By KTP Radhika
The Indian pharmaceutical industry is one of the most thriving in the world, accounting for about 8% of the total pharmaceutical production by volume as per estimates by the Department of Chemicals and Fertilizers, Government of India. Despite the sheer scale of its business, however, India’s pharma industry has not been able to focus much on research and development activities the way its global peers do.
As a result, new drug discoveries are a complete miss here. Also, drug prices remain rather high (especially of those drugs that are not covered under the controlled price list and whose patents are held by multinational corporations based in the US and elsewhere).
The reason why Indian pharma companies have mostly shied away from core R&D is simple: it is too damn expensive and time-consuming. And if that were not enough, there is no certainty of commercial success even after painstaking research and tons of money.
According to analysts, while the global pharmaceuticals industry routes about 15% of the total turnover towards R&D, India’s share is estimated to be about 6%. Even that is a recent development; it was as low as 2% in the 2000s. After 2000, with more private companies started focusing on R&D, the sector experienced some momentum.
However, post-2006, even that pace seems to be taking a gradual pause. With some initial success in developing a few molecules in-house, big players in R&D started to decrease their R&D investment since failure rate was quite high. A report by Research and Information System for developing countries (a think tank under the external affairs ministry) says the R&D investment of India top three pharmaceutical R&D spenders(Ranbaxy, Dr. Reddy and Sun Pharma) in the past 12 years has not reached $1 billion benchmark. Contrast this with Pfizer, the biggest R&D spender in the world, which in 2010 alone invested around $9.4 billion for R&D.
One of the main reasons for the dull growth in R&D is that success ratio is very low. Also, developing an NCE is a long-drawn process that can take about 10-15 years for the product to reach commercialization. Even if a company spends this much time and about a billion dollars for developing a drug, there is no certainty on the returns.
Also there are numerous standards for R&D processes that are being followed by MNCs globally. Indian companies are yet to emulate these practices and reach these set benchmarks. Thinning drug pipelines and lack of innovation makes the traditional pharmaceutical drug development process a too costly affair for domestic players.
IT adoption picks up
All these challenges have necessitated the use of modern technology tools in the space of pharmaceutical R&D. Starting from the identification of an NCE all the way to clinical trials and launch of the products, research companies now are using many types of IT solutions. Usage of IT is driving the speed of analysis and execution. Without good IT systems, the ability to sift through multiple molecules will be constrained,explains Gupta of Cipla.
Most large Indian pharmaceutical companies now are using R&D application software and IT infrastructure. Companies are also adopting innovative approaches in R&D, including modeling, simulation and other statistical analysis tools. The market influence is also forcing pharmaceutical companies to adopt new technologies that will help them deal with the large volumes of data that are being generated with respect to drug formulations, chemical compounds for drugs, details of clinical trials, etc.
Data is prime
Data is the lifeblood of the drug discovery process. With Next Generation Sequencing (NGS) becoming mainstream in the research (after the mapping of the human genome), there is an explosion of data. The amount of data being developed and needed to be processed for a clinical trial is increasing. Companies today are looking for solutions whereby they can complete the process early and hence cheap. For this, they have to better mine and correlate previous clinical data. Thus pharma companies are looking for technology solutions around big data and predictive outcomes.
Reports say that there is a four-fold increase in the number of procedures over the last 20 years in clinical research. Also, data is getting more complex and the speed in which it is gathered is increasing as well. These factors have led to the adoption of electronic data capture (EDC) in the R&D market. EDC replaces the traditional paper-based data collection method and helps in real-time capture of data in an error-free manner. It facilitates data access and update for site personnel and investigators, and also helps the Clinical Data Management (CDM) team to perform data review in real-time. Use of EDC improves efficiency and accuracy of data, speeds up decision making process and reduces cost. Data availability is probably the most compelling area of EDC since it decreases the time between the patient encounter and data capturing,says Sandeep Singla, Senior Manager (R&D), IOL Chemical & Pharmaceuticals (IOLCP).
Data management is another key area in R&D. Standardization of data architecture for R&D work has helped companies in sharing and using data in a standard way within the organization and across other organizations. As Dheeshjith of Infosys puts it, Knowledge management frameworks have helped companies manage more complex R&D projects better and use experience from past projects in improving the efficiency of new projects.”
An easy-to-use Laboratory Information Management System (LIMS) can help companies in managing their drug discovery process efficiently. According to Somenath Nag, Director, Business Development and Marketing, ALTEN Calsoft Labs, modern LIMS enables laboratories handle complex workflow and sample data management requirements. Apart from automating lab processes and increasing efficiencies, it facilitates accelerated laboratory turnaround, reduces costs in sample management and supports regulatory compliance.
Integrated with ERP and other information systems, LIMSs are now helping laboratories to incorporate scientific data into business decisions and in optimization of procedures.
Analytics: the magic wand
The tool for this is analytics. Big Data and better analytics offers quicker turnaround to complex calculations required by R&D,feels Gupta of Cipla.
Echoing the sentiment, Dheeshjith says, State-of-the-art analytics capability provided by software on top of historical R&D data has helped scientists in doing better and faster prediction of results of their research work.IT analytic tools will help in identifying unknown peaks, evaluation of methods with new products and processes and investigating faster with simpler alternatives. Some analytic tools are frequently used to troubleshoot processes and formulations. Analytics in formulation development are touted to increase the probability of success and significantly reduce the lag period in drug development. Analytic applications can help companies to get deeper insights into captured data, and they can leverage these insights to enhance processes,says Mohan Joshi, Senior Director, Applications, Oracle India.
Technologies such as predictive analysis and big data analytics are finding big space in drug discovery. MNCs today are increasingly investing in these tools. For instance, US-based contract research organization Covance has formed an alliance with the big data analytics outfit GNS Healthcare. GNS supercomputer-driven Reverse Engineering and Forward Simulation (REFS) big data analytics platform and Covance data assets together will help predict successful clinical trails. In another example, Pfizer will use Humedica’s big data solutions in R&D.
Cloud and virtualization
Usage of cloud is growing rapidly in pharma R&D. Much of the early activity in cloud centers on next-generation DNA sequencing, which is the single most important application in this area. Most of the small to mid-size companies could not get into the R&D as the cost for setting up this infrastructure was quite high. But the scenario is changing slowly with the adoption of cloud computing.
“Small to medium-size pharmaceutical and biotechnology companies are using cloud services for drug discovery and personalized medicine,says Nag of Calsoft Labs. Many services like data management, IT optimization services, LIMS, analytics, modeling and reporting tools are now available on the cloud.”
The move to get better control of their system sprawl and squeeze more out of their infrastructure has compelled companies to adopt virtualization in this space. With virtualization of R&D, multi-tiered network of innovation from multiple entities can be coordinated effectively.
PLM and more
In recent years tools like product life cycle management (PLM) and workflow management have provided many pharmaceutical organizations with the ability to increase their productivity, and ensure greater regulatory compliance and efficiencies while reducing development costs. They help companies to bring together information and systems in order to deliver products to market faster. As Joshi puts it, PLM provides the capability to both manage and centralize product information, helping pharmaceutical companies realize their IT investments by addressing some of the most essential needs, including speeding time to market, lowering overall operating and production costs and realizing quality standards.”
Similarly, workflow tools help organizations to make the drug discovery process more patient-focused with improved understanding about disease and patient care. Work-flow based approach to drug discovery is accelerated, flexible, repeatable and efficient, leading to scientific discoveries that lie beyond traditional automation and integration, says Goel.
Advanced communication infrastructure, coupled with innovations in medical devices and patient care software, has also helped in better monitoring of clinical trial results as well as in improving compliance levels on trials.
Today, there is a proliferation of technologies in the drug discovery process, but it is essential that a company is able to stitch these solutions together. Dheeshjith of Infosys says, This has led to issues around how data and knowledge is managed, which hindered the companiesability to get a seamless view of their process. Also, data standards and regulatory requirements are changing very fast. A single technology platform which addresses all the challenges of the discovery process is the need of the hour.This includes workflow management, knowledge management, collaboration platform, analytics, documentation, tracking and regulatory submissions.
New computer-based technologies will create a greater understanding of the biology of diseases and the evolution of ‘virtual man’ will equip researchers to predict effects of a new drug on people.
In this direction, efforts such as the recent launch of a Rs2000-crore venture fund by the government to promote research in pharma will need to be supplemented by initiatives from more and more pharma majors in India. Otherwise, India will remain restricted as a hub of generics pharma manufacturing.