Author: Vikram Gulati, President & CEO, Intelligroup

I am very excited to share with you a significant shift in our go forward strategy. Going forward, we are adopting an “Employee First, Customer Wins (EFCW)” management philosophy. There are many reasons for doing this. One of the most important of them is to align our employees with our customers, the point of intersection where value is delivered. We want to empower our employees to realize their potential and deliver superior value to our customers, partners, and all stakeholders.

The EFCW approach builds on our existing values, and will differentiate us as we attract and retain superior talent that is fully engaged and delivers high performance to our customers. Our employees will be empowered to take actions that benefit our customers. We want to enable innovation and co-innovation with our customers and partners, and EFCW is the management philosophy that will nurture this.

I am personally driving this initiative. The leadership teams of practices, delivery, sales and support functions are in the process of evolving a measurable code of conduct that is in conformance to EFCW. We will hold ourselves accountable to this code of conduct and evolve it on an on-going basis. We have involved a team of associates in this exercise to ensure that we remain real and alive to issues at all levels. We will also invest in building programs and initiatives throughout the year that will create a learning and fun environment for all of us. This will embody our mission of “providing our associates a platform to learn, grow, and innovate”.

As a part of EFCW, we are launching a unique program, called the Leadership Development Program (LDP). This program aims at grooming our mid-level managers. We are collaborating with ICFAI Business School (IBS), one of the premier business schools in India. The program is aimed at building out significant capabilities in the areas of finance, business communication, key accounts management, business strategy, people management, and leadership skills. The LDP program was launched in December 2010.

In the months to come, we will launch several such initiatives and programs that will instantiate EFCW. EFCW is applicable to all our associates at all levels. This will have an impact on our recruiting, performance appraisals, talent management, and all aspects of our business.

I look forward to your support and participation in our journey, which is about empowering individuals…caring for our associates, and aligning our employees with our customers. In doing this, we will deliver enhanced value to customers and our stakeholders.

Warm Regards,
Vikram
President and CEO
Intelligroup

Author: Hitesh Verma, General Manager,  Life Sciences Practice at Intelligroup

“Time to Market” is a key mantra for a product or a service to start contributing to business growth and results. While a typical product starts its commercial operation anywhere between 1 and 3 years since the inception of the idea, a new pharmaceutical drug takes typically between 8 and 10 years, after the patent has been filed, to be approved for commercial marketing. With about 15% of the new chemical entities discovered making it to the commercial market in the “Time to Market” of 8 – 10 years, pharmaceutical companies constantly ask the question – can the Drug Development Lifecycle be reduced?

Drug Discovery, leading to the filing a patent on a compound, and to a large extent the early development, establishing the readiness for First in Human Trials are more dependent on research and experimental results and can require a number of iterations in each of the various steps. While the early development can take 3 – 5 years in the development life cycle, the time taken by this process is difficult to compress.
The activities in the Late Development and Clinical Operations stage (where the Phase 1 to Phase 3 Clinical Trials are planned, executed and results submitted to Health Agencies for commercial marketing approvals) start to take the shape of business processes where steps, dependencies and sequencing of activities determine the speed and effectiveness of operations. The unknowns of patient enrolment, outcomes and the marketing approval contingencies do play a role, similar to demand supply unknowns in the commercial world. Typically, these operations (Late Development and Clinical Operations) are run by expert clinicians and pharmacists, who because of their education and training on their expertise, may not always see a repetitive pattern that can enable running these as processes across all trials and therapeutic areas.
The question that comes to mind is – can the time taken in the Late Development, both in Clinical Development and Operations, be reduced to get to the submissions stage quicker? For example, can the study protocol development and approval process be made a lot quicker, compliant (CDISC) and effective by using technology (not just Document Management Systems)? Or, can the Demand Planning, Supplies Planning and Execution of Study Drug borrow a few tricks from its sibling in the commercial world and improve its “Right Kit, at the Right Time, at the Right Site” paradigm? While other examples exist, the question is that is there consensus that these operations are more like business processes and can be made efficient and effective (using technology and other improvements), owing to their sequencing, repetitive nature and predictable outcomes and decision branches for each step?
Let us think together….

The Pharmaceutical Industry Supply Chain is highly complex in nature because of the involvement of a huge number of stakeholders in the chain. Because of this complexity, the Pharmaceutical Supply Chain is the biggest challenge for the supply chain experts, as well as the pharmaceutical professionals.


Adding on to this, increased regulatory pressures across various therapeutics, the percentage of raw materials that are non-conforming to the requirement for manufacturing the drug has also increased multifold.
How will I reduce my raw material rejection rate by having better control on my supplier’s information? How will I improve the information flow between my manufacturing locations and the contract manufacturer? How will I have better visibility of the requirement of the patient / physician / hospitals? How will I plan my forecast of a specific drug, in a specific therapeutic segment, in a specific market? Is there a solution which helps in improving my logistics operations? And many more questions are swirling in the minds of operational managers in the pharmaceutical industry. The answer to most of these questions is – Yes, all these can be achieved by implementing a supply chain visibility solution.
Supply chain visibility is a key remedy to most of the challenges being faced by the supply chain team in the pharmaceutical industry. By having an efficient Enterprise Resource Planning application combined with a Business Intelligence tool with specific customized add-ons helps in improving the Supply chain visibility of the Pharmaceutical organization. This combined with the best in class tools built for supply chain helps organization to focus on the Supply Chain visibility and makes them stronger in the Operational focus and thereby improves the bottom-line drastically. Also Information Management and sharing of best practices plays a key role for organizations that have Global presence and have their drug distribution across various markets / regions. This also is heavily controlled by the prevailing regulations in the respective markets
Real time Supply chain visibility helps Pharmaceutical companies in improving their decision making capabilities and hence they move up the corporate ranking on implementing the same. It is also gaining a huge importance due to the growth of the organization because of several factors including new Therapeutic areas, markets, Mergers & Acquisitions and so on. Many success stories back these requirements for real time Supply chain visibility solutions.
Some of the key elements of the Pharmaceutical Supply chain visibility solution include Flexible and alternate Production scheduling / synthesis, Efficient Distribution systems, Near zero Inventory planning and control and Real time decision making. Because of these key elements, Supply chain visibility is not only gaining importance in Operational focus but also on the Strategic viewpoint of the organization.
Will Supply Chain Visibility be on the radar of the CxOs of Large / Medium Pharmaceutical companies across the Globe? The answer is YES. Most of the Large and Medium Pharmaceutical players do have an Enterprise Resource Planning (ERP) application which controls the Supply chain operations to a large extent. But ERP systems combined with Supply Chain Visibility solution is the need of the hour and such integrations are made much efficiently.

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The Global Pharmaceutical market is poised to grow at the rate of 4-7% and expected to reach $ 975 bn by 2013 (Pharmtech) . This growth is on a Global scenario and has a stronger presence in US market. The therapeutic segments which fuel this huge Pharmaceutical growth are Cardiovascular and Anti diabetic drugs. Anti Hypertensive drug segment is another important area of Therapeutics which will be predominant in next few years. This is due to change in Lifestyle and demographic conditions across the Globe.

To reach these heights, Pharmaceutical industries across the Globe are facing huge challenges which include Patent Expiry, Product Recalls and Managing Regulations. The estimated revenue loss on Patent Expiry is $ 33 bn in 2011 and $ 29 bn in 2012 (IMS Health). At the same time Global Pharmaceutical companies are spending huge money from their revenue in managing the Regulations because of their Global presence and Marketing operations. Another noteworthy trend which is emanating in Pharmaceutical space is while US Pharmaceutical companies spends more than 50% in R&D, more than 20% of this spend is expected to migrate to Asia-Pacific and hence Outsourcing and managing the same has become a key for Pharmaceutical companies.
Because of the Financial, Operational and Regulation pressures, Pharmaceutical companies have to improve the efficiency of IT and also use IT to enhance business Innovation and Operational Efficiency. IT Applications helps Pharmaceutical companies in overcoming all these challenges to a larger extent. Hence the role of IT in Pharmaceutical companies have increased multifold with due importance to Regulations and Improving Brand Management / Customer Relationship Management. Smaller companies spend proportionally more on IT and the IT spending twice as fast for biotech companies, compared to branded and generic companies. IT organizations in Pharmaceutical companies are becoming lean and business focused.
Based on the above the following are the key 10 IT capabilities required for Pharmaceutical Industry
• Enterprise Resource Planning – Efficiency supply chain and batch management
• Experimental Work Management – Characteristics , Methods management, Stability testing and Results management
• Document Management – Document retention, control and 21 CFR Part 11
• Project and Portfolio Management – Workflow, Decision making and Project Financials
• Change Management – Release Management and change controls
• Security and Access Controls – Access controls and user rights administration
• Reporting – Search Engines and Business Intelligence
• Customer Relationship Management – Sales Force Automation and Consumer / Customer Relationship
• Computer System Validation – V Model of Validation and traceability
• Portal – Capture insights and manage knowledge

A Pharmaceutical company which has implemented the above integrated functionalities is expected to overcome the challenges being faced and are competing globally. Pharmaceutical companies are currently working on different stages in IT lifecycle in getting these functionalities up and running and some of the Pharmaceutical companies have these applications at matured stage and hence they are considered to be the leading player in the Global competition.

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This past week a giant drug maker expanded the recall of their blockbuster cholesterol reduction medication bottles due to a musty odor in the bottles, bringing the total number of recalled bottles to more than 360,000. In the same week, another giant drug maker agreed to pay a $750 million fine for quality related violations at one of their plants that resulted in contaminated and mislabeled product entering the supply chain.

Causes for these failures and for many other similar product quality and patient safety related issues are traceable to practices inconsistent with current Good Manufacturing Practices (cGMP) at factories operated by the companies themselves or by their suppliers upstream and downstream from their own plants. So what does IT have to do with it? Plenty, and if IT did not have anything to do with, it ought to.
A key player in the IT landscape of Life Sciences companies that manages the planning and execution of product creation are Enterprise Resource Planning (ERP) systems. The typical approach that IT has as far as whether the system comes under FDA purview and hence subject to quality regulations, is to divide functionality into GMP relevant and non-GMP relevant streams, and apply normal SDLC quality process to both streams, but have more stringent quality norms for the functions that are GMP relevant. Given the added effort required for compliance, IT typically goes to great lengths to keep the GMP relevant list as short as possible arguing that the impact on the end product quality or patient safety is remote. Given the consistency and power that such systems have to positively impact product quality this approach needs to be reversed. IT needs to look at expanding and deepening the list of GMP relevant functions by actively seeking out opportunities to support Good Manufacturing Processes.
Example: take a typical plant level operation of moving an active ingredient from Location A to Location B. QA would typically prevail over IT (not without an argument) that the feature/module that tracks such a move needs to be included in the GMP relevant list and therefore be formally tested and documented, and that would be that. The new, proactive approach would have IT asking several more questions to see how it can support GMP, with the answers resulting in a deepening of the associated features: Is the operator performing the move qualified and trained in the relevant operation? Can the system do a live query of say the system that stores training information to verify that the operator is current on reading the relevant, latest SOPs? Was the duration of the material’s storage in Location A within prescribed limits (say for temperature or light sensitive ingredients)? What flags can be raised now rather than at final product inspection time to initiate corrective action if needed? What pre-configured rules or controls can the system check to ensure that the destination Location B is an acceptable storage location? You get the drift.
Is it time for IT in Life Sciences companies to become an active partner in assuring product quality? Are the higher costs and potentially longer production cycle times worth it? Would a proactive collaboration between IT and QA have prevented the musty odor in the recalled bottles or the presence of micro-organisms in antibacterial baby skin ointment and the $750M fine? Can you come up with examples of where IT could have helped to reduce the possibility of or even to prevent the failures? So much like Homeland Security that does not get noticed because when what they do works brilliantly, nothing (bad) happens, can IT become that unsung hero for QA?

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While counterfeit drugs have been around for decades, the internet’s growth and the popularity of Pfizer’s erectile dysfunction drug Viagra in the 1990s created the “perfect storm” to fuel this underground industry. Last year, nearly 1,700 incidents of counterfeit drugs were reported worldwide, triple the number in 2004, says the Pharmaceutical Security Institute (PSI), a group funded by drug makers. Estimates for the size of the counterfeit drug market range from $75 billion to $200 billion a year. Shockingly, 75% of fake drugs supplied globally have some origins in India, says Sanjiv Shah, head—global life sciences practice, Intelligroup, a leading provider of IT solutions to help drug companies counter the fake drug menace. In a recent interaction with BV Mahalakshmi, Shah lays emphasis on safety through traceability by means of epedigree, an electronic document being used by drug companies to protect consumers from fake medicines.Excerpts:

What is the scenario of counterfeit drugs in India?
According to a report by the Organization for Economic Cooperation and Development, 75% of fake drugs supplied worldover have origins in India, followed by 7% from Egypt and 6% from China. India is also a leading source of high quality generic and patent drugs in legitimate commerce worldwide. Since drugs made in India are sold around the world, the country’s substandard drug trade represents a grave public health threat that extends far beyond the subcontinent. Unless, serious steps are taken to improve the quality of the Indian drug supply, the global spread of unsafe pharmaceuticals will persist.

How can Pharma companies be better prepared for the new regulatory environment?
Pharma and medical device companies have a lot to gain by ensuring that the supply chain contains genuine, pre-expiry products available only in the intended market. As the cost benefit ratio of related solutions become more and more favourable and related legislation comes into force and because some of the major drug distributors are requiring epedigree, Pharma companies are beginning to implement technologies that will enable track and trace. These include serialization at the package level, product labeling using 2D barcodes, creating and distributing epedigree documents in conjunction with physical shipments, installing scanners and RFID readers, etc.
How does the government track each drug?
The government does not and even cannot track every drug given the logistical challenges. Instead, its role is in providing a platform that would allow technical as well as related non-technical efforts to succeed to counter the… menace of fake drugs. Such a platform includes clear legislation that requires epedigree creation to accompany every shipment with sufficient penalties to deter violators. This has then to be followed-up with sufficient level of inspection and verification of product in the field and prosecution of violators.
How does epedigree help in evading counterfeit drugs?
The epedigree is a “living”, electronic document in the sense that every sender and receiver of the product and the accompanying epedigree document would be able to readily update the document with their own details so that all the details of who had custody of the product can be known. Chemists and or hospitals could readily verify each package in their inventory as it enters their stock, matching the bar-coded serial number on the product with information in the epedigree document. This verification would be too cumbersome and prone to fraud if the pedigree information was on paper and if the serial numbers had to be manually read.
Nigeria has taken this one step further where consumers themselves can send an SMS with the serial number directly to the manufacturer who then sends an SMS back verifying or rejecting that number or package.
Tracking the drugs from a manufacturing facility to chemist stores must be a herculean task…
The tracking process is not automatic (unless centrally managed). However, as part of an investigation, the ePedigree document in the possession of a participant upstream in the supply chain (say the manufacturer or distributor) has sufficient information to manually follow the document and hence the product downstream or upstream to each hop in the chain and thereby identify the precise point in the chain where the product got diverted or substituted.
The fact that the documentation is electronic rather than paper-based makes it difficult, if not impossible, for anyone to alter the contents of the document, thus helping the investigation. The only way the investigation would fail is if a participant in the supply chain would not verify the product on receipt and/or not enter the information of the next person in the chain. And this is where the government comes in making it illegal and punishable to ship product without updating the epedigree document.
Is IT at the core of Pharma industry’s serialization initiatives?
Numbers based on standards are generated by the system and can be placed on each product using various means. Two dimensional (2D) barcodes and RFIDs are two technologies that are currently: in use. RFIDs have the advantage that the numerous packages can be scanned much faster than with 2D barcodes and do not require line-of-sight availability of the product.
As Indian companies globalize, USFDA and other regulatory agencies have increased their focus on the quality and authenticity of products from the Indian market.
How are Pharma companies leveraging new technologies to counter counterfeit drugs?
Adoption of epedigree is mandatory in the developed markets. Already dozens of companies in the US and elsewhere have adopted it. Most companies with presence in the US and EU markets are at some stage of deployment of epedigree and it is only a matter of time before all companies will provide epedigree documents for their products.
The above also applies to Indian Pharma companies with a US/EU presence and the trend is towards increased adoption. The need for such a system is urgent in the Indian context both for global (for regulatory reasons) as well as local markets as one step to protect the supply chain. While not yet a legal mandate in India, global and local pressures may change that.

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SMB customers have already adopted Tier 2 ERP packages as Software as A Service (SaaS) and are running their business critical processes. They are benefiting from lower costs, and flexibility to ramp up or down IT resources with the business.

The question that comes to mind is whether or not, large enterprises are ready to adopt ERP on a SaaS mode. More specifically, are large customers who have traditionally bought software licenses and installed it on-premise, willing to buy SAP or Oracle software on a subscription basis from the software vendors or service providers?

Lately, service providers have been offering Infrastructure as a Utility for SAP and Oracle applications. It seems but a natural extension for service providers to offer the Application itself as a Utility on a Pay as You go/subscription model. Customers would be happy to shift their application expenditure from CAPEX to OPEX.

If you have any thoughts on the readiness of large enterprises to embrace ERP on a SaaS model, please comment and share your ideas with us.

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Due to the proliferation of data, there is a need for enterprises to gain insights to make better decisions.  Companies are good in acquiring data over a period of years but poor in transforming that into meaningful information.  BI (Business Intelligence) isn’t just reporting anymore.

Customers are demanding more BI capabilities beyond traditional query/reporting and OLAP functionality, to leverage innovation and growth arising from in-memory analytics, & service-oriented architecture. The longer term BI strategy should also include building strong Datawarehouse with powerful ETL capabilities and flexible data modeling and more importantly presentation layer comprising of KPIs/Dashboards i.e. capable of deploying globally via. web portals. This might include rationalization of multiple tools and vendors to make “One stop – One vision … One truth”.  Ability to consolidate and report at enterprise level (globally) is a challenge due to existence of silo reporting solutions that were delivered from various platforms using different tools.  This opened the door for Enterprise BI initiatives and made customers reach out to vendors with enterprise wide BI capabilities and tools.  Vendor consolidation has happened and we see end to end solutions from major vendors (SAP Business objects, Oracle, IBM, and Microsoft) in BI today than before.

What we have also seen clearly is that the focus and reach of BI has shifted from operational, tactical to more strategic i.e. how to Run the business in the past Vs Drive the business now. The increasing trend towards Service oriented architecture and Self service BI,  BI Standardization, Platform agnostic solutions and BI on cloud is the way to go….

This is a long journey and it may take years to adopt an Enterprise BI strategy. It needs clear vision, executive support, governance process, efficient change management, and last but not least ‘selecting right platform/application’.

We want to hear your views on adopting Enterprise wide BI strategy starting from assessment of current architecture, understand business KPIs, building roadmap, setting up BI Competency center, and selecting the right platform.

In my next blog, I will talk more about establishing a BI Center of Excellence, levels of maturity in BI, and importance of Data architecture & governance in this entire journey.

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The cloud is on everyone’s mind today. At Intelligroup, we seek to decipher the hype from the reality, and bring clarity to the various avatars of the cloud–Software as A Service (SaaS), Platform As a Service (PaaS), Infrastructure As a Service (IaaS), or Business Process As a Service.

We hosted a recent customer event in San Jose, California where the theme was cloud computing, and attendees shared how they are actually using the cloud. Some have their SAP application server on the cloud while others have deployed Oracle CRM on Demand or salesforce.com. Yet others, especially the larger enterprises are leveraging Infrastructure as a Cloud, and tapping into the compute and storage capacity of Amazon Web Services. However, speakers emphasized the security and data management risks. and the need to have a comprehensive cloud strategy before embarking on this journey.

 We want to hear from you as to how you view the cloud; where it fits in with your IT architecture/strategy, and how you have deployed it. If you have taken a flight to the cloud, we encourage you to share your experience with your peers–the benefits, costs, and risks involved.

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