Foreword

Kittens to Tigers

Indian Pharma

The Discovery Metamorphosis

A New Paradigm for the Indian Pharma Industry

Our strategy is based on our belief that Indian scientists can become creators of intellectual property rather than be copiers.

Innovation - The Key Driver

In the next five years, Indian pharma will do well in terms of gaining a fair understanding and being able to further evolve the drug discovery environment in India.

Drug Discovery & Development

An Indian Perspective

India is on the threshold of drug discovery research where
the next few years are going to be the most critical.

The Indian Pharmaceutical Industry

Promises and perils

The pharmaceutical industry needs to revisit its ‘doctorheavy’ marketing strategies to succeed in this continent.

Strategy

Fulfilling the Promise of China

Sustained economic growth and tremendous unmet needs in important therapeutic areas in China are creating huge potential for the industry but the ability to adapt successful practices to the nuances of the local market will be critical.

Treating Neglected Diseases

The role of orphan drugs

The Institute for OneWorld Health has developed Paromomycin IM Injection to treat visceral leishmaniasis in India. In the future, similar models can be used to bring new drugs to the people suffering from neglected diseases in the developing countries.

Reaserch & Development

Electronic Health Records and Clinical Research

Despite the value of combining EHR and EDC for multicentre trials, we are many years away from a standard, usable process for this.

Pharmacogenomics and Personalised Medicine

Synergy between the industry and academia

Despite the value of combining EHR and EDC for multicentre trials, we are many years away from a standard, usable process for this.

Materials, Manufacturing & Packaging

Redesigning Drugs to Enhance Performance

When a compound progresses to a medicinal product the complexities of disease, drug action, and the diversity of patient response can mean that nuances of drug behaviour may not be fully evident. However, new insights may emerge on more widespread use. These can provide ideas for new indications or better treatment of the existing indication.

Improving Pharmaceutical Manufacturing Performance

A four-year research project began in 2002 to study pharmaceutical manufacturing and deviation management performance. The analysis reveals five key outcomes that influence manufacturing performance.

Plant Automation in Pharma

An Asian perspective

Automation platforms that can be easily expanded to other process automation applications within the manufacturing facility would significantly reduce cost involved in ensuring regulatory compliance.

Single-Use / Disposable Technology

Considerations for biopharmaceutical facility design

Single-use / disposable technology offers a cost-effective and flexible process design for biopharmaceutical manufacturing facilities.

Clinical Trials

Ethics in Clinical Trials and Drug Development

Ethical considerations have a multiplicity of roles during the conduct of clinical trials—from matters related to the design of a study, to the conduct and even to the reporting of results.

Decision Making in Drug Development

Innovative designs

Bayesian designs are particularly suited for early drug development as they combine historical information with current trial data to make decisions on toxicity, efficacy or futility.

Foreign Biotech Trials in Asia

Emerging trends

Asian countries seem to be welcoming foreign clinical trials, which create job opportunities for researchers, scientists and medical professionals and also bring new therapies to the country.

Information Technology

Operational Excellence

IT governance, enterprise architecture and service management

IT governance defines a structure of relationships, processes and measures to direct and control IT in order to achieve the enterprise's goals.

Knowledge Tools

Increasing role in drug development

By using knowledge tools to better understand a potential new drug’s effectiveness and safety early in the development process, it becomes possible to terminate potentially problematic drugs earlier, saving both time and money.

IT in Pharma

Countering the information security risk

IT breaches lead to identity theft, counterfeit drugs, low productivity and revenue loss.

Information Technology

Right prescription for the growth of pharmaceutical companies

The IT spending of companies reflects their strategies to introduce new drugs, enter new markets, and be more competitive in the challenging Asian pharmaceutical market.