SoCalBio Weekly Update
February 7, 2014

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June 23 - 26
San Diego
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Join SoCalBio
Join SoCalBio leaders to promote the biotech and device industries in Los Angeles, Orange County and neighboring communities for job creation and overall economic growth.
Become a Member
Thanks to SoCalBio Media Partners


Make Your Voice Heard in DC 
Join SoCalBio at the BIO Legislative Day in Washington, D.C. on April 8 and 9
Join SoCalBio's team and other biotechnology executives from across the country who will go to D.C. for a day and a half of legislative briefings and advocacy on Capitol Hill. This fly-in is organized by the Biotechnology Industry Organization to give you the opportunity to meet with your congressional representative and other legislators to educate them about the importance of the biotech industry for job and wealth creation.
 
Contact SoCalBio, if you are a bioscience industry executive interested in participation and located in Los Angeles, Orange County, the Inland Empire and the communities of the Gold Coast of Ventura and Santa Barbara. Send email to: scbc@socalbio.org
Meet New SoCalBio Members
Response Genetics (Los Angeles)

 

Response Genetics is a publicly traded biotech company focused on developing molecular diagnostic assays to help determine the patient's response to cancer therapies ... Learn More

 

Pharmacos Biopharmaceutical Services (Irvine)
 
Pharmacos services small to mid-size specialty biopharmaceutical and medical device companies by providing a complete suite of outsourcing and/or consulting services which support drug development, registration, commercialization, life cycle management and commercial operations .. Learn More
 
CRB USA  (Carlsbad)
 
CRB is a global design, construction and consulting firm that services the bioscience and other advanced technology industries. The firm employs over 600 people in 10 offices serving clients throughout the world ... Learn More 
Upcoming Event 

 

Join SoCalBio at MD&M for a unique breakout session on
Building Talent to Build Medical Devices
Wednesday, February 12th from 12:30-1:00 pm 
Tech Theater, Booth 3541, Between Halls B and C
 
Click Here to Register and Attend the MD&M Conference
February 11 - 13 in Anaheim

Abstract
Recognizing the impending skills gap in medical device manufacturing, industry and academic experts from SoCalBio are teaming up with national and regional initiatives to prepare the American workforce specifically for the medical device industry. Get a progress update and learn what these initiatives promise in terms of skills development for engineering, manufacturing, and quality assurance, and find out how you can access this new talent pool to help build your expert team.

Speakers
  • Ahmed Enany, President & CEO, SoCalBio
  • A. Stephen Dahms, Consultant, Workforce Development, SoCalBio
  • John Milburn, Director, Employment Training Institute, College of the Canyons
  • William Pratt, VP of Operations and Director of Creative Design, Kinamed Inc.

Upcoming SoCalBio Events

 

  • SoCalBio Executive Luncheon in Ventura County, Feb 19, 11 to 2 at the Ventura BioCenter ...

FDA

Why FDA Supports a Flexible Approach to Drug Development 

 

Read FDA Commissioner's blog on FDA's use of different approaches to clinical trials to back the approval of drugs. Dr. Hamburg argues that the varying approach to drug trials reflects the agency's flexible and innovative approach to the development and approval of drugs. She contends that "greater flexibility doesn't mean abandoning science and standards, but using the best science to boost productivity and efficiency" ... Read Dr. Hamburg's Blog
Grants
DARPA Announces a New $70 Million Initiative to Develop Brain Implants to Restore Active Memory

The initial focus is on finding ways to treat the 280,000-plus veterans from Iraq and Afghanistan who have suffered brain injuries during combat. Geoff Ling, deputy director of DARPA's Defense Sciences office, told Bloomberg that the early-stage work may also have other benefits such as treating athletes with brain injury or seniors with dementia. But the early hope, he said, is to come up with a device that could address brain injury-related memo ...
 
Patent Litigation
Puma's Stock Soars on Favorable Ruling by the European Patent Office 

The West Los Angeles Biotech saw a 16% uptick in its stock price following a favorable ruling by the European Patent Office regarding patent claims that were challenged by German drug giant Boehringer Ingelheim. The patent is part of an IP portfolio licensed by Pum,a from Pfizer in 2011, and includes claims related to "a pharmaceutical composition for use in treating cancer in a subject with a cancer having a mutation in EGFR with a T790M mutation ... Learn more
NDA
Aliso-Viejo-Based Avanir Files NDA for AVP-825 

AVP-825 is being developed using OptiNose's novel Breath Powered intranasal delivery system, which includes low dosages of GlaxoSmithKline plc's Imitrex for the treatment of acute migraine. The NDA was filed on the basis of a pivotal phase III trial on AVP-825 and a phase II trial along with two pharmacokinetic studies ... Read more

Ophthalmics
Second Sight Medical Products Announces the First Two Commercial Retinal Prosthesis Implants in U.S. Since FDA Approval
 
Retina surgeons at the University of Michigan Kellogg Eye Center have performed the first - and second - surgeries in the United States to implant an artificial retina, or "bionic eye," since the U.S. Food and Drug Administration approved the device last year. Thiran Jayasundera, M.D.and David N. Zacks, M.D., Ph.D., performed the surgeries for patients with retinitis pigmentosa (RP), a degenerative and blinding eye disease....
 
IPO
Goleta-Based Inogen Inc. Sets its IPO Terms 
 
The medical device company will offer 4.4 million shares at between $16 and $18 per share. It would have an initial market cap of approximately $307 million, Inogen plans to trade on the Nasdaq as INGN, Inogen's shareholders include Novo AS (42.15% pre-IPO stake), Versant Ventures (26.08%), Arboretum Ventures (15.07%), Avalon Ventures (6.5%) and Accuitive Medical Ventures (5.95%) ... Learn more
Jobs ... Jobs ... jobs 
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Gilead (San Dimas)
Gilead (Oceanside)
Biolase (Irvine)

Xencor (Monrovia)
Aubery Group (Irvine)
About SoCalBio 
 
SoCalBio membership links you to partners, contract manufacturers, regulatory and legal experts, and policy makers. The organization's programs help emerging biotech and medical device companies grow. Membership is affordable -- as low as $500 -- and offers access to networking opportunities, advocacy, discounts through our group purchasing program group purchasing program and other benefits you simply can't find elsewhere ... Join SoCalBio
Join SoCalBio
Become a SoCalBio Member and Save Money by Utlizing the SoCalBio Group Purchasing Program