Bio2Device Group
August 5, 2008
Agenda & Bay Area Biospace
Calendar
|
|
1. The B2DG Philosophy
T ime is precious.
Meeting begins at 8:30 a.m.
B e courteous, professional and
attentive to our guests, speakers & fellow members!
2 people needed to start a network
D o participate actively in discussions and give
positive feedback!
G et involved with the B2DG!
2. Congratulations on New Opportunities!!
3. Upcoming B2DG Events w/ Details as they become available at BDG Meetings
Aug 19 - Nader Pourmand, UCSC, Electronic-based
readout technologies for improved clinical research and diagnostics
Aug 26 - John Bashkin, Ph.D., MBA, Business
Development Director, Artificial Muscle, Inc., SmartMOVETM
Actuators: Electroactive Polymer Devices for Biomedical System
2008 EVENING MEETINGS- 2ND Tuesday of each month
Must pre-register through Acteva or pay at a B2DG
morning meeting
August 12 - Pierre Cassigneul, CEO, XDx – Registration is open –
see below
Sept. 9 - Richard Rapoza, VP & Gen Mngr.,
Abbott Vascular – The promise of bioabsorbable
stents: early clinical results and potential
Oct. 14 – Kim Popovits, President & COO,
Genomic Health
Nov 11- Vytas Pazemenas, President, Aubrey
Group – Outsourcing Issues
Dec. 9 - Peter Ferrigno, VP Sales, BD
Biosciences
4. Resume Database: Don't forget to submit your updated resume. Notify us of any contacts that you receive as a result of the resume database.
5. Leads
and Needs
See weekly emails for new Job Opportunities. Check out the Web Jobs
Listing section under the Members Tab of the http://www.bio2devicegroup.org/
for new opportunities.
6. For an up-to-date Calendar of Professional and Educational Meetings and Seminars, please look for all the Calendar of Events.- http://www.bio2devicegroup.org/weekevents.htm
7. Diane M.
Heditsian, CEO/Founder, deClarity, Move
Your Audiences to Action! “Using Messages with Motion Throughout the
Development & Life Cycle of Your Product”
8. Networking
CALENDAR OF EVENTS – SOURCES – If you have others that should
be included, please let us know so that others may benefit!!
www.baybio.org/wt/page/calendar
ewh.ieee.org/r6/scv/embs/pages/upcoming.html
http://www.caco-ca.org/aspx/chemist.aspx
www.nocalhimss.org/calendar/calendar.html
Friday, August 8
Invitrogen/Buck Institute will have its
first stem cell symposium
With only $50 registration fee ($40 for students), you will be able to attend
two exciting programs (our stem cell symposium and HESC technical training workshop)
during the same date, interact with academic/industrial experts and net work
with over 100 researchers in local stem cell community.
This will also be a very good event for anyone who is interested in stem cell
research and therapeutic applications.
Saturday, August 9th
SUMMER PICNIC AWIS-Palo
Alto is pleased to invite you to our 2nd ANNUAL POTLUCK PICNIC
Ryder Park,
1801 J. Hart Clinton Dr, San Mateo ---This park has something for all ages with
its bike paths, kite flying and picnic area, a water park and creative
play area and walking paths by the beautiful bay. So come for lunch and stay
for as long as you like.
AWIS will
provide meat and buns to BBQ and cold drinks. We would like to
invite you to bring along a side dish
ordessert
to share that serves 6-8.
Also we
will have our first raffle at the picnic with a" Mystery Basket"
giveaway (more details on site). All donations from the raffle will
support our scholarship program for women majoring in science at local
community colleges.
TIME: 12
Noon- 3
RSVP:
online http://www.acteva.com/go/pa-awis
Park
website: http://www.cityofsanmateo.org/exploreourparks/Parks/RYDER/ryder.html
Google
maps: http://preview.tinyurl.com/579k8y
Directions,
Going South on Highway 101: Take
Directions,
Going North on Highway 101: Take
For more
information, please see www.pa-awis.org,
or email awis.pa@gmail.com.
Tuesday, August 12
Bio2Device Group Evening Meeting
NO DAYTIME MEETING
REGISTRATION
REQUIRED
XDx –
A View into a Molecular Diagnostics Company
Pierre Cassigneul
President and Chief Executive Officer
XDx Inc.
Meeting is at NEW VENUE & with new SCHEDULE
TIPS Group
1000 Elwell Court, Suite
150
Palo Alto, California 94303-4318
650.293.3350
XDx, Inc.
is a molecular diagnostics company focused on the discovery, development and
commercialization of noninvasive gene expression-based tests for the monitoring
of transplant rejection and autoimmune diseases. The company has developed a proprietary new
method for noninvasively monitoring immune system activity by measuring gene
expression in a patient’s peripheral blood.
This work is the basis for AlloMap® molecular expression testing, which
provides transplant physicians with a new tool to aid in the identification of
the probability of acute cellular rejection for postcardiac transplant patient
management. Join us to learn about the
company, its product, and future plans.
Pierre Cassigneul is the president and chief
executive officer for XDx. Mr.
Cassigneul has more than 20 years of senior management experience in the
healthcare and medical device industries, both in Europe and the
Event Schedule:
6:00 to 6:45 pm --Join us for a
light dinner and networking
6:45 pm to 8:15 --Meeting will begin, Mr Cassigneul’s presentation,
followed by open networking
9:00 pm -- Out the door.
Sponsor and Hosted by: TIPS Group
Directions: New venue at TIPS’ Conference Center
Wednesday, August 13
Free UCSC Extension in Silicon Valley (
6-8:30pm
•
Biotechnology
• Bioinformatics
• Bioscience Business and Marketing
Are you interested in learning about the Bioinformatics, Biotechnology, and Bioscience
Business and Marketing certificate programs and careers in these burgeoning bioscience
arenas? This special free information session provides an opportunity to meet instructors
and other students, learn about program prerequisites, course content and program
requirements, and see how these programs can help you advance your current
career or break into a new field.
16649-007
(use course-section number to enroll)
Go to _http://www.ucsc-
_Biosciences Program Presentation _
(http://www.ucsc-extension.edu/ucsc/public/category/courseDetails.do?method=load&courseId=2626717&selectedCategoryId=1000075&selectedProgramAreaId=1000166&selectedProgramStreamId=1528536
)
No fee, but enrollment required.
Thursday, August. 14,
North Bay SubChapter-ACRP
“Good Training Practices: U Balancing Regulatory Compliance and Professional
Development in Clinical Research”
Liz Wool, RN, BSN,
CCRA, CM
Location: John Muir Health, Walnut Creek
*RSVP: _https://www.
(click here for _Map_ (http://maps.
In 2007 and 2008, the FDA and Office of Human Research Protections (OHRP) have
communicated in a multitude of ways their concern regarding investigational site
performance and the intent to regulate investigational sites GCP and clinical
research training requirements as evidenced in FDA Warning Letters and OHRP
Determination Letters. This trend impacts IRBs, investigational sites and
sponsors-CROs in their conduct and oversight of clinical research. In fact,
OHRP has publically stated that” inadequate training and education … has been a
major root cause [of] serious, systemic noncompliance” with HHS human subject
protection regulations. In addition, the FDA Draft Guidance Protecting the
Rights, Safety,and Welfare of Study Subjects -Supervisory Responsibilities of
Investigators (May 2007) clearly outlines their expectations of site staff GCP
training, site training and protocol-specific training requirements. Similarly,
The Department of Health and Human Services (HHS) Office for Human Research
Protections (OHRP) wants public comment on providing human subject research
protection education and training programs this summer. This educational event
will review training deficiencies identified by regulatory agency inspections
that impact both investigators and sponsor organizations. This review will then
launch into the review of a systematic framework for developing and
implementing employee training programs that support both regulatory compliance
(GCP, Human Subject Protection, Protocol requirements) and the professional-
Liz Wool,
RN, BSN, CCRA, CMT, has been active for 18 years in clinical research positions
in sponsor companies, investigational sites, CROs, and academia. She is
president of the ACRP Northern California Chapter and president and CEO of
QD-Quality and Training Solutions, Inc., which offers SOPs, standards, and
training services (GCP, Clinical Skills, SOPs, training plan/training curriculum
development) to investigational site staff, IRBs, sponsors, and CROs. She is
founder, Training Institute of the Pacific, a bay area training organization
that provides both public and on-site training on Good Clinical Practices for
drug/biologics, medical devices and combination products as well as an
Introduction to Drug Development course. She is currently a faculty member in
the clinical research programs at
Monday, August 18
FountainBlue's Life Science Entrepreneurs' Forum, Issues
in Collaborative Development,
Entrepreneurs,
intrapreneurs and investors are cordially invited to attend
5:30 - 7:30
p.m
DLA Piper
LLP,
2000
University,
Pre-register
for $18-$30, by visiting http://www.acteva.com/booking.cfm?bevaid=146096
by noon on Friday, August 15.
B2DG Members can register as affiliates at
the $18 rate!!!!!
On-site
registration is $40 plus $4 in fees.
We are
delighted to announce our next panel, to be held on Monday, August 18, entitled
"Issues in Collaborative Development".
As Big
Pharma and emerging life science companies adopt a range of different
strategies for their collaboration activities, collaboration transactions are
becoming increasingly varied and complex. While creating value for both
sides, collaborations present unique challenges which should be addressed at
the outset to ensure the success of the collaboration. This month's panel
will discuss key issues in structuring and executing life science collaborations
and examine their impact on the collaboration partners and other stakeholders,
including investors.
Facilitator/moderator:
J. Howard
Clowes, Partner, DLA Piper LLP
Panelists:
Adam
Bristol, Investor, Biotechnology Value Fund
Jeff Jonker,
Director of Business Development, Genentech
Jim I
McLoughlin, Executive Director, Worldwide Business Development & Pfizer
Venture Capital; Pfizer Inc. - Biotherapeutics and Bioinnovations Center
John Wulf,
EVP & CBO, Trellis Bioscience
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=146096
by noon on Friday, August 15. 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
Through the
end of July, we invite you to become a Founding FountainBlue community member
by visiting http://www.bigtent.com/hosted/fountainblue/invitation?hosted_key=7c64713f1bb5ca6734f2cbe8830e7f0a.
From there, you are welcome to join the life science and any of the other
FountainBlue communities.
Please note
that membership is free for founding community members through the remainder of
2008, and that there will be a 25% discount for all future annual memberships.
More membership information is available at http://www.fountainblue.biz/aboutus/membership.html
and at https://www.bigtent.com/groups/fountainblue.
Please note
also that registered FountainBlue founding community members who attend this
event, and other FountainBlue events in August have the option of a free
FountainBlue polo shirt.
Wednesday, August 20
Bioscience Forum, Topic: TBA
Rodney Ferguson,
J.D., Ph.D., Managing Director, Panorama Capital
Date and Time: Wednesday, August 20, 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, date to be announced
$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_ (http://www.biosf.
Meet instructors and other students, learn about prerequisites, program philosophy,
course content, and see how these programs can help you advance your current
career or break into an exciting new field.
Wednesday, Aug. 20
Free UCSC Extension in Silicon Valley
(Cupertino) Program Overview,
• Clinical Trials
and
• Regulatory Affairs
This special free information session provides an opportunity to meet instructors
and other students, learn about program prerequisites, course content and program
requirements, and see how these programs can help you advance your current
career or break into a new field
Go to http://www.ucsc-
No fee, but enrollment required.
_Clinical Trials and Regulatory Affairs Program Presentation _
(http://www.ucsc-extension.edu/ucsc/public/category/courseDetails.do?method=load&courseId=2626746&selectedCategoryId=1000075&selectedProgramAreaId=1000166&selectedProgramStreamId=2840301
)
6-8:30pm in
August
26- October 7
CRE EXAM PREPARATION COURSE
Becoming certified as a Reliability
Engineer (CRE) can be valuable to your employer and your career.
The certification is being offered
through ASQ and IEEE jointly.
Ops AlaCarte has offered the Exam Preparation Course for several years. Students have found it very valuable in
preparing for the exam.
The success rate in passing is several times higher for students that
have taken the course compared to those that have not!
Even if you are not planning on
taking the exam but need a good, in-depth course in reliability, this can
benefit you substantially.
Instructor: Doug Farel, CRE of Ops A La Carte
Schedule: Seven
consecutive Tuesdays 6 - 10 PM from
August 26 through October 7, 2008
Location:
Course
Fee: $1,295 including materials (Text Book and
Solutions Book will be distributed the first night). A 25% discount is extended to anyone who is
currently unemployed. Please note that
this course fee does not include the fee for the examination which is collected
by ASQ directly.
Registration:
This course fills up quickly and
seating is limited. Please register at: eventsinfo
or call (408) 654-0499
Exam
Date: October
18, 2008
Also note that this course is available via
web conference if cannot attend on site.
