Friday, 25 July 2014

Indian Doctors Trained in Oncology Imaging with Cloud Technology

Indian Doctors Trained in Oncology Imaging with Cloud Technology
BRIT Systems’ Roentgen Cloud image sharing and viewing solution was recently used for an oncology imaging educational workshop in Bangalore, India, the company has announced. Sponsored by the University of Texas MD Anderson Cancer Center and Health Care Global Enterprises, the 3-day workshop trained attendees on how to read MRI oncology studies.
The Roentgen Cloud provides a DICOM-compliant, browser-based platform for viewing and sharing medical images from mobile devices, including tablets and smartphones. Using BRIT’s Webworks zero footprint viewer, 30 participants viewed nearly 100 MRI oncology cases, each consisting of 400-600 images, uploaded to the Roentgen Cloud servers in the United States. The exercise allowed attendees to interact with the system and read the studies as they would in a clinical environment. According to BRIT, molecular imaging is a rapidly growing field in India.
“BRIT Systems is proud to help support the educational efforts of leading healthcare institutions such as MD Anderson Cancer Center and HCG,” said Shelly Fisher, president of BRIT Systems. “For over 20 years, our company has helped hospitals and physicians view and share medical images in clinical practice. It is very rewarding for our solutions to now help educate young doctors around the world.” 

Monday, 21 July 2014

DCGI sets up Independent Expert Committee on Oncology for trial deaths caused by cancer drugs

DCGI sets up Independent Expert Committee on Oncology for trial deaths caused by cancer drugs
The Drugs Controller General of India (DCGI) has constituted an Independent Expert Committee on Oncology for examination of reports of serious adverse events (SAEs) of deaths occurred during clinical trials in the country.  Dr Arun Agarwal, Professor of ENT, Maulana Azad Medical College, New Delhi is the chairman of the expert committee. 
The committee will function under the provisions as specified in Appendix XII of the Schedule Y of the Drugs & Cosmetics Rules.
The chairman of the committee will receive reports of serious adverse events of death from investigators, sponsors or his representatives whosoever had obtained permission from the DCGI for conducting the clinical trial and the ethics committee.  The committee will examine the reports of serious adverse events of death, to determine the cause of death and if the cause is due to reasons which are considered as clinical trial related death , then it will give its recommendation to the DCGI.
The committee will examine whether the death has been happened due to adverse effect of investigational products; due to violation of the approved protocol, scientific misconduct or negligence by the sponsor or his representative or the investigator; whether it is due to the failure of investigational product to provide intended therapeutic effect; due to use of placebo in a placebo-controlled trial; due to adverse effects due to concomitant medication excluding standard care, necessitated as part of approved protocol; for injury to a child in-utero because of the participation of parent in clinical trial; and due to any clinical trial procedures involved in the study.
In case of clinical trial related death, the committee will also give recommendation to the DCGI the quantum of compensation to be paid by the sponsor or his representative.
Dr YK Gupta of AIIMS New Delhi; Dr Renuka Kulkarni-Munshi of TN Medical College and BLY Nair Charitable Hospital, Mumbai; Dr Hemant Malhotra of SMS Medical College, Rajasthan; Dr SD Banavali of Tata Memorial Hospital, Mumbai; Dr TN Sagar of Cancer Institute, Adayar, Chennai; Dr Kishore Singh of Maulana Azad Medical College, New Delhi; and Dr S Kataria of Safdarjung Hospital are the other members of the 8-member expert committee.

Cancer Genetics Announces Acquisition of Gentris Corporation, a Leading Global Pharmacogenomics Company, and Increases Contract Backlog to Over $18 Million

Cancer Genetics Announces Acquisition of Gentris Corporation, a Leading Global Pharmacogenomics Company, and Increases Contract Backlog to Over $18 Million
Cancer Genetics, Inc. CGIX +1.29%  , an emerging leader in DNA-based cancer diagnostics focused on developing genomic-based oncology tests and services, today announced the signing of a definitive agreement to acquire privately held Gentris Corporation, a global provider of clinical pharmacogenomics solutions, next-generation sequencing, and biomarker testing.
CGI expects the acquisition to add approximately $5 to $6 million in annual sales, and add substantially to it biopharma revenue backlog and capabilities. The company will now be positioned to provide global services for genomic and biomarker testing for biotech and pharmaceutical companies by leveraging both it's unique tests and comprehensive oncology services.
Gentris provides genomic testing and pharmacogenomics services to half of the top ten biopharma companies globally and has participated and performed genomic analysis for over 1,000 clinical trials. The company has operations in Raleigh (Research Triangle Park), North Carolina and Shanghai, China in state-of-the-art GLP, CLIA and FDA-compliant facilities.
Gentris' expertise in pharmacogenomics, the study of the role of an individual's genetics in drug response, enables its clients to quickly obtain and translate quality genomic biomarker results into safer, more effective medicines that improve and personalize the standard of care for patients globally. Gentris also adds CAP accredited biorepository and tissue management services for CGI's growing global client base through an additional 28,000 square feet of laboratory space.
Panna Sharma, CEO of Cancer Genetics, stated: "The acquisition of Gentris will serve as a strong foundation for the expansion of our programs into the clinical and hospital setting globally. We now have fully staffed laboratories in the U.S., India and China, which gives us a uniquely competitive platform to develop, commercialize, and deliver genomic and biomarker based oncology diagnostics to our clients. Importantly, this acquisition provides a clear pathway and high growth opportunity to sell our genomic based diagnostic tests to some of the largest pharma companies in the world with additional capabilities such as germline DNA testing and drug response optimization and monitoring."
Mr. Sharma also added: "The fact that large biopharma companies are continuing to invest heavily in China and that cancer is now the single largest cause of death in China, makes it important that CGI expand its operations and capabilities in this market. Gentris' presence in China provides us the platform to do so." According to Thomson-Reuters clinical intelligence service, Cortellus, 550 to 600 clinical trials are initiated in China each year with nearly forty percent focused on oncology.
With the acquisition of Gentris, and the previously announced BioServe India acquisition, Cancer Genetics will have approximately 60,000 square feet of state-of-the-art lab space and will have established itself as a unique global provider for the development and delivery of targeted, personalized oncology diagnostics.

Monday, 14 July 2014

Improving quality and access to advanced cancer care in India and South Asia

Improving quality and access to advanced cancer care in India and South Asia
Major advances in radiation therapy and radiosurgery for the treatment of cancer are being highlighted in a three-day Oncology Summit taking place in Mumbai from 10-12 July, 2014. Renowned national and international cancer experts from seven countries are meeting to share best practices and exchange knowledge on modern technologies making treatment for cancer patients more precise, accurate and efficient.
The Summit will address a wide spectrum of topics in the sphere of radiotherapy treatment. These include major advances in radiation oncology technology, emerging technologies to treat different types of cancer, expanding cancer care access in India and other countries, regulatory issues in radiotherapy practice and new medical options for cancer patients.
The Summit has been organized by Varian Medical Systems (NYSE:VAR), the leading manufacturer of medical devices and software for treating cancer and other medical conditions with radiotherapy, radiosurgery and brachytherapy.
The sessions will also cover clinical practise and new clinical trends, developments in radiation oncology treatments involving Varian's Edge(TM) radiosurgery suite, stereotactic ablative body radiotherapy (SABR), RapidArc(R) volumetric treatments, motion management techniques, brachytherapy, imaging, treatment planning software, and knowledge-based solutions designed to help clinicians implement quality clinical practices.
The panel discussion during the inaugural session focused on improving access to cancer care in the South Asia region. The panellists emphasized on the importance of quality control in radiotherapy to improve health outcomes and minimise adverse events.
Global and Indian experts present at the Summit include Deepak Khuntia, MD, Radiation Oncologist and Vice President of Medical Affairs, Varian Medical Systems, USA; Professor Carlo Greco, MD, Champalimaud Centre for the Unknown, Lisbon, Portugal; John R Adler, MD, Professor of Neurosurgery at Stanford University and Vice President and Chief of New Clinical Applications, Varian Medical Systems; Avinash U. Sonawane, PhD, Atomic Energy Regulatory Board, Government of India; SK Shrivastava, MD, Professor and Head of the Department of Radiation Oncology, Tata Memorial Hospital, Ajai Kumar, MD, founder-chairman and CEO of HealthCare Global Enterprise (HCG) and Professor Ramesh S. Bilimagga, President, Association of Radiation Oncologists of India (AROI). Over 300 oncologists, physicists and radiotherapy practitioners from across India are attending the Summit to share their experiences.
John R Adler, MD, Professor of Neurosurgery at Stanford University and Vice President and Chief of New Clinical Applications, Varian Medical Systems said "Advances in radiation oncology are changing the way cancer is treated around the world. Modern medical devices have ushered in a period of personalized medicine, enabling doctors to target tumors non-invasively, with high precision. For instance, SABR (stereotactic ablative body radiotherapy) is a form of therapy which differs from traditional radiotherapy where higher doses are given over a shorter number of treatments. It is an emerging treatment for prostate cancer and a viable alternative, in some cases, to more invasive surgical procedures."
"New techniques are offering patients efficient, minimally invasive alternatives to invasive surgical approaches which entail anaesthesia and long recovery periods in hospitals. Innovative radiotherapy and radiosurgery technologies offer image-guided patient positioning, motion-management, and real-time tumor tracking that have made the approach to fighting cancer more powerful than ever before." added Dr. SK Shrivastava, Professor and Head of the Department of Radiation Oncology, Tata Memorial Hospital
Cancer in India
"We have established a dedicated education centre in Mumbai to help train radiotherapists and physicists in the safe and effective use of the latest cancer treatment technologies crucial for the future care of India's growing numbers of cancer patients." said Ashok Kakkar, Senior Managing Director, Varian Medical Systems, India. "With the largest installed base of radiation therapy devices in India, Varian continues to equip the country's cancer hospitals with technologies for the efficient delivery of advanced radiotherapy. We have consistently invested in research and development, manufacturing and training, to improve the quality and accessibility of radiotherapy treatments."
India has a population of over a billion people and there are an estimated one million new cases of cancer diagnosed in the country each year.
"Embracing the latest advancements in radiotherapy and radiosurgery for treatment of cancer is just what we need in India. These new devices enable clinicians to deliver radiation accurately & quickly, making this not just more efficient but also a cost-effective treatment. Many more patients can be treated with a single machine than was previously possible. The newest systems complete treatments 2-8 faster than the previous generation of systems." said Professor Ramesh S. Bilimagga, President, Association of Radiation Oncologists of India (AROI).
Important Safety Information
Radiation treatments may cause side effects that can vary depending on the part of the body being treated. The most frequent ones are typically temporary and may include, but are not limited to, irritation to the respiratory, digestive, urinary or reproductive systems, fatigue, nausea, skin irritation, and hair loss. In some patients, they can be severe. Treatment sessions may vary in complexity and time. Radiation treatment is not appropriate for all cancers.
About Varian Medical Systems
Varian Medical Systems, Inc., of Palo Alto, California, is the world's leading manufacturer of medical devices and software for treating cancer and other medical conditions with radiotherapy, radiosurgery, and brachytherapy. The company supplies informatics software for managing comprehensive cancer clinics, radiotherapy centers and medical oncology practices. Varian is a premier supplier of tubes, digital detectors, and image processing software and workstations for X-ray imaging in medical, scientific, and industrial applications, and also supplies high-energy X-ray devices for cargo screening and non-destructive testing applications. Varian Medical Systems employs approximately 6,500 people who are located at manufacturing sites in North America, Europe, and China and approximately 70 sales and support offices around the world.

Wednesday, 9 July 2014

Global cos reluctant to introduce latest cancer drugs due to fear of patent infringement allegations: HCG chief

Global cos reluctant to introduce latest cancer drugs due to fear of patent infringement allegations: HCG chief
Global pharma companies are reluctant to introduce the latest cancer drugs because they fear patent infringement allegations from India. The stalling of clinical trials since January 2013 has also made access to advanced cancer drugs impossible in the country, said Dr. BS Ajaikumar, chairman, Healthcare Global Enterprises (HCG) which is India’s largest network chain of 27 dedicated cancer care centres in the country.
The hostile response from global pharma majors to boycott new cancer medicines into India ensues Novartis’ Gleevac drug which lost its patent protection here.  This has turned painful for the scores of cancer patients in the country as they do not have access to the advanced targeted therapies. In this regard, HCG has made a representation to the new government and its health minister Dr. Harsh Vardhan to take a look into the issue and provide remedial measures at the earliest.
It was at the conference of the Association of Surgical Oncologists in the US where global drug majors told the HCG chief that India was no longer on their radar for new cancer drugs. They were wary of the Union government as it did not comprehend innovation nor valued the intellectual property rights but were more keen to protect its generic drug manufacturers. Unless there is a relook by the government, only then India would be reconsidered, said Dr. Ajai during an interaction with the media.
The anti cancer drugs launched by global companies between 2012 and April 2014 which are not marketed in India are Ramucirumab by Eli lilly, Ibrutinib of Pharmacyclix, Obinutuzumab, TDM1, Vismodeb and Pertuzumab by Genetech, Pomalidomide by Celegene, Afatinib by Boerhirnger Ingelheim, Regorafinib, Radium and Regorafinib by Bayer, Dabratinib by GSK, Bosatinib, Axitinib and Crizotinib by Pfizer, Ponatinib by Ariad Pharmaceuticals, Cartilzomib by Onyx, Liposomal Vincristine by Talon, Cabozatinib by Exelixis, Enzulatamide by Mediavation, Aflibercept by Sanofi and Brentuximab by Seattle Genetions, informed Dr. BJ Srinivas, consultant medical oncology, HCG adding that these were for cancers of breast, lung, colorectal in adults and leukaemia in the paediatric population.
“The battle against cancer is an ongoing one and support from all sections of the society is the need of the hour. We need to strengthen our cause for latest drugs and emerge victorious.  It is happy to note that India is considered as a health destination for both the developed and developing world with access to expertise and good hospitals providing affordable and high quality care. But all this would make no sense if latest drugs marketed elsewhere in the world are unavailable here. Short-sighted polices leave the doctor and the patient in the lurch”, said Dr. Ajai.
“The new generation drugs have a curative outcome and it is unfortunate that is unavailable in India”, said Dr. Radheshyam, head, bone marrow transplant department, HCG.
Dr. Poonam Patil, consultant, oncologist, Manipal Hospital said that she was unaware of the global pharma boycott of cancer drugs. “There is a great concern on the Indian rupee appreciation which is increasing the prices of imported cancer drug costs. India should make speedy efforts to bring back transparent clinical trials to bring in latest oncology drugs.

Tuesday, 8 July 2014

Cipla plans U.K. investment as Indian drugmakers await economic reforms

Cipla plans U.K. investment as Indian drugmakers await economic reforms
In the weeks since Narendra Modi won the Indian election, drugmakers and other manufacturers have looked expectantly to the new government's first budget. Now, with the budget nearing, manufacturers have opened up about what they want and politicians from the United Kingdom have flown in to unveil Cipla's £100 million ($172 million) investment in the former colonial power.
The Cipla investment is intended to boost sales of its respiratory, oncology and antiretroviral drugs in the U.K. Cipla timed the news to coincide with the arrival of Britain's finance minister and foreign secretary in India. The politicians hope to position the U.K. to benefit from the economic reforms Modi's government is expected to make, leading to deals and increased exports for British and Indian companies. Cipla's planned investment in its U.K. subsidiary is an early part of this process.
Indian drugmakers would welcome changes that support increased exports to the U.K., but also have more local concerns. The Economic Times visited a top Indian pharma hub in Baddi to talk to manufacturers, who put the end of tax exemptions and infrastructure shortcomings at the top of their lists of concerns. A tax-holiday scheme implemented in 2003 helped Baddi to expand quickly, with Abbott Laboratories ($ABT), Cipla, Cadila, Dr Reddy's and others helping to drive growth.

Cipla to invest Rs 1000 crore in UK

Cipla to invest Rs 1000 crore in UK
Cipla Ltd, in collaboration with the UK government, has expressed its intention to make investments of up to GBP 100 million (about Rs 1028 crore) in its UK subsidiary over the next few years. The investments are expected to facilitate the launch of a range of products in the area of respiratory, oncology and antiretroviral medicines to further Cipla’s higher purpose of ‘universal affordable access’.
Cipla also plans to invest in R&D activities, clinical trials and expand further internationally. “The investment underscores the growing importance of UK in Cipla’s long term strategy,” said the company in a BSE filing.
Cipla has been fortifying its global base in last couple of years. Last month itself, in a two separate deals, Cipla acquired majority stakes in a Yemeni and a Sri Lankan company. In 2013, it had acquired Quality Chemical Industries (Uganda), Celeris (Croatia) and Medpro (South Africa).

Oncologist and Playback singer enthral patients

Oncologist and Playback singer enthral patients
It was an entirely new experience for patients at the Government Hospital here to listen to renowned oncologist Dr V P Gangadharan play evergreen songs from the movie "Chemmeen" on his bulbul tarang, at the 'Arts and Medicine' series of the Kochi Biennale Foundation.
Today's was the 25th programme of the series organised by the foundation here.
Award winning playback singer Sithara Krishnakumar rendered soulful melodies for the patients on the occasion.
The "Arts and Medicine" project is being conducted by the KBF in association with the Mehboob Memorial Orchestra with the aim of providing healing and solace through art.
'Doctors are generally trained to treat a human body. They are never taught to cure an ailing mind. Only an artist can touch the human mind and give solace," said Dr V P Gangadharan, who heads the Oncology Department at the private Lakeshore Hospital here.
An amateur musician himself, he plays the bulbul tarang, a stringed instrument known as the "Indian Banjo" commonly used in film and folk songs.