Drug Development
thinking can result in costly hold-ups, and even worse, loss of investment due to project failure. The pharmaceutical industry is showing signs it is beginning to recognise the importance of inter- disciplinary integration and is adopting organisa- tional frameworks that allow specialist teams to collaborate and communicate much more closely. However, even within those industries that cham- pion cross-functional working, silos still happen. A recent study published in the Harvard Business Review found that three-quarters of cross-function- al teams in leading corporations fail on at least three of five key project criteria: meeting a planned budget, staying on schedule, delivering according to specifications, meeting customer expectations and aligning with the company’s goals2.
The message is clear: interdisciplinary integrated working takes effort. To be truly effective it requires systematic implementation, clear guidance and a collective investment from the whole organ- isation in order to succeed.
Pharmaceutical outsourcing: are we building more silos?
The drug discovery landscape is rapidly evolving. External service providers such as CROs are play- ing an increasingly important role in the drug development process. Indeed, a 2016 Nice Insight survey of pharma and biotech industry representa- tives revealed spending on outsourcing is increas- ing significantly year-on-year3. It is thought that outsourcing will become a $43.7 billion industry by 2026, up from a modest $19.2 billion in 20164. However, as external service providers increas- ingly become an intrinsic part of the drug develop- ment process for many organisations, there is growing concern that the industry is compounding an existing silo culture by adding more silos into the value chain.
Some developers choose to utilise the expertise of several independent specialist contractors. And for some projects this could be a more affordable solution. However, the use of multiple contractors might not be the most efficient, or cost-effective, approach. With multiple contractors, the big risk for developers, particularly small biotech compa- nies and start-ups, is that isolated teams across companies can lose sight of the bigger picture. This often means decisions are made based on isolated and limited information, which can lead to costly delays and development hold-ups. Moreover, with multiple contractors spread over several different sites, simply managing the logis- tics of the process can be time-consuming in itself. And with tight turnaround times and narrow pro-
Drug Discovery World Winter 2017/18
ject windows, even the smallest of delays caused by a single piece of the project overrunning can quick- ly snowball as projects are rescheduled, setting back entire programmes and resulting in lost time and investment. However, there is an alternative. Increasingly, biotech and pharmaceutical companies looking to bring a quality drug to market quickly and cost- effectively are partnering with full service providers which can deliver a tightly integrated and compre- hensive development programme under one roof. By bringing all of the essential elements of a suc- cessful development programme together – from API manufacture and formulation development, through to safety and abuse liability assessment and the preparation of regulatory submission documents – the time between candidate nomination and regu- latory submission can be routinely achieved in time- frames of between 37 and 52 weeks.
Of course, this can only be achieved when care- fully managed within an organisational framework that puts interdisciplinary integration front and foremost. INDiGO programmes, for example, achieve this by eliminating the walls between pro- ject teams and ensuring specialist expertise resides within a multidisciplinary framework. Here, the highly-skilled experts responsible for heading up individual development stages are at the table when decisions are made that affect development programmes. As a result, critical decisions relating to the direction of development can be agreed between teams, based on what is right for the goals of the project, the client and the API, rather than departmental practice. This kind of collaborative working and forward thinking can eliminate the need for repeat experiments – shortening times to market and reducing development costs.
Reducing risk exposure in drug development
Interdisciplinary integration is not just about making organisations more efficient. After all, reducing the cost of developing a poorly-designed product is a cost-effective way of developing nothing at all. Collaborative working is also about managing exposure to risk and maximising the likelihood of success.
Drug development is an inherently risky busi- ness. Indeed, it is thought that just one in 10 drug molecules that enter Phase I clinical trials ultimate- ly receives market approval5. Without appropriate measures to gate projects and guard against failure, even the most experienced developers can find that potential drug candidates fall by the wayside, with associated loss of time, effort and investment.
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References 1 Jarvis, L. The year in new drugs. Chemical & Engineering News.
https://cen.acs.org/ articles/95/i5/year-new-
drugs.html. 2 75% of Cross-Functional Teams Are Dysfunctional. Harvard Business Review.
https://hbr.org/2015/06/75-of- cross-functional-teams-are- dysfunctional. 3 Nice Insight Outsourcing Trends in 2016. Nice Insight.
http://www.niceinsight.com/arti cles.aspx?post=3259&title=Nic e+Insight+Outsourcing+Trends +in+2016. 4 Pharma R&D Outsourcing Is On The Rise. BiopharmaTrend. com.
http://www.biopharma
trend.com/post/30-pharma-rd- outsourcing-is-on-the-rise/. 5 Smietana, K, Siatkowski, M and Møller, M. Trends in clinical success rates. Nature Reviews Drug Discovery, 2016, 15, 379- 380. 6 Kawabata, Y, Wada, K, Nakatani, M et al. Formulation design for poorly water- soluble drugs based on biopharmaceutics classification system: basic approaches and practical applications. International Journal of Pharmaceutics, 2011, 420, 1-10.
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