More academic groups, new start-ups, biotechs and small pharma companies are turning to external consultants for professional program management support and guidance to help them progress their ideas into medicines for patients.
Ian Hollingsworth, associate director of product development at Boyds, a global drug development consultancy, explains the common reasons why academic spinouts and small biotechnology companies may choose to partner with external consultants to support their drug development programs, and when and how to work with them to get the best results.
For fledgling and small biotechnology companies, navigating the drug development process can be a daunting prospect. There are many simultaneous activities that need to be addressed in a drug development program, and these can be easily overlooked, especially when the sponsor company is comprised of a relatively small number of staff, whose focus may be academic research, teaching and/or clinical duties.
Therefore, having access to an expert program director whose role it is to oversee outsourced development work, as well as bringing in their specialist knowledge and experience, and access to a wider expert network of skills, can be invaluable.
Preparing for investment
Good program management involvement can help give potential investors a clear view of ongoing and planned activities within the program(s) and timelines (i.e., whether they are on track to reach pre-defined milestones), which arguably improve the likelihood of investment. It is essential that biotechs trying to secure investment have a well-developed, integrated development plan describing how monies invested and entrusted to the development of the product will be spent and what the key milestones are, for example:
- Demonstrating preclinical proof-of-concept in a relevant and ideally validated animal model of the disease to be treated
- Successful tech transfer of the manufacture of an investigational product (IP), and the associated analytical methods, to a CDMO
- The successful manufacture of GMP material
- Development of a suitable formulation of the IP for pivotal toxicology studies/the clinic
- Confirmation of an acceptable safety profile in pivotal tox studies
- Submission of a CTA/IND application for a first-in-human clinical study
- Regulatory approval for the clinical study/study initiation
- Confirmation of a good safety profile and/or a suitable pharmacokinetic profile in an initial clinical study
An experienced consultant program director should be able to assemble and/or manage an internal and/or external team with the relevant expertise in manufacture, non-clinical development, regulatory strategy, clinical operations, and medical expertise in the specific therapeutic area.
Why biotechs partner with external consultants for program management support?
There are many reasons why academic spinouts and small biotech companies use external consultants for program management support, ranging from a lack of internal resource, a desire to add a specific and deep expertise to the overall skills mix, a guarantee of effective planning and scheduling of activities, and, importantly, assistance with fundraising.
Lack of internal resources
Typically, founders or senior management in start-ups still have teaching and/or clinical commitments and need the support of extra resources to move projects forward and maintain project momentum. Lack of resource may also stem from an inability – from a funding perspective or because of company strategy – to recruit and commit to employing the experts required full-time, or even part-time.
Consultants have the flexibility to develop and adopt a strategy that works best for the client. They can be engaged over a short or long-term period either on a per hour/pay-as-you-go basis, or on a daily rate undertaking a specific project.
Once the work is complete, there is no further commitment from either party, although in practice, many small companies do engage a close-knit group of consultants over a period of years to help them on their development journey.
This helps to ensure consistency and the development of an all-important ‘project memory,’ akin to what happens in development programmes in big pharma.
Access to expertise
Experienced consultants can bring deep expertise in one or more aspects of drug development and often have years or decades of experience in doing precisely what biotechs are aiming to do. Taking an investigational product through the development pathway is fraught with opportunities to waste time and money or take the wrong turn. Bringing a consultant or multiple consultants into the team to help avoid these pitfalls can be highly beneficial.
Effective planning and scheduling
The ability to plan and schedule activities effectively involves more than just sequencing a, b, and c. Scheduling the multitude of activities required, interrogating the dependencies, and analyzing the critical path is a learned discipline. An experienced project or program manager can deal with these aspects without distracting key scientists within the organization, allowing them to focus on developing the science of the asset.
Assistance with raising funds
Having experienced consultants on board who have supported companies in raising finance previously is useful. With an understanding of what venture capital firms want from a due diligence perspective, including key deliverables and milestones, consultants can help biotech companies to de-risk their project, and ensure that their asset is presented to investors in a clear and concise manner to optimize success during funding series.
Getting the best from an external consultant
An experienced consultant can help with development planning and determine how to progress the program efficiently. There are several ways biotechs and spin outs can maximize their relationship with an external consultant, including:
- Engage with them as early as possible – this may be once a lead candidate has been selected, or ideally even earlier. In drug development, long-term plans are required, with some activities requiring early and substantial investment to save time and prevent issues further down the line, for example, manufacturing process scale-up and optimization and analytical method development and validation.
- Ensure they are a good fit for the team – although obvious, a relationship with a chosen consultant(s) should ideally be the same as with any other work colleague. Organizations should be honest and open and trust that their consultant will do the best job possible. In return, they will become as invested professionally as any internal team member.
- Align working practices – for companies or groups progressing a small, perhaps single product portfolio, it can be more efficient to operate virtually and essentially outsource all development activities, including specific expertise such as program management. In this type of model, the key to success is appointing a consultant program director who is fully aligned and ideally embedded within the company’s own team, as this will help build a deep, collaborative partnership.
Turning ideas into medicines
By identifying a well-aligned program manager to orchestrate a drug development project, organizations can gain access to an extensive network of industry specialists, as well as strong project management capabilities. These are both key to avoiding issues and delays in the process and helping to accelerate the development and speed of bringing new therapies to the market.