Why your regulatory strategy needs a Trusted Regulatory Adviser
Imagine you are a small biotech with an exciting asset with promising early phase clinical results. This bodes well for the ability to raise investment to conduct larger trials. In an attempt to keep down overhead costs and provide organizational flexibility the organization in question is virtual. The largest market is anticipated to be the United States. In this scenario it is tempting to focus on commercial opportunity and clinical results but our experience shows that regulatory strategy is often given inadequate attention and as a consequence other important considerations get overlooked and delays are incurred.
For example, it is no good understanding what a regulatory agency will want in terms of clinical studies without also knowing their stance on control strategy for manufacturing processes. Or knowing target claims for the potential product without knowing what regulatory precedents exist and likely impact on indications and side effect warnings for prescribing information.
Taking a Global perspective will avoid re-work and improve decision making.
Regulatory strategy, if constructed appropriately, should sit at the confluence of multiple streams of activity from Commercial to Clinical to Manufacturing and it should also take account of the external environment and the actions of competitors.
Something so integral to company strategy must be owned by the company and this is particularly so for a small Biotech with perhaps one major asset that ‘has’ to succeed.
Assuming the US is the largest market there is an understandable temptation to seek FDA input to a proposed development program or approach to clinical study design. But what about other agencies? It would be wrong to assume that other regulatory agencies will automatically fall in line with FDAs guidance. Assuming this runs the risk of overlooking other agency requirements and can add significant cost and delay, perhaps having to redo trials or redefine regulatory starting materials to accommodate European or Chinese expectations. Even if the company has no direct interest in marketing outside of the US it is likely that a good understanding of regulatory requirements in other markets will increase the attractiveness and value of the asset for potential out licensing deals.
If, however the company has plans for a global product footprint then basing company strategy and plans on the needs of different jurisdictions is a wise move. Ultimately saving time and effort over the medium term. This is increasingly facilitated by Scientific Advice processes that are essentially aligned in how they operate for all major agencies. This means that company plans can be tested with leading agencies, in a logical sequence, to make informed choices about the direction to be pursued and tradeoffs to be made.
Outsource regulatory strategy with caution
For a small virtual company, outsourcing may be the only viable way to support all activities required. However, the basis for outsourcing needs some thought. The closer to the core company strategy the activity is the less attractive outsourcing to a CRO (Clinical Research Organisation) or Regulatory Consultancy will be. This makes outsourcing of such strategic activity undesirable and fraught with risks such as loss of control and plans that are not fully aligned with company aspirations.
As one moves to higher volume and lower value tasks then outsourcing to such organizations can make more sense. In the scenario discussed in this paper we have talked about ensuring that regulatory considerations are at the heart of company strategy. By implication company and regulatory strategy should inform each other and be owned by those leading the organization.
Prioritizing internal regulatory capability in this scenario as a part time employee or more likely contract basis as a Trusted Regulatory Adviser can add significant value in a number of areas. The first and perhaps most important is to devise a regulatory strategy that pulls all necessary strands together around which the organization can align. This has to be done in close collaboration with those leading the company.
Having achieved this then detailed plans and approaches to regulatory agencies can more easily be defined. Ensuring that such a strategy builds on existing precedents and likely challenges for each jurisdiction is more likely to deliver informed and globally focused strategies. This will ultimately accelerate speed to market and mitigate potential threats that may otherwise be missed. It also means that the strategy can more readily adapt to overall changes in company strategies and priorities.
The Trusted Regulatory Adviser model ensures internal leadership in a number of important areas. Firstly, key agency interactions such as Briefing Book development (in line with agreed strategy) and Scientific Advice interactions with target regulatory agencies.
Secondly, to determine when to bring in additional regulatory resources and of what type as the amount of ‘heavy lifting’ increases, for example compiling an NDA or MAA Submission. Finally, a Trusted Regulatory Adviser can assist with the creation of a request for external vendor services, vendor selection and delivery oversight to ensure that costs and scope of work are appropriately managed.
In Conclusion
As we hope this paper demonstrates company strategy and regulatory strategy should be closely aligned and integrated if the company is to be efficient in navigating to the market. Since the aspiration of a particular company will vary, it is self-evident that company strategy and therefore regulatory strategy will reflect this. Such decisions are therefore the preserve of those close to the heart of the organization. Without Regulatory expertise at the heart of company activities it will be challenging to deliver regulatory strategy that pulls all necessary strands together, is globally coherent and evolves with company needs. Without internal technical regulatory and regulatory outsourcing expertise deployment and management of larger 3rd party providers CROs or regulatory consultancies will not be optimized. For a small Biotech the value a Trusted Regulatory Adviser can deliver in terms of expertise, challenge and cost effectiveness is hard to replicate and should not be underestimated.
Written by Steven French, Managing Director, SFPC Ltd
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