Pharma ramps up innovation in response to COVID-1928 Apr 2021
CPhI asks industry experts at Beximco Pharmaceuticals, Catalent, DIA and Thermo Fisher Scientific to weigh in on the remarkable innovations we have witnessed and what lasting impacts they may have on our industry in a post-pandemic world
The early days of the global coronavirus pandemic sent the healthcare and life sciences industries into innovation overdrive. The rapid pace of development set over the past decade – widely recognized as a time of remarkable discovery in the life sciences – now seems sluggish in comparison.
In 2020, we witnessed an extraordinary spike in partnerships and collaborations between the public and private sectors aimed at finding effective healthcare interventions. These collaborations occurred across disciplines – from clinical diagnostics and medical devices to therapeutics and vaccines – spanning pharmaceutical and biopharmaceutical companies, medical device and diagnostics manufacturers, academic and industry researchers, biorepositories, regulatory agencies, NGOs, non-profits, and many other stakeholders. The work has changed the face of healthcare across the globe at previously unimaginable speeds.
Fundamental to virtually all of the collective advances has been the tremendous scope of collaboration. According to Karen Flynn, President, Biologics & Chief Commercial Officer at Catalent, “the unprecedented sharing of knowledge paved the way to find solutions. Early on, the virus’s genome sequence was made publicly available within two weeks of the first reported cluster of cases in Wuhan, China. From there, academics and pharma companies from around the world began fervently developing vaccine candidates, most based on the spike protein gene sequence.”
What were some of the crucial innovations during COVID-19? Flynn points to the near-overnight launch of at-scale mRNA manufacturing as a big win for the industry. “Before the recent pandemic, no mRNA therapy or vaccine had been approved, and thus there was no need to scale manufacturing of mRNA-based treatments to a commercial scale. Now, with the Emergency Use Authorization of both the Pfizer-BioNTech and the Moderna mRNA-based vaccines, much more is known about how to scale this relatively new modality. This includes all the steps of the scale-up process – plasmid DNA manufacturing, in vitro transcription and purification, lipid nanoparticle formulation, fill and finish, and even analytical testing.”
Innovations were not limited to therapeutic interventions. According to Beximco Pharmaceuticals Chief Operating Officer, Rabbur Reza, “in the field of diagnostics, we have seen rapid development and distribution of PCR tests, as well as rapid antigen and antibody tests from companies including Abbott and Roche.”
Necessity of speed and agility
One common thread among our experts was that the pandemic exposed the necessity of speed and agility. Reza points out that “medical innovation is often accelerated in a time of crisis,” while Anil Kane, Executive Director, Global Head of Technical & Scientific Affairs at Thermo Fisher Scientific, cites the need for “speed and agility to adapt” as vitally important.
Speed was also the impetus behind repurposing existing therapeutics. Reza notes, “the value of drug repurposing is to speed up the traditional process of drug discovery by identifying a novel clinical use for drugs that have already proven to be safe and effective in humans and are approved for other indications.”
“Drug repurposing has been the most widely used and effective means in finding potential interventions to combat the pandemic. We have seen a number of existing drugs emerge as potential treatments owing to their purported benefits in many trials, and some of them have played an important role, especially in alleviating symptoms and preventing further deterioration,” adds Reza.
Anil Kane characterizes drug repurposing as “an efficient and economical approach to drug development.” He points out that “in the last decade or so, the need for new approaches to drug research and development combined with the advent of big data repositories and the associated analytical tools, has generated renewed interest in developing systematic approaches to drug repurposing. Some approaches adopted by industry experts in the last five to eight years to identify drugs for newer indications in drug design include the use of big data, quantitative structured activity relationship modeling, computational tools, machine learning, neural networks, artificial intelligence, and high-power computing techniques.”
Dr. Brianne Raccor, Manager, Scientific Programs at DIA views drug repurposing as a “developmental model which has gained more attention” in the wake of the pandemic, pointing to the example of the corticosteroid dexamethasone as an adjunct treatment for patients requiring supplemental oxygen.
In addition to reduced development timelines, the repurposing approach can also reduce costs – but will it continue to gain traction? Reza believes this approach offers tremendous value post-pandemic. “It will continue to remain a major pathway or means in tackling or mitigating such a crisis and will also help speed up the traditional drug development process using AI and other modern breakthrough research tools and techniques.”
Regulatory agencies’ role in response acceleration
Regulatory agencies have also played a crucial role in accelerating our response to the global health crisis. The US Food and Drug Administration, for example, adopted the Coronavirus Treatment Acceleration Program to expedite the approval of therapies and issued guidance specifically on Emergency Use Authorizations (EUAs) for vaccines.
Reza points out that “agencies worldwide implemented fast-track procedures to expedite the development and marketing authorization of therapeutic solutions against COVID-19. This EUA has remained a critical regulatory pathway to shorten the timeline without compromising quality or compliance…The FDA also issued guidance specifically on EUAs for COVID-19 vaccines. The recommendations include key information and data that the FDA recommends to support the issuance of a EUA, including chemistry, manufacturing and controls information, nonclinical and clinical data, and regulatory and administrative information.”
“The major global regulatory agencies such as the FDA in the US, Health Canada, MHRA, EMA, and many others have done a great job in quickly adapting and responding to the pandemic situation and making critical decisions,” says Thermo Fisher’s Kane.
Flynn at Catalent echoes the sentiment: “Generally speaking, regulatory agencies enabled faster approval of COVID vaccines and therapies by granting priority review status to vaccine and therapy candidates where they could. The agencies accepted rolling submissions in some cases, and dedicated resources to do the data analysis, inspections and other tasks that are necessary to ensure that a vaccine or therapy is safe and effective for use.”
Technology boom will have lasting impact
Beyond EUAs, diagnostics, vaccines, and treatments, many of the advances resulting from the pandemic cited by experts involve technology innovation. The application of artificial intelligence (AI), machine learning (ML), digitization, and data mining to accelerate decision-making in the search for new interventions will have a lasting impact on the drug industry.
According to Kane, digital tools have made significant inroads. “Research and Development will focus on analytical tools, big data, and artificial intelligence, as well as a drive to bring drugs and therapies faster to the clinic. Digitization in clinical trial management, patient recruitment, monitoring, data collection, data analysis, and reporting will utilize digital platforms and remote decentralized units.”
As Dr. Raccor points out, the decision to use dexamethasone to treat COVID-19-related inflammation “demonstrated the value of using molecular pathology to drive therapeutic decision making.” We have also seen the utility of screening compounds with known safety profiles in high throughput assays to search for anti-viral drugs that might be effective against COVID-19.
Catalent’s Flynn adds that “studies have increasingly called upon computational methods to predict new drug targets or candidates for repurposing. In contrast to experimental screening, in silico approaches cost less and take less time, and can be used to evaluate thousands of compounds and identify the best few for further evaluation and experimental validation.”
COVID-19 innovations are also expected to drive industry investment in the future. Preventative therapies such as vaccines have historically not experienced the levels of private investment common among other therapeutic classes, often garnering broad attention only when health crises arose. Flynn believes we may have reached a turning point, and that the pandemic “may spark a bit of a renaissance in vaccine innovation and development against diseases that currently affect people around the world, as well as building vaccine development platforms that are easily able to address any new disease that may affect humans.”
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