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The 3 interview questions that matter!
Posted By Ross Petras on February 22, 2012 in Recruiting Info-All
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As a recruiter who is now going on his 9th year in this business I can say that this article by George Bradt (from Forbes) is absolutely true.......RP
Top Executive Recruiters Agree There Are Only Three True Job Interview Questions
They are as follows:
1. Can you do the job (Strengths)?
2. Will you love the job (Motivation)?
3. Can we tolerate working with you(Fit)?
That’s it. Those three. Think back, every question you’ve ever posed to others or had asked of you in a job interview is a subset of a deeper in-depth follow-up to one of these three key questions. Each question potentially may be asked using different words, but every question, however it is phrased, is just a variation on one of these topics: Strengths, Motivation, and Fit.
Can You Do the Job? – Strengths
Executive Search firm Heidrick & Struggles CEO, Kevin Kelly explained to me that it’s not just about the technical skills, but also about leadership and interpersonal strengths. Technical skills help you climb the ladder. As you get there, managing up, down and across become more important.
You can’t tell by looking at a piece of paper what some of the strengths and weaknesses really are…We ask for specific examples of not only what’s been successful but what they’ve done that hasn’t gone well or a task they they’ve, quite frankly, failed at and how they learned from that experience and what they’d do different in a new scenario.
Not only is it important to look at the technical skill set they have…but also the strengths on what I call the EQ side of the equation in terms of getting along and dealing or interacting with people.
Will You Love the Job? -Motivation
Cornerstone International Group CEO, Bill Guy emphasizes the changing nature of motivation,
…younger employees do not wish to get paid merely for working hard—just the reverse: they will work hard because they enjoy their environment and the challenges associated with their work…. Executiveswho embrace this new management style are attracting and retaining better employees.
Can We Tolerate Working With You? – Fit
Continuing on with our conversation, Heidrick’s Kelly went on to explain the importance of cultural fit:
A lot of it is cultural fit and whether they are going to fit well into the organization… The perception is that when (senior leaders) come into the firm, a totally new environment, they know everything. And they could do little things such as send emails in a voicemail culture that tend to negatively snowball over time. Feedback or onboarding is critical. If you don’t get that feedback, you will get turnover later on.
He made the same point earlier in an interview with Smart Business, referencing Heidrick’s internal study of 20,000 searches.
40 percent of senior executives leave organizations or are fired or pushed out within 18 months. It’s not because they’re dumb; it’s because a lot of times culturally they may not fit in with the organization or it’s not clearly articulated to them as they joined. |
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Embracing Generics and Emerging Markets
Posted By Ross Petras on January 25, 2012 in In My Opinion-Bio
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Atleast twice daily I get the question.....what is the future or our business from current and future Biotech and Pharma executives? Being a lowly Biotech recruiter I really can't begin to postulate on this question but I have pondered it quite a bit and I feel that Karl Theils article below sheds some light on the next decade of our business. I feel that emerging markets are quickly becoming the "next big thing" and shortly will be the benchmark for continued success in this business......RP
Article by Karl Theil
1/23/2012 3:40:55 PM Embracing Generics and Emerging Markets
Did you know that the average daily cost of drugs dropped by one third between 2005 and 2010? And that Medicare drug spending has come in below predicted levels? Seems like a strange thing in this age of stealth inflation and $200,000-a-year medicines, but the reason is quite simple: We are in freefall off the patent cliff, and the average drug spend for consumers should continue to decline as popular drugs go generic. Prices should decrease by another third through 2015, according to IMS Health estimates.
That's great news for consumers; maybe not so much for drug companies. But needless to say, they've seen this coming for a long time, and they've been planning. Plan A--to replace all those off-patent drugs with new innovative blockbusters (or value-added versions of the same products) has met with mixed success at best. Plan B--to make highly targeted, very expensive specialty drugs, often linked to companion diagnostics--is shaping up to be one of the most interesting trends of the next decade. But in the meantime, there's Plan C, and it's likely to gain momentum in 2012: The move to emerging markets.
The industry's embrace of emerging markets gained momentum during the merger mania of 2009, and it's not likely to slack off this year for a number of reasons. Obviously, these markets--particularly what IMS Health dubbed the 17 "pharmerging" markets (most notably China, Brazil, India, Russia, Turkey, South Korea and Mexico) are a source of new, and increasingly affluent, customers. The easy way to access them--and work through a tangle of regional regulation, patent laws, and more--is to buy local generics companies and manufacturers.
An added benefit is that these acquisitions can magnify the value of other assets. At the recent JP Morgan Healthcare conference, GlaxoSmithKline CFO Simon Dingemans pointed out (hat tip to the In Vivo Blog) how well its 2009 acquisition of Stiefel has worked out. GSK was able to plug Stiefel's dermatology products, which had limited international distribution, into its own expanding global network and get a lot of new business out of emerging markets that Stiefel by itself was unlikely to tap.
Emerging markets also serve as a way to help companies participate in the surging global generics market. Sanofi, for instance, got the ball rolling in Latin America with its 2009 acquisition of Medley, which made it the number one generics company throughout Mexico and Latin America. Now the company wants more. Fresh from the acquisition of Genzyme, Sanofi CEO Chris Viehbacher recently said he is looking at a potential $2.6 billion in bolt-on acquisitions this year, most likely focused on emerging markets. And German pharma Gruenenthal has just put together a $1.3 billion warchest earmarked specifically for Latin America, particularly the large markets of Brazil and Mexico.
We've seen how this focus is shifting company priorities--like fewer jobs in the U.S. and Europe, more in Asia. That too will probably continue, because the opportunities are so large and yet the obstacles so formidable. IMS predicts the pharmaceutical industry sales in emerging markets will total more than $300 billion by 2017. That dwarfs the U.S. market.
Yet it won't be easy. Consider China, which offers the dual advantages of not only being the world's fastest growing pharmaceutical market but also being a relatively cheap place to conduct R&D, particularly in preclinical chemistry. That's attracted contract research organizations to the region--Quintiles continues to expand there (see Career Track), and it has also led major pharma companies to expand their presence. But making the most of this opportunity will require a lot more effort, because even large companies have a hard time reaching their customers. There are over 7,000 drug distributors in China, and the top three account for only 20% of the market. Struggling with those kinds of issues will be taking up a lot of attention from pharma's top brass. Biotech, meanwhile, can concentrate on those expensive new drugs.
-Karl Thiel |
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Counter Offers....bad news for candidates!
Posted By Ross Petras on August 1, 2011 in Recruiting Info-All
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| This is a very good article by Carol Schultz regarding the "validity of counteroffers".....bottom line don't accept them. They're a bandaid created by your employer to buy them some time to replace you.......RP
For the sake of this article I’m going to assume you know how to qualify your candidates from the moment you speak to them until they’ve signed the offer letter and started. I’m going to assume you’ve been communicating effectively with them throughout every step of the process and have been asking quality questions to ensure you’re not getting “sunshine blown up your skirt.”
There’s nothing 100% foolproof and guaranteed, but good methods of pre-qualifying candidates regarding counteroffers will make your life less stressful and more financially rewarding. In addition, if you are straight in your qualifying methods you may even weed out the candidate who would accept the counteroffer and possibly leave you hanging.
First, I know the word “never” is a strong one. I don’t use it lightly or without substantial consideration as my world, both personal and professional, is gray. In this case I believe accepting a counteroffer is positive in a fraction of the cases and it’s just not worth the risk.
It can be career suicide. A counteroffer may be both tempting and flattering to the candidate in question. It may be very appealing to a candidate who isn’t truly committed to leaving his job. I have known people who accepted counteroffers and, most often, they regret their actions.
As a recruiter you must resist the temptation to persuade your candidates into accepting your offer if you have even the slightest hint that the position in question isn’t the right fit. It’s hard, especially if/when you’re depending on acceptance to make a living. We know people buy on emotion, and enticing someone to take your offer (or the current company getting their employee to accept a counteroffer) by getting him excited and hopeful is just plain out of integrity. Temptation can be very seductive and hard to resist. As George Bernard Shaw said, “I never resist temptation because I have found that things that are bad for me do not tempt me.” That said, let’s look a some of the reasons not to accept a counteroffer. Make sure you’re using these reasons for them to decline a counteroffer wisely throughout the recruiting cycle.
- The current employer is attempting to cover their tush. When you quit they lose money. When you quit the manager looks bad. Better to keep you on board until they can find a replacement. If that happens your pink slip will follow in short order.
- You become a fidelity risk to your current employer. You’ve threatened to quit once. It’s only a matter of time before you do it again, and smart companies won’t allow themselves to be put into this situation. You will never be perceived the same to them once you’ve threatened to quit and decided to stay.
- Any situation which causes an employee to seek outside offers is suspect. For example, if money is your issue why does it take a full court press for your employer to realize they need to pay you more? If you’re worth more money now, why weren’t you worth it 15 minutes earlier?
- The reasons for you wanting to quit will still remain, even if they are temporarily shaded.
- Quality, well-run companies won’t give counteroffers…ever! How would you feel if one of your employees forced you into something? ”If you don’t X, then I’m quitting.” I know I’d be angry. I’d be more than angry. If they don’t like working for you then they should go.
If you do get the urge to accept a counteroffer, just be prepared for the consequences whenever they do show up. |
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Genzyme get ready for the "Big Pharma" culture shock!
Posted By Ross Petras on June 16, 2011 in Recruiting Info-Bio
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 Two months after it was bought out by French pharma giant Sanofi, changes are afoot at Genzyme. The Boston Globe broke the news yesterday that several divisions of the Cambridge, Massachusetts biotech – specifically its oncology, renal, and biosurgery operations – will now report directly to Sanofi. The biotech’s core programs in multiple sclerosis and personalized genetic health, including rare diseases, will remain a part of the Genzyme division.
No layoffs have been announced, but the news is certain to make some employees antsy. “Every time the CEO makes comments like that, it makes people nervous,” says Neil Solomon of the Neil Michael Group, a New York-based agency that recruits senior executives for life-sciences firms. “It’s impossible to tell where their careers are going to be down the road.”
Thirty years old and employing 10,000 workers, Genzyme was hardly a spry young biotech when Sanofi snatched it up. But employees say the culture did retain traces of the entrepreneurial spirit that grew the company from its origins in a tiny lab over a discount women’s clothing store into a gleaming rare diseases powerhouse. The sale prompted concerns over how that culture would meld into the staid world of big pharma.
Genzyme employees have already been grumbling that decision-making within the company has slowed since the takeover. Solomon says it is too early to expect workers to flee the company en masse – some have stock options and retention bonuses to entice them to stay during the transition. But Solomon is in discussions with five executives who are weighing their options, and he is optimistic that he’ll lure at least one away in the coming month. “The reigns are loosening,” says Solomon. “In the end, you’ll see plenty of employees jumping.”
Ross Petras, senior recruiter for the biotech division of Priority Sales Recruiting, agrees. He says that his firm has placed at least five Genzyme scientists in new jobs over the past six months and is in talks with about three dozen more.
“People are listening carefully to what opportunities are inside the company versus outside,” says Alison Taunton-Rigby, a former Genzyme senior vice-president.
The decision to split up the company makes sense from a business standpoint, Taunton-Rigby notes. Sanofi lacks Genzyme’s deep experience in rare diseases, so it is likely that Genzyme will retain more autonomy in that area. Oncology, however, is a competitive area which demands an aggressive and entrenched sales force, and Sanofi will draw on its large resources in that market.
But the break-up does not make sense if the goal is to keep an entrepreneurial work force together, she adds: “‘Big’ is not good for product development.”
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Potential Bug Eats Bug-antiviral treatment for Salmonella
Posted By Ross Petras on March 9, 2011 in News-Bio
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Have you ever heard the term fight "fire with fire" some clever reseachers @ Cal Berkley are working on a way to kill Salmonella Bacteria with an engineered bacteria that actually combats the Salmonella.....RP
Researchers Turn Salmonella Into Antiviral Gene Therapy Agent
ScienceDaily (Feb. 8, 2011) — New experiments at the University of California, Berkeley, may one day lead to anti-viral treatments that involve swallowing Salmonella bacteria, effectively using one bug to stop another. Researchers at UC Berkeley's School of Public Health have reprogrammed Salmonella, the same foodborne pathogen that can cause diarrhea, fever and abdominal cramps, to safely transport virus-stopping enzymes into cells without causing disease. Not only did this technique effectively treat mice infected with cytomegalovirus, it worked as an oral solution that was swallowed instead of injected.
Virologist Fenyong Liu teamed up with bacteriologist Sangwei Lu to develop the innovative technique, which is described in a study to be published online the week of Feb. 7 in the journal Proceedings of the National Academy of Sciences.
"A number of vaccines, including those for polio and smallpox, use live but weakened viruses to build up the immune system. But this is the first time anyone has successfully engineered bacteria for treatment of a viral infection," said Liu, a UC Berkeley professor at the Division of Infectious Diseases & Vaccinology.
The researchers said Salmonella was particularly appealing because it has evolved to survive the human digestive system, allowing it to be swallowed instead of injected or inhaled.
"This is the first gene therapy treatment for viral infection that can be taken by mouth, which is far more convenient to administer than an injection," said Lu, a UC Berkeley associate adjunct professor at the Division of Infectious Diseases & Vaccinology. "Moreover, there is already an attenuated strain of Salmonella with a decent track record for safety in humans since it is now used in the vaccine for typhoid (a disease caused by Salmonella typhi)."
Researchers know that ribozymes, enzymes that are able to target and cut specific RNA molecules, can be used to inactivate a pathogen's genes. But to do their work, ribozymes need to first get into the cells, and for that they need help.
It so happens that Salmonella is very good at invading cells, so the researchers found a way to use the bacterium as a vector for the RNase P ribozyme that could stop the gene activity of cytomegalovirus, or CMV.
CMV is in the same family of herpes viruses that causes cold sores, mononucleosis and chickenpox. CMV infections are generally mild among healthy individuals, but they can become deadly for people whose immune systems are compromised and are a leading viral cause of mental retardation in newborns.
Previous research by Liu and Lu showed that Salmonella could effectively sneak the anti-viral ribozymes into human cells infected with human cytomegalovirus and reduce the viral load of the cell cultures. This new study put the technique to the test in living mice.
As an added measure of safety, researchers took the attenuated strain of Salmonella and further mutated a gene that the bacteria needs to replicate. They tested the new mutant Salmonella strain in mice and confirmed that the mice did not get sick.
They then cloned the anti-viral ribozymes into a plasmid, or DNA molecules within the bacteria that can replicate. Among mice that had been infected with cytomegalovirus, those that had been given oral doses of the ribozyme-carrying Salmonella survived much better than mice that had not been treated or mice that had been given Salmonella carrying a defective version of the ribozyme. The treated mice lived at least 50 days after infection, whereas the mice in the other two groups died within 25 days after infection.
Moreover, the researchers found that the viral load of mice treated with the ribozyme-carrying Salmonella was 400- to 600-times lower than the viral load for mice given the defective ribozymes and for mice that were untreated.
The researchers pointed out that using bacteria instead of viruses as gene-therapy vectors has a number of advantages.
"Viruses can't replicate on their own; they must be grown in host cells," said Lu. "It is more challenging to grow host cells in a lab, and there is always the risk that those cells can be contaminated with unknown viruses. To grow bacteria, you only need to add some bacteria to a simple medium, and the next day you can have 100 billion bacteria ready to go. It's safer, easier and cheaper as a vector for gene therapy."
The researchers pointed to the potential for developing this technique into a range of gene-targeting therapeutics. "This study focused on the use of Salmonella and ribozymes to fight infections, but with more research, this method could eventually be used to treat other conditions as well, including cancer," said Liu.
Other UC Berkeley authors on the paper include lead author Yong Bai and Hao Gong, both post-doctoral researchers in infectious diseases; Hongjian Li, a former post-doctoral researcher in infectious diseases; and Gia-Phong Vu, a graduate student in comparative biochemistry.
The U.S. Department of Agriculture and the National Institutes of Health helped support this research. |
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Success Rates for Experimental Drugs Declining in the US
Posted By Ross Petras on February 17, 2011 in News-All
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This article has some significant implications for those of us following the Healthcare/Pharma space. It seems that Biologics are becoming easier to get approved while chemical compounds are facing more stringent regulation by the FDA. Oncology also has seen significant challenges in getting approvals even with significant activity......RP
By Bill Berkrot
NEW YORK | Mon Feb 14, 2011 8:09am EST
NEW YORK (Reuters) - The success rate in bringing new medicines to market in recent years is only about half of what it had been previously, but biotech drugs are twice as likely to gain U.S. approval than more traditional chemical drugs, according to a new study released on Monday.
And while oncology has been one of the hottest and most active therapeutic areas for drug development, drugmakers may want to take note of a finding that new cancer drugs have proven far more difficult to gain approval than medicines for infectious and autoimmune diseases.
Drugmakers have been complaining about the difficulty of bringing new products to market in a regulatory climate that has become increasingly unpredictable and more likely to err on the side of safety in deciding risk/benefit ratios of experimental medicines.
Data from this new study appears to bear that out.
"It ain't getting any easier to develop new therapies." said Alan Eisenberg, head of emerging companies and business development for the biotech trade group Biotechnology Industry Organization (BIO), putting the findings succinctly.
"Knowing more about the magnitude of risk can lead to smarter drug development as well as smarter investing," he said.
The study, covering 2004 through 2010, found the overall success rate for drugs moving from early stage Phase I clinical trials to FDA approval is about one in 10, down from one in five to one in six seen in reports involving earlier years.
The study, conducted by BIO and BioMedTracker, which collects data on drugs in development, reviewed more than 4,000 drugs from companies large and small and both publicly traded and private. It was released in conjunction with the annual BioCEO and Investor conference in New York.
Adding weight to the desire by major pharmaceutical companies to become increasingly involved in biotechnology was a finding that biologics had a 15 percent chance of going from Phase I through to FDA approval, compared with a 7 percent success rate for traditional small molecule chemical drugs.
When broken down by therapeutic categories, the highest overall success rate from Phase 1 through likelihood of approval was infectious diseases, such as hepatitis and HIV drugs, at 12 percent, followed by endocrine system drugs, featuring diabetes treatments, at 10.4 percent, and autoimmune diseases, such as rheumatoid arthritis, at 9.4 percent, the study found.
John Craighead, BIO's managing director for investor relations, said clinical trial goals and the approval pathways for infectious diseases and diabetes drugs are clear and very well-established.
"The Phase II results are very predictive of the Phase III outcomes and very predictive of approval," he said.
"The overall success rate in oncology was the lowest of the therapeutic areas that we looked at," he said, noting that cancer studies vary dramatically in design and extending survival sets a high bar for approval.
The cancer drug success rate was a mere 4.7 percent, with cardiovascular drugs second-worst at 5.7 percent, as regulators are increasingly demanding proof that heart drugs reduce heart attacks and strokes rather than just lower a risk factor, such as cholesterol levels.
The largest dropout rate along the clinical pathway came in advancing drugs from mid-stage Phase II studies to late-stage Phase III testing.
Some 63 percent of drugs in Phase I testing advanced to Phase II, but only 33 percent of Phase II drugs made it to Phase III, which requires a commitment to larger and much more expensive clinical trials. Phase III is typically the final stage of human testing before a new drug is submitted to regulators for an approval decision.
Not surprisingly, the numbers increase after that as the drugs had already shown success in the clinic.
Approval applications were filed for 55 percent of the drugs that made it to Phase III testing, and 80 percent of those gained eventual approval, although only about half were approved on their initial FDA review.
The 80 percent approval rate, while seemingly high, is down from 93 percent seen in studies of earlier years. |
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Nicotine Pathway to Discovered
Posted By Ross Petras on January 31, 2011 in News-Bio
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Some excellent news coming out of the great state of Florida. Scripps has found a pathway for Nicotine addiction.....RP
Scientists from the Florida campus of The Scripps Research Institute say that they have identified a pathway in the brain that regulates an individual’s vulnerability to the addictive properties of nicotine. The team is now collaborating with the University of Pennsylvania to develop new drugs to boost signaling in this pathway and decrease the addictive properties of nicotine. The study appeared January 30 in an advance, online issue of the journal Nature. The paper is titled “Habenular á5* Nicotinic Receptor Signaling Regulates Nicotine Intake.”
Specifically, the research focused on the nicotinic receptor subunit á5, in a discrete pathway of the brain called the habenulo-interpeduncular tract. They found that animal models with a genetic mutation inhibiting this receptor subunit consumed far more nicotine than normal. This effect could be reversed by boosting the subunit’s expression.
The results suggest that nicotine activates nicotinic receptors containing this subunit in the habenula, triggering a response that acts to dampen the urge to consume more of the drug. “Our data may explain recent human data showing that individuals with genetic variation in the á5 nicotinic receptor subunit are far more vulnerable to the addictive properties of nicotine and far more likely to develop smoking-associated diseases such as lung cancer and chronic obstructive pulmonary disease,” says Christie Fowler, the first author of the study and research associate in the Kenny laboratory.
Nicotine is the major addictive component of tobacco smoke, and nicotine acts in the brain by stimulating proteins called nicotinic acetylcholine receptors (nAChRs). These nAChRs are made up of different types of subunits, one of which is the á5 subunit.
In their experiments, the Scripps Research team set out to determine the role of nAChRs-containing á5 subunits (á5* nAChRs) in regulating nicotine consumption. First, they assessed the addictive properties of nicotine in genetically altered mice lacking á5* nAChRs. The results showed that when these knockout mice were given access to high doses of nicotine, they consumed much larger quantities than normal mice.
Next, to determine if the subunit was responsible for the sudden shift in appetite for nicotine, the scientists used a virus that rescued the expression of á5* nAChRs only in the medial habenula and areas of the brain into which it projects. The results showed the nicotine consumption patterns of the knockout mice returned to a normal range.
The scientists repeated the experiments with rats and produced similar results. In this case, the scientists used a virus to knock out á5 nAChR subunits in the medial habenula. When the á5* nAChRs were decreased, the animals were more aggressive in seeking higher doses of nicotine. When the subunit remained unaltered, the animals showed more restraint.
The scientists then worked out the biochemical mechanisms through which á5* nAChRs operate in the medial habenula to control the addictive properties of nicotine. They found that á5* nAChRs regulate just how responsive the habenula is to nicotine, and that the habenula is involved in some of the negative responses to nicotine consumption. So when á5* nAChRs do not function properly, the habenula is less responsive to nicotine and much more of the drug can be consumed without negative feedback from the brain. |
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Hitachi, OriGene Ink Assay Development, Marketing Pact
Posted By Ross Petras on December 10, 2010 in News-Bio
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Hitachi Software Engineering America and OriGene Technologies said after the close of the market on Friday that they have entered into a co-marketing agreement to jointly promote products for assay development.
Specifically, the firms will co-market OriGene's multiplex assays built on Luminex xMAP/Bio-Plex technology with Hitachi's MasterPlex software suite for analysis and reporting of multiplex assay data. As part of the deal, OriGene will use the MasterPlex software exclusively in all immunoassay and custom assay development, the firms said. Customers who purchase OriGene's assays will be offered the use of the MasterPlex software for 30 days, they added.
Among OriGene's products are multiplexed assays for microRNA expression, transcription factors profiling, and genotyping.
"Going forward, OriGene and Hitachi Software plan to leverage our new partnership to bring an even broader range of research and analysis solutions to our current and future life sciences customers," Robert Lynde, director of sales for Hitachi Software, said in a statement.
Financial and further terms of the alliance were not disclosed |
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FDA More Conservative to Skirt Possible Controversies
Posted By Ross Petras on November 4, 2010 in News-Bio
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By Karl Thiel
FDA's hardening stance on accelerated approvals has been much in the news lately. Not only have several past accelerated approvals been revisited lately – Roche AG's Avastin for breast cancer, Pfizer Inc.'s Mylotarg for acute myeloid leukemia, and Shire plc's ProAmatine for orthostatic hypotension – but the agency seems to be getting more conservative in an effort to avoid potential future controversies.
The agency's refusal to consider Roche and Immunogen Inc.'s trastuzumab-DM1 for accelerated approval, for example, despite the fact that it has shown activity in HER-2 positive breast cancer patients who have failed multiple courses of prior therapy, has caused a lot of bewildered head-shaking in the industry. And in a recent New York Times article, Roche was taken to task for not even seeking accelerated approval for PLX4032, a promising melanoma drug.
While the implication in that piece was that the company is seeking to put together the best possible marketing package against potential future competitors, it is likely that the company is considering how to meet FDA's stricter stance on accelerated approval and subsequent data collection.
And the program seemed to be going so smoothly for the past 17 years. How did we get here?
The debate over accelerated approvals has been framed in largely black-and-white terms: On the one side, the need to speed the availability of new medicines to patients with few other options; on the other side, the desire to maintain scientific rigor and public safety. It sometimes seems as if these two goals lie at opposite poles, with a move in one direction a compromise for the other side. But that needn't be the case, and the real misfortune is that neither the FDA nor the industry seems to be moving toward a path that will mean better drugs for patients.
FDA's Office of Oncology Drug Products has a good reason to be cautious about accelerated approvals. The most commonly used surrogate market to support an early approval for a cancer drug is tumor regression, and it's just not that great an endpoint. There are lots of reasons why a drug might shrink a tumor and yet not really improve that patient's survival or quality of life. Among them is that accelerated approval focuses on drugs for very sick patients whose cancers have often metastasized, and it is these metastases rather than primary tumors that more often kill patients.
Frankly, the track record with accelerated approvals has been pretty good when you consider this. Some expectation of subsequent failure should be built into the system by definition – after all, if tumor regression was 100 percent predictive of improved survival, spending the time and money necessary to do actual survival studies would be unethical.
It is rightly assumed that there will be times when tumor regression doesn't predict survival, and when this happens it isn't a failure on the part of either the sponsor or the FDA. Thus, the recent spate of reevaluations doesn't by itself signal a problem with the system.
The real issue is making companies come up with the follow-up data to support accelerated approvals in a timely manner. Mylotarg was approved in 2000, for instance, but Pfizer (then Wyeth) didn't even start the confirmatory studies until 2004. Once a drug is on the market, companies have little incentive to gather data that could undermine an approval, particularly if there are no competitive products to deal with.
The FDA's Risk Evaluation and Mitigation Strategy (REMS) authority should do a lot to force companies to go to market with plans already in hand for following up on surrogate endpoints, but that also means companies have to think ahead more seriously about how that data will be gathered. Thus, you see cases like PLX4032, when a drug that looks like a shoo-in for accelerated approval may have to complete a traditional survival trial because no one will be willing to risk not getting an effective therapy by enrolling in a clinical trial after approval.
That small piece of perversity, however, pales in comparison to other distortions created by the current system. Looming large among these is the fact that companies now deliberately pursue tumor regression in very sick patients as an end unto itself. If FDA shakes the industry out of that tendency, it's doing a good thing.
Here's a test: Try explaining to someone with no connection to the industry that extending a patient's life for four months pretty much counts as a cancer breakthrough. They'll look at you like your nuts. How about curing someone's cancer? How about preventing it? Now that would be a breakthrough.
The problem with accelerated approval isn't that drugs sometimes get approved that shouldn't be – that's part of the system.
The problem is that it fails to incentivize the kinds of drugs we really need. It creates incentives to use relatively cheap, quick trials to get drugs that may have marginal benefits on the market so that companies can slug it out with marketing instead of science.
Of course, this cuts both ways. By getting stricter about accelerated approvals, the FDA may guide the industry back toward a focus on survival. But that's all stick and no carrot. The agency also needs to make it feasible to create the kinds of drugs that will make major differences in more people's lives.
One step would be to make it easier to test and approve combination therapies. Back in March, the FDA announced it was devising guidelines to ease the regulatory pathway for drug cocktails, which have proven crucial in controlling HIV and could undoubtedly play a greater role in improving cancer care. On June 8, the FDA published a Federal Register notice asking for comments on "co-development of investigational drugs," but so far there's been no other formal action.
Nevertheless, this has the potential to be the carrot that can coax drugmakers into creating more innovative products.
The FDA has said that its aim is to address sponsors "co-developing two or more distinct, novel investigational drugs intended to be used in combination . . ." That's a far cry from its current approach to combination therapies, which generally allows only one novel product to be combined with an already-approved agent, and won't consider an accelerated approval unless the novel agent has shown efficacy as a monotherapy. And notice the wording: Two or more distinct, novel investigational drugs.
That doesn't mean a new agent with some standard chemo thrown in; it means a chance to try treatments involving multiple new approaches. Like maybe going after cancer's rapid mutagenesis much the same way virologists went after HIV.
And who knows what might be next? Maybe the FDA will make it easier to test and approve drugs aimed at cancer prevention.
With these kinds of changes, patients may be more willing to give the agency the benefit of the doubt the next time it moves to take an approved cancer drug off the market. |
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Breakthrough in Nanocrystals Growth
Posted By Ross Petras on October 19, 2010 in In My Opinion-Bio
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Very interesting breakthrough in observence of Nanocrystals growth may have energy applications.....RP
ScienceDaily (Oct. 18, 2010) — For the first time, scientists have been able to watch nanoparticles grow from the earliest stages of their formation. Nanoparticles are the foundation of nanotechnology and their performance depends on their structure, composition, and size. Researchers will now be able to develop ways to control conditions under which they are grown. The breakthrough will affect a wide range of applications including solar-cell technology and chemical and biological sensors.
As coauthor Wenge Yang of the Carnegie Institution's Geophysical Laboratory explained: "It's been very difficult to watch these tiny particles be born and grow in the past because traditional techniques require that the sample be in a vacuum and many nanoparticles are grown in a metal-conducting liquid. So we have not been able to see how different conditions affect the particles, much less understand how we can tweak the conditions to get a desired effect."
These researchers work at the Center for Nanoscale Materials and the Advanced Photon Source (APS)-both operated by Argonne National Laboratory-and the High Pressure Synergetic Consortium (HPSynC), a program jointly run by the Geophysical Laboratory and Argonne. The scientists used high-energy X-rays from the APS to carry out diffraction studies that enabled them to gain information on the crystal structure of the materials. Thanks to the highly brilliant and high penetration of this X-ray source-the largest of its kind in the US-the researchers were able to watch the crystals grow from the beginning of their lives. The atoms scatter very short wavelength X-rays and the resulting diffraction pattern reveals the structure of these unusual particles. Quite often the chemical reaction occurs in a very short time and then evolves. The scientists used highly focused high-energy X-rays and a fast area detector, the key components to make this investigation possible. This is the first time-resolved study of the evolution of nanoparticles from the time they are born.
HPSynC, is also a part of the Energy Frontier for Research in Extreme Environments (EFree) Center, an Energy Frontier Research Center supported at Carnegie by DOE-BES. One of the missions of this center is to harness new synchrotron radiation techniques for in situ studies of materials structure and dynamics in extreme conditions and thereby to understand and produce new energy materials.
"This study shows the promise of new techniques for probing crystal growth in real time. Our ultimate goal is to use these new methods to track chemical reactions as they occur under a variety of conditions, including variable pressures and temperatures, and to use that knowledge to design and make new materials for energy applications. This is a major thrust area of the HPSynC program that we have launched in partnership with Argonne National Laboratory," remarked Russell Hemley, the director of Geophysical Laboratory. |
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