Lupin Pharmaceuticals

Kurt R. Nielsen

The convergence of vast stores of purposefully collected electronic data, ever increasing computing power, and sophisticated “AI like” software present us with many of the essential ingredients of game changing innovation in drug development and discovery. The accelerating pace of innovation fueled by these and other tools is only beginning to be felt in R&D and seen in newly marketed pharmaceutical products and health care services.

In my over 20 years of experiences in drug development for products in consumer health, brands and generics in pharmaceutical markets across the world, our collective ability to create, store and analyze data has enabled revolutionary products for treatment of several types of cancer, infectious diseases like Hepatitis C, AIDS influenza, pain, COPD, CNS disorders, and cardiovascular disease.

"Landmark initiatives like IBM Watson Health, Google Life Sciences, and Apple’s healthcare programs, in conjunction with government agencies and regulators, are being productively used to successfully fuel pharmaceutical and healthcare innovation"

The ability to supplement a wide range of laboratory based development and discovery work using in silico tools has been impactful. The applications include 3D modeling of receptor ligand interactions, receptor 3D structures, complex QSARs (quantitative structure activity relationships), predicting drug metabolism in vivo, modeling drug pharmacokinetics, designing and analyzing enormous Phase III clinical trials, and building reliable unit operations as well as facilities for manufacturing within a global supply chain.

In the last 20 years, I have witnessed a wonderful example of this game changing innovation in drug discovery and development. I am referring to a cure for Hepatitis C. Back in the late 1990s the treatment for Hepatitis C was intereferon alpha. This was a biologic that helped some patients but had serious side effects. It was a partially effective treatment “at best” in a fraction of patients. As time marched on, combination therapies were developed to better control the virus but still it was not a cure. In parallel, researchers were developing high throughput bioassays, vast compound libraries based on 3D structures, and QSARs, screening those libraries for efficacy signals and then conducting human clinical trials to establish safety and efficacy. The resulting newest families of HCV cures are being used to change the lives of patients. It’s truly amazing to me what was accomplished in going from treatment to cure of Hepatitis C. The use of ever increasingly sophisticated computer hardware and software undoubtedly accelerated the drug discovery and development process for the cure to Hepatitis C. There are certainly other examples of such game changing innovation in the treatment of cardiovascular diseases and certain types of cancer.

Lastly, one of our collective challenges is to not let ourselves be distracted from our work and noble mission with the political hyperbole of the moment. The difference between value and cost in healthcare will continue to be debated for many years to come. The fact of the matter is that drug discovery and development are fully utilizing the application of the newest technologies and collaboration models. Landmark initiatives like IBM Watson Health, Google Life Sciences, and Apple’s healthcare programs, in conjunction with government agencies and regulators, are being productively used to successfully fuel pharmaceutical and healthcare innovation. The benefits from the pursuit of excellence in drug discovery and development and healthcare services are clearer than ever before and to that end, we must continually renew our commitment to fully utilize game changing innovations.