Translational researchers face common roadblocks on the journey from preclinical studies to commercialization. To empower the translational community, we are working to provide the vital support needed to successfully deliver new therapies to patients.
As a translational researcher, you’re paving an uncharted path toward exciting new possibilities in healthcare. In a journey driven by cutting-edge science and a pioneering spirit, there are likely to be unexpected and complex challenges to overcome along the way — but you aren’t facing them alone.
When The Translational Scientist recently surveyed its audience to identify common roadblocks, many of the responses shared similar themes. Now, we are using these findings to develop the resources the translational community needs to bring innovative ideas to patients. Our “Hurdles and High Jumps” series, for example, includes informative articles written by thought leaders who have successfully partnered to bring preclinical concepts to clinical trials. By highlighting key lessons learned through their diverse experiences, we hope to provide specialized, targeted support that fosters translational success and brings new therapies to patients in need.
What are some difficulties translational researchers are facing when developing a new therapy?
- Bridging science and business
- Navigating the regulatory approval process
- Building a flexible, scalable workflow
- Managing and analyzing data
- Accessing talent and expertise
Scientific curiosity, fearless exploration, and a pure desire to help people all come together to drive the earliest stages of translational research. But once an idea sparks real-world potential, bringing commercial goals and strategy into the fold shifts a project’s focus, motivation, and scale dramatically. From knowing when and how to access funding to making key decisions around suppliers, partnerships, and outsourcing, we understand that translational researchers don’t always feel at ease transitioning from the bench to the business.
Regulatory requirements are not only complicated and rigorous, but they are also frequently changing and vary by region. Beyond the basics of regulatory submission, there is a growing need for good documentation practices and quality standards as you progress along the clinical path. We know that staying a step ahead of what regulators need to clear your therapy for human trials — and to eventually gain full market approval — is unfamiliar territory for some in translational research.
Even when entering early phase studies, researchers can reduce future risk by transitioning away from manual, labor-intensive processes to a workflow that’s both flexible and scalable. While striving for streamlined efficiency from the beginning sets the stage for success in later-phase trials, it also takes time, effort, and investment. And when working with new equipment, training and access to reliable service and technical support are crucial. Making the leap from lab-based production to a scalable platform can be a major hurdle when trying to advance translational research, especially since the highly sensitive nature of cells and other biological components leaves little room for error.
From patient baseline characteristics to endpoint metrics, data is the powerful backbone supporting every clinical trial phase. Study data allows investigators and regulators to assess a therapy’s safety and efficacy as well the overall validity of the trial. Detailed chemistry, manufacturing, and controls (CMC) data is another important element of regulatory success, ensuring therapy quality and adequate process control. With increasing scale, data can also drive process optimization. Accurate data and robust analytical capabilities are inarguably essential to successfully navigating the translational research journey. Figuring out how best to manage the influx of information is a challenge.
From experienced employees and industry collaborations to physicians with the knowledge needed to offer valuable clinical insight, building an expert team helps keep translational projects moving forward — but with biopharma’s current talent gap, this critical expertise can be hard to find, train, and retain. As therapeutics and associated manufacturing processes become increasingly complex, the demand for highly trained resources is exceeding the supply of skilled workers. Similarly, novel therapies sometimes require novel materials, systems, and processes, and identifying collaborators who are able and willing to create suitable customized solutions can be difficult.
For an ever-expanding selection of tools and tips on how to overcome translational research challenges, check out the “Hurdles and High Jumps” series or visit our translational research solutions webpage.
And if you’re facing a problem that isn’t touched on here, we would love to hear from you! Please share your thoughts and help shape future resources by filling out The Translational Scientist’s survey.