Advent of Data sciences

Pharma companies’ tryst with handling electronic data traces back to 1970s since the time Pharma companies moved on to EDC and set up IBRD(Institute for Biological Research and Development) , Cambridge Structural Database (CSD) and the Protein Data Bank (PDB)to circumvent data clean-up problems arising due to manual clinical data forms. This was only a starting point for development of tools that could analyze data and effectively using statistical models for Toxicity prediction, 3D Molecular modeling and Clinical Data analysis.

Age of Big data and Predictive Analytics

With the data deluge that follows the end-to-end drug discovery and development cycle, the resultant new age mantra is “Big data”. Pharma companies are looking to explore this data that can provide answers to questions they may not have even thought to ask. And these answers come from the most untraditional and unstructured channels of data. The key to gaining a multidimensional insight is to couple Big data with the traditional types of information that is generally collected and analyzed since time immemorial. It is a no-brainer that no organization would want to “hold” so much of data with themselves due to the sheer volume that needs to be stored and this has led to the emergence of aggregators that offer platforms and services for acquiring, organizing and analyzing big data, with enterprise-class performance, availability, supportability, and security features. Technologies such as Hadoop(open-source platform) aid in consolidating, combining, and transforming large data volumes while programming frameworks such as MapReduce support processing large data sets on distributed nodes to generate aggregated results.

Role of Data scientists

Data scientists who analyze and make meaningful inferences from big data in the Clinical side have aided Pharma companies in Patient Selection based on targeted genetic information, Real-Time Monitoring of clinical trials for Safety and efficacy and for prediction of adverse event even before commencement of a trial by tapping into historic side-effect data. Data Science has aided in targeted Sales and Marketing through Population Health Management programs focusing on target therapeutic areas and geographies, these have been facilitated through real-time analytics enabled mobile platforms. From a post-marketing perspective patient follow ups have been enabled through analyzing data from Social Media and from smart phones and wired health apps for understanding the drivers for non-compliance. Discussion forums (Patient and Physician) present the opinions about drugs in the markets. The key point here is that there is data lying everywhere in all possible forms waiting to be explored by the data scientists.

The flip side to the big data exploitation is the rising concerns on patient data privacy. As stated by McKinsey, “Pharmaceutical enterprises must understand and mitigate the legal, regulatory, and intellectual-property risks associated with a more collaborative approach.” There are consortiums such as International Pharmaceutical Privacy Consortium (IPPC) to take up issues pertaining to breach of data privacy. If the issues of data privacy are completely addressed and FDA issues a clean chit to all processes of collecting and processing Big data and the use that the results are put to, Data Science is definitely here to stay!

Why open data and crowdsourcing approaches are critical in today’s world?

In today’s increasingly connected and collaborative world, advancements in science cannot be done behind closed doors and in silos. Especially it is important for the big pharmaceutical companies where they are going through a phase of dwindling R&D pipelines and also an ever increasing demand for new drugs. Hence there is a greater need for continued and accelerated development of new therapies along with their speedy approvals. Pharma companies are in a dilemma – faced with a multi- forked problem – on one hand there is a need to strike a balance between the demand and supply of new drugs, on the other hand manage the increasing pressure to curb the rising R&D expenditure, increase affordability by reducing the price of drugs, improvise on patient safety and improve their efficiency metrics of R&D i.e. how many potential drug candidates finally come to the market and how soon. But is this steep increase in R&D costs and the static rate of drug approvals, affecting just the pharma alone? No, it isn’t – the burden has to be borne by all – all stakeholders including patients who are a part of the global healthcare community.

To tackle this plethora of problems the recent trends show a surge in collaborations amongst various stakeholders of the pharma industry with a focus on reducing the duplication of efforts, harnessing the collective insights and expertise gathered from these collaborative activities as well as testing new ideas for the betterment of the drug discovery and development process while also improving on patient safety, outcome and data quality aspects. In this context, one of the key areas of focus is on cross organization (pharma, researchers, patients, regulators, technology providers etc.) collaborations around data sharing and data transparency.

Pharmaceutical companies should be able to share information on elements under their study protocols, compound libraries, study designs and statistical analysis methodologies, trial processes and results, relevant patient data, manufacturing techniques etc.

Critical points to consider while undertaking an initiative of data sharing and transparency

To bring in real value & collaborative success and also to realize the cost-benefit, the data sharing exercise should be carefully and meticulously planned. So before an organization decides to undertake an initiative on data sharing and transparency, they should consider the following points

1. Decide on the kind of information/data and the quantum of the data that can be shared with others
2. Decide on whom to share the data with and the intended use of the shared data
3. Decide on processes and methods to address patient confidentiality, regulatory compliance and data privacy aspects
4. Implement data de-identification standards (currently the industry is still in the process of defining the rules that need to be applied for data de-identification)
5. Implement proper access controls and review mechanisms around internal data sharing guidelines
6. Secure transmission of data into the target data repositories
7. Ensure that the data shared is used in a secure manner in accordance with the data sharing and usage agreement i.e.  – intended users should be using the data, establish a traceability matrix of the data shared etc.

The debate on trial transparency and data sharing has not been new and so are the initiatives around it. Few pioneering initiatives to push this ‘open-access movement’ have been through the efforts of the Cochrane collaboration, PhRMA, EFPIA, C-Path Institute, ClinicalTrials.gov site for study results, Yale University Open Data Access, AllTrials, Transcelerate, Project Data Sphere for oncology trials historical control data, Lilly Ventures, GSK’s DPAc – Discovery Partnerships with Academia, Janssen Research and Development, etc. Data sharing has come a long way from the initial efforts of sharing just the trial summaries to now being able to do pooled analysis across trials and sponsors, to even getting access to the individual subject level data. It is predicted that the open data/open access movement will see increasing focus as more and more organizations are expected to come forward to be part of these initiatives.

IT & Procurement Organizations across industries worldwide have mastered the sourcing of “Run the Business” Services. The sourcing models in existence today have matured over a period of time and these models fulfill the organizational needs from a sourcing engagement with a service provider.

“Application Development” or “Change the Business” services on the other hand are still in the initial stages of evolution as challenges involved in AD are unique and IT organizations are experimenting various models and seeking innovative constructs from service providers. One of the key challenges in “Application Development Sourcing” is the growing Capability gap between skills required across the various stages of the entire CTB life cycle viz.  Right from Conceptualization (blue printing / Business case establishment) upto execution (Design, development, testing and implementation).

While the former needs niche consulting skills and business appreciation, the latter is more of technical expertise. De facto view that customers adopt is to have multi- vendors co-existing i.e. one vendor for each of the Business/ Technology division. There are inherent challenges due to nuances in each of the SDLC phases.

Customers are exploring newer AD Strategies and are contemplating to have exclusive vendors for “Design & Build” (proven core- competency of IOPs) and “Plan” / Business Organization  phase(Similar to Helpdesk being retained by infrastructure Vendor and outsourcing of L2 and L3 services to OSPs).

HCL through working with Customer IT Teams has evolved in building effective AD organizations. Gen 2.0 outsourcing organizations are attempting to evolve beyond the segregation into “Plan” and “Design & Build” Organizations, i.e. classification of systems into “Differentiation”, “Innovation” & “Record” based on utility of system. Another trend that’s prevalent among the AD organizations is, there is a clear interest in a very lean core team (Similar to KTLO in ASM) to have “Plan” activities functional whilst earlier approach was to have heavily loaded Development team.  The advantage of having a lean core team is twofold – a) optimal Business case & b) responsibilities of Knowledge management and transfer is bestowed upon a set of core team members.

Upcoming years will see the Industry exploring various options (not restricted to above) and a proven AD model will evolve.

In the last two decades, the world has witnessed a huge amount of technological advancements emerge. The Omnipresent nature of Mobile devices, emergence of Internet of Things , Machine to Machine (M2M) technologies  are drastically changing the way the consumers are empowered in consuming the services in wide array of industries including Banking, Insurance, Automotive and others.

Healthcare Industry is no exception and Consumerization in Healthcare is emerging as a stronger phenomenon like never before.  Once considered a domain of product companies, consumerization is becoming a key trend in Healthcare industry spanning across its sub segments including Payors, Providers and Life sciences companies.

Consumerization is generally defined as “ Reorientation of product and service designs around the end user “.  In Healthcare context, Consumerization is about the changing role of consumers ( patients ) from being a reactive recipient of care to playing a more proactive role in managing their own health, deciding their payment plans, being better informed about the choices available and demand more quality of service.

For example, the advent of wearable devices has empowered many consumers to measure and track their daily health for some of the vital parameters such as Blood Pressure, Glucose levels, Body temperature, calories intake vs calories burnt etc..   On the other hand, the advancements in mobile and Information technology have also enabled the physicians to constantly monitor their patients health and proactively advise / alert on deviations in their health patterns, so that they can quickly take necessary corrections, there by leading to increased wellness and healthcare costs.

Some of the other key interesting statistics reflecting consumerization of Healthcare worldwide:

1. The mobile health technology industry is expected to reach a compound annual growth rate (CAGR) of 61% by 2017 Research and Markets

2. By 2017, 50% of mobile users are expected to download a health app. Research and Markets

3. Remote patient monitoring is expected to save the world’s healthcare systems up to $36 billion. Jupiter Research

4.  80% of physicians are using mobile technology to provide patient care. 2nd Annual HIMSS Mobile Technology Survey

5.  30 million wearable health devices were shipped in 2012, a 37% increase over 2011. ABI Research

6.  75 million US adults used their mobile devices to access health information in 2012, up from 61 million in 2011.  Manhattan Research

Consumerization in Healthcare makes it imperative for different stakeholders of the Health ecosystem such as Payors, Providers, Life sciences companies to understand the nuances of their end consumers / patients and come out with more innovative business models that will redefine the way they engage with the consumers in terms of increased touch points with improved health outcomes.

Information Technology companies would play a vital role in implementing tools and systems that increase the consumer engagement through integration of disparate patient system records, clinical records, Claim records from different healthcare ecosystem stakeholders including Payors, Providers and Pharma companies.

As noted by one of the popular Heathcare consultant : “ Decisions regarding which technologies and services will be adopted in healthcare will be based on whether the benefits outweigh the costs. Compassion, empathy, and human connection will always be critical components to a holistic model.  Incorporating the latest technology into this emerging consumer-centric model, whereby “virtual” house calls or biometric wearables that facilitate diagnoses without ever leaving the comfort of our home, might just be the real disruptive innovations that drive the future of healthcare”.

On the whole, the consumers are now empowered to be more of proactive self health managers, rather than mere reactive Patients. Consumerization of Healthcare would be a revolutionary force that would change the dynamics of Healthcare Industry and it would be an exciting and enriching times ahead for all the stakeholders of the Healthcare industry!!!

The Indian IT segment is a strong USD 150+Billion Industry, with approximately USD 100 Billion of it coming from exports / global market. Over the past 25+ years, the industry has matured significantly, though it only became mainstream in the past 15 years and has evolved through multiple phases. It currently partners with many Global 1000 companies and has several mega relationships built over the years.

The top 5 Indian IT companies, as of the quarter ending March 2015, have 223 relationships which are each worth 50+M per annum. The number has grown from 172 to 223, 30% increase over the previous 2 years – a very strong and credible growth. A partner relationship of such significance grows over time – some over a long period of time. Having been involved in creating, nurturing and developing many such relationships across industries and geographies, I believe the following 7 tenets are key to make a relationship grow:

• Relevancy is the most important currency for any relationship. In ever-changing times, it is critical to stay relevant if relationships are to stay fresh and vibrant. The IT industry is ever-evolving and time-tested relationships which have evolved can be traced with these changes. Customers’ businesses are always evolving and dealing with new opportunities and challenges, and likewise they need partners who will not only walk with them but also provide new, contextual and innovative ideas and solutions. Today, it is equally important to provide services related to digital, cloud, analytics, etc., as it is to connect the dots and embrace the future as market segments open and opportunities arise for businesses. Stay Relevant!

• Agility: companies partner to increase their momentum and velocity. A relationship developed over time can certainly increase the agility of business quotient for customers. New product launches, new markets addressal, business processes optimization, significant cost take out, transformation delivery, merger and demerger alignment, etc. are several avenues where partners have increased customers’ agility. This is key to long term growth and success. Be Agile!

• Business value is the cornerstone of any long term partnership. Delivering business value is key to quantify, and must be properly and continuously communicated to all stakeholders. Connecting the dots from technologies, processes, IT, etc. to business is where the magic happens. At the end, what can be quantified and measured brings everyone in sync and on the same page. Relationships built on strong foundations with clearly articulated value across executive and operating levels go a long way in ensuring healthy and successful partnerships. Measure and Communicate Business Value!

• Trust is as important in any long term relationship as the premise on which the partnership was formed. Trust between partners must be built and earned inch by inch and day by day by demonstrating commitment to hard and soft deliverables. Trust matters in resolving open issues. Build Trust!

• Bilateral wins: there must be joint wins, successes, pride and honor for all sides in a long term partnership. Over time, not only are customers’ successes paramount and key, but it is equally important to ensure the same for service providers as well. Significant relationships must anchor new thoughts, ideas, seed a new business line, etc. to ensure that the scale of operations should not become a detriment. Long-term and strategic customers are equally interested in investing and creating value for service providers. Leverage Bilateral Wins!

• Leadership matters. People who can dream, take charge and deliver always take a central role in growing a long term partnership. A relationship which has grown over a number of years must certainly have had great leaders on both sides who actualized visions and demonstrated actions to build a growth partnership. Invest in and create Leaders!

• Cultural alignment is often an overlooked aspect, yet it clearly plays a pivotal part in any long-term relationship. A partnership that grows over time must ensure consistent and continuous focus on cultural aspects of the relationship at all levels of engagement. No two organizations are culturally the same as each has its own character, identity, processes, etc. Nor do cultures remain fixed, as happens with a change in leadership. A relationship which spans years has certainly stood the test of time in managing cultural alignment!