Abstract
Translational research for new drugs, medical devices, and diagnostics encompasses aspects of both basic science and clinical research, requiring multidisciplinary skills and resources that are not all readily available in either a basic laboratory or clinical setting alone. We propose that, to be successful, “translational” research ought to be understood as a defined process from basic science through manufacturing, regulatory, clinical testing all the way to market. The authors outline a process which has worked well for them to identify and commercialize academic innovation. The academic environment places a high value on novelty and less value on whether, among other things, data are reproducible, scalable, reimbursable, or have commercial freedom to operate. In other words, when investors, strategic companies, or other later stage stakeholders evaluate academic efforts at translational research the relative lack of attention to clinical, regulatory, reimbursement, and manufacturing and intellectual property freedom to operate almost universally results in more questions and doubts about the potential of the proposed product, thereby inhibiting further interest. This contrasts with industry-based R&D, which often emphasizes manufacturing, regulatory and commercial factors. Academics do not so much choose to ignore those necessary and standard elements of translation development, but rather, they are not built into the culture or incentive structure of the university environment. Acknowledging and addressing this mismatch of approach and lack of common language in a systematic way facilitates a more effective “translation” handoffs of academic project concepts into meaningful clinical solutions help translational researchers more efficiently develop and progress new and better medical products which address validated needs. The authors provide an overview and framework for academic researchers to use which will help them define the elements of a market-driven translational program (1) problem identification and validation; (2) defining the conceptual model of disease; and (3) risk evaluation and mitigation strategies.
Highlights
Cohrs, et al described translational research in medicine very well when they said: “TM [Translational medicine] as an interdisciplinary branch of the biomedical field supported by three main pillars: bench, bedside and community
Shopping for new pipeline assets by large medical device or pharmaceutical companies can be good news for translational teams in academia if they can mitigate perceived risks and can communicate clearly what the value proposition of their project is to the large company and the broader market
The main issue is how to bring the core areas of expertise and a framework to provide them into the academic model without disrupting the creative processes that lead to these successful innovation
Summary
Et al described translational research in medicine very well when they said: “TM [Translational medicine] as an interdisciplinary branch of the biomedical field supported by three main pillars: bench, bedside and community. The result is often that R and D activities are curtailed and projects with long timelines are eliminated secondary to a nearer term and limited internal pipeline capacity and the need for new revenue generation These large companies look to acquire translational assets either from academia or via the acquisition of smaller innovative companies with existing or groundbreaking products in a few franchise areas in order to white label and scale up manufacturing of the technology. The challenge to effective translational efforts at universities and medical centers has frequently been that academic researchers often understand that the market opportunity or critical unmet medical needs for new technology in their research space could be very large They may not have the resources, training, or incentives to develop data supporting necessary critical engineering/manufacturing, clinical evidence, or regulatory requirements to help position their innovations to become finished goods ready for human testing or a final product ready for regulatory approval and sale. The proper evaluation of any new medical technology needs to follow a market-based framework that insures alignment of “translational” innovation with validated de-risking steps addressing the wants and needs of likely corporate licensee, partners, co-developers, or acquirers
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