The drug development industry has seen a major shift of clinical activity away from large pharmaceutical companies in favour of therapies developed by biotechs and small-to-mid-sized biopharmas. From the 53 new treatments approved in 2020 by the FDA, 39 were from smaller biotechs – up from only 29 in 2018.
As these smaller and medium-sized firms take centre stage in drug development, comes the need to optimise the resources they invest in R&D.
One of the keys to making sure that R&D spend, effort and time are used to the fullest is to have a drug development plan (DDP) – if these are not carefully thought through, it can lead to biotechs having to rerun clinical studies.
A prime example of this is that regulators can ask for added data in a specific subgroup of patients or additional studies on particular drug interactions – barriers to regulatory approval that can be anticipated with the help of external consultants in the early stages.
What is a drug development plan?
A DDP essentially describes the steps that are required to generate the evidence to support marketing authorisation and reimbursement and it informs every part of the journey, including budgeting, capital-raising, timelines, clinical phases, research partners and locations, regulator engagement, staffing levels and much more.
An external DDP advising team is often the best placed to manage this, because as focused consultants, they are experienced experts across all regulatory affairs and product development including manufacturing, toxicology and medical writing, and planning from the pre-clinical development phase.
The planning process cuts risks including unexpected regulatory hurdles and cost, and ensures the drug’s progress aligns with investor expectations, as well as optimising resources throughout the clinical program.
In addition to the typical Phase I, II and III programmes, a DDP can highlight any extra requirements or studies that might be needed to support the application based on the consultants’ experiences – such as clinical studies in specific populations, or drug interaction studies.
A robust DPP also identifies ways to accelerate drug approval. There are a range of processes that regulators offer in order to speed up drug development and approvals. They include orphan drug designation for rare indications, and for truly exciting products that are impacting life‑threatening disease there are options including breakthrough therapy and fast track designation programs.
One of the most important processes is a commercial or competitor analysis of products on the market, or those that are currently in development – information that smaller firms may not have access to or time to research. This informs the kind of studies and information that will be needed to support the marketing authorisation of the product – invaluable in today’s economic climate.