Strategy

Twenty-first Century Crime

Counterfeit, illegally diverted and stolen pharmaceuticals

The rise in counterfeit medicines worldwide, with concomitant problems of toxicity, instability and ineffectiveness, is often underestimated...

Next Generation Pharmacovigilance

For enhanced patient safety

The pharmaceutical industry is facing a tough road ahead in the future marketplace. Though pharmaceuticals remain the most costeffective healthcare intervention,...

Research & Development

Novel Genetic Vaccines

Rational design and standardised evaluation

Vaccines play a central role in health protection and advances in biotechnologies now offers numerous novel approaches for vaccine development...

Evaluating drug solubility in lipid-based delivery systems

Understanding the solubility behaviour of the drugexcipient complex in a lipid-based drug delivery system will help...

MANUFACTURING

The Freeze Drying of Biologicals

Recent trends

Although conventional freeze drying in vials is still the predominant format, lyophilisation in alternative formats, such as pre-filled syringes,...

Clinical Trials

Managing a Major eCTD Filing

An Amgen case study

This is a case study of how Amgen manages a major electronic Common Technical Document filing. It focusses on tools and processes developed and refined from 2005 to present...

Expert Talk

M&A and Partnerships in Pharma

Rising opportunities

Because R&D productivity is a problem for pharma the partnering opportunities are basically seen in licensing and acquisitions.

M&A and Partnerships in Pharma

Indian scenario

India's growing respect and legal / regulatory framework for IPR, favourable economic policies resulting into attractive investment destination and availability of huge talent pool...

Information Technology

Regulatory Information Management

Leveraging standards and efficiencies of eCTDs

In managing Chemistry, Manufacturing and Controls documents, the larger process is involved for electronic regulatory submissions to health authorities...

Advisory Board

Alan S Louie
Research Director

Christopher
-Paul Milne
Associate Director

Douglas Meyer
Senior Director

Frank A Jaeger
Director, New Business Development

Georg C Terstappen
Chief Scientific Officer

Kenneth I Kaitin
Director and Professor of Medicine

Laurence Flint
Associate Director

Neil J Campbell
CEO, Mosaigen Inc. and Partner, Endeavour Capital Asia Ltd., USA

Phil Kaminsky
Founder, Center for Biopharmaceutical Operations, University of California, Berkeley, USA

Rustom Mody
Director, Quality and Strategic Research, Intas Biopharmaceuticals
Limited,
India.

Sanjoy Ray
Director, Technology Innovation

Sasikant Misra
Deputy Director, Confederation of Indian Industry, India.