Aubrey Group Launches Entrepreneurial Program
Irvine-based Aubrey Group has introduced a company-wide effort called the Entrepreneurial Services Program (ESP) that is focused on helping medical device entrepreneurs assemble the key ingredients required for a successful launch of product.
“For years, inventors, physicians and entrepreneurs have come to us with great medical product ideas,” says David Mishelevich, who is heading up the program. “We were able to effectively engineer their product, but that was only part of the picture. They lacked the knowledge of all the elements required to create an effective venture and actually get the product to market. Aubrey Group’s ESP helps entrepreneurs put all the necessary building blocks in place and helps them understand their choices, make solid decisions, reduce their risk, and enable realization of their dream.” For more information, contact Mishelevich at davidm@aubreygroup.com, or 949-581-0188, ext 261.
IMS Health Launches Service Program to Track and Report Promotional Expenses
IMS Health, which provides market intelligence to the pharmaceutical and health care industries, has launched IMS Aggregate Spend Compliance Services, a comprehensive set of solutions to help pharmaceutical and medical device companies comply with the growing number of federal and state transparency and marketing disclosure laws in the U.S. that are known as “aggregate spend” reporting regulations.
Since 2006, more than 20 states have introduced legislation requiring pharmaceutical and device manufacturers to disclose various financial transactions or exchanges of financial value to healthcare providers and affiliated healthcare organizations. Similar legislation has been introduced at the federal level. Information about the tracking and reporting services are posted on the company’s website.
Entrepreneurial Service Program Reaches Out a Helping Hand to Innovative Minds
Aubrey Group, Inc., in Irvine, California, recently introduced a company-wide effort called the Entrepreneurial Services Program (ESP) that is focused on helping medical device entrepreneurs assemble the key ingredients required for a successful launch of product.
ESP came about to assist the many entrepreneurs and inventors who come to Aubrey Group for engineering and technical help, but are at too early a stage to use its engineering development services. These “early entrepreneurs” had not yet faced—or even been aware of—the other related and essential issues for viability: funding, budget, patents, marketing, regulatory, manufacturing—to name a few. ESP is designed to benefit those people and companies just starting out.
The program provides quick and inexpensive access to the talent, experience, knowledge, and capabilities of Aubrey Group’s entire team. They would be happy to help and provide answers.
For further information, please contact David J. Mishelevich, M.D., Ph.D., at davidm@aubreygroup.com or call him at 949-581-0188, ext 261.
NIH Chief Stresses Economic Impact of Federal Biomedical Funding
Cancer and certain types of mental illness are diseases that appear ripe for research breakthroughs, according to Francis Collins, who just marked his sixth month as director of the National Institutes of Health.
“I’m always loath to say what’s on the brink of some big breakthrough,” says Collins, who met with local reporters while attending the annual meeting of the American Association for the Advancement of Science—which is in San Diego for the first time since the AAAS was founded in 1848. Yet Collins, who previously led the Human Genome Project, says advances in genomics and the power of genetic sequencing technologies are opening the possibility of new therapies in cancer, as well as for schizophrenia, autism, and bipolar disorders—diseases with strong genetic components.
“I would hope in another five years that we would have the capability to have the genome of your tumor completely analyzed—and then go through the list of drugs that are available” to determine which anti-tumor drug would be most effective. Collins says using genomics to assess how genetic variations affect each patient’s individual response to different drugs is an example of the growing field of pharmacogenomics, and represents another aspect of the revolution that’s underway.
Collins says cancer is a disease of the genome, and federal funding for biomedical research is not only advancing on a cure but also helping to sustain the nation’s economic recovery. Of $10 billion in stimulus funding to be spent over two years on biomedical research, Collins says about $4.5 billion has been allocated throughout the country so far.
Chairman Bill Young: Next Biogen Idec CEO May Be a Scientist
The future leader of Biogen Idec might be as familiar with a petri dish as he or she is with a spreadsheet.
That’s according to Bill Young, who took over as Biogen’s chairman of the board on January 1. Young is on the board committee that’s searching to replace CEO Jim Mullen, who announced last month that he’s stepping down after a decade at the helm of the Cambridge, MA-based biotech giant. I met with Young last week while he was visiting a startup in Seattle.
“We have a whole list of criteria, but the most important of which is that we find someone who has managed and understands the role of science in a biotech company, and how that needs to be bridged to the commercial side of things,” Young says. “That may mean it’s a scientist or someone who understands how that fits into what biotech companies are designed to do, which is develop products.”
The job is one of the higher-profile gigs in biotechnology. Biogen, which also has operations in San Diego, is the world’s largest maker of multiple sclerosis drugs. It generated $4.4 billion in revenue last year, and came close to a $1 billion annual profit in 2009. Biogen had 4,750 employees worldwide heading into this year, and a stock market valuation of $15 billion that ranks it behind only Amgen, Gilead Sciences, and Celgene among biopharmaceutical industry peers.
Icahn Making His Move On Genzyme
Carl Icahn is now officially making moves on the Boston area’s two biggest biotech companies. After boosting his stake in the slumping Cambridge, MA-based firm Genzyme, Icahn is now seeking representation on its board, according to the company. Icahn has been making similar plays for control at Genzyme’s neighbor, Biogen Idec, for years.
Icahn has nominated four candidates, including himself, for election to Genzyme’s board of directors at its annual meeting, slated for May 20. His nominees include portfolio manager Alex Denner and Harvard Medical School professor Richard Mulligan—both of whom won seats on Biogen’s board last year—as well as Steven Burakoff, a professor at Mount Sinai School of Medicine.
Icahn appears to have a hunter’s instinct for troubled biotechs. He’s boosted his stake in Genzyme stock from 1.5 million shares to 4.8 million shares, as of December 31. This follows his success in gaining two board seats last year at Biogen, the world’s largest maker of multiple sclerosis drugs, which he has criticized for underperforming its peers in the biotech industry. Last month he nominated three new candidates for Biogen’s board. Icahn and Eastbourne Capital Management succeeded last year in gaining two board seats at San Diego-based Amylin Pharmaceuticals, forcing out the firm’s chairman and an independent director.
Things Just Click for Nobel Chemist Barry Sharpless
Instead of starting from scratch each time, what if chemists took their cue from Nature, working with simple building blocks? This basic, yet innovative question has led to Barry Sharpless’ coined term “click chemistry”. Sharpless spent more than a decade grappling with this problem, and, starting in 1980, discovered several reactions that could produce just the desired form. The innovation transformed organic synthesis research practically overnight and led to faster drug discovery, more stringent FDA policies, and improved and new medicines – and won him the 2001 Nobel Prize in chemistry.
Now, click chemistry stands poised to have an even greater scientific impact than Sharpless's Nobel-winning work. Applications already visible on the event horizon are drugs that mimic hormones, materials that our bodies can't tell aren't 'real,' less expensive diagnostic PET scans, and revolutionary nanoscale diagnostic blood tests.
CalTech Professor Jim Heath and Sharpless are a match made in serendipity
heaven. Heath is a leading nanotechnologist and creator of microfluidic devices,
and a new company has licensed the Scripps Research and CalTech technologies.
Heath's click chemistry-driven "lab-on-a-chip" holds the promise of
revolutionizing testing for cancer and Alzheimer's so that individual tests may
cost a single dollar, or less, instead of hundreds; test kits containing click
chemicals will have a long shelf-life and remain stable in extreme temperatures;
an entire micro-lab could fit in a carry case. Imagine, Sharpless says, the
implications for medical treatment if diagnostic tests could happen wherever
there are people, not just where hospitals and clinics already exist.
"I'd like to see a new drug, one discovered by click chemistry, in my
lifetime," Sharpless said. "We're getting close. Really close."
Root or Shoot: Power Struggle Between Genetic Master Switches Decides Stem Cell Fate, Growth Orientation in Plants
The first order of business for any fledgling plant embryo is to determine which end grows the shoot and which end puts down roots. Now, researchers at the Salk Institute expose the turf wars between two groups of antagonistic genetic master switches that set up a plant's polar axis with a root on one end and a shoot on the other.
The scientists determined that a variant of the gene known as TOPLESS can cause the development of a root instead of a shoot, resulting in a young plant with roots at both ends. Long and his team discovered functional TOPLESS codes for a repressor protein that inactivates genes that otherwise would cause root development in the shoot area of the plant. In the study Zachery R. Smith, a graduate student in Long's laboratory, discovered that these fate-transforming genes are actually two familiar characters: the genes PLETHORA 1 and 2 had been known to act as master regulators that determine the identity of the root meristem.
Understanding these mechanisms at a molecular level can help us adjust the behavior of agricultural plants, Long noted. If scientists can identify genes that determine certain traits—such as kernel size in corn—they can better engineer plants to have more desirable traits.
With an Eye on Diseases, Company Grows Corneas in the Lab
An Oceanside stem cell company that demonstrated it could grow a human cornea in a Petri dish has a business proposition it hopes will catch on with researchers testing products on live rabbits: use our cells instead.
Kenneth Aldrich, chairman of the small, publicly held International Stem Cell Corp., said the company’s “parthenogenic” stem cells, created from unfertilized eggs, have the potential to turn into corneas with similar characteristics as rabbit eyes. An initial round of testing demonstrated that the corneas generated from stem cells have the same permeability as rabbits’ corneas, he said, an important aspect for testing products that may harm the human eye.
“We hope we’ll be able to induce some of the companies that now use rabbits to use our cells,” Aldrich said. “We can probably save the lives and probably some discomfort to a lot of small animals.”
Optimer Pharmaceuticals Battling Deadly Infection
An ugly, antibiotic-resistant bug known to creep through hospitals and wreak havoc on the gut could soon meet its match.
If San Diego drug developer Optimer Pharmaceuticals Inc. succeeds in getting its experimental treatment for Clostridium difficile to pass muster with the U.S. Food and Drug Administration, it will be the first drug aimed at the potentially deadly bacterial infection to reach the market since the 1960s, according to Optimer.
On Feb. 4, Optimer announced positive results from the second of two pivotal Phase 3 trials evaluating the safety and efficacy of its fidaxomicin drug in patients with Clostridium difficile infection. The company plans to use data from this study to support submission of a New Drug Application to the FDA in the second half of 2010.
Scripps Research Names Noted Learning and Memory Scientist to Neuroscience Department
The Scripps Research Institute has named Gavin Rumbaugh, Ph.D., as an assistant professor in the Department of Neuroscience at the institute's Florida campus.
Rumbaugh, who was an assistant professor at the University of Alabama, Birmingham, is known for his work on the brain mechanisms of information storage, learning, and memory, with a particular emphasis on the plasticity of neural circuits—the ability of neurons to adapt in the face of both developmental and environmental change.
"We're pleased to have Gavin join our department," said Ron Davis, chair of the Scripps Florida Department of Neuroscience. "He's a tremendously talented young scientist who is working in a field that holds the promise of new discoveries that could have an impact on the lives of millions of patients suffering from increasingly common neurodegenerative diseases like Alzheimer's. He's one of the people who can make a difference and we want to welcome him warmly to Scripps Florida."
Research Aims to Develop Individualized Therapies for Cancer Treatment
Scripps Health, through the Scripps Translational Science Institute, is launching a first-of-its-kind clinical research trial for cancer patients that will analyze and compare the genomics of tumor tissue with the individual’s core (native, germ-line) DNA. The hope is the data will lead to individualized therapies for cancer patients.
“The science exists to allow us to sort out what are the new mutations that account for the development of the cancer, which will bring us closer to identifying the right course of treatment not only for each type of cancer, but for each individual patient,” said Dr. Eric Topol, chief academic officer of Scripps Health and principal investigator of the study.
Patients with a new diagnosis of cancer may elect to participate in this study. While participation in the study is not likely to provide direct benefit for participating patients, the data will be shared with each patient’s treating physician and the hope is that it will have a major impact for future generations of patients.
New DNA Platform Validated for Human Identification Applications
Life Technologies announced the launch of a new genetic analysis system designed to optimize data quality and deliver increased reliability, performance, quality assurance and ease-of-use specifically for forensic DNA testing laboratories. The Applied Biosystems 3500 Series Genetic Analyzer is the latest advancement in the company's industry leading line of capillary electrophoresis (CE) DNA sequencing systems, and has been validated to support a specific feature set and workflow for human identification (HID) applications. The company made the announcement at the American Academy of Forensic Sciences 62nd Annual Meeting in Seattle, Washington.
While DNA analysis has achieved broad acceptance from both the public and members of the legal community, common challenges, including cost and time constraints, are still faced by professionals in forensic laboratories. The introduction of the 3500 Series helps forensic scientists better address these challenges by providing an integrated HID system approach and solution, including Applied Biosystems' validated HID reagents, consumables and software, which enhances productivity and enables easy generation of cost-effective analyses and high-quality data.
The Mouse with a Human Liver: A New Model for Treating Liver Disease
How do you study—and try to cure in the laboratory—an infection that only humans can get? A team led by Salk Institute researchers does it by generating a mouse with an almost completely human liver. This "humanized" mouse is susceptible to human liver infections and responds to human drug treatments, providing a new way to test novel therapies for debilitating human liver diseases and other diseases with liver involvement such as malaria.
"We found that, not only can we infect our humanized mouse with Hepatitis B and Hepatitis C, but we can then successfully treat this infection using typical drugs," explains first author Karl-Dimiter Bissig, M.D. Ph.D, an internist and post-doctoral researcher in the Laboratory of Genetics. "As a physician, I understand the importance of this type of bench-to-bedside research. This study shows a real application for our mouse model, making it relevant from both an academic and a clinical perspective."