Bio2Device Group
June 30, 2009
Agenda & Bay Area Biospace Calendar
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1. The B2DG Philosophy
T ime is precious. Meeting
starts 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. Upcoming
B2DG Events w/ Details as they become available at B2DG Meetings
July 7 - Julia
S. Rasor, Rasor Consulting
Group, The Versatility and Power of the White
Paper in Breaking Through Roadblocks for Medical Device Companies
July 21, Amish Parashar,
ITU, Why There Has Never Been a Better Time to Start a
Company
July 28 - Liz Lison, IVD Cutting Diagnostics
August 4 – Steve Benner,
MD- Sr. VP & Chief Medical Officer, OncoMed
Pharmaceuticals, Targeting Cancer Stem Cells
August 18 – TBD
August 25- Dr. Aswan, Upmo
Sept. 15 – Susan Rowinski, Sue Rowinski Group, LLC Key Drivers of Reimbursement
Strategy Development & Planning for Medical Devices
Sept. 22,
2008 EVENING
MEETINGS- 2ND Tuesday of each month- Pre-registration thru Acteva is
Required
July 14- Lori Hennessy from Marketing at Life Technologies
August 11 - TBD
Sept. 8 – Dan Levy, Intradigm- Developing siRNA-Based
Therapeutics
Oct. 13- Suneel Gupta, PhD - CSO and
Gilbert Y. Wong, MD, Senior Director of Clinical R&D, Impax
Pharmaceuticals, “Rationale for Drug Delivery Technologies
in Pharmaceutical Drug Development”
3. 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.
4. 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.
5. 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
6. June 30 - Jaye
Thompson, Senior VP, Clinical Operations, inVentiv
Clinical Solutions, The top 10 mistakes that
emerging companies make during product development.
7. Networking -
CALENDAR OF EVENTS – SOURCES – If you have others that should be included, please let us know so that others may benefit!!
American Medical Writer’s Association (AMWA) Northern California Chapter
Association for Women in Science, East Bay Chapter
Association for Women in Science (AWIS), Palo Alto Chapter
Association of Clinical Research Professionals, Northern California Chapter
Bay Area Clinical/Regulatory Roundtable
Bay Area Drug Safety Association
Bay Bio Calendar of life science events
Bio2Device Group Weekly Meeting
Biomedical Seminars at Stanford University
Biotech Entrepreneur to Entrepreneur
California Analytical Chemists Organization (CACO)
Chinese Bioscience Association
Engineering in Medicine and Biology Society, Santa Clara Valley Chapter
Fountain Blue Life Science Entrepreneurs Forum
Genetic & Environmental Toxicology Assn. of Northern California
HBA Healthcare Business Women’s Association San Francisco Chapter
Healthcare Information and Management Systems Society (HIMSS), Northern California Chapter ()
Parenteral Drug Association West Coast Chapter
Pharmaceutical Project Management Local Interest Group Northern California
Professional Women’s Healthcare Alliance
Regulatory Affairs Professionals Association
University of Santa Cruz- Extension-Biosciences
Tuesday, June 30
Bio2Device Group
The Top 10 Product Development Mistakes
Jaye Thompson, Ph.D.
Senior Vice
President, Regulatory Affairs, Emerging Biotechnology, inVentiv
Clinical Solutions, LLC
So you’ve
landed in an emerging biotechnology/device company and you work hard 20 hours a
day and can’t sleep because of the stress and anxiety of your waking
hours. In this industry, every day can
be like walking in a minefield. What
mistakes can you avoid? What pitfalls
are lurking around the corner? Jaye
Thompson, an entrepreneur who has spent her career watching early stage
companies for over two decades, will summarize the top 10 mistakes that
emerging life science companies make.
Dr.
Jaye Thompson has more
than 20 years of experience in the clinical research industry. At inVentiv Clinical Solutions, she is responsible for
regulatory affairs and assisting emerging technology companies. In addition, she is the senior executive in
the office located in The Woodlands,
Prior to
its acquisition by inVentiv, Dr. Thompson was
President and Founder of SYNERGOS, Inc, a leading clinical research
organization based in
Dr.
Thompson has advised a number of leading life science companies on strategic
planning and clinical product development. She has directed and managed
statistical analysis, data management, report writing, and conduct of clinical
trials for a wide variety of indications. In addition, she has been actively
involved in over 200 clinical trials for drugs, biologics, and devices. She has
directed and managed the data management, statistical analysis and report
writing for multiple FDA submissions, including 6 NDAs
and 3 PMAs. Moreover, she frequently represents Sponsor companies at FDA
meetings and advisory committee meetings and teleconferences.
Dr.
Thompson holds a Bachelor's degree in Applied Mathematics from
Tuesday Evening, June 30
French Bio Bay Networking Event with
Bio2Device Group and a Turkish Flavor
(6:30-10 PM)
Location: Sultana Restaurant 1149 El
Camino Real, Menlo Park, CA 94025, Tel. (650) 322-4343
_http://www.thesulta
Plenty of free parking in the rear and close to Caltrain
Menlo Park station
Register: RSVP by Monday 29 June 2009 - _www.frenchbiobay.
Cost: The informative networking dinner in a private room setting for a prix
fixe of $25 (all included price: food, soft drinks, tip and taxes) will feature
this delicious Turkish/Middle Eastern buffet:
Event Description
We are ready to get together again for our next event to kick off summertime on
Tuesday 30 June 2009 starting at 6:30 PM. The event will take place at Sultana
Restaurant in Menlo Park, where
R&D, will introduce the Bio2Device Group (_http://www.biodevic
Menu
Wine aperitif, Cacik, Lahmacun,
Felafels, Chicken shish, Kofte
or Vegeterian option Baklava
Tea or Coffee Non alcoholic soft drink
To RSVP and book by Monday 29 June 2009, go to
_http://www.acteva.
Acteva charges $1.66 for the reservation processing).
Walk-ins will be accepted but will have to pay $40.00 at the door. No one will
be admitted at this event without paying the fee, even if you do not intend to
eat. Again
Wednesday,
July 1
July
ACRP Webinars
Optimal
Handling of Laboratory Samples – Improve Your Data Quality: Guidance for
Clinical Research During
this simple but effective interactive webinar, attendees gain crucial insight
into the importance of strictly following laboratory sample handling manuals
and standardizing and controlling procedures for the collection and storage of
clinical samples taken for subsequent analysis of key biomarker data.
REGISTRATION: http://www.acrpnet.org/Events.aspx
Tuesday, July 7
“The Versatility and Power of the White Paper in Breaking Through Roadblocks for
Medical Device Companies”
Julia S. Rasor,MS, Medical Device Strategist, Rasor
Consulting
Group; Former CEO and Founder, CAPNIA, Inc.
8:30 – 10:30 am
Sunnyvale City Council Chambers, 456 W. Olive, Sunnyvale, CA (across the street
from Sunnyvale Public Library)
Cost: Free
Parking on street and in NOVA and library parking lots across the street See
details at _www.Bio2DeviceGrou
Gain invaluable insight on how to utilize White Papers to break through
roadblocks and unite thinking in medical device development, regulatory
affairs, fundraising, marketing and sales, and more. The many versatile uses of
this vehicle will be covered as well as the author background and steps needed
to create a successful White Paper. Hear case studies where the speaker’s White
Papers have yielded multi-million dollar venture funding, increased sales,
reversal of FDA’s previously stated decisions, and have been instrumental in
transforming medical device company start-ups into large cap companies such as
J&J, Medtronic, Boston Scientific, and Tyco. Speaker Bio
Julia Rasor, Medical Device Strategist at Rasor Consulting Group, is a strategic entrepreneur with an
extensive track record of leading very successful solutions for business,
clinical, or regulatory roadblocks as well as technical hurdles. She uses a
combination of science, business, and regulatory savvy and tools developed from
a 50-company experience to 'Fast Track' companies reducing cost and risk thus
seizing the competitive advantage.
Julia is inventor of a $100M/year revenue medical product (the first commercial
ultrasonic contrast agent; CEO Founder of a drug delivery company that closed
~$38M to date and whose present CEO is the former CEO of Alza and Glaxo; Member of 5 Scientific Advisory Boards; Inventor of
13 issued and pending patents; Founder of Rasor
Consulting Group celebrating 25 years of success for clients at http://www.MedicalD
Julia holds an M.S. in Human Physiology from the University of California,
Davis, a B.S. in Biology from Wright State University in Dayton, Ohio, a
Professional Certificate in Engineering Management from University of
California in San Diego (a 2-year post baccalaureate academic study in
management science), and a Multidisciplinary Medical Communications Certificate
from the American Medical Writers Association (AMWA, Founded in 1940).
Thursday, July 9
Too Much Dose? A Look at X-Ray Imaging Systems
6:00 – 9:00
pm
Location:
Triple Ring Technologies,
Speaker:
Cost: The
seminar is free of charge, but RSVPs are required to help plan for food.
On-Site
Registration: A limited number of on-site registrations may be available.
Register
Now: http://www.acteva.com/booking.cfm?bevaid=177799
by Wednesday, July 8 at noon.
About
the Seminar:
Widespread
media attention has been paid recently to increased radiation dose to the
average American due to medical imaging. In 2009, an organization chartered by
Congress to provide guidance on the measurement of and the protection of the US
population from radiation (NCRP) issued a report that found a nearly six-fold
increase since the early 1980s in medically derived radiation dose.
In this
presentation, we investigate the causes of this increase in dose. We describe
several radiation-based imaging modalities including radiography, fluoroscopy,
and CT, examining how they work, how images are formed, and how radiation dose
arises. These imaging modalities have each shown their value in clinical
practice. So the question that arises is not whether to eliminate them, but
rather, are there advanced imaging systems that offer equivalent image quality
with lower dose. We conclude by introducing a couple of innovative imaging
techniques that may meet this challenge.
About the Speaker:
Dr.
Monday Evenings, July 13-Aug. 3, 2009
Intellectual Property Essentials for the Life Science Industry Course,
Soody Tronson, J.D., M.S.
6:00PM to 9:00PM
Number of Sessions: 4
Location: 10420 Bubb Road, Cupertino
Cost: $435.00 (Early Enrollment $391.50 through June 29th)
Biotechnology, pharmaceutical, and medical device companies must acquire,
exploit, and, when necessary, enforce intellectual property rights to capture
the value of their technology and innovations.
UCSC Extension in Silicon Valley presents a four session course which through
lectures, case studies and in-class exercises, demystifies key intellectual
property principles and applications, emphasizing topics of particular
relevance to the biotechnology, pharmaceutical and medical device sectors. The
instructor explains the basic principles of patents, and explores their
strategic implications in a variety of contexts, such as securing funding,
establishing barriers to competitor entry, achieving freedom to operate,
technology transfer, and strategic alliances. Topics of particular interest to
the life science industry are addressed, including research tool patents,
reach-through royalties, the patenting of federally funded research, the
patenting of genes and living beings, and the interplay of patents and federal
regulatory schemes. While the course focuses to a large extent on patents,
other forms of intellectual property such as trade secrets, trademarks,
copyrights and contractual agreements are also discussed, particularly as they
apply to biotechnology, pharmaceutical, and medical
device companies.
.
For more information, see www.ucsc-extension.
Wednesday,
July 15
July
ACRP Webinars
Too
Important To Ignore: How to Market, Promote and Brand Your Site This webinar presents tools and
tactics necessary for an investigative site to properly market, promote and
brand themselves in their community. Discussion includes internal and external
communication, as well as outreach and networking. In conjunction with
study-specific recruitment advertising, these marketing tactics assist in
increasing enrollment at the site level.
REGISTRATION: http://www.acrpnet.org/Events.aspx
Thursday and Friday, July 16-17, 2009 +
Meeting*
“Bioscience Product Marketing”
Audrey Erbes,
Ph.D., Principal, Erbes & Associates,
* “It’s Time to Develop Product Marketing Plan”
* "Bioscience Marketing Research"
* “Bioscience Strategic Product Marketing and Planning”
* “Bioscience Product Marketing and Sales Plan”
* “Potential Bioscience Tactical Marketing Activities”
Expert Guest Speakers:
* Charles Versaggi,Ph.
* Chris Mahoney, MPA, Solution Sales Executive at IMS Health. "Patient Adherence: The Impact on Brand Performance"
* Richard Clark, Senior Director Commercial Development, ARYx
Therapeutics. "Product Management 101- Developing/Executin
* Steven Wong, B.A., Senior Consultant at Plan A. Topic–"Market Research
Information Resources."
* Bonnie McNeil, Marketing, PR, and Sales professional with Cision.
Health Care PR and Communication: The Strategy and Implementation of eMarketing."
* Erik Haghjoo, Ph.D. Consultant in
the Life Sciences division of Simon-Kucher &
Partners in
3 meetings: Thursday & Friday 8:30am-5pm, July 16-17 *plus
1 additional 3 hr meeting at a mutually agreed time by participants for
presentation of team marketing plans
Fee: $700 ($630 through July 2)
For more information and to register, visit _www.ucsc-extension
(http://www.ucsc-
This product marketing and selling-focused course gives participants an
in-depth look at product planning and research, marketing planning, and
promotional execution as they are done in the bioscience industry. Topics
include market research methodologies, information sources and applications
relevant to product planning; the development of marketing strategy, product positioning
and differentiated claims; and the creation of tactical marketing programs and
activities to maximize revenue potential. Course activities include the
creation of a preliminary marketing plan developed over several weeks after the
intensive classroom time. The plan will be presented later in the term at third
meeting date agreed upon by the registrants. The course is well suited for all
levels of professionals in bioscience marketing research, product management,
product sales, advertising, public relations, business development and
licensing, as well as other related functions, such as regulatory, clinical and
legal.
Tuesday, July 21
San Jose Biocenter,
Meet With... Takeda Research Investment, Inc.
Juan Harrison, Vice
President, Takeda Research Investment, Inc.
9:00 am - 4:00 pm
Takeda Research Investment, Inc. (TRI) is the corporate venture arm of _Takeda
Pharmaceutical Company Limited world-class pharmaceutical company and the
largest in Japan. A wholly-owned subsidiary of Takeda America Holdings, Inc.,
TRI started operations in 2002. Our aim is to encourage and support therapeutic
innovation in biopharmaceutical companies and academic centers of excellence,
through early stage capital investment and provision of access to the resources
of a multinational pharmaceutical company.
At this event companies will hear a presentation by Takeda Research Investment,
Inc. to hear what they are looking for in a company. Then the attendees will
have a private meeting with Vice President, Juan Harrison. The “Meet with…”
Series provides greater access to a pipeline of emerging companies for
Foundations, Angels, Investors, Governmental Agencies, Big Pharmas,
and others who have partnering and/or financing opportunities.
To apply,
please send executive summary to _events@sjbiocenter
Wednesday,
July 22
Windhhover Webinar: FDA Requirements for Device Software: Are You in Complicance?
2:00 p.m.
EDT • 11:00 a.m. PDT (90 minutes)
- What the most critical components are to a
software verification and validation program
- How errors are introduced into software code
- How to satisfy design control requirements for
your device software using simulation, modeling and visualization
techniques
- How much testing is enough
- The appropriate amount of documentation for the
software you are making
- How to conduct risk analysis for device software
- When an iPhone is a
medical device, and how to determine whether your software is a medical
device
- How and when an electronic health record system
should be regulated
…and much more
Dan Olivier President, Certified Compliance
Solutions Inc.
Raymond A. Bonner, Partner
Sidley
Nathan C. Sheers, Partner
Sidley
Allison Fulton, Associate
Sidley
Shawn Schmitt (moderator) Managing Editor
"The Silver Sheet"
Wednesday,
July 22
July
ACRP Webinars
People,
Process, Technology: The Three-Legged Stool of Clinical Research This webinar provides an overview
of the three main characteristics shared by almost all successful clinical
research centers – good people, good process, and good technology – and about
common problems experienced with all three, along with advice for how to
overcome them. It will also discuss how people, process and technology often
fail separately if they’re not working together properly. Specific areas of
focus during this webinar will be on recruitment and finance, but the concepts
can be applied to any aspect of running a successful research center.
REGISTRATION: http://www.acrpnet.org/Events.aspx
Thursday, July 23
"Hot Topics In
Visual Inspection"
John Shabushnig, Pfizer & PDA Chair of the Board of
Directors
6:00-9:30
PM | Dominic's at Oyster
Agenda
6:00 PM
Registration, Networking Hour
7:00 PM
Banquet Buffet Dinner
7:45 PM
Announcements
8:00 PM
Presentation & Discussion
9:30 PM
Closing
Visual
inspection of final product containers for particulates and foreign matter is a
hot topic in the pharmaceutical industry and an important regulatory
requirement. This presentation will provide discussion around why we
inspect, followed by a review of recent compendial
activity and regulatory observations in the area of visual inspection with an
historical analysis of common themes in these observations. The results
of the recent industry benchmarking study undertaken to better understand the
current state of visual inspection will follow. This study compares the
most recent responses from the 2008 survey with those from past surveys in 1996
and 2003. There will also be time for questions and discussion of
inspection issues and concerns specific to those in attendance.
John Shabushnig, Ph.D. is a Sr. Manager within Pfizer's Global
Quality Organization (GQO) Center responsible for Microbiology and Aseptic
Support. He is also Chair of the Board of Directors of the Parenteral
Drug Association (PDA), leader of the PDA Visual Inspection of Parenterals Interest Group, a member of the PDA Strategic
Planning Committee and the PDA Science Advisory Board. He serves on the
USP Parenteral Products Industrial Expert Committee and the USP ad hoc Visual
Inspection Committee.
Registration
Submit
registration requests via e-mail to rsvp@wccpda.org with "WCC PDA July 23
Dinner RSVP" as the subject line. Indicate name and company
affiliation for each registrant. Seating is limited to the first 100
registrants! It is strongly encouraged that you register in advance to
ensure seating at this event, and to allow us to provide an accurate head count
for meals.
Pricing
Policy
Pre-Registration
$ 65.00; Walk- Ins/At Door $ 75.00
Payment
Options
WCC PDA
uses PayPal® to process all credit card payments. Access PayPal
directly from the chapter website at www.wccpda.org
(click the "Events" button and scroll down to the PayPal link). You
do not need a PayPal account to use the online payment service and there is no
additional fee for registrants. For check payments, you can use the PayPal
service or make paper checks payable to "WCC-PDA." If you experience
difficulty with the PayPal link, contact the webmaster.
Saturdays, Aug 1 - Aug 29, 2009:
GOOD MANUFACTURING PRACTICES
UCSC Extension in
Familiarity with the Good Manufacturing Practices (GMP) regulations is a
necessity for employees engaged in the manufacture, regulation and quality
assurance, and control of drugs and biologics. Through lectures, discussions,
and case studies, participants gain an understanding of the FDA GMP and Good
Laboratory Practice (GLP) regulations. Emphasis is on drugs and biologics, with
additional coverage of the regulations that apply to cell and gene therapies,
including stem cells. While primarily aimed at the manufacturing, quality
control, and quality assurance worker, the course is also useful for those in
regulatory affairs and clinical research. It also has general utility for those
who wish to understand which regulatory controls apply to the manufacture of
drugs and biopharmaceuticals for human use. Detailed information: www.ucsc-extension.edu/biosciences
Wednesday, August 19
Biosciences
Program Presentation: Biotechnology, Bioinformatics and Bioscience Business
Learn about
the Bioinformatics, Biotechnology, and Bioscience Business and Marketing
certificate programs at UCSC Extension and about careers in these burgeoning
bioscience arenas. This free information session provides an opportunity to
meet instructors and other students, learn about prerequisites, course content
and program requirements, and see how these programs can help you advance your
current career or break into a new field. Presented by UCSC Extension in
Silicon Valley and held at the NEW
Detailed information: www.ucsc-extension.edu/biosciences
Wednesday, August 26
Clinical Trials
and Regulatory Affairs Program Presentation
Learn about
the Clinical Trials and Regulatory Affairs certificate programs at UCSC
Extension and about exciting careers in clinical and regulatory affairs. This
free information session provides an opportunity to meet instructors and
program alumni, learn about prerequisites, course content and program
requirements, and gain insight into in these in-demand professions. Presented
by UCSC Extension in Silicon Valley and held at the NEW
Detailed information: www.ucsc-extension.edu/biosciences
June
20 (Saturday)
#612 Design Control
8am to 12pm, 1pm to 5pm. = 8 hours
http://www.acteva.com/booking.cfm?bevaid=183723
Instructor:
Barry Craner
July
11, (Saturday)
#631
HSPM & RoHS (Restriction of Hazardous
Substances), 9am - 1pm
http://www.acteva.com/booking.cfm?bevaid=184541
July
18 (Saturday)
#611
Risk Management
8am to 12pm,
1pm to 5pm 8 hours
http://www.acteva.com/booking.cfm?bevaid=174546
Instructor:
Barry Craner
Tuesdays , Aug. 18, Aug. 25, Sept. 1
(,
6 – 10 PM)
#601 Introduction to the Biomedical Industry,
http://acteva.com/booking.cfm?bevaid=170633
Sept.
12 & 19 (Saturdays)
Course
#602: Quality System Regulation for Medical Devices,
http://www.acteva.com/booking.cfm?bevaid=174548
Sept.
15 & 17 (Tuesday & Thursday)
#618 ISO 13485:2008 - Implementing the ISO Quality
Management System (QMS) for Medical Device Organizations,
http://www.acteva.com/booking.cfm?bevaid=174553
If you have questions about registration, contact
Stanford University Biomedical Seminars
Jul 08, 2009 (Wed)
| 8:00 AM - 9:00 AM | Medicine
Medicine Grand Rounds-Short
Sleep, Poor Sleep: Novel Risk Factors for Obesity and Diabetes
Braun Auditorium in the
Jul 10, 2009 (Fri)
| 1:00 PM - 2:00 PM | Neurosciences Institute
Science in an Age of Endarkment: Some Examples from Scientific Fraud, Quackery,
Religion and University Politics, Professor David Colquhoun,