Drug Development
thinking. Take the growing number of poorly sol- uble APIs in the drug discovery pipeline, for exam- ple. It is thought that around 70% of drug molecules currently under development are poorly water-soluble6, posing potential development issues in terms of bioavailability.
From lead candidate to regulatory submission,
balancing time, cost and quality
One of the best ways to minimise exposure to risk is by performing a comprehensive assessment of the API at the earliest stages of development. Such an approach reduces the potential for unex- pected development challenges, as the characteris- tics of the API are well defined and potential issues can be planned for in advance.
Here, adopting an integrated approach reduces the potential for API characteristics to be over- looked. With all teams involved in the programme from the outset, meeting regularly to discuss progress and development challenges, the chances of fundamental oversight occurring are significant- ly reduced.
Though even with the best laid plans, unexpect- ed development challenges can and do happen. But with experienced experts from all key stages of the pipeline present at the table, programmes are more nimble and teams are empowered to more rapidly find solutions to challenges. With programmes built around clear leadership from an experienced programme leader, issues can be anticipated and planned for in a timely fashion.
Interdisciplinary integration: the right approach for tomorrow’s challenges Many of the most pressing challenges in drug dis- covery today are those that require joined-up
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For these BCS-II type compounds, where absorption is limited by the rate of dissolution rather than membrane permeability, the challenge is to develop and deploy enabling technologies to improve bioavailability through solubility enhancement. Successful implementation of appro- priate formulation strategies is reliant upon close co-operation between the ADME experts, toxicol- ogy specialists, formulation chemists and those responsible for designing the animal model. With the industry under continued pressure to reduce timelines, make cost-effective use of bud- gets and minimise exposure to risk, drug develop- ers cannot afford to build silos. After all, drug dis- covery has always been a team effort. By working with external partners which recog- nise the benefits of interdisciplinary integration and put a strong focus on intra-organisational col- laboration, effective communication and robust planning and leadership, developers can expedite programme timelines and bring medicines to mar- ket more rapidly and cost-effectively.
DDW
Dr Paul Overton is Global Head of Business Development at Evotec. He brings guidance to Evotec through expertise in business development, marketing and corporate leadership. Career high- lights include leadership positions at Aptuit, Huntingdon Life Sciences, Origin Pharmaceutical Services, Covance Laboratories, LCG Bioscience and Cambridge Life Sciences. Paul has a PhD in cell biology and immunology from the University of Surrey.
Drug Discovery World Winter 2017/18
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