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Ian Hollingsworth, Associate Director of product development at Boyds, the global drug development consultancy, explains the benefits to the drug development lifecycle of building strong partnerships with external consultants, and when and how to get the best from them.
Everyone can benefit from sharing experiences and learning from experts and specialists outside of their workplace or laboratory, and recruiting expert knowledge from outside of the organisation not only adds to a business’ knowledge bank but can also help to accelerate development and the speed of bringing new therapies to market. One indirect effect of the Covid pandemic – and the successful development of numerous vaccines at unprecedented speed – has been a greater-than-ever demand for new, effective medicines to be developed more quickly and efficiently, without compromising on safety. However, Covid vaccines were arguably a special case at a time of extreme need and often the path to the clinic and then from the clinic to market is complicated and remains a ‘long game’, with scientific and technical challenges and new regulatory hurdles to be overcome. An increasing number of academic groups, start-ups, biotechs and small pharma companies are turning to external consultants for professional programme management support and guidance to help them progress their ideas into medicines for patients.
Why sponsors use external consultants
In drug development, the originator company or sponsor is the primary stakeholder in the development of their drug, be it a small or large molecule, a cell or gene therapy. However, unless they are a large biotech or big pharma company, they will at some point, invariably need to rely on the support of consultants and experts in various specialisms to lend a hand operationally and provide expert input and guidance to ensure that their development programme(s) progresses to a successful conclusion, be that the next development milestone or value inflection point, marketing approval or product launch. There are a number of reasons why sponsors choose to work with external consultants. One of these may be lack of internal resources to carry out particular tasks. 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 momentum. Or lack of resource may 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 sponsor 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. 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 sponsors 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 invaluable. analysing the critical path is a learned discipline. An experienced project or programme manager can deal with these aspects without distracting key scientists within the organisation, allowing them to focus on the science of the asset. Bringing in external consultants into a team also offers the potential to tap into an even wider expert network of skills and experience. An experienced consultant cannot only guide you on your journey but help to identify others who can assist when required. Having experienced consultants on board who have supported companies in raising finance previously and understand what venture capital firms want from a due diligence perspective, including key deliverables and milestones, can help sponsors to de-risk their project, and ensure that their asset is presented to investors in a clear and concise manner to optimise success during funding series.
When to engage external consultants
A key question for many small sponsor companies is when to use consultants? The simple answer is the earlier the better– this may be once a lead candidate has been selected, or ideally even earlier. An experienced consultant can help with development planning and determine how to progress the programme forward efficiently.
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 optimisation and analytical method development and validation.
Important, informed decisions may need to be taken early on without the benefit of access to a complete data package, which again is where having experienced consultants available to assist can be invaluable.
External programme managers or directors can also advise on suitable lead and back-up candidates, identify necessary and useful regulatory interactions and key data-driven inflection points, assist in the selection of vendors for the programme (ie, CDMOs, non-clinical and clinical CROs) and even provide an R&D director role, reporting to the Board and investors.
How to select the right consultant for the project
Although obvious, a relationship with a chosen consultant(s) should ideally be the same as with any other work colleague. You should be honest and open and trust that they will do the best job possible. In return, they will become as invested professionally as any internal team member. Pharma and biotech professionals are all typically motivated by the potential success of the product. After all, who wouldn’t want to be able to say that they’d helped develop a cure for a disease? 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 programme management. In this type of model, the key to success is identifying and appointing a consultant programme director who is fully aligned and ideally embedded within the company’s own team, that will help build a deep, collaborative partnership. When sponsors identify a project or programme manager to orchestrate their project, the reassurance they feel knowing that activities will be effectively scheduled and are being monitored is priceless. Holding regular meetings where very one attends knowing what is to be discussed and having answered questions from previous meetings ensures the momentum of the project is maintained and built upon.
Risks of going it alone
There are many benefits to using consultants, but another way to look at this is to ask ‘what could happen if I don’t?’ Firstly, activities may take longer as studies/work may inadvertently be scheduled sequentially, which may initially appear to be acceptable, but will likely have a compound effect and significantly extend the timelines– that first-time-in-human study will always be two years away! The reality is that many tasks can be scheduled in parallel, but the dependencies between them can be complex.
There is also a real risk when developing biologics or advanced therapeutic medicinal products (cell and gene therapies), or even small molecules drugs for rare or orphan diseases, that inappropriate studies maybe conducted and suboptimal choices made, especially in terms of the non-clinical clinical trial application (CTA)/ investigational new drug (IND) enabling package. An experienced consultant will understand what studies can be left out, or for example, when a large animal species is or is not required. Similarly engaging with regulatory agencies in the correct way, to extract the required level of advice and clarification is a particular art, which an experienced consultant will be able to advise on.
Drug development is a protracted process that really is a team sport. In any group activity it is imperative to try to ensure that one has the appropriate experience available when it is required. Companies can grow organically, recruiting and building internal teams which is both distracting and time consuming. It can be difficult to identify the right people located in the right place, and even when one wants to hire. Skilled hires are costly and often have protracted notice periods so may not be available for some months. Another alternative is to bring in expert external consultants, who can start quickly and bring the years of hard-won experience directly to your project – they may join the journey for the long term, or handover to an internal team.
A strategic partnership
For any drug development programme, a strategic partnership approach that facilitates access to an extensive network of industry specialists– combined with strong project management capabilities – are key to avoid issues and delays, ensuring a smooth passage through to the next inflection point or development phase, to a successful acquisition or licensing deal, or through to regulatory approval and the market.
About the author:
Ian Hollingsworth M.Sc. is Associate Director of product development at Boyds, a pharmaceutical and biotech product development consultancy. Hollingsworth is PMP (Project Management Professional) qualified and has over 20 years’ experience in the pharmaceutical and biotech industries, working in big pharma before moving into project managing early-stage programmes. Hollingsworth has managed projects in production facilities as well as transnational drug development programmes, including the UK initiative to establish Advanced Therapy Treatment Centres (ATTC) across the NHS.