New hope for heart attack patients

A major drug trial has brought scientists closer to making a drug that could prevent thousands of deaths from heart attacks.

From the past six years, international clinical trials have been going on a new drug, ticagrelor.

The new findings have revealed that the platelet function in patients taking ticagrelor recovered much quicker after the drug is stopped, compared to the current gold standard drug, clopidogrel.

This study has also confirmed that breathlessness occurs as a side effect of ticagrelor but this is not associated with any harmful effects on lung or heart function.

The findings also include a new analysis of a previous trial looking at ticagrelor.

This new examination of the Plato trial, which was completed last year, showed that ticagrelor prevents 1 in 5 deaths after a heart attack, and patients who develop the adverse effect of breathlessness with ticagrelor still benefit from a lower risk of death compared to patients treated with clopidogrel for one year following a heart attack.

This has also confirmed that patients treated with clopidogrel, who have a genetic variant that reduces the effect of this drug have a slightly higher risk following heart attack but ticagrelor is not affected by this variant and is still more effective than clopidogrel, regardless of a patient's genetic make-up.

The study has previously shown for every 1,000 patients treated for one year with ticagrelor instead of clopidogrel, there would be 14 fewer deaths or 11 fewer heart attacks without an increase in bleeding problems.

Diabetes medication safe for Alzheimer's patients

The diabetes medication pioglitazone is generally well tolerated and could be a potential treatment option for patients with Alzheimer's disease.

"Alzheimer's disease is an immense and growing public health problem," the authors write as background information in the article.

"Although prescription drug therapy for the symptoms of Alzheimer's disease has been available since 1993, these agents do not fundamentally alter the pathological expression of the disease or its progressive course. The failure of several recent treatment trials directed at the beta-amyloid peptide, a key pathological correlate of Alzheimer's disease, suggests a need to explore alternative approaches to Alzheimer's disease treatment that are not focused on beta-amyloid metabolism," they said.

Another potential therapeutic target for the treatment of Alzheimer's disease is the nuclear receptor peroxisome proliferator-activated receptor gamma, PPAR-gamma, which acts to regulate glucose and lipid metabolism.

A class of drugs known as thiazolidinediones, originally developed to reduce insulin resistance in patients with type 2 diabetes, are potent agonists (trigger a response) of PPAR-gamma.

To evaluate the safety of one of these medications, pioglitazone, in patients without diabetes but with Alzheimer's disease,an 18-month, double-blind, placebo-controlled randomized controlled trial was conducted.

Twenty-nine patients without diabetes but with probable Alzheimer's disease were randomly assigned to receive either pioglitazone (titrated to 45 milligrams daily) or matching placebo, along with 200 international units of vitamin E.

A total of 25 patients (12 taking pioglitazone and 13 taking placebo) completed 18 months of therapy. Two of the patients who discontinued participation in the study early had a change in caregivers status, and two withdrew their consent; no discontinuations were attributed to adverse events.

Peripheral edema, swelling of the legs and feet, was the main adverse event, affecting four patients in the pioglitazone group (28.6 percent) compared with none in the placebo group.

"This is consistent with the known adverse event profile of pioglitazone. No group differences in laboratory measures were identified," wrote the authors.

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Career in clinical research

A graduate in life sciences or medical sciences is often at cross roads after completion of his/her degree. Many of them are not confident of their career and are anxious about their next move. They are often undecided on whether they should pursue a postgraduation in the same subject, prepare for foreign university exams, accept jobs offered with a decent salary irrespective of the nature of the job or try something different that is more challenging and satisfying.

There is also a category of students who are neither content with their graduation nor happy with the type of jobs offered to them. With the rising cost and competition, they are also not confident of pursuing post graduation in the main stream. It is this category of students, mostly venturing into trying something more challenging. In such a scenario, advertisements like 'Clinical research the emerging career option for lifesciences, dental and medical graduates', will certainly stimulate the students to consider clinical research as their destination. Furthermore, the terms Clinical and Research makes this field an attractive option. For many of the science graduates aspiring for growth, research is a boon because science and research are inseparable. When research offers an attractive salary too, guardians and parents are obviously drawn towards the field. The journey of exploration thus begins.

The clinical research team

At the Sponsor/Contract (Clinical) Research organisations (clinical research organisations are independent private companies to whom the sponsor sometimes outsources the clinical trial projects): Clinical Research Associate, Clinical Trial Administrator, Project Manager, Medical Writer, Quality Assurance Manager/ Eexecutive, Medical Advisor (These positions are exclusively for medical professionals, the rest are available for any lifesciences graduate/post graduates), Medical Monitor, Data Entry Operator, Data Manager, Data Validator, Bio-statistician, Manager- Regulatory Affairs.

At the Clinical trial site

Principal Investigator, Co-investigator, Clinical Research Co-ordinator, other hospital staff as per requirement

Companies into clinical research Sponsor companies: Johnson & Johnson, Biocon, GlaxoSmithKline Beecham, Allergan, Astra Zeneca, Ranbaxy Laboratories, Nicholas Piramal, Dr.Reddys Laboratories, Novo Nordisk, Pfizer etc.

CROs: Quintiles, Manipal Acunova, ICON International, Clintec, Clinigene International, Accenture, Paraxel, Asian Clinical trials, Paragon, etc.

Hospitals : St.Johns Hospital, M S Ramiah Memorial Hospital, Kidwai Memorial Hospital, Bangalore Institute of Oncology, Bangalore Diabetes Hospital, Wockhardt Hospital, Apollo Hospitals etc.

Information technology and clinical research

Information technology has been a boon to the clinical research industry. The software programmes such as Oracle data base helps the organisations to effectively manage huge amount of clinical trial data. Since we have several thousands of patient's data using software makes the job easy andgenerate high quality analysis. Clinical data management has thus emerged as one of the important off shoot of clinical research. There are many other applications of computers in clinical research.

Now clinical research opts for outsourcing

After business, knowledge and legal process outsourcing, the Indian industries are now eyeing 'diagnostics jobs' outsourcing from other countries.

According to industry experts, a number of hospitals in the US and Europe are outsourcing laboratory and diagnostic tests to India as it helps in saving cost and money while maintaining quality.

The Indian diagnostics and pathology laboratory business is around $864 million and is growing at a rate of 20 per cent annually, they say.

Accordng to the Federation of Indian Chambers of Commerce and Industry, the size of the global clinical trials market was nearly $10 billion and predicted to have touched by $26 billion by 2007.

"Diagnostics and lab testing outsourcing is certainly the most potential business domain. We are trying to tap available opportunities in it," says Dr G S K Velu, Managing Director, Metropolis Health Services India Ltd.

"There is an excellent outsourcing opportunity to test around one million samples a year," he says.

The other emerging sector --Clinical Research Outsourcing -- is also witnessing surge in the country. The drug manufacturing units are outsourcing different phases relating to development of medicine to India.

In the case of diagnostics, X-rays and other procedures are done abroad and the reports by experts are written here and sent back, while in the case of lab tests, the photomicrographs are electronically sent here and the doctors send back the results.

We plan to offer tele-pathology services to cater to the needs of foreign clients faster, he says adding that countries like West Asia, Srilanka, Africa, Nepal, Bangladesh and UK outsource tests to India.

At present, the volume is not very high but the market potential is huge as European countries as also the US are in talks to outsource their work in this area.

Metropolis, that provides hospital Laboratory management services and outsource number of diagnostic related works to India, has number of labs in Middle East and South-East Asian countries, including Thailand, Indonesia and Vietnam.

"We processes more than 10 million sample tests per year and around one per cent from outsourcing, Velu adds.

There is a great opportunity for tapping CRO in the nation. The volume of business is expected to touch $1-1.5 bn mark by 2010.

There are as many as 30 Global CROs and 100 companies involved in doing clinical research related jobs in the country.

Most of the work comes from US (almost 20 per cent) and Europe (70-80 per cent). We undertake approximately 300 studies a year

It is not the lack of expertise behind outsourcing Clinical Research related jobs. But, availability of manpower and time saving

The sector is also poised to deliver excellent job opportunity and career options to research fellows. McKinsey estimated that the Indian CR (clinical research) market will grow to $1.5 billion in value by 2010.


Asserting that the country has bouquet of products to offer to foreign clients and attract outsourcing, he said. "There is urgent need to market our products globally. The government has to start speaking globally about diagnostics and lab work outsourcing in the same way as information technology."

Pfizer continues on rare disease path with new R&D unit

Pfizer continues its foray into rare diseases as it creates a new R&D unit to investigate novel therapeutics for conditions such as Haemophilia. The pharma giant joins GlaxoSmithKline and Novartis as companies looking into producing specialised drugs as a way to offset slowing sales growth and loss of blockbuster patent protection.

The new unit created within Pfizer’s Worldwide Research and Development operation aims to capitalise on Pfizer’s existing research into such conditions as Haemophilia. In the past, Pfizer have also expressed its interest in treatments for muscular dystrophy and other conditions caused by genetic mutations.

The creation of an R&D unit represents a significant strategy shift into rare diseases for the firm. In December of last year, Pfizer agreed to pay $60 million initially with a further $55 million to license the worldwide rights to Protalix Biotherapeutic's drug for Gaucher disease.

This shift also produced job cuts as the company announced last month its intention to shed roughly 6,000 manufacturing jobs worldwide over the next five years.

This includes approximately 300 at the Andover biotechnology plant Pfizer took over when it bought Wyeth Pharmaceuticals for $68 billion last year.

With the impending expiration of blockbusters and a slowdown in emerging pipeline candidates, industry insiders believe pharma’s passing interest in specialised markets is gaining increasing momentum.Drugs produced for ultra-orphan diseases with high unmet needs have an easier time commanding high prices. Genzyme’s Cerezyme, another drug used to treat Gaucher disease can command prices of up to $200,000 a year while medicines for cancer can cost $50,000 or more a year.

In addition, the growing trend of pharma companies using biomarkers to improve on current methods to define populations of patients increases the prospect of smaller markets suddenly becomes more attractive and financially viable.

Pfizer joins a growing band of companies who are currently pursuing treatments for rare diseases. In March, GlaxoSmithKline (GSK) steeped up its efforts to build a rare diseases business which saw the UK pharmaceutical major launch its own dedicated R&D unit.

Bristol-Myers Squibb has signed agreements with clinical development service providers, Icon and Parexel, for joint strategic, operational and capability support of its clinical development program.
As per the agreement terms, Icon and Parexel are expected to provide support for Bristol-Myers Squibb’s clinical studies to support its full development pipeline over the next three years.
Bristol-Myers Squibb is preparing for a large volume of clinical development work that is expected to require expanding upon its existing partnering approach for clinical development.
Bristol-Myers Squibb also stated that, consistent with the its BioPharma strategy, the agreements with Icon and Parexel are expected to complement its internal capabilities and capacity.
Brian Daniels, senior vice president of global development at Bristol-Myers Squibb, said: “These partnerships are expected to increase the operational capability of our clinical development organisation, and support our position in productivity and innovation.
“Working with Icon and Parexel, Bristol-Myers Squibb will enhance support for our pipeline and improve our ability to deliver medicines to patients with serious disease.”
John Hubbard, president of clinical research services at Icon Group, said: ‘‘We are delighted that Bristol-Myers Squibb has selected us to support its clinical development programs.
“Over the last ten years, we have forged a partnership by working hard to fully understand Bristol-Myers Squibb’s requirements. We look forward to moving this partnership to another level and continuing to support Bristol-Myers Squibb’s goal of bringing treatments to patients."
Josef von Rickenbach, chairman and CEO of Parexel, said: “We look forward to a deeply collaborative relationship with Bristol-Myers Squibb to help provide solutions for its growing pipeline, as well as leverage our capabilities and technology infrastructure to support the effectiveness of its clinical development programs."