This week's sponsor is L.E.K. Consulting.
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Forging a Path From Companion Diagnostics to Holistic Decision Support Personalized medicine is expected to drive new levels of partnership across the life sciences spectrum. To better understand the role of collaboration, read this whitepaper for a broader decision-support analysis and the emergence of more holistic trends. Download today!
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Today's Top Stories 1. J&J opens new innovation center in quest for more early-stage deals 2. Domain opens shop in China with plans to seed biotech startups, do deals 3. Cytos Biotechnology soars on results of asthma-drug study 4. Rogue Aptuit researcher convicted of manipulating Roche, AstraZeneca studies 5. AbbVie spins out a PhII orphan drug to Receptos--with a hook attached 6. Takeda taps Scripps as the pharma extends early-stage pipeline
Also Noted: RelayHealth Spotlight On... Merck recruits Luminex for Alzheimer's diagnostics Nabsys raises $21M for sequencing tech; Supreme Court to hear 'pay for delay' arguments; and much more...
A tale of two shortages: Spectrum's Fusilev reels as generics reappear, Hikma injectables grow 83% in U.S.
Drug shortages have wreaked havoc on hospitals and drugstores over the past couple of years. They've also prompted a considerable amount of jockeying on the supply side of things. Some companies have managed to profit off the missteps of their competitors, like Hikma Pharmaceuticals, which saw its generics injectables business grow 47% last year. But growth on the back of shortages can backfire. What happens when a shortage eases? For a case study, look no further than Spectrum Pharmaceuticals. Read more from FiercePharma >>
This week's sponsor is Kony Solutions. |
| Webinar: Drugmakers go mobile Thursday, March 21st, 2 pm ET/ 11 am PT | New Speakers Added! With a steady stream of new mobile apps, pharma companies aim to catch up with their target audiences on a number of fronts. But what makes a winning mobile app in pharma? Join as we discuss how drugmakers have effectively raised their mobile games to achieve a variety of strategic objectives. Register Today! |
Sponsor: BioConference Live
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Events
> Welcome to the R&D Revolution - April 23, 2013 | Chicago, IL - Sponsored by: Accenture & MPI Research > BioBasics: Biotech for the Non-Scientist - March 21-22 - Wayne, PA > BioNetwork East 2013 - April 03-05 - Miami, FL > ExL's 4th Proactive GCP Compliance - April 10-12 - Washington, D.C. > Inaugural Healthcare Growth Capital Conference - April 11 - W Hotel NYC > MDMA 2013 Annual Meeting - April 15-17 - Washington, D.C. > 2013 BIO International Convention - April 22 ? 25, 2013 - Chicago, Illinois > Food & Drug Law Institute Annual Conference, FDA Commissioner Confirmed - April 23-24 - Washington D.C. > Women In Bio Annual Celebration Reception 2013 - April 22 - Chicago, IL > Sample Prep 2013 - May 8-9 - San Diego, CA > ATS 2013 - May 17-22 - Philadelphia, PA > 2 Singapore Events: Bio-IT World Asia & Tri Conference Asia - May 28 - 31 - Marina Bay Sands, Singapore > Clinical Diagnostics - May 29 - 31, 2013 > BioImmersion Course - October 16-18 - Washington, D.C.
Marketplace
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> Jobs at 3M > Manufacturing Equipment/Utility Engineer - San Francisco, CA – CMC Biologics > Engineering/Facilities Technician- San Francisco, CA – CMC Biologics > Senior Director, Clinical Research & Development (MD) Job -Warren Township, NJ, US – Celgene Corporation > Junior Staff Accountant Job - Berkeley Heights, NJ, US – Celgene Corporation > Senior Director, Global Marketing, Revlimid MM Job - Summit, NJ, US – Celgene Corporation > Director, Global IT PMO Operations & Portfolio Management Job - Berkeley Heights, NJ, US – Celgene Corporation > Senior Director, Regulatory Affairs, CCT Job -Warren Township, NJ, US – Celgene Corporation > Senior Director, Medical Affairs Oncology - EMEA Job - Boudry, Sw, US – Celgene Corporation > Senior Director, EMEA Marketing Oncology Job - Boudry, Sw, US – Celgene Corporation > Senior Director, National & Regional Accounts Job - Summit, NJ, US – Celgene Corporation > Principal Validation Scientist Job - Phoenix, AZ, US - Celgene Corporation > Senior Clinical Trial Manager (Oncology) - Waltham, MA – TESARO > Senior Manager, Program Development - Waltham, MA – TESARO > Associate/Principal - San Francisco, CA – Novo A/S > Validation Engineer - St. Louis, MO – ProPharma Group > CSV Consultant – California – ProPharma Group
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Today's Top News
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Paul Stoffels |
Johnson & Johnson ( $JNJ) has prominently planted its R&D flag in London. Today the giant pharma company officially opened up its new innovation center in the U.K., one of four scientific and business development outposts around the world charged with building J&J's ties to the biotech industry and academia as it fosters new development deals. And the company's chief scientific officer and worldwide chairman, pharmaceuticals, Paul Stoffels, tells FierceBiotech today that their "objective is to increase the number of deals" J&J does each year.
Last year, says Stoffels, J&J struck 71 deals with academia and biotech companies. Now Patrick Verheyen, an experienced M&A executive at J&J, will lead a team of 20 scientists and deal-makers, networking with various players inside the bustling UK life sciences hub--as well as the broader European market. The U.K. is home to some of the world's foremost research institutions, as well as a new generation of drug and device companies which enjoy active support from some new government initiatives.
"What is different now is that we brought the people much closer to where much of the action is--top scientists and venture capital and licensing and acquisitions and deal-making teams--to make sure we can interact in a much more interactive way," says Stoffels. J&J also brings its internal technological skills in chemistry, preclinical work and more to play for its collaborators, which will "reduce the amount of capital needed and increase the probability of success."
The UK life sciences industry--which has been recovering from some prominent setbacks two years ago--needs to do "more with less capital," says Stoffels. "That means building infrastructure, with more collaborative research to progress science."
"I think by becoming part of the ecosystem we can help create new companies," says Verheyen. The same thinking explains why J&J recently invested $50 million along with GlaxoSmithKline ( $GSK) into a new $200 million fund operated by Index Ventures.
The London office isn't restricted to the U.K., Stoffels adds. Verheyen's team is expected to be the flagship arm for all of Europe, with a satellite office set up in Israel to support the company's active presence in its medical research community. A new office has already opened in Boston with two other centers planned for San Francisco and Shanghai.
The innovation center's new office is at 1 Chapel Place, London, W1G OBJ.
- here's the press release
Special Reports: Paul Stoffels - The 25 most influential people in biopharma today - 2013 | Pfizer - The Biggest R&D Spenders In Biopharma
Related Articles: J&J stakes out Boston/Cambridge HQ for new innovation center J&J plans innovation centers, looking for buys and team-ups J&J's Gorsky will target device deals for emerging markets
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This week's sponsor is BioConference Live.
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Domain Associates has begun tapping its extensive biopharma network in search of products that could have a bright future in the Chinese market. The venture capital firm has partnered with a group of pharma consultants to create a new enterprise--Domain Elite--dedicated to launching a portfolio of biopharma start-ups in China which will in-license drug, diagnostic and device technology for the Chinese market.
The structure of the deal is simple. Domain already has a number of companies in its biotech portfolio. The venture partners can identify products and fund new companies, with Elite stepping in to recruit managers and staff as they forge in-licensing deals and bring over experimental as well as approved drugs, diagnostics and devices, gain regulatory approvals and begin marketing efforts. And as with all Domain investments, exits can be crafted through buyouts and public offerings.
"We have a long history of starting companies," Domain partner Brian Halak tells FierceBiotech. "We have a network we can draw on to find interesting assets and bring capital to the table. (The staffers at) Elite Consulting know the Chinese market extremely well." And that's important, he adds, "as not all interesting U.S. products will work in China."
Halak and Micah Zimmerman, a partner at Elite Consulting, which was established back in 1997, say the plan now is to set up a handful of these new companies, perhaps four, in the next 4 years. And they are already in "4 or 5 in-depth talks."
"We don't have any strict criteria," says Halak. "We need to get a certain amount of money to work, driven by opportunity. We will have enough money reserved with ourselves and potential partners to carry things through into the market. What we invest will depend on the opportunity." And while there's no specific dollar figure in mind, he adds. Domain's piece "could be up to $20 or $30 million."
Halak added that Domain will start with seeding new companies and then look to bring other venture groups to the table to create new syndicates to back new ventures.
Domain, one of the most active biotech investors in the U.S. venture community, has a history of striking unconventional partnerships in search of new opportunities. The venture group recently joined hands with a big Russian investor, steering them to new U.S. biotech investments.
- here's the press release
Related Articles: VCs agree to pump $21M more into developer's nanotech drug Rusnano, Domain team top up CoDa venture round with $20M Billions in new venture cash targeted at early-stage biotech efforts
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After closing out a failed Novartis partnership in January, Cytos Biotechnology has registered some upbeat data from a mid-stage study of its lead drug against allergic asthma. On the news, Zurich-based Cytos' shares jumped 14% as of early this morning, Bloomberg reported.
The 18-year-old biotech provided some early signs of positive efficacy from the small 63-patient Phase IIa study. Patients on the company's injected drug, CYT003, showed improved symptoms of their asthma after dropping therapy with standard inhaled corticosteroids. As expected, the patients' symptoms got worse after they stopped taking the standard asthma med and switched to placebo.
With high hopes for the candidate, a modulator of innate immune activity, the company began a larger Phase IIb study in the fourth quarter of 2012 in 360 patients, targeting those whose asthma isn't controlled with standards meds. The topline data from the study are expected in the first half of 2014, according to the company. The aim of the biologic compound is to act earlier in the disease pathway to stymie inflammation in the airways of patients with allergic asthma, which afflicts about 300 million people worldwide and growing.
Cytos has weathered some ups and downs in recent years. In January Novartis ( $NVS) ditched its rights to a smoking-cessation vaccine from Cytos and the up to $500 million deal that went with it. Yet Cytos has kept the Swiss drug giant as a partner in an early-stage effort focused on CAD106, which triggers the production of antibodies against beta amyloid, providing a potential defense against one of the key culprits in memory-stealing Alzheimer's disease.
Alzheimer's drug research has been mostly fruitless for the pharma industry, and time will tell whether Novartis' mid-stage trial initiated in 2010 will yield enough positive results to warrant further development.
- here's today's release - and Bloomberg's article
Special Report: CAD106 - 10 promising therapeutic vaccines 2012
Related Articles: Novartis dumps a long-faded $500M pact with Cytos Novartis, Cytos Alzheimer's vax shows immune response Cytos revives lead program in $40M financing deal with Amgen, venBio
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British regulators do not take kindly to researchers who manipulate trial data. And Steven Eaton can now attest to the extreme risks involved.
Eaton, a former staffer at Aptuit, today became the very first person to be convicted of violating the U.K.'s Good Laboratory Practice law. According to a report in the Financial Times, Eaton had been charged with manipulating data from animal studies done to assess new drugs for the likes of Roche ( $RHHBY) and AstraZeneca ( $AZN). He was convicted of manipulating the animal data to make them look like a success, when in fact the drugs had failed. And after Aptuit found out about it in an internal audit, the company was forced to review "hundreds" of safety studies, delaying the launch of many drugs.
"Mr. Eaton's actions directly impacted the validity of clinical trials and delayed a number of medicines coming to market, including one to treat depression," said Gerald Heddell, director of inspection, enforcement and standards at the Medicines and Healthcare Products Regulatory agency, according to the FT. "This conviction sends a message that we will not hesitate to prosecute those whose actions have the potential to harm public health."
Eaton is scheduled to be sentenced in April.
- here's the story from the Financial Times (reg. req.)
Related Articles: Senate report rules Medtronic improperly shaped bone growth data Aptuit extends GSK partnership at Italian site GlaxoSmithKline anti-smoking drug combats addictive cravings
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San Diego-based Receptos has snagged a deal to put one of AbbVie's respiratory drugs through a Phase II study, taking on the risk of mid-stage work while securing an option deal that allows AbbVie ( $ABBV) the right to step back in if the therapy looks promising enough to take it forward into Phase III.
The IL-13 antibody--now designated RPC4046 by Receptos--will be tested as a potential new therapy for Eosinophilic esophagitis, an orphan disease. "We believe that AbbVie's exceptional track record in immunology will be a strong asset in this collaboration," says Receptos CEO Faheem Hasnain.
Hasnain has a unique perspective on this. He had been CEO of Facet Biotech, which Abbott acquired in 2010 for $450 million.
If AbbVie likes what it sees following discussions with the FDA post-Phase II, it can trigger the option, splitting the cost of the Phase III and taking all the ex-U.S. rights while leaving Receptos with a potentially lucrative co-promotion deal in the U.S.
FierceBiotech queried the company on AbbVie's rationale for spinning out a Phase II asset, especially as the pharma company has been investing heavily in its pipeline in the lead-up to the recent split at Abbott ( $ABT). Doesn't the deal imply that AbbVie wants to outsource risk on a marginal product?
Receptos's response, via e-mail: "AbbVie had de-prioritized their respiratory portfolio (including pursuit of RPC4046 in the asthma indication), and was intrigued when Receptos brought forward the scientific rationale and clinical design for proof of concept in EoE, which is a GI-related immunology indication that would complement AbbVie's strong GI franchise. As an orphan Indication, AbbVie was happy to allow external investment to fund the proof of concept study and defer their further investment decision until the program was de-risked."
Risk-sharing deals like this, with biotechs taking on clinical trial work for assets in Big Pharma's pipeline, have become more popular as some of the largest companies have been quicker at prioritizing the work the companies are willing to do in-house.
- here's the release
Related Articles: AbbVie shares fall in first day of 'when-issued' trading Genetic biomarkers could help detect food allergy Receptos raises $25M in Series A
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Takeda Pharmaceutical is leaning on academics to support its efforts to discover new drugs. The Japanese drug giant has expanded an alliance with the Scripps Research Institute outpost in Jupiter, FL, hunting for new drugs to combat multiple diseases.
The expanded research deal builds on Scripps' research pact that began in 2010 with Envoy Therapeutics, which Takeda gobbled up in a $140 million acquisition in November 2012, gaining Envoy's preclinical pipeline of compounds against Parkinson's disease, schizophrenia and other neurological conditions. The East Coast labs of Scripps, which also has a large presence in La Jolla, CA, has worked with Envoy since the early days of the company, providing high-throughput screening to match compounds with the biotech's novel CNS targets.
Takeda is pouring more resources into the Scripp-Envoy collaboration as Japan's No. 1 drugmaker beefs up its early-stage pipeline. During the J.P. Morgan Healthcare conference in January, Takeda R&D chief Dr. Tadataka Yamada noted his desire to find new therapies at the beginning stages of development, highlighting the acquisitions of Envoy Therapeutics and Intellikine as deals that aided this effort. Yamada oversees the world's 7 th-largest drug pipeline, which is deep with late-stage candidates that account for about a third of the portfolio. So early-stage programs are in demand.
Like Takeda, pharma players have happily outsourced discovery work to academic labs such as Scripps, The Broad Institute of MIT and Harvard, Sanford-Burnham Medical Research Institute and others. The trend has made the academics important allies in Big Pharma's struggles to find innovative new drugs to replace aging brands facing heavy competition.
"We're pleased to expand our partnership with Takeda-Envoy and to push promising drug discovery efforts forward," Scott Forrest, Scripps' vice president for business development, said in a statement. "The high-throughput screening capability at Scripps Florida campus is in increasing demand--both from other research institutes and from industry."
The next phase of the Takeda-Envoy alliance also keeps some of the exciting discovery work Envoy and Scripps have been doing in Florida. At the time of its November buyout of Envoy, Takeda said that the majority of Jupiter, FL-based Envoy's research activities would move to Takeda's R&D hub in San Diego this month.
"Now we're moving into new therapeutic areas with different biological targets," Stephen Hitchcock, Envoy's senior VP of discovery, stated. "The first step is to find small molecules that can validate those targets--and Scripps Florida is amongst the very best places to do that."
- here's the release
Special Report: 20 Major Pharma-Academic Alliances in 2012
Related Articles: Takeda's R&D boss injects 'urgency' into Japan's No. 1 drugmaker Takeda snaps up CNS drug developer Envoy Therapeutics in $140M deal Big Pharma backers fuel $17M first round for developer of brain-penetrating protein drugs
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Also Noted
This week's sponsor is RelayHealth. |
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Webinar: Congratulations, The Doctor Prescribed Your Brand. Did Your Market Share Improve? Wednesday, March 27th, 2pm ET / 11am PT
Join us on March 27th to learn how pharmaceutical brand teams are taking advantage of connectivity into the community pharmacy to improve patient acquisition, utilize prescription analytics and so much more. Register today!
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Merck ( $MRK) is pressing forward with its controversial Alzheimer's treatment, and now it has signed a deal with Luminex ($LMNX) to develop a companion diagnostic that will screen patients for its ongoing clinical program. The blockbuster hopeful MK-8931 is designed to block an enzyme that helps produce beta amyloid peptide, believed to trigger Alzheimer's. Merck is in the midst of a Phase II/III trial of the drug, and Luminex's job is to craft and get approval for a diagnostic that will track two biomarkers in patients' cerebrospinal fluid, identifying those at risk for Alzheimer's who might benefit from MK-8931. FierceMedicalDevices story
@FierceBiotech: Editor's corner: Will biotech grow in China and India without much VC help? More | Follow @FierceBiotech
@JohnCFierce: Weird deal. Receptos gets a PhII-ready AbbVie antibody. AbbVie has option to co-dev, co-promote. If it's worth anything, why farm it out? | Follow @JohnCFierce
@RyanMFierce: Takeda expanded a discovery alliance with Sripps Florida (pharma outsourcing more discovery work to academics.) Release | Follow @RyanMFierce
> Sequencing tech startup Nabsys has raised $21 million, with Bay City Capital leading the Series D. Story
> The big showdown between pharma companies and the FTC over "pay for delay" deals will soon be in the hands of the Supreme Court. Story
Pharma News
@FiercePharma: India's Lupin joins hunt for branded products to beef up a generics portfolio. Has $1B to spend. Report | Follow @FiercePharma
@EricPFierce: Bayer & Merck have weighed in on the big pay-for-delay case that the Supreme Court takes up this month. More | Follow @EricPFierce
> Bayer, Merck join fight against FTC in pay-for-delay case. More
> Merck hid Fosamax's links to femur fractures, lawyer says. More
Medical Device News
@FierceMedDev: For GenMark, more flu was good news in 2012. More | Follow @FierceMedDev
@MarkHFierce: France's EyeTechCare, with $13M in new funding, will pursue U.S. approval of its glaucoma ultrasound medical device. More | Follow @MarkHFierce
@DamianFierce: Luminex is on board to handle companion diagnostics for Merck's blockbuster hopeful Alzheimer's drug. More | Follow @DamianFierce
> Analysts: Life Tech's suitors may balk at $15B price tag. More
> Zoll wins German patent battle over intravascular temperature management tech. More
Drug Delivery News
@MichaelGFierce: Vaginal nanogel with bee venom could prevent HIV infection. Story | Follow @MichaelGFierce
> Terumo evens with Abbott's Xience in drug-eluting stent study. News
> Study: Artificial pancreas improves overnight care in diabetic children. Article
> Shape-shifting proteins could aid drug delivery for cancer, infections. More
> Celgene drops $13M on Presage's 3-D drug delivery platform. Report
> PolyPid, MIS Implants partner for drug delivering dental bone-filler. Item
And Finally… A new survey finds that doctors often prescribe cholesterol-lowering drugs to patients who are unlikely to benefit from them. Story
> Drugmakers go mobile - Thursday, March 21st, 2 pm ET/ 11 am PT
With a steady stream of new mobile apps, pharma companies aim to catch up with their target audiences on a number of fronts. But what makes a winning mobile app in pharma? Join as we discuss how drugmakers have effectively raised their mobile games to achieve a variety of strategic objectives. Register Today!
> Congratulations, The Doctor Prescribed Your Brand. Did Your Market Share Improve? - Wednesday, March 27th, 2pm ET / 11am PT
Join us on March 27th to learn how pharmaceutical brand teams are taking advantage of connectivity into the community pharmacy to improve patient acquisition, utilize prescription analytics and so much more. Register Today!
> The Basics of Biotech 101, 102 & 301 - Individual Session: $129, Full Series: $299
This 3-part webinar series is specifically geared toward the non-science professional who needs to better understand industry terminology, science, techniques and issues. This series provides an overview of the science and technology used to enable discovery and the processes scientists use to discover new therapeutics. Download now.
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> Welcome to the R&D Revolution - April 23, 2013 | Chicago, IL - Sponsored by: Accenture & MPI Research
Join FierceBiotech Editor-in-Chief John Carroll on Tuesday, April 23rd in Chicago, as he sits down with executives from GlaxoSmithKline, AstraZeneca, Pfizer, and Johnson & Johnson to discuss the brave new world of drug R&D and how it applies to the industry's drug pipeline efforts. Register Today!
> BioBasics: Biotech for the Non-Scientist - March 21-22 - Wayne, PA
A two-day course for the non-scientist which highlights science and technology concepts that are the basis of the biotechnology industry. Register Today!
> BioNetwork East 2013 - April 03-05 - Miami, FL
Since 2003 BioNetwork has provided the essential platform for pharmaceutical and biotechnology business development executives to come together and form strategic partnerships. Don't miss out on this incredible opportunity to meet your industry's decision makers. Register today!
> ExL's 4th Proactive GCP Compliance - April 10-12 - Washington, D.C.
This event on risk-based approaches to clinical quality is a must attend for all clinical management, quality, compliance, and ops professionals. Presentations from Merck, Pfizer, BI, Shire, Endo and more. Visit www.exlpharma.com/gcp and use Code C262Fierce for 15% off standard rate.
> Inaugural Healthcare Growth Capital Conference - April 11 - W Hotel NYC
Conference to cover strategies on growing existing healthcare businesses to scale & providing expansion capital to high-growth companies with tens to hundreds of millions of dollars in revenues. Register now to receive $100 off with discount code: GCCFRC.
> MDMA 2013 Annual Meeting - April 15-17 - Washington, D.C.
Attend MDMA's 2013 Annual Meeting and cover key issues impacting the U.S. leadership position in medtech innovation, get first-hand updates on the latest news & must have information for medtech CEOs and meet with your Congressional delegation on Capitol Hill. Click here to register.
> 2013 BIO International Convention - April 22 ? 25, 2013 - Chicago, Illinois
The largest gathering of biotech professionals is coming to Chicago and it's an event not to be missed. Join 16,500 leaders from 65 countries at the 2013 BIO International Convention, April 22 - 25, for unparalleled partnering, expert-led education and the latest technology discoveries. All to help you advance your career. Register now.
> Food & Drug Law Institute Annual Conference, FDA Commissioner Confirmed - April 23-24 - Washington D.C.
Don't miss the largest and longest-running legal conference for regulated industry and the entire food and drug law community. Join more than 750 participants to hear from FDA leadership, advance your career and engage in hot topic sessions: Caronia; FDA's global strategy; role of the media; and much more. Register now.
> Women In Bio Annual Celebration Reception 2013 - April 22 - Chicago, IL
Attend the Women In Bio Annual Celebration! A networking event where you can hear the amazing success story of our keynote speaker Jill Milne, CEO of Catabasis Pharmaceuticals, as she discusses moving from bench scientist to biotech entrepreneur and provides advice for up-and-coming women leaders. Learn more.
> Sample Prep 2013 - May 8-9 - San Diego, CA
SAMPLE PREP 2013 Conference, a 7th meeting in the Knowledge Foundation's Sample Prep Conference Series. Join us in San Diego, CA on May 8 - 9, 2013. Register Now: Click Here
> ATS 2013 - May 17-22 - Philadelphia, PA
With more than 500 sessions, 800 speakers, and 5300 research abstracts and case reports, ATS 2013 will enable attendees to learn about developments in many fields or delve deeply into specific areas of interest. No other meeting provides as much information about how advances in respiratory, critical care, and sleep medicine are changing clinical practice. Learn more.
> 2 Singapore Events: Bio-IT World Asia & Tri Conference Asia - May 28 - 31 - Marina Bay Sands, Singapore
Join us in May at the Marina Bay Sands in Singapore for the upcoming Bio-IT World Asia & Tri-Conference Asia. Programs include: IT Infrastructure & Cloud, Antibody Engineering, NGS Applications, Clinical Data Management & eClinical Trials, Bioinformatics & Cancer Genomics and Molecular Diagnostics. Register by March 15th for early savings.
> Clinical Diagnostics - May 29 - 31, 2013
The 4th annual Clinical Diagnostics online conference is free to attend and will focus on medical, clinical, and research topics including Personalized Healthcare, Pathology, Oncology, Infectious Disease, Laboratory Testing, Cardiology, Diabetes, Point of Care, and more. Register today!
> BioImmersion Course - October 16-18 - Washington, D.C.
This three-day course delivers an in-depth understanding of both fundamental and advanced biotechnology concepts used in both biotech and pharma companies. View Agenda and Register today!
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> eBook: Conversations with World-Class Biotech Innovators
What elevates a researcher to the top of the industry? FierceBiotech profiled five prominent researchers and asked them how they garnered such success. Download for free today.
> UL Benchmarking Study: Measuring Training to Raise Global Quality Standards
The trends uncovered in this report deliver insight into the state of compliance training and qualifications programs in the Life Science industry: leveraging training data, increased globalization and risk-based approach to training. For all of the trends + best practices download the full study.
> SMARTER SOLUTIONS, SMOOTHER STUDIES & COMPLETE CONTROL
Cenduit provides interactive response technology (IRT) - driven services for clinical trials around the world. With expert personnel located around the globe, Cenduit helps sponsors conduct smoother, happier trials. For more information or to connect with Cenduit, visit www.cenduit.com.
> Whitepaper: Too Big to Succeed: What's Next for Big Pharma?
The biopharmaceutical industry's largest companies have grown too large to offer shareholders a compelling return. L.E.K.'s analysis shows how pharma companies can address their most pressing challenges. Learn more
> eBook: Patient-Centric Drug Formulation Principles: Formulating Drugs for Children and the Elderly
How are drug developers and doctors tailoring prescriptions to patients? FierceBiotech outlines the principles and strategies for patient-centric drug development. Learn More.
> Whitepaper: StudyLink: Community Pharmacists as an Accelerant for Clinical Trial Recruitment
Because of their access to and personal knowledge of patients and their medications, pharmacists are uniquely qualified to educate, engage and evaluate potential trial participants. In this white paper, learn how a pharmacy-based, patient-centric recruitment strategy works with real-world examples of what makes it successful. Download Today!
> eBook: Smarter Service: The Contract Center of the Future
This eBook explores the challenges facing traditional contact centers and the benefits of deploying the contact center of the future. You'll find links to further resources on the final page. Download today.
This three-day course delivers an in-depth understanding of both fundamental and advanced biotechnology concepts used in both biotech and pharma companies. View Agenda and Register today!
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> Manufacturing Equipment/Utility Engineer - San Francisco, CA – CMC Biologics
CMC ICOS Biologics is a contract development and manufacturing organization (CMO) and is the US division of CMC Biologics, a Danish CMO. Responsibilities include to assist in the start-up of a newly acquired GMP bioprocess facility for contract manufacturing production. BS in Life Sciences, Engineering, or related field/equivalent experience required... Learn more.
> Engineering/Facilities Technician- San Francisco, CA – CMC Biologics
CMC Biologics is a contract development and manufacturing organization (CMO) and is the US division of CMC Biologics, a Danish CMO. Responsible for maintaining system operational readiness of single use (WAVE) and 500L and 3000L SIP bioreactors, clarification systems, chromatography systems, and associated process skids, instrumentation and automation, autoclaves, COP carts, etc. B.S. degree preferred... Learn more.
> Senior Director, Clinical Research & Development (MD) Job -Warren Township, NJ, US – Celgene Corporation
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. The Senior Director / Executive Director, Apremilast Clinical Submission Team will be instrumental in leading the compilation of the clinical sections of the Apremilast Global Registrational Dossier. Strong scientific/technical skills required... Learn more.
> Junior Staff Accountant Job - Berkeley Heights, NJ, US – Celgene Corporation
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. Analyst II is responsible for performing various accounting functions and recording the results of the corporation. Specific duties include accounting close, balance sheet accounts, financial analysis, business support and special projects. BA/BS degree in accounting required... Learn more.
> Senior Director, Global Marketing, Revlimid MM Job - Summit, NJ, US – Celgene Corporation
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. The Director/Senior Director - Revlimid MM is a key member of the Global Multiple Myeloma(MM) franchise team responsible for providing strategic leadership to successfully drive Revlimid brand development across both current and future indications. BA/BS required; MBA preferred... Learn more.
> Director, Global IT PMO Operations & Portfolio Management Job - Berkeley Heights, NJ, US – Celgene Corporation
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. The Director, Global IT PMO Operations & Portfolio Management is responsible for providing leadership and oversight in the areas of PMO vendor and financial management, PMO operations, and PMO metrics analysis and reporting. B.A. or B.S./M.S. required... Learn more.
> Senior Director, Regulatory Affairs, CCT Job -Warren Township, NJ, US – Celgene Corporation
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. The role of Senior Director of Regulatory Affairs at Celgene Cellular Therapeutics is of key importance to the continued growth and development of CCT's clinical, research and manufacturing programs. Advanced degree in scientific discipline required... Learn more.
> Senior Director, Medical Affairs Oncology - EMEA Job - Boudry, Sw, US – Celgene Corporation
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. This position will provide leadership to and supervise the EMEA Medical Affairs Disease Leads for Oncology indications kto plan and execute the EMEA Medical Affairs strategy and tactics, the IIT program, KOL management. A good knowledge of the therapeutic area of Oncology required... Learn more.
> Senior Director, EMEA Marketing Oncology Job - Boudry, Sw, US – Celgene Corporation
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. The Senior Director of EMEA Marketing for Oncology is responsible for the development and execution of the strategy and tactics for Celgene Oncology portfolio within Europe, Middle East and Africa. BA/BS required; MBA preferred... Learn more.
> Senior Director, National & Regional Accounts Job - Summit, NJ, US – Celgene Corporation
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. The Senior Director, National and Regional Accounts is responsible for managing the strategic efforts of the National Account Managers (NAMs) and Regional Account Managers (RAMs) in the Payer, Trade GPO, and Reimbursement channels. Prior sales management and/or marketing experience preferred... Learn more.
> Principal Validation Scientist Job - Phoenix, AZ, US - Celgene Corporation
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. The Validation Scientist, Principal is responsible for managing Validation activities for Computerized Systems through the complete validation life cycle. Serves as a Subject Matter Expert in computerized systems validation and provides expert technical recommendations / guidance. Requires a Bachelors degree in Science or Engineering... Learn more.
> Senior Clinical Trial Manager (Oncology) - Waltham, MA – TESARO
Tesaro is a growing oncology-focused biopharmaceutical company whose passionate associates are dedicated to improving the lives of cancer patients by developing and providing safer and more effective therapeutics and supportive care products. The Senior Clinical Trial Manager will lead the forecasting, planning and manage the implementation of the clinical operational plans in alignment with the company's strategic objectives, and in accordance with regulatory guidelines and Good Clinical Practice. Must be willing to travel... Learn more.
> Senior Manager, Program Development - Waltham, MA – TESARO
Tesaro is a growing oncology-focused biopharmaceutical company whose passionate associates are dedicated to improving the lives of cancer patients by developing and providing safer and more effective therapeutics and supportive care products. This position will report to the Vice-President, R&D Operations and will provide tactical and operational management of program development activities for the company's development programs. Some travel may be required... Learn more.
> Associate/Principal - San Francisco, CA – Novo A/S
Novo A/S is seeking an Associate/Principal to support the Novo Ventures investment team. The team is responsible for Novo A/S' Venture Capital global investments in emerging life science companies. The responsibilities include the sourcing and evaluation of attractive investments in the life science sector. The candidate shall have strong scientific background, with a MD or PhD in Medical Sciences or a related field... Learn more.
> Validation Engineer - St. Louis, MO – ProPharma Group
ProPharma Group is an industry leader providing validation, compliance and technical services to the pharmaceutical, biotechnology, medical device and related industries. A Validation Engineer at ProPharma Group will work with our Clients and be responsible for preparing and executing validation documents. Qualified candidates will possess a Bachelor's degree in related field along with 5 plus years related industry experience... Learn more.
> CSV Consultant – California – ProPharma Group
ProPharma Group is an industry leader providing validation, compliance and technical services to the pharmaceutical, biotechnology, medical device and related industries. A Computer Validation Consultant at ProPharma Group will work with our Clients and be responsible for the CSV processes of the company. Must be willing to travel regionally and/or nationally throughout the US... Learn more.
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