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Audrey’s Life Science Meeting Picks for Jan. – Feb. 2010 (Jan. 6th Edition) ********************************************************** qed@qb3-UCSF, Entrepreneurs' Luncheon Seminar, Thursday, Jan. 7, 2010 Topic:” The Value of Versatility for an Engineer Leading a Startup” Speaker: Shyam Patel, Ph.D, Chief Science Officer for NanoNerve, Inc. Date and Time: 1/7/10, 12:00 to 1:00 pm Location: UC San Francisco, Byers Hall Room 212 Topic Description A hallmark of startup medical device companies is a small team of people performing a myriad of functions from R&D to fund raising and even plumbing. How am I supposed to design and test new products while writing patent applications, setting up computer networks, pitching to investors, researching markets and fixing the restroom all at the same time? As an engineer trained to focus on a specialized function, it can be especially challenging to wear multiple hats at once. At the same time, it is never routine and always incredibly rewarding. This talk will explore a BioEngineer's transition to an entrepreneurial role and the lessons learned along the way. Speaker Bio Dr. Shyam Patel is currently the Chief Science Officer for NanoNerve, Inc. a medical device startup in Fremont, CA. He's leading the R&D and development projects at NanoNerve for nerve, dura mater and fascia regeneration products. He obtained his Ph.D. in Bioengineering from the UC Berkeley and UCSF Joint Program in Bioengineering. As a Ph.D. student he researched novel tissue regeneration strategies involving nanofiber scaffolds, stem cells and bioactive factors. NanoNerve's core technology was spunout from Shyam's dissertation research on nanofiber scaffolds. Cost: No Cost Lunch provided, but space is limited so please reserve a seat at Register at http://www.acteva.com/booking.cfm?bevaID=195276 ********************************************************************** SVASE, Thursday Evening, Jan. 7, 2010 Event: “Angel investors to the rescue?” · Amy Paye, Partner, Cooley Godward Kronish LLP · Carol Sands, Founder & Managing Member, The Angels’ Forum and The Halo Funds 1 6/15/2022

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Page 1: Audrey’s Selected Meeting List for January 2008 · Web view... preparing data for submission using CDISC SDTM standards, tables, listings and figures for electronic submission;

Audrey’s Life Science Meeting Picks for Jan. – Feb. 2010(Jan. 6th Edition)

**********************************************************qed@qb3-UCSF, Entrepreneurs' Luncheon Seminar, Thursday, Jan. 7, 2010

Topic:” The Value of Versatility for an Engineer Leading a Startup”Speaker: Shyam Patel, Ph.D, Chief Science Officer for NanoNerve, Inc.Date and Time: 1/7/10, 12:00 to 1:00 pmLocation: UC San Francisco, Byers Hall Room 212

Topic DescriptionA hallmark of startup medical device companies is a small team of peopleperforming a myriad of functions from R&D to fund raising and even plumbing.How am I supposed to design and test new products while writing patentapplications, setting up computer networks, pitching to investors,researching markets and fixing the restroom all at the same time? As anengineer trained to focus on a specialized function, it can be especiallychallenging to wear multiple hats at once. At the same time, it is neverroutine and always incredibly rewarding. This talk will explore aBioEngineer's transition to an entrepreneurial role and the lessons learnedalong the way.

Speaker BioDr. Shyam Patel is currently the Chief Science Officer for NanoNerve, Inc. a medical device startup in Fremont, CA. He's leading the R&D and development projects at NanoNerve for nerve, dura mater and fascia regeneration products. He obtained his Ph.D. in Bioengineering from the UCBerkeley and UCSF Joint Program in Bioengineering. As a Ph.D. student he researched novel tissue regeneration strategies involving nanofiber scaffolds, stem cells and bioactive factors.NanoNerve's core technology was spunout from Shyam's dissertation research on nanofiber scaffolds. Cost: No CostLunch provided, but space is limited so please reserve a seat atRegister at http://www.acteva.com/booking.cfm?bevaID=195276**********************************************************************SVASE, Thursday Evening, Jan. 7, 2010

Event: “Angel investors to the rescue?”·   Amy Paye, Partner, Cooley Godward Kronish LLP·   Carol Sands, Founder & Managing Member, The Angels’ Forum and The Halo Funds·  Steve Schneider, Board Director, Sand Hill Angels·   Ron Weissman, Member, Band of Angels and Venture Partner, Apax Partners 

Moderator: Ron Schneidermann, Co-founder, Liftopia.comDate and Time: Thursday, January 76:00 - 7:00 pm: Networking and hors d’oeuvres7:00 - 8:15 pm: Panel discussion and Q/A8:15 - 8:30 pm: Additional networking Location: Cooley Godward Kronish LLP, 3175 Hanover Street, Palo Alto, CA 94304 Pre-registered Rates (All Rates Include Hors D’oeuvres):Members - $20; Affiliates who advertise this event - $29; General Public - $49

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Pre-registration closes at 9 PM the night before the event. Walk-in Rates: Add $10.00 to the listed price This event is co-sponsored by Cooley Godward Kronish LLP, http://www.cooley.com Seating is limited, so early registration is recommended to avoid disappointment on the day.

Register at http://www.acteva.com/booking.cfm?bevaid=193888

Topic DescriptionWith public markets in the midst of recalibrating, are Angel investors down for the count, or will they stay in the game and ride the wave back to economic recovery? According to long-time angel “god-father”, Ron Conway, Baseline Ventures, they are still actively looking at funding pitches and have money for promising start-ups. So while over-extended Venture Firms have downsized & their portfolio companies are doing more with less, Conway still feels it's a great time for entrepreneurs to start companies, and for Angels to invest in capital efficient startups. Do other Angels feel the same way, or are they hiding out in the hills till the good times return? Come meet with and hear leading angel investors in a lively exchange as they explore trends and provide insights on the following critical questions: 

• How have the dynamics and metrics of Angel investing changed in the past 12 months?

• What’s happening to valuations & how much equity are Angels now looking for?• What does a startup need to look like to be attractive for Angels today?• What investment instruments do they prefer & what involvement do they want?• How are Angels working with Venture Capitalists for the next round of funding?• What technology sectors are most attractive to Angel investors right now?

  Speaker Bios Amy Paye, Partner, Cooley Godward Kronish LLPAmy Paye is a partner in Cooley Godward Kronish's Business department. She has been with the Firm since 2008 and is resident in the Palo Alto office.Her practice includes the representation of issuers and venture capital investors in the formation and financing of emerging companies in a broad range of industries (though with a focus in life sciences) as well as counseling such emerging companies with respect to mergers and acquisitions, strategic relationships and general corporate matters.  She also has substantial experience in representing public companies with respect to their reporting requirements, corporate governance obligations, public offerings and various other financing and strategic transactions. Prior to joining Cooley, Ms. Paye practiced corporate and securities law in the Corporate/VLG practice group of Heller Ehrman LLP in Menlo Park, CA from October 2003 to October 2008. Prior to that, Ms. Paye was at Venture Law Group in Menlo Park, CA. Prior to joining Venture Law Group in May 1997, Ms. Paye was an associate at Morgan, Lewis & Bockius LLP in Miami, FL.  Carol Sands, Founder & Managing Member, The Angels’ Forum and The Halo FundsCarol Sands, 55, is the Founder and the Managing Member of The Angels’ Forum and The Halo Funds.  She has spent the last 35 years with investing, entrepreneurial, and/or large corporate institutions. Carol’s career started in the Midwest where she was a bank officer with First Bank Systems and held marketing or sales positions with Motorola and Xerox Computer Services.  After moving to San Francisco, she was hired into executive positions at Arthur Young (now Ernst & Young) and Coopers & Lybrand (now PricewaterhouseCoopers). 

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Then Carol founded Sands MarketingPlus, an international sales management and marketing consulting firm with advertising & PR agencies.

Steve Schneider, Board Director, Sand Hill AngelsSteve Schneider is Co-Chair of the Deal Management and Screening Process for Sand Hill Angels.  Most recently, from November 2004 to mid-January 2006, Stephen served as President and CEO of EnviroSystems, Inc. (ESI) where he continues as a Director. After serving as mentor to the prior CEO during the 2004 Springboard process and subsequent Stanford event, the ESI board asked Stephen to assume command in order to refinance and turn the company around. In 3 1/2 months, starting with only $5K in cash, Stephen re-positioned the company taking it public in January 2006 through a reverse triangular merger with an $8.5MM PIPE offering that retained 40% ownership in the surviving company in favor of the ESI Preferred holders.  Prior to turning ESI around, Stephen founded Molecular Delivery Corporation (MDC) in 1998 and ran it as CEO through conception, initial development and patenting of novel technology, which enables systemic administration, through the lungs, of a wide range of pure pharmaceutical compounds in their vapor states. In mid-December 2001 Stephen then merged MDC with Alexza, a company founded in 2000 by Alex Zaffaroni, to form Alexza Molecular Delivery Corporation (Alexza MDC, now known as Alexza Pharmaceuticals, Inc.) securing an additional $9M Series B investment from Alex. Stephen ran Alexza MDC as President and COO until mid-2003, but remained on the board until December 2005 when he retired upon the filing of the company’s S-1 announcing its intended IPO. Prior to MDC, from 1985 to 1989, Stephen served as Director of Corporate Development (Marketing and Sales) at Corus Medical Corporation, a start-up company which stored autologous blood for patients anticipating transfusions.

Ron Weissman, Member, Band of Angels and Venture Partner, Apax PartnersRon Weissman is a member of Band of Angels and a Venture Partner with Apax Partners where he joined the firm in 2000. Weissman has more than twenty-five years of experience in high technology operations and marketing. Prior to joining Apax Partners, he was Vice President of Strategy and Corporate Marketing for Verity, a global leader in corporate information retrieval software. During his tenure, Verity's executive team was awarded the large company turnaround of the year (1999) by the Turnaround Management Association and the company saw its market capitalization grow from under $50 million to more than $1.5 billion, and was listed two years running among the top ten technology stocks by the New York Times. Ron Schneidermann, Co-founder, Liftopia.comRon Schneidermann is the Co-founder of Liftopia.com, a niche travel website focusing specifically on applying airline-style pricing (yield management) and centralized distribution throughout the ski industry. Liftopia resort partners have the ability to adjust pricing up and down in real-time based on the quality of snow, day of the week, price of airfare/gas, and other demand components. Liftopia.com launched in October 2006, and since then has grown from 7 resort partners to over 100 today.  Liftopia raised a Series A round of funding in March 2008 led by Sand Hill Angels. Erik Blachford, former CEO of Expedia, joined the round along with North Bay Angels and several individual Angel investors. In September of 2009, Liftopia raised a $1mm Series B round. This time around it was led by Erik Blachford and Amicus Capital, and joined in by Sand Hill Angels, North Bay Angels, and several individual investors. *************************************************************Foley Webinar, Friday Morning, Jan. 8, 2010

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Date and Time: Friday, January 8, 20109:30 a.m. Pacific

Register Today

The 1 hour program is complimentary, but pre-registration is required. Participation is limited, so register today. Foley will request 1 hour of CLE credit for participants.

For more information, please contact Melissa Roth at [email protected] or 312.832.5786.

Learn more about this and other Health Care Friday Focus Web conference programs at Foley.com/fridayfocus.

Topic Description

Recently, the federal government announced that it had identified $98 billion in improper Medicare and Medicaid payments for Fiscal Year 2009. President Obama and Democratic leaders say that wiping out waste and fraud in Medicare will reduce government health care costs by several billion dollars. Consistent with these messages, the government has announced repeatedly that it is significantly stepping up its enforcement efforts, which include:

Recent revisions to the federal False Claims Act The onslaught of audits under the Medicaid Integrity Program and the permanent Recovery

Audit Contractor program The formation of the cross-department Health Care Fraud Prevention and Enforcement

Action Team (HEAT) The government's active promotion of health care enforcement recoveries as the funding

mechanism for additional costs under health care reform

Join us for this Friday Focus Web Conference as Foley Partners Judith A. Waltz and Cheryl L. Wagonhurst summarize the federal government's recently enhanced enforcement efforts and provide substantive steps that health care entities should take to prepare for this increased government scrutiny.

Topics include:

The government’s focus and targets in eliminating fraud and waste from the Medicare and Medicaid programs

How data mining is and will continue to be used in the government enforcement efforts  Five key steps that health care entities can take now in order to reduce their risks and

prepare for the increased focus on operations and billing

******************************************************EPPIC 2010 Annual Conference, Sunday, Jan. 10, 2010

Topic: “Emerging Trends and Opportunities in Life Sciences”Date and Time: Sunday, Jan. 10, 2010, 7:00 am – 7:00 pmLocation: Crowne Plaza-Cabana Hotel, 4290 el Camino Real, Palo Alto, CARegister at http://www.acteva.com/booking.cfm?bevaid=194194Cost:

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Early Bird Registration: $100 (ends on Dec 27th, 11.55 PM) Advance Registration: $125 (Dec 28 - Jan 6th, 11.55 PM) On site Registration: $150 (Jan 7th - Jan 10th till 2 PM)

Topic DescriptionThe EPPIC annual life science conference combines networking, mentoring and keynote lectures and panel discussions on current topics. The annual conference also focuses on promoting cross-border (US-India) collaborations and attracts multiple individuals and organizations interested in leveraging potential synergies. This year’s panels -- personalized medicine, bio-similars, medical devices and life science funding will give attendees a good grasp on the latest trends in industry. For the first time, the conference will host a speed networking session and a career workshop. The conference brings budding and seasoned entrepreneurs, senior executives, scientists, venture capitalists and legal experts, together to tell their stories and will attract potential partners, employers and investors.

See full, detailed agenda at http://www.eppicglobal.org/

*************************************************************Free UCSC Ext. Program Overview, Monday Evening, Jan. 11, 2010

Event: Program Overview for Biotechnology, Bioinformatics and Bioscience Business and MarketingDate and Time: Monday, Jan. 11, 2010, 6–8:30 pmLocation: UCSC Extension Classroom, 2505 Augustine Drive, Santa ClaraNo fee, but enrollment required.16649-010 (use course-section number to enroll)Register at http://www.ucsc-extension.edu/biosciences--click on enroll now

DescriptonAre you interested in learning about the Bioinformatics, Biotechnology, and BioscienceBusiness and Marketing certificate programs, and about careers in these fields?This free information session provides an opportunity to meet instructors and otherstudents, learn about program prerequisites, course content and program requirements, andsee how these programs can help you advance your current career or break into a new field.

See new downloadable catalogue of bioscience courses at http://www.ucsc-extension.edu/biosciences at bottom of page. This is separate from entire general catalogue on left side of page.

*********************************************************************UCSF Center for BioEntrepreneurship, Monday Early Evening, Jan. 11, 2010

Topic: “State of the Biotech Industry: Biomedical Innovation” Speaker: G. Steven BurrillDate and Time: Monday, Jan. 11, 2010, 4:30-6:00 pmLocation: UCSF Mission Bay Campus (Genentech Auditorium), 600 16th Street (Genentech Hall Auditorium),San Francisco, CA 94158Cost: $10Register at http://www.acteva.com/booking.cfm?bevaID=194226

Event DescriptionG. Steven Burrill, G.Steven Burrill, CEO of Burrill & Company, will provide an overview of the transformation taking place within the industry and predict critical developments.

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Join us for an expansive view of scientific events and an annual look into the state of the biomedical industry.

Reception sponsored by Alexandria Real Estate Equities (1700 Owens Street, San Francisco CA 94158) across the street from Genentech Hall from 6:00 PM to 7:00 PM.*****************************************************************JP Morgan 28th Annual Healthcare Conference, Jan. 11-14, 2010  

J.P. Morgan is pleased to announce the 28th Annual Healthcare Conference, January 11-14, 2010 at the Westin St. Francis in San Francisco.

This event is the premier conference of its kind, bringing together established industry leaders, emerging fast-growth companies, innovative technology creators and globally minded service providers.  This year we expect more than 300 companies, both public and private, to deliver presentations to more than 3,500 investors.  The format is 30 minute presentations followed by 30 minute Q&A sessions in a separate room.

To receive an invitation to this event, please contact your J.P. Morgan representative.

Please remember that all J.P. Morgan conferences are by invitation only.  Invitations are non-transferable and attendees must be pre-registered to attend.

_______________________________________________________________

JP Morgan 28th Annual Healthcare Conference, Jan. 11-14, 2010 Webcast

Many companies have elected to webcast their presentations during the conference, available (no password required) at: http://metameetings.com/webcasts/jpmorgan/healthcare10/. You will be able to click on conference and register to access the webcasts. They start on Monday, Jan. 11th (NOT Before) at 8:00 am.

Instructions for Access

You will be able to join webcast for selected live webcasts, January 11-14, 2010. Recorded webcasts will generally be available for at least three months, except where noted otherwise.

If you need to install Windows Media Player, please visit Microsoft's Windows Media Download Center and follow the instructions. If you need to install Adobe Flash Player, please visit the download site for Adobe Flash Player and follow the instructions there. For more information on system, browser, and media player issues, please see the Technical Help section.      If your Web browser does not automatically update its display to let you access the most current webcast or information, please use your browser's refresh/reload command.

**********************************************************************

OneMedPlace, Tuesday and Wednesday, Jan. 12-13, 2010

Event: OneMedPlace Finance Forum for Medical Devices and Therapeutics

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Date and Time: Tuesday-Wednesday, Jan. 12-13, 2010Location: Sir Francis Drake Hotel, Union Square (across the square from JP Morgan Conference)Its unique format of sector-oriented panel discussions, company presentations and investor meetings is designed to connect CEOs with appropriate institutional, venture and private investors.Conference Program Included in the conference ticket: 1. Full access to all sessions, luncheons and receptions.2.Conference workbook and research report.3.Trial subscription to ( New Companies & Technologies Report ).

Qualified Investors: We have a limited number of complementary tickets for qualified venture and institutional investorsand research analysts to attend panel discussions and company presentations. Please click here to submit your information. Registration Information: Space is limited for the event. Ticket prices will increase with time. Ticketholders must make their own reservations. We have not reserved any rooms for guests. Ticket price does not include price of your hotel room.Ticketholders must make their own reservations. (Purchase ticket to one session and get second session ticket at 50% off.) Ticket Rates (details)

Devices/Therapeutics(Tues/Weds)

Healthcare Information

Day(Thursday)

Both

Qualified Investor $250 $250 $375A member of recognized professionalinvestment group. (more)

Emerging Company Executive $495 $495 $750Executives of emerging companies inhealthcare or life sciences. (more)

Service Provider $1495 $1495 $2250Those attending event to meet prospectiveclients. (more)

Early Bird Registration Ends January 4th, 2009

Register at https://secure.hcid.net/conference/

Event DescriptionHeld annually in San Francisco, the OneMedPlace Finance Forum was created to connect emerging healthcare and life science companies with investors and strategic partners. Over 100 company presentations will occur by some of the most promising - and typically least recognized - companies in the world. Recognizing the impacts and opportunities connected to healthcare reform and the stimulus package, we have added a third day dedicated to Health Information. Join us at The Sir Francis Drake Hotel, as it will be the destination for those who are interested in emerging healthcare and life sciences companies.

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Expert Panels & Private Companies Expert panels offering insights from leading investors and clinicians will be followed by crisp 8 minute company presentations.Promising Small Public Companies Some of the most promising small public companies will present on dedicated tracks for biotech/specialty pharma and medical devices.Networking & One-on-One Sessions We have 7 floors of this historic hotel, including conference rooms, reserved for investor meetings. Receptions will be held each evening.OneMedTV - Internet Video OneMedTV will be producing videos on all companies and panels. This content will be made available to conference attendees.

Leading investors and experts will discuss the outlook and opportunities for investors and entrepreneurs in six areas of health and medicine.

Obesity & Metabolic Disorders. This panel will discuss a broad range of prophylactic and interventional strategies for bringing new therapies to obesity-related patient care.

Diagnostics & Personalized Medicine. This panel will explore the changing world of diagnostics, focusing on the product areas and business models that have made this such a hot area for investors.

Neurology. This panel will discuss basic science, development costs, regulation, and IP rights, along with an exploration of scenarios for new neurological product development.

Cardiology. This panel of experienced medical and business professionals will describe what is on the cardiac care horizon.

Oncology. This panel will discuss oncological product development in the context of recent changes in financial markets, regulatory processes, and IP law.

Ophthalmology. This panel of financial experts will focus on investment opportunities, IP protection, and market strategies in ophthalmologic health care.

********************************************************

Biotech Showcase 2010, Tuesday and Wednesday, Jan. 12-13, 2010

Event: Biotech Showcase™ 2010 RegistrationDates: Tuesday and Wednesday, 2010Location: Marines' Memorial Club & Hotel, 609 Sutter Street, San Francisco, California 94102-1027 USA, T: +1 415 673 6672, F: +1 415 441 3649

Registration guidelinesAll participants in Biotech Showcase™ 2010 are required to register. Participants are welcome to register on site. General attendees are required to pay a fee. Investors and research analysts may register on a complimentary basis.

Registration fees and categories  By January 11, 2010 On-site Registration

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Member Rate* Registration USD 550 USD 650

Non-member Registration USD 650 USD 750

Investors/Research AnalystsQualified investors and analysts will receive complimentary registration. Click here for registration eligibility.

*Member Rate: In order to qualify for the member rate, you must be a member of a supporting biotechnology association. No retroactive member discounts will be granted. Please note your association affiliation at the time of registration.

Investors and analysts:Qualified investors and analysts will receive complimentary registration. A qualified investor is an institutional or venture investor. Buy-side and sell-side research analysts qualify for the complimentary registration. The producers reserve the right to determine if you qualify for this category. Click here for more information.

Event DescriptionPrivate and public biotechnology companies will be showcased in individual presentations during the course of the event. Investors interested in private and public companies are invited to join this unique gathering, with the opportunity to meet in one place at the Marines' Memorial Club and Hotel, located one block from the Westin.ObjectiveBiotech Showcase, which is focused on biotechnology, will provide private and public presenting companies an opportunity to present to an audience of investors and biopharmaceutical business development executives during the course of the largest annual healthcare investor conference.ProgramThe two-day program will feature multiple tracks of presenting companies, plenary sessions, an opportunity to schedule one-to-one meetings and networking.

Plenary Speakers for 2010 (as of October 8, 2009) Karen Bernstein, BioCentury Publications Frederick Frank, Peter J. Solomon Company Evan McCulloch, Franklin Resources Dennis Purcell, Aisling Capital

AttendeesThe attendees for the event will include private and public equity investors, analysts, bankers, biopharmaceutical industry executives and other industry professionals. Register for Biotech Showcase.

AttendeesThese fees apply to all other attendees including non-presenting executives of biotechnology companies, pharmaceutical executives and professional service providers. Professional service providers include investment bankers and representatives of law, accounting, consulting, academic and economic development organizations.

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BayBio: Impact 2010 Launch, Tuesday Morning, Jan. 12, 2010

Speakers: Gail Maderis, Acting CEO, BayBio Pierre Cassigneul, President & CEO, XDx Inc. Tony Coles, President & CEO, Onyx Pharmaceuticals Paul Hasting, President & CEO, OncoMed PharmaceuticalsDate and Time: 9:30am - 11:00am, Tuesday, January 12, 2009Location: Grand Hyatt at Union Square, San Francisco RSVP: 650-871-7101x207 or [email protected] Seating is limited. Please RSV

Topic DescriptionThere are currently 233 treatments and cures in phase III in California's pipeline and companies are expected to invest $50 billion in new facilities, equipment and employees. California’s influential federal legislative leaders are receptive to their local constituents on several issues including healthcare and patent reform, giving BayBio a disproportionate influence over these affairs. In addition, the state's local elected officals are making a consious effort to capture this unprecedented opportunity. At the launch of BayBio: IMPACT 2010, life sciences leaders will present a strategic action plan to capture this massive investment in the State of California.The BayBio: IMPACT report is the preeminent, in-depth report on the state of California's life sciences industry and its productivity. No other report measures the number of treatments, cures and technologies measured in BayBio: IMPACT and no other comprehensive report identifies each company and its development pipeline.At the launch event during JP Morgan, life sciences executives will provide a perspective on innovation and the challenges of developing new treatments and cures in California.**********************************************************************

Bio2Device Group, Tuesday Evening, Jan. 12, 2010

Topic: “A Career Journey within BD”Speaker: Peter Ferrigno, Vice President Sales and Services, Cell Analysis,  BD Biosciences Date and Time: Tuesday, Jan. 12, 2010, 6:00 – 9:00 pmLocation: TIPS Group Law Offices , 1000 Elwell Court, Palo Alto, CA 94303Advanced registration is required see bio2devicegroup.org website for details a week prior to event.Cost: Fee for light dinner with range depending on timing of registration:Cost:$6 - Students/In-transition - Members only- ONLY UNTIL Midnight Sunday$11 - Early-bird Registration - Members only- ONLY UNTIL Midnight Sunday$20 - Late Registration and Non-Members$25 - Walk-insRegister at www.Bio2DeviceGroup.orgAttention B2DG members: You must login to your account first to see theEarly-Bird admission rate- which ends at midnight Sunday.

Topic DescriptionPeter will provide an overview of his career in the various BD business units, and what has changed over the years. He will then discuss BD Bioscience's products and focus for 2010 and beyond.

Speaker Bio

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Peter Ferrigno has spent his 30-year career at Becton Dickinson. He has held leadership roles in virtually every function and business unit within the company, including sales, marketing, logistics and distribution. He served as the GM for BD's home health business. Two years ago, Peter was relocated to the bay area to assume the role of Vice President Sales and Services, Cell Analysis for Becton Dickinson. Peter has an MBA in Marketing Management from NYU and a B.S. in Economics and Business with a minor in Biology from Niagara University.*****************************************************************Free UCSC Ext. Program Overview, Wednesday Evening, Jan. 13, 2010

Event: Clinical Trials and Regulatory Affairs Program PresentationDate and Time: Wednesday, Jan. 13, 2010, 6–8:30 pmLocation: UCSC Extension Classroom, 2505 Augustine Drive, Santa ClaraNo fee, but enrollment required.16650-010 (use course-section number to enroll)Register at http://www.ucsc-extension.edu/biosciences--click on enroll now

DescriptonAre you interested in learning about the Clinical Trials and Regulatory Affairs certificate programs, and about careers in these fields? This special information session provides an opportunity to meet instructors and other students, learn about program prerequisites, program philosophy, course content and program requirements, and gain insights into careers in clinical research and regulatory affairs.

See new downloadable catalogue of bioscience courses at http://www.ucsc-extension.edu/biosciences at bottom of page. This is separate from entire general catalogue on left side of page.

*********************************************************************San Francisco AWIS, Wednesday Evening, Jan. 13, 2010

Event: sfAWIS Bimonthly Networking SocialDate and Time: Wednesday, January 13, 2010, 6:30-8:00PMLocation: Bissap Baobab, 2323 Mission St., San Francisco, CACost: Free and no registration required

Event DescriptionBe a part of sfAWIS' cozy and diverse bimonthly Networking Socials--conveniently located at Bissap Baobab in the Mission. We provide opportunities for both open and structured networking. ********************************************************Bio2Device Group, Tuesday Morning, Jan. 19, 2010

Topic: “How Companies Identify 'A' Players and Positioning Yourself for the Role you Really Want “Speaker: Laura Raynak, Raynak Executive SearchDate and Time: Tuesday, Jan. 19, 8:30 – 10:30 amLocation: Sunnyvale City Council Chambers, 456 W. Olive, Sunnyvale, CA (across the street from Sunnyvale Public Library)Cost: FreeParking: On street and in NOVA and library parking lots across the street.Cost: FreeNo registration required.

Topic Description

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How to Be the Person Everyone Wants to HireHave you ever wondered why some people – who are not technically capable get hired over those with more skills and experience? How about the person who got promoted or kept in the last round of layoffs at your company? We could blame it on age discrimination or keeping people who make less than we do, but it really goes deeper than that. In this session we will explore what attitudes, behaviors, skills and attributes that you can develop while in your job hunt and in your next position that will land you a winning role more quickly.Some of the things we will cover:1. Image management2. Effective communication style3. Winning attitudes4. Demonstrating competency and ability to get along with others in an interview setting5. Building advocate and support relationships to help you land that job more quickly6. Staying organized and motivatedThese same attitudes, skills and behaviors can be employed once you land that dream job, and help keep you there, working on interesting projects, and gaining promotions, too.

Speaker BioLaura Raynak is a Managing Director at Raynak Executive Search, a twelve year old firm with a distinguished track record of successful executive management search in medical technology, life sciences and healthcare services companies. Some of her clients have included: St Jude Medical, J&J, VasoNova, Voyage Medical, Stanford BioDesign, Vivo Ventures, Genomic Health, Varian Medical Systems, Illumina, Affymetrix, Chemdex, Insight Health, and others- both public and private.Laura has made executive level management placements all areas of executive management including Board of Directors, C-level and functional Vice Presidents in Sales and Marketing, Engineering / R&D, Operations, Clinical and Regulatory Affairs, Human Resources, and technical positions. She has also developed and executed successful recruitment campaigns to find one-of-a-kind candidates for clients with unusual technical needs. Laura's work reflects her head for science and heart for people, her attention to detail while envisioning the big picture, her finely-honed instincts about people and leadership. Laura earned her BA degree in Biochemistry and Molecular Biology from the University of California, Santa Cruz; she also holds a Certificate in Human Resources Management from the University of California. Laura is a past board member of the Northern California Human Resources Association, Institute of Management Consultants, and American Diabetes Association and is an active member of numerous associations throughout the San Francisco Bay Area. Laura is the publisher of many articles on executive recruitment, and is a lecturer at University of California Santa Cruz, Extension in Biotechnology Marketing.**********************************************************************Stanford Cancer Center and NCI workshop, Tuesday Morning, Jan. 19, 2010

Topic: “Integrating Glycomics with Other Omics in Cancer Detection and Diagnosis”Date and Time: Tuesday, Jan. 19, 2010, 8:30a.m. - 5:30p.m Location: Stanford Cancer Center, Bechtel Conference Center, in Encinal Hall.No cost but must register via the conference link at http://www.omicsonline.org/Conferences/NCI2010/Registration.html

Topic Description"Integrating Glycomics with Other Omics in Cancer Detection and Diagnosis" will present a full agenda of NCI invited speakers distinguished in the fields of tumor glycomics and

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stem cells. The second day of the workshop will be a closed meeting for the Alliance members, to be held at SRI International.**********************************************************************Personalized Medicine World Conference, Tuesday and Wednesday, Jan. 19-20, 2010

Event: “Personalized Medicine: The Next Wave Of Innovation!What Is Available NOW?”Date and Time: Tuesday, January 19, 2010 at 9:00 AM - Wednesday, January 20, 2010 at 4:00 PM (PT)Location: Computer History Musuem, 1401 N Shoreline Blvd, Mountain View, CA 94043Cost: $500 through Dec. 30th, then $650 and $750 at doorRegister at www.pmwc2010.com

Event DescriptionPresented by Stanford Hospital and Clinics & Silicom VenturesYou are cordially invited to this exclusive conference that will feature industry experts and exhibits during this two-day educational and business conference.

The program consist of prominent speakers and panelists that will discuss topics such as: The impact of new genomic and proteomic technologies on diagnostics and

therapeutics in cancer and other major diseases The new challenges policy makers and regulators are facing keeping up with the

rapid advancements and availability of new molecular tests How the established biotechnology and pharmaceutical companies adopt their

strategy to personalized medicine What are the new opportunities that are emerging for investors and

entrepreneurs Continuing education units available

A technology showcase will feature select companies recognized for their breakthrough products and services. In addition we will hold a company competition that will showcase selected companies and top 5 finalist companies.

See Personalized Medicine article at  http://pwchealth.com/cgi-local/hregister.cgi?link=reg/personalized-medicine.pdf***************************************************************Deloitte Recap Free Webinar, Tuesday Morning, Jan. 19, 2010

Topic: “Leading Practices in Co-Promotion Alliances”Date and Time: Tuesday, Jan. 19, 2010, 10:00-11:00 AM PacificRegister for Recap’s free, live webinar on January 19th at http://www.recap.com/webinars

Webinar DescriptionWhat are leading practices in sales compensation and governance in regional in-market or late-stage co-promotion alliances? Learn how to incorporate these structures into early-stage and collaboration deals as well. We’ll explore:

Trends in co-promotion compensation, including use of Baseline Sales Diligence requirements & corrective mechanisms Change of control and dispute resolution provisions Use of residual commissions post-termination

Who should attend: Biopharma corporate executives

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VCs and investment banks Business development CFOs and financial executives Legal

Detailed information. At http://www.recap.com/webinars*************************************************************CABS, Tuesday Evening, Jan. 19, 2010

Seminar & Round-Table: “13 Mistakes Entrepreneurs Should Avoid” Date and Time:   Tuesday Evening, Jan. 19, 2010, 7:00 - 9:00 pm Location:   Foster City Recreation Center (650 Shell Blvd, Foster City, CA 94404); Crane Room Cost:   $1 Online; $5 on-site Register at http://www.cabsweb.org/CABSweb/feventslist.jsp?id=81#***********************************************************UCSC Ext., Molecular Biology, Introduction, Jan. 19 – March 6, 2010

Course Description:This course provides a comprehensive introduction to molecular biology for non-biologists and a review for those who want to refresh and update their knowledge of this subject. Topics include an introduction to fundamental concepts of genes and proteins, the central dogma, and the genetic code; the structure and function of genes; gene expression, transcription and translation; protein structure and function; introduction to genetics; Mendelian analysis; molecular and population genetics, genetic markers and maps; and the impact of modern molecular biology on science and medicine. The course includes an overview of experimental methods used in molecular biology, such as recombinant DNA, PCR, gene cloning, and gene expression analysis.Instructor: RAXIT J. JARIWALLA, Ph.D.Dates and Times: Tue 6:00PM to 9:00PMJan 19, 2010 to Mar 02, 2010 Sat 1:00PM to 4:00PMJan 23, 2010 to Mar 06, 2010 Number of Sessions: 10Location: UCSC Ext. 2505 Augustine Drive, Santa ClaraTuition: $560 (Early Enrollment Fee: $504 through Jan. 5See details at www.ucsc-extension.edu/biosciences

***************************************************************UCSC Extension, Regulation of Medical Devices and Diagnostics, Jan. 19 – April 13, 2010

Course DescriptionMedical devices encompass a broad array of products, ranging from the simple tongue depressor to surgically implanted stents and pacemakers. This course provides individuals from all backgrounds with a solid grounding in the laws, regulations and institutions that underlie the process of medical device and diagnostic product development and marketing. Starting with the definition of medical devices, an overview of the medical device industry, and the historical roots of medical device regulation, the instructor lays a foundation for understanding the unique aspects of medical devices and the pathways through which various classes of products are moved into the U.S. marketplace. Through lectures and case studies, students gain in-depth exposure to key routes to market, including 510(k) premarket notification and premarket approval applications (PMA). The instructor provides insight into the rationale and strategies for using each of these paths and others, including product development protocol (PDP) and

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reclassification. Also addressed are the pre-clinical and clinical testing of devices, as well as the investigational device exemption (IDE) application and process. There will be some coverage of international laws and regulations, particularly as they relate to the U.S. counterparts. The instructor also details post-marketing issues, including recalls, corrections and removals, as well as medical device surveillance and reporting requirements. Finally, he highlights topics of current interest in the industry, including combination products.Instructor:   R. MICHAEL CROMPTON, J.D., M.P.H.Dates and Times: Tue 6:00PM to 9:00PMJan 19, 2010 to Apr 13, 2010 Number of Sessions: 10Tuition: $715 (Early Enrollment $643.50See details at http://www.ucsc-extension.edu/programs/regulatory-affairs/courses

*************************************************************** BioScience Forum, Wednesday Evening, Jan. 20, 2010

Topic: “Genomic and Proteomic Biomarkers that Predict Risk for Diseases and the Outcome of Drug Therapy”Speaker: Speaker: Tom White, Ph.D., Chief Scientific Officer, Senior Vice President, Celera CorporationDate and Time: Wednesday, Jan. 20, 2010Time: 6pm Networking, 7pm Dinner, 8pm PresentationLocation: Location: The Clarion Hotel, 401 East Millbrae Ave., Millbrae, CASee website for details closer to date of event at www.biosf.org

Cost: $50 before 11PM, Monday, January 18th$60 on-site$30 full-time students pre-registration$35 full-time students on-site Acteva fees are added to the above prices

Topic Description

Pharmacogenomic markers for drug efficacy or adverse effects have traditionally been derived from two sources, variation in the drug target or its level of expression and variation in enzymes that metabolize the drug. Over the last several years, genome-wide association studies (GWAS) on common complex diseases have led to the discovery of numerous novel genetic variants that predict risk. However, most of these risk markers have been of doubtful clinical utility because of uncertainty about how risk information would influence physicians' treatment decisions. By conducting association studies using samples from patients in the placebo (or untreated) arm of drug trials,  genetic markers in the KIF6 and LPA genes have recently been identified that are associated with both risk for cardiovascular disease and with drug efficacy in terms of coronary events (fatal or nonfatal myocardial infarction, revascularizations). One of these markers can also identify individuals at elevated risk for severe adverse events and substantially improves the drug's therapeutic index. Previous genome wide studies of case-control samples may have missed discovering potential risk and pharmacogenomic markers if the extent and pattern of underlying drug use in the subjects was unknown. For example, if one is attempting to discover a clinically useful marker associated with risk for hypertension, and that risk is suppressed by an anti-hypertensive drug, knowledge of anti-hypertensive utilization patterns in the population being studied would be fundamental.

Speaker Bio

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Tom White is the Chief Scientific Officer and Senior Vice President of Research for Celera. He received his B.A. in Chemistry from Johns Hopkins University and his Ph.D. in Biochemistry from the University of California at Berkeley. His postdoctoral research was carried out at the University of California Medical Center in San Francisco and at the University of Wisconsin at Madison. From 1978 to 1989, Tom held various positions at Cetus Corporation including Vice President of Research and Associate Director of Research and Development. From 1989-2000 he worked for Roche Molecular Systems as Senior Vice President of Research and Development.

******************************************************************CACO, Wednesday Evening, Jan. 20, 2010

Event: “Poorly Soluble Drugs: Pharmaceutical Development Strategies and Approaches for Pre Clinical Applications (jointly with AAPS-BADG)”-- Dinner SeminarSpeakers: K. Nagapudi, S. Nadkarni, S. NeeravannanDate and Time: Monday, Jan. 20, 2009, 6:00 pm to 9:00 pmEvent fee:$20 online; $5 for students/postdocs/unemployed online only; $45 on site (subject to seating limit)Location: Bay Area: Crowne Plaza Foster CityOnline registration and further details: http://www.caco-ca.orgRegistration deadline: 1/18/2010 (it will close sooner if the seating cap is reached)Additional Details: See www.CACO-ca.org. A Joint CACO/AAPS-BADG event Visit CACO website*******************************************************************UCSC Ext., Good Clinical Practices, Jan. 20 – March 31, 2010

Course Description:History, ethics, and regulations provide a context for the responsible conduct of clinical research. The focus of this course is the timely, thorough and ethical conduct of clinical studies. Participants explore the translation of ethical principles into regulations (federal, state and local), recruitment and consent of research subjects, roles and responsibilities of sites, sponsors and institutional review boards, study monitoring and auditing for compliance.Instructor: Jacquie Mardell, BADates and Times: Wednesday, Jan. 20 – March 31, 2010, 6:00 – 9:00 pmLocation: UCSC Ext. in Silicon Valley, 2505 Augustine Dr., Santa ClaraTuition: $700 (Early Enrollment - $630 See details at http://www.ucsc-extension.edu/programs/clinical-trials/courses*********************************************************************UCSC Ext. SAS Programming for Clinical Trials, Jan. 20 – March 31, 2010

Course DescriptionSAS is the primary software standard in the biopharmaceutical industry for the storage, management and manipulation of clinical data and its presentation to the FDA in clinical trials. Processing clinical data in FDA-regulated industries has specific requirements, which introduce unique challenges in comparison to working with data from other industries. This course prepares individuals with SAS programming experience to process clinical-trials data to meet the increasing demand for these skills in the biotech and pharmaceutical industries. Through lecture and lab, participants learn about various aspects of SAS programming related to processing clinical data; understanding clinical-trial terminology; preparing

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data for submission using CDISC SDTM standards, tables, listings and figures for electronic submission; and managing regulatory considerations such as software-development life cycle and related documentation.Instructor: Ram Gopalan, Ph.D.Dates and Times: Wed 7:00PM to 10:00PMJan 20, 2010 to Mar 31, 2010 Number of Sessions: 10Location: UCSC Ext. in Silicon Valley, 2505 Augustine Drive, Santa ClaraTuition: $780 (Early enrollment - $702) See details at www.ucsc-extension.edu/biosciences

*****************************************************************Engineering in Medicine and Biology Society (EMBS), Wed. Evening, Jan. 20, 2010

Topic:   “SMRT (Single-Molecule, Real-Time) Biology”Speaker: Jonas Korlach, PhD, Principal Scientist, Pacific BiosciencesDate and Time: Wednesday,  January 20, 2010,  7:30 pmLocation:  Room M-114, Stanford University Medical School Optional dinner:   Nexus Cafeteria in the Clark Center, 6:15 pm (no host, no reservations)Cost: Free

Topic DescriptionOrganisms can be viewed as dynamic, highly modular, and adaptive systems able to reconfigure themselves as conditions demand. The scientific community is increasingly recognizing that multiple data sources (e.g., DNA, RNA, protein and metabolite levels, etc.) and sophisticated computational approaches that integrate diverse data are required to uncover the hierarchy of molecular, cellular, and tissue-based networks defining these complex physiological transitions, sometimes leading to disease. While a significant technological revolution in biology has led to this realization, limitations in the available technologies have hampered the ability to embrace this scale of complexity. In order to fully realize the promise of personalized medicine, scientists require a means to obtain a comprehensive understanding of the fundamental building blocks of biological systems.SMRT™ (Single Molecule Real Time) Biology is the application of Pacific Biosciences’ transformative detection platform enabling the real-time monitoring of biological processes at single-molecule resolution. The first commercial application for this transformative platform is SMRT DNA sequencing (available in 2010). Pacific Biosciences has begun expanding internal research programs and developing collaborations for additional ‘SMRT Biology’ applications and bioinformatics tools that will allow scientists to acquire new, fundamental knowledge about the molecular dynamics of life. These include simpler and more direct solutions for RNA sequencing, methylation sequencing, and even the largely uncharted real-time observation of protein translation.Jonas Korlach, PhD, will discuss this research at the January 20 meeting of the Santa Clara Valley Engineering in Medicine & Biology Society.  He will first highlight the importance of a comprehensive determination of DNA, RNA and protein sequences and abundances for the understanding of life processes. He will then describe the principles of the underlying SMRT technology in the context of an historical account of its development which is an example of both the power of multidisciplinary scientific endeavors, and the potential of transferring an academic research project into an industrial organization environment.  The current performance of the SMRT DNA sequencing system will be presented with an emphasis on the enablement of entirely new possibilities of inquiries into biological systems, followed by an outlook of projected performance potentials and implications for the changes it will bring with regard to our perception on medicine.

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Speaker BioJonas Korlach received a Diplom (Masters) degree in biology from Humboldt University (Germany) in 1996, and a PhD in biochemistry, molecular and cell biology from Cornell University in 2003 where he initiated the technology development on SMRT DNA sequencing as a collaboration between the labs of Watt Webb and Harold Craighead.  After a short postdoc at the same institution and as a technical consultant to Pacific Biosciences, continuing with this research, he joined Pacific Biosciences as employee #3 after it received the first round of venture capital funding to commercialize the method. He currently holds the title of Principal Scientist at the company, supporting commercial development of the SMRT DNA sequencing system, and performing research aimed at enabling new applications within the ‘SMRT Biology’ realm.

 *************************************************************Palo Alto AWIS, Thursday Evening, Jan. 21, 2010

Topic: “Skills, Strategies & Super Powersfor the 21st Century Woman”Speaker: Christine Arylo,Inspirational Catalyst, www.DareToLiveYou.comDate and Time: Thursday, Jan. 21, 2010, Time: 7 - 9 pm 7:00-7:30 pm Networking and light supper7:30-7:45 pm Announcements7:45-8:45 pm Program8:45-9:00 pm DiscussionLocation: PARC Auditorium, 3333 Coyote Hill Road, Palo Alto, CACost: Members pay $5 and non-members pay $10 to offset the cost of food.RSVP: online http://www.acteva.com/go/pa-awis

Topic DescriptionAs 21st century women, we now have the power to do anything! The problem is that now,we feel pressured to do EVERYTHING… perfectly, right now and all at the same time.Christine Arylo will help us discover how to activate the super powers that are alreadyinside us, so we can thrive instead of just survive. A recovering “doing” addict herself, sheknows the secrets to get beyond chasing balance, finding time, and doing it all foreveryone else, to creating harmony, finding happiness, and taking care of ourselves.Christine will reveal insights into how to get that inner achievement junkie under controland tools for trading self-sabotaging behaviors for good “ME Habits” – such as TheComparison Diet and The Pause.

Speaker BioChristine takes a fresh approach to redefining self-love for today’s woman as hip, hot andhers. Merging her MBA from Kellogg School of Management, over 12 years of marketing expertise, and extensive leadership and coaching training with a seven year self-discovery journey, Arylo traded in building brands for companies to inspire women to bust through their limiting self-images and self-expectations. She is the author of Choosing ME Before WE (www.mebeforewe.com) and the founder of Madly in Love with METM, an international movement to inspire women and girls to love themselves (www.madlyinlovewithme.com).

******************************************************************San Jose BioCenter, Thursday Midday, Jan. 21, 2010

Topic: Grant Writing: A Business Development WorkshopSpeakers

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• Shauna Farr-Jones, Ph.D. Click Here for Bio»• Amy F. Boggs, Ph.D. Click Here for Bio» Date and Time: Thursday, January 21, 2010Agenda1:00 PM - 1:30 PM   Registration and Networking1:30 PM - 3:00 PM   Workshop Location: The San Jose BioCenter, 5941 Optical Court, San Jose, CA 95138Cost & Registration*Pre-registration closes on Jan. 20th at noon!*• Regular Price: $30• Partners' Network: $20• BioCenter Members: Free (please RSVP to Aurélie)• On-site Registration: add $10 to the above Space is limited for this event, so early pre-registration is recommended to avoid disappointment on the day! http://www.sjbiocenter.com/event/ev_2010Q1-GrantWriting.html

Topic DescriptionYou may have been a master of grant writing, but things are about to change! The NIH is unrolling a shortened and restructured format for grants starting in 2010. All applications for due dates on or after January 25, 2010 require use of new forms and new instructions. New instructions mean shorter page limits! The research plan is fully restructured and reflects new evaluation criteria. Even people who have written grants in the past are going to need to “relearn” the process.

Join us for an interactive workshop with Shauna Farr-Jones, Ph.D. and Amy Boggs, Ph.D., on grant writing basics and pitfalls. This event will cover general submissions and writing strategies, with a special focus on NIH SBIRs new submission format, as well as other agencies, grants, and deadlines.

What you will learn:Why a grant?     • Eligibility     • How to get started     • Tips for a successful grant

Speaker BiosShauna Farr-Jones, Ph.D.Shauna Farr-Jones Ph.D., has ten years of experience in helping life science, instrumentation, imaging, nanomaterials, diagnostic, medical device and biopharmaceutical companies raise funding. She has a record of writing successful government grant and contract proposals and has helped companies raise over $125 million from the various government agencies and philanthropic organizations. In addition to grant-writing, she provides companies with help in preparation of technical reports, INDs and NDAs, technology assessment, and strategic research planning.

Amy F. Boggs, Ph.D.Dr. Boggs is an independent consultant with more than ten years experience in anti-infective drug discovery and development. In addition to grant-writing, she provides companies with help in the preparation of technical reports, INDs and NDAs, technology assessment, strategic research planning and competitive landscaping. Prior to her work as a consultant, Dr. Boggs worked at Microcide and at IntraBiotics, where she managed an interdisciplinary technology in-licensing team that resulted in three screening technology partnerships and two product in-licenses. Dr. Boggs is an inventor on three issued patents and has worked on investigational new drug (IND)-enabling projects.

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************************************************************

UCSC Ext. Human Physiology in Health and Disease, Jan. 21, -April 1, 2010

Course DescriptionThis course introduces the fundamental principles of human physiology in health and disease, and provides insights into the cutting-edge and established therapies being developed and used to treat a range of disease processes. Designed for individuals who lack formal medical training, the course begins with an overview of the hierarchical organization of the body, from cells to coordinated organ systems, and continues with a discussion of the key integrative/homeostatic control mechanisms. With these topics as a foundation, the instructor progresses through the functions of major systems, including renal, cardiovascular, respiratory, neuromuscular, digestive, endocrine and reproductive. This course benefits clinical research, biopharmaceutical, and engineering professionals who need a basic understanding of the physiological processes and therapeutic approaches that underlie the biomedical projects or clinical trials on which they work.Instructor: Sudhi Gautam, MBBS, Ph.D.Dates and Times: Thu 6:00PM to 9:30PMJan 21, 2010 to Apr 01, 2010 Number of Sessions: 10Location: UCSC Ext. in Silicon Valley, 2505 Augustine Drive, Santa ClaraTuition: $670 (Early Enrollment Fee - $603) See details at www.ucsc-extension.edu/biosciences

********************************************************************UCSC Ext. Regulatory Submissions: Devices and Diagnostics, Jan. 21 – March 18, 2010

Course Description:This course is designed to provide individuals who already have a foundation in medical device terminology, classification, and pathways to market, with opportunities to gain a greater exposure to key medical device submissions. Through lectures, case studies, and hands-on exercises, new and experienced regulatory professionals learn how to work with the regulations, guidance documents, and style guides to write portions of key medical device submissions that both comply with the requirements and are clear to the reviewers. Students explore the content and process of medical device submissions, as well as gain insight into timelines, important strategic considerations and business impacts. Topics include IDE; 510(k) (including unique features of in vitro diagnostics); PMA; brief coverage of HDE and PDP; combination products; foreign manufacturers filing in the U.S.; and global submissions.Instructor: Craig J. Coombs, RACDates and Times: Thu 6:00PM to 9:30PMJan 21, 2010 to Mar 18, 2010 Number of Sessions: 8Location: UCSC Extension in Silicon Valley, 2505 Augustine Drive, Santa ClaraTuition: $725 (Early enrollment - $652.50See details at http://www.ucsc-extension.edu/programs/regulatory-affairs/courses

*********************************************************************UCSC Ext. in Silicon Valley, Clinical Trials Site Monitoring I, Jan. 22 – Feb. 12, 2010

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Course Description:This course presents the essential elements of monitoring a clinical trial and the interaction between a sponsor and one or more sites during a clinical investigation. The expectations of the FDA, the sponsor and the site are covered. Participants are exposed to the process of site selection, budgeting, initiation visits, source documentation, regulatory documentation, and adverse event reporting. The use of tracking tools for compliance, screened and valid patients, product accountability and medical record review are also covered.Instructor: Patty Kasper, MSDates and Times:Fri 2:00PM to 6:00PMJan 22, 2010 Sat 9:00AM to 5:00PMJan 30, 2010 to Feb 06, 2010 Fri 2:00PM to 6:00PMFeb 12, 2010 Number of Sessions: 4Location: UCSC Extension in Silicon Valley, 2505 Augustine Drive, Santa ClaraTuition: $645 (Early Enrollment - $580.50)

See details at http://www.ucsc-extension.edu/programs/clinical-trials/courses*************************************************************

UCSC Ext. Medical/Clinical Terminology, Saturday, Jan. 23, 2010

Course Description:A basic understanding of medical and clinical terminology is essential in clinical trials design and management. This interactive workshop, for individuals with no background in medical/clinical terminology or for those who would like a refresher, reviews common terms associated with medical research and development and clinical trials. Participants review both the meaning of each term and how it is applied within a practical context.Instructor: Addy Alsumde, MD, Ph.D.Dates and Times: Sat 9:00AM to 5:00PMJan 23, 2010 Number of Sessions: 1Location: UCSC Extension in Silicon Valley, 2505 Augustine Drive, Santa ClaraTuition: $275 (Early Enrollment - $247.50)See details at http://www.ucsc-extension.edu/programs/clinical-trials/courses*******************************************************************FountainBlue Life Science Entrepreneur’s Forum, Monday Evening, Jan. 25, 2010

Topic: Life Science Angel Investor's Panel: Trends for 2010 This month's panel will feature:

Facilitator Conor Moore, Partner, KPMG Panelist Anne DeGheest, Founder and Managing Director, MedStars, Strategic

Advisor at PolyRemedy, Inc Panelist Stuart Eckmann, Keiretsu Forum and Life Science Angels Panelist Don Ross, Member, Life Science Angels and Sand Hill Angels Panelist Michael Weickert, President and CEO, S.E.A. Medical Systems, Inc.,

Member, Life Science Angels, Venture Partner, Kranenburg Fund 

Another Angel Investor to be confirmedDate & Time: Monday, January 25 from 5:30 - 7:30 p.m.

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Location: KPMG, 500 E. Middlefield Road, Mountain ViewCoordinate a Carpool by visiting http://search.zoompool.com/index.php?eventid=800.Cost: $21 members, $32 partners, $42 general On-Site Registration is $42 for members, $52 for nonmembers, or $104 for FountainBlue Ongoing membership and admission

Registration: Please pre-register by noon on 1/22 using the PayPal link at http://www.svlifescience.com. Registrations received after the deadline will be applied to next month's event, unless you've registered for the $100 ongoing or the $40-50 on-site payment.

Audience: Entrepreneurs, intrapreneurs and investors, no service providers please.

Topic DescriptionLife Science Angel Investor's Panel: Trends for 2010 Life science angel investors are generally seasoned executives with deep strategic and operational experience in running successful life science businesses, from concept to clinical trials to regulatory approvals, manufacturing and distribution. They generally also have extensive experience within corporations in various roles, and continue to develop these partnerships as they support their portfolio companies.  The life science angel investors we've recruited for this month's panel have been seen a wide range of life science business models, and have their own thoughts and recommendations on how to be successful in these challenging times. Topics will include how early stage companies can position themselves for successful partnerships and fundings, strategically plan your business based on evolving market needs, tightly manage cash flow, and build strategic alliances with larger organizations, angels, research organizations, and other key stakeholders In addition, this month, instead of profiling individual presenting entrepreneurs, we will break out into small groups, based on life science sub-industry topics: Software solutions for the healthcare industry, medical devices, personalized medicine, medical imaging, and biopharma.

**********************************************************************UCSC Ext. Sequence Analysis in Bioinformatics, Advanced, Jan. 25 – March 29, 2010

Course DescriptionDesigned for individuals who already have a solid grasp of simple alignment and phylogenic analyses, this course addresses more sophisticated and cutting-edge computational methods and algorithms for the analysis of complex biological sequence data. Lecture topics include Hidden Markov Models for gene finding and conducting profile-based searches; probabilistic methods for phylogenetic analysis; RNA structure prediction techniques; stochastic context-free grammars for RNA analysis; and methods for conducting ultra-fast database searches.Instructor: SAMI KHURI, Ph.DDates and Times: Jan. 25 – March 29, 2010Location: UCSC Ext. in Silicon Valley, 2505 Augustine Drive, Santa ClaraTuition: $670 (Early Enrollment - $603See details at www.ucsc-extension.edu/biosciences*****************************************************************Bio2Device Group, Tuesday Morning, Jan. 26, 2010

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Topic: Topic: “Key Drivers of Reimbursement Strategy Development & Planning for Medical Devices” Speaker: Sue Rowinski, Sue Rowinski, LLCDate and Time: Tuesday, Jan. 26, 8:30 – 10:30 amLocation: Sunnyvale City Council Chambers, 456 W. Olive, Sunnyvale, CA (across the street from Sunnyvale Public Library)Parking: On street and in NOVA and library parking lots across the street.Cost: FreeNo registration required.

Topic DescriptionThe presentation has two objectives. The first is to describe the key strategic decisions that will define the scope of your reimbursement plan. What are these decisions and why are they relevant will be discussed. After laying the strategic groundwork the next step will be to apply them into a planning framework. This is the presentation's second objective, to show how and when to beginreimbursement planning. I will present a reimbursement planning model that is based on three specific phases of the product development cycle. These phases are; Safety and Feasibility, Pivotal Trial and Commercial. During this part of the presentation, the emphasis will be on the Safety and Feasibility phase because it is the most important in terms ofplanning. Commencing your reimbursement planning process early in the product development cycle, such as during the phase 1 trial (safety and feasibility study), will help you to outline the scope of your reimbursement plan, understand the resources andbudget necessary to support your plan and may improve the probability of obtaining payer approvals, after FDA approval.

Speaker BioMs. Rowinski is Principal of the Sue Rowinski Group LLC, are reimimbursement and marketing consulting firm located in the San Francisco bay area. The firm is retained by private and public medical device companies and investors for proprietary reimbursement and marketing projects that can cover the entire company/product life cycle. Projects can include reimbursement due diligence and risk analysis, design and the implementation of Medicare and private payer plans and integration of these plans into a client's clinical and marketing efforts and interim onsite management services for marketing and reimbursement. In addition to her consulting work, Ms. Rowinski has over 15 years of operating experience in the medical device and imaging industries, including management responsibility for reimbursement, marketing and sales. Her experience spans the company life cycle and includes advancing companies through the fundraising, product development, and product launch phases. She has raised private equity and managed strategic corporate partners. Ms. Rowinski has secured Medicare reimbursement approvals and has been responsible for three product introductions that included the U.S., Euro zone and Japan. She was Vice President, Marketing (PharmaSonics, Sunnyvale, CA.) where she was responsible for global reimbursement and marketing. Previously, she has held several management positions with increasing responsibility; Director of Marketing (Cardiometrics, Mountain View, CA.), Global Marketing Manager (Medtronic, San Diego, CA), Product Manager (Quinton Instrument Company, Seattle, WA.). Ms. Rowinski began her life sciences career as a Cardiology Ultrasound Sales Representative for Advanced Technology Labs (ATL, Seattle, WA). Ms. Rowinski holds a M. S. in Engineering/Bioengineering from the University of Washington and a B.S. in Health Physics from Purdue University. Ms. Rowinski has been the Director and an Instructor, since 2005, at the University of California-Berkeley extension course Developing U.S. Reimbursement & Health Economic Strategies for Medical Devices. Other lecture engagements include the University of California Haas School of Business; Purdue University BIOMEDSHIP program; University of Michigan Bioengineering Dept;

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Rensselaer Polytechnic Institute (RPI) Biotechnology Management & Entrepreneurship Seminar Series; the Medical Device Manufacturers Association (MDMA) and the MedicalMarketing Association.

*********************************************************************CABS, Tuesday Evening, Jan. 26, 2010

Seminar & Round-Table: “Business Plan & Executive: How to Lay Out Your Great Idea”Date and Time:   Tuesday Evening, Jan. 26, 2010, 7:00 - 9:00 pm Location:   Foster City Recreation Center (650 Shell Blvd, Foster City, CA 94404); Crane Room Cost:   $1 Online; $5 on-site Register at https://www.cabsweb.org/CABSweb/feventdue.jsp**********************************************************************Northern Silicon Valley Partnership, Wednesday Morning, Jan. 27, 2010

Topic: “Free Entrepreneur Pitch Event to Angel Investors: Green technology, biotechnology, information technology, and sustainable products or services”Date and Time: January 27, 2010,9:00 am – 11 am Location:City of Hayward,777 B Street, Hayward, CA 94541 Cost: No Cost to pitch or attend Breakfast provided RSVP: Christine Friday, City of Union City, 510-675-5396, [email protected]

Event DescriptionThis no charge event provides entrepreneurs an opportunity to present their product and business ideas and to make connections with angel investors for green technology, biotechnology, information technology, and sustainable products or services. The Angel investors will provide feedback to entrepreneurs regarding their presentations and ideas. Pitch slots are limited, entrepreneurs should contact [email protected] or [email protected] by January 8, 2010 to submit an executive business summary and pitch request.For further information, contact Christine Friday, City of Union City Economic Development, [email protected] or 510-675-5396. Angel Investor Panelists from Keiretsu Forum Angel investor panel are members of the East Bay Chapter of Keiretsu Forum, http://keiretsuforum.com. Keiretsu Forum, founded in 2000, is the world’s largest angel investor network with 750 investor members in 18 chapters on 3 continents. Its members collaborate in the due diligence about companies and technologies, but make individual investment decisions in the range of $250K-$2M.***************************************************************BayBio Therapeutic Breakfast Series, Thursday, Jan. 28, 2010

Topic: “Planning for Success: The Balance Between Clinical Trial Design and Implementation”Moderator: Trudy Vanhove, MD, PhD, MBA ,Senior Director, Clinical Development, Neurogesx    Panel Speakers: Scott Harris, MD, Chief Medical Officer, Ocera Therapeutics, Inc. Hsiao Dee Lieu, MD, FACC, Vice President of Clinical Research, Nile Therapeutics, Inc.   Judith Quinlan, Vice President, Adaptive Trials, Cytel Inc.Todd Reul, Associate Director, Clinical Outsourcing, Facet BiotechDate and Time: January 28, 2010, 8:00 - 10:00am Location: Wells Fargo Insurance Services Inc., 305 Walnut Street,Redwood City, CA 94063Directions Parking: Free parking

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Attire: Business attire suggested Cost: Early Bird Registration through Jan. 26:$10.00 - BayBio Members$20.00 - Non-Members

On-Site Registration, Jan. 28:$20.00 - BayBio Members$40.00 - Non-MembersRegister at http://www.acteva.com/booking.cfm?bevaid=192090

Topic DescriptionPatients, physicians and clinical resources are precious assets to a clinical trial, and it is vital the sponsoring company maximize these assets. To improve clinical research process efficiency and results, the FDA in 2004 proposed The Critical Path Initiative advocating greater use of innovative methods and technologies. The FDA identified adaptive trial designs, e-clinical technologies and biomarker development as key to counter increasingly poor clinical success rates across the industry. Today, these innovations are becoming commonplace within bigger pharma, but how can biotechs and specialty developers take full advantage of these new study approaches? How can you be certain that your clinical strategy is the best one – the strategy with the highest probability of success? Join our panel from small and medium sized companies to discuss real-life experiences for a better understanding of the latest approaches and tools to better guide both study design and execution - even for those on a most cost-conscious budget.**********************************************************************East Bay AWIS, Thursday Evening, Jan. 28, 2010

Event: January Chapter MeetingDate and Time: Thursday, January 28, 2010, 6:30 – 7:00 PM light dinner and networking 7:00 - 8:30 PM Program Location: Novartis Inc*.,  Building X-310, 5300 Hollis St, Emeryville Suggested donations: $5 member/ $10 non-members

Event DescriptionOur most popular event: An entire Chapter meeting devoted to networking!Connect with other scientistsAdvance your careerFind your next jobMake new friendsNon-Scientists and Men are Welcome!Meetings are open to non-AWIS membersA brief review of networking strategies and techniques will be followed immediately by games to fine tune our networking skills and make those ever-important job contacts! Our expert hosts will engage us in effective networking games that enable you to meet and exchange information with many people in a very short time. You will meet people in an informal, friendly setting while collaborating to perfect your skills.So, invite your colleagues, (don't forget men are invited too) and print out those business cards! Come to polish up your 'introduction', exchange cards, share networking skills, make new friends, and find out who's doing what in Bay Area science.********************************************************************Bio2Device Group, Tuesday Morning, Feb. 2, 2010

Topic: “Molecular Image – fundraising in a tough environment”

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Speaker: Russ Singleton , Molecular Image Date and Time: Tuesday, Feb. 2, 2010, 8:30 – 10:30 amLocation: TIPS Group Law Offices , 1000 Elwell Court, Palo Alto, CA 94303Cost: FreeNo registration required.

Topic DescriptionMolecular Image is an early-stage personalized medicine company with a software technology which uses magnetic resonance and specific molecular data for predictive diagnostics in multiple sclerosis and other diseases. We have been in a quest to raise follow on financing this year after a successful bridge round late in 2008. We have not yet been successful and this talk discusses the company and the quest in this difficult environment.

Speaker BioSince July 2009, Dr. Russell M. Singleton has been President and CEO of Molecular Image. Dr. Singleton has over 25 years of transformational achievements in general management, marketing, strategic business development and engineering initiatives across medical device, life science and semiconductor capital equipment businesses. Prior to Molecular Image, he was GM of the SPECT Business Unit at Philips Medical Systems, responsible for driving a successful turnaround which has resulted a 17% improvement in market share and significant improvement in profitability. Prior to Philips, Dr. Singleton was VP, Engineering at Perlegen Sciences, a venture-capital backed personalized medicine company, and in the early 90’s a VP, Engineering at Molecular Dynamics, a venture-backed life sciences instrumentation company that successfully went through in IPO. Dr. Singleton also had cumulatively 18 years at at KLA-Tencor, a semiconductor inspection and metrology company. At KLA, he had VP/GM responsibility for startup and turnaround businesses spanning instrumentation, software and consulting including the acquisition of three businesses and spin-off of another. He received his BE (Electrical) from Pratt Institute, and received his MS and PhD from the University of Illinois in Electrical Engineering.

*******************************************************************CABS, Tuesday Evening, Feb. 2, 2010

Seminar & Round-Table: “Investor Pitch: How to Get Funding for Your Great Idea”Date and Time:   Tuesday Evening, Jan. 26, 2010, 7:00 - 9:00 pm Location:   Foster City Recreation Center (650 Shell Blvd, Foster City, CA 94404); Crane Room Cost:   $1 Online; $5 on-site Register at http://www.cabsweb.org/CABSweb/feventslist.jsp?id=83******************************************************************Bay Bio Medical Device Breakfast, Tuesday Morning, Feb. 9, 2010

Topic: “Company Valuation for M&A”Moderator: Mark Weeks, Partner, Cooley Godward Kronish LLPPanel Speakers:Jason Yip, Principal, Montgomery & Co., LLCJeffrey Gold, Venture Partner, Longitude Capital, Former CEO, CryoVascular SystemsTime and Date: Feb. 9, 2010, 8:00 -10:00 amLocation: Cooley Godward Kronish LLP, Palo Alto Campus, 3175 Hanover Street, Palo Alto, CA 94304

Early Bird Registration through Dec. 4:$10.00 - BayBio & MDMA Members, Bio2Device and Bio-X Affiliates

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$20.00 - Non-MembersOn-Site Registration, Dec. 8:$20.00 - BayBio & MDMA Members, Bio2Device and Bio-X Affiliates$40.00 - Non-Members

Register at http://www.acteva.com/booking.cfm?bevaid=192797

Topic DescriptionThe valuation of a medical device company for merger or acquisition is not an exact science. Some of the many variables to be taken into consideration include the company’s management, market share, prospects for growth, and potential market size. Tangible and intangible assets and financial track record will be evaluated, as well as the company's reputation in the business community. The motivation and goals of key players also come into play, and current market conditions and timing are factors. A panel of industry veterans will explore the valuation process for medical device companies, discuss case studies and provide practical answers to help you increase your company’s valuation.

*******************************************************************Bio2Device Group, Tuesday Evening, Feb. 9, 2010Topic: “TBA”Speaker: Deb Neff, Pathwork DiagnosticsDate and Time: Tuesday,Feb. 2010, 6:00 – 9:00 pmLocation: TIPS Group Law Offices , 1000 Elwell Court, Palo Alto, CA 94303Advanced registration is required see bio2devicegroup.org website for details a week prior to event.Cost: Fee for light dinner with range depending on timing of registration**********************************************************************BayBioNEST Venture Spotlight, Thursday Morning, Feb. 11, 2010

Topic: A Sweet Deal: How to Attract Investors Date and Time: Thursday, Feb. 11, 2010, 8:00 am – 10:00 amLocation: Latham & WatkinsMenlo Park Campus140 Scott Dr.Menlo Park, CA 94025DirectionsAttire: Business attire suggested

Cost: Early Bird Registration through Feb. 9:$19.00 On-Site Registration, Feb. 11:$29.00

Register at http://www.acteva.com/booking.cfm?bevaid=193973

Topic DescriptionVenture Capitalists and Angel Investors are still looking for good prospects despite the economic downturn. Understanding what they want, at what stage they want to invest and the difference between them can help start-ups form a successful relationship with investors. Join BayBioNEST for the first of our 2010 Venture Spotlight Series events and learn how best to attract investors and secure a sweet deal.

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The BayBioNEST Venture Spotlight Series is a unique forum that allows investors to speak directly to entrepreneurs in a reverse pitch format. Investors and experts have a platform to discuss their current interests, target markets, therapies and technologies, as well as the maturation level of investment targets. The Venture Spotlight Series is a breakfast panel discussion with time for Q&A and networking.

**********************************************************************UCSC Ext. Bioscience Product Marketing, Thursday Evenings, Feb. 11 – March 25, 2010

Course DescriptionThis product marketing and selling-focused course gives participants an in-depth look at product planning and research, marketing planning, and promotional execution practices in the bioscience industry. Topics include market research methodologies, information sources and applications relevant to product planning; the development of marketing strategy, product positioning and differentiated claims; and the creation of tactical marketing programs and activities to maximize revenue potential. Course activities include the creation of a preliminary marketing plan. The course is well suited for all levels of professionals in bioscience marketing research, product management, product sales, advertising, public relations, business development and licensing, as well as other related functions, such as regulatory, clinical and legal.

Lead Instructor:Audrey Erbes, Ph.D., is a life science business development and marketing consultant with more than 25 years of managerial experience in marketing and business development in the biotech and pharmaceutical industry. She was Executive Vice President and cofounder of Kowa Research Institute and held management positions at Syntex Corp. in market research, product management, strategic marketing and planning, and business development in the U.S. and abroad.

Guest Speakers: Chris Mahoney, MPA, WebMD, is an expert in the use of secondary patient data for

pharmaceutical marketing applications, consulting with companies ranging from large global pharmaceutical companies to start-up biotechnology companies and Alan Hirshman, Senior Principal, Commercial Effectiveness, IMS Health. Before coming to IMS Health, Alan was Vice President of Sales for SDI Health. At SDI he was responsible for West and Midwest sales. "Patient Adherence: The Impact on Brand Performance."

Stanley Skrzypczak, M.B.A., Director, Managed Care Marketing, Genomic Health, has over 25 years of successful biotech and pharmaceutical sales and marketing experience, including product, managed care, clinical marketing and sales management. Topic – "Product Management 101- Developing/Executing The Tactical Plan"

Charles Versaggi, Ph.D., is president of Versaggi Biocommunications®, a strategic marketing consultancy for biotechnology, pharmaceutical and medical technology companies. Topic – "Building Value through Strategic Marketing Planning and Communications."

Steven Wong, B.A., is a senior consultant at Plan A, a strategic marketing consulting firm servicing biotechnology and pharmaceutical companies. At Plan A, he has directed numerous consulting engagements, including opportunity assessments, complex population modeling, and therapeutic area. Topic – "Market Research Information Resources."

Dates and Times: Thu 6:00PM to 9:30PMFeb 11, 2010 to Mar 11, 2010 Thu 6:00PM to 9:30PM

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Mar 25, 2010 Number of Sessions: 6Location: UCSC Extension in Silicon Valley, 2505 Augustine Drive, Santa ClaraTuition: $700 (Early enrollment - $630 through Jan. 28)See details at www.ucsc-extension.edu/BPM**********************************************************************

San Jose BioCenter, Thursday Midday, Feb. 11, 2010

Topic: “Effective outsourcing: Navigating hurdles and avoiding pitfalls in virtual drug development”The panel will include:• Kate Hanham, President & Founder, Mentara, Inc.: Mentara is a consulting consortium of highly qualified drug/device discovery and development professionals.• Richard Lin, President, Explora Biolabs, Inc.: Explora BioLabs provides vivarium and pre-clinical in vivo contract research services.• An executive from a company using the virtual development model.• An investor/board member experienced in starting and running virtual companies. Date and Time: Thursday, Feb. 11, 2010, 12:00 – 2:00 pmLocation: The San Jose BioCenter, 5941 Optical Court, San Jose, CA 95138COST & REGISTRATION*Pre-registration closes on Feb 9th!* (See details at http://www.sjbiocenter.com)

• Regular Price: $30• Partners' Network: $20• BioCenter Members: Free (please RSVP to Aurélie)• On-site Registration: add $10 to the above Space is limited for this event, so early pre-registration is recommended to avoid disappointment on the day!

Topic DescriptionVirtual drug development promises savings of time and cost in the development of new drugs and devices. In order to realize this promise, managers and executives may need to learn some new tricks! In this session a panel of experts with different perspectives on the virtual development experience will discuss some of the advantages and challenges of the virtual model.**********************************************************

Bio2Device Group, Tuesday Morning, Feb. 16, 2010

Topic: “Would You Hire You?”Speaker: Denise Pringle, Global HR ExecutiveDate and Time: Tuesday, Feb. 16, 2010, 8:30 – 10:30 amLocation: Sunnyvale City Council Chambers, 456 W. Olive, Sunnyvale, CA (across the street from Sunnyvale Public Library)Parking: On street and in NOVA and library parking lots across the street.Cost: FreeNo registration required.

Topic DescriptionEver wonder what those recruiters and hiring managers think of your resume when they see it lying on their desks?. Can you imagine what a person who has seen hundreds, if

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not thousands, of applicants thinks when your resume arrives? How do they dissect each resume? What kind of knowledge do you need to posses to be able to read people from a virtual piece of paper? Well now you can know.This event is for participants who are looking for new opportunities to gain fresh insights into their resumes and interviewing skills.

Speaker BioDenise Pringle has held global Human Resources executive positions in high tech and life science companies in the Bay Area. She has worked on transition teams for mergers and outsourcing and has had responsibility for organizational and leadership development, driving cultural change, training, talent acquisition and rewards strategies.Denise has been an adjunct faculty instructor at San Jose State University, an invited speaker at a number of professional organizations, and is on the Advisory Board of OurExperienceCounts.com.Denise received her Bachelor of Arts in Social Sciences from San Jose State University.

************************************************************

Bio2Device Group, Tuesday Morning, Feb. 23, 2010

Topic: “Stem Cell Biology: Progress, hopes, hypes and hurdles”Speaker: Monica Ranes-Goldberg, Ph.D., BiotechTraining ConsultingDate and Time: Tuesday, Feb. 23, 2010, 8:30 – 10:30 amLocation: Sunnyvale City Council Chambers, 456 W. Olive, Sunnyvale, CA (across the street from Sunnyvale Public Library)Parking: On street and in NOVA and library parking lots across the street.Cost: FreeNo registration required.************************************************************

Bio2Device Group, Tuesday Morning, March 2, 2010

Topic: Successful Product Development: How Process, People and Procedures Fit Together Speaker: Larry Wray, Principal, Wray ConsultingDate and Time: Tuesday, March 2, 2010, 8:30 – 10:30 amLocation: Sunnyvale City Council Chambers, 456 W. Olive, Sunnyvale, CA (across the street from Sunnyvale Public Library)Cost: FreeParking: On street and in NOVA and library parking lots across the street.

Topic DescriptionThe presentation will include processes (e.g. protocol optimization, validations, etc.), people (e.g. teams and formal project management), and procedures (e.g. compliance/regulatory) elements of product development, as well as pitfalls (e.g. things to look out for and contingency planning) from the perspective of a practitioner. In his 25 years in product development, Larry has seen a lot and would like to share with the group things to look out for, as well, i.e. lessons learned. 

Speaker Bio

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Dr. Wray has over 25 years of experience in the in vitro diagnostics (IVD) industry, having held positions in R&D, project management, manufacturing, and business development. He has been responsible for launching over 20 products, with both domestic and international registrations. He has held positions as Senior Director, Development at Celera; R&D Director at Ventana (now part of Roche); and various management positions in R&D, manufacturing, and business development at Abbott Diagnostics. In these various positions, he has been responsible for the development and launch of both immunoassays and molecular diagnostics, which have included products for blood screening, abused drug screening and therapeutic drug monitoring, bone metabolism, anatomic pathology, viral mutation detection for drug resistance, and genetic disease. He established the core hybridoma facility for product development and led the successful restructuring of the manufacturing organization at Abbott and established the core reagents program at Ventana. He also led the start-up of a new business venture for osteoporosis and diseases of aging at Abbott. He has expertise in design control, QSR/ISO, and 510k, PMA, BLA and IVDD submissions. Larry received his PhD in genetics from the University of Texas at Austin and was a post doctoral fellow in human genetics at the University of Pennsylvania School of Medicine.

*******************************************************************

San Jose BioCenter, Tuesday Midday, March 2, 2010

Topic: The Ten Mistakes That Senior Management Teams Make with Investigational New Drug ApplicationsDate and Time: Tuesday, March 2, 2010 Agenda 12:00 PM - 12:30 PM Registration, Lunch, and Networking 12:30 PM - 2:00 PM Presentation & Panel Discussion Speakers• Panel Chair: Debra Gosling, Account Executive, Liquent Regulatory & Clinical Services, Thomson Reuters • Lorna Speid, M.R.Pharm.S., Ph.D., RAC., President, Speid & Associates, Inc. • Tom Delisi, Senior Consultant, Liquent Regulatory Services, Thomson Reuters • Kathryn Plank, Senior Regulatory Consultant, Liquent Direct, Thomson Reuters Click Here for Bio» • Jim Hilferty, Operations Manager, Liquent Regulatory & Clinical Services, Thomson Reuters Location: The San Jose BioCenter, 5941 Optical Court, San Jose, CA 95138Cost & Registration *Pre-registration closes on March 1st at noon!* (See details at http://www.sjbiocenter.com)• Regular Price: $30 • Partners' Network: $20 • BioCenter Members: Free (please RSVP to Aurélie) • On-site Registration: add $10 to the above Space is limited for this event, so early pre-registration is recommended to avoid disappointment on the day! **********************************************************************

Biotech Bay Career Fair, Tuesday Afternoon, March 9, 2010

Event: Biotech Bay Career FairLocation: South San Francisco Conference Center

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Date and Time: Tuesday, March 9, 2010, 2pm to 7pmRegister now at:http://www.biospace.com/jobs/seekersignin.aspx

Event DescriptionLooking for a new job? Networking with industry peers in an ever-changing work environment?Sectors include: Biotech * Pharmaceutical * Medical Device & DiagnosticsJob seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, medical device and diagnostics companies in the Bay area.

Who should attend? Candidates with a 4-year degree in the life sciences and a minimum of 2-years of industry related experience are invited to attend. Just register by clicking the button below.(Equivalent work experience may be considered in lieu of a four-year college degree. PhD and Postdoc candidates welcome.)

What types of positions are available? Exhibiting companies are recruiting for positions in areas such as: QA/QC, clinical research, engineering, manufacturing, biostatistics, clinical data management, chemistry, regulatory affairs, and research.

What companies will be there?

Take the time to research what each company is recruiting for to see if you are a match. Most companies will be from the Bay area, but some will travel from other regions to attract top talent! If you can’t make it on event day, you can still pre-register online to allow exhibiting companies to view your resume and contact you outside of the career fair.**********************************************************************

 

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