The Big Red Biotech Blog

CHO K1 Sequence Helps Cell Engineering Efforts at SAFC

With the report today that BGI and GT Life Sciences have sequenced CHO K1 and will soon make that sequence available, I'm excited to see the data used in our cell engineering efforts.  SAFC has licensed rights to zinc finger nuclease (ZFN) technology from Sangamo for use, among other things, in the engineering of CHO cells for bioproduction.

in fact, this past month SAFC introduced new ZFNs for the dhfr and GS genes to allow users to create CHO bioproduction cell lines under license. Soon, catalog versions of CHO cells with these genes knocked out will also be available for purchase and again under license for use in bioproduction. Our ultimate goal is to produce a SuperCHOZn platform cell line, media, feeds, protocols and application data to allow a user seeking a platform production system to buy one.  The SuperCHOZn line would be expected to have multiple knock outs and/or knock ins to confer important production properties of interest on the cells -- and would be sold with chemically-defined medium and feed sets to support their growth and productivity to high levels with desired protein quality characteristics.

To this end, it is welcomed to have the CHO genome sequence for K1 available.  It will aid our work in target discovery and ZFN design to find, validate and knock out targets to make cells more productive, better growers, more consistent protein producers with appropriate quality and lower variabilty.  We can also eventually make more efficacious molecules -- i.e. manipulating glycosylation patterns or even do a more efficient job of matching glycosylation or protein quality characteristics to aid the biosimilar market as it develops.

So, I tip my cap to Bernard and collaborators at BGI and GT Life Sciences and look forward to delivering more improvements - faster - within CHO cell line bioproduction systems.

 

Posted by Bruce Lehr Jan 6th 2011.

 

Cancer Drugs in Combination - A New Testing Trend?

This piece comes from Xconomy and notes that Merck and Sanofi are joining forces to test new cancer drugs in combination - a trend that appears to be gaining traction with other players in the oncology field as well.  Combination therapies are often used in cancer.  However, historically the combinations weren't tested together until each drug separately reached a fairly late stage (or was already approved).  Now we have companies developing philosophies to test drugs in combination at an early stage of clinical trials.  This is particularly popular in the treatment of cancer as frequently several signalling pathways that could affect the disease may be simultaneously attacked.

Previously, Merck and AZ have teamed up with their respective AKT  and MET inhibitors.  Now Merck and Sanofi plan to test their SAR245408 and SAR245409 inhibitors of the PI3K/mTOR pathway. Both partners will test each other's drug in combination with their own in Phase I trials.

The FDA issued draft guidelines designed to encourage companies to work in tandem to develop two or more new drugs to be used in combination to treat cancer and infectious diseases, among other illnesses. In addressing the new guidelines, FDA commissioner Margaret Hamburg said they are the result of a growing understanding that experimental therapies may need to be used together in order to be more effective or to prevent drug resistance.

Despite the excitement, efforts to study investigational drugs in combination are still in their infancy. Phase I is the first stage of clinical testing, so these new drug “cocktails” are still several years from reaching the market. Scientific, clinical, regulatory and intellectual property hurdles all must all be overcome if these novel combinations are to provide breakthrough cancer therapies for the patients who desperately need them.

 

 

Posted by Bruce Lehr December 30th 2010.

Vaccines: One Man's Choice as Top 2010 Healthcare Innovations

According to an article in Xconomy, Larry Corey, president and director of the Fred Hutchinson Cancer and Research Center in Seattle, chooses vaccines as providing some of the top innovations in healthcare in 2010.

Specifically, Corey tabs Dendreon's innovative Provenge vaccine for the treatment of prostate cancer.  This is the first product of its type to make it through the FDA gauntlet.  It provides the proof that immunotherapy is a viable approach to cancer treatment and likely will open the door to other such treatments in the near future.

Corey also singles out GSK's human papillomavirus (HPV) vaccine for recognition. It established the link between infectious disease and some cancers and highlights the success of a vaccine in preventing the disease from ever developing. GSK's vaccine also includes the first novel adjuvant (immune response booster) to be used in the USA in more than 30 years.  This can also be expected to usher in a new wave of more effective adjuvants to be applied to other cancer vaccines in particular. 

The resurgence of vaccines is a welcomed story.  Vaccines of course are designed to prevent disease and not treat it after the fact.  It is further welcomed by me to see vaccines singled out in a very positive light given the sordid history of the anti-vaccine movement in associating these life saving treatments with a host of side effects and diseases that are based solely on innuendo and pseudo science (autism).  Let's see the clinical trial results and then results on follow up in the field to base our conclusions on efficacy on.

 

 

 

 

Posted by Bruce Lehr December 29th 2010.

Drug Profits Down? Repurpose

It is getting tougher out there to bring novel pharmaceuticals to market -- especially when you aren't working on bringing novel compounds to market to meet unmet medical needs.  As this article in FT.com makes clear, it is now fashionable to repurpose drugs to extend their patent life or apply to a new area in an attempt to extend their revenue generating capacity. 

Famous examples cited in the article include products like Viagra or Avastin.  Viagra was repurposed from its original purpose as a "high blood pressure" treatment when it went on to fame and fortune with the brand new "erectile dysfunction" category. It has since also been introduced (different shape & color) as Revatio for pulmonary arterial hypertension.  Avastin of course has been aimed at a whole spectrum of cancers with varying success - especially with the regulators.

The appeal of such drugs of course is there solid IP portfolio which can allow their holders to fund new clinical trials and establish new applications before the patents run out. But not everyone in the market (i.e physicians and consumers) is happy about this strategy in all instances.  Biomarin, for example, recently launched a high-priced version of amifampridine phosphate to treat a rare autoimmune disease and received "orphan drug" status in the process. But Britsh physician groups have complaned the drug was formerly available in the pharmacy for a fraction of the cost.  A Biomarin spokesman explains the company upgraded quality and spent $30 M bringing it to market.

None of this obviates the fact that pursuing this path as a important strategy gets us further away from discovering and developng novel therapeutics for unmet need - and to that end I think it is a bad trend to continue without concommitant efforts on the side of innovation.

It might do us well to to remember these words in the pharma field:

"I am here for a purpose and that purpose is to grow into a mountain, not to shrink to a grain of sand. Henceforth will I apply ALL my efforts to become the highest mountain of all and I will strain my potential until it cries for mercy."

- - Og Mandino

Posted by Bruce December 25th 2010.

 

SAFC and SartoriusStedim Biotech New Mixing Application Guides

 

As part of the collaboration between SAFC and SartoriusStedim Biotech (SSB), the companies have worked to produce application guides showing rapid and scalable preparation of powdered media and buffers with single-use magnetic mixing systems and the LevMixer^R technology.

For media, batch sizes ranged from 50 L to 1000 L and utilized SAFC's Ex-Cell^TM CHO Fusion and Ex-Cell^TM EBx^R GRO-I formulations. For buffers, sodium citrate, PBS and Tris were used in tests in batch sizes from 50 L to 1000L at various transient concentrations of powders (16 g/L, 73 g/L, 224 g/L) before final dilution. The purpose of the study is to assess the performance of the Flexel^R for Magnetic Mixer technology or the LevMixer^R to dissolve the test powders.

In this study mixing time to achieve complete product dissolution was determined both by visual inspection and by conductivity measurements.  In the case of the media, conductivity measures to determine when the product was completely dissolved is a novel application. Complete study details and results are contained in the reports below.

The study concluded that large volumes of media and buffer solutions were easy to prepare using the combination of SAFC product and the high efficiency mixing provided by the Flexel with Magnetic Mixer technology or LevMixer technology.

Download SAFC SSB Media prep with Magnetic Mixer

Download SAFC SSB buffer preparation single use magnetic mixer

Download SAFC SSB buffer preparation with LevMixer

  

 

 

Posted by Bruce Lehr December 19th 2010.

 

Collins' Translational Medicine Initiative Ruffles other NIH Center's Feathers

Francis Collins' announcement that the NIH would seek to create a new center for translational science to speed drug discovery may have been hailed in many quarters but was met with some level of consternation by other NIH center directors.  Why?  Because the NIH is capped by 2006 legislation to havng no more than its current 27 centers.  So if you want to add one more, then one has to go!

Other center directors (not all) have expressed the concern that "the implications for the rest of the NIH hadn't been adequately discussed" prior to the announcement.  The money for the new center might have to come from the budgets of other insitutes.  Right now, it looks like the National Center for Research Resources (NCRR) would be odd man out. At least part of it could be slated for absorption into the new translational center -- including the  NCRR's Clinical and Translational Science Awards ($490 M budget). The Cures Acceleration Network that was created by health reform but is not yet funded is also likely to fall here as well.

NCRR's current director asked that it be expanded to house the new translational center, but an advisory panel rejected the idea and stated a need to create a new center.  It is not clear if the rest of the NCRR portfolio would be retained and possibly dispersed to other centers. See Sciencemag.org.

Posted by Bruce Lehr December 10th 2010.

AZ Survey Says: US Will Drop From #1 World Innovator by 2020

AstraZeneca conducted a survey of 6000 respondents from the United States, Britain, Sweden, Japan, India and China to seek their opinion's on who currently leads the world in innovation and how that might change in the next 10 years.  The Survey Says:

Current Innovation Ranking

• United States picked as number 1 by 30%
• Japan ranked number 1 by 25%
• China ranked number 1 by 14%

Now, fast forward by 10 years.  The Survey Says:

10 yr Future Innovation Ranking

• China selected as number 1 by 27%
• India selected as number 1 by 17%
• United States selected as number 1 by only 14%
• Japan selcted as number one by 12%

Survey respondents indicated that China's fast growing economy (currently no. 2 in the world), and its emerging technological know-how influenced the voting.  A recent Thomas Reuters study showed China is now the number two producer of scientific papers behind the US.  But R&D spending is also up across Asia as it begins to compete more vigorously with the US.  R&D spending estimates for 2008 were:

• Asia $387 B
• US $384 B
• EU $280 B

The survey also found that respondents in China and India had a strong sense of optimism as compared to a greater sense of relative pessimism in the developed Western economies. Maybe you are what you think?

 
Posted by Bruce Lehr December 6th 2010.

How To Keep Academic/Big Pharma Alliances from Going off the Rails

When you see the light at the end of a tunnel, sometimes it's a moving train.  The piece below comes from a writer at Scripps Institute and appears in Xconomy. It addresses the need for very good communication and incentive alignment between the pharma industry and academic institutions in order to properly manage broad research alliances. 

How To Keep Academic/Big Pharma Alliances from Going off the Rails.

The benefits from this type of hands on management are minimized disagreements, maximized revenue opportunities, and enhanced funding and collaborative opportunties, especially for the academic participants.  It's the best way to keep on the tracks.

 

Posted by Bruce Lehr November 30th 2010.

The Myth of the Patent Cliff and Other Red Herrings

From Stuart Lyman via Xconomy today we have a piece challenging whether there really is such a thing as a Big Pharma "patent cliff" or whether it is all a red herring.  Mr. Lyman concludes that a couple companies may have a cliff but by and large the problem in the industry is lack of R&D productivity and too much marketing expenditure on mediocre drugs.

The Myth of the Patent Cliff.

There is no cliff if you plot out "industry performance" over last 10 years versus an individual company or two.  The problem is a dearth of new drug approvals. This actually does show a decline in the past decade.  Drug sales went up 2.5x from 1997-2007 yet approvals of new drugs dropped 50%.  The increase in sales appears to parallel the 300% increase in DTC-ad spending during the same period. Wow!  No new drugs but lots of new ads.

Mr Lyman further notes that there are 6 basic approaches Big Pharma could use to bridge the revenue gaps (see his post above) but only 1 of the 6 actually was geared toward adding a new (as opposed to a modified) drug.  The primary responses were to "curtail research expenditures, cut headcount, and ramble down the other paths."

The myth of the cliff will remain until pharma changes its R&D model and gets back to understanding basic drug mechanisms - and adopts a more collaborative approach - perhaps with academic sites as their funding decreases from other sources.  When that happens, the cliff myth will begin to recede.

Until then, next time you hear about a patent cliff - think red herring - salted, pickled, with mustard, sherry or dill and little aquavit! 

 

 

 

 

Posted by Bruce Lehr November 29th 2010.

Ponder Need for Innovation on Turkey Day

Here's another good post from my favorite site - Innovate on Purpose - by Jeffrey Phillips.  I suggest that you give it a read and ponder while enjoying your Turkey holiday (if in US).  If not, read it and ponder anyway. 

The post has to do with how innovation's value is at its highest when market conditions are tough as they are now.  It will be the company's, government, or universities that innovate who will reamin on top coming out of the doldrums.  They will not only be able to stay ahead of the pack while things are bad, but will spring even further forward when the recovery hits. 

One of the more scary thoughts expressed is that company's who choose not to innovate at this down time risk being relegated to a permanent second class when the recovery hits.  This derives as from  the lack of innovation leaving them with only old products and services to sell and being forced to compete on price. 

The author further explains that historically down cycles have spawned new startups with new innovative products and services that are better attuned to the new reality and customer expectations created by the down period. Innovators thus tend to take a significant portion of the market as it recovers. Innovation is a competitive advantage.  Those firm with an active passion for innovation will accelerate away from the firms too focused on efficiency and cost cutting.

The article finishes with a paraphrase of Einstein stating that you can't solve new problems with old thinking. To solve new problems, you need new ways of thinking."

Happy Thanksgiving.  

"To raise new questions, new possibilities, to regard old problems from a new angle requires a creative imagination and marks the real advances in science."

-- Albert Einstein 
Posted by Bruce Lehr November 24th 2010.

Merck Scores Coup with its CETP Inhibitor at AHA Meeting

 

According to Fierce Biotech, Merck greatly impressed an audience at the American Heart Association meetings with "jaw-dropping" data on its new CETP inhibitor, anacetrapib.  Remarkably, in a small clinical trial, the drug increased the "good cholesterol" HDL by 140% and decreased the "bad cholesterol" LDL by 40 percent.  The study's lead investigator indicated the results were wildly unexpected in both directions.

Analysts think Merck may have a mega-blockbuster on its hands with this brand new class of drug - some have predicted that anacetrapib could rack up numbers like Pfizer's Lipitor someday. Merck is anxiously trying to avoid the catastrophic failure Pfizer experienced with torcetrapib, another CETP inhibitor. Four years ago Pfizer had to halt its pivotal study after finding that the drug arm was experiencing a higher death rate.  Merck designed this initial smaller trial to look at both the therapeutic effects and at patient safety as a result.  In this trial, no significant adverse effects were noted.  Now Merck will move on to another larger trial.

In a related post in the Forbes blog, Harlan Krumholz lauds Merck for "doing the right thing" with its trial design - given Pfizer's safety disaster with torcetrapib in late stage clinicals.  Torcetrapib was anticipated to be a sure blockbuster but was found to increase deaths and heart disease events in a large clinical trial. The results surprised most observers as the drug seemed sure to be a great success.

This Merck's DEFINE study, presented to a plenary session at the meeting, confirmed the drug’s powerful effect on laboratory values. It also showed that the drug did not have a major harm or benefit – though it was too small to detect modest harms or benefits. Nevertheless, the drug has passed an important test with this trial – and Merck is now proceeding with the next step, a large clinical trial. Merck did the right thing in looking at the safety aspects too in this early stage with an appropriately designed study.  Anacetrapib will not reach the market until at least 2015, but it has passed the latest step in a way that takes patient safety in mind, as well as clinical results.

 

 

Posted by Bruce Lehr November 18th 2010.

 

Leading Innovators Make Choices!

This is another good article from the Innovate on Purpose blog.  The basic premise of the post is "To Innovate is to Choose".  There are always far more good ideas than the resources necessary to fund and develop the ideas.  Therefore, idea selection is about making choices in the face of limited information which could be wrong in hindsight.  That's one of the first problems with innovation - we ask people to make hard choices with limited information about products or services that may, or may not, be successful. But, making the choice is necessary to realizing the success.

Innovation has another challenge to most executives when it comes to choice: every choice he or she makes is risky and uncertain.  Most executives are uncomfortable in this situation and seek to limit options and choices, seeking clarity and safety, or at least consensus.  This is why most "innovation" seem so bland. If you eliminate risk, you eliminate true innovation. Perhaps beggars can't be choosers, but innovators must be.

This leads me to examine Roche.  I've written here often that I think Roche is the leading innovator among Big Pharma companies.  They are one of the few to put a stake in the ground and state that they will not pursue follow-on biologics or generics as a key strategy for their future.  They are an innovative drug company and proud of it. 

Today's news about Roche deciding to cut its RNAi program may be another piece of evidence on their innovation leadership.  As the first paragraph indicates, resources are scarce and the best innovators make the hard choices about where to put their money to do the most good. Roche has decided it has better places to invest than in RNAi therapeutics.  This choice may or may not turn out to be correct - but it is another example of them having the resolve to make the hard choice - even after investing $331 M in Alnylam in 2007.  The In the Pipeline blog asks if other Big Pharma companies invested in RNAi wish they had the stones to do the same?

The willingness to make the hard choices is a defining characteristic of the successful innovator. 

 

 

Posted by Bruce Lehr November 17th 2010.

Merck Risks Swinging for the Fence with CETP inhibitors

Several posts this past week with the startling lack of innovation being shown with new drugs being brought to trial by the pharmaceutical industry.  Big Pharma in particular seems to be stuck in a follow-on rut or is increasingly turning its eye toward the lure of generics.

Merck is now going for a home run by pursuing its possible mega-blockbuster anacetrapib.  Analysts and competitors have called it potentially one of the biggest heart drugs to come along in decades. The drug works partially by raising a patient's HDL, and is a new class of drugs that are CETP inhibitors.  Merck is now racing Roche and Lilly for first place with an HDL drug. This race is not without risk as Pfizer's CETP inhibitor, torcetrapib, failed miserably in late stage clinicals due to safety issues.

Roche CEO Severin Schwan feels whoever unlocks the secret to CETP inhibitors may be in line for a mega-blockbuster that could deliver Lipitor type-sales in the billions and billions. So Merck is gearing up to swing for the fences with anacetrapib at the American Heart Association meeting next week. They're willing to take the risk to truly innovate and are betting 100's of millions in the process. See Fierce Biotech.  

 

 

Posted by Bruce Lehr November 10th 2010.

Where Has All The [Drug] Innovation Gone?

The Pharmalot blog reports on new drugs introduced at the ACS Meeting in Boston -- and unfortunately on the lack of innovation exhibited by these drugs. Fifty-eight drugs were introduced and not ONE was directed toward a previously unidentified target. Yikes!

Where Has All The Innovation Gone? // Pharmalot.

This is consistent with a post I made a couple of days ago based on information from the In the Pipeline blog. This analyzed 252 drugs and determined 58% were from pharma (vs. biotech or univiersities) but only 36% of pharma's drugs were classified as innovative (vs 65% and 62% for biotech and universities respectively). 

Citeline's Ian Lloyd commented, "There is much talk in the industry about the move towards focusing on new and innovative therapies, especially in orphan conditions, but the hard evidence is failing to match the rhetoric.”

 

Posted by Bruce Lehr November 10th 2010.

PhRMA says Puerto Rico's new Tax will Hurt Innovation

Puerto Rico passed a new tax bill over this past weekend that will tax off-shore multi-national companies that earn $75 M or more per year.  The law was passed in an effort to recoup lost revenues due to a recession in the Island's economy since 2006.

PhRMA President was quick to respond stating that the new law will "dramatically hinder PhRMA member companies positive efforts within Puerto Rico."  He stated that future investment was likely to slow as well as new job creation. He further criticized lack of transparency in passing the law without prior public comment.  Transparent tax policies were cited as being critical to PhRMA members to create innovation. This law's passage is seen as being counter to fostering innovation and could further hurt the island's economy.  See in-pharmatechnologist.com)

 

 

 

See PhRMA statement on Puerto Rico's new law.  

Posted by Bruce Lehr October 28th 2010.

Roche Breaks from the Herd

We seem to be able to count on Roche to pursue plans to differentiate itself from the herd.  Unlike many of its competitors who have stated an intention to pursue generics as diversification strategy (see previous post), Roche will remain true to its roots providing innovative medicines.  It plans to expand its historic franchise in oncology drugs to include new medicines in inflammation, CNS disease, and metabolic disorders.

Roche firmly rejects the idea of "diversifying" into generic drugs, consumer health or animal health.  Says CEO Severin Schwann, "A lot of people call it diversification. I call it giving up. Call me biased, but I really believe we have one of the best industry pipelines."  That's the spirit of leadership!

Roche still spends 21% of its revenues on R&D, and 57%of their current revenues come from oncology drugs.  The new shift to the three therapeutic areas mentioned above will require Roche to form some partnerships when it comes time to go to market - basically sales force deals to access physicians beyond its base of oncology specialists.

Says Schwann, "We go where science takes us."  He also talks about Roche retaining its faith in innovation - which already separates it from many of its following rivals. (See FT.com).

 

 

Posted by Bruce Lehr October 28th 2010.

 

We Need a Refocused, Kinder, Gentler NICE

The UK's NICE is often the butt of criticism with regard to its measures of drug cost effectiveness and its ability to recommend a thumbs up or down for use of a given therapy. Recently, the Association of the British Pharmaceutical Industry (ABPI) has called for a change in NICE's remit as reported in MNT.

The Director General, Dr. Richard Barker of the APBI suggested a three point plan for NICE's future:

• Broaden NICE's definition of value to capture all elements of healthcare innovation
• Refocus attention on best practice and quality standards and how innovation can enhance both
• Stop National Health Service practices that 'second-guess' NICE

"If we want the NHS and the UK economy to benefit from a vigorous life sciences sector, the reshaping of NICE's remit is an urgent priority. A focus on the future value of innovation, rather than decisions made on narrow cost-effectiveness criteria, would mean that NICE could play an important pivotal role in an outcomes-driven NHS."

Broadly, I agree with ABPI's position. I think cost-effectiveness measures of healthcare, representative of NICE's current charter are here to stay.  We really need to look at outcomes along with costs to keep medicine affordable.  However, a cost effectiveness  system that stifles or prevents the prospect of innovation is highly undesirable.  So if an organization like NICE, can have its marching orders tweaked so that it can both look at cost effectiveness but in the context of best practice and quality standards and improve access for patients that will be the best outcome.

As Frank Burns might say, "It's nice to be nice to the NICE".

 

 

 

 

Posted by Bruce Lehr October 21st 2010.

 

 

Sanofi Goes to Harvard Hunting Goodwill (and Blockbusters)

According to a Fierce Biotech report, Sanofi has inked a deal with Harvard to collaborate on translational biomedical research focused in the therapeutic areas of cancer, inflammation and diabetes. Sanofi continues to explore new research models and collaborations in an effort to boost revenues due to expected shortfalls due approaching patent expirations on key drugs.

The funded projects will be selected by a Joint Scientific Steering Committee made up of members from Harvand and Sanofi. The awards will help Harvard researcher gain quick financial support for the development of innovative solutions in areas of high patient need. Sanofi will have the opportunity to develop diagnostic, therapeutic and prognostic applications from these discoveries.

"Our relationship with Harvard underscores sanofi-aventis' approach of leveraging our innovative internal resources while actively engaging a range of external partners to develop healthcare solutions," said Marc Cluzel, M.D., PhD, Executive Vice-President, Research & Development, Sanofi.

Ok, so it was MIT not Harvard in movie - poetic license.

Posted by Bruce Lehr October 18th 2010.

 

Son of Adaptive Regulation

In a follow up to the last post, there are indications that regulators and developers are beginning to look at different models to better address health needs. According to a Market Watch interview with Margaret Hamburg, commissioner of the FDA, she indicated that the agency had to do a better job of evaluating and approving new treatments and to get them to patients more quickly.

"We're relying on 20th-century approaches for review of 21st-century therapies," Hamburg said. She said the science of regulation needs to adapt and become more innovative, just like the market it oversees.  I think that is a refreshing statement.  Hamburg further noted that lots of time and money are wasted on ineffective treatments because of the aging regulatory approach. Hamburg urged Congress to pass stalled legislation to provide budget to give the agency tools to update its approach.

Following the theme of adaptive trial design, Fierce Biotech reports UCSF is taking a leading role in the I-Spy 2 cancer trial.  This trial will test up to 12 therapies in an attempt to identify the right population for the right therapy on a much smaller budget.

Initially five breast cancer drugs from three companies - Abbott, Amgen and Pfizer - will be tested for their efficacy. The study uses MRI to track tumor response to shorten time lines. The vision is a 300-patient phase III trial instead of a 3,000 patient trial. As one drugs fails in the process another can be sustituted in for testing. Thus, the trial adapts to results as it proceeds.

Finally, the Pharma Reform blog talks about changes that need to occur in R&D to adapt to the realities of the new environment.  It points out five areas of traditional thinking to reconsider for a new approach:

• Kill early, kill fast.  This would sem best suited to the "mass market" use of a drug.  However, in the era of personalized medicine, drugs that may not have made the cut before might work well for patient subpopulations in a more targeted approach.
• 'What's the fastest, commercially viable indication that will get us to market". This may no longer be viable as FDA, Third Party payers, and others want to see data to support specific claims for use and reimbursement.  We're entering an age of comparative effectiveness.
• "if we do that study or analyze that data, we might find something we don't want to know" Product liability and coverups continue to make headlines. companies are expected to do the science to understand their products and to be transparent about it.
• "our research is built around the biological target X program" Focusing on single targets is hit or miss.  Companies will need to take a more comprehensive approach to understanding disease progression and will develop multiple ideas on how to stop disease progress across more than one perhaps interacting targets. This will cut dependency on a single target.
• "we can do it cheaper and better in-house" Innovation demands outside and inside collaboration. Many functions can be outsourced to groups with equivalent if not better expertise. This will provide more flexiblity around facilties, equipment and personnel and reduce overall costs.   

New ways of thinking and doing are coming.

Posted by Bruce Lehr October 11th 2010.

 

 

 

 

 

 

Internal Innovation Clusters

A few weeks ago, I added a couple posts dealing with innovation clusters.  One was motivated by a speech given by Lilly's CEO John Lechleiter.  In it, he was promoting the idea of our goverment to keep funding the development of innovation clusters as these seem to provide vibrancy and innovation to a given industry.

As a reminder, clusters are geographic concentrations of interconnected firms, and supporting or coordinating organizations. 

At the end of last week, I saw a nice post on the Innovate on Purpose blog dealing with what I've termed "internal innovation clusters"and the author terms the "network effect".  In his post, the author - Jeffrey Phillips - asserts that innovation is more successful when there is a critical mass or network effect in an industry or market - that sounds like a cluster to me. He says we ought to apply that same thinking to innovators in a firm.

The "lone innovator" is a myth according to him. Rather, companies need to create a critical mass of innovators who are networking with each other and sharing ideas and concepts - both within and outside the firm.  He also questions the common methodology employed by many firms of kicking off one or two small, isolated innovation efforts while the rest of the firm "stays focused" on the business. This makes innovation difficult as there are no other innovators in the firm to interact with or compare notes with. Additionally, there is no "internal competition" for the best ideas and no "synergistic" effects created by multiple teams innovating.

He argues that the creation of multiple innovation teams within an organization that exchange information with each other, and with other firms and markets, will create more and better innovation. That sounds like an "internal innovation cluster" to me.

Posted by Bruce Lehr October 11th 2010.

 

Synthetic Genomics & Novartis Innovate with Vaccines

 
As reported in Xconomy, profit-minded Craig Venter partnered with non-profit Craig Venter Institute to form Synthetic Genomics.  Synthetic Genomics in turn is collaborating with Novartis to create next generation synthetic vaccines.  The collaboration currently has a three year term and is specifcally aimed at the development of influenza seed strains needed for vaccine manufacturing.  The collaboration with Novartis is supported by an award from the U.S. Biomedical Advanced Research and Development Authority.

Novartis and Synthetic Genomics Vaccines plan to establish a “bank” of synthetically created seed viruses to the seasonal flu strains of concern to WHO. Currently, the WHO distributes live reference viruses after they have been identified to major vaccine manufacturers - like Novartis - thus their interest for an inside track so to speak. Synthetic Genomics says a "synthetic bank" could reduce vaccine production time by as much as two months - valuable in a pandemic.

I think this sounds cool. It is good to see vaccines takng front and center again in health care and in particular to see innovative approaches being applied after years of processes and methods "being locked down" in this field. The financial incentive s back and so is the innovation. Good!

 
Posted by Bruce Lehr October 9th 2010.

 

That's The Entrepreneurial Spirit!

I saw this on FastCompany.com and was both mildly amused and appalled.

This post discusses why National R&D dollars being spent to develop technology in universities is not translating better/faster to the marketplace. The US Government does spend $30 B annually on research and development afterall.  The Bayh-Dole Act (aka The University and Small Business Patent Procedures Act) was supposed to make tech transfer easy and flood the market with university technologies. The rush expected has really never happened. Why might this be?

A George Mason University social scientist Edmund Zolnik recently surveyed post-docs in the Washington, DC area.  A population he characterized as "one of the most highly skilled pools of human capital in the world," in "one of the best urban areas of the world for generating wealth."

He thought this area would be teeming with entrepreneurs if anywhere did teem.  He interviewed 126 individuals - asking them their leanings toward entrepreneurism - and TWO listed entrepreneur career tracks as their top choice. This was odd given that this group at least recognized that tech transfer was important - "the bridge between science and society". Zolnik's study suggested that awareness of entrepreneurial career tracks could be raised through model courses, like one at the University of Texas at Austin, aimed at transforming research into marketable products.

However, this was my favorite?/most horrifying? quote from the story, one person wrote in the survey,

"I don't give a damn about transferring technology, greedy bastards."

 

 

 

 

Now, that's really putting your education to good use and truly exploits those federal R&D funds as intended, I'm sure. 

Posted by Bruce Lehr October 8th 2010.

 

 

 

 

NSF Reports on US Business Innovation

The National Science Foundation published its 2008 Business R&D and Innovation Survey (BRDIS) recently to provide a map of the incidence of innovation by businesses in the USA. Interestingly, I was motivated to pull this report and read it as I had seen several sources quoting from it and bemoaning that only "9% of the estimated 1.5 million for-profit companies were active product innovators and only 9% were process innovators". 

A typical comment, derived from a summary of the report's findings, is evidenced by this quote from the Washington Post's Ezra Klein. There's also a scary takeaway: "You can’t be an innovative economy if only 9% of your companies are innovating."

I think that conclusion/representation is a tad misleading.

Let's look a little more deeply.  The BRDIS is produced by a joint effort of the NSF and the US Census Bureau.  The survey population is 1.5 million for-profit companies, public and private, manufacturing and service sectors.  Measures of innovation follow well-accepted standards described in the Oslo Manual (2005) prepared by Organization for Economic Co-operation and Development (OECD) and Eurostat. BRDIS draws on the Oslo framework. 

In the Oslo framework, "innovation is the implementation of a new or significantly improved product (good or service), or process, a new marketing method, or a new organizational method in business practices, workplace organization or external relations."

Now the data that I'd like to highlight.  Pharmaceutical and biopharmaceutical companies (as well as raw material suppliers to them like SAFC) are manufacturing companies. Manufacturers represent only 8% of the 1.5 million companies in the survey.  The companies above fall into the chemical sector NAICS 325 (or subsegment NAICS 3254).  In contrast to the 9% figure cited in study summary for all companies, 41% of chemical companies were product innovators and 34% were process innovators.

In the non-manufacturing segment, 92% of the total companies, only 8% reported product or process innovation. However, if you look at companies that specialize in scientific R&D services NAICS 5417, these had innovation rates of 33% for products and 26% for processes.

I point this out, as again, presumably most readers of this blog are interested in the pharmaceutical industry.  The industry is made up of manufacturers that work with R&D service providers/manufacturers.  What's more, the BRDIS data show that there is a large difference in innovation incidence when companies with R&D activity are compared to those without any R&D activity. Companies with R&D (either performing R&D or funding others to perform R&D) exhibit far higher rates of innovation than do non-R&D companies.  Sounds like a pharma company.

Only 3% of the 1.5 million companies in the survey perform or fund R&D.  But of these R&D intense companies, 66% were product innovators and 51% were process innovators. There is also indication that the companies with the most R&D (those in the $50–$100 million and $100 million or more annual R&D categories) report the highest incidence of innovation: 76% and 81%, respectively, for products in 2006–08, and 69% and 71% for processes. Clearly this latter group would encompass Big Pharma for sure.

My conclusion is that things may not be as bleak as the summary stats might indicate at first glance - at least not in the pharma sector.  It would be more enlightening to now compare how the US pharma sector stacks up innovation-wise versus its global counterparts in the industry.  That could show a trailing gap or it could show a leadership position.

 

Posted by Bruce Lehr October 8th 2010.

 

Singapore to Pour $1B into Focused Biomedical R&D

Bloomberg reports that Singapore's government will invest $1 B between 2011 and 2015 to promote more R&D in science and technology.  According to the country's Minister for Trade and Industry, Lim Hng Kiang, 70 percent of the investment will be aimed at projects to create "economic success".   Said Lim, "We will place greater emphasis on competitive funding, to spur innovation and bring out the best ideas for further support and development."  He indicated that Singapore needs to see a quicker return on its investment in R&D.

 The $1 B Industry Alignment Fund is aimed at making Singapore an "innovation-driven and knowledge-based economy".  One of its goals is to connect public and private sector researchers and to facilitate R&D investment. "How much we invest is important," Lim said. "But more important is what we invest it for and where we invest it."

I would refer readers to my previous post regarding PhRMA's appeal for a permanent R&D tax credit for the pharma industry in the US. I submit that this type of targetted tax policy is needed to compete with world goverments who are also backing development in the biomedical or biotech arena.  R&D investment and success clearly will have alot to do with who the winners will be in world pharma markets - especially as the global competition heats up.

Posted by Bruce Lehr October 4th 2010.

 

Sanofi Continues to Change R&D Model to Drive Innovation

Sanofi continues to morph its R&D footprint in an effort to become more focused, nimble and innovative.  As reported in Fierce Biotech, Sanofi will sell two R&D sites to CRO partner Covance in a 10 year, $2.2 B pact.  Covance will assume ownership of Sanofi's Porcheville, France and Alnwick, UK sites at a price of $25 M.  Sanofi will handle an important part of Sanofi's development pipeline.

"A key strategy for Sanofi-Aventis is to transform its R&D model and discover new medicines through the use of novel technologies and innovative partnerships," declared Sanofi R&D chief Marc Cluzel.  Covance also anounced the continuation and expansion of a similar deal with Eli Lilly today (see Outsourcing Pharma.com).

For Sanofi, this is a continuation of a flurry of activity that it has engaged in this year to reshape its R&D model. Other deals (in no particular order) announced this year include:

• A new R&D center is being built in China to support development of cures for diseases more  common to that area (here)
• Sanofi will join the Massachuesetts Life Science Center to expand its partnering and licensing activies (here)
• Sanofi and Aviesan - essentially a consortium of universities and private institutes in France - formed a research pact to develop therapies in focused disease areas (here)
• Last week the purchase of VaxDesign and its novel, rapid in vitro screening methodology to help select the best preclinical candidates to enter the pipeline (here)

It looks like they're serious and have really gotten busy in the past year and it's not over yet.  We still have a potential Genzyme acquisition looming on the horizon.  

Posted by Bruce Lehr September 30th 2010.