We’re excited to be attending Pharma CI Europe 2025, the leading global gathering of competitive intelligence professionals, taking place on April 23-24, 2025, at the Munich Marriott Hotel City West.
This event brings together top experts from pharma, biotech and medical devices to discuss the latest trends, innovations and challenges in competitive intelligence.
Visit our booth to discuss how we can collaborate on:
Enhancing competitive intelligence strategies
Strengthening regional market insights
Creating more agile and impactful global CI programs
Don’t miss our podium presentation:
Market-centricity in your Competitive Insights: Is Your Global Program Delivering Value for your Country Teams?
April 23, 2025 | 2:25 pm – 2:55 pm (CEST)
Meet our team: Dr. Cameron Mackenzie (VP) and Mareike Werle (Associate Consultant)
Let’s connect and explore how we can elevate the impact of competitive intelligence together.
The European Union’s Joint Clinical Assessment (JCA) has been underway since January 2025. It aims to harmonize health technology assessments (HTAs) across member states.
A major focus is the growing recognition of the value of real-world evidence (RWE) in complementing RCT data, especially in areas where RCTs may be limited or infeasible or unethical.
Join the Prescient RWE Roundtable in April to learn more about how the JCA and other HTA advancements will impact future evidence generation needs for new product launches.
Speakers:
Sheela Upadhyaya, Life Sciences Consultant, Co-chair for the Health Technology Assessment International (HTAi) Rare Disease Interest Group
Oliver Leatham, Vice President, Real World Evidence, Prescient
We’re excited to be attending the MAPS 2025 Americas Annual Meeting, the largest global gathering of medical affairs professionals, taking place March 23-26, 2025 at the Hyatt Regency New Orleans.
With more than 1,500 attendees from the fields of pharma, medtech, biotech and from agency partners, this event is a great opportunity to engage with thought leaders, explore cutting-edge industry insights and drive innovation in medical affairs.
📍 Visit us at Booth 721 to discuss how we can collaborate on:
Advancing medical affairs strategies
Strengthening cross-functional partnerships
Enhancing scientific engagement through innovative digital strategies
Our team—Katy Chun (Vice President), Carly Maide (Director) and Kevin Michels (Consultant)—will be there and is looking forward to connecting with fellow professionals to explore ways to elevate the impact of medical affairs.
Join Us at the Pharma Market Research Conference 2025
Taking place on February 5-6, 2025, in Newark, NJ, we are proud sponsors of the Pharma Market Research Conference. We invite you to visit us at our booth to explore how we can work together to drive success through impactful market research strategies.
We’re also excited to be taking the stage for an engaging session titled “Making Sparks Fly: Building Lasting Partnerships for High-Impact Market Research”, on Thursday, February 6, from 11:25 AM to 11:55 AM (EST).
In this session, led by Chris Lewis-DeBoos and Diana Kuritza, we’ll explore the power of strong, trust-based partnerships in pharma market research. We’ll discuss how collaboration can help you gain deeper insights, align goals and make a lasting impact on your market strategies.
Be sure to stop by our booth or attend our session to connect with our team and learn how we can help you develop stronger partnerships and optimize your market research efforts.
Discover the insights, strategies and tools transforming competitive intelligence (CI) in the biopharma industry.
The biopharma industry is evolving rapidly, and CI teams are at the forefront of driving strategic decision making. In our whitepaper, Navigating Tomorrow: Biopharma Competitive Intelligence Trends for 2025, we delve into the challenges and opportunities shaping the CI landscape.
What you’ll learn:
How resource constraints are influencing CI teams and the innovative solutions they’re using
The role of AI in reshaping CI practices and unlocking deeper insights
Best practices for building stronger, more strategic relationships with executive teams
The must-have tools and technologies driving CI success in a competitive market
Written by Dr. Mark Little, Senior Vice President, and featuring insights from top CI leaders, this comprehensive guide offers actionable strategies and forward-looking perspectives to help you stay ahead in 2025 and beyond.
Download the whitepaper now by filling out the form.
Learn how a dynamic integrated evidence generation plan (IEGP) ensures strategic alignment, flexibility and cross-functional collaboration to maximize the life cycle value of your asset.
Building on our previous insights into evidence generation, this whitepaper delves into the specifics of creating a best-in-class IEGP. Designed to support the development, launch and ongoing success of your asset, our framework prioritizes evidence gaps, synergizes global and regional needs, and enables impactful decision making across functions.
Explore how to:
Embrace a forward-thinking approach to future-proof evidence planning
Align evidence generation with asset and organizational strategies
Identify and prioritize evidence gaps
Develop cross-functional, high-priority study plans
A successful IEGP is more than just a plan – it’s a strategic tool for impactful, evidence-based decisions.
Download the whitepaper now by filling out the form.
Our newly published white paper, “Integrated evidence generation: How to ensure your organization has a built-for-purpose evidence engine“, aims to guide biopharmaceutical companies through the complexities of evidence-generation planning. The paper emphasizes the need for a strategic, proactive approach to evidence generation, which should begin early in an asset’s lifecycle. By adopting this approach, companies can better communicate the value of their therapies, thereby enhancing their chances of approval, clinical uptake and reimbursement.
Key Takeaways
This white paper identifies several critical elements for effective evidence generation, based upon Prescient expertise in evidence generation planning and interviewed industry experts, and aims to provide a how-to guide for readers to assess and improve their organization’s evidence-generation capabilities. The paper starts by underscoring the importance of cross-functional collaboration, which allows stakeholders from various departments to contribute their expertise throughout the evidence-generation process. Secondly, it recommends the establishment of a standardized operating model that includes clear roles, responsibilities and processes. This model should be flexible enough to adapt to feedback and the organization’s fluctuating needs. Lastly, the paper highlights the necessity of continuous assessment and adjustment of the operating model to ensure its effectiveness and alignment with organizational goals.
Case Study
Below is a case study showcasing how Prescient supported a mid-size oncology-focused pharmaceutical company in implementing a novel approach to improve strategic decision making in regard to evidence generation. The company faced challenges such as portfolio complexity, with multiple assets in overlapping disease areas, lack of clear governance and limited transparency across internal stakeholders, and therefore sought support to evaluate its capabilities and design and implement a bespoke evidence-generation strategy. This included the implementation of pilot programs, establishment of necessary forums, guidance on ways of working, outlining of clear governance structures and standardization of planning processes. These changes led to significant improvements in evidence generation planning, including increased transparency across asset teams and functions and faster and higher quality decision making. Ultimately, the organization achieved greater autonomy and efficiency in strategic decision-making, demonstrating the value of a robust evidence-generation strategy.
By implementing the insights and strategies outlined in our white paper, your organization can optimize its evidence generation efforts, driving long-term value and success in a competitive biopharmaceutical landscape.
Join us at Reuters Pharma Customer Engagement Europe 2024 – the premier event where medical, marketing, and commercial teams unite to reshape customer engagement in pharma. Held from 4-5 November at Novotel London West, this conference offers insights from industry leaders on delivering innovative, customer-centric strategies. Discover how cross-functional collaboration is setting new standards in customer engagement.
In today’s highly competitive biopharma landscape, it’s no longer enough to generate evidence reactively or at the late stages of an asset’s lifecycle. Integrated evidence generation requires forward thinking and dynamic execution, ensuring that you generate the right data to demonstrate the value of your asset across its lifecycle.
In this whitepaper, our authors outline critical strategies to optimize your organization’s approach to evidence generation. You’ll discover how to take your evidence generation planning from early strategy through to agile execution, and stay ahead in today’s evolving market.
Key Takeaways:
The importance of early and integrated evidence generation
Key components of an Integrated Evidence Generation Plan (IEGP)
How to align cross-functional teams for success
Overcoming common challenges in evidence generation
Steps to transform your organization’s evidence generation approach
Learn how to drive better decision-making, ensure successful asset development and launch, and create impactful data for regulators, payers, clinicians, and patients. Whether you’re working in Medical Affairs, Health Economics and Outcomes Research (HEOR), or Commercial, this whitepaper provides actionable insights to help you deliver maximum value with your evidence generation plans.
Download the whitepaper now by filling out the form.
The European Commission (EC) has set its sights on the most transformative reforms to pharmaceutical legislation in over two decades. The question is: Will the industry embrace these ambitious changes or push back?
Why Reform Now?
On April 26, 2023, the EC unveiled groundbreaking legislative proposals, marking the largest overhaul of the EU’s pharmaceutical legislation since 2004. This reform is driven through a comprehensive multi-stakeholder evaluation of its 2004 revisions. While the 2004 legislation has generally achieved its two primary goals (protecting public health and harmonizing the EU medicines market), the EC identified six major deficiencies that still need to be addressed:
Deficiencies
Drivers
Impact
1. Unmet Medical Needs of Patients
Insufficient incentives for small- and medium-sized enterprises (SMEs) to innovate, with high commercial risk for developing novel targeted treatments
Millions of patients lack effective treatments, especially for rare diseases
2. Unequal Access to Medicines Across the EU
Disparities among Member States’ health technology assessment (HTA) and pricing and reimbursement (P&R) evaluation criteria lead to significant variations in launch timings (4 to 29+ months)
Medicines encounter entry barriers and launch delays or voluntary market withdrawals
3. Affordability of Medicines
Expensive innovative medicines, combined with evergreening practices, delay the entry of generics and biosimilars
High drug costs strain underfunded health system budgets, leading to inequitable patient access (especially in Eastern and Southern Europe)
4. Supply Shortages are Becoming More Frequent
Unprecedented medicine shortages during the COVID-19 pandemic highlighted lack of agility and urgency to enhance supply chain resiliency
Patients receive delayed or sub-optimal treatments
5. Lack of Innovation Support and Administrative Burden
Rigidity, complexity and inefficiency of the current pharmaceutical framework
Unnecessary costs and time wasted for developers, weakening commercial opportunities
6. Medicines in the Environment
Attempts to regulate drug-related pollution have proven ineffective
Pharmaceutical by-products pollute ecosystems, posing health risks
The Path to Pharma Reform: Will It Work?
To increase the EU’s competitiveness and shift drug developers’ focus away from what has traditionally been a US-first commercialization approach, the EC must propose bold changes to the pharmaceutical framework. These reforms aim to enhance innovation, streamline access to life-saving drugs, and combat global health threats like antimicrobial resistance (AMR). The EC’s plans center on five key objectives.
The objectives set by the EC are ambitious, but will they be able to adequately address the deficiencies identified? The arguments presented by the EC are compelling, being backed by insights and extensive data gleaned from multi-stakeholder public consultations, retroactive analyses and budget impact assessments.
Objectives
Goals
Prescient Perspectives
1. Promote Innovation
Drive innovation in diseases with high unmet medical need as the primary focus, with a secondary focus on developing novel antimicrobials
The EC seeks to strengthen the EU’s R&D sector and boost the development of innovative medicines, noting that only 20% of authorized drugs originate in the EU. With proper incentives, the EC forecasts more innovative launches, including in addressing AMR through a first-of-its-kind transferable exclusivity voucher (TEV) scheme.
2. Ensure Access and Enhance Supply
Promote timely and equal access while ensuring continuous supply and limiting shortages of medicines
Perhaps the most ambitious objective, with the EC aiming to make sweeping, long-term behavioral changes to both industry and public players in the spirit of a level playing field; ignoring certain markets or abusing negotiating practices may become a very expensive business decision for drug developers if the EC has its say.
3. Create a Balanced System of Affordability and Innovation
Enable competition while promoting affordability and sustainable costs across the EU, with a focus on transparency
The EU hopes to see a surge of SMEs pursuing riskier innovative medicines, biosimilar developers being empowered to conduct more informed negotiations, and patients and healthcare providers making more informed decisions around treatment options.
4. Reduce Regulatory Burden and Increase Flexibility
Simplify and integrate regulatory requirements by leveraging digital technology to reduce drug approval times and costs
Efforts to simplify, digitize and eliminate duplicative administrative processes will lead to faster time-to-market and greater commercial certainty for developers.
5. Reduce Environmental Impact
Minimize medicine residues in the environment following their production, use and disposal
We expect tighter environmental regulations and standards, though the EC’s ability to broadly and effectively enforce these remains questionable.
The Fine Print: Policies at the Heart of the Debate
These objectives, and their associated policy measures, look to strike a balance between incentivizing innovation while addressing unmet medical needs, enhancing access and affordability, and better responding to an increasingly unpredictable global health environment. The EC’s reform package includes over 70 policy measures and while some have been widely accepted, others have sparked intense debate.
April 2024 Update: The European Parliament overwhelmingly approved the reform package, introducing key amendments to the EC’s original 2023 draft. With this update, important amendments have been incorporated into the initial draft released in 2023. Key revisions include changes to regulatory data protection incentives, access conditionality requirements, and priority antimicrobial development incentives, among others. Overviews of some of more important amendments are as follows:
Agreeable Policies
Cutting Red Tape
The Push into the 21st Century: Improving the agility and navigability of the EMA’s regulatory framework
Key Points: The EC seeks to reduce administrative burdens and modernize EMA operations.
Prescient Perspectives: Streamlined processes will help drug developers achieve business predictability. A clearer, revamped pediatric investigation plan (PIP) framework reduces risk and uncertainty. R&D teams will benefit from increased scientific and regulatory support, allowing their clinical development plans to evolve with the pharmaceutical framework.
Tackling AMR
The Silent Pandemic: Incentivizing the development of novel antimicrobial treatments
Key Points: TEVs incentivize developers of priority antimicrobials with exclusivity for other products in their portfolio.
April 2024 Update:
The TEV scheme now includes varying exclusivity durations based on antimicrobial priority level (based on WHO Priority Pathogens List)
Developers cannot apply TEVs to products with maxed-out RDP (8.5 years)
A milestone payment scheme and subscription-based procurement ensure developers receive fixed payments, delinking sales from usage
Prescient Perspectives: The TEV scheme could spur innovation in fighting “superbugs,” benefiting SMEs and developers with near-expiring blockbuster drugs. The potential to sell TEVs adds further value to developers.
Contentious Policies
Regulatory Data Protection
The ‘Quid Pro Quo’ Approach: Driving innovation for unmet medical needs (UMNs)
Key Points: Baseline RDP for non-orphan drugs reduced from 8 to 7.5 years, with a max of 8.5 years. Orphan drug RDP reduced from 10 to 9 years. Developers can gain back exclusivity by meeting criteria like addressing UMNs or conducting head-to-head trials.
April 2024 Update: Baseline RDPs further adjusted for non-orphan drugs, with additional RDP incentives now provided for UMN-targeting orphan drugs.
Prescient Perspectives: This strategy encourages innovation by offering incentives to regain RDP, focusing on rewarding the development of therapies for UMNs.
Access Conditionality
The Carrot and Stick Model: Achieving equal access to medicines for all
Key Points: Developers had two years (three for orphan drugs) to secure P&R approval in all 27 Member States or face earlier generic/biosimilar competition.
April 2024 Update:
The two-year data protection extension for launching in all EU Member States has been removed
Member States now formally request P&R approval, with marketing authorization holders (MAHs) required to respond within a year
SMEs get two-year deadlines to respond, with potential extensions for all developers
MAHs must ensure continuous supply once P&R is approved
Prescient Perspectives: Initially, the access conditionality was highly contentious. Following significant industry pushback, the EC has since shifted the responsibility for initiating P&R negotiations to Member States, addressing concerns about the varied capacities of national HTAs and harmonization challenges within the EU.
What’s Next?
Although the reforms have passed a key legislative hurdle, the journey is far from over. With a new EU Parliament sworn in on July 16, 2024, and ongoing industry negotiations, these proposals could still see significant changes. The next draft isn’t expected until 2025, with adoption coming in late 2025 or early 2026, and full implementation not expected until 2027-2028 due to a mandatory 18-month holding period for Member States.
Pharma companies must pay close attention to these developments. Cross-functional collaboration between R&D, regulatory and market access teams will be critical to staying ahead in this dynamic landscape. The EC has signaled a willingness to adapt its policies, so the industry must remain actively engaged in negotiations. Change is coming, and it’s time to be ready.
Call to Action: How Prescient Can Support You Through Change
At Prescient, we understand the impact policies and regulations can have on your R&D and commercial strategies. With our deep expertise in market access and competitive strategy and market-specific knowledge, we are uniquely positioned to help you navigate complex regulatory landscapes. By leveraging insights from industry peers, we enhance your market positioning and better allow you to foresee future challenges.
Whether you’re looking to de-risk your clinical pipeline, develop tailored market access, or assess regulatory impacts on your portfolio, our team are here to guide you. Contact us today to stay ahead in the EU’s evolving pharmaceutical landscape.
October 17, 2024 – The Prescient Healthcare Group is proud to announce the appointment of Jason McKenna as its new Chief Executive Officer (CEO). With more than 20 years of leadership experience in the pharmaceutical and healthcare industries, Jason is set to lead Prescient into its next chapter of growth.
Jason started his career at AstraZeneca in marketing, sales and finance roles across the US and the UK. In 2011, he transitioned to the service side when he founded STEM Healthcare, leading the company through a phase of significant growth and eventually selling it to UDG Healthcare in 2016. Jason remained as Global CEO of the company, guiding STEM through the challenges of the COVID-19 pandemic. Most recently, he served as Chief Growth Officer at Inizio Engage, overseeing global sales and marketing across five specialty areas.
Join us for a deep dive into the key challenges and strategic initiatives that will shape the future of competitive intelligence (CI) in 2024. This session by Dr. Mark Little, Senior Vice President, will spotlight what makes a project stand out as the “Most Valuable Project” (MVP) in CI, featuring real-world insights, side-bar discussions, and innovative solutions.
Drawing from Prescient’s latest 2024 survey (our sixth in the series), you’ll gain actionable takeaways to enhance your CI strategies and tackle the industry’s evolving demands head-on.
What to expect:
Fresh perspectives on CI’s biggest challenges
Dynamic strategies that deliver high-impact, high-value CI projects
Expert insights from top industry leaders
A live Q&A session
Don’t miss the opportunity to stay ahead in the ever-competitive world of CI – sign up now!
Driving competitive intelligence through community intelligence
In today’s competitive pharmaceutical landscape, your affiliate teams hold valuable market insights that are often underutilized. Our new white paper, “Are you maximizing competitive readiness by leveraging your affiliate network?”, explores how successful CI leaders in the industry bridge the gap between global and local intelligence to create holistic, action-driven strategies.
In this white paper, you will learn:
How to overcome common internal barriers to CI sharing
The importance of integrating affiliate insights into your global brand strategy
Practical steps to foster collaboration and validate insights across regions
By leveraging both global and local intelligence, you can enhance decision making, drive innovation and stay ahead of your competitors.
Download the white paper now to:
Learn how to develop a competitive edge
Understand the power of community intelligence
Get actionable steps to foster a collaborative CI culture
*Adrienne Lim has left Prescient as of August 2024
In today’s rapidly evolving healthcare landscape, the role of Medical Affairs (MA) is undergoing a profound transformation. Long relegated to a supporting role, MA is now poised to become a strategic leader within biopharma companies, standing shoulder to shoulder with Commercial and R&D teams. But while the drivers behind this shift – data expansion, digital engagement, and increased regulatory complexity – are clear, many organizations have yet to fully elevate MA to its rightful place at the strategic table.
So, how can MA step up and claim its spot? The answer lies in one often-overlooked tool: the medical plan.
The Future of Medical Affairs is Now, and It Has Been for Quite Some Time
“The time is now for Medical Affairs to take a seat at the table alongside Commercial and R&D and become a strategic leader within the organization.”
Calls for Medical Affairs to take a more prominent role in shaping strategy have been loud and clear for several years, but the time to act is now.
Indeed, looking at the dynamic healthcare landscape reveals several prominent trends, including:
An expansion in the depth and breadth of healthcare data (e.g., RWE, insights)
A paradigm shift towards digital HCP and patient engagement
MA and MSLs becoming the primary ‘face’ of the company in external engagements, thus becoming the key interface between biopharma companies and HCPs as regulations and preferences evolve
Ever-increasing complexity surrounding clinical decision making (i.e., more therapies acting on more targets, with more treatment-stratifying criteria)
A growing need to effectively demonstrate clinical value to address mounting regulatory and life cycle expiry pressures (e.g., HTA, IRA)
These developments do emphasize the essential role of Medical Affairs in driving both external success and internal alignment, reinforcing the need for its strategic evolution; however, aside from a few uneven strides forward, the foretold transformation of Medical Affairs into a leadership role has yet to come to fruition at scale across the industry.
The Medical Plan: An Overlooked Springboard to the Medical Affairs Ambition
The medical plan is far more than a checklist of activities – it’s the center of the strategy. It is critical to both the success of an asset and the establishment of leadership within a therapeutic area. The medical plan lays the foundation for strategic success, ensuring that clinicians understand the clinical utility and value of new and innovative therapies and, ultimately, driving meaningful impact on patient care. Equally important is its internal value – providing wider organizational understanding of the role Medical Affairs has in supporting the overarching strategy. Consequently, developing an exemplary medical plan has a two-fold impact: positioning your asset(s) for success in the external landscape, while also establishing MA teams as credible strategic leaders within the organization.
Six Steps That Take Your Medical Plan to the Next Level
For all its impact, the process of developing a best-in-class medical plan can be challenging. Based on our extensive medical planning experience, we have identified these guiding principles to help you maintain your medical planning A-game:
Start with strategy, not tactics: A top-down, strategy-first approach is essential to ensure that all activities in the field support the desired outcomes. Begin by taking time to define and solidify the strategy for the asset or disease state before outlining tactics. The benefits are three-fold: first, this forces teams to clearly articulate their ultimate strategic aims, which are often ill-defined if considered from a tactical mindset (i.e., too broad or too narrow). Second, a strategy-first approach affords teams the space to align on the big-picture priorities early, often across global and/or regional functions. Finally, a well-defined strategy begets well-suited activities, facilitating the development of tailored tactics whose whole is more than the sum of their parts in support of an overarching strategic pillar. Bookending this process should be purposeful medical impact assessments that measure progress toward strategic goals and provide inputs for downstream strategic and/or tactical adjustments.
Remember the audience: The best plan is a usable one. The contents of a medical plan are inherently highly detailed (NCCN guidelines aren’t exactly renowned for their digestibility, after all); however, an exhaustive account of all information related to the asset and/or disease area is unwieldy and, ultimately, counter-productive for the reader. Conscientious consideration of the key ‘must-know’ information can go a long way in elevating the utility of your medical plan; non-essential information can be linked to the medical plan, but housed in adjacent documents (e.g., insights and CI reports). This is a practical way to strike a balance that provides access to comprehensive information on an ‘as-needed’ basis without overwhelming the medical plan user.
Strive for Consistency…: All medical plans are similar, with each containing several key core components (e.g., situational analysis, gaps, strategic objectives). For midsize and large MA teams, this similarity should be encouraged even further, with an established organizational perspective on ‘must-have’ vs. modifiable components for all medical plans. Establishing a consistent medical plan structure and process for development will make planning easier, aligning expectations and avoiding wide variations in content and approach across teams. It also supports leadership by creating a standardized format for cross-asset comparison and synthesis of disease area and portfolio decisions.
… But Recognize Bespoke Plan Needs: While consistency is important, every medical plan is also unique! Although different plans contain the same types of information (ideally organized in a consistent structure), organizational and landscape context can vary greatly across teams and should be accounted for to optimize the impact of the medical plan. Some key indicators that could influence medical plan development include:
a) Content Novelty or Familiarity Resident internal expertise and external complexity can vary substantially across assets and disease areas. Label expansions can bring the team into an unfamiliar therapeutic area, or into contact with a new type of stakeholder (e.g., medical oncologists vs. gynecological oncologists; dermatologists vs. gastroenterologists). In these instances, more time and resources should be dedicated to the development of a robust situational analysis, and to building and sharing scientific expertise throughout the organization. Conversely, teams working with established assets or mechanisms of action can look to leverage synergies stemming from internal and external familiarity, redirecting resources to other areas.
b) Team Maturity When it comes to medical planning, practice certainly makes progress. Teams that have developed their fair share of medical plans have established ways of working and are familiar with what ‘good’ looks like, so they require less support compared to more junior teams; however, it’s important not to let this experience lead to complacency. By bringing everyone together for in-person brainstorming sessions or intentional, structured exercises, teams can avoid falling into ‘business as usual’ activities and instead go further, thinking more creatively and innovatively throughout the asset life cycle.
c) Internal and External Strengths and Weaknesses Much like people, biopharma organizations have their strengths and weaknesses. Some Medical Affairs teams might benefit from well-established and robust collaboration with their Commercial colleagues, while other teams might enjoy having access to pre-eminent diagnostic capabilities in-house. Identifying organizational strengths and weaknesses, and recognizing how these might have evolved from the previous year, should be a key consideration in the medical planning process. Of course, identification and recognition are incomplete without thoughtful planning that allows for the implications of your unique organizational situation. For example, a Medical Affairs organization that works seamlessly with Commercial but struggles to collaborate with R&D might allocate additional time during the planning cycle to secure stronger alignment with their R&D colleagues.
Due consideration of any potential outward-facing strengths and weaknesses is also vital. Medical Affairs teams should be intimately aware of prevailing external stakeholder perceptions and how these might be relevant to the medical plan. For example, an established therapeutic area leader might look to leverage well-established relationships by prioritizing IISs or ESRs to address evidence gaps, while newer entrants might need to focus their activities on building relationships from the ground up before they can partner and collaborate at the same scale.
Prioritize Productivity, Not Perfection: By nature, MA professionals are detail-oriented and strive for perfection. Many might hesitate to share medical plan materials with their colleagues before they have been exhaustively deliberated, aligned upon, and finalized. While this is well-intentioned and often the result of professionals’ strenuous research backgrounds, there are many instances where work-in-progress medical plan materials can be sensibly shared with regional and cross-functional partners. Compliant sharing of early perspectives helps to clarify the direction of medical thinking. Inviting cross-functional and regional colleagues to participate in strategic and tactical workshops, even as passive participants, helps avoid the “silo effect” and drives synchronized activity planning throughout the organization. Ongoing medical plan visibility is an equally beneficial practice for leadership stakeholders, who should be reviewing the plan at select time points to pressure test and ensure alignment with organizational priorities.
Plan Proactively, Not Reactively: Owing to lengthy time horizons, high pipeline activity volume and unpredictable regulatory and policy shifts, medical plans always grapple with an element of uncertainty. Medical Affairs leaders often address uncertainties by waiting for additional information, such as data releases or competitor events, to guide their strategic decision making; however, they also need to make a conscientious shift toward a more proactive approach. Proactive planning involves making informed assumptions, evaluating their likelihood of occurrence and assessing the potential impact of key events. Highly probable assumptions should provide the foundation for the medical plan, ensuring sufficient runway for time-consuming evidence generation and other market-shaping tactics, while less probable assumptions can be accounted for within the medical plan through contingency planning that sketches high-level strategies and tactics addressing a wider range of external possibilities. This two-pronged approach to proactive medical planning prevents unneeded paralysis while fostering additional readiness and agility to react to high-impact trigger events.
Medical Planning: A Launchpad for Strategic Leadership
Although the long-standing discourse on elevating Medical Affairs’ strategic standing has yet to be reflected throughout the industry, the drivers that demand this evolution will only increase in relevance moving forward. Organizations that invest in and empower MA’s strategic capabilities will be better positioned to synchronize strategies across functions, franchises and geographies from the early stages of the asset life cycle, providing material internal advantages and boosting external impact. The medical plan presents the perfect opportunity for Medical Affairs to showcase its value within the organization and catalyze a transformation in strategic leadership. We hope this article will inspire you to take the next step in elevating your approach as you develop your roadmap and processes for medical planning next year.
This article precedes a series of more comprehensive discussions on optimizing Medical Affairs capabilities and delivering on current and future-looking opportunities. Prescient looks forward to sharing these with you and your colleagues. Please fill out the form here if you would like to further explore how Prescient can support you and your Medical Affairs team.
We’re excited to announce that Prescient will be exhibiting at the Fierce Biotech Summit and the New Product Planning Summit 2024 on Sep 30 and Oct 1. This year the events are co-located in Boston, MA, offering a unique opportunity to explore both biotech and new product planning strategies at a single event.
Come find us at Booths 23 and 24 to learn how we can support your biotech, NPP and strategic initiatives with our industry-leading insights and services.
If you want to learn more about the events, click here:
Why you can’t afford to be without it, and how to think about building your CI capability.
In the rapidly evolving biotech industry, staying ahead of the competition is more critical than ever. Our latest white paper explores how biotech companies can harness the power of Competitive Insights (CI) to drive innovation, optimize strategic decisions and maximize value.
What You’ll Learn:
Why CI is essential for biotech companies looking to remain competitive
The difference in CI needs in biotech vs. big pharma
How to develop a bespoke CI strategy that aligns with your R&D, commercial and strategic planning efforts
How a forward-thinking CI strategy can strengthen investor confidence and unlock new growth opportunities
Maximize Your Competitive Advantage Whether you’re preparing for a product launch, building strategic partnerships or looking to increase investor confidence, this white paper provides the actionable insights you need to build a resilient, future-ready biotech company.
Download Now and start leveraging CI to create long-term value and drive business growth.
We’re excited to announce that we will be exhibiting at Pharma CI US 2024, taking place on September 25-26, 2024, in Newark, NJ. As proud sponsors of this prestigious event, we invite you to visit us at our booth to explore how we can partner with you to elevate your competitive strategies and drive your success.
We’re also thrilled to take the stage for an insightful session, titled “Optimal Integration of Data, Tech and Subject Matter Expertise: Empowering You to Develop a Sustainable Competitive Advantage”, on Thursday, September 26, 2024, from 11:05 AM to 11:35 AM (EDT).
In this session, led by Ben Doran, Senior Vice President, we’ll explore how differentiation, order of entry and speed to market can significantly impact your market share. We’ll focus on how our ‘Prescient’ approach to clinical data analytics can help you stay ahead of the curve. By combining data automation, visualization and expert insights, we enable you to understand competitor clinical scenarios faster and more effectively, supporting proactive decision-making and ensuring a sustained competitive advantage.
Find us at Pharma CI US 2024 and discover how we can partner with you to drive your competitive strategies forward. For more details about the event, visit Pharma CI US 2024.
Explore the evolving treatment landscape of inflammatory bowel disease (IBD) in our latest white paper. Discover the latest advancements and potential game-changers in patient care.
In this white paper, you’ll learn about:
The current challenges in IBD treatment and how innovative solutions can address these
Breakthrough therapies, like Skyrizi and Omvoh, with compelling Phase III efficacy data
The potential of TL-1A-targeting agents, such as MK-7240 and RVT-301, to revolutionize treatment approaches
The synergies between interleukin inhibitors and TL-1A-targeting therapies
Don’t miss out – download your free copy of the white paper by completing the form.
