The Big Red Biotech Blog

Smoky Mac N' Cheese. Yum! Yum!

Here's what you gonna need.

• 8 ounces dry macaroni
• 1/2 pound thick sliced apple wood smoked bacon
• 2 cups half and half
• 2 tablespoons all-purpose flour
• 1 tablespoon white truffle butter
• 8 ounces smoked gouda, grated
• 1  teaspoon smoked paprika
• sea salt, as needed for cooking macaroni

To Cook:   

1. Preheat oven to 400 degrees F.  Lightly butter baking dish or dishes.  This recipe will make enough for 10 1/2 cup ramekins.
2. Line a large, shallow baking sheet with aluminum foil.  Place the bacon side-by-side on
   the baking pan.  Bake in oven until crispy, about 20 minutes for thick-cut bacon.  Remove from oven and place on several layers of paper towels to drain.  (Do not turn off oven!)  Chop bacon into smallish pieces and set aside.
3. Pour 8 cups of water into a 3-quart saucepot.  Salt water according to macaroni package.  Bring the salted water to a boil and carefully add the macaroni to the water.  Cook only until macaroni is at a slightly firm al dente (approximately seven minutes, but depending on the quality of the macaroni, cooking times may vary).  DO NOT over-cook the pasta.  It is necessary for the macaroni to be a bit undercooked because it is going to absorb additional liquid from the sauce.
4. Drain cooked macaroni in a strainer/colander and rinse under cool water to stop the cooking process.  Drain well, then set aside while the sauce is prepared.
5. In a 3-quart saucepot, add the half and half (it's ok to use the same saucepot the macaroni was cooked in).  Whisk in the 2 tablespoons flour until smooth.  Add the white truffle butter and the smoked paprika to the half and half mixture.  Heat over medium or medium-low heat until hot and beginning to thicken, whisking constantly.
6. When the sauce is hot, stir in the cheese.  Continue to stir until cheese is melted and sauce is smooth.  Turn off heat.  Reserve about 1/4 cup of the chopped bacon, set aside.  Stir the remaining bacon into the sauce.  Taste and add salt, if needed.
7. Fold the macaroni and the sauce together.  Pour macaroni into the ramekins or casserole dish.  To help catch potential spills, place baking dish or dishes on a baking pan.  Top with reserved bacon.
8. Bake for approximately 10-20 minutes, depending on the size of the container, until hot and bubbly.  Serve immediately.

To Drink:  

Trenel Sanit-Veran 2010

Pale gold in color, this Saint-Veran offers up an intense and complex combination of white flowers, green apple, and ripe peach aromas.  The palate is soft on the entry with lemony apple flavors and a clean, crisp finish.

Saint-Veran is an appellation of dry white wines produced in the southern half of the Maconnais sub-region of Burgundy.  This clean and crisp 100% Chardonnay is a perfect compliment to the rich and creamy mac and cheese.

Recipe courtesy of Terri at That's Some Good Cookin' Blog.

Posted by Bruce Lehr Feb 28th 2013.

 

Ooooh! This isn't Good for US Manufacturing Economy

Here's a sobering report from Xconomy on a new study out of MIT.  In it, MIT researchers claim that US manufacturers (150 in study from diverse industries) hit problems when they go to scale operations at full commercial level.  This leads them to seek foreign investors and set up foreign facilities. Wave bye-bye to some good jobs.

That's not good and is why there is beginning to be more clamoring for manufacturing supports in the US (i.e. tax credits and the like).  It would be nice to have the manufacturing base remain strong (US is still No. 1) bu there is a trend toward moving to Asia and other sites abroad. We need to nip it.

Posted by Bruce Lehr Feb 28th 2013.

 

 

Innovation Lost

Here's the latest epistle from Innovate on Purpose on why innovation desires from the C suite are often lost in translation to the rest of the organization.  Some of the issues discussed include: conflict between near term sales/profitability goals and longer term innovation, prioritization conflicts around activities, and lack of innovation skills in the organization. 

The conclusion is that until the concept of innovation is firmly established and constantly communicated and resourced, it will be hard for firms to innovate consistently. Innovation is not a project but a corporate capability.

Posted by Bruce Lehr Feb 28th 2013. 

Roche's T-DM1 Crosses Finish Line as Kadcyla

The second ADC in the past year has crossed the finish line to be approved by the FDA.  This time it is Roche's (Genentech) Kadcyla to be used in the treatment of HER2 positive breast cancers.  The drug has performed in clinicals -- despite missing out on accelerated approval -- as it was widely expeced to be approved this time around.

"Kadcyla is an antibody-drug conjugate representing a completely new way to treat HER2-positive metastatic breast cancer, and it helped people in the EMILIA study live nearly six months longer," said Hal Barron, Roche's chief medical officer and head of global product development

Unfortunately, it is priced at $9800 per month per patient and is expected to cost about $94,000 for a single course of treatment -- about double its predeccessor (non-ADC) Herceptin alone.  While I am excited to see ADCs make it to market --- and to be successful clinically.  I do worry about pricing models that have most new biological drugs -- particularly in oncology areas --- costing a minimum of 6 figures per patient course. 

It is the type of thing that does not seem sustainable in the current world fiscal and economic crisis.  See reports from Fierce Biotech and Xconomy for more on the medicine and FDA approval.

On a happier economic note, Genetech (no doubt boosted by successes like Kadcyla) announced that it will be adding 600 new staff in the US.  Just to put that into perspective, 600 staffers would easily handle the work of more than 30 average biotechs in pursuit of their first drug approval.  Genentech says it prefers to promote from within, making a number of these new hires replacements for upward bound employees. And they pay well, with many of these positions tied to starting salaries that range from $70,000 to $80,000 a year.  At least this company is hiring for more success as it experiences new successes. Huzzah!  See Fierce Biotech.

Posted by Bruce Lehr Feb 23rd 2013

 

PS - There is no truth to the rumor that Kadcyla battled Xalkori to a draw over Tokyo for control of that fine metropolis.    

Well, yeah! And your point.....

"No man but a blockhead ever wrote, except for money."            --- Samuel Johnson

High Drug Pricing Next Industry Challenge?

The good news from 2012 might be that more drugs were actually approved (39) than in the very recent past -- but the bad news is that many were VERY expensive.  Xconomy's Luke Timmerman did a nice piece summarizing this a couple of days ago.  It seems that many of the very high priced drugs are coming into the oncology and "rare disease" or orphan arenas.  Many of these drugs carry price tags into the serious 6 digits and are $300K or more annually.  Is this sustainable?  Are any of these products worth it?

Those are questions that the industry must face as healthcare systems around the world struggle with costs.  Individual patients oft times may have to struggle as well depending on what type of insurance coverage they carry.  And even in the industry, some players must worry that the action of their peers might be in danger of killing a golden goose if these prices are perceived publicly -- even by physicians -- as being out of line with reality. 

What's a drug worth?  One answer might be what the market is willing to pay.  But will that number change as government and other third party payers become budget constricted. Yes, is the obvious answer.  From a payers perspective, they want a price that they feel is commeasurate with the benefits that are received.  Same from a patient's perspective, I hope.  Do I feel I got my money's worth in terms of improved health or quality of life? 

There is no doubt that this issue will not go away. 

Posted by Bruce Lehr Feb 13th 2013.

New Drug Approvals in 2012

Here's a quick piece from CEN-Online that overviews and discusses the 39 new drug approvals by FDA in 2012.  The good news is that we have seen a 2 year trend now where more drugs have been approved than in the recent past.  This may say that changes being made to R&D departments throughout the industry are starting to have an effect but more than likely it is too early to make such a statement -- however at least the trend is "good". 

It does appear that the relationships between FDA and the drug companies have improved and there is better information sharing and collaboration.  A troubling trend has been developing though with pricing and this may be the next hurdle that needs to be addressed in the industry and among goverments and payers -- not to mention patients and physicians.

Posted by Bruce Lehr February 13th 2013

 

FDA's Sprinter Pathway to Possible Approval

The FDA's new "breakthrough" designation may allow drug makers to get their products through to commercialization after only performing enhanced Phase I trials -- of course they have to meet the criterion and actually show their product works.  No small task.  However, this could be a game changer in terms of shortening the path to market and gaining return on investment --- not to mention giving patients a shot at a new treatment much earlier.

Vertex has already expoited this pathway twice in gaining approval for its cystic fibrosis medication Kalydeco and in testing its cobination therapy VX-809.  A third drug also has breaktrhough status and 18 more applications are pending with FDA.  It seems the race is on -- and its a sprint.

This will no doubt have many backers with drug makers, patients, payers and investors.  It offers many potential benefits for novel treatments of diseases with unmet needs in particular.  We'll just have to see if the program lives up to its advertisements.  See Fierce Biotech.

Posted by Bruce Lehr Feb 13th 2013.

A Real Cluster

Here's the new 2012 report on Life Science Clusters issued by Jones Lang LaSalle.  It highlights biotech clusters around the globe.  This year's top 10 ranking in the US follows with the change from last year's ranking in parentheses:

1. Greater Boston (no change)
2. San Diego (+5 spots)
3. San Francisco Bay area (no change)
4. Raleigh-Durham (+5 spots)
5. Philadelphia (+1 spot)
6. Washington DC metro area (-1 spot)
7. New Jersey/New York city (-5 spots)
8. Los Angeles/Orange county (-4 spots)
9. Minneapolis-St. Paul (-1 spot)
10. Seattle (no change)

Three major trends were cited in the report to account for some of the movement:

• M&As and growth of middle-market life science companies are benefiting smaller metropolitan areas
• Proximity to innovation -- including intellectual capital -- is more important than ever
• Build it (labs) and they will come -- states are agressively competing for life science as economic drivers for their region

You can access the whole report here - Download Life Sciences Cluster Report_Global_2012 

Posted by Bruce Lehr Feb 8th 2013

Where Has All The Pharma Talent Gone?

If this weren't so sad, it would be comical.  Big Pharma cans about 150,000 scientists since 2009 and now complains it can't find enough good talent to hire.  Need we say anymore? 

Where, Oh Where, Has All The Pharma Talent Gone? // Pharmalot.

  

 INTO THE MUD SCUM CHEMISTS!

Posted by Bruce Lehr Feb 5th 2013

One Little Indian

Late last year, GSK said it would release (anonymous) patient level information from clinical trials to allow researchers more access to provide independent analytics.  It is sticking to its guns by endorsing the AllTrials movement to do just that.  GSK also says that it is working on its web porthole that will provide researchers the promised open -- yet secure -- access to trial data.

Glaxo Clashes With PhRMA Over Data Disclosure // Pharmalot.

PhRMA -- which GSK belongs to -- and the Association for British Pharmaceutical Industry however both demur, saying it is a bad idea.  PhRMA claims that this level of disclosure will inhibit trial participants from signing up and also will promote second guessing of regulatory decisions -- both ideas being BAD in their view.

I guess they wouldn't be in favor of instant replay in baseball either?  Oh wait, I got them confused with Bud Selig.

Posted by Bruce Lehr Feb 5th 2013.