COVID 19 Impact on Pharma Sector
by Mike Aantonio BloggerCOVID 19 Impact on Pharma Sector
Author: Sameer Jian, 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.
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. Acceleration in
approvals by Regulators — Regulatory & Approval teams are working 24x7
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%.
7. 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 COVID 19 related trials through its GBP 10 Mn
COVID 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
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Created on Jun 29th 2020 00:07. Viewed 428 times.