Pharma Focus Asia

Previous Issue - Issue 11

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.

ahhm-current-issue

Issue 11 | 2009

Issue 11

PREVIOUS ISSUE

Strategy

Rethinking R&D

Novel approach to partnering

Like the majority of industries in todays economy the pharmaceutical industry faces a range of business challenges The number of new drug approvals in was the lowest in almost a quartercentury and was only slightly higher A continuing increase in patent expirations would result in a projected US billion loss in revenue by With a decrease in...

Shaping the Future of Drug Development & Marketing Strategies

Payer perspectives

The US ranks th in the world in life expectancy and th in infant survival rates Virtually all the statistics point in the same direction Compared to other developed nations health outcomes in the US are worse and costs are higher US health outcomes and costs are unacceptableFor example the US ranked last out of developed nations in a study of...

Twenty-first Century Crime

Counterfeit, illegally diverted and stolen pharmaceuticals

The worldwide markets for pharmaceutical products are generally well regulated efficient and profitable It is their profitability that attracts many individual criminals and criminal organisations anxious to peddle counterfeit illegally diverted and stolen pharmaceuticalsThrough the systematic collection analysis and dissemination of informatio...

Personalised Genetic Diagnostics

Warrants global expansion

I was at the Burrill Personalised Medicine in the Clinic Beyond Cancer panel where G Steven Burrill invited me to explain for the audience Why dont you take your company and products to China My response at the moment was fairly succinct and addressed our need to focus on domestic United States production and follow with a launch of our products du...

Next Generation Pharmacovigilance

For enhanced patient safety

In an environment where development costs have increased exponentially while filings and launches have dropped drastically the pharmaceutical industry and drug regulators face numerous challenges in Pharmacovigilance PV patient safety and in addressing areas of unmet medical needsThis combination of issues not only adds unsustainable access res...

Research & Development

Biosimilars

Succeeding in the market of the future

Biosimilars are promising remarkable costsavings for booming healthcare budgets Yet the full potential can only be harvested when a number of significant markets regulatory and clinical hurdles have been overcome globallyThe European Union EU and its medicines agency the EMEA have successfully addressed the regulatory challenges needed to fulfi...

Global Biogenerics Market

Opportunities and Challenges

Biopharmaceuticals can be broadly defined as drug substances obtained from a living organism using biotechnology Typically biopharmaceuticals are large molecules with complex structural features and conformations compared to small molecule drugs In biologic drug sales were about US billion comprising per cent of total drug sales and this number...

Strategies for Biosimilar Development: Regulatory Framework and Technical Issues

The Current State of Play

IntroductionBy biologics are expected to constitute more than of the global pharmaceutical market with some products worth around billion expected to go off patent by Most first wave biologics are already off patent and the first few biosimilars or followon biologics have been approved in Europe The first wave of biosimilars includes produc...

How Similar are Biosimilars in India?

A blind comparative study

Indias rising prominence in the field of biogeneric products offpatent biopharmaceuticals also known as Biosimilars in Europe or Followonbiologics in US is evident from the large number of biogeneric products getting marketing approval A number of biopharmaceutical proteinbased products are due to go offpatent in the next few years which will bring

Novel Genetic Vaccines

Rational design and standardised evaluation

Edward Jenners work in developing the worlds first smallpox vaccine in the s demonstrated that it was possible to protect the general population from major threats to public health and vaccine development aimed at combating the major concerns of the day has continued ever since There have been many successes and vaccines are now available to immuni...

Evaluating drug solubility in lipid-based delivery systems

Poorly soluble drugs are often formulated in lipidbased Self Emulsifying Drug Delivery Systems SEDDS to improve their oral bioavailability These SEDDS are multicomponent formulations containing lipids surfactants and polar organic solvents necessary to solubilise the drug One key factor affecting the performance of these formulations is the solubil...

Can Genomics Provide?

Blockbuster Drugs in Defiance of \\\'Personalised Medicine?

Despite years of chemotherapy there is still no effective treatment for stage IV metastatic disease If there were cancer would lose its terror The current treatment first popularised by Emil Frei in s involves the use of cytocidal or at least cytotoxic drugs Cancer cells are treated as if they were viral or bacterial microorganisms Drugs that expl...

Manufacturing

The Freeze Drying of Biologicals

Recent trends

Lyophilisation or freeze drying is a process widely used in the preparation of biopharmaceuticals and biologicals Rey May because it allows greater storage stability for otherwise labile biomolecules provides a convenient storage and shippage format and following reconstitution rapidly delivers the product in its original formulation ready for us...

Information Technology

Regulatory Information Management

Leveraging standards and efficiencies of eCTDs

Within a Regulatory department there are Information Management needs particularly related to the electronic Common Technical Document eCTD submission process There are a number of methods for adding efficiencies to the submission process particularly through automation and standardsTo begin with what does it mean to add efficienciesFrom Th...

Expert Talk

M&A and Partnerships in Pharma

Indian scenario

Where do the current partnering opportunities lie for Pharma and biotech Partnering opportunities exist across all segments of the Industry namely drug discovery development clinical trials data management IT manufacturing and marketingWith more multinational companies showing interest the MA activity in India is expected to go up in t

M&A and Partnerships in Pharma

Rising opportunities

Where do the current partnering opportunities lie for Pharma and biotechBecause RD productivity is a problem for pharma the partnering opportunities are basically seen in licensing and acquisitions There are many opportunities because this year itself you have seen the speed of deal making in the US and in Europe between all kind of companies on...

magazine-slider-image