With both the cost and time to bring a drug to market ballooning, the importance of an integrated product development (IPD) strategy is gaining traction. This multidisciplinary approach to drug development brings key stakeholders together, breaking down barriers to an efficient and cost-effective path to market. But while more organisations are adopting an IPD strategy, a recent industry survey found most aren’t doing so early enough. Frédéric Pailloux, Senior Director, Head of Integrated Product Development and Consulting at PharmaLex examines the IPD journey
The response to COVID-19 demonstrated how quickly and effectively new drugs can be released. While the circumstances were exceptional – nothing mobilises forces like a global pandemic – companies that embrace transformational strategies in drug development can also reduce timelines and costs. Key to this is the early adoption of an integrated product development (IPD) strategy, a multidisciplinary approach designed to improve efficiencies from start to finish. Unlike the long-established approach to drug development, which is phase driven with functions working in silos, IPD uses a holistic framework that integrates all functional teams, including clinical, regulatory and commercial. Biopharma companies are increasingly recognising the ability of a strong IPD strategy to transform drug development, inviting participation from internal and external stakeholders across different platforms for the greater good. In a recent survey commissioned by Pharmalex and conducted by Censuswide, almost half of the 107 senior leaders from US pharmaceutical and biotechnology companies polled had already implemented an IPD program or were conducting a pilot. Another third is expected to roll out an IPD program within the next year. The respondents work across a range of fields, at all sizes and stages of development, including biostatistics, clinical, regulatory affairs, patient safety, market access, medical affairs and CMC (chemistry, manufacturing and controls). Almost all (98%) believe IPD is integral to their ability to innovate across research and development (R&D). Indeed, innovation is essential in an industry that has seen the price of bringing a drug from conception to market double in a decade – a journey that takes more than 10 years and costs almost $2.6 billion.1 Those who have already invested in IPD and are starting to measure their returns believe the strategy will reap dividends in three key areas:
- Compressing time to market
- Increasing productivity
- Delivering on innovation
Over the next 12 months, industry leaders say they plan to bolster their IPD strategies, with the development and implementation of target product profiles (TPPs) or end goals; improved management of timelines, costs and resources; and the creation of more detailed strategic and operational plans to underpin a robust IPD. But while companies are clearly warming to the value of a crossfunctional approach that dismantles silos and promotes an agile and decisive response to myriad challenges, the data shows that most are starting their run too late. Only a third believe IPD should begin early in clinical development, while almost half (48%) believe IPD should start at Phase 3, or after they have received regulatory approval. This is despite an overwhelming number of those already in the process of implementing IPD believing that the strategy will help them meet key milestones (96%) and to identify where therapies could be marketed earlier (94%). By pushing the adoption of IPD later in the drug development phase, companies are making it harder to capitalise on those key areas, which represent potentially huge savings in both time and money.
Creating a Road Map for the Future
When leaders from different disciplines and departments are brought together to form a cross-functional team at the start, a road map encompassing all areas of drug development can be created. By inviting input from all parties, companies develop a clearer understanding of potential pitfalls at each stage of development, as well as a multidisciplinary approach to finding solutions. This, in turn, means decision makers are not stuck in silos, where counter-intuitive steps can be taken without the knowledge of what is happening outside their self-imposed walls, but have a clear picture of the broader development program. This enables activities and decisions to be conducted in parallel across different functions, thus improving efficiencies.