DATA ANALYTICS PLAY KEY ROLE IN ENABLING DRUG DISCOVERY TO APPROVAL
Ephicacy Lifescience Analytics Pvt. Ltd., a clinical research organisation focusing on biostatistics and statistical programming services in the clinical domain, recently won an award at the ‘Big Data, Analytics & Insights Summit’ in the ‘Excellence in Industry Application Award (Pharma & Healthcare)’ category. During his interaction with Bio Spectrum, Head of Operations – India, Siva Ramamoorthy, elaborates on Ephicacy’s India plans and other details:
How important are analytics and statistical methods for the pharmaceutical sector?
Pharmaceutical companies are subject to a variety of laws and regulations regarding patenting, testing and marketing of drugs. It takes an average of 12 years (eight years remain from the 20 years’ patent granted) and over USD350 million to get a new drug from the laboratory onto the pharmacy shelf. Once a company develops a drug, it undergoes around three and a half years of laboratory testing, before an application is made to a regulatory
body such as FDA to begin testing the drug in humans. Only one in 1,000 of the compounds that enter laboratory testing will ever make it to human testing.
Current challenges in the pharma industry include shortening time to approval; identifying meaningful end points and criteria for treatment effectiveness; handling erroneous data; dealing with global regulatory environments. All of these have implications as to how statistics has evolved and continues to evolve in the drug industry.
Statisticians play significant role in designing and analysing the experiments (here, experiments mean clinical trials), thus ensuring the clinical study objectives are met, thereby reducing the likelihood of any repeat experimentation and hence reducing cost, time and any implied ethical considerations.
Please explain the importance of statistics while compiling clinical trials data.
Statistical methods provide formal accounting for sources of variability in patient responses to treatment. The use of statistics allows the clinical researcher to form reasonable and accurate inferences from collected information and to make sound decisions in the presence of uncertainty. Mastery of statistical concepts can prevent numerous errors and biases in medical research, define and quantify the objective, to use appropriate study designs and proper methods of analysis.
The journey of any drug has two important goals – to prove its safety and efficacy. Having been through the journey, the drug would have entered the last phases of the trial and with huge data in place, making sense out of this data is a daunting task.
Data presentation (tables, graphs) and appropriate interpretation of results play a key role in analysing the clinical trial data, thus forming an integral part of a clinical study report. Statisticians and statistical programmers’ role here in ensuring the right interpretation to be part of the final document is a crucial activity which decides the fate of the drug.
Please elaborate on the statistical support services that Ephicacy offers.
Data analytics play a key role in enabling the drug discovery to drug approval by regulatory bodies. Ephicacy works with pharma companies and enables their structured data into knowledge. As such we work in three areas: Statistics - Our statisticians enable pharma companies in designing drug trials. During trials, they also assist the pharma companies decide what success would look like.
Stats programmers - programme to structure the data generated during trial.
Data standardisation - pharma industry accepted standards for clinical trial data which are recognised by global regulatory authorities.
Ephicacy provides biostatistics and statistical programming services to its clients in the entire clinical development cycle - protocol development, study design, statistical analysis, and regulatory submission.
Our services include:
• Statistical Input to Protocol/Study Design Development
• Sample Size Estimation
• Randomisation Schedule
• Review of CRF and Data Management Plan
• Statistical Analysis Plan (SAP) and Mock-up Shells
• Analysis of Safety, Efficacy Data for CSR and Regulatory submissions
• SAS Programming - SDTM/Adam Datasets and Tables, Listings, Figures
• Design and Deployment of System-level SAS Macros
• PK/PD Analysis
• Integrated Safety and Efficacy Analysis (ISS/ISE)
• Analysis for BA/BE Studies, Meta-Analysis
• CDISC standards Implementation Service
• Support Safety Monitoring, Interim and Exploratory Analysis, Manuscripts and Abstracts
• Patient Profiles/Safety Narrative
• Statistical Report Writing
What are the key trends and factors driving your business in India and the US?
Pharmaceutical organisations depend on block-buster drugs. And they team up with several service companies to achieve this goal. Being in the pharma domain, Ephicacy believes in the motto ‘bringing smiles’- smiles on a pained lot. By joining hands with pharmaceutical organisations, biotechnology research firms, clinical research organisations we strive to achieve this motto.
The founding team, comprising Ganesh Gopal – entrepreneur and an expert in statistics domain along with Pratap Malik – thought leader, strategist and entrepreneur, sowed the seeds of this organisation. I am heading the India operations. I have worked with various firms and provided expertise in groom-
ing start-ups. This team, coupled with technical and operation experts in the clinical domain, is laying the bricks of growth at Ephicacy based on a strong foundation of values.
Over the years, pharmaceutical development and service provision have been growing significantly in India thanks to economic liberalisation. Though the fruits of economic liberalisation reached our sector over a period of time, it has been relatively successful in creating job opportunities and has given birth to several business verticals. Talent pool in the region has significantly increased, giving opportunity for several multinational players to set up offices here. Cost-effective working models have created a win-win situation for all players in the domain.
At Ephicacy, highly qualified professionals, professionals with international pedigree and work exposure are forming part of the intellectual bank of the industry and are guiding our growth to the next level.
We have the ISO 9001 certification for quality management and ISO 27001 certification for information security management. With immense focus on compliance to regulatory and statutory needs of the industry, we have added several success stories to our cap and are continuing to grow with steady focus on timely and quality service to our customers.
Apart from services in the areas of biostatistics and programming, we have partnered with a US-based technology start-up firm working on launching products, which could add value to current working models of biostatistics and statistical programming. We are an extended arm of their product development, quality testing and interface design teams.
Ephicacy is strengthening its base in India and has offices in Chennai and Bengaluru. What is your overall strategy in the Asia-Pacific (APAC) region in general and India in particular?
We believe in organic growth; by this, we mean a robust, quality-oriented growth in the niche area of biostatistics and statistical programming, ensuring long-term partnership with our customers. We have been catering to the needs of organisations based out of the US and EU regions. Though FDA approved drugs have found acceptability in several countries, the regulatory framework varies country-wise. Ephicacy handpicks individuals who have global regulatory exposure, knowledge and skill. We’ve seen growth in Hyderabad in the past year. We also have customer-facing offices at New York and New Jersey. We see India as a major playground in the APAC region and the opportunities here are yet to be tapped. Over the last few months, we’ve seen significant traction of customer requests in the Delhi-NCR and Mumbai regions.
We have been servicing studies/projects conducted in the APAC region in collaboration with other clinical research organisations. We have been receiving service requests directly from potential customers based out of this region and are in several phases of discussion. Hopefully, we should be directly serving APAC customers in the coming years.
Apart from the US, how big is India and APAC market for Ephicacy?
Ephicacy has built its presence over the last seven years and has catered to the needs of several multinational and Indian customers. We have consistently increased our prominence in industry-wide conferences by presenting papers, posters etc. both in India and in the US.
Asia as a market for drug discovery is growing significantly in geographies such as China, Japan, Korea. We are excited about these markets and are engaging with prospective customers. Indian clinical industry is poised for a bigger growth having being the second most preferred country after China for clinical trial conduct and services. The financial growth of clinical trials in India has increased from Rs50 to Rs5,000 crores during the last decade. And Ephicacy is excited about this growth and would look at this as an opportunity for creating more jobs and taking up challenging projects.
Recognition too has come to us as part of Ephicacy’s journey. Our papers and posters at conferences have won us accolades both in India and in the US. We have also been recognised recently by being awarded the ‘Big Data & Analytics Award’ for excellence in industry application – Pharma and Healthcare.
India’s clinical trials industry has been through a trying phase for the past few years. In your opinion, what could be the major reasons?
India’s decision to become TRIPS compliant in 2005 and the amendment to schedule Y of the ‘Drug and Cosmetics Rules’ had an impact on the clinical trial industry. This is common across industries; ini-
tial hiccups, trying phases followed by a sustained growth curve is the pattern seen in business. This is true to our industry too, since our regulatory and legal thoughts had to be re-looked into both at the intellectual and bureaucratic levels. This led to a slow start. Marred by few regulatory findings such as FDA audits on Indian companies, we have recovered extremely well and have shown the world that compliance and confidentiality with respect to data integrity is of high-importance and we adhere to it.
Today, global pharmaceutical companies, clinical research organisations are looking at the sub-continent as source of talent and man-power. With the growth of companies like Ephicacy, the prospect of growth is high in countries such as India. India boasts of resource advantages in the following areas:
• Specialists in different therapeutic areas
• English trained professionals
• Treatment protocols in-line with the West.
• ICH/GCP compliance
Large diverse gene pool Disease segment
Clinical research infrastructure
Over 250+ medical colleges Hospitals, diagnostic labs
Skilled computer-savvy workforce
India is known for its IT brains, IT support is another factor of importance.
In your opinion, which are the major countries in the world that lead in conducting clinical trials and why?
Undoubtedly, the United States is the leader in this space, followed by Canada and EU countries which have excellent R&D spending and relevant infrastructure. It ought to be clear then that when the Western multinational corporations are shifting the clinical part of drug development to countries like India, it is not for altruistic reasons, nor is it for their inability to recover their costs incurred in R&D in the western countries, but because they have been presented by the WTO Pat- ent Regime an opportunity to maximize their profits by using the easy availability of patients from developing countries.
According to Pharmaceutical Research and Manufacturers of America (PHRMA), R&D expenditure of US pharma companies has been growing moderately since the year 2000 and currently amounts to around USD58.8 billion. R&D spending by Indian pharma industry has increased from around USD426 million in 2005 to 1013 million in 2012.
Can you elaborate on some major differences between the clinical trial industry in the US and the APAC?
US, wielding high financial power and availability of skilled and trained professionals, has been in the driver’s seat, followed by countries in EU.
The global clinical trials market has been estimated to reach USD14.2 billion in 2016 and is projected to reach around USD22 billion by the year 2021, growing at a compound annual growth rate of 7.5 per cent during the forecast period 2016 to 2021.
Cost for clinical labour is considerably low. For example, if the overall clinical cost is 1 unit, then in India it would be as low as 0.11 units. India stands fourth in clinical cost-maximisation after Russia, Argentina and China. Currently, top multinational pharma/biotech companies like Pfizer, Glaxo Smith Kline, Novartis, Astra Zeneca, Eli Lilly and others are conducting clinical trials in India. Amongst Indian pharma/biotech companies, Dr. Reddy’s, Piramal Healthcare and Cipla are also conducting major trials.
The number of contract research organisations (CROs) in the country is also growing; Quintiles, Parexel, ICON, Clinigene International, INC research, to name a few. Global CROs are reducing their presence in developed economies and are expanding in emerging economies like India to achieve greater overall profitability.
In the forecasted global market, the developed countries will likely account for about 66.8 per cent by 2020, down from 76 per cent at present; whereas the emerging countries combined together will likely account for 25.2 per cent, up from 15.7 per cent at present.
Most companies are outsourcing the clinical trials of their newly developed drugs to various contract research organisations as this could save them the hassles of regulatory issues and patient recruitment burden from the
research and development phase. Clinical trials allow the drug to be tested for safety by different ethnic populations. Due to the higher medical needs and increasing disease prevalence, developing countries are becoming a hub for clinical trial execution.
US and Canada have the highest market share in the clinical trials market, followed by Europe where Germany leads the market followed by Poland and Western Europe. Asia is one of the fastest growing markets. India, China, Singapore and South Korea are the major players.
The Indian government’s initiatives and vision for bringing in more investment in this space has been yielding results with many top CROs having made India their major base.
What is your business plan for 2017?
Ephicacy looks 2017 as a year of ‘five’ with focus on five major activities, viz, geographical expansion in new regions of India to tap the best talent everywhere; grow customer base significantly, especially emerging biotech companies; leverage our strength in statistics and analysis and help customers in other business; groom high performing talent and win a reputation as a great place to work; grow technical infrastructure, including a data centre. Also, customers in the pharma space require on-premise data centres due to data security needs. We shall look into that aspect.
How will the life science sector perform in 2017?
The life science sector in 2017 will continue adding value to the economic growth only next to IT sector. Origination of several innovative technologies converging with healthcare and application of these in the sector will continue having an impact on the field. Along with these, come the challenges of operating performance in a regulated and risky environment, supply chain management, changing political landscapes such as Brexit, cost and pricing pressures, changes in regulations, adoption of technological advances and most importantly, the quality of the product.
Achieving operational excellence across the organisations post-mergers/acquisitions, within their organisations and with several service providers would be an interesting aspect since it’s important to realise the complete value of synergies.
Employment opportunities will see an upward growth. Life science companies will have to work towards finding a fine balance between organisational efficiency and innovation.
Analytics will play a major role in the coming year, with experimentation on patient-centric models; analysing population behaviour using social media; analysing the data from electronic systems. Different business models to accommodate risk-based monitoring will come into vogue to meet the requirements of the ever-changing technological and research landscape.
What are the emerging trends in bioscience/ medtech/drug discovery/technology fields?
Technological trends such as wearables and electronic health management systems are on an upswing. Reduced source date verification practices using risk-based methodologies would continue to play a major role in revolutionising the sector.
Real-world evidence-based studies in concurrence with randomised control trials would gain prominence. Adaptive designs would continue to be of interest in the bio-statistical fraternity. Standardisation would also enter the list of trends to be looked into with respect to the clinical domain. Simulations and modeling would be another area of focus that could impact the clinical industry in the long run.
What are the new technologies and trends that the company is focusing on?
Ephicacy, known for its ethical and compliant business model, would focus on continuing the compliance levels. Data security and subject data integrity being important, our in-house data centre would undergo transformation by embracing cutting-edge technologies/solutions.
Focus on learning and development to sustain the competency level of our employees to have an edge in the competition will be one of the primary goals. Metrics-driven and flexible project management model implementation would be another area of interest.
Engaging with customers and delivering value to the world through innovative methodologies would be of interest too. Application of new trends and methodologies in biostatistics and statistical programming including using R, WPS softwares is on the anvil.