“Pharma should start treating investments in IT as a prerequisite rather than a luxury”

Ram Yeleswarapu,
President and Chief Executive Officer, TAKE Solutions
"The predominant ly generic Indian pharmaceutical industry has been voraciously adopting technology solutions, more than ever before," says Ram Yeleswarapu, President and Chief Executive Officer, TAKE Solutions. Excerpts from an interview Yeleswarapu had with Mahesh Kallayil.

Please let us know of TAKE Solutions complete service and solution portfolio and their application in life science industry
TAKE Solutions is a business technology company with deep subject matter expertise in Life Sciences. We serve the global pharmaceutical, biotechnology, and medical device companies. Our solutions and services cover the clinical, regulatory, and safety functional areas at these companies and we work closely with the business and operational decision makers in bringing experimental drugs and devices to market and provide extensive support in the post approval life cycle management stage.

TAKE Solutions provides strategic advisory and consulting services, license our IPR and enable technology solutions along with enterprise software partners, and support outsourcing of core functional services. Our consulting services are primarily extended to heads of businesses who are facing either non-compliance issues cited by the regulators, or are looking to set up process and governance structures and establish best practices to prepare their respective organizations for new and emerging regulations.

Our technology and engineering team builds and maintains IPR based technology solutions for the industry and also collaborates with leading enterprise software companies like Oracle, EMC, Axway, Sparta Systems, Generis Corp, DSG, etc. In several instances, our partnerships extend into collaborative codevelopment of value-added solutions for the industry. Our solutions enable our customers to perform their operations with greater efficiencies, enhanced compliance with existing and emerging regulations, and enable growth of their respective businesses while controlling costs.

Deep expertise in the subject matter of clinical research and drug development along with knowledge of global regulations and cutting edge technologies allows us to be the partner of choice for our customers, when it comes to outsourcing of core functional services. To ensure compliance with global regulations we provide following solutions:
  • Standards based clinical data management
  • Statistical programming, biostatistics
  • Medical writing
  • Regulatory publishing
  • Submission management along with tracking and
  • Drug safety services
Our infrastructure and global presence allows us to interact with the customer teams with ease, giving them the requisite support and comfort, so that they may pursue core discovery and research activities rather than development. TAKE is also actively engaged in pursuing enhanced analytics in the realm of Life Sciences R & D and healthcare using unstructured data artefacts, contained in legacy repositories maintained by customers as well as meaningful public domain data that is monitored and moderated by experts in the field.

As a business technology solution provider, what is your perspective on Life science industry in India? What are the main drivers of life science industry?
The predominantly generic Indian pharmaceutical industry has been voraciously adopting technology solutions, more than ever before. A spate of noncompliance and quality issues along with enhanced regulatory scrutiny are forcing companies to adopt best practices, enhance their processes and systems and make the necessary investments. TAKE's PharmaReady software suite is used by most Indian pharmaceutical companies to prepare, package, and submit their ANDAs to global regulatory authorities across highly regulated, semi-regulated and unregulated markets. We also provide drug safety systems, Quality Management Systems, and serialization or track & trace solutions for the industry.

What do you see as the biggest challenges facing Life Science Industry in India? In what ways do you see TAKE Solutions helping to overcome these challenges?
Accountability, transparency, awareness and adherence to quality are paramount and these are some big challenges that the industry is faced with. The industry in India also needs to invest more in R & D efforts and make a deliberate attempt to enhance their portfolio beyond generics. Making drugs domestically affordable in an already slim margin business is quite a challenge which becomes the motivating factor for them to compete in the international arena. However, rising costs and increased competition in the global markets, compounded by enhanced fees imposed by the regulators are sure signs of a market that will plateau. A well balanced strategy should include a pursuit for Biosimilars and NCEs (New Chemical Entities) alongside a healthy portfolio of generics. The regulatory framework in India needs to be stabilized as well and should be conducive for clinical research. Given the extensive prevalence of chronic diseases and the widely stratified patient population, pursuit of clinical research under a well-defined and managed regulatory environment will surely yield safe, effective, and affordable drugs.

TAKE Solutions has been serving the Life Sciences industry for a few decades and has tremendous expertise and insights, having worked with global customers and regulators. We are advocates of cGxP frameworks which are essential for the industry, and we provide assistance with laying the foundational strategies to address the issues of quality, compliance, and risk management. We can then extend help with deploying systems, solutions, and processes built upon best practices, which will fortify the foundations upon which companies can grow and scale.

Please brief us on the need for improved connectivity between IT and life science industry
IT can play a pivotal role in ensuring adherence to regulations and compliance requirements, while allowing the companies to focus on growth. A well thought through IT strategy can tremendously improve efficiencies and collaboration between the various departments, improve accountability and provide transparency which are key ingredients for building relationships with global trading partners. The Life Sciences industry should start treating investments in IT as a prerequisite rather than a luxury in order to gain the trust and confidence of the stakeholders of the healthcare ecosystem. It is equally important to increase the awareness of the stringent requirements of the industry, which will ensure a top down and a bottom up approach to quality and compliance resulting in the adoption of best practices and enablement of good processes.

Do you think life science industry is still dubitative about how to use and make the most of the new IT scenario? Why is that?
We notice a gradual change in attitudes in the industry towards adoption of technology to solve business problems. While much of this is because of the increased regulatory scrutiny coupled with quality and compliance issues that got highlighted and which led to stiff penalties, the industry awareness is improving. Cross border M & A, partnership arrangements with global partners, and a strong desire to quickly get products approved and commercialized in larger healthcare economies around the world are spurring a wave of investments. Globally, regulators are increasing their own collaboration efforts with agencies in other countries and initiatives like IDMP (Identification of Medicinal Product) and Track & Trace for establishing the electronic pedigree of a drug or a device are testament to this. The industry needs to realize that regulations are here to stay and will only increase in stringency and frequency. Sitting on the fence with respect to investments in good governance, solid processes, and supportive technology solutions will only complicate matters and will eventually cause a dent in the 'Make in India' brand slogan.

How is technology changing the relationship between Pharma and Patients? And between Pharma and Doctors?
Increased technology adoption by manufacturers, providers of care (hospitals and physicians) and insurance payers is enhancing the connectivity between these entities. Knowledge about drug products and devices, potential adverse events caused by their consumption and changes in labelling are just some of the key pieces of information that are now readily available, thanks to the herculean efforts by regulators around the world. The decision to move from paper to electronic and then make the information available in a consumable format for the greater good of the partners in the healthcare ecosystem has opened up a plethora of transparency initiatives.

Information is now far more readily available than ever before and patients can more easily learn about the authenticity of a drug product. Two-way communication channels can be established between the physicians and the patients to provide consultation, tips about diet and exercise regimen and how to stay healthy and fit. EHRs (Electronic Health Records) now capture details of patient visits in a digital format, making it easy to exchange health records between the network of care providers, thereby ensuring continuity of care at controlled costs (procedures need not be repeated unnecessarily) and also ensuring that medication errors are eliminated. Some healthcare economies are vigorously pursuing quality of care metrics aka 'pay for performance', whereby readmission rates are being monitored along with hospital acquired conditions and other provider related issues that could potentially escalate healthcare costs and the overall burden of paying for it.

Going forward how do you see IT solut ions to t ransform the life science industry?
IT solutions are crucial to enabling business and operational efficiencies, and are drivers of growth while ensuring quality and compliance which are essential to the life sciences industry. While Indian manufacturers need to steadily move up the maturity curve of adoption of technology while moving away from paper and legacy practices, there is a transformational element that can catapult us as a major contributor to solving healthcare issues in a significant way in the global arena. With the advent of genomics and enhanced repositories of knowledge on drugs and diseases as well as environmental and behavioural factors, a lot more can be accomplished via R & D efforts than ever before. India has a vast scientific talent pool, a rich background of being the largest generics producer by volume, and a diverse patient population suffering from chronic conditions like diabetes and cardiovascular disease that can be treated by a vast network of physicians and state-of-the-art hospitals and clinics. We need to figure out our own indigenous strategy where affordability of care is essential, while ensuring drugs are safe and effective. Advancements in technology can today enable deep analysis of data to seek insights and inferences from clinical research data on one hand and close the loop with feedback from actuals findings on the ground in the healthcare segment.

How is TAKE Solutions set up to adapt new, innovative technology to keep a pace with the changing dynamics of the Indian life science market ?
TAKE Solutions is a global business technology solutions provider and our ability to do knowledge share amongst ourselves while keeping track of best practices and new and emerging technologies gives us an advantage. Steadily working over the last decade, we have established a very loyal set of customers in the sub-continent, and frequent interactions and the strength of the relationships that have been built all these years are enhancing our business. The experience of working with global manufacturers and regul a tors gives us the foresight required to advise our customers in India and today we are well entrenched with Indian pharmaceutical companies as partners of choice. Besides helping them with ANDA regulatory dossier submissions and other paper-to-electronic transformational needs, we are now deploying quality management systems, drug safety systems, serialization and track & trace systems, mobility solutions on shop floors to avoid product mix-ups, etc. to name a few.

Please detail about your future plans in terms of strategic alliances, capacity expansion, products launches, investment, etc.
As a company, we are constantly on the lookout for strategic opportunities via M & A to enhance our global footprint as well as capabilities and expansion of leadership bandwidth. Simultaneously, we are forging alliances and partnerships with partners who have the right solution for the right problem, thereby providing increased value to our customers. Wherever possible, we are co-developing to co-own IPR, we have won a patent and are building solutions leveraging it, we have registered additional patents, and are working towards launching additional products and solutions for the industry. Recognizing that innovation is key to enterprise viability and value creation, we are actively investing in building IP assets across Life Sciences and Healthcare. Our investments are commensurate to our strategy of becoming one of the leading and largest providers of knowledge, relevant technology, infrastructure, best practices and good governance, and subject matter experts for an industry that holds the hope and promise for a world bereft of disease and suffering for mankind.