Audrey’s Updated Selected Meeting Picks for Sept. – Oct., 2009 (Sept. 27th Edition)

 

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2010-11 Biodesign Innovation Fellowship Informational Session, Monday Evening, Sept. 28

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Topic: Q & A with Biodesign FellowsSpeakers:  Dr. Krummel, Dr. Yock, and Dr. BrintonDate and Time: Monday, September 28, 2009, 6 – 7:30 pm Location: Clark Center Auditorium, 318 Campus Drive, Stanford UniversityWebsite: http://biodesign.stanford.edu/bdn/fellowships/infosession2009.jsp

 Topic DescriptionExplore the basics of biomedical technology innovation through an intensive, hands-on fellowship at Stanford University's Biodesign Program.  Join an interdisciplinary team of graduate engineers, business professionals, bioscientists and physicians for a hands-on, dedicated training experience in innovation.

Fellows learn - by doing - the key stages of the biodesign process: identification and verification of clinical needs, brainstorming, invention, prototyping, patenting, early-stage testing, regulatory and reimbursement, planning, financing and project implementation. Eligibility:  Candidates with graduate degrees in engineering, medicine or business, or comparable industry

training will be considered.  Applicant will be judged on their potential to become leaders in biomedical technology innovation.  Fellows chosen for the program will have a track record of early innovation which may include inventions or significant technology research projects.

 Support      Full stipend and benefits provided Apply          Please apply online at http://biodesign.stanford.edu/

Fellowship begins August 2010Application deadline October 16, 2009 

Please direct inquires to: Biodesign@stanford.eduhtttp://biodesign.stanford.edu/fellowships/ *******************************************************************Bio2Device Group, Tuesday Morning, Sept. 29, 2009

Topic: “Beyond P-values — Or My Struggle to Make Sense of Biotech Press Releases“Speaker: Ron Leuty, Reporter, San Francisco Business Times Date and Time: Tuesday, Sept. 29, 2009, 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.Further details will be posted at www.bio2devicegroup in September.******************************************************************************************PharmaVoice Free Webinar, Wednesday Morning, Sept. 30, 2009

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Topic of Webinsar: “Pharmaceutical Market Access 2010: Strategic Developments Impacting the US, EU and Emerging Markets, ” "Featuring: New Research on Public Reactions to the Proposed Obama Reforms"

Guest Speakers: Lee Blansett, Se nior Vice President, Oncology Market Access, KantarHealthDr. Susanne Michel MD, MSc, Head of Global Market Access, Pricing and Reimbursement, KantarHealthStephen Potts, Regional Director for Healthcare - , Asia Pacific, the Middle East and Africa, KantarHealthDate and Time: Wednesday, Sept. 30, 2009, 9:00 am – 10:00 am (PT)Cost: FreeRegister at http://video.webcasts.com/events/pmny001/viewer/index.jsp?eventid=31508

Topic DescriptionThe pharmaceutical and biotechnology industry is confronting significant short-term and long-term challenges. Financial pressures from current generic competition, upcoming patent expirations, and pending healthcare legislation and reforms in both the US and EU, are forcing the industry to "rethink" everything from R&D to Marketing. Future revenue growth in the US and EU is unclear, so pharma and biotech companies are looking to Emerging Market opportunities in Brazil, Russia, India, and China (i.e., BRIC) to drive future business. The EU is wrestling with the cost effectiveness of treatments and working through key changes in important regulatory processes. In addition, US healthcare reforms and pending legislation are pointing to universal coverage or the emergence of a "national plan."What does this all mean for patients, physicians, payers, and pharmaceutical / biotech manufacturers especially as payer actions and priorities converge across borders?

Key Take-Aways Guidance on Creating Effective Access Strategies for the High-Growth Emerging Markets Critical Developments

Influencing US Market Access for High Cost Drugs: The Strategic Implications for Pharma and Biotech

Insights Into New Trends for Financing Healthcare (Including Specific Country Examples Showing Key Changes in Health Systems and Regulatory Processes)

The Growing Focus on Cost Effectiveness in the EU: The Impact on Future Branding and Pricing Strategy

Understand How to Identify and Impact Decision Makers at Every Level – National, Regional, and Individual Insurer

How and Why EU Healthcare Initiatives Can Better Inform the Debate on US Healthcare Reform

Who Should Attend C-Level Executives: CEO, CFO, COO Vice Presidents of Sales, Marketing, and Branding Market Access Executives for All Therapeutic Areas (Especially Oncology) Marketing and International Oncology Brand Executives

*****************************************************************************************Bay Bio, Gene Acres Conference, Wednesday, Sept. 30, 2009, Volunteers Needed

BayBio is looking for volunteers to assist with Gene Acres     conferenceFrom now up until the day of the conference, BayBio is looking forvolunteers to assist with its annual Gene Acres conference:http://www.baybio.org/wt/home/GeneAcres17

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Volunteers are needed on site at the BayBio offices (400 Oyster Point>Boulevard, Suite 221, in South San Francisco) during business hours (8:30-5:30, or some portion thereof). Volunteers will have meals provided and be admitted to the conference without charge. Exceptional volunteerswill also be prioritized for volunteering at any of BayBio’s other multipleconferences.

If interested, please contact Misha Tsirulnikov misha@baybio.org and enter“VOLUNTEER” in the subject line.

Lori LindburgDirector of Workforce and Education*BayBio Institute**PLEASE NOTE OUR NEW ADDRESS:*400 Oyster Point Blvd, Suite 221South San Francisco, CA 94080T: +1 (650) 871-7101 x208 / F: +1 (650)871-7555lori@baybio.org

******************************************************************************************Triple Ring Technologies, Thursday Evening, Oct. 1, 2009

Topic: The Bright Future of Nuclear Medicine: PET and SPECT imagingDate: Thursday October 1, 2009Time: 6:00 – 9:00 pm, presentation begins at 6:45 pmLocation: Triple Ring Technologies, 39655 Eureka Drive, NewarkSpeaker: Dr. Tobias Funk, Staff Physicist, Triple Ring TechnologiesCost: The seminar is free of charge, but registration is required for planning purposesTo Register, visit http://www.acteva.com/booking.cfm?bevaid=177802On-Site registration: A limited number of on-site registrations may be available

About the Seminar:Single Photon Computed Tomography (SPECT) and Positron Emission Tomography (PET) are highly sensitive medical imaging modalities that are clinically used for diagnosis and staging of diseases such as cancer and heart disease. SPECT and PET are based on radiolabeled tracers that are injected into the patient and concentrate at specific sites depending on the biochemical characteristics of the tracer. The radioactive probes decay and emit ã-photons that are recorded by the imager. The resulting images are used to reconstruct a 3D representation of the radiotracer distribution in the body. Importantly, in contrast to anatomic imaging modalities like CT, SPECT and PET are functional and molecular imaging modalities. Thus they are sensitive to metabolic processes, perfusion, and biologic processes taking place at the cellular and subcellular levels.

In this seminar we review the basic principles of SPEC and PET, provide an overview of common procedures, and discuss in some detail the challenges and opportunities in the development of instrumentation for these modalities..

About the Speaker:Dr. Tobias Funk has over 10 years of experience in the development of instrumentation for science and medicine. Dr. Funk has broad experience in the areas of SPECT/CT imaging, image reconstruction, X-ray spectroscopy and NMR of biological and solid state materials, and he has expertise in low temperature, vacuum technology, detector physics, algorithm development and modeling and simulation of complex systems. Dr. Funk has worked as a researcher at Lawrence Berkeley National Laboratory and in the Department of Radiology at the University of California, San Francisco. He received his MS and Ph.D. from Free University Berlin, Germany.

*****************************************************************************************FountainBlue Funding, Friday Morning, Oct. 2, 2009

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Event: FountainBlue’s Funding Road Trip: Your Value Proposition Date and Time: Friday, October 2, 8:30 a.m. – 1:00 p.m.Agenda for the ‘Your Positioning’ Workshop:

8:30    Networking and Registration9:00    Welcomes, Thank Yous and Introductions9:15    Top Ten Mistakes in Business PlansYour business plan is the most important document you'll write as an entrepreneur. It can be the ticket to funding, and interest from potential clients and partners. Learn what NOT to do so you can develop a hard-hitting, compelling business case for your company.10:15  Break10:30 Your Positioning          Before you can pitch your company to raise funds or attract strategic partners and alliances, you've got to perfect your positioning. This session will provide you with a systematic approach to help you better determine your all important market definition and value propositions. This program features a hard-copy, walk-away tool that helps define these for a technology based start-up company and also includes powerful and practical techniques from market research pros to validate your customers’ real pain points and the value of your painkiller. Participants will be taught how to use this tool which is based on a case-study example of a real startup12:00  Lunch Break and Networking12:30  Optional Working Session, with Feedback 1:00   Adjourn and Networking

Location: Cooley Godward Kronish, LLP, 3175 Hanover Street in Palo AltoAudience: Early-Stage, Funding-Bound Clean Energy, High Tech and Life Science Entrepreneurs and IntrapreneursCost for 2 Entrepreneurs: $80 for FountainBlue members, $85 for Partners, $90 General, $100 On-SiteRegistration: We will plant a tree for everyone who pre-registers by noon on 9/30 using the PayPal link at http://www.fountainblue.biz/fundingroadtrip.html. Late and on-site registration is $100 if e-mail is time stamped after that, regardless of membership status.

Topic DescriptionFountainBlue is pleased to launch its fall Funding Road Trip Series event, the first of a three-month series serving high tech, clean energy and life science entrepreneurs within Silicon Valley. Begun in spring 2008, our workshop series is designed to help entrepreneurs think through their company’s offerings as well as the market opportunity, and then communicate that opportunity succinctly and compellingly to strategic investors.

This first workshop of this fall 2009 series focuses on ‘Your Positioning’, with modules on top ten mistakes in business plans and positioning. Our November 6 follow-up workshop will focus on the pitch to investors and our December 4 workshop will feature presentations to angel and other investors.

******************************************************************************************Bio2Device Group, Tuesday Morning, Oct. 6, 2009

Topic: “Medical Device Startup: Heated Transkeratin Drug Delivery” Speaker: Todd Weinfield, CEO/Founder, Innovation Biomedical Devices, Inc. Date and Time: Tuesday, Oct. 6, 2009, 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.Further details will be posted at www.bio2devicegroup in September.

Event Description

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Overview of a medical device startup, from funding (NIH, Angel, VC) to regulatory requirements (FDA), to clinical trials, to patent protection (PTO, PCT) to white papers. Will also include some theory and background of the technology - - why it works.

Speaker BioTodd Weinfield is a mechanical engineer who spent half of his career in semiconductor capital equipment (AMAT, Ultratech) and the other half in medical / medical device (Applied Biosystems, Laserscope, Oraya Therapeutics). Todd holds 4 patents (5 patents pending) and discovered the technology for his startup while sitting in a hot tub. Todd is a graduate of Cal Poly Pomona with a degree in mechanical engineering.*************************************************************************************Bioscience Business and Marketing Essentials, Thursday and Friday, Oct. 8-9, 2009

Intensive Course: Bioscience Business and Marketing Essentials, Thursday and Friday, October 8-9, 2009 (2 days of classroom and 2 months to complete project guided by instructor)

Lead Instructor: Audrey S. Erbes, Ph.D., Principal, Erbes & Associates and www.audreysnetwork.comExpert Guest Speakers: Donald Holsten, Pharm. D., Regulatory Consultant and Educator Bev Hudson, MBA, General Manager, Clinical Research Services, MedPoint Communications, Inc Julie Tompkins, MBA, Sr. Vice President, Timely Data Resources (TDR)Please see www.ucsc-extension.edu/biobusiness for complete biographiesDate & Time: Oct. 8-9, 2009, Thursday and Friday, 8:30am-5pmLocation: UCSC Extension in Silicon Valley, 2505 Augustine Drive, Santa Clara, CA 95053Fee: $730; $657 through Sept. 24

Topic DescriptionThe bioscience industry is like no other. Lengthy timelines and unique financial, legal, regulatory, social and political challenges impose constraints that impact every aspect of the business. This course helps participants gain: a practical understanding of the bioscience industry landscape, key business drivers and challenges; insight into the critical roles that business and marketing disciplines play at all stages of a bioscience company's development; and hands-on experience implementing important bioscience business processes that are essential to success within the industry. Two days of intensive classroom are followed by 2 months to complete individual project with guidance of instruction and access to research resources.  For more information: See www.ucsc-extension.edu/biobusiness.

Instructor BioAudrey Erbes, Ph.D., Principal of Erbes & Associates and www.audreysnetwork.com, is a marketing consultant with more than 25 years of managerial experience in marketing and business development in the biotech and pharmaceutical industries. She was Executive Vice President and cofounder of Kowa Research Institute, a biopharmaceutical licensing and investment subsidiary of Kowa Company Ltd., Japan and before that held management positions at Syntex Corp. in market research, product management, strategic marketing and planning, and business development in the U.S. and abroad.

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Bay Bio Medical Device Breakfast, Tuesday Morning, Oct. 13, 2009

Topic: “Design for Manufacturing”Moderator: Hugh Sharkey, Chief Executive Officer, AEGEA Medical, Inc.Panelists:Mohan Sancheti, Sr. Vice President, Manufacturing,VNUS Medical TechnologiesRandall J. Sword MBADesign Servicesm Creganna Medical DevicesShelley Trimm, Senior Project Manager, AlquestTime and Date: Oct. 13, 2009, 8:00 -10:00 am

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Location: Cooley Godward Kronish LLP, Palo Alto Campus, 3175 Hanover Street, Palo Alto, CA 94304 DirectionsBusiness Attire Suggested

Register at http://www.baybio.org/wt/home/Manufacturing_Design

Cost: Early Bird Registration through Oct.11:$10.00 - BayBio & MDMA Members, Bio2Device and Bio-X Affiliates$20.00 - Non-Members

On-Site Registration, Oct. 13:$20.00 - BayBio & MDMA Members, Bio2Device and Bio-X Affiliates$40.00 - Non-Members

Topic DescriptionPriorities for product development groups introducing a new medical devices are clear. Demonstrate clinical efficacy. Get it to market quickly. Produce a high quality device at the lowest total cost. Traditionally these priorities are addressed in series. First, “proof-of-concept” models are fabricated and evaluated in the lab. Once the clinical concept is set, the goal is to get devices representative of the final form, fit and function into human clinicals as quickly as possible. Finally the design is validated and transferred to production. The curse of success is that momentum carries the device into the market with a “prototype” design which was perfect for clinical evaluations but is expensive and inconsistent to manufacture. A panel of experts and practitioners will discuss how to design process where a multi-disciplinary team address manufacturing, supply chain and cost issues in parallel to the design team early in development.*************************************************************************************Bio2Device Group, Tuesday Morning, Oct. 13, 2009

Topic: “Rationale for Drug Delivery Technologies in Pharmaceutical Drug Development” Speakers: Suneel Gupta, PhD., CSO and Gilbert Wong, MD, Sr Dir of Clinical R&D, Impax Pharmaceuticals, Inc.Date and Time: Tuesday, Oct. 13, 2009, 6:00 – 9:00 pmLocation: Location: TIPS Group Law Offices , 1000 Elwell Court, Palo Alto, CA 94303Advanced registration is required: See www.bio2devicegroup.org website for registration now.Cost: Fee for light dinner with range depending on timing of registration:$6 - Students/In-transition $11 - Early-bird Registration $20 - Late Registration online (fee if you pass deadline)$25 - Walk-ins (when you haven’t preregistered, but only if space is available)

Topic DescriptionThe drug delivery technology landscape has evolved rapidly and considerably in recent years. However, appropriate selection and use of drug delivery technology must be based on addressing patients’ unmet medical needs in order to develop effective pharmaceutical products. This discussion will review a number of commercially successful pharmaceutical products that were developed with this underlying premise.

Speaker BiosDr. Gupta joined Impax Pharmaceuticals in Feb 2008 from Johnson & Johnson/ ALZA, where he was most recently Sr.Vice President. Dr. Gupta held several leadership positions with increasing responsibilities over almost 20 years at ALZA/JnJ. Dr. Gupta made significant contributions to development of several drug delivery-based products, such as Duragesic®, Durotap®, Nicoderm®, Testoderm®, Effidac®, Covera-HS®, Ditropan-XL®, Concerta®, Ionsys®, Jurnista®, Invega® and Priligy®. Dr. Gupta has worked across several therapeutic areas, his research interest focuses on the influence of rate and route of drug delivery to discover new indications, maximize clinical utility and/or effectiveness. He is often credited for being the lead inventor of several drug delivery products such as for Concerta®, Ditropan-XL® and Invega® products.

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Before ALZA, Dr Gupta worked for about four years at Ciba Geigy (India) in scale-up and manufacturing of several products. Dr. Gupta did his PhD from Univ. of Manchester and Post-Doc from University of California, San Francisco, and is. Dr. Gupta is a coauthor on more than 200 research publications and co-inventor on more than 40 patents.

Gilbert Y. Wong, MD is a Senior Director of Clinical Research and Development at Impax Pharmaceuticals. His Clinical R&D responsibilities include the development, design, implementation, medical monitoring, and supervision of early to late stage clinical trials for CNS drug development. Previously he held similar positions at ALZA Corporation / Johnson & Johnson and Anesiva, Inc working on analgesic and CNS compounds ranging from small molecules to peptide therapeutics that were NCEs.

Dr. Wong holds BS and BA degrees in Biochemistry and Psychology from UC Davis, a Medical Degree from Loyola University Stritch School of Medicine, and completed an Anesthesiology residency along with Pain Medicine and NIH Research fellowships at Mayo Clinic, where he then served in a faculty position for 10 years. He is well published with over 60 publications in clinical and pre-clinical sciences.

*********************************************************************Palo Alto AWIS, Monday Evening, October 19, 2009

Topic: “Stories of AWIS”Speaker: Jaleh Daie, Ph.D Managing partner at Aurora Equity And Past President of National AWIS Schedule7:00-7:30 pm Networking and light supper7:30-7:45 pm Announcements7:45-8:45 pm Program8:45-9:00 pm DiscussionDate and Time: Wednesday, Sept. 23, 2009, 7:00 pm - 9:00 pm Location: Palo Alto Research Center (PARC), 3333 Coyote Hill Road, Palo Alto Directions to PARC. For details and to register, http://www.acteva.com/go/pa-awis

Welcome!! You don’t need to be a member to attend.All scientists, students, and their friends are welcome. Men too!Members pay $4 and non-members pay $7 to offset the cost of food.

Topic DescriptionDr. Daie will share stories about AWIS history, its impact and her years as its president. With a versatile background in academia, philanthropy, science policy, education, non-profit, public service, and finance, Jaleh has a unique perspective on present and future challenges that face the scientific community and our society in general

Speaker Bio

Dr. Daie is currently managing partner at Aurora Equity, a Palo Alto-based company investing in technology start-ups. Her career includes serving as head of science and senior advisor at the Packard Foundation, over 20 years as professor and administrator at Rutgers Univ. and UW-Madison, Chair of the Council of Scientific Society Presidents, and science liaison to the President's National Sci &Tech Council while on assignment in Washington DC. She was inducted into the Women in Technology International Hall of Fame in 1996.

She was named one of Silicon Valley/San Jose Business Journal's 40 people to watch under the age of 40 in 2006, and one of Silicon Valley's Women of Influence in 2008..

     A donation of $5 for members or $10 for non-members is requested at the door to help cover the cost of refreshments. For more information about AWIS Palo Alto, visit our website at www.pa-awis.org.

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*******************************************************************************Bio2Device Group, Tuesday Morning, Oct. 20, 2009

Topic: “Deciding Who Decides, Deciding, and Doing: A BioPharma Primer”Speaker: Joseph A. Carlino, Ph.D., Principal, Carlino Consulting; Project Management and Drug Development Consulting.Date and Time: Tuesday, October 20, 2009, 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 DescriptionWitnessing or participating in slow, inefficient, and obtuse decision-making can be one of the most professionally painful and de-motivating processes in the BioPharma industry. It is also something over which project teams and even those on oversight/management committees often feel they have little control. However, understanding the roles and responsibilities of those involved in decision-making, knowing what makes a good decision, and leveraging that information in an objective and project-centric fashion, can help cut through inefficiencies and self-interests and achieve a clear, actionable decision.

Joe will use biopharma industry examples to illustrate some of these challenges, and will highlight how individuals at all levels can understand, manage, influence, and execute upon decisions to enable greater accountability, ownership, and progress. Participants are also encouraged to bring their own (blinded) decision challenges for evaluation and discussion.

Speaker BioJoseph A. Carlino, Ph.D. is an independent Biopharmaceutical Project Management (PM) and Drug Development consultant with over 30 years of experience in biomedical and pharmaceutical R&D, including more than 20 years in BioPharma PM. He received his Ph.D. in Pathobiology/ Immunology from Columbia University, and worked at institutions including Memorial Sloan-Kettering Cancer Center, Cetus, Celtrix, and Chiron. His clients have included a spectrum of small-to-medium sized biotech companies where he leads project teams, manages corporate partners, drives project decisions, defines and implements team and committee structures, and writes development plans. Joe is an active speaker on drug development and PM, and contributes to the management of professional association in Northern California such as Project Managers in Pharmaceuticals (PMPharma, www.projmgr.org) and BioScience Forum (BioSF, www.biosf.org). **************************************************************************BioScience Forum, Wednesday Evening, Oct. 21, 2009

Topic: “TBA”Speaker: Stephen Quake, D. Phil., Professor, Stanford UniversityDate and Time: Wednesday, Oct. 21, 2009 6:00 PM – Networking7:00 PM – Dinner8:00 PM - Presentation

Location: The Clarion Hotel, 401 East Millbrae Avenue, Millbrae, CA650-692-6363 | Map Price: $50 before 11PM, Monday, Oct. 19$60 on-site$30 full-time students pre-registration$35 full-time students on-site Acteva fees are added to the above prices

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**************************************************************************Bay Bio Therapeutic Breakfast, Thursday Morning, Oct. 22, 2009

Topic: “Funding for Stem-Cell Research: a Changing Landscape”Moderator: Stacy Taylor, Partner, DLA Piper LLP (US)Panel Speakers:Elona Baum, Esq., General Counsel, CIRMGregory A. Bonfiglio, Managing Partner, Proteus Venture PartnersA. Franklin Rice, MBA, Chief Financial Officer and Director, VistaGen Therapeutics, Inc.Rodney Young, Chief Financial Officer, StemCells Inc.Date and Time: Oct. 22, 2009, 8:00 – 10:00 amLocation: Elan Pharmaceuticals, Inc., 180 Oyster Point Blvd., South San Francisco, CA, 94080DirectionsRegister at http://www.baybio.org/wt/home/Funding_StemCellsCost: Early Bird Registration through Oct. 20:$10.00 - BayBio Members$20.00 - Non-Members

On-Site Registration, Oct. 22:$20.00 - BayBio Members$40.00 - Non-Members

Topic DescriptionEmbryonic stem cells have come to represent potential salvation for many people suffering from incurable diseases. State governments, most notably California with the passage of Prop 71, have taken the unusual step of funding biomedical research – usually done with federal grants – because of federal decisions to restrict funding. Recently President Obama signed an executive order ending an 8½-year ban on federal funding for the creation of new embryonic stem cell lines, paving the way for a significant amount of federal funds for the new research and development possibilities. With the climate for stem-cell research funding changing rapidly, a panel of industry executives will discuss funding opportunities – in the state of California, nationally and internationally, how companies can directly benefit and what pitfalls to avoid.****************************************************************************************************

San Jose Biocenter, Thursday, Oct. 22, 2009

Topic: “Meet With... Genentech.” Date and Time: Thursday., Oct., 22 2009 | 9:00am-4:00pm Location: The San Jose BioCenter, 5941 Optical Court, San Jose, CA 95138Click here for Venue Directions» Topic DescriptionEmerging companies find it increasingly difficult to reach the right person when seeking funding and/or partners. Through the “Meet with...” Series, we provide emerging companies with greater access to partnering and/or financing opportunities.

In this session, Genentech Partnering’s Business Development organization will talk to potential licensees to first explain what they are looking for in a company.

After the presentation, each attendee will be granted a private meeting with Anna Williamson - Senior Manager of Business Development at Genentech, Inc. - Peter Condon - Associate Director of Business Development at Genentech, Inc.

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ApplicationAttendees must apply and be approved to attend. To apply, please send your Executive Summary to Aurélie at aurelie@sjbiocenter.com by October 2nd . The Review Board, composed of the BioCenter management team, sponsors, partners and mentors, will meet in early September to consider your application. You will then be notified if your application is accepted or rejected. Registration must be completed upon approval to secure your meeting slot.

• Application fee: FREE• Registration for one: $100• Registration for two: $175• Registration for three: $225• BioCenter Members: Free*All registrations include lunch*

Speaker BiosAnna Williamson, Senior Manager, Business Development, Genentech Inc. Anna Williamson is a Senior Manager in the Business Development Department at Genentech. Anna's responsibilities include sourcing, evaluating, and in-licensing research technologies and therapeutic products. While at Genentech, Anna has developed strategic collaborations with academic institutions and with companies such as Curis, Sangamo, Abbott and Symphogen. Prior to joining Genentech in 2004, Anna worked at the University of California Office of Technology Transfer where she was responsible for managing and out-licensing a portfolio of life sciences inventions from multiple UC campuses. Anna holds a BA in Natural Sciences and a Ph.D. in Neuroscience from the University of Cambridge, UK, and carried out post-doctoral research at the University of Colorado and the University of California, San Francisco.

Peter Condon, Associate Director, Business Development, Genentech Inc. Peter Condon has worked at Genentech since 2000. Peter holds an MBA from the Wharton Business School, and has an undergraduate degree in economics from Harvard University. At Genentech, Peter began his career in the Market Development group where he conducted the launch planning efforts for Xolair and led the market research and forecasting activities for Genentech's specialty therapeutics group. In 2003, Peter joined Business Development in the Oncology licensing group and has successfully completed a number of research and product licensing transactions. Prior to Genentech, Peter worked as a consultant to health care companies in the Health Care Group at Booz Allen & Hamilton.

**********************************************************************Bio2Device Group, Tuesday Morning, Oct. 27, 2009

Topic: “Effective Transfer of Complex Biological Methods in the GMP/GLP Environment “Speaker: Ana T. Menendez, Ph.D., Senior Director of Biotechnology, CatalentDate and Time: Tuesday, Oct. 27, 2009, 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.Further details will be posted at www.bio2devicegroup in September.

Topic Description50% of the drugs presently in discovery are biopharmaceuticals - these numbers lead to an "outsource or perish" philosophy for GMP/GLP development, validation and sample analysis. Unlike synthetic drugs requiring only straightforward analytical testing biopharmaceuticals require more elaborate assays to attain regulatory compliance. The industry has a significant underestimation of the discipline, skills and planning required to successfully transfer these assays. Naiveté in this area causes loss of precious time and money during development. This seminar systematically outlines the steps needed to successfully transfer validated biological assays between GMP/GLP labs and also acquire non-validated assays for GMP/GLP development. Topics to be addressed are:

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- Setting a realistic timeline for your assay transfer- Issues that need to be addressed in preliminary discussions between the labs- Proper method writing- Parameters to be evaluated during the transfer protocolParticipants in this seminar will attain a valuable checklist of critical information that will reduce delay and confusion during method transfer. The hands-on, common sense approach will provide a chronological pathway that can easily be adapted for any complex assay.

Speaker BioAna T. Menendez, Ph.D., implemented GMP/GLP biotesting at Catalent with the following services: Cellular Technologies, Molecular Technologies and Virology. The expertise of the department ranges from recombinant proteins to therapeutic viruses, bacterial vaccines and aptamers. Dr. Menendez joined Catalent from Bristol-Myers Squibb (BMS) where she held a number of positions of increasing responsibility from 1995 to 2001. As the head of the Cancer Cell Biology department Dr. Menendez worked on several compounds currently in clinical trials, including second-generation taxanes and inhibitors of the ras and src oncogenes. While Associate Director of Regulatory Sciences she assisted the transition of Oncology and Infectious Diseases leads from the lab bench to the clinic. From 1982 to 1995, Dr. Menendez pioneered monoclonal antibody technology at American Cyanamid/Wyeth and was responsible for all the immunoassays and in vitro bioassays for Mylotarg, an anticancer monoclonal antibody – toxin conjugate that was approved in 2000.

Dr. Menendez obtained her Ph.D. in Microbiology/Immunology in 1995 from NY Medical College while simultaneously fulfilling her supervisory functions at Wyeth. She is an international instructor and consultant on Development and Validation of Bioassays.

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Bio2Device Group, Tuesday Morning, Nov. 3, 2009

Topic: "7 Steps to a Successful Life Science Startup"Speaker: Naeem Zafar, CEO of 3 Silicon Valley startups and Faculty Member at UC Berkeley Haas Business School,  business author-www.startup-advisor.com  and www.ConcordiaVentures.com Date and Time: Tuesday, Nov. 3, 2009, 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 Description  This talk will outline the steps needed for entrepreneurs to launch their startups.  Two questions that face any entrepreneur are: “when do I know that I am ready to quit my day-job” and “am I investor-ready”.  This talk will answer both of these questions.  An interactive and high energy talk will look at the overall process of starting up and what it takes to get attention from investors interested in life science companies.   

Speaker BioNaeem Zafar has extensive experience in advising entrepreneurs on starting new ventures. Naeem is a faculty member at the University of California, Berkeley, where he teaches entrepreneurship and innovation at the Haas School of Business.Naeem has worked in Silicon Valley for many startups, serving as the president and CEO of three of them. He served as a member of the Board of Directors or as a Board advisor for several startups and small companies.He has launched products in several countries. As a part of  his advisory positions, he has helped several companies in life sciences and medical device startups.Naeem has raised over $70 million from venture capitalists, angel investors public markets, and venture debt from banks.He led or played critical roles in over a dozen mergers and acquisitions. Naeem advises founders and CEOs in multiple countries, giving them information and feedback that helps them start and scale their businesses. Naeem advises governmental organizations regarding how to create an ecosystem of innovation.

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UC Berkeley Extension Career Course, Saturday Afternoon, Nov. 7, 14 & 21, 2009

Event: Career Opportunities in Biotechnology and Drug DiscoveryInstructor: Toby Beth Freedman, Ph.D, Principal, Synapsis Search and Author, Career Opportunities in Biotechnology and Drug DevelopmentDates and Time: 3 meetings, Nov. 7–Nov. 21: Sat., 1–6 pmLocation: Redwood City: Peninsula Center,1991 Broadway St.

Enroll Nowwww.unex.berkeley.edu(510) 642-4111Cost: $750 (EDP 401729)

Course DescriptionIdentify a biotechnology career path that best suits your interests, skill sets, and career goalsin this one- or three-day course (depending on location). Develop an understanding of avariety of career paths in biotech including venture capital, sales and marketing, businessdevelopment, clinical and regulatory affairs, and project management. You also get practicaljob search advice on topics such as informational interviews, résumé writing, networking, andinterviewing strategies.

Speaker BioToby Beth Freedman, Ph.D., is the author of Career Opportunities in Biotechnologyand Drug Development and owner of Synapsis Search, a life sciences recruiting company.She has a Ph.D. in molecular biology from UNC Chapel Hill.*******************************************************************************Bio2Device Group, Tuesday Morning, Nov. 10, 2009

Topic : “Acquire and Fire! Utilizing robotics and image guidance to annihilate cancer”Speaker: Michael Saracen, Director of Product Development for IGRT & Robotics at Civco Medical SolutionsDate and Time: Tuesday, Nov. 10, 2009, 6:00 – 9:00 pmLocation: Location: TIPS Group Law Offices , 1000 Elwell Court, Palo Alto, CA 94303Advanced registration is required: See www.bio2devicegroup.org website a week prior to event for preregistration detailsCost: Fee for light dinner with range depending on timing of registration:

Topic DescriptionRobots are commonplace in many industries today demonstrating the benefits reliability, precision and accuracy have to offer. Medicine is starting to embrace technology, realizing some tasks are performed better and in some cases better performed by a machine. One area which has greatly benefited from this marriage of technology and medicine is Radiation Oncology. Targeting tumors inside the body with high precision and accuracy throughout a treatment is challenging, often requiring immobilization devices to prevent the patient from moving. The problem becomes significantly more difficult when treating tumors that move with respiration like those found in the lung, liver or pancreas. One system, the CyberKnife, has successfully integrated robotics into patient setup and delivery of radiation, making treatments safer and more precise. Leveraging fully integrated image guidance capabilities, the system automatically adapts to movements and changes in the patient’s breathing patterns without user input. Robotics has a place in medicine, the question is, to what extent does it improve patient care and can reduce costs in the long run.

Speaker BioMichael Saracen is the Director of Product Development for IGRT & Robotics at Civco Medical Solutions. He has over 15 years experience creating, patenting, developing and launching new products and services into the

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medical device industry. Prior to Civco Michael worked at Accuray Inc. as director of product management and product marketing departments overseeing all aspects of the product lifecycle. Before Accuray, Michael worked in three different medical device companies overseeing their Image Guided Surgery product lines. He has extensive experience in robotics, biomaterials, radiation delivery and medical software systems. Michael received his Masters from Brown University in Biomaterials and Artificial Organs. Prior to getting his masters he worked in protein biochemistry research in the Orthopedic Department at Rhode Island Hospital.

While at Accuray Michael was a lead inventor on the RoboCouch, a fully robotic patient positioner, and took the product from concept to prototype in 6 months and received FDA clearance within 9 months. Michael has 9 issued and 10 pending patents covering robotics, quality assurance, tracking & vision systems and treatment planning software.

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CBA, Saturday Afternoon, Nov. 14, 2009

Topic: “Annual Conference: Emerging Trends in Biotechnology Industry” Date and Time: Sat, Nov 14, 2009, 1:00- 5:30 PM

Location: Double Tree Hotel San Jose 2050 Gateway Place, San Jose, California 95110

Online registration: Oct 3 - Nov 12, 11:30 PM On site registration: Starts at noon, Nov 14. Seatings will be very limited for on site registration.

Conference: Dinner with seminar: Starts at 6:30 PM at the same location

For CBA Members:     Conference Only          Free   Conference and Dinner    $50For Non CBA Members and Students/Postdocs:   Conference Only          $10   Conference and Dinner    $60For Other Non CBA Members:   Conference Only          $20   Conference and Dinner    $70   CBA will pay for the parking at Double Tree Hotel.

Details are going to be announced soon.

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Bio2Device Group, Tuesday Morning, November 17, 2009

Topic: “Puzzles, Mysteries, and Complexities: Problem Solving in Life Science Organizations"Speaker: Jerry L. Talley, JLTalley and Associates and Deborah Lynne Lombardo, Executive Associate with Barnes & Conti AssociatesDate and Time: Tuesday, November 17, 2009, 8:30 – 10:30 am

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Location: 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 DescriptionOn the door of every manager, project managers, or team leader an invisible sign that says "Bring your problems to me", or at least that's how people behave. –And in an industry characterized by innovation and research, you can be guaranteed a high volume of problems to solve. If you're lucky you have your team members to deal with their own problems.

Whether you work on your own or through a team,, your fluency in problem solving is a key component of your success. Dr. Jerry Talley (Professor of Sociology at Stanford University-retired) and Lynne Lombardo of Barnes & Conti Associates will share some new thinking in the art and science of problem solving that can give you a faster, more powerful way to think through the inevitable problems in any endeavor. Dr. Talley’s research over 10 years of examining business problems and how people solve them revealed that there are really only 6 types of problems and each problem has a best strategy for finding a solution. By accurately identifying the fundamental type of a problem rather than treating every problem with the same approach, you and your team members will save time, resources and increase good will -- not to mention fewer sleepless nights. Please join us to learn about the 6 problem types, the components of an ideal problem-solving group, and key skills you’ll need in your role as leader or facilitator.

Speaker BiosJerry L. Talley is a veteran of multiple careers. He started with 18 years on the Stanford University faculty in the department of Sociology. While there he also had a private practice as a Marriage Family Therapist for 10 years. And almost 30 years ago he moved into organizational development consulting. He has worked with over 300 clients in the Bay area, nationally, and some international. He has consulted to companies in high tech, pharmaceuticals, hospitals and health care, banking and finance, consulting houses, the military, manufacturing, public utilities, public sector, not-for-profits, publishing, hospitality, entertainment, and one organic grocery store. He specializes in strategic planning, non-profit governance, and advanced problem solving and decision-making. His practice is summarized on www.JLTalley.com.

Deborah Lynne Lombardo has more than 25 years’ experience in providing creative and practical approaches to developing high performance in organizations. At UCLA’s Anderson School of Management, she became convinced that the true challenge of any endeavor is to mobilize human talent, energy, and brilliance to achieve extraordinary results. This has been her focus ever since.

Lynne’s career has built a broad base of management, sales, and consulting experience that have benefited organizations on every continent except Antarctica. Her clients have come from nearly every sector of the economy: financial, manufacturing, high tech, communications, insurance, biotech/pharmaceutical, education, transportation, energy, health-care and not-for-profit theaters such as The Marsh and ACT in San Francisco. Her interest these days is on building high performance through better problem solving approaches; and helping companies to grow through innovative sales approaches.

Among other affiliations, Deborah Lynne is an Executive Associate with Barnes & Conti Associates who has partnered with Jerry to bring his problem solving methodology to a wider audience. Learn more at www.barnesconti.com

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Bioscience Business Development: Building Value, Thursday and Friday, Dec. 3-4, 2009

Intensive Course: Bioscience Business Development: Building Value, Thursday and Friday, Dec. 3-4, 2009 ((2 days of classroom and 2 months to complete project guided by instructor)with 2 months to complete project

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Instructors: Audrey S. Erbes, Ph.D., Principal, Erbes & Associates and www.audreysnetwork.comand and Gilbert R. Mintz, Ph.D., President of GRM AssociatesExpert Guest Speakers: Ginger Dreger, J.D., M.S., Goodwin Procter Harold (Hal) Etterman, MBA, Business Strategist Carolyn Feamster, MBA, VP, Business Strategy & Analysis Tom Gutshall, Chairman & Co-Founder of Cepheid Michael G. McCully, M.S., Director, Recombinant Capital Herwig von Morze, Ph.D., International Patent ConsultantPlease see www.ucsc-extension.edu/biobizdev for complete biographies Date & Time: Oct. 8-9, 2009, Thursday and Friday, 8:30am-5pmLocation: UCSC Extension in Silicon Valley, 2505 Augustine Drive, Santa Clara, CA 95053Fee: $770; $693 through Nov. 19

Topic DescriptionUCSC Extension in Silicon Valley presents a two-day intensive course that brings the breadth of the Bay Area’s biobusiness development expertise to our Cupertino classroom. Whether financing start-up activities, trying to keep pace with the current burn rate, or moving a product into the marketplace, bioscience companies, both large and small, have a critical need for business development at every stage of their evolution. Learn the key roles that business development and licensing play in the commercialization of a new product and the development of a successful bioscience company. Santa Clara, CA. For more information, see www.ucsc-extension.edu/biobizdev

Instructor BiosAudrey Erbes, Ph.D., Principal, Erbes & Associates and www.audreysnetwork.com has more than 35 years of marketing experience in the biotech and pharmaceutical industries, of which 25 years was in corporate management at Kowa Research Institute and Syntex Corporation.Gilbert R. Mintz, Ph.D., President of GRM Associates, a biotechnology consulting firm with expertise in business development, licensing and strategic planning.

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Bio2Device Group, Tuesday Evening, Dec. 8, 2009

Topic: “Science + Commercialization = Valuation. Building a Commercial Story that Resonates with Prospective Partners.”Speaker: Harris Kaplan, President and Chief Executive Officer, HealogixDate and Time: Tuesday, Dec.. 8, 2009, 6:00 – 9:00 pmLocation: Location: 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:

Topic Description

The biotech IPO window has been closed for some time now and is unlikely to reopen anytime soon. As a result, biotech executives are increasingly reliant on a big pharma or big biotech to provide the capital needed to continue to develop promising new compounds and the competition for pharma or biotech dollars is intense. The larger companies differ significantly from financial investors. They are at least as concerned about how the product will perform in the market post launch as they are about the science. Thus, it is as important for a biotech executive understand the commercialization opportunity and to make that story come to life for an executive. Think venture capital but without a requirement that “monies have to be put to work.”  A biotech executive has to make one of these larger companies want to do a deal with your company.

This talk will focus on how biotech executives go about building a robust commercial story – what elements need to be included in that story and how to position compounds so they are very attractive to pharma and big

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biotech scientists and business development executives. Most biotech deals get one opportunity to present their technology and/or product. This talk will help company executives make that one time count.

Speaker BioHarris Kaplan is currently President and Chief Executive Officer of Healogix, a consultancy formed in late 2005 that advises companies on how to create and maximize the value of new products in development.Harris has extensive experience in the pharmaceutical industry both on the client and consulting side of the business and has worked on the introduction of more than 75 new products including Lipitor, Crestor, Nexium, Rituxan, and Herceptin.

Harris co-founded Migliara-Kaplan Associates which became the world’s largest custom marketing research company serving 19 of the top 20 pharmaceutical companies. Migliara-Kaplan Associates specialized in helping companies identify new product opportunities and then maximizing the commercial potential of new products in development. Migliara-Kaplan was acquired by NFO in 1996 and is now part of TNS Healthcare. Harris was also cofounder of Cozint Interactive which was acquired by GFK, the German based research company. Harris serves as an advisor to several venture capital funds and is on the Board of Directors of Informedix and the Kernan Orthopedic Hospital.

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