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August 16, 2010

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Tableau

Metrics to Understand Your Brand and Help It Thrive
August 18th, 2 pm ET / 11 am PT

Pfizer is the world's largest research-based pharmaceutical company. But how do they continue to thrive in an ever-changing and highly competitive environment?
This real life case study will explain how Pfizer's Animal Health division utilizes analytics and data visualization to quickly find patterns and key insights within their data to drive informed decision-making. Register Now!

Today's Top Stories
1. PacBio files for $200 million IPO
2. The virtual model works for biotech, Big Pharma
3. Former Solvay CEO moves to Selecta
4. ARYx stays afloat with $6.3M bridge loan
5. ISCT works with industry to launch cell therapy partnership

Also Noted: Spotlight On... Vaccine sales up 16% in 2009
Novartis hints at higher offer for Alcon; Malaria group announces first partnership; and much more...

More Fierce Life Sciences News
1. India sees rise in trial deaths
2. Pharma contractors hiring fastest in sector
3. iPhone app helps to ID adverse events
More headlines...


Dealmaking will reach its peak at BioPharm America,
September 15-17, 2010 in Boston

Meet one-to-one with biotech industry leaders and accelerate your partnering!

Millennium • Bayer • Biogen Idec • Genentech • J&J • Pfizer • Nycomed • Merck & Co.

Register Now >>



Sponsor: Enterprise Florida

FierceLive! Webinars

> Metrics to Understand Your Brand and Help It Thrive - August 18th, 2 pm ET / 11 am PT

Events

> DIA 2011 Call for Proposals Open Until September 13 - September 13
> Rutgers Mini MBA: BioPharma Innovation Program
> Pharmaceutical Strategic Alliances 2010 - Sept 21-23 - New York City
> Life Sciences Summit 2010
> Windhover's PharmAsia Summit 2010 - Oct 25-26 - San Francisco
> Tomorrow's Project Manager: Evolving Competencies for Biopharmaceutical Professionals - October 26 - 27 - Bethesda, MD
> Windhover's Therapeutic Area Partnerships 2010 - Nov. 2-4 - Boston

Marketplace

> Products to watch in the biotech pipeline
> Drug Development Self-Study Course
> White Paper: Five Essentials for Minimizing Risk in Clinical Trials
> From H1N1 and Beyond: Growing The Flu Vaccine Pipeline
> Optimize your Media with our Animal Component Free Products and Supplements
> State of the Clinical Trials Industry
> Innovations in Life Sciences

Jobs

> Director Global Health Economics and Outcomes Research - Shire Pharmaceuticals
> Senior Director/Vice President Fibrosis - Regulus Therapeutics Inc.
> Senior Scientist Basic microRNA Mechanisms - Regulus Therapeutics Inc.
> Senior Scientist Metabolic Diseases - Regulus Therapeutics Inc.
> Senior Research Associate/Senior Scientist Immunology - Regulus Therapeutics Inc.
> Senior Director/Vice President Immunology - Regulus Therapeutics Inc.
> Senior Scientist/Associate Director Immunology - Regulus Therapeutics Inc.
> Senior Scientist/Associate Director Fibrosis - Regulus Therapeutics Inc.
> Need a job? Need to hire? Visit FierceBiotech Jobs

* Post a classified ad: Click here.
* General ad info: Click here

Today's Top News

1. PacBio files for $200 million IPO

By Maureen Martino Comment | Forward | Twitter | Facebook | LinkedIn

Money-raising machine Pacific Biosciences--a 2009 Fierce 15 winner--has decided to take its act public. The company has filed a $200 million IPO, the proceeds of which will help the company fund R&D of its products and SMRT technology (photo, click to enlarge), which uses nanofabrication, biochemistry, molecular biology, surface chemistry and optics to enable real-time analysis of biomolecules.

Just last month, PacBio closed a $109 million Series F, bringing its total haul to $370 million, and in June landed a PacBio gets $50 million investment from Gen-Probe. In addition to R&D expenses, PacBio will boost its sales and marketing in advance of commercial launch, increase its manufacturing operations, and for general corporate purposes. PacBio added in its filing that it may be in the market to acquire complementary technology or businesses that would boost its own operations, but that no acquisitions were planned at this time.

In the short term, PacBio will focus its technology on clinical, basic and agricultural research. It hopes to expand into molecular diagnostics, drug discovery and development, food safety, forensics, biosecurity and bio-fuels. "We believe that our SMRT platform represents a new paradigm in biological science...that has the potential to significantly impact a number of areas critical to humankind, including the diagnosis and treatment of disease as well as efforts to improve the world's food and energy supply," the company boasts in its SEC filing.

- find PacBio's SEC filing
- read the Forbes article for more

Related Articles:
Pacific Biosciences adds $109M to its venture haul
PacBio unveils software developer's network
PacBio gets $50M investment from Gen-Probe
Pacific Biosciences - Top 20 Biotech VC Deals of 2009
PacBio raises $68M for sequencing tech

Read more about: Pacific Biosciences, Biotech IPO


This week's sponsor is Enterprise Florida.

The Future of Biomedical Innovation White Paper
Learn about the work of leading scientists in the life sciences field. Find out about new technologies, research focus areas and commercial applications. Developed in partnership with FierceBiotech. Download the white paper now.



2. The virtual model works for biotech, Big Pharma

By Maureen Martino Comment | Forward | Twitter | Facebook | LinkedIn

The virtual model of drug development features a core management group that coordinates R&D activities, which are largely outsourced to other parties. The benefits include less overhead and faster clinical progress. But when the idea first surfaced in the 1990s, venture capital funding was plentiful and biotech wasn't under as much pressure to keep its operations lean and mean.

Funding has become less readily available in the last few years. Biotechs that were once encouraged to build fully-integrated companies are now doing what they can to keep costs down and make their dollars last as long as possible. That's led to wider adoption of the virtual model. And biotechs aren't facing those development pressures alone; Big Pharma is trying to get a handle on the ever-rising cost of developing new drugs. That's led companies like Eli Lilly to take a closer look at biotech's stripped-down model as a tool to cut their research budgets.

Lilly founded its Chorus division in 2002. The group, which includes 22 employees, moved deprioritized compounds from the preclinical through proof-of-concept trials. Of the 19 compounds the group has handled in the last five years, Seeking Alpha notes that nine of them have reached the proof-of-concept stage. Chorus has moved these drugs through development 1.5 years faster than industry average at just 10 percent of the cost. For Big Pharma and small biotechs alike, keeping fixed costs down while quickly moving potential drugs through development is one of the biggest challenges. And according to Seeking Alpha, that means the virtual model is here to stay. 

- check out the Seeking Alpha story

Related Articles:
Live from BIO: What do biotech VCs want?
Experts share tips for developing drugs using a virtual model
Eli Lilly sets out to rewrite the R&D playbook

Read more about: Virtual model, Eli Lilly, Chorus



3. Former Solvay CEO moves to Selecta

By Maureen Martino Comment | Forward | Twitter | Facebook | LinkedIn

Former Solvay CEO Werner Cautreels has taken the reins at Selecta Biosciences, a Watertown, MA-based developer of synthetic nanoparticle vaccines and immunotherapies. Cautreels was CEO at Solvay when the company was acquired by Abbott Labs for $6.6 billion earlier this year.

Selecta is using self-assembled nanoparticles that can better resemble a virus, a process scientists believe can trigger a more potent immune response. The company announced earlier this year that it raised about $15 million--enough cash to see the company into 2012 and obtain proof-of-concept data on a lead program.

"I envision Selecta's technology to unlock novel treatment approaches in high unmet medical need areas beginning with our synthetic vaccine product candidates using the tSVP nanoparticle technology and potentially expanding into other immunotherapies developed as proprietary compounds and in collaboration with partners," Cautreels explains in a statement.

Selecta also announced that it has garnered a $3 million grant from the NIH's National Institute of Drug Abuse to develop a nicotine vaccine for cigarette addiction, according to Xconomy.

- see Selecta's release
- read the Xconomy story for more

Related Articles:
Money comes calling at Selecta Biosciences
Emerging Drug Developer: Selecta Biosciences
Selecta Biosciences raises $15.1 in Series B

Read more about: Selecta Biosciences



4. ARYx stays afloat with $6.3M bridge loan

By Maureen Martino Comment | Forward | Twitter | Facebook | LinkedIn

Fremont, CA-based ARYx Therapeutics has secured a $6.3 million loan from several existing investors. The first loan gives the company up to $4 million, while an amended agreement with Lighthouse Capital Partners allows approximately $2.3 million of required payments to Lighthouse to be deferred and extended as a new loan commitment to ARYx. The company says that the proceeds from the financing should allow it to perate through the end of 2010.

Back in February, ARYx saw licensing discussions for its antiarrythmia drug budiodarone collapse. That caused the developer to cut its staff to a bare minimum. It also brought in Cowen and Company to explore strategic options. The developer hopes that the loan will give it time to execute a transaction for the drug.

"The securing of this bridge financing is significant to ARYx since it now gives us the time to complete a strategic transaction that, if finalized, could realize real value from our product portfolio. The participation of our existing investors in the bridge loan financing follows their conducting significant due diligence on the company and our progress to date towards a potential transaction. Therefore, we believe this financing is a vote of confidence by important current investors," says ARYx CEO Paul Goddard in a statement.

- here's Aryx's release

Related Articles:
Licensing talks collapse at struggling ARYx, fresh cuts follow
ARYx gets FDA nod on tecarfarin path
ARYx axes staff as it negotiates new deals

Read more about: Aryx Therapeutics



5. ISCT works with industry to launch cell therapy partnership

By Liz Jones Hollis Comment | Forward | Twitter | Facebook | LinkedIn

Biotech firms Roche, Genzyme, Athersys, Miltenyi Biotec, Hospira, Lonza and Life Technologies are joining the International Society for Cellular Therapy (ISCT) to launch a series of initiatives to create greater strategic alignment within the industry and drive late stage clinical development.

Established in 1992, ISCT works to foster international translational research; inform national and global regulatory framework development and harmonization; drive commercialization strategies; and educate principal investigators, lab directors, technologists, regulators and commercial stakeholders, according to the society's website.

The society's industry task force, which includes these biotechs, has unveiled a series of recommendations to re-charter the ISCT Commercialization Committee to drive the creation of forums for discussion of shared concerns on process and product development, business models, and clinical development, and to catalyze the development of consensus standards.

"Working in partnership to develop standards around cell characterization and potency as well as treatment approaches and trial endpoint design we aim to facilitate entry into the cell therapy space for large healthcare and pharmaceutical companies, those members of the industry most reliably able to initiate and maintain advanced phase clinical trials. Ultimately, this will expedite the maturation of the field and bring cell therapy treatments to patients faster," says Ed Horwitz, president of ISCT, in a statement.

- check out ISCT's release

Related Article:
Money, money, money and medical innovation

Read more about: translational research



Also Noted

SPOTLIGHT ON... Vaccine sales up 16% in 2009

Vaccine sales hit $22.1 billion in 2009, up a healthy 16 percent from 2008. And forecasts predict that sales will continue to rise annually at a rate of 9.7 percent for the next five years. Wider adoption of currently available vaccines and the introduction of new products could push annual sales as high as $35 billion by 2015. Report

 @FierceBiotech: GSK orders Sirtris execs to stop selling resveratrol. Article  | Follow @FierceBiotech

> Novartis AG CEO Joe Jimenez left open the possibility the Swiss drugmaker may raise its $9.8 billion offer to buy out eye-care company Alcon's minority shareholders. Report

> The Medicines for Malaria Venture (MMV) today became the first product development partnership to contribute intellectual property to the Pool for Open Innovation against Neglected Tropical Diseases. MMV joins GlaxoSmithKline, Alnylam Pharmaceuticals, and the Massachusetts Institute of Technology in contributing to the Pool, which is administered by BIO Ventures for Global Health. MMV release

> Chongqing Lummy Pharmaceutical and Jiangsu Lianhuan Pharmaceutical led gains among Chinese drugmakers in Shanghai and Shenzhen trading after a news website reported the companies make medicines that can combat a drug-resistant bacteria. Article

> Morphotek, a subsidiary of Eisai, announced today that the John Wayne Cancer Institute in Santa Monica, California has opened enrollment in a Phase I clinical study with MORAb-028 in patients with advanced melanoma. Morphotek release

> KemPharm announced today that it has received a Notice of Issuance from the USPTO for its patent application titled "Polar Hydrophilic Prodrugs of Amphetamine and Other Stimulants and Processes for Making and Using the Same," U.S. Patent No. 7,772,222.  KemPharm release

And Finally... When the North Carolina Biotechnology Center awarded Thrombotargets a loan to further its research on ways to stop bleeding, the company was riding high on promising news from regulators and touting its lead candidate as a potential blockbuster. Today, there is no sign of progress on the company's bleeding treatment. In fact, there's very few signs of the company at all: Phones at Thrombotargets' Durham offices go unanswered, and the company has cut communication with its scientific advisers. Story


@FiercePharma: Genomics might have rescued Sanofi diet drug. Article | Follow @FiercePharma

> FDA faces outcry with Avastin breast-cancer choice. News

> Genzyme, Sanofi negotiations remain in low gear. Story

> Alcon minorities may get higher Novartis bid. Article

> Will new PhRMA chief turn right? Article

> Aspen nabs Sigma's drug biz for $804M. News


> Data-sharing helps researchers in Alzheimer's fight. News

> Database breaches remain healthcare vulnerability. Report

> Lit search used to personalize cancer cures. Story

> Segregating trial data may ease EMR concerns. News


Webinars


* Post listing: Click here.
* General ad info: Click here.

> Metrics to Understand Your Brand and Help It Thrive - August 18th, 2 pm ET / 11 am PT

Pfizer is the world's largest research-based pharmaceutical company. But how do they continue to thrive in an ever-changing and highly competitive environment? This real life case study will explain how Pfizer's Animal Health division utilizes analytics and data visualization to quickly find patterns and key insights within their data to drive informed decision-making. Register Now!



Events


* Post listing: Click here.
* General ad info: Click here.

> DIA 2011 Call for Proposals Open Until September 13 - September 13

DIA 2011 features new content areas to help you optimize your operations and succeed in the changing global landscape. Click here for track descriptions. Submit proposals for sessions, presentations, workshops, and forums. Proposal Details

> Rutgers Mini MBA: BioPharma Innovation Program

Focused learning for science & business professionals to expand business knowledge, creativity & decision making skills in the Biotech & Pharma industries. Upcoming sessions start in September 2010 & June 2011. Learn more at www.cmd.rutgers.edu/mini-mba-biopharma.html. Call 732 445-5526 or info@cmd.rutgers.edu .

> Pharmaceutical Strategic Alliances 2010 - Sept 21-23 - New York City

PSA, the industry's most respected strategic event, focuses on the new dealmaking trend of risk-sharing between big and small companies, drug developers and payors. PSA features the most senior-level case studies for dealmaking and strategy available in the industry. Register now: www.windhover.com/psa.

> Life Sciences Summit 2010

Translational science partnering meeting focused on commercially relevant next-generation biomedical solutions. 2010 Focus: Infectious Disease: Oncology, Neurology & Regenerative Medicine. 500 individuals representing over 200 unique companies, institutions and organizations expected to attend. Lean More

> Windhover's PharmAsia Summit 2010 - Oct 25-26 - San Francisco

Windhover Conferences, sponsor of the blockbuster Pharmaceutical Strategic Alliances, delivers the most senior experts in the Asian markets who will show you how to take the risk out of doing business in Asia, expected to be a driver for pharma growth for the next 10 years. Register now: www.windhover.com/pharmasiasummit

> Tomorrow's Project Manager: Evolving Competencies for Biopharmaceutical Professionals - October 26 - 27 - Bethesda, MD

Project management in the pharmaceutical industry is evolving to meet the ever-changing environment. Advances continue in project management skills and technology. This project management workshop will provide an opportunity to discuss the evolving role of the project manager and stimulate an interactive environment in a series of workshops that will focus on the key project management competencies. Learn more.

> Windhover's Therapeutic Area Partnerships 2010 - Nov. 2-4 - Boston

TAP is the industry's most targeted, efficient, strategic-level partnering meeting for life science companies seeking partnerships in the top therapeutic areas: oncology, cardiovascular, metabolic and neuroscience. The biggest players in these areas attend to make deals. Register now: www.tapartnerships.com



Marketplace


* Post listing: Click here.
* General ad info: Click here.

> Products to watch in the biotech pipeline

Identify emerging products with a comprehensive review of pipelines for the world’s top biotech companies. Compare pipelines and financials such as R&D spend with easy-to-read charts. Get competitive insight on promising new molecular entities and products to watch: Top 50 Biotech Companies & Their Pipelines. Learn more.

> Drug Development Self-Study Course

6-Module self-study course teaches the whole process of drug development. Q&A, narrated presentation , e-Book summary (also in Chinese and Japanese) and optional web seminar. As used internationally in industry and academia. See www.alladex.com or write to j.gray@alladex.ch for further information, samples and quote.

> White Paper: Five Essentials for Minimizing Risk in Clinical Trials

Potentially valid drugs and devices are often denied regulatory approval when flawed clinical data undermines efficacy and safety findings. Discover the elements that every trial should deem mandatory to avoid such unnecessary risk. Download the free white paper: “What You Don’t Know Can Hurt You”

> From H1N1 and Beyond: Growing The Flu Vaccine Pipeline

The rise in influenza strains like H1N1 — and the demand for new vaccines — signals a new era in vaccines. Learn how flu vaccines have evolved and where they’re headed. Read the white paper from Quintiles’ vaccines experts.

> Optimize your Media with our Animal Component Free Products and Supplements

The Biotech market relies on Sheffield Bio-Science for cell culture optimization products like HyPep™ UltraPep™, Hy-Soy™ and rAlbumin. Every day we expand our capabilities to meet the changing needs of the cell nutrition market. Learn about the newest animal component-free (ACF) products we've developed at our state-of-the-art Center for Cell Culture Technology. Visit www.sheffieldbioscience.com or call 800.833.8308

> State of the Clinical Trials Industry

This annual publication a comprehensive resource that examines all aspects of the global clinical trials industry and is comprised of more than 645 charts and graphs, including 400 new and updated ones for the 2009 edition. Click here and reference coupon code 7712 to order your copy now!

> Innovations in Life Sciences

What are some of the most promising new technologies used in life sciences research today? Find out at the FierceBiotech-Enterprise Florida "Innovations in Life Sciences" microsite. Access insightful white papers, videos, news and more.



Jobs


* Post listing: Click here.
* General ad info: Click here.

> Director Global Health Economics and Outcomes Research - Shire Pharmaceuticals

Primary Role: To provide strategic planning & design input and implementation of health outcomes programs to support the go/no go decision of product candidates, pricing and reimbursement for Shire products across global markets. Learn more.

> Senior Director/Vice President Fibrosis - Regulus Therapeutics Inc.

Reporting to the Chief Scientific Officer, the Senior Director/Vice President, Fibrosis will be an integral member of the Regulus team and will contribute significantly to the advancement of numerous discovery and preclinical compounds into the clinic. Read more

> Senior Scientist Basic microRNA Mechanisms - Regulus Therapeutics Inc.

We are seeking a Senior Scientist to investigate how microRNA-modulating drugs interact with RNAi machinery. The successful candidate will be experienced in analyzing the biochemistry of RNAi pathways. He/she will also have broad knowledge of microRNAs and expertise in fundamental aspects of the RISC complex. Read more.

> Senior Scientist Metabolic Diseases - Regulus Therapeutics Inc.

The successful candidate will have considerable expertise in metabolism and/or adipose tissue biology and will be expected to spend the majority of his/her time working in the lab. He/she should have experience working with in vivo models of metabolic disease. Read more.

> Senior Research Associate/Senior Scientist Immunology - Regulus Therapeutics Inc.

The successful candidate will have considerable expertise in modern and classical experimental models in immunology and will be expected to spend the majority of his/her time working in the lab. He/she will also have broad knowledge and expertise in fundamental immune mechanisms as well as experience with animal models in immunology. Read more.

> Senior Director/Vice President Immunology - Regulus Therapeutics Inc.

Reporting to the Chief Scientific Officer, the Senior Director/Vice President, Immunology will be an integral member of the Regulus team and will contribute significantly to the advancement of numerous discovery and preclinical compounds into the clinic. Read more.

> Senior Scientist/Associate Director Immunology - Regulus Therapeutics Inc.

The successful candidate will have considerable industrial experience and expertise in modern and classical experimental models in immunology. He/she will also have broad knowledge and expertise in fundamental immune mechanisms as well as experience with animal models in immunology. He/she will be working closely with a small team of scientists involved in cutting-edge research to develop microRNA therapeutics. Read more.

> Senior Scientist/Associate Director Fibrosis - Regulus Therapeutics Inc.

The successful candidate will be an expert in fibrosis/wound healing, with considerable industrial experience in experimental fibrosis research. He/she will also have broad knowledge and published expertise in molecular/cellular biology. He/she will be working closely with a small team of scientists involved in cutting-edge research to develop microRNA therapeutics. Read more.

> Need a job? Need to hire? Visit FierceBiotech Jobs

50+ new jobs just posted. Employers now post to the web site free. Find the perfect job or post your openings at http://www.fiercebiotech.com/jobs.