Pharma Focus Asia Magazine

Foreword

Biosimilars
A new era in biotech

Biosimilars will eventually bring down the cost of biological medicines and in doing so will expand the market Cecil Nick Principal Consultant PAREXEL Consulting UK..

Strategy

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 they should bring about a significant transformation in their organisations to realise the..

Personalised Genetic Diagnostics
Warrants global expansion

Directtoconsumer genetic tests should be advertised as genomic art to avoid the increase in general anxiety that they will introduce without including a properly informed healthcare provider..

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 It is a hidden risk because counterfeit medicines are largely overlooked in the official public health statistic..

Shaping the Future of Drug Development & Marketing Strategies
Payer perspectives

Two questions from patients about drug therapydoes it fix my problem does it cause other problemssuggest three new pharma strategies to address payers priorities for improved results These strategies are affected by payer perspectives as they shape t..

Rethinking R&D
Novel approach to partnering

With a decrease in RD productivity increase in the cost of latephase drug development and a greater competition for licensing opportunities the stakes are high for the major players in the pharmaceutical industry..

Research & Development

Can Genomics Provide?
Blockbuster Drugs in Defiance of \\\'Personalised Medicine?

It has become dogma that the era of genomics will require extensive genotyping of each patient personalised medicine and that this will carve up the pharmaceutical marketplace making blockbuster drugs a thing of the past In the extreme each patient w..

Evaluating drug solubility in lipid-based delivery systems

Understanding the solubility behaviour of the drugexcipient complex in a lipidbased drug delivery system will help formulation scientists in rational selection of the appropriate excipients and in the determination of the optimum excipient levels to ..

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 The goal of developing new vaccines to immunise people against infectious diseases has long been a key prio..

How Similar are Biosimilars in India?
A blind comparative study

It is important to show that biogeneric drugs are comparable in structure and function to that of the innovator and any differences have to be supported with data showing no influence on these parameters..

Strategies for Biosimilar Development: Regulatory Framework and Technical Issues
The Current State of Play

Companies developing biosimilars face a challenge of adopting the right commercial and regulatory strategy as the regulatory environment is not yet harmonized across the major markets Draft guidelines for Japanese biosimilars were published by its re..

Global Biogenerics Market
Opportunities and Challenges

The number of new biotechnology therapeutics makeup a significant proportion of all new drug development programmes However some of these new therapies are prohibitively expensive Many toptier generic firms today have developed scientific and technol..

Biosimilars
Succeeding in the market of the future

Translating the pharmacoeconomic potential of biosimilars into real improvements in access to expensive cuttingedge medicines remains a challenge that must be urgently addressed by healthcare authorities and policy makers..

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 During this time Amgen has filed three original Marketing Applications with an..

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 prefilled syringes and alternate technologies such as spray freeze drying are becoming more popular..

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 This is a case of an entire process standard providing significant gains in efficiency A solution is..

Expert Talk

M&A and Partnerships in Pharma
Indian scenario

Indias growing respect and legal regulatory framework for IPR favourable economic policies resulting into attractive investment destination and availability of huge talent pool for sustaining and growing operations is making India an attractive dest..

M&A and Partnerships in Pharma
Rising opportunities

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

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