Foreword

Personalised Medicine

What next?

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.

Strategy

Indian Pharmaceutical Industry

On the cusp of a great opportunity

Leading research-based 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 sequential steps, is essential to pharmaceutical development of new and improved medicines and public health and is indeed the major way in which medical science has progressed.

Mega Mergers

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 short-term myopic M&A approach. The Innovation Gap for new drugs has widened to a cavern. In 2009, the industry has some interesting questions to answer. How to close this innovation cavern and how will the pharmaceutical industry manage short-term perceived benefits at the expense of long-term woes in building sustainable drug pipelines?

Pharma and Biotech

Collaborative models

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 various types of collaborations used in this industry.

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.

Innovation

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 re-engineering during the process patent regime.

Research and Development

Targeted Therapies

A sustainable business model?

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 precursor for personalised medicine therapies and can offer a viable business model to expand from. Society should develop consensus for such new models in multi-stakeholder partnerships which will also make it sustainable.

Personalised Medicine

Changing business models

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 require substantial original clinical research, which may or may not be intermingled with development costs for the drug.

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 biomarkers will become a more integral part of future drug development and commercialisation and, therefore, foster the “promise of personalised medicine” over the coming years.

Biosimilar Medicines

Understanding the challenges

“Follow-on” 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 affordable and better biological medicines to patients throughout the world.

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 between academia and industry in the discovery and elucidation of new biological targets; however, the delineation of the roles of academia and industry are beginning to blur.

Preclinical Research in Big Biotech

Vertical integration is the key

As companies transition from young, start-up 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 long-term consequences, whether they happen by strategic design or circumstance. The key element for growing companies is vertical integration.

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 post-marketing studies. Properly automated cognitive function assessments have considerable benefits over traditional pencil and paper tests, and can bring additional value to all stages of drug development.

Manufacturing

Lyophilisation Process Development

The development of optimised process for freeze-dried product is described. New available analytical tools are reviewed and different steps from early phase to life cycle management are covered.

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 addressing the said challenges and aids in enhancement of overall operational efficiency.

Clinical Trials

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.

Accelerating Central Nervous System Trials

Neurophysiological approaches

Techniques 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 investigational compounds, speeding the search for biomarkers and leading to better GO / NO-GO decisions.

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.

Expert Talk

Innovation for Growth

Glenn Saldanha who has steered the organization for the last nine years holds a Bachelor’s 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 Lily, USA and PricewaterhouseCoopers, USA.

Developing Benefit-Risk Management Programmes

Best practices

There are four distinct elements to consider in developing benefit-risk management programmes. They are: protocol design and review, active surveillance, provider and patient education and appropriate use programmes. The entire programme from design through implementation and maintenance will be overseen by programme management, quality management, continuous improvement and comprehensive communication.

Clinical Trials in China & Japan

Dynamic opportunities for sponsors and CROs

This article focusses on how to leverage the regional strengths of key Asia-Pacific countries such as China and Japan in clinical trials, while at the same time proactively ensuring consistency and quality.