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The Blog of Drug Discovery News

Third time’s a charm for patent reform?

So, for the third consecutive session of the U.S. Congress, Sen. Patrick Leahy (D-Vt.), the chairman of the Senate Judiciary Committee, has introduced patent reform legislation, along with former committee chairman Sen. Orrin Hatch (R-Utah) and other senators [notably: Jeff Sessions (R-Ala.), the committee’s ranking Republican, and fellow senators Chuck Schumer (D-N.Y.), Jon Kyl (R-Ariz.) and Ted Kaufman (D-Del.)].

It’s legislation that, if passed, would affect more than just pharmas and biotechs, obviously, but certainly those types of companies are among the ones who most rely on patent protections to keep themselves going. Here’s what the Pharmaceutical Research and Manufacturers of America (PhRMA) has to say about the proposed reform, by way of PhRMA Senior Vice President Wes Metheny:

“Senator Leahy’s patent reform bill would strengthen the patent system while protecting patent owners and maintaining incentives for innovation. The bill balances the diverse interests of various stakeholders across American business sectors while maintaining strong and reliable intellectual property protection. A strong patent system is crucial to America’s economic competitiveness and our global leadership in medical innovation, especially in these economically trying times.

“The U.S.patent system provides American businesses with incentives that drive innovation and create jobs across the country. By creating a positive environment for innovative R&D, the patent system encourages the development of ideas into life-changing products and further encourages the ideas of the future.

“This couldn’t be more true than in the biopharmaceutical research sector. In a field where the development of an average new medicine can take 10-15 years and cost more than $1.3 billion, the incentives provided by intellectual property play a key role in encouraging this costly – and risky – investment.

“In the end, the benefits are great. Life expectancy is at an all-time high and previously life-threatening diseases are now viewed as controllable conditions, largely on the strength of the innovative R&D taking place through America’s biopharmaceutical sector. Meanwhile, the sector – one of the most research-intensive in the world – employs more than 650,000 direct biopharmaceutical workers and supports a total of more than 3 million jobs.

“America’s biopharmaceutical research companies have a real and significant effect on healthcare and on the economy. This just wouldn’t be true without a reliable and predictable patent system.

“Senator Leahy’s bill – and the support of its cosponsors – demonstrates their appreciation for the importance of intellectual property protection to the U.S. economy and to the jobs – and life-saving innovation – that it provides.”

“With this agreement, we are closer than ever to advancing patent reform legislation through the Senate,” said Leahy in a prepared statement Feb. 3. “Senator Hatch and I have worked through many Congresses to make meaningful reforms to the nation’s patent system, and I appreciate his commitment to this effort. This compromise may not be everything that everyone wants, but it makes important reforms to the outdated patent system. Strengthening American patents will improve the quality of our inventions and innovations, which will translate into jobs and economic growth in Vermont and across the country. Congress is committed to strengthening our economy, and the Patent Reform Act is an important component of that effort. I hope the leaders will soon schedule floor time for this important legislation.”

February 3, 2011 Posted by | Corporate, Government, Lawsuits & Legal Matters | , | Leave a comment

PhRMA’s take on the State of the Union

Washington, D.C.—Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO John J. Castellani released the following statement after President Barack Obama’s State of the Union address:

“We commend the President for offering an ambitious agenda that focuses on bolstering the economy, job growth and strengthening our education system to ensure that we attract and retain the world’s best and brightest talent.

“While innovation and American competitiveness were also central themes in the President’s address, we believe that medical innovation specifically will continue to play a crucial role in advancing patient health and spurring economic growth in the U.S. The President recognized this crucial point tonight, as he stressed the need for investments in biomedical research. The good news is that this important research is already taking place—with more than $65 billion invested in R&D by the biopharmaceutical industry in 2009 alone.

“There is no doubt that innovation is a critical building block for growing the U.S. economy. For this reason, it is important that the Administration and Congress view the biopharmaceutical research sector—one of the most innovative, technology-driven sectors in America—as a national health and economic asset. Our global leadership in medical progress, and the domestic jobs and economic output that goes along with it, is ours to lose if our nation’s leaders don’t support policies that help preserve and nurture future medical innovation.

“We will continue to work with the Administration and members of Congress, on both sides of the aisle, on bipartisan solutions that can help spur growth in the U.S. economy, preserve timely patient access to new medicines, maintain market-based competition and foster future development of life-enhancing and life-saving treatments.”

January 26, 2011 Posted by | Corporate, Government | , , , | Leave a comment

Genentech fires back at FDA

FDA doesn’t want to give the thumbs up for Avastin’s use as a first-line therapy for breast cancer, and Genentech has a few things to say about that:
_____________________________________________

GENENTECH SUBMITS RESPONSE TO FDA’S NOTICE OF OPPORTUNITY FOR A HEARING ON PROPOSAL TO WITHDRAW APPROVAL OF METASTATIC BREAST CANCER INDICATION FOR AVASTIN

SOUTH SAN FRANCISCO, Calif. (January 18)—Genentech Inc., a member of the Roche Group, today submitted its response to the U.S. Food and Drug Administration’s (FDA) Notice of Opportunity for a Hearing (“NOOH”) on the Agency’s proposal to withdraw approval of the metastatic breast cancer (mBC) indication for Avastin (bevacizumab). Genentech has submitted the response and supporting documentation electronically to http://www.regulations.gov under Docket No. FDA-2010-N-0621. Regulations.gov controls the timing of the documents being made public on its website. Click here to view the response on Genentech’s website.

The response explains Genentech’s right to a hearing to allow full and fair discussion of the issues in a public forum, and sets forth the data, analyses and information on which Genentech intends to rely at a hearing to demonstrate why Avastin should remain an FDA-approved option for women in the United States with HER2-negative mBC.

Genentech believes women with mBC in the United States are entitled to Avastin as an FDA-approved choice and that accelerated approval of Avastin in combination with paclitaxel should be maintained. The company has proposed conducting a new confirmatory trial of Avastin plus paclitaxel, the chemotherapy combined with Avastin in the study that led to accelerated approval, in HER2-negative mBC to the FDA. The trial would have a biomarker component with the intent of identifying people who may be more likely to derive a greater benefit from Avastin.

At this time and until the conclusion of the proceedings with the FDA, Avastin remains approved for use in combination with paclitaxel for the first-line treatment of HER2-negative mBC in the United States. The effectiveness of Avastin in HER2-negative mBC is based on an improvement in progression-free survival in the E2100 study. There are no available data showing that Avastin improves disease-related symptoms or survival in HER2-negative mBC. Avastin is not approved for patients with breast cancer that has progressed following anthracycline and taxane chemotherapy administered for metastatic disease.

Doctors with questions about the use of Avastin for mBC can call Genentech’s Medical Communications group at (800) 821-8590. Patients with questions or concerns about insurance coverage can call Genentech’s Access Solutions Group at (866) 4 ACCESS.

______________________________________

Also worth noting is a story from the San Francisco Business Times:

Genentech Inc. responded to the Food and Drug Administration, saying it wants to present evidence and make arguments against the FDA’s plan to withdraw approval for use of Avastin as a breast cancer treatment.

The FDA said Dec. 16 it planned to withdraw its OK for Avastin as a first-line treatment for metastatic HER2-negative breast cancer combined with paclitaxel. South San Francisco-based Genentech asked the FDA for a hearing on Dec. 23. Today’s submission includes all the evidence and data that Genentech plans to rely on in its arguments at the hearing, for which no date has yet been set.

Genentech, which is owned by Swiss giant F. Hoffman-La Roche Ltd., told the FDA that “a hearing is particularly warranted” because the drug has already been used for this treatment (the FDA approved it in early 2008) and because European regulators, who reviewed the same data, supported the use of Avastin in breast cancer.

“Since this approval, thousands of women with MBC have been treated with Avastin in the United States,” Genentech said.

For its part, the FDA looked at Avastin when it was later tested in combination with two other types of chemotherapy than paclitaxel. Avastin didn’t do as well in those tests as it did with paclitaxel. Genentech disagrees with the FDA’s interpretation of that data and those two tests.

“We look forward to the opportunity to present our views more fully on these important issues,” said Michelle Rohrer, Genentech’s vice president of regulatory affairs, in a letter to the FDA.

Until talks with the FDA are finished, the drug is still being used to treat breast cancer along with paclitaxel. Avastin isn’t used by patients who’ve already had chemotherapy.

January 20, 2011 Posted by | Corporate, Government | 2 Comments

Looking for similars parity

So, I’m seeing talk of biosimilars showing up a bit more on the news feeds and in my e-mail inbox. Hard to say yet whether it’s a sign of a rising trend in pharma and biotech or whether it’s just a little jump in the frequency.

But I will say that in our January issue (heading out in the mail and also available online – key stories here and full issue in PDF form here), we had a sizable commentary about biosimilars. Given that the FDA is supposedly going to finally catch the U.S. up somewhat with its European peers in terms of an approval pathway and regulatory guidelines, I won’t be at all surprised to see a lot more stories on biosimilars like the one below that hit the newswires yesterday:

Merck & Co. and PAREXEL form strategic alliance focused on clinical development of biosimilar candidates

WHITEHOUSE STATION, N.J. & BOSTON—Merck & Co. Inc. and PAREXEL International Corp., a leading global biopharmaceutical services provider, today announced that they have entered into an alliance by which PAREXEL will provide strategic access to global clinical development services for designated biosimilar candidates to Merck BioVentures. Merck BioVentures, a division of Merck, is focused on the delivery of high quality biosimilars to the patients that need them.

“PAREXEL has extensive, industry-leading experience with biosimilar development, and we truly understand the scientific complexities, and regulatory pathways involved,” said Josef von Rickenbach, chairman and chief executive officer of PAREXEL. “We are committed to working with Merck BioVentures to assist in advancing its biosimilar portfolio in this rapidly developing market segment for the benefit of patients worldwide.”

Under the terms of the agreement, PAREXEL will provide Merck BioVentures with strategic access to a broad range of regulatory strategy and clinical development planning capabilities for the development of certain broad classes of biosimilars across various therapeutic areas, including exclusivity for certain candidates. The agreement also provides for the establishment of a dedicated Merck BioVentures unit within the PAREXEL organization. Further details of the agreement were not disclosed.

“Through this agreement, Merck BioVentures has secured broad strategic access to PAREXEL’s proven biosimilar clinical development experience,” said Michael Kamarck, president of Merck BioVentures. “This agreement positions Merck BioVentures for success with an industry leading partner that has the expertise and resources to conduct clinical development of our diverse portfolio of candidates to allow timely delivery of products to the marketplace.”

I think probably the biggest hangup for biosimilars (and thus news about any work on them) really has been the sluggish pace at which FDA seems to have been addressing this topic. I know that biosimilars pose many more challenges than do generic versions of some small-molecule drug or the like, but I can’t help but think that with European regulators already having trod this ground that the FDA has really been dropping the ball (as opposed to simply being wisely cautious).

Of course, that assumes that they agency even makes good on getting workable guidelines out this year. Lot of people and organizations fail at New Year’s resolutions.

January 13, 2011 Posted by | Corporate, Government, Labwork & Science | , , , | 1 Comment

People on the move: NIGMS head gives notice

BETHESDSA, Md.—Having served as director of the National Institutes of Health’s National Institute of General Medical Sciences (NIGMS) since November 2003, Dr. Jeremy M. Berg has announced that he will step down from his post to become associate senior vice chancellor for science strategy and planning in the health sciences at the University of Pittsburgh. He will also be a faculty member in the department of computational and systems biology at the university’s school of medicine. However, he does not anticipate leaving NIGMS for some months yet, with a planned exit date of the end of June 2011. At that point, if the search for a new director is still underway, an acting director will be named.

“The time I have spent at NIH has been a highlight of my career, and I hope to be able to continue to contribute to this exceptional institution from my new position,” Berg says. “When I joined NIGMS, I was fortunate to come to an outstanding organization with an extremely talented and dedicated staff. With this strong team, I have worked hard to make the institute even better, more transparent and more responsive to the needs of the scientific community.” He adds that he had no intention of leaving NIGMS but is doing so in support of the career of his wife, a leading breast imaging clinical researcher, who was recruited by many institutions around the country, among them the University of Pittsburgh. He says that the university “offered tremendous opportunities for each of us.”

As NIGMS director, Berg oversees a $2 billion budget that primarily funds basic research in cell biology, biophysics, genetics, developmental biology, pharmacology, physiology, biological chemistry, bioinformatics and computational biology. The institute supports more than 4,500 research grants, which make up about 10 percent of all grants funded by NIH. NIGMS also funds a substantial amount of research training and programs designed to increase the diversity of the biomedical and behavioral research workforce.

January 3, 2011 Posted by | Government, Promotions and Moves | , , | Leave a comment

Seeking the ‘eye of the tiger’

WASHINGTON—Science funding is getting an infusion of cash after Congress in December passed a $45 billion reauthorization of the America Competes Act—a bill designed to invest in research and science education, and to fund and foster innovations that will help keep the United States competitive in tech-driven industries.

It signals another key milestone for scientific research, and history teaches us that building and maintaining a competitive advantage is vital to our country.

The importance of maintaining a competitive advantage on the global stage can be defined by one striking moment that occurred Oct. 24, 1957: Sputnik I was launched, an event that marked a 20-year race for supremacy in space between the Soviet Union and the United States. For two decades, the two nations traded volleys in the space race, with the United States gaining the upper hand by the late 1960s. By the 1970s, space exploration stood as a symbol of the competitive nature between the world’s two superpowers for technological, military, cultural and intellectual supremacy.

In a less grandiose analogy, the United States must regain the “eye of the tiger.”

In Rocky III, the fictional boxer Rocky Balboa must come back from a rattling defeat to Clubber Lange and the death of his longtime manager, Mickey. He trains with his old nemesis, Apollo Creed, learning along the way that he needs to stay hungry and keep “the eye of the tiger.”

Sadly, the story has changed in recent decades, with the United States slowly losing its competitive edge. It seems as if we no longer place a premium on education, research and innovation. Evidence of this is seen in the World Economic Forum’s recent ranking of the quality of math and science education around the world—the United States stands 48th. We are lagging behind other countries in the issuance of patents and ­even—in an era of high unemployment—American companies consistently suffer from a shortage of individuals with critical skills.

The America Competes Act can serve as an investment in regaining our competitive edge and becoming the world leader in education, research and innovation.

The bill, which has been in legislative limbo throughout the year, sets funding levels for the next three fiscal years for the National Science Foundation, the Department of Energy’s research programs, and the National Institute of Standards and Technology. It also funds education initiatives and a range of other programs.

The legislation provides a total of $23.5 billion for NSF, $16.9 billion for the DOE’s Office of Science, $2.9 billion for NIST, $600 million for education efforts and $1.4 billion for other programs.

The original America Competes Act was approved in 2007. The legislation is based on recommendations outlined in the “Rising Above the Gathering Storm” report released by the National Academy of Sciences in 2005. It urged the United States to work harder to support technological innovation and enhance science, technology and mathematics education.

“In acting to update and extend the America Competes Act, we will spur innovation, invest in cutting-edge research, modernize manufacturing, and increase opportunity,” says House Speaker Nancy Pelosi. “Simply put, we will continue to ‘rise above the gathering storm’—and keep America No. 1.”

Earlier this year, the bill stood in political limbo, with an earlier draft that was nearly double the cost of the version passed through the House and Senate. A compromise was reached during the lame duck session to cut down the term of the bill from five years to three, creating most of the savings from the original $86 billion draft.

“If we are to reverse the trend of the last 20 years, during which our country’s technological edge in the world has diminished, we must make the investments necessary today,” House Science and Technology Committee Chairman Representative Bart Gordon, D-Tenn., said in a statement.

“More than half of our economic growth since World War II can be attributed to development and adoption of new technologies. These investments are the path toward sustainable economic recovery and growth and the path toward prosperity for the next 50 years,” Gordon said.

Among the new programs in the act, 98 percent of which will fund new scientific research, is the creation of an inter-agency public access committee in the Office of Science and Technology Policy. The committee will coordinate federal science agency policies related to the stewardship and dissemination of research results, including digital data and peer-reviewed scholarly publications.

Another aspect of the bill welcomed by the research community is the authorization of the funding boost for NSF, NIST, and DOE, which “puts us on a path towards a continued increasing investment in those programs over the next 10 years,” Jennifer Zeitzer, director of legislative relations at the Federation of American Societies of Experimental Biolog.

“It’s a bipartisan bill, which we’re happy about because it sends a signal that investing in science and paying attention to science issues is something that both parties care about,” she said.

Rep. Dan Lipinski, D-Ill., a former professor and one of the few members of Congress trained as an engineer, says he was proud to have helped write and pass the measure, which he says “makes essential, job-creating investments in advanced research and science, technology, engineering and mathematics education.”

“I am grateful for the valuable feedback I received from the Association of American Universities and the Association of Public Land-grant Universities while writing the NSF title of this bill,” he adds in a statement. “Because of their expertise, and because of what I learned from scientists and research administrators across the country, I believe this legislation will have an enduring positive impact on university-based research and STEM education programs.”

The Business Roundtable lauded Congress for its swift action in passing the America Competes Reauthorization Act.

“The bill will attract more young Americans into technical fields, expand the employment horizons and earnings potential of millions of new American workers, and strengthen America’s future. The Act helps increase our nation’s competitiveness by driving recruitment of K-12 math and science teachers, enhancing the skills of existing teachers, and increasing investments in both scientific research and math and science education. The reauthorization of this act will ensure America remains a global leader in technology, innovation and science in the 21st century,” said Larry Burton, Executive Director, Business Roundtable.

Nonetheless, it was a long and winding road to passage for the bill. The scientific community made an urgent call for it to be reauthorized in September—even issuing a stirring update to the original National Academies report—but despite their best efforts the legislation expired in October before the Senate had time to pass it.

The bill was revived in early December with Tennessee Republican Sen. Lamar Alexander among those credited for bringing the bill forward. Alexander is a strong supporter of the Department of Energy’s Office of Science, which is another of the agencies set to benefit from the funding increases mandated by America Competes.

“We’re very pleased. We think it’s a very, very important statement in support of research,” says Robert Berdahl, president of the Association of American Universities in Washington, D.C.

Society of Photographic Instrumentation Engineers (SPIE) leaders are among researchers, engineers, and others in the science and engineering community celebrating the passage today of the America COMPETES Act of 2010.

“We are delighted to see continued strong support for the National Science Foundation and the National Institute of Standards and Technology,” said SPIE CEO Eugene Arthurs.

“We are also happy to see approval for both continued and new spending for Department of Energy (DOE) research, and support for ARPA-E (Advanced Research Projects Agency-Energy),” Arthurs said. “This is a vital step in building a vigorous innovation pathway, linking the excellent R&D produced by DOE and other agencies to successful commercialization and the creation of jobs.”

Deborah L. Wince-Smith, president and CEO of the Council on Competitiveness, says the group applauds the passage of the America Competes Reauthorization Act with bipartisan support.

“By passing this legislation, Congress has taken a critical step in maintaining America’s leadership in innovation and entrepreneurship, which serves as the foundation for economic growth and long-term prosperity,” she says in a statement.

“The America Competes Act reauthorization paves the way for the vital funding of research, STEM education and American innovation, and will help keep America competitive through a time of great economic uncertainty. We encourage the 112th Congress to build upon this reauthorization and show their commitment to raising the standard of living for all Americans.”

December 30, 2010 Posted by | Academia & Non-Profit, Corporate, Government, Labwork & Science | Leave a comment

Brilique…yes, Brilinta…not sure

Earlier this week in a Dec. 14 blog post, I noted that European regulators had given the go-ahead to AstraZeneca’s ticagrelor for the prevention of atherothrombotic events in adult patients with acute coronary syndromes. In that post, I noted it was likely the U.S. Food and Drug Administration (FDA) would make a similar move for Brilinta (as the drug will be known in the United States) as the European Commission did for Brilique (as it will be known in Europe).

Well, today’s decision by the FDA shows why it was a wise move I became a journalist and not a market analyst.

While the FDA didn’t exactly say “No way,” it also didn’t say “Yes.” Instead, we have a solid, “We’re not sure yet.”

More specifically, the FDA has issued a complete response letter (CRL) for the New Drug Application (NDA) for ticagrelor in the United States. In the CRL, the FDA has requested additional analyses of data from AstraZeneca’s PLATO trial. The agency did not request additional studies, clinical studies or otherwise, as a prerequisite for approval of the ticagrelor NDA. At this point, it seems to want the numbers crunched a bit more from the studies that have been conducted.

AstraZeneca has noted that it is evaluating the contents of the CRL and will respond to the agency’s request for additional analyses of the PLATO data as soon as possible. The company reports that it remains confident in the NDA submission for ticagrelor and in its ability to respond to the agency’s questions.

“Our highest priority is to provide the requested PLATO analyses to the FDA and progress to completion of the Brilinta NDA review,” says Martin Mackay, president of research and development for AstraZeneca.

December 17, 2010 Posted by | Corporate, Government | , , , | Leave a comment

Oversaturation vs. tunnel vision

One of the things that drives me nuts when I go to the grocery story is heading down the aisles and seeing a slew of new products that seem to be designed solely to part me with my money and make less space for established items that I already like more than they do to enhance my life. Truly, I have to wonder if adding marshmallow bits to a cereal or making a chocolate version of a healthy oat-based staple of the breakfast table is really necessary. And cheeseburger flavored Doritos? Don’t get me started.

I admit that I sometimes feel the same way when I see multiple iterations of drugs, whether over-the-counter or prescription, or when I see large-scale research efforts that cover the same ground but with different budgets and different researchers.

Then I realize that it’s just that growing “grumpy old guy” persona that started to kick in just before I officially entered middle age. Yes, sometimes pharma companies do simply re-tool a product or create a knock-off version of something for the sole purpose of capturing market share and providing something that seems new but really isn’t.

But so many other times, products that seem similar (particularly when it’s a new chemical compound from the same company for the same target or a similar-acting one from a rival company) need to be pursued for the very reason that subtle differences can have big impacts in terms of efficacy, adverse reactions and off-target effects. I was reminded of that in writing a story yesterday for the web site on Amarin’s promising new omega-3-based triglyceride-lowering drug, which on the surface seems a lot like GSK’s Lovaza.

On the research side, I also got the reminder of how looks can be deceiving when I wrote two stories for the upcoming December issue of ddn that cover the 1000 Genomes Project and the PGP-1K, respectively. When you have two high-profile projects doing complete human genome sequencing with the magic number 1,000 involved, you start to ask questions like: “How is your project different from that one?”

But the fact is that they do have different focuses and different approaches, and because of that, they aren’t duplicated efforts that are redundantly spending money, but rather two projects doing work that will likely provide support to each other’s efforts in the long run, as well as each provide distinct and unique contributions to genomics.

Because, in the end, if there’s anything we’ve learned from decades of pharma and biotech breakthroughs, failures and other newsworthy outcomes, the human body and human diseases are an arena where we aren’t ever likely to have all the answers, and might be lucky to get even a handful of them, no matter how many similar or even duplicative efforts we have.

Too much money poured into certain areas, even important ones like cancer, can mean oversaturation and dilution of research dollars that might be needed on other disease areas. But too little diversity in the research and development sphere, and we can end up with tunnel vision…and look where that got us when we took our eyes off new antibiotic research and ended up with a whole lot of resistant pathogens and not enough ways to fight them.

November 30, 2010 Posted by | Corporate, Government, Labwork & Science | , , , , , | Leave a comment

Putting a face on diabetes isn’t too hard

In my role with ddn, whether in the print publication or the online venues, I get to write about myriad diseases that affect the human population on this planet.

From Huntington’s and Alzheimer’s diseases to diabetes and cancer, companies that we cover each month are working to find new ways of battling these insidious diseases.

In talking with many of the people on the front lines of the research effort to develop these treatments, I get to put a name and face to efforts to improve our chances of surviving and thriving when these illnesses strike.

Over the years, the pages of ddn have featured stories about diseases that strike particularly close to home for those of us writing the articles. For me, it’s diabetes.

November is Diabetes Awareness Month, and it serves as a reminder for us all of a disease that is a growing problem.  According to some health studies, by 2050, one in three adults could be diabetic.

Today, nearly 24 million Americans have diabetes – including an estimated 6 million Americans who have it and don’t know it. It is estimated that another 57 million adults in the U.S. have pre-diabetes, placing them at increased risk for developing type 2 diabetes. Type 2 is the most common form of diabetes, accounting for 95 percent of all cases.

I don’t have to look too far to put a face on diabetes. My wife was diagnosed with type 2 diabetes just over a year ago. Her father was diagnosed five years ago, but he lived with the disease for many years and didn’t know it, choosing to ignore the warning signs.

As a result of years of living with uncontrolled diabetes, my father-in-law today is 64 years old, legally blind and must undergo kidney dialysis three times a week. For him, it’s a matter of life or death.

After being diagnosed, my wife felt as if she were just handed a death sentence. I knew from the stories I’d written that there are two ways to live – you can control the disease or it can control you.

We’ve learned that type 2 diabetics can take a number of oral medications to help their body metabolize sugars, increase insulin production or block the absorption of carbohydrates.

My wife also has a key advantage over her father in her fight against diabetes – early detection. While a diagnosis is a life-changing experience, knowing the what you’re up against is instrumental in effective treatment.

It also is key in thwarting the ravages of diabetes, which include neuropathy, which causes tingling, numbness and destruction of nerves. Because of neuropathy, diabetics must check their feet regularly to ensure they have no wounds. If undetected, a wound can lead to infection that could lead to amputation. Diabetes may also lead to kidney disease, heart disease and blindness.

We’ve learned from the endocrinologist that the goal of diabetes treatment is the prevention of long-term complications. We’ve also had to talk to dietitians and diabetes educators, learning that it truly takes a village to keep a diabetic well.

I’ve learned that even a simple trip to the optometrist can heighten anxiety in my wife. She has her father as a constant reminder of what can happen with this disease.

Type 2 diabetics can take a number of oral medications to help their body metabolize sugars, increase insulin production or block the absorption of carbohydrates, and that’s where we are at. Thanks to the work of countless researchers over the decades, these treatments are available to help diabetics keep their blood sugar levels in check.

Researchers today are at work to discover new drug candidates that have greater efficacy against these diseases. Stepping outside of my role as a journalist and speaking as a husband and father, I have to say just how grateful I am for the work of these researchers. Whether you work at the biggest pharma or the smallest of labs, your work is having an impact on the lives of people the world over.

Some of you may even be motivated in the lab by your own personal experience. We all can share that common bond in the human condition. The faces of these diseases are all around us, and the battle is no less important today. That key discovery that could deliver the knock-out punch to a disease could be occurring in a lab right now.

And to all of the researchers who toil each day to find the Holy Grail, I thank you.

November 17, 2010 Posted by | Academia & Non-Profit, Corporate, Government, Labwork & Science | , , , | Leave a comment

For stem cell case plaintiff, faith and science go hand-in-hand

Yesterday, we shared a Q&A with the lead plaintiffs in the controversial federal lawsuit challenging federal funding for embryonic stem cell (eSC) research, Dr. James L. Sherley, a biological engineer at Boston Biomedical Research Institute, and Dr. Theresa Deisher, research and development director at AVM Biotechnology LLC in Seattle.

Both researchers agreed to field questions about their beliefs regarding eSC research. Deisher, who has been especially vocal about her Catholic faith and how it informs her research, also agreed to take a few questions about the connection she sees between her beliefs and science.

According to Deisher’s bio, she has 17 years of experience in scientific and corporate leadership positions involving research, discovery, production and commercialization of human therapeutics. She obtained her Ph.D. in molecular and cellular physiology from Stanford University. Prior to founding AVM Biotechnology in 2007, Deisher held positions at Repligen Corp. in Cambridge, Mass., ZymoGenetics Inc., Immunex and Amgen in Seattle and CellCyte Genetics Corp. in Bellevue, Wash. She has had 23 patents issued and has published numerous scientific manuscripts.

ddn: Do you find any conflict between your faith and the scientific research you engage in?

Deisher: I do not find any conflict between my faith, which is Catholic, and my research. My faith enhances my work. My Christian faith calls me to focus on drugs and treatments that are affordable so that the greatest number of people will benefit. My faith calls me to use reason and the order of natural law to determine, for instance, the stem cell most optimal for clinical use. My faith calls me to focus only on those treatments that will be effective. My faith also calls me to respect the intrinsic dignity of human life in my work.

ddn: How does your faith impact your research approach?

Deisher: My faith is completely complementary to my research, which focuses currently on stem cells for regenerative medicine and alternative vaccines.

Adult “self” stem cells, meaning a patient’s own stem cells, are affordable, compared to all other stem cell therapies. For the most part, therapies using adult stem cells will cost about $25,000 compared to Geron’s projected $500,000 for embryonic stem cell-based therapies. Adult “self” stem cells are found naturally in every organ, in each of us, and they are “preprogrammed’” to perform the functional regeneration that patients require. They also lack the issues of immune rejection or tumor formation that plague pluripotent stem cells such as embryonic stem cells. Adult “self” stem cells are far advanced in clinical trials, and in comparison to “patented” stem cell lines, they show more effectiveness in patients. Whether one believes in God or Darwin, one can arrive at an optimal stem cell for patients using objective measures, common sense and business criteria to generate the greatest good for the most people.

I would apply these same criteria to any type of treatment that I would work on, including biologics and small molecules: Will the therapy be affordable, or will only the very few benefit? Will the therapy be effective or merely enhance my stock price or financing temporarily? Will the therapy be undermined by adverse side effects? These criteria are sound business objectives and compatible with my faith.

November 11, 2010 Posted by | Academia & Non-Profit, Corporate, Government, Labwork & Science, Uncategorized | , , , , , , , , , , , , | Leave a comment