Conquering the challenges in medical affairs by outsourcing
Written by Dr Andrea Cowley
With the expansion of medical affairs functions across the entire drug development life cycle, what was a fledgling function has since transformed into a core business operation. However, this transformation has led to significant challenges and pressures faced by medical affairs to demonstrate product value and deliver on performance (Figure 1).
Medical affairs face significant challenges
The regulatory environment is becoming more rigorous with increased collaboration between global regulatory bodies.1,2 As a result, drug approval and reimbursements require companies’ medical affairs to generate increasing amounts of complex, real-world patient outcomes data to demonstrate product value.2,3
The expiration of patents for primary care blockbuster drugs has shifted focus towards specialty drugs.4 This has in turn, led to a reliance on medical affairs to provide an increased depth of knowledge in specialty therapy areas. However, this is stifled somewhat by the decreasing percentage of specialists that are able to be accessed by pharmaceutical company representatives.4
The advent of readily accessible medical information has resulted in the evolution of the stakeholder landscape where new and diverse players such as patients and advocacy groups are now becoming key decision-makers.3 Furthermore, demands for transparency and intensifying public scrutiny adds significantly to the compliance pressures already felt by medical affairs to increase credibility and improve stakeholder engagement.3
Medical affairs play a pivotal role in overcoming barriers to accessing healthcare professionals (HCPs). Moreover, compliance requirements mean medical affairs is responsible for providing HCPs with real-time, unbiased and transparent medical information.4
Ultimately, in such an increasingly challenging environment, the onus is on medical affairs to not only generate high level data but to translate this data into quality insights and programs that address the needs of all stakeholders, from patients and HCPs to payers and government bodies.
Figure 1. Challenges in the pharmaceutical industry and the pressures felt by medical affairs.
The value added in outsourcing
Recent trends show an increase in outsourcing of critical functional activities particularly in medical affairs, such as field-based medical teams, medical information and medical publications.1 Outsourcing medical affairs offers companies a flexible and economic solution to meet the growing demands and challenges facing the business.5 Discipline-specific teams with therapy area expertise can be formed on an ad hoc basis. This allows companies the opportunity to shift their headcounts to key initiatives, driven by the changing dynamics within the company and within the market.5 Companies can therefore increase their economies of scale, increase their strategic capabilities and broaden the value proposition (Figure 2), thereby maximising and sustaining strategic management and profitable growth.
Figure 2. Advantages of outsourcing medical affairs.
The CRC advantage and value proposition
At CRC our team of experts with extensive global and local networks allows us to strategise, plan and execute tailored medical affairs projects to unlock the product value at all stages of the drug development lifecycle. This enables our clients to re-deploy their resources to maximise commercial opportunities, thus expediting market access, increasing efficiencies and economies of scale. Our strong strategic presence in the biopharmaceutical industry, high standards of corporate governance and Medicines Australia membership ensure we achieve our client’s goals to the highest quality and compliance.
1 Otto, R., Santagostino, A. & Schrader, U. Rapid growth in biopharma: Challenges and opportunities. (Stuttgart, 2014).
2 Coopers, P. W. From vision to decision Pharma 2020. (UK, 2012).
3 Evers, M. et al. Pharma medical affairs 2020 and beyond. (2012).
4 Systems, V. Reimagining medical affairs: Creating value as stakeholders, commercial models and therapies evolve. (Pleasanton, 2015).
5 Price, B. Medical affairs outsourcing. (Titusville, 2013).