septmeetingsept-5 - Audrey` s Network

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Audrey’s Selected Meeting List for September 2008—Update Sept. 5
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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.
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Bio2Device Group, Tuesday Evening, Sept. 9, 2008
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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
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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
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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
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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)
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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:
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Russell Singleton, President and CEO, Molecular Image Inc.
Panelists:
William Goure, Ph.D., President and CEO, Acumen Pharmaceuticals
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David Horwitz, M.D., Ph.D., World Wide Vice-President of Clinical Affairs and
Evidence-Based Medicine, LifeScan
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Ed Torres, Managing Director, Lilly Ventures
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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:
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Technology changes and how they impact development schedules and
collaborations
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Regulatory changes and how they are impacting R&D and go-to-market strategies
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Market changes and how they are affecting our projections and pipelines
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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,
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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.
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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).
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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.
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PWHA Summer Social, Wednesday Evening, September 17, 2008
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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 .
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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.
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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
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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
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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
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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.
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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
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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.
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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.
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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
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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.
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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
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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
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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
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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
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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.
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