The pharma podium is a fortnightly newsletter by National Pharma Machinery      Edition #1                                                                                        15th, March -2011                 Featured Article   Personalised medicine is a “necessity not a luxury”, but there are numerous obstacles currently in place hindering true advancement in this area, industry has been told. Speaking at last week’s joint BIA/MHRA Personalised Medicine Conference, Sir Gordon Duff, chairman of the UK’s Commission on Human Medicines said there was no clear plan or leadership when it came to personalised medicines and this was particularly seen within the clinical trials landscape. “We tend to think of stratified medicine as new but stratification occurs on the market by trial and error – the patient says it doesn’t work so the doctor gives something else. But we need to understand how to do this at the development phase rather than in the clinic. We need to move upstream and stratify populations in clinical development with biomarkers. We need to stratify in Phase I and II and then on the market with a Phase III/IV type trial. As a result we’ll probably produce more and better drugs – that’s where we need to head.” But in order for this to work, Sir Gordon said there were several things that needed to change, including a need for a more adaptive approach to clinical trials, the use of all available information, early authorisation in exchange for post-market commitments and a risk-based approach to regulation. “Progress needs to be based on multiple convergent changes. We have progressed but not as a united front with all stakeholders. We need public involvement – an awareness and willingness to share data. We need healthcare systems – the NHS could be seen as one large clinical trial. In development, the model needs to change and there’s a need for collaboration. And regulators need to take on a facilitator role. We are at the beginning of a new era in convergent healthcare.” Dr Tom Lillie, international therapeutic area head, oncology, at Amgen, agreed, saying there was “great inequality” in the way healthcare was approaching personalised medicines. “It’s very disappointing we haven’t made more progress but our current trial and regulatory framework is not set up for that,” he said. He feared development of personalised medicines was currently quite risky with the emphasis being on “single agent activity” when a “combination approach was empirically desirable”. For example, different cancers have different genetic signatures, he said, and that points to combination therapy.  Furthermore, there were too many studies generated on retrospective analysis, which slowed down development, cost more and was unsustainable, he said. There was general consensus that the current clinical trial framework did not fit with the development of genomic drugs and there was possibly the need for a “radical rethink” of how clinical trials should be done. However, Dr Ian Hudson, director of licensing division of the Medicines and Healthcare products Regulatory Agency, said there was flexibility in the system. “Companies need to talk to regulators for advice on what trials might be needed. We know large studies are impossible for many orphan diseases. I think regulators are more flexible than we are given credit for.” But Dr Eric Abadie, chairman of the European Medicines Agency’s committee for Medicinal Products for Human Use, acknowledged there were a lot of open questions with the answer ‘it depends’. For example, questions like, is retrospective biomarker identification adequate for regulation and are biomarker negative patients required in clinical trials? Likewise, Seren Phillips from the National Institute for Health and Clinical Excellence, said there were still a lot of issues to be resolved.  Source :- PHarma Times Reach us @Twitter (@npmachinery),        IN THIS ISSUE   Global News Insys Therapeutics, Inc. announces positive results from the pivotal phase III efficacy trial. FDA turns down Salix' antibiotic for IBS Breaking the Taboo Associated with Hemorrhoidal Disease  Indian News DCGI to ask centre to increase drug inspectors under CDSCO to 500 Maharashtra FDA detects 25 not-of-standard drugs in February Health ministry assures on making PSU vaccine units fully GMP   compliant in 3 years Events & Expos Medical Fair India March 25th-27th Bio Pharma Asia Convention InterpheX Expo , USA Also In The News Acton Biotech offers full genome scan at Rs 20,000 How man 'lost his penile spines' World’s Richest Man’s wealth jumps up by 38% Material World :-  Reinvention of silk     Insys Therapeutics, Inc. announces positive results from the pivotal phase III efficacy trial. Insys Therapeutics, Inc. announces positive results from the pivotal phase III efficacy trial for patients utilizing the Fentanyl Sublingual Spray (SL Spray) technology to treat breakthrough cancer pain. All primary and secondary endpoints were achieved in the study, and the drug is the first product to ever show statistically significant pain relief.                                                                                           FDA turns down Salix' antibiotic for IBS   Salix Pharmaceuticals' antibiotic Xifaxan has failed to win favour with the US Food and Drug Administration for the treatment of irritable bowel syndrome.                                                                                                                                        Breaking the Taboo Associated with Hemorrhoidal Disease Experts assume that more than 50 percent of Americans over the age of 50 have had symptoms related to hemorrhoidal disease at some point in their lives(1). For Europe similar data have been reported(2) and a German study reveals that 20 percent of the patients suffered more than five years from hemorrhoidal disease before they finally got the right treatment.                                                                       DCGI to ask Centre to increase drug inspectors under CDSCO to 500 The office of Central Drugs Standard Control Organisation (CDSCO) may ask the Centre to increase the number of drug inspectors under it to 500 as the requirement of the regulatory staff will be much more with its increased responsibilities, according to Dr Surinder Singh, DCGI.                                                                                           Maharashtra FDA detects 25 not-of-standard drugs in February The Maharashtra Food and Drugs Administration (FDA) has detected 25 not-of-standard drugs during the month of February in the random sample testing. Seven of these products belong to the manufacturers of the tax-free state of Himachal Pradesh and 6 from Uttaranchal.                                                                                          Health ministry assures on making PSU vaccine units fully GMP   compliant in 3 years The health ministry has assured the Parliamentary Standing Committee on Health and Family Welfare headed by Brajesh Pathak that the three public sector vaccine manufacturing units would be fully GMP compliant within a period of three years for which revamping of the existing production facilities at each location is in progress.                                                                                                                                    Acton Biotech offers full genome scan at Rs 20,000  Acton Biotech has recently offered a full genome scan to identify potential health risk. This full genome scan will cost Rs 20,000 and the report will be ready in a month. According to the company, patients can give blood samples at collection centers in their respective cities and                                                                  How man 'lost his penile spines' Scientists believe men once had small spines on their genitalia such as those found in chimpanzees, cats and mice. Analysis of the genomes of humans, chimpanzees and macaques indicates that a DNA sequence thought to play a role in the production of these spines have been deleted in humans, but has been preserved in other primates.                                                                                       World’s Richest Man’s wealth jumps up by 38% Mexico's Carlos Slim has topped the latest Forbes magazine rich list, as his wealth grew by more than a third. The telecoms magnate's fortune rose by $20.5bn (£12.65bn) to $74bn, again beating Microsoft founder Bill Gates ($56bn) into second place                                                                  Material World :-  Reinvention of silk As some silk researchers see it, if spiders were gregarious vegetarians, the world might be a different place. For spiders are nature’s master silk makers, and over millions of years of evolution have developed silks that could be useful to people — from sticky toothpastelike mush to strong and stretchy dragline                                                                                        Go to..   25th  -27th March, 2011   Venue :- Pragati Maidan   New Delhi, Delhi, India    Details :- Click Here        28th  -31st March, 2011     Venue:- Marina Bay,sands     Singapore city,Singapore     Details :- Click Here          29th - 31st March,2011  Venue :- Jacob Javits,Covnention Centre      New York, USA     Details :- Click Here 22nd - 24th March,2011  Venue :- Dubai international Convention  Centre      Dubai, UAE     Details :- Click Here 12th-18th May,2011  Venue :- Dubai international Convention  Centre      Dusseldorf, Germany     Details :- Click Here                    To Receive our subsequent mails ,White list our email address by adding to your contact list.                                                         If you want to  unsubscribe to The Pharma Podium  click here    For a Browser view click here.                        All rights with NATIONAL PHARMA MACHINERY .Copying the design in any form is strictly prohibited. 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