Monday, November 15, 2010
How job seekers can overcome phone interviews easily??
Phone interviews are becoming a common way for employers to screen potential employees during the hiring process. Unlike traditional, in-person job interviews, phone interviews are usually fairly short, require less preparation, and can even be outsourced by the employer if necessary. These features make phone interviewing an effective way to narrow down the list of candidates before scheduling in-person interviews. Unfortunately, many people are not comfortable conducting a conversation of that importance over the phone. If the prospect of a phone interview makes you nervous, these tips can help turn an awkward interview into a confidence-inspiring success.
Preparation is the Name of the Game
When preparing for a phone interview, don’t forget that not all recruiters and employers schedule them ahead of time. At any moment, a recruiter could stumble across your resume or an employer could decide to call you in regards to a recent application. Your chances for success in your job search will be greatly improved if you try to always expect the unexpected (especiallyduring a job interview).
Keep Your Resume Near the Phone
Knowing that you could get a call from a recruiter or an employer at any moment, you should always keep a recent copy of your resume near the phone. That way, whether or not your phone interview is anticipated, you will have all the information you need right at your fingertips. Of course for a job interview, your resume is not the only resource you should keep handy.
Create a log for keeping track of the resumes you send out, recording each company, position title, contact name, date the position was applied for, and qualifications for the job. If you have a chance to research the company, make a file with that information, and keep it near the phone as well. Finally, you should always have access to a notepad and pen during a phone interview, so that you can write down the interviewer’s name, key questions he or she asked, and your responses.
Practice (and a Cheat Sheet) Makes Perfect
Just like with a traditional job interview, you should try to anticipate questions the interviewer might ask. If you have come up with examples and practiced your answers ahead of time, you will sound much more intelligent and confident in the interview. Moreover, since the interviewer cannot see you, there is nothing to stop you from referring to a “cheat sheet” – notes to help you remember your practiced answers, so that you never sound like you have been taken off guard.
When you practice your answers and put together your cheat sheet, you should think about job interview questions that are traditionally asked, such as:
• Tell me about yourself.
• What are your strengths and weaknesses?
• Where do you see yourself in 1/5/10 years?
• What is your leadership style? Please give an example of a real situation.
• Describe a situation where you had to work with others to solve a problem.
• Give me an example of a stressful situation you have encountered on the job. How did you handle it?
• Tell me about your three greatest accomplishments in your career.
• Do you have any questions?
Many of these questions are difficult to answer on the spot. By preparing your answers ahead of time, you give yourself the opportunity to think through your answers carefully. Your notes will refresh your memory if you draw a blank, and help prevent you from freezing up during the interview.
Giving a Fabulous Phone Interview
If you’ve done your homework, the phone interview itself should be a breeze. The important thing at this point is to remember to make sure the interviewer can hear and understand you – and vice versa – as well as possible. During the phone interview, you should:
• Find a quiet place. Children, pets, televisions, and radios are all noisy distractions that should be avoided. If the phone interview is scheduled in advance, you can arrange to have a quiet room all to yourself. If you receive the phone call unexpectedly, retreat into a quiet room or suggest another time for the interview.
• Sip water periodically. Nervousness often causes your mouth to dry out, which can in turn change the way your voice and pronunciation sounds to the interviewer. If you know about the phone interview ahead of time, you can have a glass of water on hand, along with the other materials you have prepared.
• Avoid eating, smoking, or chewing gum. Excess movement of your mouth and throat will make you harder to understand, and possibly distract or even irritate the interviewer.
• Give short answers. Many people talk too much when they are nervous. This is especially easy to do in a phone interview, because you don’t have the other person’s visual cues to indicate when it’s their turn to talk. To make sure you don’t make this mistake, only talk long enough to answer the question. A moment of silence, while it might seem awkward to you, lets the interviewer know that you are done.
Speak slowly and clearly. Speaking too fast, whether out of nervousness or habit, will hurt your chances by making you harder to understand. Instead, make a conscious effort to slow down and enunciate clearly.
• Stand, stretch, or pace occasionally. Standing improves the quality of your voice by increasing airflow to your lungs. Additionally, many people find it easier to adopt a salesperson-like attitude when they are standing or moving around. As a result, changing your posture occasionally can make you sound more confident to the interviewer.
• Smile. Believe it or not, a smile changes the quality of your voice. If you are smiling, the interviewer will hear it in your tone!
Finishing Your Phone Interview on the Right Foot
The phone interview is drawing to a close; what do you do now? These final moments are just as important as the preparation and the interview itself, as they can determine what comes next.
• Thank the interviewer. Verbally thank the interviewer for taking the time to speak with you. If you don’t remember his or her name, ask for it again and write it down, so that you can send a thank-you note as well.
• Suggest an in-person interview. The whole point of the phone interview was to score a traditional job interview, so if the interviewer doesn’t mention what will happen next, you should bring it up. For example, you can say, “Thank you very much for taking the time to call me. I’d like to have the opportunity to meet in person. When will you be scheduling the next round of interviews?”
• Reiterate your interest in the position. You want to leave the interviewer with the impression that you are enthusiastic about the job. Let him or her know how excited you are about the prospect of working with the company.
• Send a thank-you note. Just as with a traditional job interview, you should follow up with a polite thank-you note. You can also use the thank-you note to reiterate your interest in scheduling an in-person interview. Just be sure to send the thank-you note out promptly, as the interviewer may soon be making final decisions about who to call back!
Many people find a phone interview more nerve-wracking than a traditional job interview. This doesn’t have to be the case, however. While some phone interviews happen with little or no warning, in most cases you have just as much time to prepare as you would ordinarily, with the added benefit of being able to use your notes during the interview.
Thursday, October 28, 2010
CMA Award of Excellence in Education for Anovus
The region´s premier educational institute, Anovus Institute of Clinical Research, has been honoured with the "Award of Excellence in Education" for 2010.
At the management meet of Chandigarh Management Association (CMA) held at Hotel Mountview, chief guest and the keynote speaker on the occasion, renowned multifaceted personality and Member of Parliament, Mr. Navjot Singh Sidhu, handed over the award to Dr. Dharinder Tayal, founder director of Anovus.
Anovus received the recognition for its innovative programme in clinical research that fulfils the much needed gap that existed in the region which opens up newer employment opportunities for the life-sciences graduates.
Dr. Dharinder Tayal was elated on receiving the honour, and said that Anovus is gradually building an ecosystem in the clinical trials domain in the region by partnering with various stakeholders, including hospitals, research organizations, clinical research organizations, academicians and institutes engaged in life sciences, etc.
Anovus is the only institute north of Delhi which provides M.Sc. in Clinical Resarch, besides one-year and two-year diploma programmes.
Wednesday, October 13, 2010
New Treatment to cure Uterine Cancer
A new class of experimental cancer drugs could be a potential alternative to standard chemotherapy for women with advanced endometrial or uterine cancer.
Researchers from London's Institute of Cancer Research (ICR) found that drugs known as PARP inhibitors were able to kill off endometrial cancer cells in lab dishes and said their findings should now progress into tests on human patients.
Several large drugmakers, including Abbott, Merck, Pfizer, Sanofi-Aventis and AstraZeneca, are developing PARP inhibitors, which work by blocking DNA repair mechanisms in cancer cells, stalling the cell cycle and leading to cell death.
AstraZeneca's experimental PARP drug Olaparib and Sanofi's BSI-201 are the furthest ahead in development, and results of Sanofi's drug in breast cancer showed this week that it helped women with an aggressive form of the disease live an average of almost five months longer.
PARP is short for "poly (ADP-ribose) polymerase," which is used by cancer cells to repair DNA damage. By blocking the enzyme, the drug is designed to undermine the ability of cancer cells to heal themselves.
The deletion of a gene called PTEN is key to how PARP inhibitors work and around 80 percent of cases of a common type of cancer of the uterus have this gene mutation.
"PTEN is like a predictive marker for tumors that benefit from PARP inhibition and given that around 80 percent of these cancers have PTEN gene mutation ... it would be very interesting to test this finding in clinical trials."
According to the U.S. National Cancer Institute (NCI), uterine cancer, which usually occurs after menopause, is the most common type of gynecologic cancer in the United States. This year, it is estimated that more than 43,000 women will be diagnosed with it, and almost 8,000 will die of it.
Researchers from London's Institute of Cancer Research (ICR) found that drugs known as PARP inhibitors were able to kill off endometrial cancer cells in lab dishes and said their findings should now progress into tests on human patients.
Several large drugmakers, including Abbott, Merck, Pfizer, Sanofi-Aventis and AstraZeneca, are developing PARP inhibitors, which work by blocking DNA repair mechanisms in cancer cells, stalling the cell cycle and leading to cell death.
AstraZeneca's experimental PARP drug Olaparib and Sanofi's BSI-201 are the furthest ahead in development, and results of Sanofi's drug in breast cancer showed this week that it helped women with an aggressive form of the disease live an average of almost five months longer.
PARP is short for "poly (ADP-ribose) polymerase," which is used by cancer cells to repair DNA damage. By blocking the enzyme, the drug is designed to undermine the ability of cancer cells to heal themselves.
The deletion of a gene called PTEN is key to how PARP inhibitors work and around 80 percent of cases of a common type of cancer of the uterus have this gene mutation.
"PTEN is like a predictive marker for tumors that benefit from PARP inhibition and given that around 80 percent of these cancers have PTEN gene mutation ... it would be very interesting to test this finding in clinical trials."
According to the U.S. National Cancer Institute (NCI), uterine cancer, which usually occurs after menopause, is the most common type of gynecologic cancer in the United States. This year, it is estimated that more than 43,000 women will be diagnosed with it, and almost 8,000 will die of it.
Tuesday, September 14, 2010
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.
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.
"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.
Monday, August 30, 2010
A golden opportunity to earn a MSc Degree for 1 yr Post graduate Diploma Holders in Clinical Research
Advanced Diploma/ Diploma holders in Clinical Research from a recognized university can now get direct entry into 3rd sem of MSc.in Clinical Research through Lateral entry program at Anovus Institute of Clinical Research Chandigarh Affiliated to Punjab Technical University Jallandhar.
Anovus Institute of Clinical Research, located at Chandigarh, India, is a premier institute north of Delhi, providing modular courses in clinical research. Anovus offers two-year MSc. degree programme in Clinical Research, besides a one year Advanced Diploma and six months' Diploma programmes.
2010 - 2011 Batch starting soon. Book your seats Hurry !!!
For more info. visit www.anovus.net or contact 0172 2726730 , email at info@anovus.net
Anovus Institute of Clinical Research, located at Chandigarh, India, is a premier institute north of Delhi, providing modular courses in clinical research. Anovus offers two-year MSc. degree programme in Clinical Research, besides a one year Advanced Diploma and six months' Diploma programmes.
2010 - 2011 Batch starting soon. Book your seats Hurry !!!
For more info. visit www.anovus.net or contact 0172 2726730 , email at info@anovus.net
Thursday, July 22, 2010
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.
Tuesday, July 13, 2010
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."
Wednesday, June 30, 2010
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.
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."
Monday, June 28, 2010
US CRO Kendle sets up in Ahmedabad
US CRO Kendle has opened a new services centre in India, attracted by the country’s thriving contract research sector and favourable climate for clinical trials.
The 14,000 sqft centre, in the Ahmedabad-Gandhinagar special economic zone (SEZ), will provide clinical data management, pharmacovigilance and biostatistics services to sponsors running trials in the region.
Kendle has had a presence in India since 2004 with its unit in New Delhi and has been expanding to allow its clients increased access to the nation’s favourable research conditions.
COO Stephen Cutler said that: "Growth in India is a key component of our strategy and will be very important to the future" adding that an "expanded presence in Asia, and in India in particular, creates efficiencies in the clinical development process.”
In an interview in the Business Standard Cutler contrasted India with Asia’s other contract research hotbed China, explaining that “India's edge… lies in its favourable regulatory environment and research initiatives as well as investor-friendly duty structure.”
The new unit will begin operations with a staff of fifty although Kendle plans to scale up this up in the next few years, benefiting from the units “proximity to multiple universities” in and around Ahmedabad.
Aside from access to large population centres and proximity to a number of pharmaceutical manufacturers the Ahmedabad-Gandhinagar also provides Kendle with others benefits due to its status as an SEZ.
Operating in an SEZ gives contract research organisations (CROs) like Kendle, and GVK Biosciences who set up there in March , staged tax benefits, including a five year 100 per cent exemption on export income.
The 14,000 sqft centre, in the Ahmedabad-Gandhinagar special economic zone (SEZ), will provide clinical data management, pharmacovigilance and biostatistics services to sponsors running trials in the region.
Kendle has had a presence in India since 2004 with its unit in New Delhi and has been expanding to allow its clients increased access to the nation’s favourable research conditions.
COO Stephen Cutler said that: "Growth in India is a key component of our strategy and will be very important to the future" adding that an "expanded presence in Asia, and in India in particular, creates efficiencies in the clinical development process.”
In an interview in the Business Standard Cutler contrasted India with Asia’s other contract research hotbed China, explaining that “India's edge… lies in its favourable regulatory environment and research initiatives as well as investor-friendly duty structure.”
The new unit will begin operations with a staff of fifty although Kendle plans to scale up this up in the next few years, benefiting from the units “proximity to multiple universities” in and around Ahmedabad.
Aside from access to large population centres and proximity to a number of pharmaceutical manufacturers the Ahmedabad-Gandhinagar also provides Kendle with others benefits due to its status as an SEZ.
Operating in an SEZ gives contract research organisations (CROs) like Kendle, and GVK Biosciences who set up there in March , staged tax benefits, including a five year 100 per cent exemption on export income.
New norms for clinical research organizations soon in India.
The government will soon make it mandatory for all firms involved in clinical research to maintain minimum quality standards and register themselves with the country’s drug regulator.
Once the law is implemented, the names of all the approved Clinical Research Organisations (CROs) in the country will be uploaded on the website of Drug Controller General of India (DCGI). A violation of the norms could lead to the firm being barred from conducting clinical studies in India.
Several inspectors at the DCGI have been trained by the US Foods and Drug Administration to audit CROs. The country’s highest technical body on medicines, Drug Technical Advisory Board, has approved an amendment to the Drugs and Cosmetics Act to make CRO registrations compulsory.
Industry experts believe that this will regulate the entire clinical protocols, ethical norms and other practices. At present, there are 40-50 CROs in the country, a number that is increasing steadily. All these provide research services to drug companies in developing medicines, especially the clinical trials.
Once the law is implemented, the names of all the approved Clinical Research Organisations (CROs) in the country will be uploaded on the website of Drug Controller General of India (DCGI). A violation of the norms could lead to the firm being barred from conducting clinical studies in India.
Several inspectors at the DCGI have been trained by the US Foods and Drug Administration to audit CROs. The country’s highest technical body on medicines, Drug Technical Advisory Board, has approved an amendment to the Drugs and Cosmetics Act to make CRO registrations compulsory.
Industry experts believe that this will regulate the entire clinical protocols, ethical norms and other practices. At present, there are 40-50 CROs in the country, a number that is increasing steadily. All these provide research services to drug companies in developing medicines, especially the clinical trials.
Friday, June 25, 2010
Admissions for the Next Batch
Admissions for the next batch of clinical research (2010-11) are now open. The application form can be downloaded from our website
Labels:
Anovus,
clinical reseasrch admission,
CR
Tuesday, April 6, 2010
Clinical Research: Issues and Opportunities
Clinical research is an indispensable part of the drug discovery process to ensure the safety and efficacy of any new drug. In today’s global scientific era, clinical trials are the mainstay for bringing newer and better drugs to market. Although a set of robust guidelines is available to govern the conduct of clinical trials in any country, the conduct of clinical research is also looked upon as an area of humanitarian concern. Various articles published recently in the professional and popular press enumerate the opportunities and challenges of conducting global clinical trials
in India.However, the majority have been from the perspective of authors who have never conducted clinical trials in India themselves.
A nation with more than 1 billion people, India has the second largest population in the world.Having gained its independence from British rule in 1947, its prime minister is the head of government and its president is the head of state. Internationally, India became a member of the World Trade Organization (WTO) in 1995 and agreed to adhere to the product patent regime by 2005. As a result, the global pharmaceutical industry has the rights to patent products as well as processes throughout the world, including India. This has led to a significant
growth of the pharmaceutical industry, both domestically in India and globally, including increased stakes of multinational companies in Indian operations. As a signatory to the WTO agreements, India is looked upon as a favorable destination for conducting global clinical trials. India clearly provides an opportunity in terms of availability of large patient populations, highly educated talent, a wide spectrum of disease, lower costs of operations, and a favorable economic and intellectual property environment. The overall time and cost advantage in bringing a drug to market by leveraging India’s resources could be as high as US $200 million, hence the steadily
increasing number of global studies in India over the past two years. Major pharmaceutical companies estimate the total market for conducting clinical trials either directly or through contract research organizations (CROs) in India through 2010 at US $2 billion. CROs themselves are fast gaining importance because of their global presence, specialized local expertise, and competitive pricing strategies. And a significant number of new CROs have set up operations
in India over the past two years. However, some key barriers stand in the way of opportunities, including patients’ rights and safety, regulatory framework, infrastructure, organization of ethics committees, data quality, lack of training curricula focusing on clinical research, and other factors.Most of these barriers are common to all developing countries and need to be addressed in a similar way.
Because the clinical investigator plays a major role in the ethical conduct of any clinical trial, its successful outcome depends on how the investigator(s) has assumed overall responsibility. Most of the barriers mentioned above can be easily addressed if a clinical investigator is
committed to the ethical conduct of trials.
A segment of ideologues in India believe that clinical trials conduct poses a serious threat to society because of issues related to patient rights and safety, regulatory compliance, unethical trials, infrastructure and training issues, and exorbitant drug pricing. These threats are perceptions, not reality.
A well-designed and executed study has built-in provisions to ensure patient rights and safety.In fact, a patient may be far safer in a clinical trial than in routine medical care because careful
observations are made on safety (toxicity) and efficacy.
Although it typically takes 10 to 12 years and millions of dollars to bring one new drug to market, the success rate is small
In the developing world, no company or institute wants to, or can, invest such time and resources for a marginal improvement in responses over existing therapies. Fortunately, in a majority of cases, clinical trials can provide answers regarding the use or not of a therapeutic
agent that can benefit millions of patients worldwide. Being the second most populated country in the world, India can contribute significantly to global drug development programs.
The foundation of knowledge-based industries in India was laid down by the information technology industry, and there is no reason why clinical research cannot follow in those footsteps. Indian investigators and clinical research professionals have already demonstrated their
medical and scientific skills by participating in multiple global clinical trials. It
is time now to move forward to capitalize on the opportunity.
Labels:
Anovus,
Clinical Research,
drug discovery
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