Why Hire An Interim Chief Medical Officer?

By Karen Mullen, MBBS, FRCP, FFPM, GFMD, chief medical officer, Boyds

In the competitive and ever-evolving drug development landscape, biotechs, medical technology startups, and small pharma companies are increasingly calling on the expertise of service providers and fractional executives to accelerate the progress of their program cost-effectively. Chief medical officers (CMOs) with practical drug development experience are particularly in demand, with more businesses outsourcing strategic leadership and operational delivery.

Interim CMOs are an increasingly appealing prospect for cost-conscious biotechs, either for bridging the gap for those seeking to fill the role permanently or working with those who do not yet need a full-time CMO.

The role of a CMO is a complex and multifaceted one, requiring clinical acumen and the ability to balance responsibilities both internally and externally, all while representing the voice of the patient. CMOs play a crucial and unique role in upholding ethical standards and overseeing the setup and conduct of clinical trials that adhere to the highest standards of patient safety while maintaining a commercial focus to enhance the company’s credibility and value, particularly with key stakeholders and, crucially, investors.

The Role Of An Interim CMO

Interim CMOs are helpful to organizations in a range of situations. Separate from replacing the existing CMO, they may also provide part-time CMO support, particularly within biotechs or companies working at the preclinical stage and planning clinical activities. This is because the timing of this form of clinical expertise can be critical, especially when translating preclinical to clinical and developing the correct regulatory strategy. Additionally, interim CMOs can bring specific expertise or leadership that is not within the remit of existing full-time team members, including other medical professionals within the company.

The Value Of Working With An Interim CMO

Hiring an experienced interim CMO allows businesses to benefit from their wealth of knowledge and strategic insights, strong industry network, and experience in overcoming a range of clinical challenges faced by growing biotechs. Indeed, there are many key benefits biotechs can reap from working with an interim CMO, each creating a positive impact on the overall conduct of a clinical trial.

• Cost efficiencies

From a cost perspective, hiring an interim CMO can reduce fixed cash expenditure through flexible engagement terms. It eliminates the need to pay for a full-time CMO or to provide a share of the company’s equity. The arrangement also can be consultancy-based, so businesses can pay for advice as and when it is required.

Working flexibly with an interim CMO allows organizations to scale this resource up and down according to demand and the phase of clinical development. This can be particularly helpful for smaller biotechs where cost control is key.

• Strong leadership expertise

An interim CMO may provide leadership and strategic direction, oversee clinical trials, and represent the company when engaging with key stakeholders, including investors and regulatory authorities.

Internally, an interim CMO provides mentorship and support to team members, fostering strong relationships and providing reassurance that development efforts are on the right track. They can help the team make difficult decisions, providing objective leadership to help the team progress. An external CMO can reform or maintain budgetary management for all aspects of clinical development, providing insights that can result in significant cost or time savings.

The leadership skills of an interim CMO are particularly valuable when moving from a preclinical to a clinical focus or during other leadership changes. They can provide a fresh perspective and outlook on the clinical development process. Unbiased by previous challenges faced by the organization, they can clearly assess the current situation and provide key strategic frameworks, including the use of key performance indicators (KPIs) relevant to optimizing clinical trial design, patient care, and operational efficiency, and driving quality improvement through refining processes throughout the trial life cycle.

• Clinical and regulatory pharmaceutical expertise

An interim CMO offers established “how to” clinical, regulatory, and pharmaceutical development knowledge. This is often directly derived from experience working across organizations that have navigated similar challenges. This knowledge can be invaluable: clinical development is renowned for its complexity. CMOs will know the latest regulations and clinical trial requirements, such as promoting patient-centered drug development approaches by using patient-reported outcomes and patient advocacy groups.

An interim CMO provides practical and strategic regulatory support, assisting regulatory affairs teams in making strategic drug development decisions and planning and executing interactions with regulators, including scientific advice meetings, and filing IND applications.

A company may have a doctor or scientist with extensive clinical knowledge of the target therapeutic area. An interim CMO can complement these skills, providing the pharmaceutical and drug development knowledge required to accelerate clinical development. However, where specialist clinical knowledge is not already embedded within the company, an interim CMO can facilitate this, including the recruitment of KOLs or a scientific advisory board, enabling a company to refine its clinical development program, particularly with aspects such as the target product profile, patient population selection, and establishing a clinical trial road map.

Ideally, an interim CMO will implement and embed clinical best practices from the very beginning of the clinical research and development process to ensure clinical quality and compliance throughout.

• Better clinical development program design and execution

An interim CMO’s unbiased perspective and experience with data-driven decision-making also can assist with the planning of clinical development programs. They can implement systems within the organization to enable better clinical operations performance. An experienced CMO will have an existing network of trusted vendors, consultants, KOLs, or other collaborators and a good awareness of the expertise needed to support the business, leading to direct cost and time savings. This network is essential for successfully navigating the various stages of clinical trials and the subsequent market authorization applications.

• Trust and credibility

Externally, an interim CMO's successful leadership reassures stakeholders, particularly shareholders, that the project is in good hands. Their expertise helps build a credible brand, positioning the company as knowledgeable, driven, and successful in the highly competitive world of drug development. Moreover, their knowledge and previous interactions with regulatory authorities can maximize the value of regulatory meetings, ensuring strong alignment with regulatory expectations and fielding questions on the company’s behalf.

From The Clinic To The Market

Talent shortages in the drug development sector mean specialist pharmaceutical physicians are in high demand. Drawing on their extensive expertise, interim CMOs can help drug developers navigate complex medical and administrative challenges without the financial commitment of a full-time executive. Hiring an interim CMO can provide organizations with a cost-effective solution that bolsters the clinical development of their drug candidate(s), accelerating the journey from the clinic to the market and, ultimately, improving patient outcomes.

About The Author:

Karen Mullen MBBS, FRCP, FFPM, GFMD, is the chief medical officer at Boyds and leads the clinical and medical affairs department and its team of pharmaceutical physicians, providing medical monitoring support, and safety, pharmacovigilance, scientific and medical advice across a wide range of client projects including advanced therapies, orphan drugs, and oncology. Karen is a Fellow of the Royal College of Physicians (FRCP) and a Fellow of the Faculty of Pharmaceutical Medicine (FFPM) in the U.K., for which she is a trustee on the board. She also has been recognized as a Global Fellow in Medicines Development (GFMD) by the Academy of Global Medicines Development Professionals.