Success parameters of pharma companies are typically attributed to their R&D productivity and ‘time-to-market’ of productised innovations. Quite obviously, they have a high dependence on data and information ï¿½ often with massive requirements for high volume storage capacity and powerful applications for data mining, data management, analysis, extraction and compilation at various levels of drug discovery, development, clinical trials, compliance submissions and commercialisation process.
With relatively long product-discovery and development cycles (ranging from five to fifteen years) for pharma sector, and increasingly stringent enforcement of patent expiration timelines ï¿½ companies need to take faster and flawless decisions at every phase of the business in order to ensure sustained success. In this context, pharma industry have started to foresee the differential advantage of IT deployment that can leverage their entire value chain, from research lab to consumers – eventually leading to market success.
IT Challenges in Pharma
IT challenges for a typical pharma company primarily entails the following operational areas –
R&D Productivity Management
Data Handling & Information Management
Safety and Regulation Compliance
Work Process Efficiency
R&D productivity mana-gement – is crucial for companies in order to possess requisite knowledge for taking informed-decisions regarding high value investments in drug development, and reduce risks through timely entry or exit decisions.
Data Handling & Informa-tion Management – is one of the most important aspects of pharma companies, to ensure accurate capture, storage, management, administration and access of data/information across research and business groups. Invariably, it also pertains to issues of knowledge management, information security and IP protection.
Safety and Regulation Compliance ï¿½ is yet another critical area for pharma industry and serves good for drug developers if they can use advanced informatics to detect early signals and trends, or construct predictive modelling and in-silico techniques.
Alliances and Collaboration ï¿½ is a continuously evolving and a high value-add aspect of pharma business that deals with partnership management and seamless collaboration between internal and external collaborators. Virtual collaborative platform for multi-locational competence teams proves to be highly effective.
Work Process Efficiency ï¿½ is one of the primary criteria for business success in pharma sector. Focus on core research or business activities need to be increased by automating routine, repeatative and manual work.
Applications in Pharma IT
In a typical pharma enterprise, IT can come into play almost entirely along the organisational workflow and can prove to be a critical success differentiator in certain areas. Considerable advantage has been brought in by dramatically reducing time-line for drug design and development; lowering research cost (through in-silico testing technologies); and depreciate financial risks with efficient prediction-optimisation models, derived through robust software applications.
Computer Aided Drug Design (CADD) technology is revolutionising drug discovery by delivering powerful ‘molecular modelling’ capabilities. CADD technologies perform computerised analysis of molecule-protein interactions, virtual bio-chemical experimentations and efficient lead optimisation techniques, which delivers far greater advantage over traditional methods.
Some important application areas of molecular modelling are as follows:
Virtual Screening ï¿½ computerised screening of molecular databases against disease-causing protein, for fast and efficient lead generation
Sequence Analysis ï¿½ computer based exploration of genetic and protein sequence, for similarity or dissimilarity finding within bioinformatic databases, and estimation of compatibility based on level of sequence match
Homology Modelling ï¿½ three dimensional modelling of amino acid configuration in protein molecules for facilitation in drug research and design
Quantitative Structure Activity Relationship (QSAR) ï¿½ statistical modelling of molecular structure in compounds for estimation and prediction of chemical and biological activity
Lead Optimisation ï¿½ software assisted optimisation of structural and bio-chemical characteristics of potential drug leads for better drug development and design
Similarity Searches – exploration of compound databases for searching similar molecules based on multi-parameter criteria including molecular structure, sequence and electro-static properties
Pharmacophore Modelling ï¿½ computer generated three-dimensional atomic modelling of compounds for assessing biological properties and construction of new models for deriving desirable substances from known compounds/ligands
Drug Bioavailability & Bioactivity ï¿½ software based estimation and analysis of absorption, distribution, metabolism, excretion and toxicity (ADMET) characteristics of new drugs for finding their bio-feasibility prior to clinical trials
For all such applications, high-end softwares and high-capacity computing device and servers are a definite pre-requisite. Increasingly, pharma companies are embracing IT and deploying enterprise-wide capacity to retain competitive edge in the drug discovery market.
Approximate estimation of the drug discovery software market in India is pegged between $1.5-2.0 billion. However, the market is expected to grow much more in the coming years as more players emerge into this industry, riding on the outsourcing wave.