication plan, and schedule
- Internal slide decks
- Consider web-based hosting to "facilitate enterprise-wide SCP standardization, steamline updates and simplify version control, and allow assesment of use via various metrics":
"An SCP provides the strategic foundation for a product's medical communication plan and all initiatives generated from it
"Integrates scientific data, research aspirations, and treatment landscape through coordinator scientific themes"
"Provides guidance to ensure consistent communication about a product and its clinical profile"
"Communication objectives: prioritized set of objectives that address key educational gaps and opportunities"
"Short, high-level summary of scientific statements that provides a clear overview of key story elements"
"Scientific statements: hierarchically organized, standardized, scientifically accurate statements that describe the disease state and product"
"Lexicon: common vocabulary for communications that maintains accuracy and integrity while providing guidance on key specific language and terminology"
FIELD-BASED TRAINING AND EDUCATION
Staying on top of the latest information can be challenging, but we can help you educate and train your team on the latest data, consensus guidelines, new products, and marketing messages using modules, slide decks, annotated reprints or package inserts, clinical compendiums, newsletters, monographs, white papers, or other training pieces.
SATELLITE SYMPOSIUM
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NEEDS ASSESSMENTS
Our priority is that your needs are met, to your full satisfaction, every time.
LEARNING OBJECTIVES
Your satisfaction is our #1 priority. We'll do what it takes to find the best solution.
How to Audit-Proof Your Publications
"Medical Affairs staff typically have responsibility for publications and, although their knowledge of GPP and other publication-specific guidelines is increasing, strong support may be required to ensure audit readiness."
COMPETITIVE INTELLIGENCE
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MEDICAL MEETING COVERAGE
Expand your team's ability to learn from and network with Key Opinion Leaders, Investigators, and vendors by allowing us to help you gather competitive intelligence at major medical meetings and quickly disseminate key takeaways to your team, MSLs, account managers, and sales and marketing teams.
ADVISORY BOARDS
Allow your team to fully focus during advisory boards while we capture all the details for you in an Executive Summary Report.
[???] MARKET ACCESS AND EVIDENCE-GENERATION STRATEGIES
We specialize in providing expert service to fill your online needs.
LITERATURE REVIEWS
As a comprehensive literature review is often the first step for follow-on research, it is important that they be thorough and of high quality.
- Disease definitions, etiology, diagnosis
- Epidemiology and burden of illness
- Treatment guidelines and practice
- Competitor treatments overview of clinical effectiveness and cost
- Unmet needs
GAP ANALYSIS
We work with you to come up with ideas that are right for you and your clients.
MARKET ACCESS DOCUMENTATION
[ADD SLIDE OF INFORMATION THAT CAN NOW BE INCLUDED]
PAYER VALUE PROPOSITION STATEMENTS
- Usually developed separately from scientific communication platforms
- Central pillar of payer communication strategy and tools
- More efficient with regard to time and resources to update the SCP and product value proposition together with the Market Access teams and Medical Affairs
GLOBAL VALUE DOSSIER AND STRATEGY PLAN
- Introduction and Executive Summary
- Disease Background
- Product Description
- Clinical Evidence
- Humanistic Evidence
- Economic Evidence
GVD
Value Story
Disease Burden
Unmet Needs
Value of the Product (Clinical, Humanistic, and Economic)
Market Access Strategy
Objection Handling
Market Access Toolkits
Slide Sets
Objection Handlers
Onsite or Virtual Training & Workshops
AMCP FORMULARY DOSSIER
- Preparing AMCP formulary dossiers for sharing with managed care partners is yet another way that we can assist your inhouse teams.
- AMCP, NICE, or IQWIG bodies
- OPTIONAL: Accompanying Payer value slide deck
F E A T U R E S
Medical Affairs Quotes
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"The biggest change in Medical Affairs in the last 10 years is that we now have a seat at the table as strategists. We are in less of a supportive role. Now we are seen in a proactive, strategic position. Medical Affairs has always had external experiences dealing with clinical trials and patients. Now, we can drive decision-making actions by bringing information from external sources into the company to generate strategy." --Ramin Farhood, VP, Head of Global Medical Afairs, AveXis (MAPS Launch Excellence Document)
Organize
"The imperative vision for Medical Affairs is to participate in product strategy discussions early in the product development phase. Beginning strategic planning as early as 5 years pre-launch enhances Medical Affairs' ability to identify and communicate critical issues and gaps to support short- and long-term planning." --Greg Keenan, MD, Former Vice President, Medical Affairs & US Head Medical Officer, AstraZeneca (MAPS Launch Excellence Document)
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"The communication process established within the medical strategy results in the synthesis of relevant concepts and educational messages that are accepted by all members of the team." --Tricia L. Gooljarsingh, Senior Director, Ironwood Pharmaceuticals (MAPS Launch Excellence Document)
"We either prove our innovative value by adapting to and addressing the external changes happening in healthcare and our industry, or we will continue to remain a mainly support function. There's a lot to do."
--Dr. Ameet Nathwani, Sanofi's Group Chief Medical Officer
Encrypt
"Now, we can drive impactful decision-making actions by bringing insights and information from external sources into the company to influence strategies." --Meg Heim, VP, Head of North America DCV Scientific Communications, NA DCV Medical Affairs, Sanofi (MAPS Launch Excellence Document)
Notify
"Medical Affairs needs to embrace digital technology. And when we want to explain our product, we tend to pile on the data. Instead, we should develop a narrative. Use the data on a digital platform to tell a medical story that can be understood by the healthcare provider and a value story that can be understood by the payer." --Lobna Salem, Chief Medical Officer, Developed Markets, EMB, Pfizer (MAPS Launch Excellence Document)
Target
"The imperative vision for Medical Affairs is to have a seat at the strategic table early in the product development phase, and to be well positioned to take the lead on scientific strategy development." --Paul Tebbey, Therapeutic Area Head, US Oncology Medical Affairs, AbbVie (MAPS Launch Excellence Document)