In a partial victory for Ranbaxy Laboratories in its patent litigation against Pfizer ,an Australian court has ruled in the Indian company's favour in a case relating to cholesterol lowering drug atorvastatin(Lipitor).The court at the same also ruled that a proposed Ranbaxy generic product under a different patent infringed Pfizer's basic Lipitor patent (number 601981)
Ranbaxy's senior vice president (global intellectual property) Jay Deshmukh said "We are pleased with this decision as it advances the entry of ranbaxy's generic atorvastatin in Australia to May 18,2012"
Thursday, May 29, 2008
Wednesday, May 28, 2008
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Tuesday, May 27, 2008
New RAPS White Paper Details Career Development Of Regulatory Affairs professionals
SOURCE: Regulatory Affairs Professional Society
RAPS has released a new white paper, Regulatory Affairs Professional Development Framework: An Overview, which describes the knowledge, skills and abilities of regulatory professionals. This is the first report of its kind to be published. Download the white paper: http://www.raps.org/pdFramework/WhitePaper
Regulatory affairs is a dynamic and challenging profession that is vital to making safe and effective healthcare products available worldwide. Regulatory Affairs encompasses a variety of disciplines and job responsibilities, which may begin during the product development and continue into when a product is widely available for use.
Individuals who ensure regulatory compliance and prepare submissions as well as those whose main job function is clinical affairs or quality assurance are all considered Regulatory Affairs professionals.
Regulatory Affairs professionals are employed in industry, government and academia and are involved with a wide range of products, including: pharmaceuticals,medical devices,in vitro diagnostics,biologics and biotechnology,nutritional products,cosmetics and veterinary products. The professionals' roles and responsibilities often begin in the research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labeling and advertising and post-market surveillance.
Core Competencies
Regulatory Affairs professionals come from diverse backgrounds. Most Regulatory Affairs professionals have earned a bachelor's degree, and over half have an advanced degree, most often in a scientific or technical field. Regulatory Affairs professionals usually have experience in other careers before transitioning into regulatory affairs. Often, they have worked in the fields of medicine, nursing, pharmacy, engineering, clinical laboratory science, research or healthcare manufacturing.
Although some university degrees and graduate certificates are being developed, experience is a key asset for Regulatory Affairs professionals. Other valuable skills include project management/organizational skills, negotiation and communication skills and the ability to learn from the experience of others, both inside and outside the organization.
Continuing education and professional development are critical to the Regulatory affairs professional. Regulatory Affairs professionals must keep up-to-date with regulatory policies and procedures for one or more countries as well as maintain an understanding of the scientific and technical background of products. Many Regulatory Affairs professionals seek opportunities to expand their business-related skills, including project management, communication and financial management.
Individuals who ensure regulatory compliance and prepare submissions as well as those whose main job function is clinical affairs or quality assurance are all considered Regulatory Affairs professionals.
Regulatory Affairs professionals are employed in industry, government and academia and are involved with a wide range of products, including: pharmaceuticals,medical devices,in vitro diagnostics,biologics and biotechnology,nutritional products,cosmetics and veterinary products. The professionals' roles and responsibilities often begin in the research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labeling and advertising and post-market surveillance.
Core Competencies
Regulatory Affairs professionals come from diverse backgrounds. Most Regulatory Affairs professionals have earned a bachelor's degree, and over half have an advanced degree, most often in a scientific or technical field. Regulatory Affairs professionals usually have experience in other careers before transitioning into regulatory affairs. Often, they have worked in the fields of medicine, nursing, pharmacy, engineering, clinical laboratory science, research or healthcare manufacturing.
Although some university degrees and graduate certificates are being developed, experience is a key asset for Regulatory Affairs professionals. Other valuable skills include project management/organizational skills, negotiation and communication skills and the ability to learn from the experience of others, both inside and outside the organization.
Continuing education and professional development are critical to the Regulatory affairs professional. Regulatory Affairs professionals must keep up-to-date with regulatory policies and procedures for one or more countries as well as maintain an understanding of the scientific and technical background of products. Many Regulatory Affairs professionals seek opportunities to expand their business-related skills, including project management, communication and financial management.
Thursday, May 22, 2008
Careers In Regulatory Affairs: From Practitioner To Professional
Larry E. Gundersen
Source: CenterWatch
Avoiding the pitfalls of the regulatory affairs practitioner will distinguish you in this growing field.
Findings from a recent survey on employment trends in the clinical trials industry from CenterWatch show that the position in highest demand and with the fastest growth rate is that of regulatory affairs professional. The reasons cited most, in order of popularity: lack of candidates, increased business, and turnover1. Realizing this, those interested in entering or advancing in the field should seek out the proper training2 in order to capitalize on the demand for qualified regulatory affairs professionals.There are two major groups of individuals in regulatory affairs: simple practitioners and truly professional individuals. This article discusses some of the types of regulatory affairs practitioners I have observed in my career, and provides some suggestions about how a regulatory affairs practitioner can become a regulatory affairs professional. This is very much a personal view, and I would hope that this article might prompt additional positive suggestions from others on how each of us might become more professional and effective in our jobs.
Wednesday, May 21, 2008
Changing Face Of Drug Regulation
S Lakshmanan
Source : Pharmabiz.com
The face of Indian regulatory affairs is changing. The government of India is taking enormous steps to showcase India as the destination for multinational companies to conduct their global clinical trials in India. Pharma companies and CROs are keen looking on India since the development cost of a new drug is comparatively one -fifth of other developed countries.The vibrant nature of Indian regulatory affairs is gaining rapidly the attention of world countries since India is turning to be the credible destination. As Indian regulatory affairs increase in complexity and scope, and globalization occurs within the field, there will be constant watch from the developed countries
Tuesday, May 20, 2008
Careers in Regulatory Affairs: A Sure Bet!
Regulatory affairs is one of the hottest and fasting growing career tracks in the pharmaceutical, biotechnology and medical devices industries. Not surprisingly, due to expansive growth of the biotech and medical devices industries, there are ongoing shortages of regulatory affairs professionals, most notably in the area of regulatory writing
For those of you graduate students and post-doctoral fellows who enjoy writing, are not bored by clinical research and like to work on computers most of the day, a career in regulatory affairs may be right for you!
Friday, May 16, 2008
MSD PHARMACEUTICALS LAUNCHES NEW ANTI DIABETES DRUG
On 26 April,MSD Pharmaceuticals ,the Indian arm of Merck&Co., the world's #5 drug maker launched its patented anti-diabetes (type 2) drug,Januvia,in India.Already a best-seller in the US ,the drug uses a new class of molecules that enhances the body's own ability to lower blood sugar when it is elevated.
Naveen A . Rao ,the MD of MSD , said that the next on his radar are drugs for other major ailments in the country like dylipidemia( high cholesterol) and cervical cancer ,which is more prevalent than breast cancer among Indian women
source:-Business Today,May 18, 2008
Naveen A . Rao ,the MD of MSD , said that the next on his radar are drugs for other major ailments in the country like dylipidemia( high cholesterol) and cervical cancer ,which is more prevalent than breast cancer among Indian women
source:-Business Today,May 18, 2008
India's Drug Regulator Can't Be In Isolation
INDIA'S drug regulatory landscape has changed a lot in the last four-five years,thanks to a clutch of legislative changes and new rules and regulations - new good manufacturing practices through amendments to the Schedule M of Drugs & Cosmetics Act, registration norms for imported drugs, amendments to the ScheduleY that lays down the protocols of regulatory assessments and approvals for manufacturing/import of 'new drugs' and clinical trials, and new norms for medical devices,to name a few.But the regulatory machinery and systems have yet to be in sync with these new laws for their meticulous enforcement and effective delivery of regulatory services.
Thursday, May 15, 2008
CLINICAL RESEARCH
Source: Ehealth
The clinical research industry continues to expand, creating new and lucrative vistas of employment. The Average nominal salary growth across all the positions is 4% as against less than 1% for other segments. India’s pharmaceutical market, the second largest in Asia, is growing by over 9% per annum. McKinsey estimates that the outsourced pharmaceutical clinical trial industry will touch INR 5,000 by 2010, requiring 50,000 professionals. As the amount of clinical research expands, a large numbers of researchers, trainers and business development management will be required. Industry analysts expect total clinical research spending in India to increase by more than 30% annually through 2010. Over 250,000 positions remain vacant worldwide and salaries start at Rs. 2.4 lacs p.a. and go to over Rs. 15 lacs p.a. for professional with less than 5 years experience.
The clinical research industry continues to expand, creating new and lucrative vistas of employment. The Average nominal salary growth across all the positions is 4% as against less than 1% for other segments. India’s pharmaceutical market, the second largest in Asia, is growing by over 9% per annum. McKinsey estimates that the outsourced pharmaceutical clinical trial industry will touch INR 5,000 by 2010, requiring 50,000 professionals. As the amount of clinical research expands, a large numbers of researchers, trainers and business development management will be required. Industry analysts expect total clinical research spending in India to increase by more than 30% annually through 2010. Over 250,000 positions remain vacant worldwide and salaries start at Rs. 2.4 lacs p.a. and go to over Rs. 15 lacs p.a. for professional with less than 5 years experience.
RANBAXY INKS DRUG DEALS WITH MERCK
Source: Times of India: 13th May; 2008(Tuesday)
New Delhi: Ranbaxy has signed a collaboration agreement with US-based Merck for drug discovery and clinical development in anti-infective drugs.
Ranbaxy and Merck will work together to develop clinically validated anti-bacterial and anti-fungal drug candidates , Ranbaxy will carry out drug discovery and clinical development through Phase IIa clinical trials, with Merck conducting development and commercialization of drug candidates after that.
Ranbaxy CEO and MD, Malvinder M Singh told TOI: The agreement has already been signed and returns will start flowing to the company from this (second) quarter it-self”. He, however, didn’t provide details of revenues expected from the deal this year.
Ranbaxy will be paid an undisclosed sum, with potential to receive payments over $100 million (per drug) associated with achievement of various R& D regulatory approval for each target included in the collaboration. Ranbaxy will also receive significant royalties on worldwide net sales of any product commercialized under the agreement. TOI had first reported the Ranbaxy- Merck deal in May 10 edition.
The collaboration will begin with an initial term of five years and can be extended further with mutual agreements.
New Delhi: Ranbaxy has signed a collaboration agreement with US-based Merck for drug discovery and clinical development in anti-infective drugs.
Ranbaxy and Merck will work together to develop clinically validated anti-bacterial and anti-fungal drug candidates , Ranbaxy will carry out drug discovery and clinical development through Phase IIa clinical trials, with Merck conducting development and commercialization of drug candidates after that.
Ranbaxy CEO and MD, Malvinder M Singh told TOI: The agreement has already been signed and returns will start flowing to the company from this (second) quarter it-self”. He, however, didn’t provide details of revenues expected from the deal this year.
Ranbaxy will be paid an undisclosed sum, with potential to receive payments over $100 million (per drug) associated with achievement of various R& D regulatory approval for each target included in the collaboration. Ranbaxy will also receive significant royalties on worldwide net sales of any product commercialized under the agreement. TOI had first reported the Ranbaxy- Merck deal in May 10 edition.
The collaboration will begin with an initial term of five years and can be extended further with mutual agreements.
PHARMA GAINS FROM DIABETES
Source: Times of India 6th May’08, (Tuesday)
Mumbai: Diabetes, Cardiac and gastrointestinal hold sway in India, where chronic therapies comprise more than 40% of the entire market. Like developed markets, India is gradually shifting to lifestyle disorders. And drug companies are profiting form diabetes and cardiovascular cases.
The over searching trend of lifestyle diseases is dictating the fortunes of various therapeutic categories. Prescriptions for diabetes have grown over 15% compounded since 2000 in urban India. With India poised to have the largest number diabetics in future, the antidiabetic therapeutic area has had the highest growth rate of 26.1%, followed by cardiology at 21.3% and gynaecology at 18.3%, according to ORG-IMS data. The antidiabetic segment has grown from 19.5 %( MAT December 2006) to 26.1%
(MAT December 2007). The gynaecology segment too recorded growth from 15.9% to 18.3% m during the same period.
Not only are drug majors benefiting from the growing cases of diabetes and gastrointestinal illness, several therapeutic segments have witnessed a high number of new product launches in recent years.” It is not just new drugs coming into the market .MNCs like Novo Nordisk and Elli Lilly have launched insulin pens which are patient compliant,” said Ranjit Kapadia of Prabhudas Lilladher, a financial services firm.
Mumbai: Diabetes, Cardiac and gastrointestinal hold sway in India, where chronic therapies comprise more than 40% of the entire market. Like developed markets, India is gradually shifting to lifestyle disorders. And drug companies are profiting form diabetes and cardiovascular cases.
The over searching trend of lifestyle diseases is dictating the fortunes of various therapeutic categories. Prescriptions for diabetes have grown over 15% compounded since 2000 in urban India. With India poised to have the largest number diabetics in future, the antidiabetic therapeutic area has had the highest growth rate of 26.1%, followed by cardiology at 21.3% and gynaecology at 18.3%, according to ORG-IMS data. The antidiabetic segment has grown from 19.5 %( MAT December 2006) to 26.1%
(MAT December 2007). The gynaecology segment too recorded growth from 15.9% to 18.3% m during the same period.
Not only are drug majors benefiting from the growing cases of diabetes and gastrointestinal illness, several therapeutic segments have witnessed a high number of new product launches in recent years.” It is not just new drugs coming into the market .MNCs like Novo Nordisk and Elli Lilly have launched insulin pens which are patient compliant,” said Ranjit Kapadia of Prabhudas Lilladher, a financial services firm.
PHARMA GAINS FROM DIABETES
Source: Times of India 6th May’08, (Tuesday)
Mumbai: Diabetes, Cardiac and gastrointestinal hold sway in India, where chronic therapies comprise more than 40% of the entire market. Like developed markets, India is gradually shifting to lifestyle disorders. And drug companies are profiting form diabetes and cardiovascular cases.
The over searching trend of lifestyle diseases is dictating the fortunes of various therapeutic categories. Prescriptions for diabetes have grown over 15% compounded since 2000 in urban India. With India poised to have the largest number diabetics in future, the antidiabetic therapeutic area has had the highest growth rate of 26.1%, followed by cardiology at 21.3% and gynaecology at 18.3%, according to ORG-IMS data. The antidiabetic segment has grown from 19.5 %( MAT December 2006) to 26.1%
(MAT December 2007). The gynaecology segment too recorded growth from 15.9% to 18.3% m during the same period.
Not only are drug majors benefiting from the growing cases of diabetes and gastrointestinal illness, several therapeutic segments have witnessed a high number of new product launches in recent years.” It is not just new drugs coming into the market .MNCs like Novo Nordisk and Elli Lilly have launched insulin pens which are patient compliant,” said Ranjit Kapadia of Prabhudas Lilladher, a financial services firm.
Mumbai: Diabetes, Cardiac and gastrointestinal hold sway in India, where chronic therapies comprise more than 40% of the entire market. Like developed markets, India is gradually shifting to lifestyle disorders. And drug companies are profiting form diabetes and cardiovascular cases.
The over searching trend of lifestyle diseases is dictating the fortunes of various therapeutic categories. Prescriptions for diabetes have grown over 15% compounded since 2000 in urban India. With India poised to have the largest number diabetics in future, the antidiabetic therapeutic area has had the highest growth rate of 26.1%, followed by cardiology at 21.3% and gynaecology at 18.3%, according to ORG-IMS data. The antidiabetic segment has grown from 19.5 %( MAT December 2006) to 26.1%
(MAT December 2007). The gynaecology segment too recorded growth from 15.9% to 18.3% m during the same period.
Not only are drug majors benefiting from the growing cases of diabetes and gastrointestinal illness, several therapeutic segments have witnessed a high number of new product launches in recent years.” It is not just new drugs coming into the market .MNCs like Novo Nordisk and Elli Lilly have launched insulin pens which are patient compliant,” said Ranjit Kapadia of Prabhudas Lilladher, a financial services firm.
Saturday, May 10, 2008
US puts India on watch list for IPR violations(T.O.I,30-4-08)
The US govt. has put India on its 'Priority Watch List ',along with nine other countries ,saying that the country's failure to protect Intellectual Property Rights is putting health, safety and jobs of its citizens at risk.
According to US trade representative Susan Schawb "Pirates not only steal ideas they steal jobs and too often they threaten our health and safety"
According to US trade representative Susan Schawb "Pirates not only steal ideas they steal jobs and too often they threaten our health and safety"
Ranbaxy gets patent boost in Lipitor battle(T.O.I.,29-4-08)
India's Ranbaxy Laboratories has received a boost in its patent litigation with Pfizer over cholesterol lowering drug Lipitor, with the US Patent and Trademarks Office rejecting the world's biggest pharma firm's request for reissue of patent. Lipitor is the world's largest selling drug and the two companies are engaged in patent infringement battles in various geographies, including U.K. and other countries in Europe.Originally the Lipitor patent is scheduled to expire in June 2011
Friday, May 9, 2008
Bioinformatics Institute of India participated in Bangalore Bio 2008
Bangalore Bio is the flagship event on Biotechnology held annually in Bangalore, India. Over the past 4 years, it has emerged as the India's Biggest Biotech Show. Dr. Kumud Sarin, Program Director of Bioinformatics Institute of India had participated in this huge event held at Bangalore International Exhibition Centre, Bangalore from 24-26th April, 2008.
Objectives of Participation
Creating awareness about potential of Bioinformatics among students and professionals
Creating awareness about BII courses to visitors, Institutional visitors from India and overseas
Interaction with existing BII Correspondence program students.To discuss the business opportunities and tie-ups with Corporates.
The event comprises of International Conference, Trade Show (Biotech Expo), RICH (Research Industry Collaboration Hub) to bridge the innovations to investors, Networking Dinners & B2B Forum to facilitate business meetings and many other avenues for forging alliances and form collaborations for the stakeholders of Biotechnology.
She interacted with eminent professionals and CEOs and took active part in technical discussions.
Our Program Director also visited Bio Exhibition and had the opportunity to interact with biotech
Industry people.
Wednesday, May 7, 2008
GENE THERAPY RESTORES VISION
Source: Hindustan times
29th April, 2008
Persons with congenital retinal disease get partial sight with experimental method in the US
An experimental gene therapy has helped restore partial vision to persons with congenial retinal disease, according to studies published Sunday in a breakthrough which provides hope for treating various eye illnesses.
In one study, clinical trials showed success on 3 young adults at children’s hospital of the Philadelphia who suffered from a rare and as yet incurable form of congenital blindness.
The retinal degenerations include leber congenital amaurosis, or LCA, a group of diseases that affect light receptors in the retina beginning in early childhood and often causing total blindness in patients in their twenties or thirties.
“This result is important for the enter field of gene therapy”. study leader Katherine High was quoted as saying in a new England Journal of Medicine whose website reported the findings by a collection of international doctors and scientists.
“Gene transfer has been in Clinical Trials for over 15 years now, and although it has an excellent safety record, example of therapeutic effect are still relatively few” High said.
“The results in this study provide objective evidence of improvement in the ability to perceive light, and thus lay the ground work for future studies in this and other retinal disorders.”
Scientists used a genetically engineered virus known as vector to carry a normal version of the gene known as RPE65, which is mutated in the form of LCA, to the patients via surgical procedures performed between October 2007 and January 2008.
About 2 weeks after the surgery all three patients, age 19,26 and 26,reprted improved visions in the injected eye, and became approximately 3 times more sensitive to light than in the other eye, according to study co-author Albert Auricchio from the second University of Naples, in Italy.
“Standard vision tests showed significantly improved vision in the patients” Auricchio said.
There vision “improved from detecting hand movement to reading lines on an eye chart”
Said Albert Maguire, Associate Professor of Opthalmology at the University Of Pennsylvania School Of Medicine.
In 2001 Maguire and his wife Jean Bennett were part of a team which reported successfully using gene therapy to reverse blindness in Dogs affected by the same Congenital blindness.
A separate clinical Trial parallel to the Philadelphia study was conducted at Britain’s University College London, also on three young adults, with one 18-year-old patient showing improved visual function.
Researchers of that study concluded that there were no major adverse effects of the so called Adeno-Associated Virus (AAV) treatment.
“of course, additional studies are needed in order to access the approach fully, including the expansion of the study to include younger children but these initial results suggest that AAV based delivery of Genes in the eye can be accomplished,” said research co-author Barrie Carter, executive vice president of Targeted Genetics.
29th April, 2008
Persons with congenital retinal disease get partial sight with experimental method in the US
An experimental gene therapy has helped restore partial vision to persons with congenial retinal disease, according to studies published Sunday in a breakthrough which provides hope for treating various eye illnesses.
In one study, clinical trials showed success on 3 young adults at children’s hospital of the Philadelphia who suffered from a rare and as yet incurable form of congenital blindness.
The retinal degenerations include leber congenital amaurosis, or LCA, a group of diseases that affect light receptors in the retina beginning in early childhood and often causing total blindness in patients in their twenties or thirties.
“This result is important for the enter field of gene therapy”. study leader Katherine High was quoted as saying in a new England Journal of Medicine whose website reported the findings by a collection of international doctors and scientists.
“Gene transfer has been in Clinical Trials for over 15 years now, and although it has an excellent safety record, example of therapeutic effect are still relatively few” High said.
“The results in this study provide objective evidence of improvement in the ability to perceive light, and thus lay the ground work for future studies in this and other retinal disorders.”
Scientists used a genetically engineered virus known as vector to carry a normal version of the gene known as RPE65, which is mutated in the form of LCA, to the patients via surgical procedures performed between October 2007 and January 2008.
About 2 weeks after the surgery all three patients, age 19,26 and 26,reprted improved visions in the injected eye, and became approximately 3 times more sensitive to light than in the other eye, according to study co-author Albert Auricchio from the second University of Naples, in Italy.
“Standard vision tests showed significantly improved vision in the patients” Auricchio said.
There vision “improved from detecting hand movement to reading lines on an eye chart”
Said Albert Maguire, Associate Professor of Opthalmology at the University Of Pennsylvania School Of Medicine.
In 2001 Maguire and his wife Jean Bennett were part of a team which reported successfully using gene therapy to reverse blindness in Dogs affected by the same Congenital blindness.
A separate clinical Trial parallel to the Philadelphia study was conducted at Britain’s University College London, also on three young adults, with one 18-year-old patient showing improved visual function.
Researchers of that study concluded that there were no major adverse effects of the so called Adeno-Associated Virus (AAV) treatment.
“of course, additional studies are needed in order to access the approach fully, including the expansion of the study to include younger children but these initial results suggest that AAV based delivery of Genes in the eye can be accomplished,” said research co-author Barrie Carter, executive vice president of Targeted Genetics.
Friday, May 2, 2008
BII successfully conducted exams all over India
Bioinformatics Institute of India (BII) successfully conducted exams for the various programs offered by the institution on 26th & 27th April, 2008 all over the India.
The examination was conducted on 15 centers across the India for the various industry programs offered by the institute. Thousands of students across the India appeared in the examination on 26th & 27th April 2008 at the following centers all over the India:
Noida, Pune, Bangalore, Hyderabad, Chennai, Calcutta, Ahmedabad, Mumbai, Chandigarh, Kottayam, Patna, Lucknow etc.
Bioinformatics Institute of India is a premier and reputed Bioinformatics institution for the promotion, growth and prosperity of bioinformatics, Biotechnology, Pharma, Clinical Trial & allied sciences. The aim and vision of the institute is to provide a platform for individuals, professionals, R&D Organizations, Pharmaceutical & Software companies to utilize and harness the Indian bioinformatics potential.
The institute aims not only educational and research initiative in this direction but also vouch for creating a talent pool of professionals from various fields who can contribute for the growth and prosperity of Bioinformatics/ Cheminformatics / Biomedical informatics as a career .
The Admission for new Batches in BII is now open and one can have detailed information about all the programs by visiting BII’s website www.bii.in.
For any further assistance / query please contact:
Bioinformatics Institute of India
C-56A/28, Sector – 62
Noida – 201301, U.P
India
Tel: 0120-4320801-02
Mobile:09818473366,09810535368 E-mail: info@bii.in, support@bioinformaticscentre.org
The examination was conducted on 15 centers across the India for the various industry programs offered by the institute. Thousands of students across the India appeared in the examination on 26th & 27th April 2008 at the following centers all over the India:
Noida, Pune, Bangalore, Hyderabad, Chennai, Calcutta, Ahmedabad, Mumbai, Chandigarh, Kottayam, Patna, Lucknow etc.
Bioinformatics Institute of India is a premier and reputed Bioinformatics institution for the promotion, growth and prosperity of bioinformatics, Biotechnology, Pharma, Clinical Trial & allied sciences. The aim and vision of the institute is to provide a platform for individuals, professionals, R&D Organizations, Pharmaceutical & Software companies to utilize and harness the Indian bioinformatics potential.
The institute aims not only educational and research initiative in this direction but also vouch for creating a talent pool of professionals from various fields who can contribute for the growth and prosperity of Bioinformatics/ Cheminformatics / Biomedical informatics as a career .
The Admission for new Batches in BII is now open and one can have detailed information about all the programs by visiting BII’s website www.bii.in.
For any further assistance / query please contact:
Bioinformatics Institute of India
C-56A/28, Sector – 62
Noida – 201301, U.P
India
Tel: 0120-4320801-02
Mobile:09818473366,09810535368 E-mail: info@bii.in, support@bioinformaticscentre.org
Thursday, May 1, 2008
Jubilant Organosys Acquires Clinical Research Organization (CRO) in USA
Jubilant Organosys Ltd. (Jubilant),an integrated pharmaceuticals company, has acquired Target ResearchAssociates, Inc. (Target), a US-based, full service Clinical ResearchOrganization (CRO). This is the first ever acquisition of a U.S. CRO by anIndian company, and it represents a major initiative supporting Jubilant'splan to expand its CRO services globally. This acquisition makes Jubilant thelargest Indian CRO having operations in India and USA. Jubilant providesproducts and services to the global life sciences industry and has reportedrevenues of US$ 270 million in its fiscal year ended 31st March 2005. Jubilant has acquired a 100% equity stake in Target for a payment of US$33.5 million in cash. The purchase price assumes zero closing working capitalon the date of acquisition and is subject to adjustment in case of any changein working capital. Target is a debt free company with a healthy EBITDAmargin, and it has been consistently profitable with a solid operating base inthe CRO industry. The acquisition is earnings accretive to Jubilant. Itprovides an established and robust business platform for the rapid growth anddevelopment of Jubilant's clinical research business. Jubilant has an Indian subsidiary, Jubilant Clinsys Ltd., which conductsbioavailability studies through its world-class, 54-bed facility andbioanalytical laboratory. The company also has the skills to provide clinicalPhase I-IV services. Target is now able to offer its U.S. based clients all of the benefits ofproviding clinical research services out of India, including high quality,cost competitive data management services and access to a large patientpopulation of diversified ethnicity. This will enable faster patientenrollment, thus reducing the time taken to complete clinical studies. Thiswill also allow clients to accelerate the process of obtaining marketingauthorization for their new drugs, resulting in faster realization of revenuesfrom their investments. Target, founded in 1992 and headquartered in Berkeley Heights, New Jersey,conducts clinical trials in Phases I to IV. Target is the preferred servicesprovider for clinical research for some of the leading global pharmaceuticalplayers. It offers services in study protocol development, investigatorrecruitment, project management, monitoring, data management, biostatisticalanalyses, medical writing, regulatory affairs, quality assurance, and drugsafety for the pharmaceutical and biotech industry. Target has particularlystrong experience in the oncology, pulmonary, allergy, dermatology,cardiovascular, gastrointestinal, transplant, and anti-infective therapeuticareas. Commenting on the proposed acquisition, Shyam S Bhartia, Chairman &Managing Director and Hari S Bhartia, Co-Chairman & Managing Director ofJubilant said: "Target fits very well with Jubilant's strategy to expand its strongrelationships with many of the leading pharmaceutical companies in the world.We are one of the largest players in India providing discovery services topharmaceutical companies in their drug development efforts. Clinical researchis an important part of drug development, and it is natural for us to have asignificant presence in this segment as well. The acquisition of Targetfurther enables Jubilant to increase its presence in the U.S. market, whichhas the highest concentration of pharmaceutical and biotech companies. This acquisition offers a great opportunity to Jubilant to strengthen itsposition as a preferred outsourcing partner to pharma companies to reducetheir drug development costs and time to market. Further, integration ofJubilant Clinsys, our Indian CRO, with Target will enhance business potentialin the area of data management and clinical research services." According to Lloyd Baroody, Chief Executive Officer and Co-Founder ofTarget: "India, with its large cadre of highly educated professionals in thehealthcare and medical fields and competitive cost environment, has become avery attractive country for conducting clinical research. Its large, untappedpatient population will allow us to accelerate our clients' clinical studiesand deliver quality and cost-effective services to our clients at a time whenthey are seeking much greater value from their service providers. We are very excited about our future prospects with Jubilant as our parentcompany. They have a world-class management team, and their goals ofcontinuously strengthening their operations as a global CRO are in perfectalignment with those of Target. Jubilant's large local presence in India willgive us a definite competitive edge. Target will maintain its global face inthe U.S. while operating as part of a strong integrated pharmaceuticalindustry player out of India. I believe that this acquisition of a U.S. CROby an Indian company is a milestone event in the CRO industry." About Jubilant Organosys Ltd. Jubilant Organosys Limited is an integrated pharmaceutical companyproviding products and services to the global life sciences industry.Jubilant has a presence across the value chain from drug discovery services tofinished dosage forms and including Custom Research and Manufacturing Services(CRAMS), Active Pharmaceutical Ingredients (APIs), and Contract ResearchServices.
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