An innovative approach to overcome the risk factors and stem the failure of drugs which are often developed on a trial and error basis the concept of personalised medicine comes with its own share of benefits and challenges..
The key growth mantra
The Indian life sciences industry has been innovating within its means right from its early days by mastering the art of process reengineering during the process patent regime..
New Patents for Old Drugs
Label-based strategies in the United States
Repurposed pharmaceuticals are attractive candidates for clinical development but only with sufficient marketing exclusivity Patents that focus on the uses and compositions in the product label can provide up to 20 years of exclusive marketing rights..
Pharma and Biotech
Collaborations are a common business practice within the pharmaceutical and biotechnology industry This article discusses both the strategic and tactical drivers for engaging in collaborations as well as some of the distinguishing features of the var..
Are they turning pharma companies into Zombies?
Biotech consolidation through acquisition was the primary trend in 2007 for the big pharma and the global financial crisis in 2008 has driven the pharmaceutical industry towards adopting a shortterm myopic MA approach The Innovation Gap for new drugs..
Indian Pharmaceutical Industry
On the cusp of a great opportunity
Leading researchbased Indian pharmaceutical companies spend less than 10 per cent of their sales on research In the interest of overall public health India should allow patents for incremental innovation Incremental innovation or innovation by sequen..
Research & Development
Drug Discovery in Academia
An evolving model
As economic pressures mount on the current industrial model of drug discovery and development there is growing momentum in academic institutions to enter the fray of drug discovery and development There has always been a symbiotic relationship betwee..
Understanding the challenges
Followon proteins pose complex questions for patients biopharmaceutical companies and regulators Understanding the challenges in the development of biosimilars by the industry and regulators and addressing them could pave the way for delivering affor..
Personalised Medicine & Drug Development
Biomarkers leading the way
Applying biomarkers as part of drug development efforts only started to materialise a few years ago Given the recent efforts by not only regulatory authorities but also pharmaceutical companies several case studies are now available that suggest that..
Changing Business Model
Personalised medicine in which sophisticated diagnostics guide drug choice dosing and patient appropriateness challenges older business models for both pharma and diagnostic tests In particular the diagnostic tests are original inventions and often r..
Targeted Therapies A Sustainable
Personalised medicine breaks the cycle of trial and error medicine and helps ineffectiveness rates of medicines to decrease dramatically Orphan drugs targeted therapies for rare diseases with their innovative nature and improved efficacy make it a pr..
Computerised Cognitive Function Assessment
Coming of age
The role of automated cognitive function testing in contemporary drug development is assessed here from the early stages as an aid to translational medicine through pivotal trials of cognition enhancers to postmarketing studies Properly automated cog..
Preclinical Research in Big Biotech
Vertical integration is the key
As companies transition from young startup phase organisations to a more mature and successful stage the needs and demands placed on the management teams from both internal and external sources change These changes can have longterm consequences whet..
Clinical Trials in China & Japan
Dynamic opportunities for sponsors and CROs
This article focusses on how to leverage the regional strengths of key AsiaPacific countries such as China and Japan in clinical trials while at the same time proactively ensuring consistency and quality..
Innovation for Growth
Glenn Saldanha who has steered the organization for the last nine years holds a Bachelors Degree in Pharmacy from Mumbai University and is an MBA from Leonard Stern School of Business New York University Prior to Glenmark Saldanha has worked with Eli..
Developing Benefit-Risk Management Programmes
There are four distinct elements to consider in developing benefitrisk management programmes They are protocol design and review active surveillance provider and patient education and appropriate use programmes The entire programme from design throug..
Optimising the Site Selection Process
Assessment of investigator motivation
Identifying sites which enroll in line with expectations represents a major challenge in clinical research This article discusses strategies to address this challenge and explores the golden site profile concept..
Accelerating Central Nervous System Trials
WTechniques such as electroencephalography and evoked potential are useful tools for translation of preclinical findings into Phase I studies These methods can be used early on to show the presence or absence of central action and adverse effects of ..
Clinical Trials in Oncology
Some sense and simplicity
With the advancement of our understanding of pathobiology of many cancers many biologically targeted agents have been developed This requires a paradigm shift in clinical development based on rational design and moving towards personalised medicine..
OEE Systems and Software
Enhancing operational efficiency
Making the best use of the equipment and reducing costs are two of the key challenges among many that the manufacturers in general and pharmaceutical companies in particular strive to overcome Overall Equipment Effectiveness software is a boon in add..
The development of optimised process for freezedried product is described New available analytical tools are reviewed and different steps from early phase to life cycle management are covered..