Interview of Dr Paul Stoffels, executive VP and CSO, Johnson & Johnson (J&J)
Today’s TOI published an interview
of Dr Paul Stoffels, executive VP and chief scientific officer of US-based drug
biggie Johnson & Johnson (J&J).
Treatment
for the dreaded disease tuberculosis, spreading in alarming proportion in
India, has been largely ignored by most drug companies because of "limited
or no financial incentive" and lack of basic research, according to
Dr Paul Stoffels, executive VP and chief scientific officer of US-based
drug biggie Johnson & Johnson (J&J). He minces no words in saying it's
a disease of emerging countries. J&J, which rolled out a breakthrough
treatment bedaquiline in 2016 for multi-drug resistant TB - the first in 40
years - is now spearheading a new and universal regimen to cover every form of
TB infection, in "a unique and unprecedented" partnership with
India's CSIR to develop four new drug targets in parallel.
Complimenting India's "openness" in moving swiftly on the agreement
within six months, Stoffels -largely credited with simplifying treatment
for HIV - said a similar approach will be attempted for TB too. Excerpts
from an exclusive interview:
What are the details of this partnership with CSIR's arm IMTECH in terms of funding and timelines?
Drug
development of an infectious disease takes multiple million dollars as it
involves a huge amount of clinical work, coupled with significant risks
involved. At this stage, we are yet to discuss and finalise the modalities and
contribution from each side. We have four drug candidates ready to work on,
which could lead to possibly a triple regimen. At present, an MDR patient
needs to take 10-15 pills a day or 15,000 for two years. We will attempt a shorter,
safer and sustainable treatment involving a combination of drugs in a single
pill. Getting drugs in infectious diseases, which are safe to use, is an
expertise.
Knowing the magnitude of the TB problem, why has there been such a dearth in treatment?
Knowing the magnitude of the TB problem, why has there been such a dearth in treatment?
It's
a huge challenge to find a drug in infectious diseases. Also, TB is a disease
of emerging countries, so there is limited or no big pull for doing big
research. It takes a lot of commitment for a big company like us to work in
this area. So there are two reasons: First, basic science is not there to
research and develop drugs. And second, there is lack of financial incentive.
What could be the drug development costs here?
Drug
development typically involves hundreds of millions of dollars, with the clinical
work done over 10 years or so, fraught with huge risks till finally the therapy
is rolled out of the labs. We were lucky in the case of bedaquiline as we were
able to taste success (quickly). The same range of one to two billion dollars
could be applicable in the development of these drugs too, but there is no
specific figure at present as it's still early stage.
What are the broad timelines you have in mind?
At
this point, J&J has two early stage drug targets, while IMTECH also has two
in pre-clinical stage. We will work together on these four drug targets. We
hope that the first testing of the drug on people will be done by 2019. Though
it's difficult to determine the exact rollout of the drugs, we expect it will
take four to five years.
The government has often been criticised for its handling of the TB programme. What is your opinion with regard to the rollout of bedaquiline?
Implementation
of the programme across the country, with proper diagnostics and treatment, is
a huge challenge. It is not an easy task in the case of infectious diseases.
Most countries like South Africa are also grappling with similar issues in the
rollout of the medicine. What is important to remember is, we need to maximise
the chance that a person gets the right treatment, and make sure the right
combination is used. India will do a fantastic job if the additional 156
centres are up and running, and a total of 10,000 regimens (doses) are
distributed, in over a year.
What are the other therapies which J&J could roll out?
We
have been working on a vaccine for HIV which could be the next breakthrough
globally. In India, we are looking at bio-tech capabilities for a possible
collaboration, but there is no clarity yet.
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