Chemtech

Pharma Bio World is a comprehensive business magazine that caters to the strategic information needs of senior professionals in the pharmaceutical and biotechnology industries, covering the best manufacturing and management practices, technological developments, new markets and cutting edge products and services. Through a well-defined combination of news analyses, snapshots of major happenings, and thoroughly researched features on best practices, quality, biotechnology, environment, markets, human resources, and so on, the magazine aims to provide well-rounded information on issues of strategic interest to practising managers in the industry.

December 2011 Issue

INTERVIEW

India Could be the World's Leading Country for Translational Research

Started in 2002, Banyan Biomarkers is now recognised as a leader in developing in vitro diagnostic assay for TtBI. In this interview Dr Jackson Streeter, CEO, Banyan Biomarkers Inc. throws light on how biomarkers can be used in diagnosing TtBI and also on its potential in future. Eexcerpts from the interview...
- Dr Jackson Streeter, CEO, Banyan Biomarkers Inc.

Empowering Women in Lifesciences

If the term 'Bullet Train' could be used in Contract Research Organisation (CRO) industry, it would aptly describe the speed at which Karmic Lifesciences has grown under Nidhi Saxena, President & CEO, Karmic Lifesciences. Nidhi is also the President of Women In Bio (WIB) India, which is committed to promoting careers, leadership and entrepreneurship of women in the lifesciences. She talked to Pharma Bio World on the sidelines of launch of WIB India chapter in Mumbai...
- Nidhi Saxena, President & CEO, Karmic Lifesciences

FEATURES

Transition from "Rreactive" to "Pro - active" Pharmacovigilance

Over the last few years, pharmacovigilance has gained substantial importance, thanks to the numerous drug withdrawals due to safety reasons. The regulatory authorities and pharmaceutical companies are now working towards pre-marketing identification of potential risks, hazards and side effects of drugs. The article gives an overview of importance of pharmacovigilance and its current status in India...
- Dr Manoj Swaminathan

Strengthening the Risk Culture in Clinical Trials

Risk is an integral part of business life. Risk management is vital in clinical research with the lives of patients and new drug introductions in the market at stake. Placing ethical issues on the forefront, the author emphasises on important aspects of timely risk evaluation and mitigation in clinical trials...
- Dr Sonal Vora

One World One Rule: Towards Harmonisation

The globalisation of clinical trials is an unquestionable and optimistic drift in the endeavour of delivering new life changing medicines and therapies. Clinical Research Organisations CROs) have not only gained from the drift, but also have been key drivers behind globalisation as the need for larger and more multifarious clinical trials that must be balanced with a desire for speed and efficiency. In this scenario it has become utmost important to have a common procedure of rules and regulations which can help in harmonising clinical trials...
- Shiv Raman Dugal

Wake Up to The Clinical Research Industry

Inspite of its necessity and importance in healthcare, clinical research has a maligned reputation among laypersons in India due to certain wrong allegations. Both, Chairman and Vice-Chairman of ACRO, rubbish these claims and present a brighter picture of clinical research to Pharma Bio World, highlighting the aims and initiatives of ACRO along with the importance of clinical trials in India....
- Apurva Shah and Ashish Dasgupta

Stumped by Stem Cells: A Look at the Current Scenario

There are only a few things that fascinate man as much as the idea of regeneration. And although this has become a plausible reality in recent times - courtesy stem cell research - much has to be known about its optimised application and utility, since clinical trials being conducted in this regard have been proved to be a mixed bag. Dr Deepa Ghosh gives us a glimpse of the current scenario of stem cell research in the country...
- Dr Deepa Ghosh

Curbing the Spurious Drug Menace

Counterfeit drugs are a serious problem in India and other developing nations. India ranks as the second largest country to produce fake drugs. The health ministry estimates that 5 per cent of drugs in India are counterfeit, while another 0.3 per cent are spurious. According to World Health Organization (WHO), the counterfeit drug market could be upwards of USD 75 billion worldwide. In this wake, it is essential to come up with ways to curb the spurious drug menace...
- Rajesh Varrier

One Size Doesn't Fit All - Challenges in Selecting EDC Solutions

IT-based data capture solutions have shown to be quite promising for clinical trial records. However, they also incur drawbacks along with them. The sponsor always looks for the trade-off between benefits and challenges. This article discusses some of the parameters considered in vendor selection process, associated challenges and possible solutions...
- Mrunalini Jagtap

Wilson's Disease - Not Fatal if Promptly Diagnosed

Being a rare copper metabolic disorder, Wilson's disease can be deadly if not diagnosed and treated on time. The author lays emphasis on the challenges in diagnosis and developments in various treatment options available for Wilson’s disease...
- Dr Annu Aggarwal

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