Audrey’s Selected Meeting List for September 2008—Update Sept. 5 ***************************************************** ***************************************************** BayBio MedTech Breakfast, Tuesday Morning, Sept. 9, 2008 Topic: “Accelerated Commercialization: Lessons Learned” Panel Moderator: Frank F. Rahmani, Partner, Cooley Godward Kronish LLP Panel Speakers: Hanson Gifford , President and CEO, The Foundry Carl Simpson , Managing Director, Coronis Medical Ventures Shelley Trimm, Senior Project Manager, Alquest, Inc. Date and Time: Sept. 9, 8:00am - 10:00am Location: Cooley Godward Kronish LLP, Palo Alto, CA Registration: If you are an employee of a Partner or Sponsor company, please contact Program Director, Misha Tsirulnikov to obtain your complimentary registration. Early Bird Registration through Sept. 8, 2008: $10.00 BayBio Members $25.00 Non-Members On-Site Registration, Sept. 9, 2008: $20.00 BayBio Members $40.00 Non-Members Pre-registered attendees will receive an immediate receipt/confirmation after submission. Please print this receipt/confirmation and bring it with you to receive your conference credentials. Photo ID (driver's license or passport) will be required at check-in. All sales are final - BayBio offers no refunds. Go to http://www.acteva.com/booking.cfm?bevaid=164479 Reservations by mail or fax: http://www.baybio.org/pdf/BayBio_Order_Form.pdf Topic Description Experts in cardiovascular and orthopedic medical devices will share lessons learned on the key drivers of accelerated commercialization. A panel will consist of a venture capitalist, a medical device executive and a CRO consultant. Within the context of critical and parallel paths to commercialization, panelists will discuss such issues as design/development testing, regulatory and clinical affairs, and reimbursement. Each participant is guaranteed to leave with at least one valuable new insight. ***************************************************** Bio2Device Group, Tuesday Evening, Sept. 9, 2008 1 2/12/2016 Speaker: Richard J. Rapoza, Ph.D. Divisional Vice President, Abbott Vascular Topic: “The promise of bioabsorbable stents: early clinical results and potential” Date and time: Tuesday evening, Sept. 9th, 6-9 pm Note New Schedule: 6:00 to 6:45 pm --Join us for a light dinner and networking 6:45 pm to 8:15 --Meeting will begin, speaker’s presentation, followed by open networking 9:00 pm -- Out the door. Evening Location: TIPS PC Group 1000 Elwell Court, Suite 150 Palo Alto, California 94303-4318 650.293.3350 NO DAYTIME MEETING REGISTRATION REQUIRED <http://www.acteva.com/booking.cfm?bevaid=165823> (becomes active at 8am on 8/26) Details at www.bio2devicegroup.org coming soon Topic Description One year results on the ABSORB trial (a first-in-man, 30 patient feasibility trial for Abbott Vascular's bioabsorbable coronary stent) show results comparable to metallic DES in simple lesions. Further development is underway for larger scale human trials. A review of Abbott Vascular's efforts, both technical and clinical, will be presented. Speaker Bio Richard Rapoza began his career with the company as a materials engineer at Advanced Cardiovascular Systems, Inc., now part of Abbott Vascular through the acquisition of Guidant. From there, his career progressed through several manager and director roles in research, marketing and quality systems, both in coronary and peripheral areas. Richard was promoted to Vice President of Operations for Endovascular Solutions in March 2000. He was appointed to his current role, Divisional Vice President and General Manager for Bioabsorvable Vascular Solutions at Abbott Vascular in March 2007. Richard is a graduate of the University of California at Berkeley, where he earned a B.S. in chemical engineering and a M.B.A. He also received his Ph.D. in chemical engineering from the University of Washington, Seattle. Directions: New venue at TIPS' Conference Center. 1000 Elwell Court, Palo Alto. Exit 101 and head North on San Antonio Road. Turn left onto East Bayshore Road. The TIPS 2 2/12/2016 office is on the corner of East Bayshore and Elwell. A large parking area is at the rear of the building (either turn right at the FEDEX box off of Bayshore, or turn right onto Elwell and then right into the first driveway). See map and photo of the site at http://biodevicegroup.org/addl_directions.htm See map andphoto of the site at http://biodevicegroup.org/addl_directions.html ***************************************************** ACRP Program, Thursday Evening, September 11, 2008 Program: New Clinical Trials Registry Law Speaker: Patty Kasper, P. Kasper & Associates, Adjunct Instructor, UCSC Ext. in Cupertino Date and Time: Thursday, September 11, 2008 Schedule: 6:00 – 7:00 PM Registration, Networking & Dinner Buffet 7:00 – 7:30 PM Welcome & Announcements 7:30 – 9:00 PM Educational Program Location: Universtiy of California Santa Cruz Extension, 1180 Bordeaux Dr., Sunnyvale, CA 94089 Registration Costs: ACRP members No Charge with RSVP on Acteva before Sept. 9th Nonmembers with RSVP on Acteva before Sept. 9* --$10 Register at event--$20 ACRP members Online Contact Hours—No Charge ACRP members Paper Contact Hours--$25 NonACRP members Paper Contact Hours--$25 Event Door Prizes Free Membership to ACRP for One Year Free Registration: Good Clinical Practices: Medical Devices Course San Bruno, CA October 2008 Topic Description: New federal law expands the scope of the Clinical Trials Registry DataBank known as ClinicalTrials.gov. The FDA Amendments Act of 2007 impacts sponsor reporting requirements for drug, biologic, and now device studies. Additional trials, additional data including results, and device studies must be made accessible to the public. This Act has stimulated much discussion in the industry and in the public arena. This presentation provides an overview of the history of the law, the ClinicalTrials.gov website, the new 2007 requirements, and penalties for non compliance. Speaker Bio 3 2/12/2016 Patty Kasper is the owner of P. Kasper & Associates, offering clinical research training and operations services for the biopharmaceutical industry. She has over 20 years of experience in Phase 1‐ 4 clinical trials in many indications in the US, Canada, and Europe. She has also written and trained on SOPs during the past 15 years. She is on the faculty at UCSC Extension and has taught one of the core courses for the Clinical Trials Design and Management Crtificate Program since its inception in 1999. Patty is currently Secretary of the Northern California Chapter of ACRP. She has a BS and MS from Washington State University. To Register: https://www.acteva.com/go/nccacrp (currently not functioning; have notified the sponsor) ***************************************************** FountainBlue's Life Science Entrepreneurs' Forum, Monday Evening, Sept. 15, 2008 Topic: “From Strategy to Execution: Growing Your Company to the Next Level” Facilitator/moderator: · Russell Singleton, President and CEO, Molecular Image Inc. Panelists: William Goure, Ph.D., President and CEO, Acumen Pharmaceuticals • David Horwitz, M.D., Ph.D., World Wide Vice-President of Clinical Affairs and Evidence-Based Medicine, LifeScan • Ed Torres, Managing Director, Lilly Ventures • Other Panelists to be confirmed Date and Time: Monday, Sept. 15th, 5:30 - 7:30 p.m. Location: DLA Piper LLP, 2000 University, East Palo Alto, CA. Cost: Pre-register for $18-$30, by visiting http://www.acteva.com/booking.cfm?bevaid=146097 by noon on Friday, September 12. On-site registration is $40 plus $4 in fees. Panel Topic Description For this month’s life science entrepreneurs’ forum, we will focus on how large companies and small companies are addressing the rapidly evolving trends in the market and growing their organizations to the next level, despite and in alignment with the rapidly evolving life science industry. We will specifically address: · Technology changes and how they impact development schedules and collaborations · Regulatory changes and how they are impacting R&D and go-to-market strategies · Market changes and how they are affecting our projections and pipelines · Ethics challenges and how our clients and partners and the media are impacting the business Information and Registration: NO SERVICE PROVIDERS PLEASE. To pre-register now for the discounted rate of $18-$30, plus $2-$4 in fees, visit http://www.acteva.com/booking.cfm?bevaid=146097 by noon on Friday, 4 2/12/2016 September 12. A limited amount of on-site registration is available for $40 plus $4 in fees, on a first-come, first-served basis. Additional information about our life science entrepreneurs' forum and notes from our previous meetings are available at http://www.SVLifeScience.com You are cordially invited to join FountainBlue’s community online by visiting http://www.bigtent.com/hosted/fountainblue/invitation?hosted_key=7c64713f1bb 5ca6734f2cbe8830e7f0a. Membership benefits are highlighted at http://www.fountainblue.biz/aboutus/membership.html. ***************************************************** Bio2Device Group, Tuesday Morning, Sept. 16, 2008 Topic: "Tomography: from the micron to the nanometer level". Speaker: Joy C. Andrews, Ph.D., Staff Scientist, Stanford Synchrotron Radiation Laboratory, and Professor of Chemistry and Biochemistry, CSU East Bay Date and Time: Tuesday, Sept. 16th, 8:30 am to 10:30 am Location: NOVA, 505 West Olive, Sunnyvale, Room 510 Cost: Free Details at www.Bio2DeviceGroup.org Topic Description Three-dimensional tomography can yield important information on the structure of biological systems and materials. On the micron level, for example, it can portray details of the structure of bone and other biological materials, and give insight into responses to various drug treatments and mechanical stresses. On the nanometer level, with 40 nm resolution, the transmission x-ray microscope is capable of imaging cellular detail and environment. This detailed information, particularly in 3 dimensions can yield valuable insight into various biological, environmental and materials samples. Speaker Bio Joy C. Andrews, Ph. D. is a Staff Scientist at the Stanford Synchrotron Radiation Laboratory (SSRL) and full professor of chemistry and biochemistry at California State University East Bay. She has brought many students to SSRL to study metals in biological systems and has published numerous papers on this work, including several on plants that can be used for remediation of metal contamination. She is currently working with an x-ray microscope that can look at individual biological cells, nanoparticles and other materials. Joy was chair of the Synchrotron and Neutron Users Group (2005-2008), a group of scientists who regularly visit Washington DC to inform policy makers about the value and varied applications of basic science. She was also graduate coordinator of the Chemistry and Biochemistry Department at CSUEB (2006-2008), and chair of the SSRL User’s Organization Executive committee (2005-2006). 5 2/12/2016 ***************************************************** Bioscience Forum, Wednesday Evening, September 17, 2008 Topic: Translating Preclinical Data to the Early Clinical Development of Kinase Inhibitors for Cancer Speaker: Dana T. Aftab, Ph.D.,Vice President, Translational Research, Exelixis, Inc. Date and Time: Wednesday, Sept. 17th, 2008 6:00 pm – networking 7:00 pm – buffet dinner 8:00 pm - presentation Location: The Clarion Hotel, 401 East Millbrae Avenue, Millbrae, CA, 650-692-6363 Cost: $50 before 11PM, Monday, Sept. 15th $60 on-site $30 full-time students pre-registration $35 full-time students on-site Acteva fees are added to the above prices See details at www.biosf.org Topic Description Kinases play critical roles in tumor biology, and Exelixis has primarily focused on this class of enzymes for the discovery and development of small molecule drugs for cancer. Dr. Aftab will describe case studies of several investigational agents that target key kinase pathways in cancer cells. The presentation will focus on the results from preclinical and early clinical studies with these agents, and will highlight the use of translational approaches to select patient populations and to assess drug responses early on in treatment. Biography: Dr. Aftab is Vice President of the Translational Research division at Exelixis, a biotechnology company in South San Francisco focused on the discovery and development of new agents to treat cancer and other serious diseases. He has previously held positions as a senior scientist, as project team leader for drug discovery programs, and as head of the Pharmacology department, and has been with Exelixis since 1999. Prior to joining Exelixis, Dr. Aftab held senior scientist positions at Versicor, Inc. and MetaXen, LLC. He received a B.A. in Pharmacology from U.C. Santa Barbara, a Ph.D. in Pharmacology from Yale University, and completed postdoctoral training in Molecular and Cell Biology at U.C. Berkeley. . ***************************************************** PWHA Summer Social, Wednesday Evening, September 17, 2008 6 2/12/2016 Event: Back to School Networking Date and Time: Wednesday, September 17, 5:30 pm-8:00 pm Location: Cooley, Godward, Kronish LLP, 3175 Hanover Street, Palo Alto, CA 943041130 Cost: Pre-registration $25 and at the door $30 Event Description Come meet old friends and make new ones; expand your professional opportunities at PWHA's 5th annual (highly successful) Summer Networking Event, sponsored by Cooley, Godward, Kronish LLP We hope to see you there! Registration: Click here to Register! If you are unable to click through above, see http://www.pwha.org/Events_summer_networking.html; you will be able to register at the website . ***************************************************** Engineering in Medicine and Biology Society (EMBS), Wednesday Evening, Sept. 17, 2008 Topic:”Applied Innovation: How to find the next big thing in MedTech” Speaker: Joshua Makower, M.D., CEO, ExploraMed Development, LLC. Date and Time: Wednesday, September 17, 2008, 7:30pm Location: Clark Center auditorium, Stanford University Optional Dinner, Stanford Hospital Cafeteria, 6:15 pm (no host, no reservations) Cost: Lecture is free Topic Description So you'd like to do something with your career that will make the world a better place for patients,. but where do you start? How do you find the next big opportunity in Medtech? Dr. Makower will share with you the secrets of the Stanford Biodesign Innovation Process and show how he has applied these same principles to help create new companies in several medical fields. Speaker Bio Joshua Makower, M.D. is the Founder & Chief Executive Officer of ExploraMed Development, LLC, a medical device incubator based on the west coast and is also a Venture Partner with New Enterprise Associates. Dr. Makower serves as a Consulting Associate Professor of Medicine at Stanford University Medical School and is Co-Founder of Stanford's Biodesign Innovation Program. 7 2/12/2016 Prior to this, he was Founder, Chairman and Chief Technical Officer of TransVascular, Inc. a company focused on the development of a completely catheter-based coronary bypass technology, which was acquired by Medtronic, Inc. in 2003, and Founder and Chairman of EndoMatrix, Inc., a company focused on the development of a novel therapy for incontinence and GI Reflux, which was acquired by C.R. Bard in 1997. Up until 1995, Dr. Makower was Founder and Manager of Pfizer's Strategic Innovation Group, a group chartered to create new medical device technologies and businesses for Pfizer's medical devices businesses. Dr. Makower holds over four dozen patents for various medical devices in the fields of Cardiology, ENT, General Surgery, Drug Delivery, Orthopaedics and Urology. Dr. Makower holds a Masters of Business Administration degree from Columbia University, a Doctor of Medicine degree from the New York University School of Medicine, and a Bachelor of Science degree in Mechanical Engineering from the Massachusetts Institute of Technology. Dr. Makower also serves as Chairman of the Board for Acclarent, Inc., NeoTract, Inc, Vibrynt, Inc. and moximed, Inc. - ExploraMed's most recent spin outs, and on the Board of Directors for Intrinsic Therapeutics, Inc. - a venture backed private company developing innovative spinal therapies. PDA:West Coast Chapter Meetings and Events, Thursday Evening, Sept. 18, 2008 Moderator Elizabeth Leininger, Ph.D., VP Regulatory Affairs, QA and Clinical Operations, StemCells Inc. Panelists: Lucia Cabral, Director Supplier Quality, Genentech, Inc. Karen Walker, Senior Director, Quality, Solstice Neurosciences Inc. Daniel Lobato, QA/QC Professional Date and Time: Thursday Evening, Sept. 18, 2008 Agenda 6:00 PM Registration/Reception 7:00 PM Dinner 7:45 PM Announcements 8:00 PM Presentations & Discussion, Q & A 9:30 PM Closing Cost: Pre-Registration: $65 Walk-ins/At Door: $75 See registration details below. Topic Description 8 2/12/2016 The product owner is responsible and accountable to regulatory agencies, and required to qualify its suppliers and maintain suitable oversight. Recent events such as with contaminated heparin API, and diethylene glycol in glycerol, indicate that the risks to product quality and patient safety are real, and can be severe. Challenges to the biopharmaceutical and pharmaceutical industry include: international, complex, long supply lines; difficulty in obtaining complete information on the basic manufacturers, and the challenges in exercising oversight on numerous firms all over the world. Several industry professionals from local Bay Area companies will present and discuss their current methodology and experience. Attendees are invited to send in questions in advance with their registration and participate in the Q&A session that follows the presentations. Speaker Bios Lucia Cabral has been with Genentech since 1990. She has held several positions in Quality Control, Compliance, and Quality Assurance in the areas of environmental control and validation, incoming material testing, biochemical lot disposition, deviation management and the management and oversight of suppliers, contract manufacturers and laboratories. Ms. Cabral has over 12 years of experience managing over 210 Genentech suppliers/contractors worldwide and holds a B.A. degree from the University of California, Davis, in Biological Sciences with emphasis in Microbiology. Karen Walker has been employed in the biotechnology/biologics industry for over 20 years. She began her career in research, process development and process transfer, focusing on mammalian cell culture production of therapeutic proteins. Since then, she has held positions in the areas of validation, regulatory affairs, and quality assurance. Currently Ms. Walker is the Senior Director of Quality Assurance at Solstice Neurosciences, Inc. Karen’s responsibilities include the oversight of manufacturing, establishment, and maintenance of the quality systems, and she also liaisons with clients and partners on quality-related issues covering an international scope. Daniel Lobato was most recently Director of Quality Control at Genitope Corp, maker of MyVax® personalized cancer therapy. There, he was responsible for assay and instrument validation activities in preparation for FDA inspection, and led the strategy for specifications on personalized therapies. Prior to that, he was vice president of Quality at Micro-Virology Laboratories, Inc., a contract laboratory where he implemented quality systems to service biotechnology and pharmaceutical companies on the west coast. Before that, he was associate director of QC at Onyx Pharmaceuticals. He has more than 20 years of experience in QA and QC, with a strong emphasis on biopharmaceuticals and raw materials. Mr. Lobato has held positions at other leading pharmaceutical companies, including SmithKline Beecham Pharma, Synergen, Inc., Onyx Pharmaceuticals, and Geneva Pharmaceuticals. Mr. Lobato’s received his bachelor’s degree in chemistry from Metropolitan State College of Denver. He regularly presents on QC and QA topics and is a member of ACS and PDA. Registration Preregistrations are now taken via e-mail to rsvp@wccpda.org with "WCC PDA September Dinner RSVP" as the subject line. Specify if you will require a vegetarian 9 2/12/2016 pasta meal. The registration fee covers dinner, presentation, and validated parking. Receipts are available upon request. It is strongly encouraged that you register in advance to ensure seating at this event. Payment via PayPal ® Please RSVP too, as described above. WCC PDA meeting attendees can now use PayPal® to process all credit card payments. You do not need a PayPal account to use the online payment service and there is no additional fee. You may access PayPal directly via the attached link or complete a credit card form to sign and bring the night of the event. Important Notes: Make sure that the quantity in the shopping cart is correct and don't use the back button on your browser. Some employers may block access to PayPal. In this case, you may have to register from home or we can do it for you if you complete a credit card form. Once you have entered the number of attendees for whom you are paying, click the "Proceed to Checkout" button. Do not use the "Continue Shopping" button. A charge from PayPal will appear on your credit card bill. If you experience difficulty with this link, contact the webmaster. $15 discount is offered to government employees and university students. Payment Options: • Cash, check, or credit charge (Amex, MC, Visa only) • For credit card payments, request form with your registration, complete, sign, and bring it with you the night of the event. • For check payments, make payable to "WCC-PDA"and include the names of the attendees on the stub. Cancellation Policy! Dinner seating is reserved and confirmed in advance. We regret that no refunds can be offered for non-attendance. If a registrant is unable to attend, substitutions are welcome. Sponsorship Sponsors have the opportunity to showcase their company, network with the attendees, and be mentioned in the evening’s announcements and color brochure. If your company is interested in sponsoring the reception hour for an upcoming dinner meeting, please let us know! Hotel Information: Clarion Hotel Directions Highway 101, exit Millbrae East. Hotel parking lot is on the right hand side. Note: Bring your parking ticket to the WCC PDA registration desk for validation. Parking Clarion Hotel parking lot is on the right-hand side of the entrance. There is a $4/auto charge, but parking tickets will validated upon request at the registration desk. Transit Info BART CalTrain System Map CalTrain Schedules ***************************************************** 10 2/12/2016 San Jose BioCenter, Thursday Afternoon, Sept. 18, 2008 Topic: Overcoming M&A Challenges - Planning a Good Deal and Your Exit Confirmed Panelists include: • Peter McWilliams, Ph.D., Principal, Sanderling Ventures, and Chairman & Acting CEO of Actimis: a biopharmaceutical company currently being acquired by World Bio-giant Boehringer Ingelheim GmbH for as much as $515M. • Gary Titus, Senior Vice President and Chief Financial Officer, Kosan Biosciences: currently being bought by Bristol-Myers Squibb for $190M. • Ellen Koskinas, Partner, InterWest Partners LLC: a successful Venture Capitalist with outstanding board member experience, including active observer on the board of Epicor (acquired by St. Jude Medical), and who led - prior to InterWest - Guidant's acquisition of CardioThoracic Systems. Date and Time: Thu., Sep. 18, 2008 | 3pm-6:30pm | Menlo Park, CA Location: Orrick, Herrington & Sutcliffe LLP, 1000 Marsh Road, Building 1100, Menlo Park, CA 94025-1015 This event is typically sold out, therefore please register early to secure your spot. • Panel + Networking Reception: ° Regular Price: $40 ° Partners' Network: $30 ° BioCenter Members: free • Networking Reception only: $20 • On-site Registration, if space allows: add $10 to the above Topic Description We have seen significant changes in M&A activity in the life sciences industry, but how does that affect the future of your company and the industry as a whole? Has M&A stalled or are deals fewer and far between but larger in scope? Alternatively, has the pace quickened but with monumental changes to the structure of a deal? Most importantly, how can you position your company to make acquisition an attractive option? Join this panel to hear M&A strategy perspective from the acquirer and the acquired, the investor, and the lawyer. ***************************************************** Bio2Device Group, Tuesday Morning, Sept. 23, 2008 Speaker: Connie Hoy, VP RA/QA, Xoft, Inc. Topic: “Managing Complaints, Adverse Events, and Recalls” Date and Time: Tuesday, Sept. 16th, 8:30 am to 10:30 am Location: NOVA, 505 West Olive, Sunnyvale, Room 510 Cost: Free Details at www.Bio2DeviceGroup.org 11 2/12/2016 ***************************************************** PWHA Executive Breakfast, Wednesday Morning, Sept. 24, 2008 Panelists: Maureen Conners, President, Conners Consulting Gabrielle Lajoie, Managing Director, Russell Reynolds, Associates Nola Masterson, Managing Director, Science Futures LLC Laura Raynak, Managing Director at Rusher, Loscavio & LoPresto Date and Time: September 24th, 2008, 8-10 AM Location: Morrison and Foerster Offices 425 Market Street, corner of Market and Fremont (lefthand side of Fremont before crossing Market), San Francisco, 94105 Advance registration required for security purposes. Go to www.pwha.org to register Cost: $45 for members and $55 for non-members Topic Description As a senior executive in your organization, you have interacted with Board members - the good, the bad and the ugly. Please join us for breakfast and a fascinating panel discussion on what qualities define a "good" Board member. Our panelists bring a wealth of experience in executive recruiting and Board participation in life sciences companies, and will share their views on how to become a Board member, roles and responsibilities of Board members, and what it takes to distinguish yourself as a really great Board member. Go to www.PWHA.com to register. ***************************************************** BayBio Therapeutic Breakfast Series, Thursday Morning, Sept. 25, 2008 Topic: Developing Treatments for Ovarian Cancer Panel Moderator: Fahti Khosrow-Shahi Vice President, Brand Management Practice, Campbell Alliance Date and Time: Sept. 25, 8:00am 10:00am Location: Latham & Watkins LLP,140 Scott Dr., Menlo Park, CA 94025-1008 Map and Directions. Parking: Ample parking available at no cost in the employee lot. Topic Description Ovarian cancer is the fifth leading cause of cancer-related deaths among women in the United States. Although incidence rates have been declining since the early 1990s, the five-year survival rate has increased by a mere 8 percent over the past 30 years. According to the Ovarian Cancer National Alliance, while one in 72 women will develop ovarian cancer in their lifetime, one in 95 will die as a result of the disease. If diagnosed and treated early, however, ovarian cancer can often be cured. With the potential to have a significant impact on the treatment of ovarian cancer, many companies in Northern California's life sciences industry are focusing product development efforts on the disease. Please join us to learn more about their approach and their hope for future treatments for ovarian cancer. Registrations: If you are an employee of a Partner or Sponsor company, please contact Program Director, Misha Tsirulnikov to obtain your complimentary registration. 12 2/12/2016 Early Bird Registration through May 20, 2008: $10.00 BayBio Members $25.00 Non-Members On-Site Registration, May 22, 2008: $20.00 BayBio Members $40.00 Non-Members Pre-registered attendees will receive an immediate receipt/confirmation after submission. Please print this receipt/confirmation and bring it with you to receive your conference credentials. Photo ID (driver's license or passport) will be required at check-in. All sales are final - BayBio offers no refunds. Go to http://www.acteva.com/booking.cfm?bevaid=164484 for registration For registration by mail or fax: http://www.baybio.org/pdf/BayBio_Order_Form.pdf ***************************************************** Palo Alto AWIS, Thursday Evening, Sept. 25, 2008 Topic: Effective “Boss” Management: Winning Strategies for Managing “Up” Speakers: Rossella Derickson and Krista Henley Date and Time: Thursday, September 25th, 200Schedule 7:00-7:30 pm Networking and light supper 7:30-7:45 pm Announcements 7:45-8:45 pm Program 8:45-9:00 pm Discussion Location: PARC Auditoriumm, 3333 Coyote Hill Road, Palo Alto Cost: Members pay $4 and non-members pay $7 to offset the cost of food. RSVP: http://www.acteva.com/go/pa-awis Topic Description When you engage with your boss it helps to be armed with awareness and tools so that you can prepare to make the best of any communication or situation. Few can deal effectively and smoothly with their current boss but most authority figures trigger negative reactions that could be managed with greater wisdom. In this talk, we will explore different types of bosses and winning strategies for managing up effectively. Rossella Derickson and Krista Henley have translated their business and organizational psychology experience into Wisdom in the Workplace, consulting, training and coaching modules that support healthy group and company dynamics. Rossella and Krista have co-authored a book “Awakening Social Responsibility-A call to Action” and are directors of the South Bay Organizational Developmental Network. Raffle Ticket Sale: At our September and December meetings, we will be selling Raffle tickets with a “Theme- Mystery basket” giveaway; winner will be announced at our December event. All proceedings from the raffle will support our scholarship program for women majoring in science at local community colleges. 13 2/12/2016 Welcome!! You don’t need to be a member to attend. All scientists, students, and their friends are welcome. Men too! Directions from 280: Take Hwy 280 and exit at Page Mill Rd and go East towards Palo Alto (if coming from the South, turn right, if coming from the north, turn left onto Page Mill. Turn RIGHT onto Coyote Hill Rd. Turn LEFT into PARC (formerly Xerox PARC). Follow signs to the Auditorium on your left at end of parking area, down flight of outdoor stairs. Directions from Stanford: Take Foothill SOUTH towards Los Altos. Turn RIGHT on Hill view and PARC is 2nd driveway on the right. Park and follow signs to the Auditorium (walk uphill through parking lot then down a flight of outdoor stairs). Pacific Drug Safe Safety Summit, Sept. 26th, 2008 Date and Time: Friday, September 26, 2008, 8am - 5pm PST Location: Westin San Francisco Airport, One Old Bayshore Highway, Millbrae, CA 94030 Registration: $225 * Early Bird Registration: $195 (Register by September 5th) http://guest.cvent.com/EVENTS/Info/Custom.aspx?cid=17&e=5bc8da7e-45ea-45d4a23c-a00bd9cee904 ***************************************************** Bio2Device Group, Tuesday Morning, Sept. 30, 2008 Speaker and Topic: Tour of Stanford’s Goodman Simulation Center- Limited space- so you must pre-register Date and Time: Tuesday, Sept. 30, 8:30 am to 10:30 am Location: TBD Cost: Free See details at www.Bio2DeviceGroup.org when available ***************************************************** Bioscience Business and Marketing Essentials Course, Thursday and Friday, Oct. 910, 2008 Course Description The bioscience industry is like no other. Lengthy timelines and unique financial, legal, regulatory, social, political, and healthcare-system challenges impose constraints that impact every aspect of the business. This course will help you understand the dynamic bioscience industry landscape; appreciate important business drivers and challenges in 14 2/12/2016 the industry; gain insight into the critical roles that business and marketing disciplines play at all stages of a bioscience company's development; and learn the skills needed to develop key documents to inform important business decisions. Experienced and novice business and marketing professionals--as well as scientific, clinical, regulatory, financial and legal professionals--can benefit from this practical introduction to the business and marketing facets of the bioscience industry. Instructor: Audrey Erbes, Ph.D., is a marketing professional 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, a biopharmaceutical licensing and investment subsidiary of Kowa Company Ltd., Japan. Prior to that, she held management positions at Syntex Corp. (acquired by Roche) in market research, product management, strategic marketing and planning, and business development in the U.S. and abroad, with a special emphasis on Europe and Asia/Pacific/Canada. Guest Speakers: Donald Holsten, Pharm D., a regulatory consultant and educator with over 20 years of national and international experience as a senior regulatory affairs and quality assurance executive, has expertise in food, drug/biopharmaceutical, medical device and cosmetic products. He has an intimate knowledge of the FDA approval cycle and has helped prepare numerous biotechnology and pharmaceutical companies for FDA interactions and panel reviews. Don has held management positions at several companies, including Liposome Technology, Inc and Oclassen Pharmaceuticals, Inc. where he was Director of Regulatory Affairs/Quality Assurance and Director of Regulatory Affairs, respectively. Earlier in his career he held a senior level position as Assistant Chief, Food and Drug Branch, Department of Health Services for the State of California. Topic: "Operating in the U.S. Regulatory Environment: Is Product Approvable" Bev Hudson, M.B.A., is general manager of clinical research services at MedPoint Communications, Inc., a global leader in medical communications and professional medical education. Her previous experience includes running sales and operations for Mayo Clinical Trial Services, and she spent eleven years at Genentech in sales and marketing management roles. Topic: "The Impact of U.S. Health Care System on Marketing Biotech Products" Julie Tompkins, M.B.A., is senior vice president at Timely Data Resources (TDR), a healthcare market research and consulting firm. She has nearly 30 years experience in the pharmaceutical and biotech arenas, including more than 12 years in industry and 17 years in market research consulting, and has worked with pharmaceuticals, diagnostics, and drug delivery systems. At Syntex (now Roche), Julie worked in both R&D and Marketing, including positions as Analytical Chemist, Market Research Analyst, Manager of New Product Planning, and Manager of Market Analysis. She spent most of her time in Marketing as the primary liaison between Marketing and R&D, serving as a key member on multi-disciplinary project teams and strategic planning committees. After leaving Syntex, Julie was President and Founder of MedSearch, a primary market 15 2/12/2016 research company that merged with TDR in January 2000. She holds a B.A. in Human Biology from Stanford University and an MBA from Santa Clara University. Topic: "Using Marketing Research to Optimize Product Planning, Development and Marketing" For Credit 1.5 Units Date and Time: Thu, Fri 8:30AM to 5:00PM, Oct 09, 2008 to Oct 10, 2008 Number of Sessions: 2 Required Text(s): No textbook required; fee includes extensive materials. Recommended Text(s): None Section Note(s):Early Enrollment Fee: $657 through Sept. 25. $730 after Sept. 25. 16 2/12/2016