Archive for April, 2007

NanoBioNexus’ Patenting & Licensing Nanotechnology – “Where Much Can Go Wrong If You Don’t Get It Right”

Written by on Sunday, April 8th, 2007

The event NanoBioNexus’ Patenting & Licensing Nanotechnology–"Where Much Can Go Wrong if You Don’t Get it Right" will be held at the Radisson La Jolla, 3299 Holiday Court, La Jolla, CA  92037 on April 26, 2007 from 5:30 to 8:30 p.m.  The speakers will include:

  • Vicki G. Norton, Ph.D., J.D., Partner, Intellectual Property, IP Litigation, IP Counseling & Patents, Life Sciences, Wilson Sonsini Goodrich & Rosati Law Firm;
  • Esther Kepplinger, Director, Patent Operations, IP Counseling & Patents, Wilson Sonsini, Goodrich & Rosati Law Firm; and 
  • Jane Moores, Ph.D.
    Interim Director, UCSD Technology Transfer.

 



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BayBio 2007

Written by on Sunday, April 8th, 2007

 BayBio 2007  will be held on Thursday, April 26, 2007 from 8 a.m. to 6:30 p.m. at the Crowne Plaza Hotel SFO, 1177 Airport Blvd., Burlingame, CA  94010.  This conference will focus on Northern California’s strength in life sciences product development and commercialization.

 

 


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Is an IP Holding Company Still Just a Troll? Licensing and Enforcement Strategies for IP Holding Companies and Others

Written by on Sunday, April 8th, 2007

This month’s LES Silicon Valley Chapter event,  Is an IP Holding Company Still Just a Troll?  Licensing and Enforcement Strategies for IP Holding Companies and Others,  will be held on Wednesday, April 25, 2007 from 11:30 a.m.-1:30 p.m. at Cooley Godward Kronish LLP, 3175 Hanover, Palo Alto, CA  94036.  The speakers will include Eric Reifschneider, Partner in the Technology Transactions Practice Group at Cooley Godward Kronish LLP, and Tim Teter, Partner in the IP Litigation Group at Cooley Godward Kronish LLP


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Life Sciences Law Institute

Written by on Sunday, April 8th, 2007

The event Life Sciences Law Institute will be held April 25-27, 2007 at the Parc 55 Hotel in San Francisco, CA.  The program is designed to address the unique issues faced by in-house and outside counsel for pharmaceutical companies, biotechnology companies, device manufacturers, academic medical centers, and healthcare providers who have relationships with the life sciences industry. Daniel Meron, General Counsel at the Department of Health and Human Services, will give this year’s keynote address. Following the keynote, Linda Freidman from Astellas, and Bruce Garren from Edwards Lifesciences Corporation will discuss The In-Box Issues for Biotech, Drug and Device General Counsels. Breakout sessions will include:

  • Coverage, Reimbursement and Fraud and Abuse Basics for FDA Lawyers;
  • FDA Basics for Healthcare Lawyers;
  • Conducting Effective Internal Investigations and Managing the Whistleblower Threat;
  • Postmarket Safety Issues for Devices;
  • Recent Life Sciences Corporate Integrity Agreements: Consequences for Compliance Auditing and Monitoring;
  • Medicare Part B Coverage, Billing and Payment for Drugs and Biologics Furnished in an Outpatient Setting;
  • Global Compliance Challenges for Life Sciences Companies;
  • Off-Label Promotion: Current Government Theories/Legal and Policy Defenses; and
  • Pharmaceutical Industry Data: What Litigating and Compliance Attorneys Need to Know.

BayBioNEST’s First Annual Partnering Event

Written by on Sunday, April 8th, 2007

BayBioNEST’s First Annual Partnering Event will be held on April 24, 2007 from 12 p.m. to 5 p.m. at the Sheraton Palo Alto, 625 El Camino Real, Palo Alto, CA 94301.  This high level partnering event will provide an opportunity for local companies to identify partners, build relationships, and evaluate technology.


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USCD Extension: Introduction to Nanotechnology

Written by on Sunday, April 8th, 2007

The event USCD Extension: Introduction to Nanotechnology will be held on April 24, 2007 from 8 a.m. to 5 p.m. in Room 107, UCSD Extension Sorrento Mesa Center, 6925 Lusk Blvd., San Diego, CA. 


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Winning Product Submissions – Find Out What the FDA Is Looking for & How to Get Your Product Approved Sooner

Written by on Sunday, April 8th, 2007

The teleconference event Winning Product Subsmissions–Find Out What the FDA is Looking For and How to Get Your Product Approved Sooner will be held on Tuesday, April 24, 2007 from 11 a.m. to 12:30 p.m. PST.  The audioconference will address the following:

  • The importance and underlying principles of the FDA drug development process from Phase I through market approval;

  • How to create adequate and appropriate FDA submissions throughout the drug development process covering CMC, Nonclinical and Clinical areas;

  • What information about your new product should and should not be included in application packets;

  • How to effectively prepare for, and communicate during, meetings with the FDA;

  • The common pitfalls that lead to delays and non-approvable determinations ;

  • How to maintain investor confidence throughout the review process;

  • An overview of the different types of submissions from IND and IDE through marketing applications [NDAs, BLAs, PMAs, 510(k)s];

  • Advice on how to communicate with the FDA during your development program and upon submission of your marketing application;

  • Tips on the submission process — strategies for filing and how to avoid delays;

  • The review process and related correspondence;  and

  • What’s new in compliance guidance documents.


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Winning Product Submissions – Find Out What the FDA Is Looking for & How to Get Your Product Approved Sooner

Written by on Sunday, April 8th, 2007

The teleconference event Winning Product Subsmissions–Find Out What the FDA is Looking For and How to Get Your Product Approved Sooner will be held on Tuesday, April 24, 2007 from 11 a.m. to 12:30 p.m. PST.  The audioconference will address the following:

  • The importance and underlying principles of the FDA drug development process from Phase I through market approval;

  • How to create adequate and appropriate FDA submissions throughout the drug development process covering CMC, Nonclinical and Clinical areas;

  • What information about your new product should and should not be included in application packets;

  • How to effectively prepare for, and communicate during, meetings with the FDA;

  • The common pitfalls that lead to delays and non-approvable determinations ;

  • How to maintain investor confidence throughout the review process;

  • An overview of the different types of submissions from IND and IDE through marketing applications [NDAs, BLAs, PMAs, 510(k)s];

  • Advice on how to communicate with the FDA during your development program and upon submission of your marketing application;

  • Tips on the submission process — strategies for filing and how to avoid delays;

  • The review process and related correspondence;  and

  • What’s new in compliance guidance documents.


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UC Berkeley Extention: The Drug Development Process.

Written by on Sunday, April 8th, 2007

The event UC Berkeley Extension: The Drug Development Process will be held April 23-27, 2007 at  the UC Berkeley Extension – Downtown Center, 425 Market Street, 8th Floor, San Francisco, California U.S.A.  This four-day course will provide a thorough overview of all major activities involved in bringing a pharmaceutical therapy from discovery to market.  Topics will include the following:

  • pharmacology,
  • metabolism and pharmacokinetics,
  • toxicology, pharmaceutical development and production,
  • clinical trials and statistical support,
  • current regulations and the approval process,
  • QA/QC compliance,
  • intellectual property,
  • commercial development planning and strategic marketing,
  • program management,
  • financing, and
  • FDA perspective on industry inspections.

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LES Technology Transfer Seminar

Written by on Sunday, April 8th, 2007

The LES TEchnology Transfer Seminar will be held April 23-24, 2007 in San Diego, CA.


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