California Biotech Law Blog

According to an Associated Press report, Harvard researchers have been reviewing the recent rash of problems with approved drugs and have come to a "disturbing" conclusion: drugs that were approved by the FDA in a rushed timetable have had more problems than drugs that were approved on a more leisurely timetable.  The results of this research have just been published in Thursday's New England Journal of Medicine and provide support for the researchers' conclusion.

The Associated Press explains as follows:

Deadlines were first imposed on FDA by a 1992 law that allowed drug makers to pay millions of dollars in fees directly to the cash-strapped agency so it could hire more reviewers and clear a backlog of pending drug applications. In return, FDA had to make a decision — either approve or reject — on 90 percent of all drug candidates within 12 months of their application, or lose money. The deadline was 6 months for drugs so novel or potentially lifesaving to be classified high-priority.  Congress tightened the deadline for most drugs to 10 months in 1997.

Amid concern about risky drugs, Harvard professor Daniel Carpenter took a closer look at the impact. First, he found approval is 3.4 times as likely in the two months leading up to the user-fee deadline as at any other time.  Drugs approved in that just-before-deadline period had a four-to five-fold higher rate of later being withdrawn or requiring serious safety warnings, compared with drugs approved faster — presumably slam-dunks — or those that miss the deadline, Carpenter concluded.

While the FDA is denying that an accelerated review timetable is responsible for the recent wave of problems with approved drugs, the New England Journal of Medicine report certainly suggests that the contrary may in fact be true. 

In light of this evidence, what should be done to protect the public? 

Two possibilities quickly come to mind: first, there is the option of bulking up the FDA staff to more effectively deal with accelerated review timetables, and second, there is the option of lobbying Congress to loosen the tight deadlines, so that the FDA has more time to do a more thorough review of new drugs.  Given the current budget deficit, the second option is likely more realistic.

Perhaps patients who are pursuing class action suits against Merck and other companies who have sold these problem drugs should redirect their efforts towards lobbying for new legislation in Congress to relax the current FDA approval deadlines.  Taking this action--rather than pursuing class actions suits--may very well be the step most likely to produce real change in order to best protect the public. 

The Practicing Law Institute event Handling Intellectual Property in Business Transactions will be held in San Francisco on April 30-May 1, 2007.  The event will cover the following issues:

• Strategies in creation of intellectual property assets;
• Obtaining ownership of intellectual property assets;
• Strategies for licensing of intellectual property assets;
• Trademark licensing and branding issues;
• Understanding and analyzing intellectual property assets;
• Maximizing the value of intellectual property assets;
• The impact of Sarbanes-Oxley and FAS 141/142 on IP issues;
• Critical open source issues; and 
• Protecting IP assets in the event of bankruptcy.

The ABA Science and Technology Section's Biotechnology Law Roundtable Teleconference on Regulatory & Policy Implications of Personalized Medicine & Pharmacogenomics will be held from 8:30 a.m. to 10:30 a.m. PST on April 30, 2007.  The speakers for this event are Janet Woodcock, Deputy Commissioner & Chief Medical Officer, U.S. Food and Drug Administration, Rockville, Maryland, and Ellen Flannery, Partner, Covington & Burling LLP, Washington, D.C.  The event will explore the regulatory and policy issues that will arise as researchers, industry, and government regulators move towards implementing a pharmacogenomic approach to medical care.

The event HRx for Success--Strategies every Life Science Leader Should Know to Increase Company Performance will be held on Thursday, April 26, 2007 from 7 a.m. to 9 a.m. at the

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.

 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.

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

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 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.

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. 

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.

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.
  

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

The event GTCbio’s Enforcement & Litigation In the Biotech & Pharmaceutical Industry will be held April 19-20, 2007 in San Francisco, CA.  The event will address:  winning litigation strategies, minimizing product liability risks, controlling litigation costs, conducting successful internal investigation, and implementing anti-bribery compliance plans. 

The event  Biotech Demystified: The Science Behind the Business will be held at the UC San Diego Rady School of Management in San Diego, CA  on June 18th-21, 2007.  The program is designed toprovide executives and decision makers with a practical understanding of the basic science behind the biotechnology and pharmaceutical industries.  Topics will include:

The event Tunnel Consulting Summit -  BioProcessing Throughout the Product Life Cycle  will be held on Thursday, April 19, 2007 at Office Pavilion, 6920 Carroll Rd, San Diego, CA 92121from 8:00 a.m. to 4:30 p.m. The event will cover the following topics:

This month's Bioscience Forum event, Community-Based Approach to Neglected Infectious Disease Research, will be held on Wed., April 18, 2007 from 6 to 9 p.m. at The Clarion Hotel, San Francisco Airport, 401 E. Millbrae Ave., Millbrae, CA  94030.  The featured speaker will be Dr. Barry Bunin, CEO & President of Collaborative Drug Discovery Inc.  His presentation will provide perspectives on a new type of web-database to help scientists more effectively develop new drug candidates from commercial and humanitarian academic drug discovery research.

The event Clinical Quality Assurance and Management Policy: Two Case Histories will be held on Wednesday, April 18, 2007 from 10 to 11:30 a.m. by audio conference.  The event will look at two different case studies on clinical trials and what went wrong and how to avoid it, addressing the following:

• What corporate decisions occurred?

• Why did one site close down in response to the FDA enforcement action?

• Why does corporate management not share the clinical research or the regulatory perspective?

• What is the required corporate management CQA interface?

• Where and why did it fail?

• FDA sponsor obligations - what are they?

• What is the sponsor's liability and exposure for FDA enforcement action?

• How do the concepts of misconduct, fraud, and sponsor due diligence impact the FDA application of enforcement actions?

• How can CQA enable corporate management to empower the CQA function?

• What is the role of clinical project management and regulatory affairs in ensuring FDA compliant sponsor corporate management decisions?

The event Entrepreneurship and Building a Sustainable Organization will be held on Wednesday, April 18, 2007 from 7:15 to 8:30 a.m. at the University of San Diego, Institute for Peace & Justice. The speakers will include Michael Gallegos, CEO of American Property Management Corporation; John Kontopuls, CEO of Elite Show Services; and Tina Nova, Ph.D., CEO of Genoptix Inc.

The event CEOSummit 2007 Presents: From Startup to Sustainability will be held Tuesday, April 17, 2007 from 11:30 to 5:00 p.m. at the Joan Kroc Center at the University of San Diego, 5998 Alacala Park, San Diego, CA  92110.   This event is by invitation only and will provide over 100 life science Chief Officers (CEOs and CFOs) and the BIOCOM Board of Directors with the opportunity to discuss issuees pertinent to their companies and to interact with one-another on a peer to peer level.

The event Third Annual Venture Capital Awards will be held at the Computer History Museum in Mountain View on April 12, 2007 from 6 to 8 p.m.  The event will recognize and honor investments in women made in 2006, including the following: 

      •   Largest Percentage of Investments in Women CEOs
      •   Highest Number of Investments in Companies with a Woman CEO
             - current fund greater than $250M
      •   Highest Number of Investments in Companies with a Woman CEO
             - current fund smaller than $250M.

The sfAWIS April Networking Social will be held on Wednesday, April 11, 2007 in San Francisco, CA.  The event will be sponsored by Genentech and will take place at The Pub at UCSF, Mission Bay, 1675 Owens St., San Francisco, CA.

The event Invitrogen Distinguished Lecture will be held at 6:30 p.m. on  April 11, 2007 at the San Diego Marriott - Del Mar.  The speaker will be Zhu Chen, Ph.D, Vice President of the Chinese Academy of Sciences.  Dr. Chen has made important discoveries in the molecular foundations of several types of human leukemia and was recently named as one of the coordinators for the Human Genome Project in China. Dr. Chen will speak on “Opportunities and Challenges for Life Science and Biotechnology in China.”

The event IBF's 18th  Annual Venture Capital Investing Conference will be held on Wednesday, June 6, 2007 through Friday, June 8, 2007 at the Four Seasons Hotel , 75 Market Street, San Francisco, CA, 94103. 

The event 2007 Dean's Symposium: Exploring Proteins will be held on Friday, April 6, 2007 from 8 a.m. to 5 p.m. at UCSD Mandel Weiss Theatre.  The event will cover the following topics: protein folding and function; protein assemblies and machines; and proteins within cells.

The event 11th Annual Life Science Live – At the Opera will be held Wednesday, April 4, 2007 at 6:15 p.m. at the San Diego Civic Theatre and Golden Hall.  The event will provide networking with members of the life sciences community and an evening of opera.

The event French-American Biotech Connection will be held Wednesday, April 4, 2007 from 6 to 9 p.m. at the Salk Institute for Biological Studies.  The event will compare two successful approaches to fostering innovation in the life sciences.  The speakers will include as follows:

• François Ferré Ph.D., CEO, Althea Technologies, Member, Tech Coast Angel
• Luc Rousseau, Vice-Minister of Industry, General Directorate for French Enterprises
• Professeur Fabien Calvo Ph.D., Chairman, Hospital Saint Louis, Medicen bio-cluster
• Antoine Cournot, President EUCROF (European CRO Federation) and CEO, Therapharm
• Dr Catherine Lassale, MD, Scientific, Pharmaceutical and Medical Affairs Director, Leem
• Patrick Seroin, Attorney at Law, Fidal
• Jacques Warcoin, European Patent Attorney; European Trademark and Design Attorney, Cabinet Regimbeau.
  

The event Licensing: When, What, Where & How will be held on April 3, 2007 from 7:30-11:30 a.m. at Theatre at Office Pavilion, 6920 Carrol Road, San Diego, CA 92121, and will address turning intellectual property assets into cash. 

On April 3, 2007, BIOCOM will hold a legislative roundtable with Congressman Bob Filner.  To RSVP or for more information about this event, please contact Faith Picking at fpicking@biocom.org.

Bay Bio's Member Orientation will be held on March 29, 2007.  Contact Maya Hovey for additional information at maya@baybio.org.

The event BioBasics Briefing will be held on Thursday and Friday, March 29-30th in Menlo Park, CA.  The event will cover Industry Sectors, DNA, Proteins, Gene Expression, Transgenic Technology, Disease and Therapeutic Strategies, Pharmacogenomics, Drug Discovery and Development, and Stem Cells. Technologies: Recombinant DNA, Gel Electrophoresis, PCR, DNA Fingerprinting, and MicroArrays.

Santa Clara Law School is going to be hosting a Blawgers Roundtable on Wednesday, March 28th from 6 to 8 p.m. at the Wiegand Room, Arts & Sciences Building at Santa Clara University  The event will cater to Bay Area blawgers, but everyone is welcome.  I will be in attendance, as well as the following, who are confirmed:

Mike Dillon of Sun (see http://blogs.sun.com/Dillon)
Cathy Gellis (see http://www.cathygellis.com)
Eric Goldman of SCU (see  http://blog.ericgoldman.org)
Joe Gratzof Keker & Van Nest (see http://www.joegratz.net)
Chris Hoofnagle of Boalt (see http://choof.org/blog)
Cathy Kirkman of Wilson Sonsini (see http://www.svmedialaw.com)
David Levine of Stanford Law CIS (see http://cyberlaw.stanford.edu/blog/david-levine)
Colin Samuels (see http://www.infamyorpraise.com/)
Jason Schultz of EFF (see http://lawgeek.typepad.com/lawgeek)
Colette Vogele (see  http://cyberlaw.stanford.edu/blog/colette-vogele)

To attend,  please RSVP to Eric Goldman at egoldman@gmail.com.

The event California Life Sciences Day will take place on March 28, 2007 at the historic Sutter Club in Sacramento, CA. Attendees may participate in face-to-face meetings with legislators and state government officials; network at a luncheon featuring a keynote address by a leading policy maker; and join legislators and their staffs at a closing reception.

The grand opening of the BayBio Sacramento office will be held on March 27, 2007 from 4:30 to 6:30pm at 400 Capitol Mall, 11th Floor Board Room, Sacramento, CA.  The establishment of the Sacramento office will give BayBio an active presence in the State Capitol to continue advocacy work with state elected leaders on public policy priorities important to the life sciences industry. The presence of this office recognizes the growing number of companies in Sacramento's life sciences industry in conjunction with the increasing life sciences research occurring in the region, spurred by research at UC Davis and increasing investments by the private sector. . There is no cost to attend but space is limited. RSVP to Christopher Draper at cdraper@baybio.org or 650-871-7101 x206.

The event Oracle Life Sciences Community Day will be held on Thurs., March 22th from 8:30-5:00 p.m. at Oracle Conference Center, 350 Oracle Parkway, Redwood Shores, CA 94065.  The event will feature:

• Perspectives from industry strategists and thought leaders;
• Business best practices and lessons learned from leading companies;
• Customer presentations about their experience with Oracle’s many application solutions; and 
• A unique networking opportunity with Partners, Industry Peers, and Oracle experts.
  

The webinar event Hiring a Clinical Research Associate--What You Don't Know Can Hurt You  will be held on Tuesday, March 20, 2007; 1:00 - 2:30pm EST.  The program will address:

The event FountainBlue's Life Science Entrepreneurs Forum on Positioning Your Life Science Company for Outside Funding will be held on Monday, March 19, 2007.  The speakers will include:

• Facilitator Geetha Rao
• Panelist John Cornwell with a Life Science Angel perspective
• Panelist Ken Martin, Onset Ventures with a VC perspective
• Panelist David Miller Founder, InnoSpine, with an entrepreneurs' perspective

Registration is limited to entrepreneurs and investors and is $10-$15, plus $3 in fees.  Registration closes on March 16, 2007.

The event BIOCOM Legislative Round Table with Assembly Member Joel Anderson will be held on Friday, March 16, 2007 from 8:00 a.m. to 9 a.m. at the BIOCOM Boardroom, 4510 Executive Drive, Plaza Seven, San Diego, CA  92121.  The roundtable is a complimentary event for members.  Breakfast will be served.  To RSVP, contact Faith Picking at fpicking@biocom.org.  Joel Anderson represents the 77th State Assemby District, which includes almost all of San Diego's East County and is primarily a rural district.  Cities and communities include El Cajon, La Mesa, Santee, Lakeside, Ramona, Alpine, and parts of Sand Diego.

The bioe2e event Myelin Repair Foundation--Revolutionizing Medical Research will be held on Wednesday, March 14th, 2007 from 7:00 to 10:00 p.m. at Wilson Sonsini Goodrich Rosati, 950 Page Mill Rd., Palo Alto, CA  94301.  The pre-reigstration discount is $25 for registration before midnight on Monday, March 12, 2007; registration at the door is $35.  The program will address:

• How was MRF able to attract the top researchers from around the globe to collaborate? 
• Why have they been so successful? 
• How did MRF raise funding? 
• What were the issues surrounding IP and interactions with University Technology Transfer groups?
• Also, how could this model be applied to other diseases? 

The presenters will include the following:

• Scott Johnson, President and Founder  Scott Johnson brings more than 20 years of experience in business, including President and CEO of three startups. Johnson led such companies as Thermatrix, a venture-capital-backed company that developed, patented and sold a highly-efficient thermal oxidation technology that destroyed hazardous air pollutants. He also served as President and CEO of Cinemation, an entertainment company headquartered in Hawaii. Johnson's first startup was SeparaSystems LP, a joint venture between DuPont and FMC that utilized advanced membrane technology for food processing. Before these entrepreneurial roles, Johnson was an executive at FMC Corporation and in management consulting at the Boston Consulting Group. He holds an M.B.A. from the University of California, Berkeley Haas School of Business and a B.S. in Civil Engineering from the University of California, Davis. Johnson was diagnosed with MS in 1976.

• Russell "Rusty" Bromley, Chief Operating Officer   Rusty Bromley brings a unique combination of business experience in both academic and commercial research environments. His expertise includes the creation and protection of innovative technologies, business development, and marketing strategies for high tech and life sciences firms. Formerly he was CEO of LabVelocity, Inc., an Internet information portal for the life science research community. Prior to that he was CEO of Berkshire Holding Corporation, a privately-held, multinational manufacturer of contamination control materials for microelectronics and pharmaceutical production. Bromley's experience also includes 17 years with American Hospital Supply Corporation and Baxter Healthcare, in both the distribution and diagnostics businesses, culminating with seven years as President of the Burdick and Jackson Division. Bromley holds a degree in Biochemistry from Rice University.

• Ben Barres, M.D., Ph.D. Dr. Ben Barres is Professor of Neurobiology and Developmental Biology and Vice-Chair of the Department of Neurobiology at Stanford University School of Medicine.Dr. Barres's laboratory brings expertise in the development and function of glial cells in the mammalian central nervous system (CNS). They have found evidence of several novel glial signals that induce the onset of myelination, the clustering of axonal sodium channels, the survival and growth of retinal ganglion cells, and the formation of synapses. Their work for MRF compliments Dr. Robert Miller's work on characterizing the processes related to myelination and identifying relevant glial-derived signaling molecules. To understand the interactions between axons and glial cells Dr. Barres's laboratory has developed methods to highly purify and culture neurons as well as oligodendrocytes and astrocytes (the glial cell types they interact with). The laboratory has developed a variety of novel methods to generate purified cell cultures that allow direct study of molecular interactions between the cell types and has considerable expertise in identifying and purifying these molecules.

The event sfAWIS March Networking Social will be held from 6:30-8 p.m. on Wednesday, March 14, 2007 at The Pub at UCSF, Mission Bay, 1675 Owens St, San Francisco.  There is no charge to attend and no registration is required. 

The event Fourth Annual Counseling Workshop for Careers in Biotechnology and Medical Devices  will take place at Joe Rindone Regional Technology Center, San Diego County Office of Education, 6401 Linda Vista Road, San Diego, CA  92111 from 12-4 p.m. on Tuesday, March 13, 2007.  Program attendance is limited to career counselers and related professionals and registration is free (but required).  The program will provide of an overview of the industry and views from the "bench" and the "desk." 

The Second Annual Stem Cell Meeting will be held on March 12-13, 2007 at the Mission Bay Conference Center at the University of California, San Francisco.  This event is the premier international event bringing together world-renowned scientists at the frontier of embryonic and adult stem cell research with decision makers and thought leaders in policy, ethics, patient advocacy, finance, business, and media to explore the challenge and promise of the research and the compelling potential of emerging therapies.  The speaker list includes:

The event Clinical Trial Essentials--An Intensive Course  at the University of California Extension, Santa Cruz at the Cupertino Campus on March 12-16, 2007.  The program will examine the many facets of the clinical trial process.  The program instructors will include:

• EUGENIA BUDMAN, who has over 20 years of industry experience, in roles including clinical data management and programming, clinical operations, project management, finance, software installation and development. She is currently the manager of the Data Management, Biostats and Systems groups at Abbott Vascular.
• R. MICHAEL CROMPTON, J.D., M.P.H., who is a regulatory affairs professional with over 20 years of experience in the medical device industry. He has held senior management positions at medical device start-ups as well as multi-national medical device corporations and practiced law at a leading food and drug law firm.
• MICHAEL HUSTON, M.B.A., who is the president of Huston Associates, LLC, has more than 20 years of experience in the life science industry, from basic research to strategic drug development. Mr. Huston has directed project teams through preclinical evaluations, Phase 1-3 clinical studies, and numerous regulatory submissions.
• JACQUIE MARDELL, B.A., who has more than 20 years of pharmaceutical and biotech industry experience in both large and small companies. She has a broad background in planning, implementation and analysis of Phase 1-4 clinical trials and has lead teams in the preparation and execution of clinical development place in a wide range of therapeutic areas.
• JEAN MASONEK, RN, B.S.N., who has worked in drug safety for a large multinational pharmaceutical corporation and mid-sized and small biotech companies in the Bay Area. She is currently drug safety manager at a small pharmaceutical company on the peninsula.  
• FRANCES A. MCKENNEY, M.S., who is the director of GCP compliance at Genitope. Ms. McKenney has 20 years experience in the pharmaceutical/biotechnology industry working for both sponsor/manufacturers and a CRO.
• TAMMY MORTON-TAYLOR, M.S., who is a clinical project manager for Bailer Research, a contract research organization specializing in cardiovascular medical devices. She has 16 years of research experience, with more than 10 years devoted to coordinating, monitoring and managing clinical trials.
• NANETTE NANJO-JONES, M.B.A., who is the former director of contracts and proposals/business development for ICON Clinical Research, is now an independent outsourcing consultant. She has more than 12 years of experience in the biotechnology/pharmaceutical industry, from financial analysis to clinical-site budget negotiation and contracts management.
• EDWARD ROZHON, Ph.D., who is the senior manager of clinical trial management at Genentech and was formerly the associate director of development planning and program management at PPD Development. Dr. Rozhon has 18 years of pharmaceutical experience in preclinical and clinical areas of drug discovery and development.
• PETER SHABE, M.S., who is president of Advance Research Associates, Inc., a contract research organization (CRO) providing data-management and biostatistical services to medical-device, biotech and pharmaceutical industries.

The event Startup-U SFO: Building a Clear & Significant Product Roadmap with Eric Walcyzkowski will take place on Thursday, March 8, 2007 at 11:45 a.m. at DLA Piper Rudnick, 153 Townsend Street, Suite 800 San Francisco, CA 94107.  This program will address how entrepreneurs put together a clear product roadmap on how to get their products to market, focusing on the following:

• Defining the product that you would build to target that market
• Sizing the market
• Estimating the cost to develop and sell the product, and calculating a rough ROI
• How to take into account your team’s experience, and the learning curve
• Understanding the competition, and differentiation.

The featured speaker is Eric Walczykowski of Deloitte Ventures.  The registration cost is $5 (member) or $15 (affiliate/non-member), plus a $1.50 credit card processing fee, and includes event and lunch, available through advanced online registration. A $10 or $20 fee is collected at the door.

The event Nanotechnology in Drug Delivery-"How Close Are We?" will be held on Thursday, March 8, 2007 from 5:30-8:30 p.m. at Morrison & Foerster, 12531 High Bluff Drive, Suite 100, San Diego, CA  92130.   This program will discuss some of the highlights of the major nano-enabled drug delivery technologies that are commercially available or under development.  Participating speakers in the program will include Martin Woodle, Ph.D., Professor of Chemistry and Biochemistry, UC San Diego; Don Ackley, Ph.D., CEO, Nanotrop, Inc.; and Aartin Woodle, Ph.D., Chief Scientific Officer, Intradigm Corporation.

The event CALBIO/Annual Dinner 2007 will take place on March 6, 2007 from 7:00 - 9:00 p.m. at the San Diego Marriott & Marina, 333 W Harbor Drive, in San Diego, CA. CALBIO will provide a forum to learn from the experts and discuss best strategies for aligning FDA/CMS strategies. The topics include the following: 

• The Crucial Alignment between the FDA and CMS;
• Financing your Innovation from Global Sources; NIH Funding: Will the new Congress stop the trend of declining budgets?; and
• Drug Manufacturing: Quality Compliance, Process Execution and Manufacturing Excellence.

CALBIO will also present a first hand report from the world's top pharmaceutical companies of what exactly they are looking for in their upcoming licensing agreements, strategic partnerships, and acquisitions in 2007.

The event The 2nd Annual California Life Science Career Fair will take place on March 5, 2007 at the San Diego Marriott Hotel and Marina in San Diego, CA. This statewide career event will include the biotechnology, pharmaceutical and medical device industries, and it  will give job seekers the opportunity to meet face-to-face with the region's elite biopharmaceutical employers and interview for hundreds of open positions. BIOCOM and BioSpace will sponsor the event.

The event IBC’s 18th International Antibody Development & Production Successful Upstream and Downstream Processing Approaches will take place from February 28 – March 2, 2007 at La Costa Resort and Spa in Carlsbad, CA. This forum explores every critical stage of process and product development and is designed to help companies of all sizes accelerate their antibody therapeutic programs. The registration deadline for this event is December 15, 2006.  For more information, contact IBC at  800.390.4078 (telephone); 941.365.0104 (fax); reg@ibcusa.com.  The Priority Code is B4155BPIEM1.

The event Federal Circuit Judges Come to California will take place on February 27, 2007 at the Ritz-Carlton Marina del Rey, 4375 Admiralty Way in Marina del Rey, CA. The judges will provide a brief commentary on the latest initiatives of the Court, including technology enhancements. Topics will include:

• Decision Making and Effective Advocacy at the Federal Circuit;
• the New Federal Circuit Mediation Program;
• "What's Up with the Supreme Court?"; and
• Patent Litigation: Perspectives of the Trial Courts.
  
  
  

The event BAYBIO ADVANTAGE Molecular Medicine Tri-Conference will take place from February 27 - March 2, 2007 at Moscone Convention Center, in San Francisco, CA. Cambridge Healthtech Institute's Thirteenth Annual Molecular Medicine Tri-Conference and Exposition is considered one of the fast-growing pharma/biotech events on the west coast.

The event CHI's Third Annual Biomarkers in Preclinical Development will take place from February 27-March 2, 2007 at Moscone North Convention Center, in San Francisco, CA. The conference will address the extrapolation of findings from preclinical studies and the importance of carefully weighing biomarkers including imaging markers.

The event Calculating & Proving Patent Damages Conference will take place from February 26 - 27, 2007 at the Hotel Monaco in San Francisco, CA. This comprehensive two-day conference will provide tips and strategies that go beyond the usual courses of action for pursuit and defense in a patent infringement case. Program Co-chairs Alan J. Cox, Ph.D., NERA Economic Consulting, and Daralyn J. Durie, Esq.of Keker & Van Nest LLP, will lead a distinguished faculty of patent professionals including: David J. Silbert, Esq. of Keker & Van Nest LLP; Mark A. Lemley, Esq., Professor at Stanford Law School; and Michael R. O’Neill, Esq.of McDermott Will & Emery, LLP.

The event BIOCOM February Breakfast Meeting:  Getting Your Ship in Shape: Moving with the Currents will take place on February 22, 2007 from 7:00 - 9:00 a.m. at the Hilton Garden Inn, 6450 Carlsbad Blvd., in Carlsbad, CA. This meeting will address charting a destination such as:

• taking a business public;
• searching for a partner or looking to get acquired; and
• planning for other paths to commercialization.

The event Research Expo will take place on February 22, 2007 from 8:30 a.m. - 2:00 p.m. at the University of California, San Diego, in San Diego, CA. The Expo will provide an inside look at the latest technology advancements from bioengineering, bioinformatics, and nanotechnology to high speed communications and RF MEMS. The Jacobs School of Engineering Research Expo will include research poster exhibits by more than 200 M.S. and Ph.D. students, technical breakout sessions led by engineering faculty, and a luncheon featuring remarks by Alan Eustace, Google VP of Research and Systems Engineering.

The event Partnering and Outsourcing Models in Biology and Preclinical R&D will take place from February 20 - 21, 2007 at the San Diego Marriott Mission Valley in San Diego, CA. The conference will present ideas in practical tools to find, manage, and execute successful outsourcing/partnerships in biology, preclinical R&D, and chemistry , and will also feature a service provider showcase.

The event Business to Business: Networking Extravaganza will take place on, January 31, 2007, from 6 p.m. - 8:30 p.m. at the Santa Clara Valley National Bank, One North Market St., in San Jose, CA. This NAWBO event provides Silicon Valley Women Business Owners with opportunities to meet and network. Register by Monday, January 29, 2007.

The event Law Seminars International presents Biotechnology 2007 will take place on January 29-30, 2006 at Crowne Plaza Union Square in San Francisco, CA. This year's update on the key legal and business issues facing the biotech industry will cover topics such as how state legislation and research programs are layering on top of the federal ones; stem cell research; and new developments in the area of the generic follow-on products.

The event High-Content Analysis 2007 will take place from January 24-25, 2007, at The Fairmont Hotel: 950 Mason Street, in San Francisco, CA. This event is a comprehensive coverage of high-content analysis applications and technologies. The Intro-Net offers the opportunity to set up meetings with selected attendees before, during and after this conference, allowing to connect to key people.