Pharma Focus Asia

Previous Issue - Issue 10

This Pharma Magazine is the source for a plethora of unique Pharma articles. Several notable figures from top pharma organisations are featured in the R&D, Manufacturing and Clinical Trials sections, with their expert knowledge of the field.

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Issue 10 | 2009

Issue 10

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Strategy

Indian Pharmaceutical Industry

On the cusp of a great opportunity

The pharmaceutical industry in India is on the cusp of a great opportunitythe opportunity to innovate and create novel medicines to meet unmet medical needs of today and the future thus making a positive impact on global health It is imperative to capitalise on the enormous wealth of creative and scientific resources that our country has been bless...

Mega Mergers

Are they turning pharma companies into Zombies?

Over the past two years big pharma has strived to achieve revenue growth and pipeline stocking through MA In the pharma industry mainly targeted latestage biotechnology acquisitions to consolidate some drug development platforms namely those with disease franchises and drug class expansion Then came the everworsening financial crisis during that...

Pharma and Biotech

Collaborative models

Collaborations are the voluntary joint actions of two or more parties to achieve a common goal This is a straightforward concept in principle but often more complex in the real worldWithin the pharmaceutical and biotechnology sectors one can easily identify at least six major classes of stakeholders viz private industry academia regulatory agen...

New Patents for Old Drugs

Label-based strategies in the United States

In recent years particularly since the Dotcom stock market crash in venture capitalists have been increasingly reluctant to fund US companies engaging in drug development Such investments are often considered to be too risky too capitalintensive and to take too long to fit the new more conservative venture capital model Indeed it has been estimate...

Innovation

The key growth mantra

Innovation which is expected to be the leading growth driver has made the Indian life sciences industry focus on building their portfolios of speciality and niche drugs or entering into alliances with the innovator companies to tap this key business opportunity Indian life sciences industry is making constant efforts to have a thrust on innovation...

Research & Development

Preclinical Research in Big Biotech

Vertical integration is the key

In the biotechnology world starting a new venture is fraught with a mixture of excitement and anxiety Using a new technology or drugs platform that has yet to prove itself in the clinic and the marketplace can be one of lifes greatest adventures for scientists and entrepreneursAs companies transition from that initial phase and with some succes...

Computerised Cognitive Function Assessment

Coming of age

Cognitive function testing was first introduced into drug development to assess the unwanted side effects of many medicines to produce impairments to mental functioning and is still widely utilised to establish whether newer medicines are relatively free from such effects However the opportunities for medicines to improve cognitive function in the...

Targeted Therapies A Sustainable

Business Model

For many rare diseases there is as yet no satisfactory treatment Rare diseases are defined as lifethreatening and or serious and chronic diseases according to the European Orphan Medicinal Products regulation These diseases represent a high unmet medical need Rare diseases with their genetic origin and because of small number of patients to be tre...

Personalised Medicine

Changing Business Model

It has become clear that pharmaceutical development in the first decades of this century will be dominated by the personalised medicine concept Personalised medicine encompasses the development and marketing of molecular tests which help to target the use of pharmaceuticals and biologicals in ways that maximise their effectiveness Of course lab tes...

Personalised Medicine & Drug Development

Biomarkers leading the way

Up to the last decade the pharmaceutical industry had followed a trialanderror approach to medicine by applying a drug to an entire patient population when treating a given disease As a result the overall drug efficacy in selected diseases was only around per cent Moreover adverse drug reactions were among the leading causes for hospitalisation an...

Biosimilar Medicines

Understanding the challenges

Many of the blockbuster biological products that currently dominate the markets are coming to the end of their patent protection The opportunity to provide more affordable generic versions is now attracting the interest of both generic and researchbased pharmaceutical companies The development of generic biological medicines referred to as

Drug Discovery in Academia

An evolving model

Over the past decade there has been increasing pressure on the pharmaceutical industry to increase economic efficiencies in drug discovery This has been driven by several factors including the increased costs of RD lower productivity patent expiration generic competition and the increasing difficulty in bringing new chemical entities to marketT...

Clinical Trials

Clinical Trials in Oncology

Some sense and simplicity

The burden of cancer as a global health problem is underscored by its increasing incidence With better understanding of the biologic processes underlying the causes and progression of cancer great strides have been taken in inducing incremental improvements in survival Indeed the face of oncology has changed in the last decade from a paradigm where...

Accelerating Central Nervous System Trials

Neurophysiological approaches

The incidence of Central Nervous System CNS illness is on the upswing and exacts a heavy human and economic toll According to the World Health Organization more than million people worldwide suffer from depression and the number is expected to rise The occurrence of Alzheimers disease is slated to grow by more than per cent in developed countries...

Optimising the Site Selection Process

Assessment of investigator motivation

According to some estimates up to per cent of Investigators participating in a trial may recruit no patients When considering this statistic it is important to remember that every sitealso those that have not recruited to targethas been through a process of selection Whilst this process may determine whether a site can provide suitable staff and f...

Developing Benefit-Risk Management Programmes

Best practices

Understanding the interrelationships among all key stakeholders is the critical aspect in risk management planning in todays rapidly changing complex global healthcare environment These can include payers providers patients care givers patient advocacy groups regulators and other government agencies All these stakeholders should be considered when...

Innovation for Growth

Where does the company stand today with respect to its motto To emerge as a leading integrated researchbased global pharmaceutical companyWhen we began the process of discovery research in very few believed that we could do it We were clear at that time and even now that innovation was the only way for sustained growth and for that one had to ve...

Clinical Trials in China & Japan

Dynamic opportunities for sponsors and CROs

The historical approach to clinical drug development and one that served drug companies well for the past thirty years was to initiate testing in humans at clinical research units typically located in the UK and the US and to proceed further to Phase II testing and beyond to patients with clinical evidence of the disease with investigators mostly l...

Manufacturing

Lyophilisation

Process Development

Freezedrying is used by the pharmaceutical industry for years Its a way to protect sensitive molecules from degradation allowing their shelf life to be extended from days or months to years Moreover the technology is perfectly integrated inside industrial GMP Good Manufacturing Practice production giving a high degree of confidence in product steri...

OEE Systems and Software

Enhancing operational efficiency

Pharmaceutical manufacturers encounter unique demands in their endeavour to manage improvement with operational excellence In the past it was easier for pharmaceutical manufacturers to achieve the desired margins But in the current scenario of competition price pressure stringent FDA regulations and the ongoing economic crisis pharmaceutical manufa...

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