Medical Affairs Strategy
Pubrica develops medical affairs strategies and tactical plans for medical affairs teams in life-science companies. Medical affairs exists to answer scientific questions, close evidence gaps and conduct scientific exchange, so its plan should start from what is not yet known rather than from a launch calendar. Our medical affairs strategists work with your team to prioritise evidence gaps, set scientific objectives and measures and plan tactics, and we deliver the plan and a written commercial boundary document.
- Built from evidence gaps, identifying what the field does not yet know and which of those gaps medical affairs can close
- Scientific objectives with measures that are not sales measures, because a function measured on prescriptions becomes a sales function
- The commercial boundary documented, setting out what medical affairs does, what it does not do and where it legitimately works with commercial teams
- Tactics that follow from the objectives, rather than a standing list of activities repeated every year
- Integrated with publications and evidence generation, since a medical affairs plan is largely a plan about evidence
Evidence gaps identified and prioritisedIncluded
Scientific objectives with measuresIncluded
Tactical plan against objectivesIncluded
Commercial boundary documentedIncluded
A medical plan built on sales targetsNot offered
Gaps → objectives → tactics → measured → evidence
- Built from evidence gaps
- Scientific measures, not commercial ones
- Boundary with commercial documented
- Tactics traced to objectives
- Integrated with the publication plan
Deliverables
Four Components of Every Medical Affairs Plan
A sound medical plan would still make sense if the commercial forecast changed.
Example from a gap analysisSome gaps are closed with a study, some with a publication and some with better dissemination of existing evidence. Treating all three as the same problem leads to budget being spent on the wrong one.
Example from a set of objectivesIncrease awareness of the product among key prescribers.Close the evidence gap on outcomes in patients with renal impairment, where no dedicated analysis exists, through a post hoc analysis and a publication, and make it available to the three guideline groups currently reviewing this indication.
Example from a boundary documentMost organisations know the boundary exists, but few have written down where it lies, so it is renegotiated informally whenever there is pressure.
Example from a tactical planThe standing list of annual activities usually holds most of the budget, and it is rarely tested against whether it closes any evidence gap.
The samples shown are illustrative and anonymised. Hover over a sample to replay it.
Compliance and Standards
Medical Affairs Standards: GPP 2022, ICMJE and PhRMA Code
Medical affairs is not itself a regulated activity, but almost everything it produces is regulated.
GPP 2022 (good publication practice)
The 2022 update replaces GPP3. It covers company-sponsored research, including translational, biomarker and real-world studies, and extends to preprints, plain language summaries and social media. Professional medical writing support is legitimate, provided it is disclosed.
ICMJE Recommendations (authorship and disclosure)
Sets four criteria, all of which each author must meet. Contributors who do not meet all four are acknowledged. Employment by the sponsor neither qualifies nor disqualifies anyone.
PhRMA Code (and the OIG speaker program alert)
The Code revisions effective January 2022 responded directly to the OIG Special Fraud Alert of November 2020. The alert’s suspect characteristics, including minimal educational content, alcohol, unsuitable venues, repeat attendance, sales-influenced speaker selection and compensation above fair market value, define the boundary.
Quality management (cert. H3CR9TCU20251212INDQM10N)
Our certified quality system governs how work is run, recorded and released.
Responsible Use of AI
Our Approach to AI Use in Medical Affairs Strategy
Medical affairs work must distinguish scientific exchange from promotion, a boundary that regulators monitor. That judgement depends on context, jurisdiction and the individuals involved, so it is always made by our specialists rather than by an AI tool.
Why We Do Not Publish AI Accuracy Figures
Accuracy figures for AI tools are usually reported by the companies that sell them.
Pubrica therefore does not quote a self-generated accuracy figure, because it would carry the same conflict of interest. Instead, we tell you which tool was used on your project, at which stage, and what a specialist changed afterwards.
Our Process
How Our Medical Affairs Planning Process Works
We start with evidence gaps. A plan built from a list of tactics is a budget allocation rather than a strategy.
Evidence and insight
We map the current evidence, review field insights and identify the questions stakeholders are asking.
Gaps and priorities
We rank gaps by their impact on decisions and by whether medical affairs is the function that can close them.
Objectives and measures
We write scientific objectives against the priority gaps, each with a measure that is not a commercial proxy.
Tactics and integration
We select and cost activities against the objectives and integrate them with the publication plan and the evidence-generation programme.
Our Experts
Your Medical Affairs Strategy Team
A named team of subject specialists stays with your project from scoping to delivery. Your project coordinator introduces each team member by name before work begins.
Reviews the scientific content for accuracy and confirms that each conclusion is supported by the evidence. Each expert is matched to your field.
Writes the content against the brief and the applicable code of practice, with every claim traceable to its reference.
Reviews the content for scientific accuracy, fair balance and compliance with the applicable code before it reaches your internal review.
Manages the timeline, keeps you informed at each stage and coordinates the team so that questions are answered and deadlines are met.
Packages
Medical Affairs Strategy Packages
Costs depend on the breadth of the portfolio and the number of markets or affiliates in scope.
Strategy and tactical plan
For a product or an indication
Quoted per projectBased on portfolio and markets
Delivery Agreed at scoping
- ✓Evidence gap analysis
- ✓Stakeholder questions mapped
- ✓Objectives with scientific measures
- ✓Tactics traced to objectives
- ✓Boundary from commercial documented
- ✓Integrated with publication planning
This package is usually run alongside the publication plan, because most medical affairs tactics produce or disseminate evidence.
Deliverables Request a quoteLaunch medical plan
For pre-launch and launch
Quoted per projectBased on markets and timeline
Delivery Agreed at scoping
- ✓Pre-launch evidence position assessed
- ✓Data generation sequenced against filing
- ✓Scientific exchange plan
- ✓Congress and publication timing
- ✓Affiliate guidance
- ✓Readiness measures
The evidence needed at launch is decided years in advance. A launch plan that starts twelve months out is mostly logistics.
Deliverables Request a quotePlan review
For a plan already in progress
Quoted per projectBased on plan scope
Delivery Agreed at scoping
- ✓Tactics tested against objectives
- ✓Activities with no objective identified
- ✓Measures checked for commercial proxies
- ✓Boundary practice assessed
- ✓Findings reported clearly
Activities that trace to no objective usually represent the largest single saving available.
Deliverables Request a quoteSend your current medical plan and we will trace each tactic to an objective at no cost. Tactics that do not trace to an objective show where budget may be misdirected.
FAQs
Frequently Asked Questions About Medical Affairs Strategy
If your question is not answered here, please ask an expert. No quote is required.
A medical plan starts from what is not known rather than what needs to be sold, and its measures are scientific rather than commercial.
A practical test is whether the plan would still make sense if the forecast changed. If it would not, it is a commercial plan written in medical terms.
They should be aligned, but they should not be the same document. Shared objectives blur the boundary that makes scientific exchange credible.
It helps to document the boundary: what each function does, what is shared and where they legitimately meet.
Medical affairs should be measured on evidence generated and gaps closed, scientific questions answered, guideline and formulary positions informed by evidence, and the quality of insight fed back into development.
Measuring the function on prescriptions turns it into a sales function with a different reporting line, which creates compliance risk and wastes its capability.
We can do either. Often the most useful approach combines facilitation and drafting: your team holds the insight, and an external facilitator can ask why an activity exists without it becoming a political question.
We do not present a plan as your team’s work unless your team has shaped it.
Related Services
Related Medical Affairs Services
These related services put the medical affairs plan into practice.
1EVIDENCE AND FIELDexecution
Publication planningPublishing the evidence most tactics produce. MSL and field medicalScientific exchange in the field.2EXPERT INSIGHTinputs
KOL mapping and insightsIdentifying who is asking and what they ask. Advisory boardsStructured expert input.3THE SCIENTIFIC BASEunderneath
Scientific platformDefining what the evidence supports. Evidence gap mapIdentifying where evidence is missing.Request a Free Review of Your Medical Affairs Plan
Activities that do not trace to an objective are identified for review.