Fwd: Join Roche, Novartis, AstraZeneca & Pfizer at the 4th World Companion Diagnostics Summit

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Subject:	Join Roche, Novartis, AstraZeneca & Pfizer at the 4th World Companion Diagnostics Summit
Date:	Tue, 9 Aug 2011 10:00:32 -0400 (EDT)
From:	FierceBiotech Research <editors@fiercebioresearcher.com>
Reply-To:	editors@fiercebioresearcher.com
To:	nbrauchitsch@yahoo.com

This week's FierceBiotech Research is brought to you by Hanson Wade.

Dear Colleague,   The final agenda is now complete for the 4th World Companion Diagnostics Summit, Boston, November 29th - Dec 1st.   The event brochure has just been released and you can see it for yourself here. < span style="font-size: 10pt;">  My research with over 60 leading drug developing companies, has revealed the key challenges holding back progress for the industry in delivering personalized medicines to market. With input from key biomarker, diagnostic and commercial specialists from organizations such as Novartis, Roche, AstraZeneca, Pfizer, J&J, Eli Lilly and Medco I’ve put together the 4th World Companion Diagnostics Summit.   35 leading authorities in personalized medicine will be sharing their insights at the meeting over the 3 days, including:   Dr Vijay Modur, Head, Diagnostic Discovery, Novartis  Richard Schatzberg, Co-Founder, President & Chief Executive Officer, Generation Health Dr Finley Austin, Personalized Healthcare & Biomarker Strategy Director, Astra Zeneca Dr David Geho, Senior Biomarker & Experimental Medicine Leader, Roche Dr Mitch Raponi, Senior Director, Molecular Diagnostics and Translational Medicine, Clovis Oncology Dr Carol Pena, Associate Director, Oncology Biomarkers, Bayer Dr Robert Beckman, Executive Director, Clinical Development Oncology, Daiichi Sankyo Dr Troyen Brennan, Executive Vice President & Chief Medical Officer, CVS Caremark Dr Ian Taylor, Senior Director, Translational Oncology, Pfizer Scott Taylor, Executive Director, Industry Relations, Geisinger Health System Dr Amy Miller, Public Policy Director, Personalized Medicine Coalition Dr Jeffrey Fill, Director, Clinical Diagnostics Laboratory, Eli Lilly Dr G. Mike Makrigiorgos, Associate Professor of Radiation Oncology, Dana-Farber Cancer Institute, Harvard Dr Jorge Villacian, Integrative Solutions Leader in Infectious Diseases, Janssen Pharmaceuticals (a company of Johnson & Johnson) Dr Donald Chalfin, Medical Director, Health Economics & Outcomes Research, Abbott Dr Leonard Reyno, Chief Medical Officer, Oncology, Astellas Pharma The full speaker line up can be viewed here.   In the meantime, here’s the full list of organizations participating on the agenda so far:   Novartis – Pfizer – Eli Lilly – Roche – Johnson & Johnson – GSK – Daiichi Sankyo – Abbott – AstraZeneca – Transgene – Merck – MedImmune – Eisai – Janssen Pharmaceuticals – Astellas – Bayer – Clovis Oncology – Generation Health – CVS Caremark – Medco – Geron – Asuragen – Morphotek – Dana Faber Cancer Institute, Harvard – MIT – Phadia – Pangaea Biotech – Geisinger – Genetic Alliance – Personalized Medicine Coalition    Make sure you visit our event website: www.companion-dxsummit.com for full details and to download the brochure.   Here’s a snapshot of some of the key topics we’ll be looking for answers to at the meeting :  Where are we now with the development, approval and commercialization of companion diagnostics? What are the different patient stratification strategies companies are taking, both in large pharma and smaller drug developing companies? How do you successfully translate treatment stratification markers from bench to bedside and move from a research grade assay towards a clinically useful diagnostic test? How do you take a biomarker test from clinical validation to commercialization? Should you invest in in-house development or outsource? Should you develop LDTs or IVDs? What are the benefits and challenges associated with both prospective and retrospective biomarker development and in defining biomarker positive and negative patient populations? Understand the latest FDA guidance and its impact on your research and development of stratified medicines What does the reimbursement landscape of companion diagnostics look like and how do you achieve a positive reimbursement decision? How do we articulate the value of companion diagnostics to the wider healthcare community and drive adoption?  These are just a few of the key questions we’ll be addressing at the meeting. Full details of all topics for discussion over the 3 day meeting can be viewed in the event brochure.   Hear from just a few of our previous attendees:     “The best molecular dx meeting I have attended in several years” VP, Translational Oncology, Pfizer   “An excellent view of the landscape with well integrated content from pharma, dx, clinical research and agency perspectives. This has been one of the best commercial meetings I have attended in memory” Advanced Cell Diagnostics   “The event has been very valuable. A great conference to be informed of importance and current issues related to cdx/mdx. I am very glad I chose to attend as it has been a wealth of information” Immunogen “This was my first conference I have attended by Hanson Wade - great job! The people made this conference extraordinary” PricewaterhouseCoopers   “One of the best meetings I’ve attended. Outstanding!” Director, Merck    “An intimate session where Rx meets Dx and vice versa. Very informative in terms of Rx vs. Dx perspectives” Director, Dako   Visit the testimonials page for more feedback from our Personalised Medicine series of events.   And what’s more, we have a special discounted rate for the first 50 people to sign up to the meeting. This would entitle you to up to 500 USD off standard prices. So don’t delay to secure the best rates. To take up one of these limited spaces:   Call: +1 212 537 5898 Email: register@hansonwade.com Visit: www.companion-dxsummit.com/register   Remember the discounted rate will expire after the first 50 registrants   If you have any questions, don’t hesitate to get in touch.   I look forward to meeting y ou on site in November.   Best wishes,   Janine   Janine Bur rows Program Director Hanson Wade      P.S. There are 5 tailored workshops for you to choose from on the 28th November: A) Bridging the Gap: Co-Development of Targeted Therapeutics and Companion Diagnostics with FDA Sabah Malek, Senior Regulatory Scientist, Voisin Consulting Life Sciences Eric Lawson, Vice President, Compliance & Regulatory Affairs, Metamark Genetics B) How Molecular Diagnostics will Affect Pharma Business Models and How to Keep Up Dr Keith Batchelder, Founder & CEO, Genomic Healthcare Strategies Peter Miller, Chief Operating Officer, Genomic Healthcare Strategies   OR   C) Stratified Medicine: Commercial Opportunities, Competitive Advantage and R&D Challenges Mark Trusheim, Visiting Scientist & Executive-in-Residence, MIT Sloan School of Managements D) Accessing the Capabilities Required for Companion Diagn ostics Development and Commercialization through Strategic Partnerships Dr John Bloom, President, Bloom Consulting Services & Special Government Employee, FDA   OR   E) Commercial Return on Companion Diagnostics: Strategies and Tactics for Market Access, HTA, Pricing , Coverage, and Payment Patrick Terry, Partner & Principal, Pricing, Reimbursement & Market Access, Scientia Advisors   Download Brochure | Pricing & Discounts | Register Now

Want to reach 40,000+ FierceBiotech Research subscribers with your own message? Contact ryan@fiercemarkets.com or call 202-824-5089.   About this email: In order to receive FierceBiotech Rese arch for free, we ask that you accept an occasional email promotion from our sponsors. We carefully screen each promotion and never sell or give away your personal information. If you do not want to receive these messages, you can unsubscribe entirely from FierceBiotech Research. Click here to unsubscribe. FierceMarkets 1900 L St. NW Suite 400  Washington, DC 20036

Fwd: | 08.09.11 | Texas Gov. Perry backs adult stem cells after undergoing procedure

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Subject:	| 08.09.11 | Texas Gov. Perry backs adult stem cells after undergoing procedure
Date:	Tue, 9 Aug 2011 09:03:52 -0400 (EDT)
From:	FierceBiotech Research <editors@fiercebioresearcher.com>
Reply-To:	editors@fiercebioresearcher.com
To:	nbrauchitsch@yahoo.com

If you are unable to see the message below, click here to view.

August 9, 2011 Sign up for free: Subscribe | Website | Jobs Refer a Colleague Today's Top Stories 1. Texas Gov. Perry supports adult stem cells after undergoing procedure 2. Gene discovered that regulates the timing of our tickers 3. Scientists discover possible genetic route to killing pain 4. Researchers find faulty gene responsible for some ovarian cancers 5. DoD gives NeoStem $1.7M to develop adult stem cells for osteoporosis Also Noted: Spotlight On... Stanford's SPARK hosts ideas so 'crazy' they just might work A roadmap to induce iPSCs out of the dish; cancer research is government money well-spent; and much more... News From the Fierce Network: 1. Social network algorithm helps identify protein 'communities' 2. 'Systems biology' integrates all that's known about disease and humans 3. Dendreon has only itself to blame for Provenge fiasco This week's sponsor is Hanson Wade. Are you confident that your in vitro models accurately predict efficacy and toxicology results? The Predictive In Vitro Models Summit brings together the field's experts from Novartis, Pfizer, Genentech, Amgen & Astra Zeneca to discuss best-practice and share case studies and data on up-to-date in vitro trials. 21-22 September Boston Register Now Events > Predictive In Vitro Models Summit - September 21-22 - Boston, MA Marketplace > New Fierce eBook: Between an Industry Rock and a Political Hard Place: The FDA's 510(k) Initiative > Capitalizing on the Outsourcing Option - New Fierce eBook Jobs > Regional BD Director > Need a job? Need to hire? Visit FiercePharma and Biotech Jobs * Post a classified ad: Click here. * General ad info: Click here Today's Top News 1. Texas Gov. Perry supports adult stem cells after undergoing procedure By Howard Lovy Comment | Forward | Twitter | Facebook | LinkedIn Texas Gov. and possible GOP presidential contender Rick Perry got everybody talking about stem cells again when he announced that he received an injection of his own stem cells during spinal fusion surgery last month. He was quick to point out the obvious--that his own stem cells are not of the embryonic variety, which he vehemently opposes using on religious grounds. There are three main angles to this story: Political, economic and, of course, medical. First, the political: Natasha Lennard puts it best in the last paragraph of her story in Salon: "Perry's adult stem cell success story will no doubt serve as a useful weapon in the highly politicized fight against" embryonic stem cell research. Those who oppose ESC research argue that breakthroughs in induced pluripotent stem cells, derived from adults, make ESC unnecessary. Most medical experts say that the two are not mutually exclusive and there are still many hurdles to overcome before iPS stem cells can make it to prime time. Then, the economic: Perry, along with his friend, Dr. Stanley Jones, who performed the governo r's surgery, have been working with another lawmaker to create an adult stem cell bank in Texas. Perry's procedure gave the effort just the kind of public relations push it needed. Last month, Perry wrote a letter to the Texas Medical Board, which is considering new rules regarding adult stem cells, saying that he hoped the state would "become the world's leader in the research and use of adult stem cells," according to a report in the Texas Tribune. Last, the medical: The procedure undergone by Perry is experimental, not approved by the FDA and, according to some medical experts, may only have a placebo effect. MedPage Today was one of the few publications covering the issue that at least hazarded a guess as to what exactly was done to the governor. Experts not involved in the procedure guessed that Perry had his own mesenchymal stem cells concentrated in a lab and then re-injected onto a scaffold device implanted in the spine. "The procedure is similar to spinal fusion surgery using a piece of bone harvested from the patient's own iliac crest to fuse two or more vertebrae," MedPage Today reports. - read the medically oriented story on MedPage Today - and more in the Texas Tribune - Salon filed this report, which focused more on the political - and the Star Telegram focused more on stem cell economics Related Articles: Scientists often use adult, embryonic stem cells in tandem iPSC use may be limited by 'memory' Adult stem cell trial for spinal disc disease Read more about: Stem Cells, adult stem cells, Human Embryonic Stem Cell, iPS cells back to top 2. Gene discovered that regulates the timing of our tickers By Howard Lovy Comment | Forward | Twitter | Facebook | LinkedIn A scientist with the Gladstone Institutes, a nonprofit biomedical research foundation affiliated with University of California, San Francisco, has discovered how a gene regulator controls a mechanism that helps the heart keep time. When this gene, Iroquois homeobox gene 3 (Irx3), is switched off, the result is heart arrhythmia, a cause of death for 300,000 Americans per year, out of millions who suffer from heart failure. The breakthrough could result in better drugs to treat heart arrhythmias. "This is the first published research about a genetic regulator that coordinates the timing of the electrical impulses that make the heart beat properly," Deepak Srivastava, who directs cardiovascular research at Gladstone, said in a statement regarding the work of investigator Benoit G. Bruneau. Irx3 coordinates electrical impulses that need to spread quickly along a dedicated network of cardiac cells in order for the ticker to keep ticking in the proper rhythm. When Bruneau and colleagues switched off the gene in mice, electrical impulses had difficulty reaching the right path through the heart and the mice developed arrhythmias. "Now that we know the importance of Irx3," Bruneau said in a release, "we need to dig deeper to see if it's possible to use drug therapy to target any of the electrical-impulse pathways that Irx3 regulates with drug therapy." - read the Gladstone Institutes' release - and the abstract in PNAS Related Articles: Heart failure progression is in the PINK1 gene Cardiac gene names get a heart-y laugh Read more about: heart, heart arrhythmia, Gladstone Institutes back to top 3. Scientists discover possible genetic route to killing pain By Howard Lovy Comment | Forward | Twitter | Facebook | LinkedIn With opioid painkiller abuse reaching near-epidemic proportions, the search is on for better drugs that can take care of pain without the risk of addiction. Geneticists in Canada accidentally stumbled on a possible genetic route to solve the problem. It started when researchers at the University of Montreal Hospital and CHU Sainte-Justine Hospital started working with patients who suffer from a rare disease that causes sensory organs to degenerate. The genetic mutations responsible for the disease could be key to disrupting pain for everybody else. Dr. Jean-Baptiste Rivière, lead author of a paper appearing in the American Journal of Human Genetics, writes about his team's research into an incurable disease known as "hereditary sensory and autonomic neuropathy type II," in which patients lose the sensation of heat, touch and pain. Rivière, working with the University of Montreal's Dr. Guy Rouleau, found the genetic basis for the disease. "After showing that the WNK1/HSN2 protein interacts with the KIF1A gene, we were able to go back to the cohort of patients and identify mutations of the KIF1A gene," Rivière said in a release. "The study results will be of immediate benefit to HSAN2 patients, as the identification of this new gene has made it possible to provide valuable genetic testing to assess the risk or the cause of the disease in individuals at risk or presenting the disease." Now that it is known which genes, when mutated, can lead to loss of sensation, this presents an opportunity to use the knowledge gained about KIF1A to develop new painkilling drugs. "Further research could help us to identify other proteins that are transported by KIF1A or that interact with it, and that will help to better refine our understanding of pain mechanisms," researcher Patrick Dion, who also contributed to the findings, said in the release. - take a look at the University of Montreal release - and the abstract in the American Journal of Human Genetics Related Articles: Anti-pain peptide a possible alternative to addictive opioids Researchers measure pain in the expressions of lab mice New remedies block pain 'at its source' Preclinical pain drug shows first-in-class potential Read more about: Pain therapy, drug abuse, genetic mutations back to top 4. Researchers find faulty gene responsible for some ovarian cancers By Howard Lovy Comment | Forward | Twitter | Facebook | LinkedIn The RAD51D gene is ordinarily involved in repairing damaged DNA. But, in rare cases of a mutation, women have about a one in 11 chance of developing ovarian cancer. The discovery is being called the most significant in ovarian cancer genetics in the last decade, according to Cancer Research U.K. The researchers looked at the genomes of 911 families affected by hereditary ovarian and breast cancers. It was a fishing expedition to see if there was anything in the genome to account for the higher risk compared to the general population. They found that out of the 6,500 women diagnosed with ovarian cancer each year in the U.K., between 40 and 50 had a mutation in RAD51D. "Women with a fault in RAD51D gene have a one in 11 chance of developing ovarian cancer. At this level of risk, women may wish to consider having their ovaries removed after having children to prevent ovarian cancer occurring," Professor Nazneen Rahman of the Institute of Cancer Research in London, told The Independent. The solution also could come in the form of PARP inhibitors, already being used to treat breast and ovarian cancer caused by faults in the BRCA1 and BRCA2 genes. RAD51D is also sensitive to PARP inhibitors, Reuters reports, adding that Abbott, Merck, Pfizer, Sanofi-Aventis and AstraZeneca are developing PARP inhibitors. Meanwhile, the website of the National Health Service in the U.K. is attempting to put this study into perspective. "Although women who carry mutations in RAD51D are estimated to be at about six times the risk of ovarian cancer than those who do not, this must be considered in context," reports NHS Choices. "The mutation itself is rare (estimated to be found in 0.1% of women), and carrying it does not guarantee that a woman will develop the disease. Also, it's thought that over 99% of women with ovarian cancer do not carry mutations in this gene." - read the report on NHS Choices - and Reuters filed this story - and here's The Independent's take on the study Related Articles: Ovarian cancer detection study disputed Study says docs often discount dad's side in breast cancer screening Nanoparticles offer ovarian cancer treatment approach Read more about: genetics, ovarian cancer, RAD51D back to top 5. DoD gives NeoStem $1.7M to develop adult stem cells for osteoporosis By Howard Lovy Comment | Forward | Twitter | Facebook | LinkedIn NeoStem, a New York-based biopharmaceutical company, has been awarded almost $1.8 million from the U.S. Department of Defense to develop the company's Very Small Embryonic-Like (VSEL) stem cell technology to treat osteoporosis. VSELs are adult stem cells found in bone marrow that have characteristics similar to embryonic stem cells. They "hold the promise of natural pluripotency," according to the company. The award comes via the DoD's Peer Reviewed Medical Research Program of the Office of the Congressionally Directed Medical Research Programs. "This research effort has the potential to dramatically change the way in which osteoporosis and bone fracture is treated in the military and in the general population," the University of Michigan's Dr. Russell Taichman, who will work with NeoStem on the study, said in a statement. The company says its technology has the "potential to achieve the positive benefits associated with embryonic stem cells without the ethical or moral dilemmas or the potential negative biological effects associated with embryonic stem cells." NeoStem acquired VSEL technology in 2007, when it bought out Stem Cell Technologies. - read the release from NeoStem - here's a story from Proactive Investors - watch a video explaining NeoStem's VSEL technology Related Articles: Stem cell team crafts a replacement bone part Once-daily pill rebuilds bone in rats, mice Read more about: Stem Cells, osteoporosis, bone repair, Department of Defense back to top Also Noted SPOTLIGHT ON... Stanford's SPARK hosts ideas so 'crazy' they just might work Stanford University School of Medicine tells the tale of one researcher's desire to move her research into better heart disease drugs out of the lab and into the clinic--a quest that, she learned the hard way, turned out to be naive as doors were politely slammed in her face. So, Daria Mochly-Rosen decided to take matters into her own hands. And that was the spark for SPARK, Stanford's bioscience incubator, founded 5 years ago to nurture "crazy ideas" that pharmaceutical companies won't touch. Feature Stem Cells > Nearly 5 years after an article first described induced pluripotent stem cells, many obstacles remain toward the use of adult stem cells in the clinic. Paul S. Knoepfler, of the University of California, Davis, has a roadmap "Inducing iPSCs to escape the dish." Article > Kidney cells could be reprogrammed to act like any other kind of kidney cell, raising hopes for new treatments and cure for kidney disease. Report > Japanese researchers have produced viable sperm from mice stem cells, in a breakthrough that could lead to treatments for infertile men. Story Cancer Research > Op-Ed: "With the nation focused on federal spending in Washington, one area that more than pays for itself is funding for cancer research." More here > New Canadian cancer research institute hopes to halve the time it takes to turn lab breakthroughs into patient-ready therapies. Article > Smokers who light their first cigarette early in the morning are more likely to get cancer, researchers say. Item Genetics > Researchers at Columbia University Medical Center find that "de novo," or new mutations--those not present in the parents--play some role in about half of all "sporadic" cases of schizophrenia. Release > Michigan State University scholar: Find a better way to introduce genetics to middle-schoolers. Release And Finally... Some evidence that the building blocks of life here began "out there." More here Events * Post listing: Click here. * General ad info: Click here. > Predictive In Vitro Models Summit - September 21-22 - Boston, MA The Predictive In Vitro Models Summit brings together experts from companies including Novartis, Genentech, Pfizer, AstraZeneca, Amgen and Millennium in Boston this September to take you through the specific challenges and solutions to developing more predictive in vitro assays and how you can use this in vitro data for in vivo predictions. Marketplace * Post listing: Click here. * General ad info: Click here. > New Fierce eBook: Between an Industry Rock and a Political Hard Place: The FDA's 510(k) Initiative This FierceMedicalDevices eBook examines the background situation, current position and the future of the CDRH’s revision of the 510(k) premarket notification process. Click here to download today. > Capitalizing on the Outsourcing Option - New Fierce eBook Risk areas for many biotechs and pharmas in today's changing market include lack of expertise and infrastructure. This eBook addresses recalibration challenges and strategies to capitalize using the contract development and manufacturing (CDMO) option. Download now. Jobs * Post listing: Click here. * General ad info: Click here. > Regional BD Director We are considering candidates for a Regional Business Development (BD) Director to join our BD team! The ideal candidate should have specific experience calling on and selling into the R&D and clinical development/operations and study start up side of the industry, including but not limited to Phase I-IIIB as well as Phase IV post marketing surveillance, outcomes research and patient registry programs. Learn more. > Need a job? Need to hire? Visit FiercePharma and Biotech Jobs 50+ new jobs just posted. Employers now post to the web site free. Find the perfect job or post your openings at FiercePharma Jobs. ©2011 FierceMarkets This email was sent to nbrauchitsch@yahoo.com as part of the FierceBiotech Research email list which is administered by FierceMarkets, 1900 L Street NW, Suite 400, Washington, DC 20036, (202) 628-8778. Refer FierceBiotech Research to a colleague Contact Us Editor-in-Chief: John D. Carroll. Executive Editor: Ryan McBride. Managing Editor: Maureen Martino. Publisher: Arsalan Arif. VP, Sales: Ryan Willumson. Advertise Advertising/Lead-Generation: Ryan Willumson. Request a media kit. 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CAPITALIZING ON SPACE

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THE R&D INDICATOR

The amount of money a corporation spends on research and development, especially in aerospace technology and space is a: good guide to its earnings prospects.  Generally, the higher the expenditure in relation to sales, the greater the company’s emphasis on new-product development.  Benchmark: 5 % of annual sales spent on research is considered a sizable commitment to research spending.  Source:  Merrill Lynch Stockfinder Research Service, 165 Broadway, New York 10080.  

OPTIONS AS INDICATORS

Often the first sign of a rally in a stock is increased activity in its options.  Recommended: Look for newcomers on the “Most Active Options” list in The Wall Street Journal.   Then, all you have to remember is …sell high…buy low...Happy climbing!

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