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SoCalBio Weekly Update
Thanks to SoCalBio Weekly Update Sponsor
Coming in June
 
SoCalBio/Image 2000 Golf Classic
   
Benefiting
 
When: June 28, 2010
Time: 10:00am - 8:30pm
Where: Old Ranch Country Club, Seal Beach, California
More Info: Click here
Sponsorship: See prospectus
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Join SoCalBio
 
Join well-known entrepreneur Alfred Mann and other SoCalBio leaders to promote the biotech and device industries in the Greater Los Angeles Metro Area for job creation and overall economic growth.
Become a Member
Past Weekly Updates
March 22, 2010

Who Got PMAs in 2009?
2009 FDA Pre-Market Approvals

In 2009, Ninteen Pre-Market Approval (PMA) decisions concerning new medical devices were made by the Food and Drug Administration. Click here to see the list of companies that won PMA decisions.
 
Coming This Week

SoCalBio Networking Forum in Orange County
Managing Obesity Through Minimally-Invasive Medtech Approaches

March 25, 2010, 7:00 am - 9:30 am
UCI University Club in Irvine
RSVP:https://www.123signup.com/register?id=jyrvf

Keynote Speaker
  • Bill Murray, President & CEO, Reshape Medical (San Clemente)
Panel Discussion Participants 
  • Fred Cahn, Ph.D., CEO, Biomedical Strategies LLC (La Jolla)
  • Neal Kaufman, M.D., M.P.H., Founder and CEO, DPS Health (Los Angeles)
  • Tom Kinder, CEO, Bariatric Advantage, Inc.(Irvine)
  • Roger Zickfeld, Managing Director, Zickfeld Advisors (Los Angeles)
  • Monica Welling, Consultant, Atheln, Inc. (Los Angeles)
RSVP Now for Upcoming SoCalBio Events
SoCalBio Executive Roundtable Discussion
Regenerative Medicine Luncheon and Discussion
(Open only to executives and managers in regenerative medicine companies) 

Date: April 6, 2010

Time 11:00 am - 2:00 pm
Location: Offices of Reed Smith in Downtown Los Angeles
By Invitation Only (for more info, contact SoCalBio at scbc@socalbio.org or call 213-236-4890)

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SoCalBio HR Symposium
Best Practices in Designing Wellness Programs
Join us to learn how to craft wellness programs to improve employee health, reduce medical claims, and guarantee a return on investment (Open only to HR professionals in medical device, IVD, biotech and generic pharma firms)

Date: April 15, 2010

Time: 9:00 am - 1:30 pm
Location: Four Seasons Hotel in Westlake Village
By Invitation Only (for more info, contact SoCalBio at scbc@socalbio.org or call 213-236-4890)

Join the SoCalBio HR Network on LinkedIn

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SoCalBio Regulatory Best Practice Workshop
The Shifting Paradigm in FDA Process Validation

This SoCalBio workshop focuses on the FDA's guidelines regarding Process Validation. It is designed for device and pharma regulatory affairs professionals to learn what is required to approach process validation from a life cycle perspective and incorporates modern risk management and quality systems tools and concepts.

Date: May 13, 2010

Time: 8:00 am to 5:00 pm
Location: UCLA Faculty Center
RSVP: 
https://www.123signup.com/register?id=mqpmv
Welcome New SoCalBio Member
Regulatory & Clinical Research Institute, Inc. (Minneapolis, MN)
RCRI was founded in 1999 and has become one of the nation's largest contract research organizations (CROs) assisting medical device, biologics, and in vitro diagnostic medical product firms obtain market releases from regulatory authorities. RCRI was one of the first CROs to obtain ISO 9001:2000 certification to provide expertise in regulatory affairs, clinical trial design and management, reimbursement strategies, health economics, quality systems, Biostatistics, and venture capital due-diligence... Learn more

Applied Biocode (Santa Fe Springs)


Applied BioCode, Inc. (ABC) is a spin-off of Maxwell Sensors. Applied BioCode develops cutting edge barcoded magnetic bead technology for multiplex bioassay. The Barcoded Magnetic Beads (BMB), utilizing a digital technology instead of conventional analog methodology, offers unmatched decoding accuracy, excellent fluorescence detection precision and unlimited number of barcodes for multiplex tests ... Learn more
New Sponsor
Image 2000 Joins the List of SoCalBio Sponsors 

Image 2000 (Van Nuys, CA), a multi-manufacturer, document imaging solutions & full service provider, has joined the list of SoCalBio Sponsors. Image 2000 will support the SoCalBio Networking Forum and assume the title sponsor of the SoCalBio Golf Classic. Learn more about Image 2000
IPOs
GenMark Diagnostics Files Registration Statement for Initial Public Offering
The Pasadena-based company owns Osmetech Molecular Diagnostics. Piper Jaffray & Co. will act as the sole book-running manager, and Leerink Swann LLC will act as the co-manager for the proposed offering. The number of shares to be offered and the price range of the proposed offering have not yet been determined. All of the shares of common stock will be offered by GenMark.... Read more
Clinical Trials
The Pasadena-Based Calando Pharmaceuticals, Provides First Proof of RNA Interference in Humans with Systemically Administered siRNA Therapeutic

The study was led by Professor Mark E. Davis and a team of scientists at Caltech. It also included researchers and clinicians from UCLA and South Texas Accelerated Research Therapeutics (START), the two sites conducting Calando's clinical trial. The trial, which is investigating the safety and efficacy of drug candidate CALAA-01 and the broader RONDEL nanoparticle delivery system, represented the first time siRNA was systemically administered using a delivery system and the first use of siRNA against cancer in humans.... Read more

Cameron Health Commences FDA-Approved IDE Clinical Trial of the Minimally Invasive Totally Subcutaneous Implantable Defibrillator for Treatment of Sudden Cardiac Arrest

The San Clemente-based Cameron Health's trial is a prospective, multicenter, single-arm design approved by the FDA under an investigational device exemption (IDE). The company plans to enroll up to 330 subjects at up to 35 sites globally. The study has primary clinical endpoints of arrhythmia conversion efficacy and complication free rate at 6 months for patients at risk of SCA.... Read more

Abraxis Bioscience's ABRAXANE Meets Primary Endpoint in Phase 3 Trial for Advanced Non-Small Cell Lung Cancer 

The Phase 3 trial completed enrollment of 1,052 patients in July 2009 at 102 sites globally and was led by principal investigator Mark Socinski, M.D., at the University of North Carolina Lineberger Comprehensive Cancer Center. It is one of the largest NSCLC clinical studies to be conducted.... Read more
Magellan Spine Technologies Announces Full Enrollment in the Spinal Disc Annular Repair Technology (DART) 20 Patient Initial Human Use Study
This first of its kind study was performed by Dr. Juan Dipp, Hospital Y Centro Medico Del Prado in Tijuana, Mexico, and Dr. Ricardo Flores, Almater Hospital, Mexicali, Mexico. The study design included patients with single level visually confirmed lumbar disc herniation that had failed conservative therapy.... Read more
M&As
Los Angeles-Based Spectral Molecular Imaging, Inc. Acquired by Cascade Technologies Corp. 

Spectral Molecular Imaging, Inc. was established in September 2006 by Daniel L. Farkas, Ph.D. of Cedars Sinai. The company is developing non-invasive devices that use its patented technology for improved clinical diagnostics, primarily in the field of cancer pathology.... Read more 

Valeant to Acquire Branded Generics/OTC Company in Brazil

Valeant Pharmaceuticals announced that it has signed a binding agreement to acquire a private branded generics and over the counter (OTC) company located in Brazil for approximately US$28 million. A large portion of the company's product portfolio is in dermatology and the company had annual sales of approximately US$19 million in 2009... Read more
Tech PR
New Flat-Fee PR Service for Tech Start-Ups
SoCalBio member, Olmstead Williams Communications, a public relations agency in Los Angeles, launched a new division that charges a flat monthly fee for a full range of PR services. The new division is called "PRTechConnect." It is geared toward tech start-ups with limited marketing and PR budgets.... Read more
Jobs Available
Midmark, a medical device manufacturer, is seeking to fill the following positions in Los Angeles County:Masimo, a medical device manufacturer, seeks to fill the following positions in Orange County:
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