Need For Exclusive Focus On Cancer Drug Development, Oncology Services India CEO Dr. Vimal Sanghavi Says
The advances in cancer care over the last decade have been achieved as a result of research through successful clinical trials, which has led to many new treatment options for cancer care. To conduct clinical trials in Oncology is one of the most challenging tasks for research organizations.. In recent years, investment in development of oncology therapeutics has grown exponentially. In oncology drug development, “time-to-market” for a particular drug and ready availability of resources are of paramount importance. The changing global trends have now translated into a high degree of co-operation and partnership between ‘innovator’ regions like United States, Western Europe and emerging ‘outsourcing’ destinations for clinical trials in the developing world, particularly India, with its vast patient pool, well trained professionals and a good track record of conduct of clinical trials.
The global clinical research outsourcing market is projected to touch US$ 23 billion by 2011, with consultancy firm KPMG estimating that India will corner 15 per cent of this in two years. While the industry attributes this to the growing interest of pharmaceutical majors in emerging markets like India, some medical experts see faster recruitment as the main attraction
As better knowledge is acquired on various subtypes of cancer, more complications are coming to light, which require new and innovative therapy approaches. This has made it essential to treat the field of Oncology as a specialized, exclusive realm being catered to by specialized, skilled manpower. These requirements have mandated the need for niche oncology clinical services provider with a dedicated focus on oncology drug development and relevant experience in the field.
India is fast emerging has a hot favorite outsourcing destination for drug development companies due to its sizable patient population, which translates into a faster recruitment process. In addition to the vast pool of potential subjects, an efficient and well-trained English-speaking medical community lower over-all trial costs and faster completion of clinical studies have all contributed to India’s clinical robustness. The regulatory authorities in India have also stepped in with crucial support to streamline the approval process and ensure a smooth flow of global clinical trials. Considering this as an ideal opportunity and perfect time, Oncology Services launched its clinical research operations in India. As an extension of its operations in Europe, the Oncology focused CRO has an added advantage, which helps avoid pitfalls and be aware of latest clinical and therapeutic trends to allow positioning and competitive advantages, thus defining strategy for the development phase.
The approval time in India for clinical trials approved by the U.S. FDA, EMEA, Australia, Japan, South and a host of other leading drug development countries is fast-tracked, making the regulatory process swifter than most places.
Another important factor that establishes India’s Clinical development credentials is the evolution of Indian GCP guidelines. These have been modeled on internationally accepted guidelines such as ICH and have been formed to ensure the best possible channel for drug development.
In 2005, India also became compliant with the Trade Related Intellectual Property Rights Act (TRIPS), which takes care of patent protection and IP issues. This has made innovator companies much more comfortable with the idea of conducting trials in India.
Despite the competitive edge that India has to offer, currently, less than 2 percent of all global Oncology trials are being carried out in India, since most of the advantages of coming to India have only recently come to light. Reputed international journals and experts predict this figure to significantly rise in the near future, with an exponential annual growth in the coming years. With this optimistic scenario, Oncology Services India aims to emerge as the leading drug development partner and consultant for pharmaceutical and biotech industry.
In the current inter-linked global environment, sustained efforts at cancer drug development, with efficient multi-national co-operation, time-effective and quality work practices and swift results, promise better healthcare to patients in the near future.
The global clinical research outsourcing market is projected to touch US$ 23 billion by 2011, with consultancy firm KPMG estimating that India will corner 15 per cent of this in two years. While the industry attributes this to the growing interest of pharmaceutical majors in emerging markets like India, some medical experts see faster recruitment as the main attraction
As better knowledge is acquired on various subtypes of cancer, more complications are coming to light, which require new and innovative therapy approaches. This has made it essential to treat the field of Oncology as a specialized, exclusive realm being catered to by specialized, skilled manpower. These requirements have mandated the need for niche oncology clinical services provider with a dedicated focus on oncology drug development and relevant experience in the field.
India is fast emerging has a hot favorite outsourcing destination for drug development companies due to its sizable patient population, which translates into a faster recruitment process. In addition to the vast pool of potential subjects, an efficient and well-trained English-speaking medical community lower over-all trial costs and faster completion of clinical studies have all contributed to India’s clinical robustness. The regulatory authorities in India have also stepped in with crucial support to streamline the approval process and ensure a smooth flow of global clinical trials. Considering this as an ideal opportunity and perfect time, Oncology Services launched its clinical research operations in India. As an extension of its operations in Europe, the Oncology focused CRO has an added advantage, which helps avoid pitfalls and be aware of latest clinical and therapeutic trends to allow positioning and competitive advantages, thus defining strategy for the development phase.
The approval time in India for clinical trials approved by the U.S. FDA, EMEA, Australia, Japan, South and a host of other leading drug development countries is fast-tracked, making the regulatory process swifter than most places.
Another important factor that establishes India’s Clinical development credentials is the evolution of Indian GCP guidelines. These have been modeled on internationally accepted guidelines such as ICH and have been formed to ensure the best possible channel for drug development.
In 2005, India also became compliant with the Trade Related Intellectual Property Rights Act (TRIPS), which takes care of patent protection and IP issues. This has made innovator companies much more comfortable with the idea of conducting trials in India.
Despite the competitive edge that India has to offer, currently, less than 2 percent of all global Oncology trials are being carried out in India, since most of the advantages of coming to India have only recently come to light. Reputed international journals and experts predict this figure to significantly rise in the near future, with an exponential annual growth in the coming years. With this optimistic scenario, Oncology Services India aims to emerge as the leading drug development partner and consultant for pharmaceutical and biotech industry.
In the current inter-linked global environment, sustained efforts at cancer drug development, with efficient multi-national co-operation, time-effective and quality work practices and swift results, promise better healthcare to patients in the near future.