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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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DoD selects Paragon Bioservices for Filovirus vaccine contract
Posted By Ross Petras on January 25, 2012 in In My Opinion-CRO
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It seems to me as an executive recruiter focusing in the CRO (Contract Research Organizations or Clinical Research Organizations) space that more and more of our clients are looking for people with "security clearance". Obviously BioTerrorism is a huge concern for our nation however many of our candidates are "foreign nationals" which can cause fits for recruiting high level scientists or even senior managers with CRO/Pharma experience. This article details yet another example of Government retaining CRO's to do the front line fighting against BioTerrorism......RP
Article Care of Centerwatch News Online
Wednesday, January 18, 2012 12:15 PM
Paragon Bioservices has been awarded the JVAP-CBMS contract from the U.S. Department of Defense (DoD) to develop and manufacture the “VEE Replicon Particle Trivalent Filovirus Vaccine."
Paragon will develop a large-scale mammalian process suitable for cGMP manufacturing. Paragon will receive approximately $15 million, with a future optional CLINs that, if exercised, will more than double that amount.
This contract is being performed in parallel to a contract Paragon formed with the U.S. Army in October 2012, which involves process development and scale-up production to support the efficacy and potency of filovirus vaccine candidates against deadly Ebola and Marburg viruses.
Currently, there are no licensed vaccines or treatments against filoviruses, even though they are a potential agent of bioterrorism due to a 90% fatality rate in humans. |
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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 "Big Pharma" culture shock!
Posted By Ross Petras on June 16, 2011 in News-CRO
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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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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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More Orphan Drug Approvals
Posted By Ross Petras on January 31, 2011 in News-CRO
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More Orphan drugs being approved a very quick way to speedier approval.......RP
AROG Pharmaceuticals, LLC ("AROG") is pleased to announce that the U.S. Food & Drug Administration (FDA) has granted orphan drug designation to CP-868,596 for the treatment of glioma and assigned the generic name crenolanib.
CP-868,596 is an orally bioavailable small molecule, highly potent, selective inhibitor of PDGFR kinase that targets malignant tumors. AROG plans to initiate a Phase II trial with CP-868,596 for the treatment of adult gliomas and a Phase I/II trial with CP-868,596 for the treatment of pediatric gliomas in the first half of 2011.
"We are looking forward to aggressively developing CP-868,596 for the treatment of gliomas and other rare cancers," said Vinay Jain, MD, Chief Executive Officer of AROG. "The orphan drug designation is an important step forward to support the development of CP-868,596."
According to the Orphan Drug Act of 1983, the orphan drug designation is granted to companies with products aimed at treating rare diseases or conditions that affects fewer than 200,000 Americans. If the company's product is granted the orphan drug status by the FDA, the company will be eligible to receive various financial incentives, including tax credits, access to grant funding for clinical trials, accelerated FDA review and marketing exclusively after drug approval for a period of as long as seven years.
Crenolanib Designated as Generic Name for CP-868,596
AROG is also pleased to announce that the United States Adopted Name Council (USANC) and the World Health Organization' s INN program have adopted crenolanib as the generic name for CP-868,596. The USANC is tri-sponsored by the American Medical Association (AMA), the United States Pharmacopeial Convention (USP), and the American Pharmacists Association (APhA), and establishes drug nomenclature classifications based on pharmacological and/or chemical relationships.
About Crenolanib (CP-868,596)
Crenolanib is a potent and selective inhibitor of platelet derived growth factor receptors (PDGFR). In April 2010, AROG signed an exclusive worldwide license with Pfizer for the development and commercialization of crenolanib. Phase I single agent and Phase Ib (combination with docetaxel and axitinib) clinical trials with crenolanib have been completed.
About AROG Pharmaceuticals, LLC
AROG is a private, oncology-focused drug development company based in Dallas, TX. AROG's mission is to develop novel anticancer drugs for the treatment of rare cancers with significant unmet medical need. To learn more about AROG, please visit www.arogpharma.com. |
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NIH Funding more Immunodeficiency Grants
Posted By Ross Petras on January 12, 2011 in News-CRO
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Good to see more funding going in the direction of Immunodeficeniency research in this area is beginning to show some promise.....RP
NEW YORK (GenomeWeb News) – The National Institutes of Health will use its Small Research Grant program to fund science into rare immunodeficiency diseases, including studies focused on molecular knowledge, biomarkers, and diagnostic technologies.
Funded by the National Institute of Allergy and Infectious Diseases and the National Institute of Child Health and Human Development, this program will give provide up to $50,000 for direct costs per year for each award. The institutes expect to support two new awards each fiscal year.
Primary immunodeficiency diseases are caused by inherited defects in the immune system, and the group includes around 150 diseases and 120 different genes. Although individual primary immunodeficienies are rare, according to NIH, this group as a whole affects one to two percent of the population.
These Small Grants on Primary Immunodeficiency Disorders will fund research that identifies the immunological and molecular characteristics of these diseases, and it will support research seeking to discover and develop improved diagnostic or newborn screening tools.
The studies also could seek to identify and validate biomarkers for these diseases, or aim to understand how a genetic variant can result in immunodeficiency.
Researchers seeking support under this program could propose pilot and feasibility studies, secondary analysis of existing data, and self-contained projects, as well as new research methodologies and technologies. Researchers who have no prior history of receiving independent NIH funding or no NIH funding in immunodeficiency diseases are encouraged to apply for these grants. |
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Global Pharmaceutical Industry Outlook Remains Negative
Posted By Ross Petras on December 10, 2010 in In My Opinion-CRO
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I'm not 100% sure this will affect some of the more agressive/nimble CRO's in the business however I feel that if investment capital in the form of Venture funded Biotech's stay's low then over outlook will remain bearish over the next 12-24 months however I imagine we'll see a significant shift in the overall outlook in the next 5-10 years.....RP
The negative outlook primarily reflects the sector's increasing exposure to major patent expirations, peaking in 2011 and 2012, at a time when the quality of late-stage pipelines is on average insufficient to offset this trend, says Moody's Investors Service in an Industry Outlook published today. The report explores Moody's expectations for the fundamental credit conditions in the industry over the next 12-18 months.
"In addition to the negative exposure towards patent expiries, regulatory hurdles remain high for new drugs, exacerbating the situation for players with fewer innovative drugs in development. Furthermore, ongoing global healthcare reforms aim to limit drug spending. The cutbacks in drug spending is a trend that is accelerating in Europe as governments grapple with massive fiscal deficits," explains Marie Fischer-Sabatie, a Moody's Vice President-Senior Analyst, and lead author of the report.
Moody's expects these negative pressures to remain a key feature of the industry until the patent cliff is over. In late 2011 and early 2012, the industry will face expiries on some of its largest-selling drugs (e.g. Lipitor, Zyprexa and Plavix in the US), heralding a major exposure period that will continue into 2012 and 2013, when several other larger products will become affected. Companies will need to step-up their efforts to dilute the negative effects of patent expiries and strengthen their pipelines to off-set future revenue losses in what is likely to be a tougher regulatory environment. Moody's therefore expects debt-financed consolidation to continue in the near term as these challenges intensify.
"From a credit standpoint, the companies best equipped to deal with these challenges are those with robust pipelines capable of offsetting the impact from patent expiries. Diversified players, those which can offset difficulties in one segment or region with better performance in another, are also well placed. However, the expected debt-financed consolidation could exert pressure on some ratings within this sector. Despite the challenges, the industry remains solidly profitable and lowly levered compared with other industries," adds Ms Marie Fischer-Sabatie. |
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FDA More Conservative to Skirt Possible Controversies
Posted By Ross Petras on November 4, 2010 in News-CRO
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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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Medidata EDC and IVRS partnership with Progenics (CRO)
Posted By Ross Petras on October 19, 2010 in News-CRO
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Medidata Solutions Selected by Progenics Pharmaceuticals for Seamless Integration of EDC and IVRS.....RP
Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical development solutions, today announced that Progenics Pharmaceuticals, Inc. has selected the Medidata Rave® electronic data capture (EDC) and clinical data management (CDM) platform. Progenics has decided to implement Rave integrated with United BioSource Corp’s (UBC) interactive voice response system (IVRS) to manage a Phase III study evaluating methylnaltrexone, an opioid-induced constipation treatment, throughout investigative sites in Europe, Canada and the U.S.
Based in Tarrytown, NY, Progenics focuses on innovative therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases, with principal programs directed toward supportive care, oncology and infectious diseases.
To implement the integration process, UBC also provided a unified project management system for multi-technology implementation and integration. UBC has strategically partnered with Medidata for a number of years, joining the Medidata ASPire to Win® partner program for contract research organizations in 2007 and becoming a Medidata Technology Partner for its IVRS integration with Rave in 2009.
“We are pleased that Progenics’ clinical development team selected an integrated EDC and IVRS solution – one that will enable seamless sharing of key clinical data for streamlined data management, subject screening, randomization, drug supply management and site management processes,” said Glen de Vries, President, Medidata Solutions. “We’re continuing to see sponsors make significant investments in best-of-breed, easily interoperable solutions that will meet their specific requirements across all areas of the clinical research process.”
About Progenics
Progenics Pharmaceuticals, Inc., of Tarrytown, NY, is a biopharmaceutical company focusing on the development and commercialization of innovative therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases. Principal programs are directed toward supportive care, oncology and infectious diseases. Progenics is developing RELISTOR® (methylnaltrexone bromide) for the treatment of opioid-induced constipation. RELISTOR is now approved in over 50 countries, including the U.S., E.U., Canada, Australia and Brazil. Progenics is pursuing strategic alternatives for RELISTOR, including licensing, collaboration, strategic alliances and U.S. commercialization or co-promotion, following termination of its 2005 collaboration with Wyeth Pharmaceuticals, now part of Pfizer Inc., which is continuing manufacturing, sales, marketing, clinical, and certain development and regulatory activities for RELISTOR during the transition. Ono Pharmaceutical Co., Ltd. has an exclusive license from Progenics for development and commercialization of subcutaneous RELISTOR in Japan. In oncology, the Company is conducting a phase 1 clinical trial of PSMA ADC, a human monoclonal antibody-drug conjugate for the treatment of prostate cancer. PSMA is a protein found on the surface of prostate cancer cells as well as in blood vessels supplying other solid tumors. In virology, Progenics is also developing the viral-entry inhibitor PRO 140, a humanized monoclonal antibody which binds to co-receptor CCR5 to inhibit human immunodeficiency virus (HIV) infection. PRO 140 is currently in phase 2 clinical testing. In early development, Progenics is evaluating novel antibodies to toxins produced by the bacteria C. difficile, as well as single-agent multiplex PI3-Kinase inhibitors as a potential strategy to combat some of the most aggressive forms of cancer, and is also seeking to identify novel entry-inhibitors of HCV infection.
About UBC
United BioSource Corporation (UBC) is a global scientific and medical affairs organization that partners with life science companies to develop and commercialize biopharmaceuticals, medical devices, and other health care products. We help deliver authoritative, real-world evidence to characterize product effectiveness, address safety risk, and demonstrate value. UBC brings together recognized scientific and industry experts, research operations professionals, and new technologies to provide innovative solutions across the product lifecycle. The company is headquartered in Bethesda, Maryland, with offices in North and South America, Europe and Asia. For more information about UBC, visit www.unitedbiosource.com.
About Medidata Solutions Worldwide
Medidata Solutions (www.mdsol.com) is a leading global provider of SaaS-based clinical development solutions that enhance the efficiency of customers’ clinical trials. For over 10 years, Medidata has consistently brought next-generation innovation to the life science industry to lower the total cost of clinical development through informed trial planning and management, optimized clinical processes and platform interoperability. Medidata’s advanced solutions address key functions throughout the clinical development process including protocol development (Medidata Designer®), trial planning and management (Medidata Grants Manager®, Medidata CRO Contractor®), user and learning management (iMedidata™), randomization and trial supply management (Medidata Balance™), monitoring (Medidata Rave Monitor, Medidata Rave Targeted SDV), Serious Adverse Events capture (Medidata Rave Safety Gateway) and clinical data capture, management and reporting (Medidata Rave®). Our diverse customer base spans biopharmaceutical companies, medical device and diagnostic companies, academic and government institutions, CROs and other research organizations, and includes more than 20 of the top 25 global pharmaceutical companies as well as organizations of all sizes developing life-enhancing medical treatments and diagnostics. |
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About Ross Petras
Ross Petras founded CRORecruiter.com-a PSR Company in 2003. Since it's inception Ross has become one of the most successful Clinical recruiters in the US. He has personally recruited some of the highest level clinical and contract research talent in the US for our CRO and Pharma Clients.
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