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#ChemCoach Carnival: From Big Pharma to Non-Profit

We’re almost at the end of National Chemistry week, folks, and the Haystack is finally kicking in to blogger SeeArrOh’s now rampant #ChemCoach carnival. The goal of any carnival is to get a lot of different bloggers to post on the same topic–in this case, to write about how they got to where they are today as a way of educating young chemists on their career options. Round-ups of the dozens of posts this week can be found here, here, and here. Since the science writing field has been well covered here and by our own Carmen Drahl, and because the Haystack is focused on all things pharma, I thought I’d enlist the help of someone with a much more illustrious career than my own. Without further ado, I give you some words of career wisdom from TB Alliance‘s chemistry guru Christopher Cooper:

Your current job.
 
I’m Senior Director of Chemistry at the Global Alliance for TB Drug Development (TB Alliance), a non-profit, product development partnership headquartered in New York City.  My job encompasses all chemistry activities for the Alliance from early-, mid-, and late-stage drug discovery right through drug substance/API manufacturing for clinical trials.  The TB Alliance is dedicated to identifying safe, novel chemical entities for the rapid treatment of tuberculosis worldwide, and my job is to oversee the Alliance’s chemistry needs to achieve our goals (seewww.tballiance.org for more details).


What you do in a standard “work day.”
 
Define “standard” … oh, and define “work day,” as well, please? All kidding aside, working for a small (~45 employees), entrepreneurial, research and development organization means that every day is truly different, whether it’s engaged in project team discussions with collaborators in Chicago and Belgium, or proposing new analogues/chemical series to pursue with chemists in Auckland or Seoul!  In fact, as we engage chemists (medicinal, process, manufacturing) on TB Alliance projects around the globe, my work “day” doesn’t really begin or end.  After all, if it’s 9:00 P.M. on the East Coast, it’s already 9:00 A.M. in Beijing!  Fortunately, the virtual nature of our business model translates into my own flexibility in addressing issues wherever and whenever they occur … and I don’t have to wash my glassware anymore (yey!).


What kind of schooling / training / experience helped you get there?
 
In many ways, my background would appear fairly conventional, despite the more unconventional nature of my current position.  I received my B.S. from Clemson University in 1980, and my M.S. (1982) and Ph.D.’s (1988) from Stanford.  Having worked briefly in the pharmaceutical industry (CIBA-Geigy from 1982-1984), I was eager to return so I accepted a position at Pfizer Central Research in 1988.  From 1988 to 1998, I enjoyed a varied career at PFE, working in both veterinary medicine and “conventional” human drug discovery.  I was also a strong proponent/practitioner of combinatorial chemistry, and solution-phase array approaches for the rapid interrogation of lead chemical series and the development of program-specific SAR/SLR. This interest in combichem provided me with an opportunity to “take a risk” and join Bristol-Myers Squibb in 1998, in a newly created position within their Early Discovery Chemistry department.  As head of the Lead Synthesis group, our small, dedicated team of chemists helped to shape the BMS corporate screening collection, and, more importantly, to rapidly “explode” attractive hit series for a host of therapeutic targets.  In late 2008, I was approached about “taking a risk” with another newly created position, this time working with a small, dedicated team of seasoned drug hunters striving to find safe and effective cures for an infectious disease which kills one person every 20 seconds.  I had no idea what I was getting myself in for … but having now been at the TB Alliance for just under 4 years, I see this as one of my greatest life adventures (… thus far)!  So, what helped me get here? I suppose it was a mix of hard work, personal energy, a bit of risk taking, and scientific – not just chemistry – curiosity which helped provide me with the breadth of experiences necessary for tackling the breadth of challenges I face every day.  

How does chemistry inform your work?
 
Without hyperbole, chemistry is truly the lifeblood of our efforts to identify novel, safe, and effective treatments for tuberculosis.  Consider the following: the youngest component of the standard four drug regimen for drug-sensitive TB (e.g., rifampin, pyrazinamide, isoniazid, and ethambutol) will celebrate its 50th “birthday” in 2013.  That’s fifty years old.  This is completely unacceptable.  Wehave to change this, and we ARE changing this, and we are changing this through the use of 21stcentury chemistry approaches to both optimize antimicrobial chemical series, and to produce such materials safely and efficiently on large scale.  Whether I’m challenged with scaffold “hopping” to a new lead series, or looking to decrease the cost of goods (COG’s) for a 120 kg GMP API campaign, chemistry remains front and center.

Finally, a unique, interesting, or funny anecdote about your career*
 
About two years’ ago, I was on a business trip with the TB Alliance in northern France.  Our hosts graciously invited us to visit the famous cathedral city of Rouen for a bit of site-seeing before dinner.  While crossing one cobblestoned street intersection, I heard someone call my name from behind.  It turned out to be an old friend and fellow chemistry colleague from Stanford whom I had not seen in ~25 years!! The moral of the story is to make, develop, and appreciate the chemistry friendships which you “acquire” over time – it is truly a small (chemistry) world, after all!

A123 Systems Files Chapter 11, Johnson Controls to Buy Assets

It looks like it’s pretty much all over for A123 Systems. The advanced battery company announced today that it would file for Chapter 11 bankruptcy in order to reorganize its debts. Johnson Controls, which also makes large-format lithium ion batteries for the auto industry, will purchase facilities and other assets for $125 million. A123 was earlier mulling an offer to sell itself to Chinese auto part maker Wanxiang Group.

A123 Systems makes advanced lithium ion batteries. Credit: A123 Systems

A123 was one of a host of battery, battery materials, and electric drivetrain companies to receive government money as part of the Recovery Act. The goal was to set up a full manufacturing supply chain to for U.S.-made advanced batteries. Those batteries were intended to go into U.S.-made electric vehicles. A123 received $249 million in government grants. It also has shareholders, who will likely lose their investment in the re-org.

Overall, Recovery Act funding for the advanced battery industry totalled $2 billion. A123 Systems stood out – and was most vulnerable to market forces – because it was a tech-driven, pure-play battery company. Unlike Dow Kokam, or Johnson Controls, it has no deep pocketed parent or additional technologies and markets to sell into. (A123 will license back techology for batteries used for stationary storage).

And the market A123 sells into is the hyper-oversupplied market for electric car batteries. As we’ve mentioned recently in this blog, electric cars are selling very, very slowly. A recent article in MIT’s Technology Review says battery production capacity in 2013 will greatly outpace demand with 3,900 MW hours of capacity to serve 330 MW of demand, based on estimates from Menahem Anderman at the consulting firm Advanced Automotive Batteries. Needless to say, many production lines are sitting idle at the moment.

When A123 was still a young firm, it was selling batteries for power tools to Black & Decker. Indeed, when it went public its S1 filing was based on that partnership. The company certainly had its sights set on what was to be a huge automotive market.

But one has to wonder, what would have happened if A123 hadn’t received the “free” money? What if it hadn’t been swept into the government’s big plans to create a new advanced manufacturing industry from nothing?

BMS Cuts R&D Jobs

The ax is falling on more pharma R&D jobs. Earlier today, Derek Lowe brought word from readers that research jobs were being cut at Bristol-Myers Squibb. The company just confirmed that “fewer than 100″ positions were being eliminated in the U.S. Here’s the official word from BMS:

“Bristol-Myers Squibb is strategically evolving the company’s Research focus to ensure the delivery of a sustainable, innovative drug pipeline in areas of serious unmet medical need and potential commercial growth.


The Company is aligning and building internal capabilities to support the evolution of its Research focus. In doing so, certain research areas will be streamlined and there will be investment and growth in other areas. This strategic evolution has resulted in job eliminations in the short term to allow longer term investment. This initiative will result in a reduction in employee headcount of fewer than 100 people in an R&D organization of more than 7,000 employees. Impacted employees were notified on August 1, 2012 and transitions will take place within two weeks of this date.”

The company will not confirm whether they are, as Derek’s sources suggest, in the metabolic disease area or limited to New Jersey. If indeed they are all coming out of its N.J. labs, today’s announcement will add to challenging times for the state.  As we wrote last month after Roche announced plans to shutter its Nutley site, costing some 1,000 jobs, the number of drug industry jobs in N.J. fell by 22.4% between 2007 to 2010, according to a report by Battelle and the Biotechnology Industry Organization.

Making Markets for Bio-based Fuels and Chemicals

Minnesota has long been the heart of ethanol fuel consumption. With plenty of corn and corn ethanol facilites – and a lot of drivers in E85 vehicles – the state was an early and enthusiastic supporter of bio-based fuel. But times have caught up with the northern-Midwesterners.

Now a new ethanol facility, owned by Gevo and being renovated to make isobutanol from corn, has run into an obstacle in state legislation that prevents the company from selling the alcohol to in-state fuel blenders. According to the Star Tribune, the state’s laws only specify that ethanol can be blended with gasoline (at 10% biofuel). Gevo’s Lucerne, Minn. isobutanol plant will have to ship out of state to access the fuel market.

Currently the site is being renovated to switch from making corn-based ethanol to isobutanol. Though the goal is to sell into the higher-margin chemicals market, fuels are usually a key destination to make the capacity/revenue equations work out.

There’s still time to get that settled, though. Gevo won’t be in commercial production until June, and the state can update the regulation to include other bio-based fuels. The Star Tribune points out that the President of the state’s ethanol trade group, Minnesota Bio-Fuels Association, is also CEO of Highwater Ethanol, which is also considering making isobutanol.
Highwater says it is in discussions with Butamax, a joint venture of BP and DuPont and competitor to Gevo. The two firms are been engaged in a major patent dispute. With Gevo poised to be the first in Minnesota to make isobutanol, I’m sure the firm would like to see the law changed sooner, rather than later.

Meanwhile, back in Washington, there are efforts to greatly expand the products that carry the USDA BioPreferred label. The program is a labeling/economic development/domestic bio-based materials promotion vehicle. President Obama gave it a boost last week when he signed a presidential memo requiring government agency purchasers to increase the amount of BioPreferred products they purchase. He also asked USDA to double the number of categories and products that are designated BioPreferred over the next 12 months. In the Senate, Debbie Stabenow (D-Mich.) has introduced the Grow It Here, Make It Here Bio-based Manufacturing Act which would further invigorate the effort.

I’ve been seeing a great deal of support Senator Stabenow’s bill in my in-box, from groups who expect to benefit from a higher profile for bio-based materials. DuPont, Novozymes, and the Biotechnology Industry Association trade group have publicized their support.

From a DuPont press release this morning: “The President’s action and the Grow It Here Make It Here bill demonstrate that the administration and policymakers understand the value of U.S. leadership on innovative biobased products in the United States,” said James C. Collins, president, DuPont Industrial Biosciences. “This action is a shot in the arm to America’s bioeconomy – helping support our overarching goals of boosting the U.S. agricultural sector and reducing our reliance on imported petroleum while offering a wealth of
environmental and health benefits.  This is U.S. innovation that can help create U.S. jobs for a growing global market for sustainable products.”

Tough Times for Thin Film Solar Makers

Two U.S. manufacturers of thin film solar cells based on cadmium telluride have been having a tough couple of weeks.

Tempe, Arizona-based First Solar put out a sobering fourth quarter earnings report. While sales were up a bit from last year’s quarter – to almost $2.8 billion, the firm reported a net loss of almost $40 million, compared to net income of $664 million for the fourth quarter of 2010. First Solar used the last quarter of the year to take a big goodwill impairment charge of $393 million – residue of acquisitions of OptiSolar and NextLight.

Without the goodwill charge and some restructuring charges, the quarter still brought in less profits than the previous year’s quarter. Going forward, the company cut its 2012 guidance on net sales to $3.5 billion-$3.8 billion from $3.7 billion-$4 billion. First Solar stayed firm on an earnings forecast of $3.75-$4.25 per share.

But other issues are haunting First Solar – the company’s filing with the SEC says that it is spending more than expected on warrantee replacements of solar panels deployed in hot climates. And it has a new head of investor relations after an internal investigation of company leaders who may have improperly disclosed that First Solar would not receive a DOE loan guarantee for a large utility solar installation due to not making a deadline for application. Its SEC filing said that the SEC was now investigating the issue (the loan news negatively affected First Solar’s stock price).

Meanwhile, Abound Solar, which makes  solar cells similar to First Solar, but is a smaller firm, recently said it would lay off 180 workers in Colorado. It plans to shift manufacturing to a more efficient production line, and says the workforce action is temporary. House Republicans have already been asking DOE why the company received a $400 million DOE loan guarantee for its manufacturing operations in Indiana.

First Solar and Abound Solar will go on, in spite of these hiccups. But they will continue to struggle to compete against traditional crystalline silicon solar cells because the latter have gone down in price by close to 40% in the last year. Thin film modules are well liked – First Solar is doing well with utility scale projects. But the firms have to move very quickly to increase efficiencies while decreasing production costs. To do so, they will have to stop work on older production lines – and they may have to do so abruptly or they will lose money on each module they sell.

AstraZeneca to Shed 2,200 R&D Jobs

AstraZeneca wielded a heavy ax to its workforce today as it prepares for tougher times ahead. The British-Swedish drugmaker is chopping 7,300 jobs, including 2,200 R&D positions, in hopes of achieving $1.6 billion in annual cost savings by 2014.

This is the third round of major cutbacks at AstraZeneca. In 2010, the company announced plans to slash 8,000 jobs over four years, a move that added to the elimination of 15,000 jobs between 2007 and 2009. This specific round girds against an onslaught of generic competition for key products and accounts for several disappointments in the company’s late-stage pipeline. In the coming months, the company will lose patent protection in various markets for the anti-psychotic Seroquel IR, the anti-cholesterol drug Crestor, and the blood thinner Atacand. Meanwhile, AstraZeneca’s late-stage pipeline has faltered. The recent setbacks (adding to earlier ones) include ending development of the PARP inhibitor olaparib, which prompted it to take a $285 million charge; a failed Phase III trial for the antidepressant TC-5214; and a thumbs down from FDA last month for dapagliflozin, a Type II diabetes drug being developed with Bristol-Myers Squibb.

R&D has taken a heavy hit in each round of cuts. During the Q&A session following AstraZeneca’s earnings presentation, one analyst said his back of the envelope calculations suggest the company will have shed 7,600 R&D jobs between 2006 and 2014. Based on comments by AstraZeneca’s R&D chief Martin Mackay, small molecule research has born the brunt of those cuts. He noted that headcount in biologics research has grown, and pointed out that biologics now account for 40% of the company’s early-stage pipeline (candidates in studies earlier than Phase II), up from 15-20% in recent years.

The latest R&D revamp will be primarily focused on AstraZeneca’s neuroscience activities, where the risk of investment is seen as particularly high. “It’s a really tough area,” Mackay said.  “The industry hasn’t produced enough and we haven’t produced enough.”

The challenge was highlighted in November, when TC-5214, an anti-depressant being developed by Targacept and AstraZeneca, failed to show benefit in a Phase III trial. The bad news came as a surprise, as TC-5214 had demonstrated strong efficacy in smaller trials. Three other Phase III trials are underway, but analysts are skeptical that the program can be salvaged. “Prospects appear grim,” Leerink Swann analyst Joshua Schimmer said in a note last month.

AstraZeneca is creating a small team of 40 to 50 scientists that will work with external partners in academia and industry to discover and develop neuroscience drugs. The adoption of this new strategy means that the company’s Montreal R&D facility will be shuttered, and it will end R&D at its Södertälje site in Sweden.

AstraZeneca’s overhaul of its neuroscience activities is the latest in what appears to be a big pharma exodus from internal central nervous system R&D. In December, Novartis said it would close its neuroscience research facility in Basel, Switzerland, and GlaxoSmithKline two years ago decided to end research in certain central nervous system areas, such as depression and pain.

Genzyme R&D Layoffs Today

The other shoe has dropped at Genzyme, which last year was acquired by Sanofi, but had yet to experience the kind of major research restructuring that typically accompanies the integration of two pharma companies. Today, Genzyme scientists were told whether their job was being shed or moved. Here’s an excerpt from the official statement:

As part of the integration process between Sanofi and Genzyme, R&D activities were reviewed and assessed. On January 31, 2012, the results of the review of U.S. R&D Genzyme activities were announced, including synergies that unfortunately make some positions redundant. All US R&D Genzyme employees impacted by the integration received notice regarding whether their position would be relocated or eliminated.

The job cuts are separate from the latest round of R&D layoffs at Sanofi. As readers might recall, Sanofi announced last November that it was closing its Bridgewater R&D site, and move discovery and early development activities to Boston. A Sanofi spokesperson tells the Haystack that despite today’s cuts at Genzyme, the company is committed to its presence in Massachusetts, and to maintaining a stable level of jobs there. While R&D is falling under the axe, the company is hiring in manufacturing and multiple sclerosis, she says.

The company has not provided details on how many R&D scientists will be shed, but once more information comes to light, we’ll update readers.

Haystack 2011 Year-in-Review

Well, 2011 is in the books, and we here at The Haystack felt nostalgic for all the great chemistry coverage over this past year, both here and farther afield. Let’s hit the high points:

1. HCV Takes Off – New treatments for Hepatitis C have really gained momentum. An amazing race has broken out to bring orally available, non-interferon therapies to market. In October, we saw Roche acquire Anadys for setrobuvir, and then watched Pharmasset’s success with PSI-7977 prompt Gilead’s $11 billion November buyout.  And both these deals came hot on the heels of Merck and Vertex each garnering FDA approval for Victrelis and Incivek, respectively, late last spring.

2. Employment Outlook: Mixed – The Haystack brought bad employment tidings a few times in 2011, as Lisa reported. The “patent cliff” faced by blockbuster drugs, combined with relatively sparse pharma pipelines, had companies tightening their belts more than normal. Traffic also increased for Chemjobber Daily Pump Trap updates, which cover current job openings for chemists of all stripes. The highlight, though, might be his Layoff Project.  He collects oral histories from those who’ve lost their jobs over the past few years due to the pervasive recession and (slowly) recovering US economy.. The result is a touching, direct, and sometimes painful collection of stories from scientists trying to reconstruct their careers, enduring salary cuts, moves, and emotional battles just to get back to work.

3. For Cancer, Targeted Therapies – It’s also been quite a year for targeted cancer drugs. A small subset of myeloma patients (those with a rare mutation) gained hope from vemurafenib approval. This molecule, developed initially by Plexxikon and later by Roche / Daiichi Sankyo, represents the first success of fragment-based lead discovery, where a chunk of the core structure is built up into a drug with help from computer screening.From Ariad’s promising  ponatinib P2 data for chronic myeloid leukemia, to Novartis’s Afinitor working in combination with aromasin to combat resistant breast cancer. Lisa became ‘xcited for Xalkori, a protein-driven lung cancer therapeutic from Pfizer. Researchers at Stanford Medical School used GLUT1 inhibitors to starve renal carcinomas of precious glucose, Genentech pushed ahead MEK-P31K inhibitor combinations for resistant tumors, and Incyte’s new drug Jakifi (ruxolitinib), a Janus kinase inhibitor, gave hope to those suffering from the rare blood cancer myelofibrosis.

4. Sirtuins, and “Stuff I Won’t Work With  – Over at In the Pipeline, Derek continued to chase high-profile pharma stories. We wanted to especially mention his Sirtris / GSK coverage (we had touched on this issue in Dec 2010). He kept up with the “sirtuin saga” throughout 2011, from trouble with duplicating life extension in model organisms to the Science wrap-up at years’ end. Derek also left us with a tantalizing tidbit for 2012 – the long-awaited “Things I Won’t Work With” book may finally be coming out!

5. Active Antibacterial Development – In the middle of 2011, several high-profile and deadly bacterial infections (Germany, Colorado, among others) shined a spotlight on those companies developing novel antibacterials. We explored front -line antibiotics for nasty Gram-negative E.coli, saw FDA approval for Optimer’s new drug Fidiclir (fidaxomicin) show promise against C. difficile  and watched Anacor’s boron-based therapeutics advance into clinical testing for acne, and a multi-year BARDA grant awarded to GSK and Anacor to develop antibacterials against bioterrorism microorganisms like Y. pestis.

6. Obesity, Diabetes, and IBS – Drugs for metabolic disorders have been well-represented in Haystack coverage since 2010. Both Carmen and See Arr Oh explored the vagaries of Zafgen’s ZGN-433 structure, as the Contrave failure threatened to sink obesity drug development around the industry. Diabetes drugs tackled some novel mechanisms and moved a lot of therapies forward, such as Pfizer’s SGLT2 inhibitors, and Takeda’s pancreatic GPCR agonist. Ironwood and Forest, meanwhile, scored an NDA for their macrocyclic peptide drug, linaclotide.

7. The Medicine Show: Pharma’s Creativity Conundrum – In this piece from October, after Steve Jobs’ passing, Forbes columnist Matt Herper both eulogizes Jobs and confronts a real ideological break between computer designers and drug developers. His emphasis? In biology and medical fields, “magical thinking” does not always fix situations as it might in computer development.

We hope you’ve enjoyed wading through the dense forest of drug development with Carmen, Aaron, Lisa, and See Arr Oh this past year. We here at The Haystack wish you a prosperous and healthy 2012, and we invite you to come back for more posts in the New Year!