Pharmaceutical and biotechnology industries are always on the edge due to regulatory scrutinies, mergers and acquisitions, patent expiry and ever mounting cost-cutting pressures. At every stage of operations, starting from R&D, manufacturing and packaging to the distribution of the product, there is one sector that works hand-in-hand with the drug manufacturing industry i.e. information technology (IT). To be more specific, softwares manufactured by IT have given a considerable breathing space to the pharma sector. Use of softwares has allowed the industry to cut down on human intervention, reduced operation time, and as a result, adds considerable savings on overall investment.
Software, applications and challenges
Today, various tailor-made or ready-to-use branded softwares and programmes are the backbone of pharma and biotech research and development. Without such cutting-edge platforms, R&D cannot move ahead. Starting from deriving to tentative structures of complex multi-thousand Dalton sized bioactive molecules, by scanning huge generated and fed data to multiple assaying of lakhs of samples through advanced high-throughput systems (HTS), several softwares are being developed and used.
“There are unique challenges in developing them for biological research and how the field of computational biology, as a whole, can move research agendas forward,” emphasises Dr Girish Mahajan, Consultant-Microbiology.
Mahajan explains, “It is well reported that Basic Local Alignment Search Tool (BLAST) was the first program to assign rigorous statistics to useful scores of local sequence alignments. Before then, people had derived many different scoring systems, and it wasn’t clear why any should have a particular advantage. When MAQ came out, there was no other software that could do integrated mapping and single-nucleotide polymorphism (SNP) calling.”
He adds, “The BLAST or allied softwares available today are key drivers in phylogeny and genome mining in both prokaryotes and eukaryotes systems. Several factors have contributed to the usability of ImageJ. Primarily, it has a relatively simple graphical user interface, similar to popular desktop software, such as photoshop. Scientific software often needs quite a strong insight—that is, algorithmic development. The algorithm implements original ideas, is based on deep scientific understanding of data and the problem, and takes a step ahead of what has been done previously.”
Thus, software development in pharma or biotech area is always very challenging involving diverse and multiple variables. The number of expertise available in such areas is very sparse compared to other commercial software development.
Why it is needed?
Indian pharma industry is a generic superpower and the next goal for it would be to transform itself into an innovation-driven industry. Another challenge is in enhancing the speed of bringing drugs to the market. Researchers will not be in a position to keep pace with the changing market demands unless they are aided by modern technologies. Softwares are going to play a key role in achieving this target. Hence, it is important to know the IT company’s perspective in this regard.
Dr Abhay Jere, Associate Vice President and Head–Persistent Labs, Persistent Systems, informs, “Currently, the pharma industry is very much dependent on software solutions in its every department like production, QA/QC, packaging, regulatory compliances and sales and marketing. In the production category currently all renowned pharma companies use ERP and LIMS solutions to ensure that various formulation batches are planned, scheduled and produces as per the protocol. Mobile apps are used to monitor critical formulation steps and control instrumentation.”
Persistent’s life sciences group has combined science and technology to provide solutions to organisations across pharma, biotech, device manufacturers, clinical and cancer research institutes as well as universities and helps deliver services and solutions at reduced cost. The company has expertise across social, mobile, analytics and cloud technology platforms and in-depth knowledge of essential regulatory standards and compliances.
Jere provides a case study of how their software solutions helped their pharma clients. “At Persistent Systems, we have a big group of approximately 700 people who work on projects related to pharma companies, lab instrumentation companies and life science/ healthcare companies. We work closely with companies like Agilent, Thermo Scientific, BD, etc. to build software for their instrumentation. They are 21CFR part 11 compliant which is very critical for pharma industries. We have developed multiple apps for pharma industries.” He gives the instance of an app they developed for a major pharma company in the US. The app was aimed at motorists and drivers, it sought to inform them about pollens and allergens as they drive across the US. It gives alerts to drivers as they drive from one province to another, based on their locations and also suggests drug and pharmacy stores in the vicinity so that they can purchase the suggested anti-allergic drug in case of allergy.
Clinical trial sector perspective
Developing new therapies to treat various diseases is a very long, tedious and complex process, of which, the clinical trial sector is an integral part. So, as for the pharma industry, use of softwares is an imperative for the clinical trial industry as well.
“Overall, advancements in technology are playing an increasingly important role in our understanding and management of healthcare and disease. These advancements are also impacting the way clinical trials are being conducted and managed with technology driving end-to-end customer value, incorporating design, execution, engagement and commercialisation within the drug development process. The industry has seen a lot of innovation in the application of technology and will continue to do so with Quintiles playing a pioneering role in this development,” says Naz Haji, Senior Vice President & Head, Quintiles India.
Haji explains his point of view by giving two examples of how Quintiles has leveraged technology to deliver value in clinical trials. He explains, “With the Quintiles Infosario platform, Quintiles has developed the technology to take data from multiple source systems and integrate, synchronise and normalise and present this data in near real-time. The Infosario platform creates a seamless integration of data, therapeutic expertise and clinical trial processes in a system that provides data transparency, optimised workflows, and real time insights into patient, study/ site and programme activities. Powering this is the Infosario Data Factory which is the clearing house and data hub for clinical and commercial data for the industry, supporting clinical development and integrated health analytics.”
The other example that Haji offers is of Risk-Based Monitoring (RBM). “With our Data Drive Trial Execution (DTE) led by RBM, we are using data-driven processes and insights to drive faster, more informed decisions that can improve a customer’s probability of success. We are currently engaged in more than 130 studies using RBM processes and policies, across more than 26,000 sites and 260,000 patients. We have seen our RBM model deliver value in several areas like ability to impact clinical monitoring costs, decreased time to analysis-ready data, increased quality/ reduced risk and ability to impact medical monitoring,” he explains.
Quintiles recently announced two enhancements to its RBM. These enable study teams to identify the right signals and predict clinical trial site performance as well as potential patient safety issues before they occur. Called Predictive and Advanced Analytics, the capabilities combine advanced statistical monitoring and predictive analytics to improve precision in risk identification and are the first such model-based capabilities, fully integrated into an RBM solution in the market today.
India has a potential to build a $100 billion software product industry by 2025, according to Indian Software Product Industry Roundtable (iSPIRT). The India IT-BPM industry intends to add $13-14 billion by FY-2015, according to National Association of Software and Services Companies (NASSCOM). The current estimated size of the industry is about $2.91 billion and is expected to grow to $8.08 billion by 2016 (Source: http://www.expressbpd.com/article/pharma/management-pharma/impact-of-it-on-indian-pharma-industry/56552/)
The pharma industry is likely to be an important growth driver in enabling the software industry to touch the projected figure. As stated before, the Indian pharma industry is in a transition phase and the software industry is going to be a trump card in making this transition smoother and successful.
“Regulation of content and target audiences is key to sending relevant information to doctors and patients alike. Reporting the right information back to management to enable them to make right decisions and deliver the right products to the market is the road to success for all pharma companies. And with new age digital research and approach this puts a lot of responsibility back on the solutions providers to be accurate, fast and scalable,” says Aatish Shroff, Executive Director, Business Operations, Sunways (India).
According to Jere, in the future, the software industry will work very closely with pharma industry in each and every department. In R&D, software industry will have tools to study systems biology, genomic analysis, toxicity prediction and formulation development for predicting bio-availability. Software will become essential for vaccine design and predicting immunological responses.
Pharma industry has undoubtedly benefitted with the use of softwares. However, on the other hand, medicine consumers are also silent beneficiaries. To achieve the goal of scaling up drug production, with low cost and considerable reduction in delivery time, strengthening the bond between the pharma and IT sectors will become exigent.