Information technology (IT) and software have been the buzzwords of the past few decades, and for good reason. Technology innovations have completely transformed the way we transact, communicate and collaborate. This is as true in pharma outsourcing and life sciences R&D as in anything else we do these days.

As FDA regulations have grown more stringent and strict, error-free documentation has become critical than ever before. Software solutions have played their part to help improve operational efficiencies. Traditionally software applications in the pharma domain have been broadly classified into the following four categories:

1. Laboratory Information Management System (LIMS)
2. Enterprise Resource Planning (ERP)
3. Customer Relationship Management (CRM)
4. Sales Force Automation, for the bio/pharma outsourcing industry (SFA)

In the background runs a common layer of hardware and infrastructure that supports storage and transmission of the clinical data. As the bio/pharma industry has significantly consolidated and matured, the software offerings under those four categories have become virtually standardized, leaving very limited space to add value or to innovate.

The next “growth wave” of software solutions for the bio/pharma industry will be driven by those IT-based companies that have the ability to understand the scientific domain and build software solutions keeping science as the focal point. Bio-Analytical Technologies (B.A.T.) is one of those companies engaged in making software that is an enabler and facilitator for R&D in bio/pharma and life sciences domains, including the pharma outsourcing space.

Software addresses multiple challenges that bio/pharma colleagues face in the world of R&D. Some of these are interfacing complex devices and technologies, interoperability of data, and translation and communication of the outcome of results out of R&D. Despite the availability of several tools, users still face a major challenge in analysis, extraction and interpretation of meaningful information from their experiments. The software programs that B.A.T. has developed make the experiments and analysis more targeted, and assist with the interpretation and user-friendly presentation of data. This enables pharma companies to compile regulatory dossiers for submission. It also allows pharma outsourcing providers companies to directly interface with a sponsor’s mainframe system and provide data into a ‘SharePoint’ virtual data rooms (VDRs). This is a significant step that IT/ERP has enabled bio/pharma companies gain significant efficiencies.

One Team, Multiple Skills
I have seen B.A.T. up close and interviewed its management specifically for this column during the AAPS Annual Conference in 2012. Ajit Chaphalkar, the company’s chief executive officer, told me it employs more than 200 experienced professionals with specialization in biotechnology, microbiology, analytical and organic chemistry, electronics and instrumentation engineers and software engineers. The company is backed by an infrastructure of R&D laboratories, as well as an analytical instrumentation lab, a wet chemistry lab and a software development lab.

The company has demonstrated full understanding of the life sciences, biotechnology, healthcare and pharma outsourcing domains. A unique blend of science and technology professionals have enabled them to cater to various customers from various segments like proteomics, genetic engineering, analytical instrumentation, imaging, environmental research, biomedical devices, nutraceuticals, cell and tissue culture, and forensic analysis, to name a few.

They have proven their ability to cater to broad array of disciplines. These days, gaining business efficiencies has become an attractive trait of prime importance for companies who want to do more for less. B.A.T. has become a magnet of sorts for bio/pharma and analytical instrument companies. In general, one needs to look at the current business needs and demands and accordingly focus on R&D and building a knowledge repository. High-end instrument manufacturers as well as researchers are already benefitting from such an IT-based service provider. I realized tremendous value of such a service throughout my pharma tenure. B.A.T. is a fine example of a software company supporting the scientific community in a dedicated manner.

I believe that multi-disciplinary companies such as B.A.T. will be ideal partners for any bio/pharma, life sciences and CRO/CDMO companies. It is known that software solutions play a significant role to enhance efficiencies, reducing costs and shortening the eventual time to market. The ultimate beneficiary of such confluences will be the end-consumer — the patient — who will have access to products with better efficacy and safety at the end, at very affordable costs. 

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Makarand (Mak) Jawadekar most recently served as Director, Portfolio Management and Performance at Pfizer Global R&D, until February 2010, when he opted for an early retirement after 28 years at Pfizer Inc. He currently serves on several companies’ advisory boards and also consults with bio/pharmaceutical companies for global outreach in emerging market regions. He can be reached at mjawadekar@yahoo.com.