For New Drug Discovery, What is Industry Best Practice?
September 18, 2020
Understanding the ethos and processes that comprise industry best practice will ready academic researchers for commercialisation.
For academic researchers in the early stages of drug discovery, understanding the ethos, the attitudes and processes that comprise industry best practice is an important prerequisite for embarking on the commercialisation journey. Here, we explore what comprises industry best practice, principles of engagement between parties during drug development, and how you can optimise your chances of successfully bridging academia and industry.
This document will aid researchers in familiarising themselves with the expectations of collaborating with industry to translate early-stage research.
Communication and Collaboration
It can be understandably challenging for researchers who have invested many years, even decades, to gain a deep understanding in a particular field, to then feel comfortable handing on that research to others. However, the successful translation of great ideas into real-world impact requires input from multiple disciplines. One of the first major differences that may be noted is that an industry research Project Team does not only consist of research scientists. Depending on the stage of development, the team could include project managers, research scientists, toxicologists, process development and technology transfer specialists, quality experts, manufacturers, clinical operations staff, bio-statisticians, regulatory affairs experts, clinicians, finance and marketing specialists, legal and intellectual property (IP) experts.
The successful scientific entrepreneur must be willing to work with individuals who have expertise in different fields and to engage in robust debate about data – not only with respect to the science, but also with regards to validation of their results, assumptions about clinical use, differentiation from competitors and market potential. Sometimes, this can be confronting, but as we all know deep down, skepticism and constructive criticism is a critical pillar of research and key to a healthy, collaborative partnership.
Open, clear and honest communication also extends to matters of intellectual property, presentations and publications. Disclosing results in public forums must be managed strategically. Implicit in this strategy is consideration of costs and benefits of disclosure, prioritisation and management of tradeoffs from both an academic and industry perspective. For example, investors may not be willing to invest if disclosures have the potential to compromise intellectual property undermining the commercial endeavour. Once a publication strategy has been agreed, a detailed publication plan can be created, i.e. a roadmap detailing what to present, when, and in what forum, be it seminars, conferences, or a publication. It is important to stress that industry involvement does not preclude publication. Industry will often want to publish research alongside their academic counterparts, however, timing and content may differ and will be agreed as part of the Publication Plan.
Communication and collaboration are critical to the commercialisation process. To effectively drive and manage projects, we recommend you work with a partner who can bring commercial insight based on extensive industry experience and provide you with honest feedback made in good faith, working closely with you to translate new discoveries into new medicines.
Raw data and Validation
The conversation surrounding the ‘reproducibility crisis’ has demonstrated the clear need to thoroughly and completely ensure the robustness of results. For industry, standard practice involves constantly and consistently validating data, even when statistically significant results have been presented from earlier experiments. The emphasis here is on the validation of reagents and repeating experiments, ensuring systematic use of positive and negative controls, blinding, randomisation, benchmarking, a priori definition of endpoints and success, adequate powering and confirming results with an orthogonal method. In addition, raw data will often be independently re-analysed.
This is not a sign of distrust or doubt in the original research but is simply, due diligence. It is a sad truth that many independent studies have found the reproducibility of scientific findings to be poor, with one stating that no more than 25% of assessed published preclinical studies could be validated to the point at which projects could continue.
Considering the time and cost of developing potential drug candidates, a thorough vetting process is critical and as such, is the norm in industry. With a robust evidence base that supports the development of a drug candidate, there is less risk and thus, greater confidence. Ensuring that your data is “robust” and reproducible will greatly assist in the odds of securing a deal with a biopharmaceutical company to translate a discovery made at the lab bench into a therapy used at the bedside.
Funding and Timelines
Funding allocation in industry is specific and focused, which often differs from how the more familiar funding bodies from government or philanthropic organisations operate. Industry funding is usually aligned with a tightly prescribed set of activities, deliverables and milestones, with a strict requirement for adherence to budgets and timelines. Funds are often staged or tranched, meaning a milestone or Go/No Go point needs to be achieved in order to trigger release of the next tranche of funding.
As well as timelines and the meeting of experimental milestones that are consistent with industry standards, the successful execution of a drug development program relies upon regular, responsive and dynamic communication between all members of the research and project teams. Collaborators must be accessible and do their utmost to avoid any delays in response times. If delays in communication or collaboration become systematic and unresolved, milestones may not be reached on time leading to possible project termination.
While all BioCurate funding is necessarily directed towards the activities detailed in the overall project plan, the specifics will vary depending on the project. We focus on optimising the three pillars of execution: timeline, budget and quality. In some cases, we will outsource research to a CRO who is accustomed to high throughput or undertaking research activities at scale. In other cases, we prefer to work directly with research labs at the University given their unique expertise and availability of specific models. In these situations, funding may be used to support extra personnel in the University researcher’s laboratory.
Working with you
Our team has expertise in both academia and industry and have been directly involved in multiple partnerships, in bringing drugs to market in several different modalities and therapeutic areas all over the world. Experience from the early-stage discovery process through to approval from the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has informed our team of the processes, knowledge, behaviours and mindset that are required to see a drug candidate all the way through the development and commercialisation pipeline.
Ultimately, BioCurate is here to discuss the potential of your research project and to ready scientists like you for the next stage of an exciting journey that may see your research translated into products that improve the quality of patient’s lives. There is nothing more exciting, rewarding or valuable than seeing that vision realised!