In the headquarters of a mid-sized pharmaceutical company preparing for its first product launch, a scene once considered standard has become increasingly rare: a fully staffed medical affairs department with permanent employees occupying corner offices. Instead, a new paradigm is emerging across the biotechnology field, reshaping how emerging companies approach the critical pre-launch phase of drug development.
Fractional medical affairs, pioneered by firms like BioLogic Pharma Solutions, is transforming how companies find and use talent. This flexible model lets organizations access expert medical affairs leadership on a short-term or project basis, making it easier to manage the unpredictable demands of clinical trials and regulatory approval without the cost of full-time hires.
The stakes could hardly be higher. Biotech startups operate in an environment where capital efficiency is not merely advantageous but essential. Every staffing decision carries outsized consequences, and the traditional method of building comprehensive medical affairs teams years before commercialization has become increasingly untenable for all but the most well-funded enterprises.
The Broken Economics of Traditional Medical Affairs Staffing
Conventional understanding in pharmaceutical development has long dictated that companies assemble full medical affairs departments — typically including medical science liaisons (MSLs), medical information specialists, and scientific communications experts — well before product approval. Large pharmaceutical companies, which dominate the landscape, initiated this process, which includes substantial upfront investment with lengthy commitments.
For emerging biotech companies, particularly those with no commercially approved products, this model presents a fundamental mismatch with their operational reality. These organizations face extreme outcome volatility; a successful clinical trial can dramatically accelerate timelines, while disappointing results might necessitate layoffs or complete restructuring.
Fixed staffing commitments become particularly problematic during the long regulatory review periods following clinical trials when aptitude remains essential, but full-time build-out utilization is risky.
Acknowledging this mismatch and potential impact on product development and timely testing, the BioLogic Pharma Solutions perspective comes at an opportune moment.
“Our clients don’t need and certainly can’t afford a full-time VP of medical affairs in addition to a field medical liaison, a project manager, and an admin,” says Mary Hames, PhD, EMBA, founder and CEO of BioLogic Pharma Solutions. “With small companies, they hire one person, and then that VP ends up making reservations, printing fliers, things that are not good uses of their time.”
Specialized Expertise on Demand
BioLogic Pharma Solutions’ outlook on fractional medical affairs represents a structural reimagining of how specialized medical proficiency is deployed. Rather than hiring permanent staff across various medical functions, companies engage BioLogic Pharma Solutions’ team on a flexible, project-specific basis, accessing seasoned professionals precisely when needed.
“We’re different from others because unlike what you often get with a contract MSL, ours are experienced,” Hames argues. “We’re not in contract roles because we’re in between jobs or because we’re new. We’re in it because we’re smart, hard-working, and we get bored when we’re not challenged.”
This distinction proves critical. Traditional staffing agencies often fill positions with professionals seeking temporary roles while pursuing permanent employment, which results in higher turnover and variable aptitude levels.
BioLogic Pharma Solutions’ model instead draws from a pool of highly experienced professionals who specifically choose fractional work. They provide companies with access to talent that might otherwise be unattainable at their funding stage.
The incorporation of artificial intelligence enhances human knowledge. With its team’s sophisticated fluency in AI, they understand its power, limitations, and how to integrate it into efficient workflows seamlessly. This technological edge enables the fractional team to deliver outputs that typically require substantially larger permanent teams.
Fractional Team, Big Advantage
While easy access to capability is one of the drivers of fractional medical affairs, the model also offers equally valuable strategic advantages. One fundamental operational advantage is the ability to rapidly scale resources up during critical periods, such as medical conferences or following data readouts, and then scale down during quieter phases.
Hames explains, “Unlike hiring full-time employees, we can be hired for a short-term or in anticipation of data. If you don’t like what we’re doing or your company has a downturn, you can easily cut us loose. When things go really well, we will help you hire and transition to a permanent team.”
This flexibility proves particularly valuable during the volatile period following clinical trial completion. A successful readout might necessitate rapid expansion of medical affairs activities, while disappointing results could require immediate contraction — scenarios where fixed staffing commitments become either insufficient or unsustainable.
Equally as important, this flexibility presents an excellent opportunity for cost savings. BioLogic Pharma Solutions’ fractional team of consultants distributes specialized help across multiple client organizations. This fractional method means biotech startups can access a VP-level medical strategist, field medical, and operational support simultaneously, all within budgets previously inadequate for the variety and depth of expertise.
Expertise in Application: Rare Disease Patient Identification
Perhaps nowhere is the impact of this viewpoint more evident than in rare disease clinical trials, where patient identification represents a critical bottleneck. Traditional methods often use clinical research organizations (CROs) that may not specialize in genetic testing, which is vital for ultra-rare conditions.
“Speedy clinical trials and successful commercialization depend critically on patient finding. Particularly important in rare, monogenic diseases, patient finding can make or break,” notes Hames.
BioLogic Pharma Solutions’ work with autism spectrum disorders (ASD) illustrates this distinction. Through systematic analysis of diagnostic laboratory capabilities across the United States, the company discovered a critical gap: most laboratories did not have comprehensive testing protocols for one of the most common genetic causes of autism.
BioLogic Pharma Solutions is driving improved genetic testing at key diagnostic centers, impacting patient finding not only for clinical studies, but also for eventual commercialization. This has a significant impact on patients and families as well, increasing diagnostic yield. Such specialized capabilities would be challenging to develop and maintain internally for most pre-commercial organizations.
Implications for New Industry Structure
The fractional model in the medical setting signals a potentially fundamental restructuring of how the biotechnology industry approaches talent acquisition and deployment. BioLogic’s long-term vision is nothing less than “shifting the market toward consulting versus hiring full-time medical employees before commercial launch.” This suggests that the slant is not merely a service offering but a game-changer in the industry.
As organizations embrace fractional medical affairs, consultancies gain specialized prowess, while pharma and biotech companies concentrate on core research and development and commercialization.
For biotech startups undergoing the journey from promising science to commercial viability, the BioLogic Pharma Solutions model offers a lifeline. This means access to capabilities once reserved for industry giants, deployed with the agility essential for survival in an increasingly competitive arena. This has profound implications for the economics and pace of pharmaceutical innovation.
Spencer Hulse is the Editorial Director at Grit Daily. He is responsible for overseeing other editors and writers, day-to-day operations, and covering breaking news.
