If you’re leading a biotech in 2025, every challenge can feel existential. Breakthrough science is just the start. Turning that innovation into actual success means aligning the smartest people in your orbit: internal teams, external experts, clinicians, and KOLs.
But when you’re small, nimble, and already working at max bandwidth, working with these brilliant, busy people is like conducting an orchestra mid-flight—everyone's moving fast, and there's zero room for error.
That’s precisely where a modern steering committee comes in. Think of it as your strategic brain trust, a mission-critical hub for turning complex clinical plans into clear action steps. Done right, steering committees aren’t just routine checkpoints; they're accelerators—driving faster clinical trials, sharper evidence planning, and stronger launch strategies.
But let’s be honest: Traditional approaches—endless email chains, scattered files, manual logistics—don’t cut it anymore. They're exhausting and error-prone. We’ve built Health Expert Connect™ to address those challenges head-on: a platform designed to streamline steering committee management, eliminate logistical headaches, and free your team to focus on what actually matters—bringing groundbreaking therapies to the patients who need them most.
This guide offers a comprehensive overview of medical affairs steering committees for early- and growth-stage biotech organizations. Whether you’re building your first steering committee or seeking to optimize an existing one, this resource provides strategic and operational insights to support your efforts.
We’ll walk through definitions, key functions, common challenges, and best practices—and explore how digital tools like ExtendMed's Health Expert Connect™ can help your team to streamline steering committee planning and execution while relieving administrative burden.
Today, steering committees aren’t just groups of advisors you consult occasionally. They’re structured, strategic hubs made up of carefully chosen internal and external experts who guide clinical development, shape evidence generation, and inform product launch strategies throughout the entire lifecycle.
Rather than merely reviewing and rubber-stamping proposals, a good steering committee proactively takes on nuanced challenges—such as refining study endpoints, assessing patient recruitment feasibility, and strategically aligning trial protocols with evolving standards of care.
They're designed to tap into a rich spectrum of perspectives, blending medical, regulatory, commercial, and real-world clinical insights.
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Typical participants include:
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Here are two relevant examples to illustrate the function of these committees:
Example 1: Accelerating protocol developmentConsider a biotech developing a novel therapy for a rare autoimmune condition. Initially, their clinical team proposes complex, burdensome patient assessments—potentially limiting enrollment and slowing trials. By convening a strategic steering committee early, comprising KOLs, patient advocates, and community clinicians, they streamlined their protocols dramatically. The committee recommended practical adjustments to the assessment schedule and at-home monitoring options, boosting patient enrollment and accelerating trial timelines by several months. |
Example 2: Optimizing a real-world evidence (RWE) strategyImagine a biotech finds itself facing skepticism from payers about its product’s real-world effectiveness. They could bring together regulatory experts, KOLs, and health economics specialists early in the process. Instead of relying solely on traditional randomized trials, the committee advised developing parallel RWE collection strategies—including digital health trackers and pragmatic trial designs—resulting in compelling evidence that directly addressed payer concerns and improved market access at launch. |
Steering committees can take different forms, depending on your company’s needs, from long-term groups that meet regularly across development stages (standing committees) to temporary teams focused on specific studies or milestones.
“A steering committee is where you say, ‘Let’s plan out our next clinical trials.’ It’s not just a forum to discuss ideas—it’s where actionable plans begin. That’s where the right advisors come in. It’s structured, strategic, and it really helps organize all the different moving pieces, whether it’s endpoints, patient recruitment strategies, or post-marketing objectives.”
— Amy Ravi, CEO, ExtendMed
When you're leading an early-stage biotech, you almost never have the luxury of deep internal teams or expansive in-house expertise. Your resources are lean, and every decision can have massive downstream implications. We use steering committees to bridge these gaps by delivering targeted expertise exactly when a team needs it most. Teams we work with get the scientific input and validation they need when resources and time are limited. They also use these committees to get real-world insights from investigators and clinicians to inform trial design and launch strategy.
For example, let’s say your team is designing a pivotal trial. Without a steering committee, you risk costly, avoidable amendments because crucial practical insights from clinicians weren’t available upfront. A committee—filled with the right mix of external investigators and clinicians—could have helped you foresee enrollment bottlenecks or refine eligibility criteria early, saving time and resources down the line. |
These committees also break down organizational silos—pretty fast. They help create direct alignment across clinical, regulatory, commercial, and medical affairs functions, making sure every department’s goals align neatly into a cohesive strategy. Instead of fragmented, reactive decision-making, you get proactive, strategic alignment—making you faster and more agile.
In effect, an effective steering committee is a way for small biotechs to leverage the strategic depth of a much larger organization.
A strategic steering committee does far more than provide periodic input—it acts as a continuous, agile partner across several critical functions:
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“I always urge teams to think of the steering committee as a strategic engine, not just a checkpoint. With the right advisors and tools, it becomes a source of actual continuous feedback, structured iteration, and long-term alignment. We’ve seen clients use this structure to get alignment not just on study design, but on lifecycle planning and even publication strategy.”
— Amy Ravi, CEO, ExtendMed
Platforms like ExtendMed’s support these functions by integrating the logistics, collaboration, and analysis components into a unified environment. The biotech teams we work with manage each function with the agility and precision that would be just about impossible to achieve without a dedicated platform.
One of our biotech partners leveraged their steering committee not only to refine their trial design but also to create a robust evidence-generation roadmap tailored precisely to payer needs, significantly accelerating their market access strategy.
The modern steering committee isn't about managing complexity; it's about harnessing and actually driving it into a focused strategic advantage.
Despite their value, steering committees can be difficult to manage—especially in growing organizations. We frequently hear from medical affairs leaders who are bogged down and distracted from higher-value strategic work.
Here are some of the most common challenges we encounter from biotechs seeking something better.
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A biotech can spend weeks manually consolidating feedback from multiple reviewers across scattered document versions—until they adopt a centralized collaboration tool, instantly streamlining their entire review and approval process. This change alone can save hundreds of hours annually.
Technology, in combination with best practices, is increasingly offering solutions to persistent challenges like those above. Digital tools can streamline every aspect of steering committee operations, increasing flexibility, scalability, and compliance—critical advantages for lean biotech teams needing to move fast while maintaining quality and regulatory rigor.
“We’ve had steering committees go from kick-off to delivering a publication-ready protocol in under eight weeks. That speed comes from aligning the right minds early and creating an environment that’s both structured and flexible—where advisors know their feedback is valued, documented, and will be acted on.”
— Amy Ravi, CEO, ExtendMed
Let’s briefly run through the solutions that are available to biotechs right now.
Using a single platform for planning meetings, sending updates and reminders, and contacting participants can make it easier to keep track of communications and the status of individual tasks.
Tools like ExtendMed’s offer secure, expert communication hubs that offer real-time meetings (via a Zoom integration) and asynchronous interactions such as discussion boards and surveys within the same platform, so your meeting information from different channels can be captured and stored centrally. Moreover, all communications and data management are HIPAA-compliant and built to meet global regulatory standards.
The expense and logistical challenge of gathering experts who live in different regions, or even countries, is a large part of why traditional, in-person meetings can feel daunting for some biotechs. Increasingly, however, virtual meetings have become an attractive alternative to gathering stakeholders in person. Secure, online discussion boards, meanwhile, provide a way for participants to not only avoid travelling to a meeting, but participate on their own time, asynchronously. This eliminates the need to find a single meeting time across time zones and busy schedules.
When you combine synchronous and asynchronous digital engagement approaches, you can leverage both the humanity of synchronous, face-to-face engagement with the convenience of asynchronous discussion.
This can also make gathering continuous feedback an affordable option. ExtendMed recently worked with a client who took this hybrid approach, since our platform has both synchronous and asynchronous capabilities, and they were able to not only meet their objectives but cut costs by ⅔ compared to a traditional solution.
When participants are each marking feedback on a separate copy of a document, or have difficulty accessing the document in the first place, it can mean laboriously granting access and consolidating feedback.
Thankfully, today we have the ability to digitally capture feedback asynchronously and reflect changes instantly with shared documents. They allow stakeholders to participate at their convenience, enabling them to respond to edits by peers who may be viewing the document simultaneously. Tools like Health Expert Connect™ enable this type of collaboration within a centralized platform, and allow steering committees to create their own custom-branded digital libraries stocked with all the content stakeholders have been assigned.
Ensuring teams maintain consistent engagement and deepen relationships with key stakeholders is essential for steering committees to be effective. To do this, it’s key to keep track of stakeholder activities, such as completing assigned readings and participation in discussions.
Making sure everyone is equally informed with background information and feels empowered to contribute creates a healthy and productive environment. A system like Health Expert Connect™ that tracks each stakeholder’s contributions and feedback over time, as well as documents they have viewed, can help the moderator more easily stay on top of stakeholder participation.
When you are storing data in disparate places, especially tools that are not designed for a pharma/biotech application, it is possible to run up against regulatory challenges. That’s where regulatory-compliant places to store and access data come into play, not only in protecting sensitive information, but supporting audit readiness.
For example, ExtendMed’s platform is built for compliance, storing all data securely. It also has integrated Sunshine reporting features, audit trails, and contract management, supporting secure and transparent documentation.
As a growing biotech, you likely don’t have an excess of time and attention for the logistics, planning, and learning curve required by your first steering committee. This is where a third-party consultant combined with automation to handle repetitive tasks can be immensely helpful as you’re learning the ropes. We’ve often helped clients in this capacity, providing advice on setting clear objectives and agendas for each meeting, how to stay focused and measure success, defining roles and responsibilities, and other best practices.
Here’s an example of how we used solutions like the ones above to get results for a steering committee client:
A global pharmaceutical company collaborated with ExtendMed to manage a steering committee of 5 experts across three countries and four time zones. The goal: create a patient database to collect real world data post-pharmaceutical launch through an affordable, and largely asynchronous, virtual steering committee.
Using the platform’s discussion board, questionnaire, and virtual meeting tools, the panel was able to provide use cases for the database, goals, protocol, site enrollment process, variable fields and values, patient consent, patient FAQ and quality of life assessments in less than six months. By using the platform, the company saw a time savings of more than 200 hours and cut the cost of soliciting the perspectives of these thought leaders by 2/3.
Read the whole story >
Whether you’re launching your first committee or scaling to support a growing pipeline, ExtendMed offers the tools and service to help biotech teams build relationships, gather insights, and stay compliant without sacrificing speed or precision.
ExtendMed’s Health Expert Connect™ platform offers biotech companies a robust, scalable infrastructure for managing steering committees including capabilities such as:
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By partnering with ExtendMed, you can jumpstart your steering committee, optimize the value of your KOL interactions and ensure that the insights gathered during these events are effectively shared and integrated into your broader strategies.
Don't let the complexities of logistics and planning hinder your mission to advance clinical research and promote your products. With ExtendMed's Health Expert Connect™ platform, you can transform your approach to steering committees, creating more meaningful connections with KOLs and maximizing the return on your investment.
Ready to take your steering committee strategy to the next level? Schedule a demo today to discover how we can help you optimize your stakeholder engagement efforts for 2025 and beyond.
📄 Full Case Study
A pharmaceutical company needed timely and frequent feedback from a panel of KOLs around the creation of a patient database to collect real world data post-launch. . .