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Today's Top Stories
1. Early-stage investor Lux targets biotech with new $245M VC fund
2. J&J, Pharmacyclics score 'breakthrough' coup with blockbuster hopeful ibrutinib
3. Tetraphase tees up $86M IPO to back late-stage antibiotics effort
4. India drags its feet on new drug trials as activists clash in court
5. Langer's Bind Biosciences raises cash as lead cancer program heads to PhII
6. Ziopharm shares spike as PhIII palifosfamide reckoning looms
Also Noted: MPI Research
Spotlight On... Bayer, Algeta nab priority review for prostate cancer drug
Aveo releases final OS data on tivozanib; Ablynx reports success for PhII RA study; and much more...
 The 25 most influential people in biopharma today
Influence is a fungible asset. A lot of cash on hand can help tremendously, of course. But at this stage, who in this business hasn't seen billions incinerated in pursuit of sheer folly? Far more influential is the savvy executive who can marshal experts as well as financial resources in pursuit of a smarter, better, faster way to develop and market important new drugs. And intelligent research strategies are far more rare than we acknowledge. You'll find some here in our second annual report on the 25 most influential people in the industry. Read the report >>
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 From a strictly numbers point of view, last year's results are pretty obvious. As the accompanying chart indicates, 2012 was the slowest in 5 years in terms of both number of deals and dollars on the table.
To Christian Dokomajilar, manager and senior biotech analyst at Deloitte Recap, that actually bodes well for 2013. Having digested some of the largest acquisitions in pharma history, gotten costs out and much of the patent cliff behind them, pharma and biotech execs may again be ready to tango. "There are only so many megacompanies you can acquire in a given period," Dokomajilar says.
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| Click the image to enlarge >> |
He points to deals like Pfizer's ( $PFE) $68 billion acquisition of Wyeth Pharmaceuticals in 2009, or Merck ( $MRK) paying $41.1 billion the same year for Schering-Plough. Just a couple of years ago, Sanofi ( $SNY) bought Genzyme for $20 billion."M&A is definitely in a period of consolidation as far as pharma is concerned," after some of the megamergers of recent years.
There are endless ways to slice and dice the major mergers and acquisitions of the year, but I like the way EvaluatePharma lines it out. It takes those that have closed in the year. It is nice and simple and filters out any equivocation over deals announced but not yet through the legal machinery to the finish line. We used its numbers for a reference point. As they show, 2011 had 70 more deals worth nearly 40% more than in 2012. And the big year in the last 5 was 2009, when there were not only 25 more deals, 169 vs 146, but the values were much higher. M&A activity in 2009 totaled $142 billion compared to just $57 billion in 2012.
Dokomajilar, who uses his own figures to track M&A, has some other astute observations about 2012. He points out that the "appetite for buying mature companies continued." Target companies with their most advanced therapeutic products in Phase II trials, and those with marketed products, made up even larger percentages of deals in 2012, 35% and 45% respectively, than they had in the past 5 years.
He also observes that the "contingent-structure M&A deal type" were not more prevalent as some had expected them to be. By his count, only 10% of all mergers and acquisitions in the category had a contingent component. "However, we did see an increasing, fairly new deal structure, the call option or option to acquire," he said.
"The numbers by themselves are not that important. What is more important is the dollars and structure of the deals," Dokomajilar says. With the economic turmoil in the last two to three years, he sees deals more focused on things like options to buy after a licensing.
"Things like these come out when money gets tight," he said. "What we are seeing is smarter deals being done." Read the full report >>
-- Eric Palmer ( email | Twitter)
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Today's Top News
Lux Capital has nailed down a new fund, its first since 2007, to back startups in healthcare as well as energy and tech. With $245 million in commitments, more than the $200 million it originally targeted, Lux is closing its largest fund to date and staying the course with investments in biopharma. The news comes after ex-Pfizer ( $PFE) Chairman and CEO Jeff Kindler, the man who pulled the trigger on the $68 billion merger with Wyeth, joined Lux last year as a venture partner, adding his high-profile name in pharma to the firm's roster.
"Our healthcare strategy will maintain a focus on therapeutics and drug delivery, as well as making new investments in healthcare IT and surgical robotics," said Peter Hébert, managing partner at Lux, in an email to FierceBiotech. "But we remain committed to biotech."
Lux, which has offices in New York and Palo Alto, has a reputation for going in early on investments and taking gambles on science and technology with more promise than proven performance. In biotech, this strategy has led Lux partners to take founding and early leadership roles at startups such as Kala Pharmaceuticals, a Bob Langer vehicle focused on delivery of drugs to the eye, and Genocea Biosciences, which is developing next-generation vaccines against herpes and other diseases.
Lux aims to invest from $100,000 in seed money to $15 million in companies, with plans to target investments in brand new startups as well as more established businesses through corporate spinoffs.
Beat down but not broken, biotech venture investing has been shaky in recent years amid a squeeze on available funds for the venture industry. Too many traditional venture backers of biotech have thrown in the towel on raising new funds. And last year biotech outfits raised $4.1 billion, down from $4.9 billion in 2011 and only marginally better than the $3.9 billion snapped up in 2010, according the National Venture Capital Association and PricewaterhouseCoopers' MoneyTree report, based on Thomson Reuters data.
Depending on how Lux places its future venture bets, we'll see how much the firm can aid cash-starved biotech entrepreneurs. In a phone interview with FierceBiotech, Hébert said that the firm is already in late stages of due diligence for several new biotech investments, but hasn't made any bets on drug startups with the latest fund. Its strategy for the new fund calls for investments in a mix of healthcare sectors, including health IT and medical technology, he said.
- here's the release
Related Articles: Ex-Pfizer chief Kindler finds new role at VC firm Kala Pharmaceuticals, co-launched by MIT's Langer, snags $6.2M Genocea taps $35M venture round as it seeks new CEO
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| Pharmacyclics CEO Robert Duggan |
J&J ( $JNJ) and Pharmacyclics ( $PCYC) nabbed the FDA's new breakthrough designation for their cancer drug ibrutinib, a promising late-stage therapy that will be put in the hands of regulators later this year.
Lawmakers created the breakthrough category to accelerate a select group of programs through a quick review process, possibly shaving a significant amount of time off the slow and expensive development process. The government's idea here is that some drugs that have demonstrated significant promise in offering new hope to patients in early studies should make it to the market without being required to first complete the traditional three-phase development plan.
Ibrutinib fits that bill nicely. The therapy blocks a key enzyme involved in the growth of cancer and helped control the cases of 68% of 116 patients--with a relatively improved safety profile among treatment-resistant patients. The data has driven Pharmacyclics' shares to new heights, making CEO Robert Duggan a paper billionaire in the process. J&J stepped in in late 2011, providing a rich $975 million deal to collaborate on development and marketing.
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| J&J CSO Paul Stoffels |
"We are pleased that the FDA has granted two Breakthrough Therapy Designations for ibrutinib as the designation represents a major leap forward in accelerating drug development timelines," said J&J CSO Paul Stoffels. "We are committed to realizing the full potential of ibrutinib for patients with mantle cell lymphoma, Waldenström's macroglobulinemia, as well as other B-cell malignancies, and will work with Pharmacyclics and the FDA to ensure the clinical development program for ibrutinib continues to move forward as quickly as possible."
Ibrutinib follows two of Vertex's ( $VRTX) cystic fibrosis drugs-- Kalydeco and VX-809, being studied as a combination treatment--down the new breakthrough path at the FDA. All three are being managed by well-known development teams and earned a high profile for early promise. And the industry will be paying close attention to the FDA's announcements on future breakthrough designations, looking for more signs of what the agency is looking for.
The FDA's Janet Woodcock stirred considerable interest yesterday with her remark that it will be possible to win an approval based on expanded Phase I data. But given its cautious history on the approval front, it's likely that they will stick with proven developers who have a solid reputation, working in areas where the biology of the disease is well known, especially as they move up the R&D stream. As the FDA proved recently with its rejection of the diabetes drug Tresiba, it won't hesitate to require major new studies before green-lighting any drug headed for a mass market.
- here's the press release
Special Reports: Paul Stoffels - The 25 most influential people in biopharma today - 2013 | Dr. Janet Woodcock - The 25 most influential people in biopharma today - 2013
Related Articles: FDA: 'Breakthrough' designation allows for drug approval on PhI data J&J keeps cash flowing on blockbuster Pharmacyclics deal for ibrutinib Booming Pharmacyclics snags $50M paycheck as J&J pact drives blood cancer trials FDA gives generic drugs 'super' status Support seen for U.S. plan to speed nods for 'breakthrough' drugs
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Watertown, MA-based Tetraphase has joined the queue of biotechs willing to test the tepid IPO waters on Wall Street. The biotech, one of a small group of companies out to develop next-gen antibiotics, believes it can raise $86 million in a new offering.
Tetraphase--a 2010 Fierce 15 company led by Guy Macdonald--launched in 1996 with technology developed at Harvard, where Andrew Myers and his colleagues in the Department of Chemistry and Chemical Biology had opened the door to creating new tetracyclines through synthetic chemistry. Its lead program, Eravacycline (TP-434), is an IV broad spectrum antibiotic, but there's a lot of excitement at Tetraphase about the possibility of creating unique oral antibiotics.
"We recently completed a successful Phase 2 clinical trial of eravacycline with intravenous administration for the treatment of patients with complicated intra-abdominal infections, or cIAI, and are currently finalizing our pivotal Phase 3 program for eravacycline," the company reports in its S-1. "Consistent with recent draft guidance issued by the (FDA) with respect to the development of antibiotics for cIAI and our discussions with the FDA at our end-of-Phase 2 meeting in January 2013, we expect to conduct two global Phase 3 clinical trials of eravacycline, one for the treatment of cIAI and one for the treatment of complicated urinary tract infections, or cUTI. We expect to have top-line data from both of these clinical trials in the first quarter of 2015."
The lead program is backed with a $67 million contract from the Biomedical Advanced Research and Development Authority. Another two antibiotics are listed in its pipeline.
- here's the release - see the S-1
Special Reports: Tetraphase Pharmaceuticals - 2010 Fierce 15 | Top 10 biotech IPOs of 2012
Related Articles: Tetraphase hauls in $45M C round to back antibiotic work FDA blamed for stymying new antibiotics Antibiotics developer Paratek Pharma files for $92M IPO |
A group of health activists in India has garnered headlines over a case before the country's Supreme Court which claims that drug developers have been using the poor as human "guinea pigs" for their clinical studies. And a number of drug developers and analysts in the country tell Reuters that as a result regulators have slammed the brakes on green-lighting new clinical studies, raising fears about the future of drug development in the subcontinent.
"The situation was never quite easy in India," ICICI Direct analyst Siddhant Khandekar told Reuters. But as the Supreme Court case has unfolded "the scenario has worsened and getting new approvals has become more time consuming."
Piramal Enterprises says that gaining regulatory approval for a new study--which takes about 28 days in Canada and Europe--now consumes 6 to 8 months in India. As a result, the company says it may do future studies outside of the country, which gained a reputation for low-cost drug studies.
Nilesh Gupta, Lupin's group president, told Reuters that "For NCEs in particular in India, the process is extremely long."
India has had a love/hate relationship with the pharma industry for decades. The country has competed with China to become a major offshore site for drug development, but a variety of horror stories has fed the belief that many of the developers simply look to India as a cheap place to test potentially dangerous medications. Meanwhile homegrown biotechs have been trying to establish themselves as viable developers, a process which has proven to be fraught with difficulties.
- here's the Reuters report
Related Articles: ACRO: Proposed Indian trial reforms are unclear Indian Supreme Court wants answers on clinical trials Indian Supreme Court: Unregulated trials causing 'havoc' India group wants change in clinical trial regs for children Indian regulators want crackdown on unethical CROs |
Bind Biosciences has landed an $8.7 million chunk of a planned $20 million raise designed to fuel the biotech's midstage study of its lead cancer drug. Bind--which was launched by serial biotech entrepreneur and MIT professor Robert Langer--reported the financing in SEC documents.
Much of that money is being earmarked for BIND-014, which is being steered into Phase II studies after racking up some notable solid tumor activity in an early-stage study. The big idea here is to use Bind's nanotechnology to precisely deliver an amped-up dose of docetaxel right to cancer cells and blood vessels that feed a variety of tumors. Bind was co-founded by Harvard's Omid Farokhzad, one of Langer's former graduate students.
"Proceeds from the financing will be used to fund Phase II clinical studies of BIND's lead drug candidate, BIND-014, a PSMA-targeted Accurin containing docetaxel, in multiple solid tumor indications," company CFO Andrew Hirsch tells FierceBiotech in an e-mailed statement. "Based on preclinical and clinical studies to date, the company believes there is potential for BIND-014 to offer a significant improvement in patient outcomes in a broad range of solid tumor indications. In addition, the company plans to continue to advance the capabilities of its nanomedicine platform for novel Accurins, including identifying further opportunities for proprietary drug candidates as well as pursuing collaborative drug development programs with pharmaceutical and biotech partners."
Bind, which is helmed by industry vet Scott Minick, has been busy since it was founded about 6 years ago. In the fall of 2011 the biotech--a 2008 Fierce 15 company--garnered a $47.25 million investment from RusNano, a Russian group which has been looking to import some cutting edge-nanotech into Russia. And Amgen recently inked a $180 million deal to use Bind's delivery tech with one of its cancer drugs, packaging one of the Big Biotech's kinase blockers in Bind's tiny transports and aiming them at malignant cells.
Bind execs have said that they expect to land additional collaboration deals this year as it moves its lead drug ahead in the clinic.
- here's the SEC document
Special Reports: Robert Langer - The 25 most influential people in biopharma today - 2013 | Bind Biosciences - Fierce's 5 Drug Delivery Companies to Watch
Related Articles: Bob Langer biotech lands first big biopharma deal with Amgen Nanomedicine standout spotlights first human cancer data Exclusive: MIT's Langer, Farokhzad launch combination-med biotech
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Another small-cap biotech company is about to find out whether it can beat the odds and pull off a successful late-stage cancer study. Ziopharm Oncology ( $ZIOP) saw its shares spike yesterday after reporting that investigators now have enough progression-free survival events to come up with a Phase III report card on palifosfamide, which is angling for an approval to treat metastatic soft tissue sarcoma.
Investors were buying in ahead of a late-March review of top-line data, even though the small-cap crowd will be buzzing about Ziopharm's chances at the finish line. As Adam Feuerstein at TheStreet has noted, the Feuerstein-Ratain study found that no cancer drug developer with a market cap under $300 million has had a success in Phase III. Move into the next market cap stage of $300 million to $1 billion, where Ziopharm sits at the low end, and the success rate is a marginal 17%.
It's somewhat unusual for any biotech to go into a Phase III trial without a big partner to lend the initiative some credence. But Ziopharm CEO Jonathan Lewis tells Bloomberg that he's busily pursuing partnership talks, though he allows that it's unlikely at this point for anyone to sign on ahead of the data.
"All options are on the table," Lewis told the business wire. "There are discussions going on right now as regards potential partnering."
Add it all up and you have a classic high-noon gambling event for a small-cap biotech. If the data are positive and a partnership looms, the stock will likely move fast. Failure, without a net, would lead to the opposite outcome. Lewis is staying positive--at least as long as the data remain blinded.
"Reaching the target number of progression events for PICASSO 3 positions us one step closer to understanding palifosfamide's full potential for this significant unmet medical need," he said in a statement. "With a positive study outcome, palifosfamide has the potential to become the first new treatment option in nearly 30 years for patients with first-line metastatic soft tissue sarcoma."
- here's the release - get the Bloomberg report
Related Articles: Ziopharm vows to wow cancer field with synthetic biology drugs Ziopharm gains access to Intrexon's synthetic biology tech Ziopharm soars on promising cancer data |
Also Noted
| This week's sponsor is MPI Research. |
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Faced with a continuing economic crisis and an aging and increasingly obese population, healthcare providers are seeing where they can cut costs. Generics saved the U.S. healthcare system $192 billion in 2011 alone. To read more on this timely topic, download this eBook today.
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Bayer's next big cancer prospect, radium-223 for castration-resistant prostate cancer, has won priority review status at the FDA. In-licensed from Norway's Algeta, Alpharadin is one of the pharma company's top late-stage prospects, following a string of regulatory wins on the development front. Analysts believe this treatment has good prospects at the regulatory agencies. Release | More
 @FierceBiotech: In case you missed it: The 25 most influential people in biopharma today - 2013. Special Report | Follow @FierceBiotech
@JohnCFierce: J&J, Pharmacyclics score 'breakthrough' coup with blockbuster hopeful ibrutinib. Article | Follow @JohnCFierce
@RyanMFierce: J&J's Alzheimer's R&D chief sticks by 'golden age' prediction after bapi bust. But where's the data? More | Follow @RyanMFierce
> Aveo ( $AVEO) and Astellas reported final OS results for tivozanib's Phase III. Investigators are blaming a one-sided crossover for the fact that the OS data on the experimental drug failed to match the OS rate for Nexavar. The therapy hit the endpoint on progression-free survival. Release
> Belgium's Ablynx says it is recording positive results in a Phase II study of a new rheumatoid arthritis therapy. Release
> Peregrine ( $PPHM) reports that in a Phase II study patients treated with a combination of bavituximab and gemcitabine had a 28% tumor response rate as compared to 13% in the control arm. Median OS, the primary endpoint of the trial, was 5.6 months for the bavituximab plus gemcitabine arm and 5.2 months for the control arm. Release
Pharma News
@FiercePharma: Sanofi plans to boost Lantus production in Ireland with a $59 million upgrade to Waterford site. More | Follow @FiercePharma
@EricPFierce: 2012 M&A was slow in biopharma as cos. choked down previous mega mergers. Execs may be ready to tango in 2013. Special Report | Follow @EricPFierce
@AlisonBFierce: The WHO granted PharmaJet's Stratis Needle-free Injector performance, quality and safety pre-qualification status. Release | Follow @AlisonBFierce
> U.K. gatekeepers shut out Novartis cancer treatment. News
> Discount program robs pharma to pay hospitals, report claims. Story
Medical Device News
@FierceMedDev: Attorneys: JNJ knew of mesh problems before marketing. Article | Follow @FierceMedDev
@MarkHFierce: Medtronic won FDA approval for its next-gen Advisa MRI-friendly pacemaker. Release | Follow @MarkHFierce
@DamianFierce: More regulatory struggles for St. Jude as it recalls a component of its Amplatzer heart plug. Story | Follow @DamianFierce
> J&J metal hip trial stirs up renewed call for 510(k) reform. Item
> Dako inks companion diagnostics deal with Pfizer. Article
Drug Delivery News
> Alnylam joins Spanish team to deliver successful RNAi. Story
> Genelux, Sloan-Kettering test delivery of mesothelioma drug. More
> Germany grants reimbursement for Delcath's chemo delivery tech. Item
> UCLA team snuffs cancer cells with nanoshell delivery. News
> Smiths Medical wins FDA clearance for 'smart' infusion pump. Report
And Finally… Investigators at the University of Pennsylvania vet school say they found a new pathway to stimulate bone growth, and the discovery could be useful both for humans as well as animals. Release
> Orphan Drug Differentiation - Thursday, February 28th, 11 am ET/ 8 am PT
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> Wharton Health Care Business Conference - February 14-15 - Philadelphia, PA
Leading forum for industry professionals and academics to discuss issues facing the health care industry. This year's theme is "Reshaping Healthcare: Emerging Trends Changing the Face of Our Industry." Keynote speakers from DaVita and Humana. Go to http://www.whcbc.org for more details.
> Webinar: Innovative Solutions for Efficiently Managing and Analysing Local Laboratory Data in Clinical Trials - February 20 & 21
Managing local lab results tends to be resource intensive; reactive; re-iterative; and costly. By making this process easier and more streamlined Biopharma companies can improve quality, increase efficiencies and reduce costs. Register now for Feb 20 (11:00 AM EST) OR Feb 21 (08:30 IST/GMT+5.5).
> Meet Top Pharma Dealmakers - February 27-28 - La Jolla, CA
BIOCOM's 3rd Annual Global Life Science Partnering Conference is an exclusive global partnering and networking forum that brings together senior executives and business development professionals from leading pharmaceutical and biotech companies. The conference will include dynamic panel discussions, individual company presentations, one-on-one meetings, and numerous networking opportunities. To register, click here.
> Regulatory Affairs for Biologics - March 11-12 - Horsham, PA
This two-day course will provide strategies to achieve regulatory compliance for the development of biologics, as well as the current regulatory, global, and public opinion trends that have the potential to impact biologics. 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!
> Bio-IT World Conference and Expo 2013 - April 9-11, 2013 - Boston, MA
Tracks include Bioinformatics, Next-Gen Sequencing Informatics, Collaborations and Open Access Innovation, Data Visualization, Clinical Omics and More. Register at Bio-ITWorldExpo.com
> 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.
> Chief Medical Officer Summit for Biotechs - May 6-7, 2013 - Boston
Finally, CMOs have their own conference thanks to the idea from MPM Capital. The Summit addresses the unique CMO challenges of managing all R&D functions with limited resources, while raising capital and strategizing for appropriate exits. 10% discount with code FR10. For more information and to register please visit http://www.theconferenceforum.org.
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> eBook: Facing Up to the Biosimilar Challenge: Preclinical and Beyond
Faced with a continuing economic crisis and an aging and increasingly obese population, healthcare providers are seeing where they can cut costs. Generics saved the U.S. healthcare system $192 billion in 2011 alone. To read more on this timely topic, download this eBook today.
> eBook: Special Report: China's Rise Drives Investment in Biotech Drugs
The Chinese government's devotion to biotech has sparked major expansion efforts by some of the country's leading pharmaceutical players, also making it fertile ground for venture capitalists in the U.S. Click here to download the complete report today.
> Free Trial offer to "The Pink Sheet"
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> Director, Scientific Operations - Irvine, CA - Allergan
Allergan, Inc. discovers, develops and commercializes products in the ophthalmology, neurosciences, medical dermatology, medical aesthetics, obesity intervention and other specialty markets. The Director of Scientific Operations provides scientific, technical and administrative leadership for the Drug Safety Evaluation (DSE) Scientific Operations department by providing logistical support for other DSE departments. Ph.D. degree in one of the biological sciences with at least 8 years relevant management experience in industrial environment... Learn More.
> Clinical Data Manager/Senior Clinical Data Manager - Waltham, MA – TESARO
Tesaro is a growing oncology-focused biopharmaceutical company whose passionate associates are dedicated to improving the lives of cancer patients. This position will be responsible for providing data management expertise while working within Electronic Data Capture (EDC) environment for oncology clinical trials. The successful candidate will provide support for form design, specification review and effectively manage all aspects of the clinical trial data management process... Learn more.
> Senior Clinical Trial Manager - Waltham, MA – TESARO
Tesaro is a growing oncology-focused biopharmaceutical company whose passionate associates are dedicated to improving the lives of cancer patients. 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. Demonstrated knowledge of FDA/EMA/GCP/ICH guidelines... Learn more.
> Clinical Scientist - Waltham, MA – TESARO
Tesaro is a growing publicly traded oncology-focused biopharmaceutical company dedicated to improving the lives of cancer patients. The Clinical Scientist is responsible for providing scientific support for all Medical Development activities. This cross-functional role includes assembling, evaluating, and presenting scientific and medical data, writing manuscripts (paper, abstracts, posters, etc.) and monitoring the competitive landscape and reviewing and summarizing relevant literature. Advanced, doctoral level degree preferred... Learn more.
> Teach Pharma In Japan - Tokyo, Japan - International Education Services
Pharmaceutical professionals with a minimum of three years work experience in various areas of the pharma/biotech industry needed to teach at big pharma companies in Japan. Teaching is in English to small groups of Japanese pharma executives. Annual contract and compensation with paid vacations, medical insurance, work visa sponsorship and training provided... Learn more.
> Scientist - Purification Development Job - Plainsboro, NJ, USA – Yoh
Yoh has a direct hire opportunity for a Scientist - Purification Development to join our client in the Plainsboro, NJ area. Our client is actively looking for a Scientist to join their Purification Development team. Reporting to the Head of Purification Development, the incumbent will be primarily responsible for supporting the development/optimization of purification processes for biopharmaceutical production. BS / MS in Chemical Engineering, Biochemistry, related Life Science discipline required... Learn more.
> Clinical Scientist Job - Danbury, CT, USA – Yoh
Yoh has a contract opportunity for a Clinical Scientist to join our client in Danbury, CT. This position will provide in house Local Clinical Monitor (CML) trial support for approximately 1-3 trials per person. Seven plus (7+) years' experience within the pharmaceutical industry supporting clinical trials required... Learn more.
> Associate Scientist - Analytical Development Job - Princeton, NJ, USA – Yoh
Yoh has a contract to hire opportunity for an Associate Scientist- Analytical / Formulations / Development Sciences to join our client in the Princeton, NJ area. Job responsibilities include development, qualification, and implementation of analytical methods for protein therapeutics. Minimum of one (1) year relevant experience in analytical sciences of protein biotherapeutics (mAbs, antibody fusion proteins, and other protein constructs) required... Learn more.
> Clinical Statistician Job - Fairfield, NJ, USA - Yoh
Yoh has a contract opportunity for a Clinical Statistician to join our client near Pine Brook, NJ. This is an exciting opportunity for a Mid-Senior level Biostatistician to join with one of the world's leading healthcare companies. The successful candidate will have an MS or PhD in Statistics or Biostatistics and over three to five (3-5) years of experience working with clinical trial data... Learn more.
> Senior Principal Informatician - Big Data Analytics - Waltham, Massachusetts, USA - AstraZeneca
AstraZeneca is a global, innovation-driven, integrated biopharmaceutical company seeking a talented Senior Principal Big Data Informatics Scientist to drive the vision and strategy of Big Data Analytics in R&D and provide advanced hands on support to R&D activities across all therapeutics areas and phases of the drug discovery and development pipeline. Proven in-depth experience in the field actively employing Big Data Analytics expertise required... Learn more.
> Junior Staff Accountant Job - Berkeley Heights, NJ, US – Celgene
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... 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.
> Clinical Nurse Consultant - St. Louis Job- St. Louis, MO, US – Celgene
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. The Clinical Nurse Consultant will educate health care providers on Multiple Myeloma, CTCL, PTCL, and MDS. While primarily focused on the nursing segment, the Clinical Nurse Consultant will also educate other health care providers in the community and academic hematology/oncology setting... Learn more.
> Clinical Nurse Consultant - Minneapolis Job - Minneapolis, MN, US – Celgene
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. The Clinical Nurse Consultant will educate health care providers on Multiple Myeloma, CTCL, PTCL, and MDS. While primarily focused on the nursing segment, the Clinical Nurse Consultant will also educate other health care providers in the community and academic hematology/oncology setting... Learn more.
> Clinical Nurse Consultant - Great Lakes Job -Detroit, MI, US – Celgene
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. The Clinical Nurse Consultant will educate health care providers on Multiple Myeloma, CTCL, PTCL, and MDS. While primarily focused on the nursing segment, the Clinical Nurse Consultant will also educate other health care providers in the community and academic hematology/oncology setting... Learn more.
> Clinical Nurse Consultant - Seattle / Portland Job - Seattle, WA, US – Celgene
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. The Clinical Nurse Consultant will educate health care providers on Multiple Myeloma, CTCL, PTCL, and MDS. While primarily focused on the nursing segment, the Clinical Nurse Consultant will also educate other health care providers in the community and academic hematology/oncology setting... Learn more.
> Director/Senior Director, IT Enterprise Architecture (Information Architect) Job - Berkeley Heights, NJ, US – Celgene
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. Responsible for the overall design of the Celgene's enterprise information architecture, across all data types (structured, semistructured and unstructured), balancing the need for access against security and performance requirements. This individual focuses primarily on enterprise business information requirements: design, access, usage and stewardship... Learn more.
> Senior Director, Lead Global Product Safety Physician Job -Warren Township, NJ, US – Celgene
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. This position will be working with the Immunology-Inflammation (I&I) franchise. At least 10 years experience as an MD in clinical research required... Learn more.
> Senior Director, EMEA GxP Lead - UK Based Job – Anywhere – Celgene
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. Responsibilities include to manage audit activity and personnel for assigned region and drive coordination across disciplines. Minimum of four years of Compliance related Auditing experience 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.
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