Elizabeth Edwards is a woman on a mission and her mission is healthcare.  Mrs. Edwards wants us to know that we are facing a crisis in healthcare.  Ours is a system that is the best in the world but that is too expensive for many.

Last week at the BIO 2008 conference, Amgen hosted a media event to discuss the importance of innovation in medicine and the support needed to achieve success.  The keynote speaker was Elizabeth Edwards, who shares her husband’s (former Sen. John Edwards) commitment to improving healthcare.

She sees the cause in a nation with a fast-food mentality.   We’re a nation that wants what it wants and wants it now.  But we don’t save, invest or plan for the future.  She wants us to adopt a long-term planning strategy as a nation and this will require collaboration of all the players in the system if it is to produce a win.  And a win requires winners at all levels although acknowledging that to win, all players will need to give up something along the way.

While not all problems with heathcare can be solved with collaboration, it is a necessary first step with a nation that won’t even wait for french fries.

What is holding us back?  There is little will to analyze the efficiencies of our system.  Collaboration is viewed suspiciously at all levels.  There is a lack of common goals.  Mrs. Edwards believes that to achieve our goals, we need to have long-range planning, an ability to take risks and a system that is patient-centered.

So, what would a win look like?

A Win for Citizens

A win for citizens/patients would be healthcare made available at an obtainable cost with assured access to (reasonable) choices.  Our government needs to understand this.

Mrs. Edwards said “The disease holds all the cards and the researchers and doctors are the ones that get to play.  I don’t get to know most of the rules.  But I am not only willing to play, I need to play.”

A Win for Healthcare Providers

A win for healthcare providers would be healthcare with a manageable caseload — for a reduction of errors — and at a reasonable compensation.  “This depends on a universality of paying patients,” said Mrs. Edwards.

Right now, our system shifts the cost from the uninsured to the insured.  This is generally ignored in discussions of healthcare as though universal healthcare would mean millions of people suddenly getting care they wouldn’t have otherwise.

A Win for Government

A win for the government would be healthcare that is not cost prohibitive for patients or the government.  Joking that not even her husband John Edwards will touch it, Mrs. Edwards points out that no one is even discussing the looming crisis of long-term care for an aging population.

A Win for the Industry

A win for the pharma industry would be getting buy-in from the public (trust) with increased transparency.

So, how do we get all this?

Mrs. Edwards believes that we need a greater role by the federal government to make this happen.

First, we need increased funding of research by the NCI and NIH to get more innovation.  However, the funds need to be doled out in a different manner.  Under the current system, research grants typically to research proposals where the results are largely assumed (the established researchers).  Mrs. Edwards noted that “If you look at the past, it is when people went in new directions that there are successes.”

Second, we need to improve reporting capabilities.  The current system at the FDA relies on flawed (her words) system of self-reporting of effects.  She also points to increased user fees that put stress on the FDA to earn those dollars.  She wants to see more user fees used for reporting.  She also wants to see more efforts at pursuing treatments that don’t just favor the more profitable ones.

In closing, Mrs. Edwards tells that her breast cancer has now metastasized to her bones.  But she still feels lucky.  Noting that “cancer does not care if you have insurance,” she points out that because she can afford better insurance and is near quality research facilities, she received the best in care.  In many poor and rural areas, this would not be the case and she doesn’t see that as fair.

Everyone should hold out such hope.

Posted June 25th, 2008 by Stephen Albainy-Jenei in Conferences, Biotech, Current Affairs
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You couldn’t swing a dead cat at the BIO2008 conference today without smacking at least one governor out pressing the flesh and showing their state’s support for the biotech industry.

Joining Wisconsin Governor Jim Doyle in announcing initiatives for biosciences and stem cell research, Colorado Governor Bill Ritter gave a talk today on Colorado’s growing biotech and bioscience economic sector, representing over 400 bioscience companies in the state.

Gov. Ritter just signed a bill putting $26.5 million investment in the industry through the new Colorado Bioscience Discoveries Grant Program. Gov. Ritter noted that private research is increasing and that venture capital funding is improving.

When asked about the outlook for bioscience research funding, Gov. Ritter said that the change in administration will most certainly bring a change in the mindset within the government. He felt both candidates would support increased research and noted that Sen. Barack Obama has a belief in biotech as a 21st century economy.

The Governor said that there will not only be additional research funding with a change in the administration but that he also foresees a different mindset at the FDA, which will lead to increased efficiencies in the drug approval process.

Also on tap later today, California Gov. Arnold Schwarzenegger.

Posted June 18th, 2008 by Stephen Albainy-Jenei in Ventures, Conferences, Biotech
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The BIO 2008 Convention was in full swing this week as over 20,000 attendees all crushed together gathered in the San Diego Convention Center.  With everything from a golf swing analysis to an oxygen bar, attendees are being treated to an all-out marketing blitz.

With a new billion-dollar initiative seemingly announced daily, the stakes certainly are high. Wisconson noted it spends $250,000 per conference saying that this is Main Street for biotech and if you want the business, you need to have a storefront on Main Street.

You can follow my coverage, as well as many other bloggers, at Bio On The Road — similar to last year’s BIO Voice.  If you’re attending BIO this week, drop me a note and we’ll meet up.  And don’t forget, I’m giving away some iPods from Patent Baristas while I’m hanging out around the Exhibition floor (see details here).  In the meantime, be sure to check out the BIO Party List - Ohio’s reception is tonight at Buster’s Beach House.

Posted June 18th, 2008 by Stephen Albainy-Jenei in Conferences, Biotech
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Wisconsin Governor Jim Doyle held a press conference this afternoon on why Wisconsin is way more than cheese.  Announcing that the Genetics Policy Institute picked Wisconsin as the host of the World Stem Cell Summit 2008, Gov. Doyle laid out how the state is on pace in building the Wisconsin Institutes for Discovery at the Biotechnology Industry Organization (BIO) conference in San Diego.

The Institutes are twin institutes, one public and one private, to be constructed in the heart of the UW–Madison campus as a hub for interdisciplinary research.  These will be the largest outside the coasts in the U.S. and they represent a potential $5 billion opportunity for Wisconsin.

When asked how any new administration would impact stem cell research and commercialization, Gov. Doyle said that both candidates have indicated that they will broaden stem cell research.  The governor predicted that Sen. Barack Obama, if elected, would totally lift the ban on stem cell research and that either candidate would likely make critical research available and set strong ethical rules for development.  The National Institutes of Health (NIH) would assure that any recipient institutions operate under the correct scientific and ethical standards.

“I don’t think we’ll see another false, arbitrary standard where limits on research are based on the date the president happened to give a speech, ” said Gov. Doyle.  He indicated that science, not politics, should set the standards.

It was three up and three down for the as rejected the claims of its patents on human embryonic stem cells.

Embryonic stem cells, as their name suggests, are derived from embryos that develop from eggs that have been fertilized in vitro. Embryonic stem cells possess two properties that make them valuable for cell therapy. First, because embryonic stem cells are at a very early developmental stage (pluripotent), they retain the ability to become any one of the more than 200 cell types that make up the human body. A second feature of embryonic stem cells is their ability to remain in an undifferentiated state and to divide indefinitely.

Earlier, the U.S. Patent and Trademark Office (USPTO) announced it would re-examine patents covering embryonic stem cell discoveries made by University of Wisconsin researchers. The patents, US Pat. Nos. 5,843,780, 6,200,806, and 7,029,913, cover all embryonic stem cell research in the U.S. and are owned by the Wisconsin Alumni Research Foundation (WARF).

WARF has made free licenses and cells available to more than 300 academic research groups but charges companies $75,000 to $400,000, depending on their size and the terms of the license.  WARF also claims royalties from products produced using the patents.

Now, if only we could figure out why Wisconsin is called the Badger State.

See related items here:
Ding! WARF Wins Round 2 As Stem Cell Patent Upheld
WARF Stem Cell Patents Knocked Down in Round One

Posted June 17th, 2008 by Stephen Albainy-Jenei in Conferences, Biotech, Biotech News
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“Biotechnology is not merely a set of technologies, but also an underlying philosophy of entrepreneurship, risk-taking and long-term vision.”  ~BioSynergy

Students at the Massachusetts Institute of Technology (MIT), Stanford University and the University of Toronto have launched a new biotech magazine called BioSynergy.  Their stated goal is to “[C]atalyze the birth of the next generation of biotech’s pioneers by conveying its ideas through the stories of biotech’s luminaries and the exciting technologies they are creating to students and executives across North America.”

Targeted at those with a background in the life sciences, executives and students alike, the magazine features contributions from luminaries including James Watson, Nobel Prize Winner and co-discoverer of the double helix, and Daniel Vasella, CEO of Novartis. The inaugural theme is biology’s transition to a quantitative discipline.

Thirty thousand print copies are to be distributed at BIO2008 and ten biomedical campuses across North America. The group is also planning an entrepreneurship competition and a case-study workshop to occur alongside the BIO2009 Convention in Atlanta, Georgia.  They are also looking for campus partners.  If you are a biotech club somewhere in the world, you can mail info@biosynergyonline.com and they’ll send some print copies of BioSynergy your way.

BioSynergy is a non-profit magazine originally founded by students at the University of Toronto that aims to be the leading source of inspiration and excitement for entrepreneurship in the life sciences.

We’ll be looking for their team at BIO2008.  See more on-line here.

Posted June 13th, 2008 by Stephen Albainy-Jenei in Biotech, Cool Tools, Biotech News
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The Alliance of Minority Medical Associations (AMMA) and the Benenson Strategy Group held a national media briefing on poll results examining health care access and affordability in the US today.

Dr. Randall Maxey, M.D., said that polling data show that most voters are unhappy with Washington and they are looking for change.  While Iraq and the economy are most important issues, health care is a major concern.  Of the findings, the group said that voters want more affordable prescriptions and believe that pharmaceutical companies often have too many advantages over the public.

One of the highest priorities for the public, not surprising, is to reduce the cost of prescription drugs.  The findings were the same across all demographics.  The second highest priority is increased access to health facilities.

The AMMA believes that one way to make prescription drugs more affordable is make follow-on biologics available.  A person living with MS, for example, might spend from $16,500 to $29,000 each year on their biologic MS therapy.  Meanwhile, MS drugs Betaseron® (interferon beta-1b) and Avonex® (betaferon-1a) are off patent but increasing in price without competition.

The AMMA believes that follow-on biologics would provide needed competition and decrease the cost of these drugs.  They acknowledge that concern for patent and intellectual property rights are important but that it is also important for patients to be able to afford their prescriptions and 80% of those polled support making follow-on biologics available.

Interestingly, the findings show that (1) consumers have confidence in existing generics and (2) consumers have confidence in the FDA to properly oversee and regulate the approval of such follow-on biogenerics.  The study showed that 79% consider current generics safe and 85% would support biogenerics if the FDA can appropriately test the safety of the drugs.

The key issue, of course, is that any follow-on biologics have to be certified as to their biological effects and clinical efficacy through proper clinical and biologic testing.  While proper testing is certainly possible, the question is how much testing will be required in order for the FDA to adequately determine that a generic version of a biologic is the same as the original product.

With a small molecule/chemical drug, this determination is very easy because it is a matter of routine chemical analysis. A chemical structure either is or is not the same.  Biologic products are quite different in that they are far more complex. A biologic is manufactured in a living system such as a microorganism, or plant or animal cells. Most biologics are very large, complex molecules or mixtures of molecules often produced using recombinant DNA technology.

It is difficult, and sometimes impossible, to characterize a complex biologic by testing methods available in the laboratory, and some of the components of a finished biologic may be unknown.  Therefore, for biologics, the product may be inseparable from the process of making the product. Because the finished product cannot be fully characterized in the laboratory, manufacturers must ensure product consistency, quality, and purity by ensuring that the manufacturing process remains substantially the same over time.

Unfortunately, when the follow-on manufacturer establishes a new manufacturing process, beginning with new starting materials, it will produce a product that is different from and not therapeutically equivalent with that of the innovator. Because of the complexity of biologics, the only way to establish whether there are differences that affect the safety and effectiveness of the follow-on product is to conduct clinical trials.

To be approved as a generic, a drug must have the same active ingredient, strength, dosage form, and route of administration as the reference drug, and it must also be bioequivalent. This means that generic drugs are the same chemically as their innovator counterparts and that they act the same way in the body. The bioequivalence of the generic drug is demonstrated through relatively simple analysis such as blood level testing, without the need for human clinical trials. In approving a generic drug under 505(j) of the FDCA, FDA determines that the generic is “therapeutically equivalent” to the innovator drug, and is interchangeable with it.

The FDA has stated that it has not determined how interchangeability can be established for complex proteins (Biosimilars, September 2006).

See more from the AMMA here.
See the Biotechnology Industry Organization (BIO) fact sheets here.
More here: Draft Bill Lays Down Path to Follow-On Biologics.

Posted June 4th, 2008 by Stephen Albainy-Jenei in Biogenerics, Biotech, Biotech News
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MedImmune and Genentech have announced that they reached a settlement regarding their patent lawsuit over MedImmune’s best-selling drug Synagis®, which is used to prevent respiratory infections in infants.  “The parties advise the court that they have reached a settlement,” according to a telephone conference recorded on the docket in the U.S. District Court for the Central District of California.

Lawyers had wanted to see this fight continue in light of the interesting legal questions raised — and the pure amusement value — but litigants tend to not want to continue suits just to please lawyers.

The settlement follows a Supreme Court decision last year that allowed MedImmune to sue in an attempt to overturn a Genentech patent while MedImmune continued to pay royalties to use it. Medimmune, Inc. v. Genentech, Inc., et al. (S.Ct. No. 05–608).  The patent, U.S. Patent No. 6,331,415, covers a technology that uses cell cultures to manufacture human antibodies. MedImmune said Genentech had illegally obtained the patent by conspiring with a British biotech company.

Earlier, the Supreme Court ruled that licensees would have a chance to get out of bad license deals by challenging the validity of the underlying patents.  The case is about whether a company must stop paying royalties on a patent license to challenge the validity of the patent. MedImmune is paying licensing fees to Genentech for an antibody technology used in Synagis, while at the same time challenging Genentech’s patent in court.

In an 8-to-1 decision, the Supreme Court ruled that MedImmune could sue Genentech for patent infringement even though MedImmune continues to pay fees to Genentech to use the disputed technology to develop the drug Synagis.

Genentech argued that MedImmune had no case since it was not seeking an interpretation of its present contractual obligations since (1) there is no dispute that Synagis infringes the Cabilly II patent, thereby making royalties payable; and (2) because while there is a dispute over patent validity, the contract calls for royalties on an infringing product whether or not the underlying patent is valid.

The Court didn’t buy this since MedImmune “disputes its obligation to make payments under the 1997 License Agreement because [petitioner’s] sale of its Synagis product does not infringe any valid claim of the [Cabilly II] Patent.” App. 136. The Court also felt that the phrase “does not infringe any valid claim” (emphasis added) cannot be thought to be no more than a challenge to the patent’s validity, since elsewhere the amended complaint states with unmistakable clarity that “the patent is . . . not infringed by [petitioner’s] Synagis product and that [petitioner] owes no payments under license agreements with [respondents].”

MedImmune had said it would vigorously pursue its case in the lower court and Genentech said it remains confident in the validity of the patent.  They must have received their lawyers’ bills in the meantime.

See also:

• MedImmune Asks: What’s A Patent Lawsuit Among Friends?
• Genentech v. MedImmune Briefing
• MedImmune v. Genentech
• Supreme Court to Review MedImmune’s Bid to End License Payments on Synagis

Posted May 28th, 2008 by Stephen Albainy-Jenei in Biotech, IP Litigation
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While it seems that just about everyone is jumping on the green bandwagon, there is money to be had in global disaster, too. Climate change can be profitable.

Human-induced climate change could trigger climate shocks in all ecosystems that will profoundly affect crops, livestock, fisheries and forests and the billions of people whose livelihoods depend on them. Extreme climate events (especially hotter, drier conditions in semi-arid regions) are likely to slash yields for maize, wheat, rice and other primary foodcrops.

Seed companies are now positioning themselves to take advantage of such changes with genetically engineered seed crops that can withstand such changes.  While good for the seed companies, this has some groups concerned.  ETC Group, a nonprofit dedicated to the conservation and sustainable advancement of cultural and ecological diversity and human rights, has issued a report showing the policy implications of such a gene patent grab.

The group sites examples such as:

• A temperature increase of 3–4 degrees Celsius could cause crop yields to fall by 15–35 percent in Africa and west Asia and by 25–35 per cent in the Middle East according to an FAO report released in March 2008. 
• 65 countries in the South, most in Africa, risk losing 280 million tonnes of potential cereal production, valued at $56 billion, as a result of climate change.
• Projected increases in temperature and changes in rainfall patterns will decrease growing periods by more than 20 percent in many parts of sub-Saharan Africa.
• Farmers in dryland areas of sub-Saharan Africa will experience revenue losses of 25% per acre by 2060. The overall revenue losses of $26 billion per annum would exceed current levels of bilateral aid to the region.

The report shows that many of the world’s largest seed and agrochemical corporations are obtaining patents on genes in plants genetically engineered to withstand environmental stresses such as drought, heat, cold, floods, saline soils, and more. BASF, Monsanto, Bayer, Syngenta, Dupont and biotech partners have filed 532 patent documents (a total of 55 patent families) on so-called “climate ready” genes at patent offices around the world.

This can be seen two ways: One, it is a way for companies to prepare to meet a foreseeable demand in the face of climate change and a potential world food crisis. Or, it is an opportunity for corporations to push genetically engineered crops using climate change as a scapegoat. The truth is probably somewhere in between but the concern is that proprietary technologies will ultimately concentrate corporate power, drive up costs, inhibit independent research, and further lessen the ability of farmers to save and exchange seeds.

Beyond the U.S. and Europe, patent offices in major food producing countries such as Argentina, Australia, Brazil, Canada, China, Mexico and South Africa are also seeing huge increases in patent application filings. Monsanto and BASF have put togehter a $1.5 billion partnership to engineer stress tolerance in plants. Together, the two companies account for 27 of the 55 patent families (49%) of those identified by ETC Group.

The question now according to the ETC Group: “Will farming communities now be stampeded by climate change profiteering?”  While I disagree with their assertion that “the patent grab on so-called climate-ready traits is sucking up money and resources that could be spent on affordable, farmer-based strategies for climate change survival and adaptation,” there can be an issue when the top 10 seed companies control 57% of the global seed market.

ETC Group is now urging governments meeting at the U.N. Convention on Biological Diversity in Bonn (May 19-30) and at the joint United Nations-FAO High-Level Conference on World Food Security and the Challenges of Climate Change and Bioenergy (3-5 June 2008) must recommend that governments suspend the granting of all patents on climate change-related genes and traits.

What do you think?

more at twiigs.com…

Download the report here: “Patenting the “Climate Genes” … And Capturing the Climate Agenda”

Note:  Amended 22 May 2008 to better reflect the opinions  of ETC Group.

Posted May 21st, 2008 by Stephen Albainy-Jenei in BioAg, Biotech
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