The proposed new 21st Century Cures Act could
herald in a new era of drug development, with the search for a new drug
shifting from research laboratories to computer systems.Last week, we analyzed the
impact of the new Act on accelerating drug development through biomarker
based approvals. This week we share how generic pharmaceutical companies could
create new sources of revenue through the use of Big Data.The ability to conduct successful clinical research is what
differentiates innovator pharmaceutical companies from generic manufacturers.
However, the proposed 21st Century Cures Act , which has been passed by the US House of Representatives and awaits clearance from the Senate, may level the playing field to some extent with measures that seek to shift drug development from research laboratories to computer systems.However, what seems imminent is a Big Data revolution that
could be a boon for the generic business.The proposed legislation includes a number of directives related
to electronic health records (EHR) and health information
exchange. The relevant sections of the
Bill are designed to help drive medical innovations and create better
information flow, by increasing incentives to foster interoperability between
different electronic medical record systems. Adequate focus on privacy
and data sharing The Bill aims to accelerate the development and regulatory
approval of medical innovations. According to the proposed Act, electronically
accessible health information and health information technology systems must
also allow for secure transfer of information and allow complete access to
exchange of such information. In its current form, the Bill includes several health IT and
interoperability provisions. If the vendors are not able to confirm that their
EHR software complies with these interoperability provisions by January 2018,
they run the risk of having their software decertified for use.For instance, there are provisions
on the pricing of transmitting data, on having application programming
interfaces that provide instructions on how to access EHR data to outside users
and developers; and provisions on meeting The US Department of Health and Human
Services (HHS) standard of allowing "everyday" data exchange. The big, Big Data
opportunityElectronic health records are becoming a gold mine to
discover ways in which existing drugs can be repositioned or repurposed to find
new indications for them. Last week, a Big Data study
conducted by researchers from the Regenstrief Institute and Indiana University,
found that the combination of two drugs, both available as generics, could
consistently amplify blood pressure reduction in patients. Using information from EHR of 17,291 hypertensive patients,
who were prescribed the diuretic drug hydrochlorothiazide
with or without triamterene,
the researchers are the first to demonstrate triamterene's ability to enhance
the blood pressure lowering effect of hydrochlorothiazide.Similarly, another study which analyzed the EHR data of more
than 110,000 patients suggests the
commonly used anti-diabetic metformin was associated with decreased mortality
after a cancer diagnosis, indicating its potential as a
chemotherapeutic regimen. Another study
suggests the bestselling cholesterol lowering medicine, atorvastatin
can be positioned as a new therapeutic for organ transplantation based on the
retrospective analysis of EHRs of 2,515 renal transplant patients followed for
up to 22 years.Additional therapeutic benefits for existing generic drugs,
is a natural extension of the current generic pharmaceutical business model
which has been struggling of late to find new opportunities as more and more
biologics have been getting approved. EHRs to accelerate
drug repositioningFinding new uses for existing drugs—a process referred to as drug repurposing or repositioning – is an area which will get accelerated as more EHRs become available for computer-aided analysis. Perhaps the most recognizable example of successful repositioning
effort is Viagra (sildenafil). Originally developed as an anti-hypertensive, sildenafil was repurposed for the treatment of erectile dysfunction and pulmonary arterial hypertension. Viagra generated more than US $ 2 billion in worldwide sales in 2012.Japanese pharma major, Otsuka paid US $ 3.5 billion to acquire the rights for repurposing the combination of an old heart drug – Quinidine – with a common cough syrup ingredient – Dextromethorphan – as a treatment for a neurological disorder called the Pseudobulbar Affect (PBA).Since computer aided-repurposed/repositioned drugs are not
protected by the same degree of intellectual property as a new chemical entity
(NCE), there could be an opportunity for generic drug manufacturers to market a
branded version of the generic drug. Questions over
quality and completeness of dataA new indication for an existing drug still requires
navigating through hurdles created by the regulatory pathways in different
countries. The use of EHRs in regulatory submissions will raise questions about
the quality and completeness of data entered into an electronic health record. Under the current industry standard, clinical studies are
controlled by various organizations to ensure the data collected during the
trial meets the stringent norms of the regulatory agencies. However, EHRs do
not undergo the same degree of rigor when it comes to data entry. It remains to be seen how regulatory agencies will process
applications based on EHRs.Moreover, security of patients’ health information coupled with access restrictions will play a very large role in determining how much of this data will become available for analysis. If patients choose not to share their information, an incomplete data set of records can lead to incorrect conclusions. A string of Big Data
initiativesThe focus of computer-based research is not only on drug
repositioning but also on new drug development. The National Institute of Health (NIH) in the United States
has already launched a Big Data website
to allow biomedical researchers to capitalize on research from various communities.
Following this, in March, the NIH launched an Alzheimer’s Big Data portal in an effort to accelerate drug development against a disease where currently the industry’s success rate has been about 0.4 percent. Other than the government, there is Optum Labs – a research collaborative that has brought together data from the administrative claims of more than 100 million patients and the EHR of over 30 million patients, along with researchers, patient advocates, policy makers, providers, payers, and pharmaceuticals and life sciences companies. The vision of Optum Labs is to boost the generation of high-quality comparative-effectiveness evidence, accelerate translation of knowledge into the development of new predictive models and tools, and improve the delivery of care. Our viewNew indications for existing drugs is an extremely lucrative
business opportunity. Analysis of EHRs to reach conclusions without having to
conduct expensive laboratory research is a prospect definitely worth
evaluating. However, since most of the data is available in the open
domain, the intellectual property generated would be limited. For this reason, the
business model should appeal a lot more to generics than to innovator companies
who rely extensively on patents to drive their business. Regardless of who
seizes the opportunity first, the Big Data era has arrived.
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