Author: Sameer Jain, Chief Business Officer, PureSoftware
COVID-19 has had a major impact on the economy and lives of almost everyone globally. Everyone is looking up to the Pharma Industry to find quick solutions so that lives can get back to normal or maybe the new normal. But can the Pharma sector deliver what the world is expecting?
Recently, we have seen a series of announcements by some large Pharmas that they would be able to deliver treatment by early to mid-2021.
Previous data has shown that it takes anywhere from 10-15 years to develop a drug. So how is it that a Pharma company which takes years before coming up with drug will be able to pull this off in such a short span of time. While we must wait to see whether the Pharma companies can achieve the above, however, looking at some of the current actions being taken there seems a good possibility for them to achieve this remarkable feat. In terms of treatment, many approaches like vaccines, anti-virals, immune modulators are being explored.
Let’s now look at the different strategies being adopted, and actions been taken by the ecosystem actors comprising of Pharma companies, Regulators, Governments, CROs, and others.
High level of Collaboration in Research with other Pharma companies, Universities to shorten cycle times
- AstraZeneca is collaborating with Oxford University and is hopeful of a vaccine by September 2020.
- GSK has given access to its vaccine platform to Clover Biopharmaceuticals and has also recently partnered with Xiamen Innovax Biotech.
- J&J has partnered with BARDA to develop a vaccine candidate.
Build on what you have inhouse and invest further
- Merck plans to build on its success from the Ebola vaccine and develop a VSV (vesicular stomatitis virus) based COVID-19 vaccine.
- Novartis evaluating its existing products for treating malaria and pneumonia and explore if they can be utilized.
Explore the innovative and promising but unproven mRNA
- Recently, Pfizer announced a joint venture with BioNTech to distribute its COVID-19 vaccines.
- Sanofi is collaborating with Translate Bio to bring its vaccine expertise together with Translate’s mRNA expertise.
Proactively ramping up Manufacturing in advance for supplying doses for clinical testing and later for mass production.
- AstraZeneca announced agreements with CEPI, GAVI, and Serum Institute of India to double its capacity for manufacturing 2 billion doses.
- Pfizer is ramping up sites Kalamazoo, Michigan, and Andover, Massachusetts, as well as St. Louis for the early stages of its mRNA vaccine ramp-up.
- J&J has entered multiple manufacturing deals including Emergent BioSolutions and Catalent.
Overcome challenges in conducting clinical trials
One of the main concerns while conducting the trials is to maintain the safety of the patients and logistics to travel to the trial site.
- Explore innovative ways to bring the trial to the patient and conducting trials at the home of the patients.
- Also virtualizing several other aspects like patient consent, remote randomization, remote data capture, reporting, etc.
Acceleration in approvals by Regulators
Regulatory & Approval teams are working 24×7 to support the Pharma companies in every possible way.
- On 1st May, FDA did an emergency authorization of Remdesivir which was just a couple of days after some promising clinical results were seen.
- FDA has proactively provided guidelines on the pre-IND process and in the clinical trial design for the Phase II and Phase III trials.
- EMA has also fast-tracked the development support and approval process and reducing cycle time by more than 80%.
Support and collaboration of governments around the world to help the ecosystem in achieving its objectives.
- The US has agreed to pay $483Mn to Moderna to develop and test its COVID-19 vaccine.
- The German Federal Government has allocated Euros 140 Mn for vaccine development in CEPI (Coalition for Epidemic Preparedness Innovations).
- The UK Medical Research Council has announced to fund 15 Co-19 related trials through its GBP 10 Mn COVID-19 research fund.
In addition to the above WHO has also been leading efforts in accelerating a vaccine for COVID-19.
- They have enabled a global coalition by bringing together 300+ scientists from different pharma companies and universities to develop and evaluate vaccine candidates.
- While over 120 vaccine candidates have been proposed, WHO is mapping candidate vaccines and keeping a close track of their progress.
- They are also defining the acceptable characteristics of the vaccine so that it is safe and effective.
- Working with pharma companies to coordinate the clinical trials.
- Working with regulatory authorities to fast track approvals for manufacturing.
“Accelerating the investigation of safe and effective therapies that could benefit people affected by the COVID-19 pandemic is one of the FDA’s highest priorities. We are committed to maximizing our regulatory flexibility and using every tool at our disposal to speed the development and availability of these medical products and believe these new guidances will help innovators and researchers do just that”, said FDA Commissioner Stephen Hahn. “
This will be a real test of true global collaboration and leadership across Pharmas, Regulators, Governments. The leaders must think differently and innovatively to be able to fight this battle and prevail.
It is also a belief that we will see more of such pandemics in the future and therefore it is not just about fighting the current pandemic but also preparing for the future. So, what can or should be done to get ready for future challenges?
- More automation in research will be required. AI/ML, Data Science, Big Data solutions will have to mature to be able to assist the scientists in Drug Discovery. Automation adoption should be increased across Drug Development, Manufacturing, Regulatory Submissions, etc.
- Clinical services providers must re-model their plans to bring in more use of technology and virtualize as much as possible to have a wider reach while keeping safety in view.
- Supply chains will need to be further optimized so that the availability of raw materials and manufacturing happens more locally but can still give a better market reach. Also, the digitization of the supply chains should happen in parallel.
- FDA and other regulatory agencies will also need to re-think their policies concerning submissions and plant
inspections. Again, automation solutions like RPA and IOT could come into play.
The big hope is that the current pandemic will lay the foundation of a ‘new normal’ by accelerating cycle times across the Pharma value chain. This would not only greatly help fighting future pandemics like COVID-19 but also enable the faster release of medicines for other critical ailments/diseases and possibly at a lower cost as well.
PureSoftware has been serving the Pharma Industry for close to a decade. It is also a GOLD Partner with Oracle and working together with them to deliver Clinical and Pharma-Covigilance services leveraging platforms like Inform, ClinicalOne, OCRDC, Argus, IRT, etc. to a number of the global Pharmas.
Information Sources: WHO, EU Pharmaceutical Review, Fierce Pharma, Stat News and others
Sameer Jain is the Chief Business Officer at PureSoftware, with more than two decades of experience in the IT industry. Before leading business functions for PureSoftware global locations, Sameer has held leadership positions with Virtusa and HCL Technologies, wherein he outpaced the business growth in global markets. He firmly believes in aligning to the digital trends and in driving automation across all spheres of IT to drive efficiencies. Sameer believes that one should keep changing and reinventing with time.