5 minute read
DR PRABUDDHA KUNDU
CO-FOUNDER & MANAGING DIRECTOR, PREMAS BIOTECH PVT. LTD.
COVID-19 ACCELERATES PHARMA R&D AND INNOVATION
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During COVID-19, the entire health care research got a big boost and shifted into hyperdrive
this emerging trend where the nascent technology would be incubated, till a certain time, where it was being sold off at a huge valuation. With the advent of COVID-19, the entire health care research ecosystem got a big jolt in the right direction and shifted into hyperdrive in response to the pandemic. COVID-19 offered both an opportunity and risk simultaneously. This led to the unleashing of different forces, perhaps more asymmetric than anticipated. Unprecedented collaboration, rapid development, regulatory landscape change and breakdown of the silos were seen to promote a culture of a greater good. The economic and public health burdens that came along, demanded that we rethink our approach to developing new vaccines and therapies.
Pandemic pushed the boundaries
Researchers and business leaders in pharma and biotech companies are evaluating the lessons learnt in the past 14 months, and how we can utilize the learnings from these experiences and apply the lessons to the route to rapid development in the future. The major lessons and impact are technology; im-
Technology and Innovation have been hallmarks of proving the clinical development path, the global pharmaceutical and biotech industries and building partnerships. along with being one of the most regulated in- For the technology route, there has dustries. With competition evolving over the past been an enormous effort and spurt of few decades, blockbuster drugs were becoming the utilization of new technology to comincreasingly difficult to deliver, given the fact that there were bat the pandemic, whether it is Medtech, no new classes of antibiotics, nor other classes of blockbuster biotech or vaccine tech. Initially, repurdrugs being launched. The innovation had moved to different posing of the available drugs was done, modalities of biologics, more evolved and niche technolo- like, anti-viral, anti-malarial, gies, CAR-T, stem cell therapies and custom medi- plasma therapy, anticocines. Moreover, large companies were suffering agulants, etc. Concomifrom their inherent large size, which came with “Researchers tantly, new modalities, silos and internal bureaucracy. This led to in- and business like mRNA, DNA novation moving out to a burst of smaller tech leaders in pharma vaccines, monoclocompanies globally who kept the innovation and biotech companies nal antibodies, RNAi engine running. This contrasted with large are evaluating the and cell therapy have companies who had strength in processes and lessons learnt in the taken off, with sevregulatory insight, whereas the smaller compa- past 14 months” eral vaccines being apnies gave space for innovative thinking and fertile proved under emergency grounds for newer exploratory technologies. Partner- use authorisation and other ships evolved with the larger pharma/biotech companies therapies being rushed through accessing newer tech via M&A strategy or funding at the onset, large scale human trials. etc. The Venture Capitalists (VC) of the world understood this As of March 4, 2021, there were evolution and started putting huge amounts of investments in 1,084 drugs and vaccines in develop-
ment targeting the Coronavirus disease (COVID-19). Comparing this to June 2020, where there were about 415 therapies and vaccines being developed. The vaccines that are approved are mostly mRNA and DNA modalities. Whole viral vaccines and Virus-Like Particles (VLP) are on the fast track developmental path, and with the new strains and mutations surfacing, there are multiple opportunities and possibilities as well. Hence, it is very evident that technology has made an enormous push on the development and acceleration of the potential therapies and vaccines into clinics. That brings us to the second point that has undergone robust innovation and rapid change in the design, implication, and outcomes of the clinical trials. And here it is very important to mention that this would not have been possible without the wholehearted involvement of the regulatory agencies globally. Regulators acted and are acting in an advisory role, empowering biopharma to apply judgement to their clinical trial conduct and enable progress, trial by trial, depending on the data being presented and the outcomes demonstrated. Clinical trial design and out-
comes were pegged at 10.5 years from entry to Phase 1 to commercial approval and launch. The present COVID-19 trials are predicting outcomes in months and this has been possible due to a continuous engagement with the regulators and biopharma companies. Within silico R&D design, characterization, data predictions becoming a norm, IND prioritization, overlapping phase trial designs, early indicators or surrogate endpoints, real-time reviews and conditional approvals became part of the clinical trial and regulatory innovative steps taken during this pandemic.
The widespread adoption of telehealth services enabled due to social distancing measures was a step towards a novel thought process, as it allows geographically diverse patients to access trials where clinical sites aren’t available. treatments. So, as they launched a trial for their lead investigative neutralizing antibody against the novel coronavirus, they did so in a way that did not require residents to travel. The first-of-its-kind study design relies on mobile labs built from custom retrofitted recreational vehicles that can be brought directly to residents and staff, while trailer trucks transport the supplies needed to create on-site infusion clinics. Such paths would not have been possible unless we were in a pandemic situation.
Way forward
Competition, innovative ideas and intellectual property remain a critical and vital point for potential friction and material right amongst companies, it is very necessary to fuel the innovation engine that enables the collaborations to take place along with meaningful discussions. Positions taken by the pharmaceutical industry to help address this and other crises during the pandemic has been highly commendable. The pandemic is catalyzing conversations amongst the smaller tech players and the pharma companies. It is about expanding partnerships in ways that can mutually benefit both the players involved and this is the biggest gain from the pandemic of COVID-19. It is that we stand as a team against the virus or we will fail as humankind. That would indeed be a large price to pay. As they say – A rising tide lifts all boats.
Cloud-based technologies saw a massive spurt in their utilisation and deployment. We must capitalise on their potential. An approach taken by Lilly offers an example of rethinking clinical trials in the age of Coronavirus. Given the pressing challenges caused by the pandemic, Lily needed an innovative solution to fast-track potential COVID-19
