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 that do not yet need a full time CMO.
Chief Medical Officers (CMOs) with practical drug development experience are particularly in demand, with more businesses outsourcing strategic leadership and operational delivery. In this article, Dr Karen Mullen, Chief Medical Officer at Boyds, explores the benefits and value of hiring an interim CMO.
Chief Medical Officers (CMOs) with practical drug development experience are particularly in demand, with more businesses outsourcing strategic leadership and operational delivery. In this article,The role of a CMO is a complex and multi-faceted one, requiring clinical acumen and the ability to balance responsibilities both internally and externally, all whilst representing the voice of the patient. CMOs play a crucial and unique role in upholding ethical standards, overseeing the setup and conduct of clinical trials that adhere to the highest standards of patient safety, whilst maintaining a commercial focus to enhance the company’s credibility and value, particularly with key stakeholders and crucially, investors.
Interim CMOs are helpful to organizations in a range of situations. As well in some cases replacing the existing CMO, they may provide part-time CMO support, particularly within biotechs, or companies working at the pre-clinical 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 with the end goal in mind. Additionally, interim CMOs can be brought into an organization to provide specific expertise or leadership that is not within the remit of existing full-time team members, including other medics within the company.
Benefits of working with an interim CMO
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 can also be consultancy-based, so businesses can pay for advice as and when it is required.
Working on a flexible basis 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 or 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 to tackle difficult decision-making, 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 can be of particular value when moving from a pre-clinical to a clinical focus, or during other leadership changes. They can also provide a fresh perspective and outlook on the clinical development process. Unbiased by previous challenges faced by the organization, they can assess the current situation clearly and in a focused way 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 lifecycle.
Clinical, 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 a variety of organizations that have navigated similar challenges. This knowledge can be invaluable: clinical development is renowned for its complexity. CMOs will have knowledge of the latest regulations and clinical trial requirements such as promoting patient-centered drug development approaches including 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, planning and executing interactions with regulators, including scientific advice meetings, and filing Investigational New Drug (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 act to facilitate this, including the recruitment of key opinion leaders (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 roadmap.
Ideally, an interim CMO will implement and embed clinical best practice 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 can also 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, key opinion leaders (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 proven track record of 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 help to maximize the value of regulatory meetings, ensuring strong alignment with regulatory expectations and fielding questions on the company’s behalf.
Accelerating your drug development journey
Drawing on their extensive expertise, interim CMOs can help drug developers to navigate complex medical and administrative challenges, without the financial commitment of a full-time executive and the salary associated. 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.
Interim chief medical officer support
Boyds’ team of experienced Pharmaceutical Physicians provides interim Chief Medical Officer (CMO) support to biotechs. Whether you are waiting to find the right individual to fill the CMO role or are not currently in need of a full-time permanent hire, the team at Boyds can provide experienced, flexible resource as your interim CMO. Find out more about how we can help you with interim CMO support.
The full version of this article first appeared on Clinical Leader here.
