The pharmaceutical industry has gone through dramatic changes since the birth of biotechnology. Pharmaceutical companies no longer have a monopoly on drug development, nor do they represent the primary source of biomedical innovation. Since biotech firms have emerged on the scene and academia has embraced translational research as a way to help advance their own discoveries, pharma companies have begun to foster relationships with those sectors in a strategy to externalize innovation. Public–private partnerships offer a low-risk way for pharmaceutical companies to tap into academic talent and stay abreast of cutting-edge research into new targets, technologies, and tools for advancing drug development. The COVID-19 pandemic broke many barriers, bringing fierce competitors together more closely than ever before via precompetitive collaborations to expedite the creation of countermeasures in response to the crisis. The question is whether this will trigger long-term change that can accelerate the translation of laboratory discoveries to new medicines and reduce their costs.
Pharma has gone through dramatic changes since the birth of biotech. Pharmaceutical companies no longer own a monopoly on drug development and have all but acknowledged that they are not the primary source of innovation. As biotech companies have emerged on the scene and academia has embraced translational research as a way to help advance their own discoveries, pharma companies have begun to foster relationships with those sectors in a strategy to externalize innovation. Public–private partnerships offer a low-risk way for pharma companies to tap into academic talent and stay abreast of cutting-edge research into new targets, technologies, and tools for advancing drug development. Precompetitive consortia represent perhaps the biggest turnaround from the previous pharma era of insular attitudes in which company knowledge was kept strictly under wraps, and companies are now embracing the notion that by sharing data and expertise, they can solve industrywide problems more efficiently than by acting independently.
The NIH is rethinking its strategy for translating stem cell therapies. Stakeholders hope the message will be that the NIH should focus less on drug development and more on standardizing procedures and protocols.
Although the NIH is taking steps to improve the reproducibility of preclinical data, many researchers are not waiting for guidelines and instead are angling to elevate standards at their own institutions.
The lack of predictive animal models for neuropsychiatric diseases is arguably the biggest single factor stifling early drug development in the field. To kick-start discovery for diseases such as autism, schizophrenia and depression, stakeholders will need to abandon traditional models, build on emerging genetic findings and capitalize on new capabilities in stem cell technology, imaging and computational modeling.
Comments from Christopher Austin, director of the National Center for Advancing Translational Sciences, on how the center is delivering on its promise to overcome roadblocks and accelerate the translational process.
As university technology transfer offices grapple with how best to commercialize their discoveries, some are experimenting with different operating models that vary in the number and type of inventions they pursue for profit.
A new campaign to petition Congress to increase NIH funding has the backing of several academic heavyweights but stops short of defining how the money would be spent.
Enzyme-replacement therapies are highly effective for most patients with Gaucher's disease but do little for those with the neuronopathic childhood forms of the disease. Now, an Israeli and U.K. team has unlocked the mechanism of nerve destruction in neuronopathic Gaucher's disease and identified receptor-interacting serine-threonine kinase 3 as a new target.
Although public-private partnerships and tech transfer offices provide paths for commercializing academic discoveries, many ideas languish because researchers lack the experience to navigate translation. Several universities are starting programs that help, but bridging the mindset differences between academia and industry is challenging.
A tool for in vivo detection of liver toxicity could represent a substantial improvement over in vitro methods. The litmus test for the Stanford University inventors will be to show that the nanoparticle-based method can detect toxicity in compounds that previously eluded standard analysis and later failed in the clinic.
The FDA's first two centers for regulatory sciences were focused on modernizing methods and building bridges to academia. The agency now is at earlier drug development and has partnered with Stanford and UCSF to create a center focused on quantitative pharmacology that will give the FDA a foothold on the West Coast.
The NIH has joined with over 15 companies and not-for-profit organizations to create the Accelerating Medicines Partnership, a public-private partnership focused on discovering new targets and biomarkers for 4 diseases. The precompetitive PPP will make results publicly available, aiming to spur innovation from all sectors of the industry.
Simple experimental error has opened up the potential for nanoparticles to treat disease rather than be used as payloads. By accidentally using negatively charged nanoparticles instead of neutral ones, a team from Northwestern and the University of Sydney observed selective tagging of inflammatory monocytes for destruction.
A Brookings Institution report has helped quantify inefficiencies and expenses associated with licensing university patents. The report advocates an emphasis on company creation instead of IP protection, although technology transfer offices contacted by SciBX were not convinced newcos are the best approach.
New York has long been a producer of top science but has struggled to retain and develop its own innovations. Now, with a flurry of activities aiming to establish it as a biotech hub, New York's next task is to persuade VCs to seed local companies.
Moving discoveries from academia to industry requires a delicate balance of risk, reward, skill sets and personalities, according to a translational panel held at BIO-Europe's partnering conference.
Although the 'rule of five' has altered medicinal chemistry for oral small molecule drugs, Chris Lipinski believes that predicting the behavior of newer biologics might not be far off and optimization of RNA or protein delivery could be the opportunity for the next big breakthrough in computer-based predictions.