Evidence-Based Medicine at New York Biotechnology Association 2009 annual meeting(NYBA).
Sarah Evans moderated the highly successful Evidence-Based Medicine panel on April 20th.
The panel speakers included, Dr Renee Arnold, Prof Mount Sinai Medical School, who gave an over view of Evidence-Based Medicine: How will it Shape Healthcare in the coming Decades.
Stuart McConchie, VP Jarvik Heart speaking on behalf of the medical device industry.
Teresa Zyczynski, PharmD, MBA, Senior Director Health economics & Outcomes Research, GE Heathcare, Diagnostics.
Dr Jaiwei Xuan, from Pfizer, representing the mature pharmaceutical industry.
According to the Institute of Medicine Roundtable on Evidence-Based Medicine, with "per capita expenditures more than 20 percent higher than any other country in the world and more than twice the average expenditure for European countries, the nation ranks well below at least two dozen others on key health indices such as infant survival and life expectancy." What's the problem? Lack of application of the best evidence to medical decision-making, both to individual patients and to patient populations as a whole. Will we have government regulation imposed on us, such as the U.K.'s National Institute for Health and clinical Excellence (NICE), the NHS' cost-effectiveness watchdog? Can we monitor ourselves using well-established methods, such as outcomes registries, retrospective database analysis and cost-effectiveness analysis, to generate the evidence we need to rein in our spiraling healthcare costs, while improving patient outcomes?
ACT busy in the International arena
ACT is setting up a four site study for a project in CAPS at the Royal Free, London; Hopital Kremlin Bicetre, Paris, France; Germany & Italy.
Along the way we also manages to enjoy the local environment- see pictures of Renee outside Buckingham Palace and Sarah outside the Palais Gardnier, Home of the National Opera De Paris, where we saw the 'Spectacle de l'Ecole de Danse, and spectacular Ballet it was too. While in the UK we managed a trip on the Thames from Tower Bridge to the Houses of Parliament, Tea at the Ritz and to see the 39 steps at the Criterion Theater. I thought it appropriate as The first performance at the Criterion on 21st March 1874, consisted of 'An American Lady.' We really did fit in quite a bit of work and learnt a huge amount about the CAPS affliction.
We are also collecting the opinion of 10 KOLs, in Eight Countries on Osteoarthritis.
At the end of May we are expecting our 1st overseas Intern for the summer, While Kirsten our winter intern goes off to Greece. Our interns can see the Statute of Liberty from our new office window.
Along the way we also manages to enjoy the local environment- see pictures of Renee outside Buckingham Palace and Sarah outside the Palais Gardnier, Home of the National Opera De Paris, where we saw the 'Spectacle de l'Ecole de Danse, and spectacular Ballet it was too. While in the UK we managed a trip on the Thames from Tower Bridge to the Houses of Parliament, Tea at the Ritz and to see the 39 steps at the Criterion Theater. I thought it appropriate as The first performance at the Criterion on 21st March 1874, consisted of 'An American Lady.' We really did fit in quite a bit of work and learnt a huge amount about the CAPS affliction.
We are also collecting the opinion of 10 KOLs, in Eight Countries on Osteoarthritis.
At the end of May we are expecting our 1st overseas Intern for the summer, While Kirsten our winter intern goes off to Greece. Our interns can see the Statute of Liberty from our new office window.
Inaugural meeting of the Medical Device & Diagnostic Affinity group of the Healthcare Businesswomen's Association.
Sarah as co-chair of the Medical Device & Diagnostic Affinity group of the Healthcare Businesswomen's Association, organized for Dr Renee Arnold, CEO of Arnold Consultancy & Technology, to speak at the inaugural meeting on June 5th 2008. Renee's topic was Evidence-Based Medicine in readiness for the launch of our new Evidence-Based Health Division.
The Blood Spots visit the Capitol in Albany
The New York Chapter of the Leukemia & Lymphoma Society has asked me to spear head their Clinical Trials Advocacy effort. The first event I attended was visiting Senators and Assembly-members in at the Capitol in Albany in support of A. 10624 (Gottfried) and S.7211 (Hannon). An act to amend the public health law, in relation to establishing the clinical trial access and education fund.
While fewer than 5% of Adult cancer patients participate in clinical trials, 60% of pediatric cancer patients do. This fund will help pay for patient and physician education, and improve patient eligibility and accessibility.
My 2nd outing was to Brooklyn, to help celebrate National Cancer Survivors Day at the Lutheran Medical center, where we gave out literature and Shasta Daisy Seeds, a symbolic event to show the world that life after a cancer diagnosis can be a reality.
Arnold Consultancy & Technology
Arnold Consultancy & Technology an online clinical outcomes research group, specializing in Evidence-Based Health.
One of my 1st contributions was to organize for Dr Renee Arnold, to participate in the inaugural Medical Device and Diagnostic Metro meeting of the Healthcare Businesswomen's Association (HBA) to discuss the current big issues of the industry. The thrust of the event centered around the tightening of the data requirements, particularly Evidence-Base Medicine and how that will change product development. Since it's inception earlier this year I have been the co-chair of the Metro Medical Device and Diagnostics (MD&D) Affinity group of the HBA. We hope to run at least two meeting a year, specifically for this growing segment of the healthcare industry.
My next task will be to revamp ACT's web presence and add a new section for the Evidence-Based Health division.
Venture Philanthropy
A new business model called ‘Venture Philanthropy’, is a real symbiotic partnership between not-for-profits and for-profits, which can provide funds for small pharmaceutical companies - especially useful for rare disorders or orphan drugs and early Biopharmaceutical companies. The not-for profits help fund pre-clinical research and clinical trials, that would other wise languish through lack of resources. Many of the organization are ‘start ups’ that are still at the ‘proof of concept’ stage, when Venture Capitalists are too shy to invest – maybe not understanding the full knock on market potential etc. Not all are small, even in big corporation useful drugs with limited returns, do not always get the resources to see them through the long clinical process. Legal contracts ensure payments are tied to results and the not-for-profit may often take a monitory return when the drugs get to market, allowing them to plough back the funds into future developments. The Multiple Myeloma Research Foundation (MMRF) is spearheading this exciting new funding initiative; they provide grants, some in the order of $1m, to pharma companies anywhere in the world, to do
research and clinical trials in the field of Multiple Myeloma (MM). Myeloma is a rare blood Cancer, with only an estimated 110,000 diagnosed worldwide, with maybe only 2,500 in Australia. Alan Liddle, CEO of Immune System Therapeutics Ltd, an Australian company, specialising in the development of monoclonal antibody therapies for multiple myeloma and other blood cancers indicated that the MMRF was as excellent resource. The MMFR has supported over 215 such research grants, spending $75m, and currently funding more than 30 compounds! They report a major contribution to the four drugs that are through the clinical process, approved by the FDA and now on the market for MM. It is impressive that a relatively small organization could be involved in such a large number of compounds.
Some of the companies who have received funds from the MMRF presented at their recent Investor Summit and included, Sunesis, Semafore, Proteolix, Novartis & Keryx. The MMRF can also muster about 1/2 of all MM patients in the USA 
(~50,000 with 19,000 new cases in 2006, losing ~11,000/yr). They claim a database of 30,000 research subjects, ready and willing to participate in clinical trials. A sister organization the MMRC, is a consortium of 13 expert investigators and experienced clinical research sites, which can also advise on protocols, and accompany visits to the FDA. They also have their own tissue bank, of almost 1,000 bone marrow samples.
(~50,000 with 19,000 new cases in 2006, losing ~11,000/yr). They claim a database of 30,000 research subjects, ready and willing to participate in clinical trials. A sister organization the MMRC, is a consortium of 13 expert investigators and experienced clinical research sites, which can also advise on protocols, and accompany visits to the FDA. They also have their own tissue bank, of almost 1,000 bone marrow samples. At Advanced Bionics UK, we pioneered a similar, but a precursor, relationship, with a number of deaf children’s charities/not-for-profits. With The Ear Foundation, The Link Center and the NDCS, we outsourced many of our training, seminar (including housing) and some research needs. They in turn provided us with subjects for our clinical trials and marketing initiatives, and access to clinical trial investigators and luminaries etc. They also encouraged new product initiatives, product extensions and accessories. We counted them as part of our distribution channel, which ultimately helped with our sales figures.
According to CenterWatch there are only a few (5 in total) organizations that can offer this type of funding and services – Cystic Fibrosis Foundation, Muscular Dystrophy Association, Juvenile Diabetes Research Foundation, Michael J. Fox Foundation for Parkinson’s Research, along with the MMRF but together they plan to fund over $75m worth of research in 2007. However, there is the potential for any patient driven group to exercise this concept, and nearly all disciplines have such not-for-profit organizations.The Secret Science Club
All in one week, I attended a fascinating lecture, at the Secret Science Club in a Brooklyn Pub, by a noble prize winner, and Director of the Sloan-Kettering Caner Center - Dr Harold Varmus. He discussed the fast moving and exciting future of cancer research, and the importance of being a science savvy citizen.
The Healthcare Businesswomen Seminar at Downtown Pfizer, was excellent, on the future of the Electronic Medical Records – Did you know that the UK just spent $16billion, to put a computer on very GPs (PCP)desk, and the US is rushing to catch up. - In order to cut down the 7,000 deaths a year (= 1 plane crash/week), caused by medication errors! I think this maybe my next project. I was sold on the idea, and bought Newt Gingrich's book, Paper Kills - Transforming Health and Healthcare with Information Technology. Yes! at last but I never thought I would agree with Newt! Which one of us has changed?
The Healthcare Businesswomen Seminar at Downtown Pfizer, was excellent, on the future of the Electronic Medical Records – Did you know that the UK just spent $16billion, to put a computer on very GPs (PCP)desk, and the US is rushing to catch up. - In order to cut down the 7,000 deaths a year (= 1 plane crash/week), caused by medication errors! I think this maybe my next project. I was sold on the idea, and bought Newt Gingrich's book, Paper Kills - Transforming Health and Healthcare with Information Technology. Yes! at last but I never thought I would agree with Newt! Which one of us has changed?
I also went to the opening of a new Art Gallery with a friend, Slate Gallery, in Williamsburg Brooklyn – showing an exhibition of tote bags! (see the one I purchased, I thought it looked a bit like a slice though a skull!).
Next week, I’m off to a Myeloma Research Investors Summit and to Defend Science - which I strongly recommend that you sign up too!
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