march 13, 2016 august 2016 complimentary service of … · 2016. 3. 14. · clinical data...
TRANSCRIPT
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Audrey’s Life Science Meeting Picks for March 13, 2016 – August 2016
Complimentary Service of AudreysNetwork.com
March 13, 2016
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PBSS Workshop, Monday – Friday, March 14-18, 2016
Workshop: “Clinical Trials Essentials: An Intensive One-Week Course (Register for full week
or 4-hr sessions)”
Speakers: Edward Rozhon, Mike Huston, Pete Shabe, Savita Sinha, Clarisa Tate, Narinder
Singh, Frances Ann McKenney
Date and Time:: Monday, March 14, 2016, 12:30-17:00
Registration fee (US$): (USD$)One-week full course: $1865; Mon AM: Drug Development
Process: $250; Mon PM: Science of Clinical Trials Design: $250; Tue AM: Clinical Data
Management: $250; Tue PM: Applied Statistics in Clinical Trials; Study Site Perspective:
$250; Wed AM: Monitoring Clinical Trials: $250; Wed PM: Medical Devices, An Overview:
$250; Thur AM: GCP & ICH Investigator & Clinical Research Site: $250; Thur PM: Clinical
QA/Compliance Audits and the FDA: $250; Good Manufacturing Practices and regulatory
trends: $250; Fri PM: Global Clinical Trials Perspective; Business of Clinical Research: $250;
Location: SF Bay Area: 2505 Augustine Dr, Santa Clara (UCSC-Extension in Silicon Valley)
Registration: http://www.PBSS.org
Registration deadline:3/12/2016 (it will close sooner if the seating cap is reached)
About the Topic
Clinical Trials Essentials: An Intensive One-Week Course
A joint course between UCSC Extension Silicon Valley and
Pharmaceutical & BioScience Society -- San Francisco Bay
March 14-18, 2016
(Register for the full-week or any half-day sessions)
Monday March 14, 2016 – 8:30 am—12:30 pm
Drug Development Process 4 hours – Edward Rozhon
Major players in drug development
Assay development and discovery of new medical entities
Non clinical and clinical development of new drugs
History and regulatory oversight of FDA
Structure of Phase I, II, & III clinical trials
FDA review of New Drug Application.
Monday March 14, 2016 – 1:30 pm—5:30 pm
Science of Clinical Trials Design 4 hours – Mike Huston
Phases of drug development
Objectives of clinical studies
Basic clinical trials designs
Underlying science for clinical trials designs.
Tuesday March 15, 2016 – 8:30 am—12:30 pm
Clinical Data Management 4 hours – Speaker TBA
Key data management activities for study startup, conduct, and closeout
Regulations applicable to data management activities
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Clinical data management systems and electronic data capture (EDC)
Working with contract research organizations (CROs) for data management.
Tuesday March 15, 2016 – 1:30 pm—3:30 pm
Applied Statistics in Clinical Trials 2 hours – Pete Shabe
The role statistics plays in clinical research
Basic data summarization techniques
Estimation and Hypothesis Testing Introduction
Estimation and Confidence Intervals
Statistical Hypothesis Testing.
Tuesday March 15, 2016 – 3:45—5:30 pm
Study Site Perspective 2 hours – Speaker TBA
Translational research in an academic center: fundamental strengths and
weaknesses
Research Process and Operations management as the success of a trial
Essential conversations between academia, biomedical and pharmaceutical
companies, venture capitalists and consultants
Data Integrity and well-supported metrics (Case Studies).
Wednesday March 16, 2016 – 8:30 am—12:30 pm
Monitoring Clinical Trials 4 hours – Savita O. Sinha
Review the basic regulatory requirements of monitoring a clinical research study
Describe the tasks that should be performed before, during, and after a monitoring
visit
Learn how to track all key parameters involved in monitoring a site
Know how to complete visit reports and follow-up on action items after each site
visit.
Wednesday March 16, 2016 – 1:30 pm—5:30 pm
Medical Devices, An Overview 4 hours – Clarisa Tate
What is a medical device, an general overview of regulations
Medical devices regulatory pathways: 510(k), PMA, and HDE
Medical device clinical trials: Focus on Investigational Device Exemptions
Post-market surveillance: Focus on 522, complaints, and recalls
Globalization and changing regulatory environment.
Thursday March 17, 2016 – 8:30 am—12:30 pm
GCP & ICH Investigator & Clinical Research Site 4 hours – Narinder Singh
Historical and legislative roads to Good Clinical Practices (GCP)
Principles of GCP and the research-care conflict
Role of various stakeholders in Clinical Trials
Elements of informed consent.
Thursday March 17, 2016 – 1:30 pm—5:30 pm
Clinical QA/Compliance Audits and the FDA 4 hours – Frances Ann McKenney
Qualifications needed for GXP auditors and FDA Inspectors
Objectives of sponsor audits and regulatory inspections
Similarities and differences between sponsor audits and regulatory inspections
General approach to hosting an audit or inspection
Types of findings that cause concern for auditors or inspectors.
Friday March 18, 2016 – 8:30 am—12:30 pm
Good Manufacturing Practices and regulatory trends 4 hours – Narinder Singh
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Good Manufacturing Practices (GMP) for drugs
GMP for biologics and related products, including Good Tissue Practices
Considerations for Quality Systems.
Friday March 18, 2016 – 1:30 pm—2:30 pm
Global Clinical Trials Perspective 1 hour -- Narinder Singh
Trends in global clinical trials.
Role of FDA and local regulatory culture.
Friday March 18, 2016 – 2:45 pm—5:30 pm
Business of Clinical Research 2 hours – Mike Huston
The Market Players – Pharma, Biotech, Contract Research Organizations (CROs)
Cost of Doing Business – Cost of conducting clinical research
Outsourcing and CROs – It costs money to make money
Innovative Ways to Reduce Cost – Business Strategies and Process Innovations.
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Bio2Device Group, Tuesday Morning, March 15, 2016
Topic: Developing Transformative Medical Devices in the Digital Health and Mobile
Technology Era”
Speaker: Gregg A Jackson, Principal Consultant, ProPharma Group, and most recently
Gershon MedTech
Date and Time: Tuesday, March 15, 2016, 8:30 am
Location:Sunnyvale City Council Chambers, 456 West Olive Ave., Sunnyvale, CA
No fee or registration required for morning meetings.
Topic Description
We are all hearing about how Digital Health, IT and Mobile Technology are transforming
health care, and especially the medical device industry, but how much of this is hype, and
how much is reality? And most importantly, what can you be doing to help your medical
device have more market value, clinical efficacy and investment potential?
Come hear from a prolific entrepreneur and innovator who was a significant contributor to
some of Silicon Valley’s biggest medical device blockbusters. Listen to him share real world
examples of where this truly is occurring, as well as get front line, leading edge tips on
what’s up and coming that’ll help you take full advantage of this transformation. He’ll share
info about how smart innovators and medical device development programs can learn from
their mistakes, and maybe even leap-frog them, as well as discuss tidbits that can be
gleaned from the recent events at Theranos.
Speaker Bio
Mr. Gregg Jackson has over 25 years’ experience in Program, Project, and Engineering
Management with Value To Business such as: Turnarounds, innovation, transformations and
creation of breakthroughs...a true visionary, strategic thinker, and implementer, dedicated
and focused on bottom line results for successful business growth and expansion.
Well known in the Bay Area and West Coast for his successful entrepreneurial work at
startup, small, medium and large companies, he is a founding team member of Channel
MedSystems, Barrett’s MedSystems, BE Technologies, and Physiocue, and had significant
roles at the world’s most successful medical device blockbusters ACS/Eli Lilly IPO to Guidant
(later acquired by Abbott for $27B), and a huge bay area success, St. Francis Medical
Technologies (acquired by Kyphon for $725M which was shortly later acquired by Medtronic
for over $4B). He was also Consulting as the Acting Director of R&D for N-Spine in San
Diego, helping them to get ready for the acquisition by Synthes ($40-60M). Most recently
he has joined the Advisory Board for Ziteo Medical, become an advisor in the FAST/CLSA
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program, and is a Principal Consultant for ProPharma Group, the prestigious Kansas-city
based, but globally operating, Life Science consulting firm.
Mr. Jackson utilizes an extensive background in Program, Project, R&D, Process and
Contract Manufacturing Engineering Management for the development and launch of Medical
Devices, Biotech, mobile-health, clinically used, and hospital based technology, including
but not limited to: implants, minimally invasive, drug delivery, catheter-based, orthopedic,
aseptic fill, cardiovascular, diagnostic, and ablation.
He is currently a Principal Consultant at ProPharma Group www.ProPharmaGroup.com. A
description of his most recent work in the medical device field, prior to joining ProPharma
Group is at: www.GershonMedTech.com.
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JLABS, Tuesday Morning, March 15, 2016
Event: “Meet with GE”
GE Representative: Alex de Winter | Director, Healthcare Ventures, GE Ventures
Date and Time: Tuesday, March 15, 2016,
10:30am | Registration Opens and Networking
11:00am | Presentation and Q&A
11:45am | Networking Lunch
1:00-5:00pm | One-on-one Meetings*
Location: Johnson & Johnson Innovation, JLABS, 329 Oyster Point Blvd - 3rd Floor, South
San Francisco, California
Fees:
Presentation & Lunch
$25 | General Public
$35 | General Public Onsite
Includes presentation, Q&A, and lunch. All attendees must pay this fee, regardless of one-
on-one meeting status. Registration to attend the presentation, Q&A, and lunch will remain
open until March 14th, 2016 (or sold out).
One-on-One Meeting
FREE | Application
FREE | Accepted Companies
Companies must have applied for a one-on-one meeting ahead of time. The one-on-one
application period ends on February 17th, 2016. Your application will be reviewed and you
will be notified of acceptance by March 1st, 2016. Acceptance of a one-on-one meeting is
not guaranteed as all applications must be approved.
Details and Registration:
http://www.eventbrite.com/e/meet-with-ge-ventures-tickets-19183383015?aff=weekly
Topic Description
Accelerate your Innovation with a capital partner that can help scale your ideas and grow
your company! GE Ventures' unrivaled access to a global network of GE expertise and
resources along with investment capital can help bring business to the next level. GE
Ventures' investment themes include:
• Digital Health - Use of combinations of devices, sensors, software, services and data
to improve patient care
• IT/Service - Software and connectivity solutions that improve efficiency and decision
making
• Minimally Invasive Procedures - Devices that enable new less invasive methods to
deliver therapies and diagnostics
• Precision Medicine - Life science tools and diagnostics that enable personalized care
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Representatives from GE Ventures will be in attendance to give an overview presentation
about the company's key areas of interest and funding opportunities. Following the
presentation, don't miss this opportunity to introduce yourself to Alex DeWinter, Director,
Healthcare Ventures during the networking lunch. And finally, for those companies who
apply online and are approved, one-on-one meetings with GE Ventures will provide a forum
to discuss your company.
*Companies must have applied for a one-on-one meeting ahead of time and be approved.
The application period ends on February 17th, 2016.
GE Ventures Participating Representative’s Bio
Alex de Winter invests in life science instrumentation and clinical diagnostics startups,
leading GE Ventures' investment in Veracyte (VCYT). Alex joined GE Ventures from Mohr
Davidow Ventures, where he served as a board director with On-Q-ity and board observer
for CardioDx, Corventis, Crescendo Bioscience, didimi, DVS Sciences, and Personalis. He
started his career as a research scientist with 454 Life Sciences (acquired by Roche) and
Pacific Biosciences (PACB). Alex has an MBA from UC Berkeley, a Ph.D. in chemistry from
Stanford, and graduated magna cum laude from Amherst College with a BA in English and
Chemistry. When not working, Alex enjoys cooking and supporting/lamenting the Dallas
Cowboys.
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Nanotechnology Council, Tuesday Morning, March 15, 2016
Subject: Nanoscale Magnetic Resonance Imaging – the Quest For a Molecular Structure
Microscope
Speaker: Dr. John Mamin, IBM
Date and Time: Tuesday, March 15, 2016, 11:30 - Networking, Pizza & drinks; 12:00 noon
to 1 pm - Seminar
Suggested $5 donation for lunch
Location: Texas Instruments Building E Conference Center, 2900 Semiconductor Dr., Santa
Clara
More detail here: http://sites.ieee.org/sfbanano/
Topic Description
Magnetic resonance imaging (MRI) has had a huge impact in the biomedical field, with its
ability to image the body non-destructively in three dimensions. A number of groups around
the world are working to develop nanoMRI, applying the principles of MRI to perform three
dimensional microscopy, with the ultimate goal of imaging individual biological molecules
such as protein. Because nuclear magnetism is such a weak effect, any such technique will
require a magnetic sensor that is both extremely sensitive and nanometer scale. In the past
our group has used ultra-sensitive force detection to sense the minute forces (~10-18 N)
between a magnetic tip and small ensembles of hydrogen nuclei. More recently, we have
explored the use of nitrogen vacancy centers in diamond as quantum magnetometers for
detecting nuclear magnetic resonance. I will describe both recent progress and the
considerable challenges that lay ahead.
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EMBS, Wednesday Evening, March 16, 2016
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Title: “The Evolution and Future of Mechanical Circulatory Support for Congestive Heart
Failure”
Speaker: Dr. J. Donald Hill, MD
Date and Time: Wednesday, March 16, 2016, 7:30 PM
Location: Room M-114, Stanford University Medical School
Optional dinner location: Stanford Hospital cafeteria, 6:15 PM (no host, no reservations)
Topic Description
The modern era of mechanical circulatory support (MCS) for chronic congestive heart failure
(CHF) began circa 1964. Michael Debakey in 1963 ushered it in. He convinced fellow Texan
and then President of the United States Lyndon Johnson that the world needed an artificial
heart. A small amount of contract funding was provided. It was not a moment to early. The
therapy for CHF was based on very rudimentary drug therapy. In the last 5 decades that
has improved substantially but is not a significant deterrent for the increasing morbidity and
mortality of CHF. Heart transplantation, introduced in 1967, and leaping forward in the early
‘80s with the introduction of cyclosporine immunosuppressive therapy is an excellent
therapy. Its weakness, as a public health solution for CHF, is the stubborn limited
availability of donor hearts being at stuck at 2000-2200/yr. for two decades. That falls far
short of the 40,000-50,000 hearts/year needed. The number of patients at risk is increasing
every year as the baby boomers reach 65 years of age. Now approximately 5-6 million
people have some stage of CHF at any one time.
The National Institute of Health (NIH) managed the Artificial Heart Program (AHP). There
were four research pathways that included energy, a control system, biomaterials, and the
pump. This original AHP was the seed that drove much of the applied science that fortified
private companies to get into the sector later.
Nature’s very successful biological heart was the model adapted to reproduce. Aggressive
specs were adapted. Total implanted heart replacement, pulsatile flow > 10/min, and
tether-less power supply. This meant valve pusher plate pumps that were attached to the
atrial remnant after the heart was removed.
The holy grail of chronic MCS is conquering the blood-foreign surface interface that leads to
thrombus and patient embolic strokes. Much progress has been made but it remains today
the single most troublesome property of Mother Nature to tame. The design and
management act of balancing anti-thrombogenic surfaces and anticoagulation vs. thrombo-
embolism and/or bleeding has never gone away.
Speaker Bio
Dr. J. Donald Hill was born and raised in Halifax, Nova Scotia, Canada. He graduated from
Dalhousie Medical School in Halifax in 1960. He received his general and thoracic surgical
training at Cincinnati General Hospital, Victoria General Hospital in Canada, and California
Pacific Medical Center in San Francisco. Dr. Hill also spent one and a half years doing animal
based cardiac device research at the Thoracic Clinic of the Karolinski Hospital in Stockholm,
Sweden from 1961-1963.
Dr. Hill was a practicing cardiovascular surgeon from 1966 - 2009. He served as Chairman
of the Department of Cardiac Surgery at California Pacific Medical Center (“CPMC“) in San
Francisco from 1979 to 1999. He served as Director of the Heart Failure, Transplant,
Artificial Heart and Circulatory Support Program at California Pacific Medical Center in San
Francisco from 1984 to 2003.
Dr. Hill also served as Surgical Director of the Artificial Heart Program at the University of
California in San Francisco from February 2004 to November 2007.
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Dr. Hill is a founder of Thoratec and a director since its inception. He is a pioneer in the
development and use of ventricular assist devices and played a major role at Thoratec
throughout the history of the company.
Dr. Hill served as Chairman of the Board at Thoratec Corp. from January 1995 to June 2007
and became an Independent Director and Vice Chairman of Thoratec Corp. from June 2007
until May 2009.
In September 2009 he retired from clinical practice and transitioned from his role on the
Board to full time Sr. Medical and Clinical Advisor within Thoratec. Dr. Hill works primarily in
Technical Operations and R&D, Scientific Affairs and Research, and Business Development.
He currently has more than 25 patents of his own in various cardiac surgical areas and
other patents associated with Thoratec.
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QB3, Thursday Mid Day, March 17, 2016
"Pricing Your Life Science Innovation: Critical Activities from R&D to Launch"
Speaker: David Lee, Simon-Kucher & Partners
Date and Time: Thursday, March 17, 2016 from 12:00 PM to 1:00 PM (PDT)
Location: Room 160, Helen Diller Bldg., 1450 3rd Street. UCSF Mission Bay, San
Francisco, CA 94158
Fee: General Admission - $10
Register at https://www.eventbrite.com/e/qed-david-lee-simon-kucher-partners-
pricing-your-life-science-innovation-critical-activities-from-tickets-
21120319444?mc_cid=695d6e35f3&mc_eid=cb4c38a44a
Event Description
Pricing is the most important profit lever for any business, but it is too often an
afterthought in most new product launches, resulting in sub-optimal monetization. By
integrating key pricing activities from R&D through launch, companies can ensure
that they maximize the value of their assets. We will highlight a step-wise approach
to pricing that has been used successfully at start-ups as well as large life science
companies.
Speaker Bio
David Lee is a Partner in the San Francisco office of Simon-Kucher & Partners where
he advises life science clients on optimal pricing, marketing, sales, and negotiation
strategies. He has over 15 years of experience in healthcare and consulting,
specializing in medical technologies, diagnostics, healthcare IT, and digital
health. Prior to joining Simon-Kucher & Partners, David worked in sales and
marketing operating roles at Johnson & Johnson, Boston Scientific, and
AccessClosure, Inc (acquired by Cardinal Health). David received his MBA from the
MIT Sloan School of Management and graduated from the University of California at
Berkeley, with a BA in Latin Language.
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WIB, Thursday Evening, March 17, 2017
Event: “Womens History Month Event: “Women in Leadership: Seizing Opportunities,”
Panel: Jennifer Riggs (Nektar Therapeutics), Chris Meda (InCellDx), Gail Maderis (Antiva
Biosciences), and Barbara McClung (Caribou Biosciences).
Date and Time: Thursday, March 17, 2016, 5:00 -8:30 pm PT
5:00 p.m. – 6:00 p.m. Check-in and Networking
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6:00 p.m. – 8:00 p.m. Panel Discussion
8:00 p.m. – 8:30 p.m. Breakout Session and Networking
Registration Deadline
March 16, 2016
Location: Nektar Therapeutics, 455 Mission Bay Boulevard South, Suite 100, San Francisco,
CA 94158
Pricing Information*
Members: $35
Non-Members: $55
WiLS Members and Nektar Employees please email [email protected] for
special discount codes!
On-Line Registration Deadline
Register at http://www.womeninbio.org/eventdetails.aspx?EventId=28029
Event Description
Women In Bio-San Francisco Bay Area and UCSF Women in Life Sciences (WiLS) will
celebrate Womens History Month by hosting a special event at Nektar Therapeutics focused
on leadership and opportunities in the life sciences.
Join us for a stellar panel moderated by Jennifer Riggs (Nektar Therapeutics) featuring
panelists Chris Meda (InCellDx), Gail Maderis (Antiva Biosciences), and Barbara McClung
(Caribou Biosciences). Learn more about our speakers.
Come get inspired by leaders who are at the forefront of cutting edge biotech companies
and network with a wonderful group of women!
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HBA, Saturday Morning, March 19, 2016
Event: “New Member Orientation and Volunteer Onboarding: Maximize Your Membership”
Date and Time: March 19, 2016, Saturday
8:30 - 9:00 AM Registration/networking breakfast
9:00 - 9:30 AM President's welcome, agenda overview and icebreaker
9:30 - 9:45 AM Benefits of membership/role of the volunteer
9:45 - 10:00 AM Using your HBA experience to reach your development goals
10:00 - 11:00 AM Leadership and volunteer committee overviews
11:00 - 11:15 AM Next steps/roundtable discussions
11:15 - 11:30 AM Evaluations/adjourn
Location: Genentech (Gateway Campus), Building 82, 15th Floor, Room 82-15A, 651
Gateway Blvd.,
South San Francisco, CA 94080
See details and registration at
https://my.hbanet.org/MyHBA/EventDetails.aspx?MeetingID=A45EC9F8-95B8-E511-87AE-
0050569C00A7
Event Description
Join us on Saturday, March 19 at Genentech to learn about all the opportunities that your
HBA membership provides. In addition to discounts on a dazzling array of programs, a key
benefit of membership is the opportunity to participate as a volunteer in one of HBA's
committees. These volunteer committees provide an informal setting for networking and a
forum for skills development in many areas.
At this new member orientation and volunteer onboarding event, you will meet the HBA San
Francisco leadership and learn about the various roles that volunteers can play. This event
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is open to all current and prospective members, and a delicious breakfast and ample
networking time will be provided.
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CBA, Saturday, March 19, 2016
Topic: “Mitigating Future Financial Uncertainties with Current Planning”
Speakers:
2:00–2:30 pm Investment Strategies during Volatility
Kai Chen, CFA
Founder & Managing Director, OceanIQ Capital
2:30–3:00 pm Taming the Bear Market
Stephen Koh, CLF
Vice President, MassMutual Northern California
3:00–3:30 pm Personal Lessons for Financial Planning
Bill Choy, PhD
Pharmaceutical Director, ZC2 Consulting
Moderator:
Frank Zhou, PhD
Date and Time: March 19th, 2016 Saturday
1:30 - 2:00 pm Registration | Refreshment
2:00 - 3:30 pm Facilitated Speech & Discussion
3:30 - 4:00 pm Q&A
Location: Oshman Family Jewish Community Center, Meeting Room E104
Address: 3921 Fabian Way, Palo Alto, CA, 94303
The seminar is free to active CBA members when registered online.
Registration:
Active CBA Members:
Online registration (at www.cbasf.org): Free (Please login first and then click event on
right).
On-site registration: $5
Non-CBA Members:
$10. Either use the link to PayPal (Credit Cards or PayPal account) at www.cbasf.org or use
the following link directly to PayPal:
Register at https://www.paypal.com/cgi-bin/webscr?cmd=_s-
xclick&hosted_button_id=E2HCJZWWRNMPS
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El Camino Hospital Health Forum, Saturday, March 19, 2016
80% of heart disease can be prevented. Knowing the signs, symptoms, and what you can
do to prevent heart disease, and understanding available treatment options is a first step
toward a healthier heart.
Please join us for our free, annual Heart Forum to hear about the latest advancements in
cardiovascular medicine from world-class physicians.
Learn about innovative treatment options, how genetics play a role in heart disease, and
tips for living a heart-healthy lifestyle.
Date and Time: SATURDAY, MARCH 19th, 9:00 am – 1:00 pm
Location: El Camino Hospital - Mountain View Campus, 2500 Grant Road, Mountain View,
CA 94040
Conference Center (located on the ground floor of the main hospital)
Map and directions
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The event is free, but space is limited and registration is required. Reserve your spot today.
Register online or call 800-216-5556.
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San Francisco HBA, Sunday Morning, March 20, 2016
Event: Coffee Chat
Date: Sunday, March 20
10:30 AM: meet at Café La Flore, Irving St.
10:45 - 11:45 AM: walk through Golden Gate Park
11:45 AM: lunch at Nopalito on 9th Ave.
To RSVP or for more information, please contact Michelle Lerman or Priya Mitty Ryali
HBA SF Bay Area is hosting a series of coffee chats at four convenient locations throughout
the Bay Area. Join fellow HBA members in an informal setting to share interests, current
HBA events – happening locally and globally. Enjoy these opportunities to meet HBA
members or reconnect with members you met at previous events. Coffee chats have had a
reputation for forming long-lasting friendships with women in all areas of healthcare. Please
note any topic of conversation is under the code of confidentiality; Coffee chats also provide
a safe environment for our HBA members to talk about their potential career development.
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California Life Sciences Association, Monday-Tuesday, March 21-22, 2016
Event: “Bristol-Myers Squibb Partnering Day”
Confirmed BMS Participants:
Carl Decicco, SVP Discovery
John Houston, SVP Disease Sciences and Biologics
Michael Burgess, SVP Head Exploratory Clinical and Translational Research
Michael Giordano, SVP Head Oncology Development
Douglas Manion, SVP Head Specialty Development
Nils Lonberg, SVP Head Oncology Biology Discovery and BDC
Alan Korman, VP Discovery Immuno-Oncology
Paul Biondi, SVP Business Development
Date and Time: Monday-Tuesday, March 21-22, 2016
Monday March 21, 2016
Networking Cocktail Reception
4:30pm — 6:30pm
This event, part of the CLSA Partnering Day, will provide a great opportunity to network
with BMS Senior R&D and Business Development Leadership.
Tuesday, March 22, 2016
Partner of Choice Plenary (AM Session)
8:30am – 9:00am
Join us for a morning plenary and learn how a large biopharmaceutical company evaluates
external research and approaches licensing and partnerships. Registration will open at
8:00am and presentation will start promptly at 8:30am.
One-on-One Private Meetings
9:00am – 12:00pm
Application Required. Accepted applications will be given a private 45 minute one-on-one
meeting with a representative from BMS.
Partner of Choice Plenary (PM Session)
1:00pm – 1:30pm
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Join us for an afternoon plenary and learn how a large biopharmaceutical company
evaluates external research and approaches licensing and partnerships. Registration will
open at 12:30pm and presentation will start promptly at 1:00pm.
One-on-One Private Meetings
1:30pm – 5:00pm
Application Required. Accepted applications will be given a private 45 minute one-on-one
meeting with a representative from BMS.
Location: Sofitel, 223 Twin Dolphin Drive, Redwood City, CA 94065
Cost: Complimentary
Admission: One-on-One Meeting: Application is required for one-on-one meetings. Only
companies reviewed and approved will be scheduled for a one-on-one partnering meeting.
Application review is on a rolling basis, so we suggest applying early due to a limited
number of available appointments.
Networking Cocktail Reception: Due to high demand the reception is limited to employees of
bioscience companies only. For questions please email [email protected].
Plenary & Panel Discussion: Due to high demand the plenary is limited to employees of
bioscience companies only. For questions please email [email protected].
Attire: Business attire suggested
• Early registration is highly advised as space is limited and there will be no on-site
registration
• 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
Please mail your event-related questions to: [email protected] or you can
contact us via phone: 650-871-3257.
Bristol-Myers Squibb is a leading global BioPharma company. Our mission is to discover,
develop and deliver innovative medicines that help patients prevail over serious diseases.
We have combined the passion and entrepreneurial spirit of a leading-edge biotech
company with the experience and capabilities of a major pharmaceutical company. One of
the ways we are doing this is through innovative partnerships with external companies to
develop innovative medicines.
For decades, partnering has been an important element of our business strategy and as
such partnering is in the DNA of Bristol-Myers Squibb having established a collaborative
culture, leading alliance management capabilities and successfully built multiple blockbuster
franchises and consistently realized more than half our global sales from partnered or in-
licensed products. Our Business Development team works closely with R&D and commercial
leadership to identify external opportunities which fit our strategy to provide
transformational medicines in areas with high unmet medical need. We actively seek
innovative drug programs, especially with biomarker for companion diagnostics for patient
stratification, which complement our internal R&D efforts from discovery to late stage
clinical trials and commercialization in following therapeutic areas:
• Oncology – Novel immune checkpoint inhibitors and co-stimulatory agents, tumor
intrinsic targets with demonstrated impact on anti-tumor immunity and the tumor
microenvironment, synergy with immune checkpoint inhibitors, established non-
immunosuppressive mechanisms of action, new approaches to validated cancer pathways,
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emerging areas of cancer biology and antibody drug conjugates (novel targets) and late
preclinical / clinical-stage programs in areas of unmet medical need.
• Cardiovascular – Heart Failure, cardiomyopathy, highly validated targets addressing
CV risk with clear specialty medicine development path
• Immunoscience – Rheumatoid arthritis, Inflammatory Bowel Disease, Lupus
• Fibrosis – Idiopathic Pulmonary Fibrosis, Liver fibrosis (NASH), Systemic sclerosis,
IgA Neuropathy
• Genetically Defined/Rare Diseases – Focus in monogenic diseases and genetically
defined therapeutics in neuromuscular (Duchenne’s and other muscular dystrophies),
neurological diseases (tauopathies, synucleopathies, Nav1.7 small fiber neuropathies, other)
and cardiomyopathies. Interested in novel approaches for AAV delivery and other molecular
delivery systems targeting tissues such as muscle, heart, brain.
• Technologies – Pathway analysis & novel target identification, Gene editing &
bioinformatics tools, In vitro and in vivo disease models, Transgenic animals, High
throughput label free platforms, Novel chemistry, compound libraries & platforms, Antibody
discovery and screening,Protein and antibody engineering, Small molecules and linkers for
antibodydrug conjugates (ADCs), Microfluidic systems & cellular models predicting ADME,
Subcutaneous Depot Controlled Release Delivery, Drug Delivery of Highly Concentrated
Injectables, Oral Delivery of Macrocyclic Peptides, Clinical biomarkers, Toxicogenomics–
expression levels in cells/tissue, high throughput single cell capture and characterization,
tumor specific antibody binding, Pharmacodiagnostics and imaging technologies for Bristol-
Myers Squibb products
Additional information can be found on the BMS Partnering web site:
http://bms.com/partnering/Pages/home.aspx
When requesting a meeting, please describe what you would like to discuss with Bristol-
Myers Squibb. Please include information about your company (services offered, technology,
geographic reach, etc).
***************************************************************
Bio2Device Group, Tuesday Morning, March 22, 2016
Topic: “Successful PR strategies and techniques for emerging medtech companies”
Speaker: Reena Mishra, Senior Director, Marketing , VisionCare Ophthalmic Technologies
Date and Time: Tuesday, March 22, 2016, 8:30 am
Location: Sunnyvale City Council Chambers, 456 West Olive Ave., Sunnyvale, CA
There is no fee or registration required for morning meetings.
Topic Description
Have you ever wondered how new medical technologies make it onto the 5pm news? Do
you wish YOUR revolutionary technology would be featured in the media but don't have an
expansive budget to hire a PR agency? In this session, you will learn how one small medical
device company landed hundreds of news placements without a formal agency and on a
shoe string budget. You, too, can raise your products awareness, pique interest and drive
demand with both patients and healthcare providers following some sharply focused and
creative steps.
Speaker Bio
Reena Mishra joined VisionCare Ophthalmic Technologies in 2011 with over 11 years of line
marketing experience in medical device companies in both high growth and development
stages. VisionCare has developed the first FDA-approved telescope prosthesis demonstrated
to improve vision and quality of life in individuals with End-Stage AMD. The telescope
implant is integral to the CentraSight® treatment program which has been created to help
patients follow the necessary steps for proper diagnosis, surgical evaluation, and
postoperative care. Reena currently leads VisionCare’s global marketing, practice
13
development and CentraSight® Access case management programs. Prior to joining
VisionCare, Reena held various marketing positions with Pivot Medical, Spinal Modulation
and ArthroCare Corporation.
Reena holds an MBA from Santa Clara University, a MA in Kinesiology from San Jose State
University, and a BA in Kinesiology from Occidental College.
*********************************************************************
BioScience Forum, Wednesday Evening, March 23, 2016
Topic: "Development of Pluripotent Stem Cell Based Therapies for
Central Nervous System and Oncological Disorders"
Speaker: Jane Lebkowski, Ph.D., President of R&D and Chief Scientific Officer,
Asterias Biotherapeutics
Date and Time: Wednesday, March 23, 2016 6:00 PM - 9:00 PM
6 pm - 7 pm networking
7 pm - 8 pm dinner
8 pm - 9 pm presentation
Location: The Holiday Inn , 275 S Airport Blvd, South San Francisco, California 94080, USA
Fees: $50 before 9PM, Monday, March 21st
$60 on-site
$40 full-time students pre-registration
$50 full-time students on-site
$3 service fee will be added to the pre-registration price
Register at BioSF.org
Speaker Biography
Jane Lebkowski has been actively involved in the development of cell and gene therapies
since 1986 and is currently Chief Scientific Officer and President of R&D at Asterias
Biotherapeutics Inc.
From 1998 to 2012, Dr. Lebkowski was Senior Vice President of Regenerative Medicine and
Chief Scientific Officer at Geron Corporation, where she led Geron’s human embryonic stem
cell program. Prior to Geron, Dr. Lebkowski was Vice President of Research and
Development at Applied Immune Sciences. Following the acquisition of Applied Immune
Sciences by Rhone Poulenc Rorer (RPR, currently Sanofi), Dr. Lebkowski remained at RPR as
Vice President of Discovery Research.
Dr. Lebkowski received her Ph.D. in Biochemistry from Princeton University in 1982, and
completed a postdoctoral fellowship at the Department of Genetics, Stanford University in
1986.
Dr. Lebkowski has published over 70 peer reviewed papers and has 13 issued U.S. patents.
She is on the Board of Directors of the American Society for Gene and Cell Therapy, as well
as several scientific advisory boards and other professional committees. Dr Lebkowski has
also served as an industry representative to FDA’s Office of Cell, Tissue and Gene Therapy
Advisory Board and as the co-chair of the Industrial Committee of the International Society
for Stem Cell Research.
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Click here to forward this and future announcements to them automatically
14
Follow us on Twitter @BioSci_Forum
Join us from 6-9 pm to network and hear the latest scientific and business advances in the
San Francisco Bay Area biotech community
Event Registration ($3 service fee will apply)
Pre-Registration $50.00
On-Site Registration $60.00
Pre-Registration ends Monday, March 21st, at 9 pm
Cash or check accepted on the day of the event
$10 discount for full-time students
Or you can pay with a check made out to "BioScience Forum" and sent to:
BioScience Forum
1442A Walnut Street, #308
Berkeley, CA 94709-1405
Please do not mail checks later than Thursday, March 17th
If paying with check, do not complete online registration with Cvent
***********************************************************************
QB3,Thursday, March 24, 2016
Topic: “Advances In Biologics Development And Delivery”
Moderated by: Prof. Carolyn Bertozzi
• Kent Iverson, Biotechnology Consultant and Contractor
• Dr. Douglas Crawford, Assoc. Director, QB3
Dr. Greg Bleck, Global Head R&D, Biologic, Catalent Pharma Solutions
Date and Time: Thursday, March 24, 8:00 to 5:00 pm
AGENDA
8:00-8:30 Registration and Breakfast
8:30-8:45 Welcome and Introduction Dr. Cornell Stamoran Managing Director, Catalent
Institute; Prof. Carolyn Bertozzi Professor of Chemistry, Stanford University
8:45-9:30 Asialoglycoprotein receptor mediated delivery of antisense oligonucleotides to
hepatocytes enhances potency >10-fold in animals Dr. Punit Seth Exec
Director, Med Chem Ionis Pharmaceuticals
9:30-10:15 Monoclonal Antibodies To HLA/Peptide Tumor Antigens Dr. William
Hildebrand Founder/Chief Scientist
Pure MHC
10:15-10:30 Break
10:30-11:15 Antibody Drug Conjugates Using SmarTag Technology Dr. David Rabuka
15
Global Head R&D, Chem Bio Catalent Pharma Solutions
11:15-12:00 Ultralong CDR3s Of Cow Antibodies: Biology And Engineering Dr. Vaughn
Smider
Chief Scientific Officer, Sevion
12:00-1:30 Networking Lunch & Meet The Experts
1:30-2:15 Construction Of Versatile Carriers For Therapeutic Cargo Using Viral Capsids
Prof. Matt Francis
Professor of Chemistry, UC Berkeley
2:15-3:00 Latest Trends And Development In Non-Invasive Macromolecule Delivery
Dr. Randy Mrsny
CSO & Co-Founder, Applied Molecular Transport
3:00-3:30 Break
3:30-4:30 Expert Panel Discussion: Trends In The Development And Delivery Of
Biologics Moderated by: Prof. Carolyn Bertozzi
• Kent Iverson, Biotechnology Consultant and Contractor
• Dr. Douglas Crawford, Assoc. Director, QB3
• Dr. Greg Bleck, Global Head R&D, Biologic, Catalent Pharma Solutions
4:30-4:45 Closing Remarks
Please join us for a cocktail reception following the session from 5:00 PM – 7:00 PM.
Location: UCSF Mission Bay, Genentech Hall, Byers Auditorium
Register at https://www.eventbrite.com/e/advances-in-biologics-development-and-delivery-
tickets-20142658233?mc_cid=b9047f4535&mc_eid=cb4c38a44a
Event Description
Catalent Institute experts from Catalent Pharma Solutions, Ionis Pharmaceuticals, Pure
MHC, Sevion, UC Berkeley, and Applied Molecular Transport will present on the latest
developments in development of biological therapies and delivery. This event is designed to
cater to VPs, directors, principal investigators and graduate students joining us from leading
pharmaceutical companies and universities.
The expert panel, moderated by Professor Carolyn Bertozzi (Stanford University, formerly of
QB3-Berkeley), will focus on providing solutions for biologic development challenges facing
every R&D team today. Participants are encouraged to bring their toughest development
challenges to discuss with the expert panel.
*************************************************************************
EPPICON 2016 Conference, Saturday, March 26, 2016
Event: “3D - Convergence of Drug Discovery, Diagnostics and Digital Health”
Date and Time: Saturday, March 26, 2016, 8:00 am - 7:30 pm
Location: Crowne Plaza, San Francisco Airport - Burlingame
Early Bird Registration OPEN!!
Log on to register now: https://www.123signup.com/register?id=ppjrk
Early Bird Registration: $125 (ends Mar 14)
Advance Registration: $150 (Mar 15 - 25)
On-site Registration: $175 (Mar 26)
Early Bird Student Registration: $50 (ends February 29)**
EPPIC Charter Members* / Sponsors* / Event Speakers*
*Renew or Register: Conference is complimentary
16
**Student promo code "STCON16". Valid student ID to be presented at Conference
Registration includes food and beverage
Conference Agenda
Registration / Breakfast and Networking
Welcome Address: Chitra Sharma, President, EPPIC Global
Opening / Plenary Keynote: James Sabry - Genentech
Panel 1: Drug Development
» Paul Hastings - Oncomed
» Carlos Garcia - Gilead
» Anil Singhal - AbbVie
Panel 2: Digital Health
» Jack Lloyd, Inventor (Nellcor & Humphrey Instruments)
» Gregg Jackson - ProPharma Group
Lunch (Speed Network open)
Conference Remarks: Anjali Pandey, Co Chair, EPPICon 2016
Panel 3: Digital Health
» Catherine Mohr, Intuitive SurgicalMohan Iyer - Second Genome
» Ramesh Hariharan - BioTheranostics
» Ravi Srinivasan (OncoNano &, Corium)
Panel 4: Investor Panel
Speed Pitch: Entrepreneurs in Life sciences pitch their ideas to seasoned investors - a
unique opportunity for symbiosis of ideas and investments
» Ben Dubin - Asset Management Ventures
» Ajit Singh - Artiman Ventures
Conference Description
It all begins with accurate diagnostics. Discovery of accurate biomarkers triggers the
development of new therapeutic drugs as well as companion patient side diagnostic tools. In
addition, advances and miniaturization in digital health technology are now leading the
democratization of diagnostics by placing these critical tools in the form of wearables and
cloud-connected home devices in the hands of end users. With an increasing emphasis on
personalized medicine and targeted therapies, diagnostics and biomarkers are playing an
important role in drug discovery and development.
EPPICon 2016 will present brilliant speakers and invigorating panel discussions to spark the
entire day of programming on hot topics related to the development of drugs, diagnostics
and digital health. In keeping with the tradition of EPPICon, the organizing committee has
invited thought leaders that are shaping the future of the life science industry through
technological innovation. There will be time to jostle around ideas, meet individuals about
investment opportunities and form new alliances.
Don't miss this one rich in content conference and an exquisite opportunity to help build
many synergies!
Join us for an exciting EPPICon 2016!
Who Should Attend:
Entrepreneurs, Innovators, Researchers, Investors and Professionals (including Service
Providers) from Biotech, Pharma, Medical Devices, Diagnostics, Digital Health, IT,
Innovative Technology and Academia
Speed Pitch
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What, When, Why for EPPIC:
EPPIC was formed in March 1998 by Pharmaceutical, Bio-technology Professionals in San
Francisco Bay Area with the following goals.
» To provide a forum for developing entrepreneurial opportunities for professionals from the
Indian sub-continent in the Pharmaceutical, Biotechnology and Related Industries.
» To provide a forum for networking and expanding professional opportunities.
» To provide a forum for establishing ties with, and to act as a liaison for Pharmaceutical,
Biotechnology and Related Industries and educational institutions in the Indian sub-
continent, and creating opportunities for mutual benefit.
» To be a resource for students aspiring for careers in Pharmaceutical, Biotechnology and
Related Industries in the U.S.
What is the Need for Speed Session:
This is a fabulous opportunity for start-ups get on stage and make a five-minute pitch to a
distinguished panel of top-notch VC’s and biotech executives. Multiple entrepreneurs of
early stage companies in the life-sciences can talk about their idea, technology, market,
etc., get quick feedback from the VC panel and get exposure to various potential
collaborators / partners.
Selected presentations will get highlighted on the EPPIC website and other promotional
material.
Why present at the Need for Speed Session:
This conference attracts more than 200 professionals in the life science industry. The
conference attendees are experienced life-sciences professionals in the R&D, Service and
management careers. Our members are distributed across therapeutics, devices,
diagnostics and informatics and are the ideal audience for early stage companies.
What's in it for Entrepreneurs:
» Get VC's interested in your idea.
» Attract advisors, mentors
» Attract business, technical partners
» Get constructive feedback and potential reinforcement of technology.
What do you need to do in five minutes.
Prepare an elevator pitch. You have just five minutes so please focus on the most important
aspects of your company or technology.
» Mission statement
» Product opportunity and market potential
» State of the company, management team, development timelines and key milestones
» Key differentiating factors from existing products and how they meet market need
» What is the entrepreneur looking for - specifically clearly articulate funding goals, use of
proceeds and potential milestones achieved with this funding
What, When, Where
Please email a presentation to [email protected] by March 8, 2016, to be
considered for selection. Shortlisted candidates will be notified by March 22, 2016.
Closing Keynote: To be announced
Closing Remarks: Amita Goel, Co-Chair, EPPICon 2016
Evening Reception and Networking
**************************************************************
JLABS, Tuesday Afternoon, March 29, 2016
18
Topic: “Choose Your Exit: How to Benefit from IPO Preparation”
Speakers:
Matthew Hudes | US Managing Principal, Biotechnology, Deloitte Consulting LLP,
Angela Rusakova | West Region Life Sciences Audit Partner, Deloitte & Touche LLP
Date and Time: Tuesday, March 29, 2016
Agenda:
12:00 PM | Registration Opens, Lunch and Networking
12:40 PM | Life sciences company - life events
1:10 PM | Financing strategies
1:30 PM | Exit strategy: M&A vs. IPO
1:50 PM | IPO requirements - Job Act
2:20 PM | Coffee Break
2:30 PM | Ready for IPO?
3:00 PM | Going through the IPO process
3:30 PM | Company post IPO
3:50 PM | Next events: IPO readiness bootcamp; Lessons learned
4:00 PM | Program Close
Location: JLABS, 329 Oyster Point Blvd - 3rd Floor, San Francisco, CA
Fees:
$30 | General Public
$45 | Onsite
Details and registration at http://www.eventbrite.com/e/choose-your-exit-how-to-
benefit-from-ipo-preparation-tickets-20106147027?aff=weekly
Topic Description
The business development professional's purpose is to optimize optionality and long
term value at each stage of a company's life. As a company grows and gains traction,
it's easy to get enticed and overwhelmed by the numerous opportunities that arise.
How do you determine the direction that will add the most value to your company?
How do you avoid the constant pursuit of "shiny objects?" How do you know when it's
the right time for a strategic partnership?
At this event, you will learn how to prepare your company for IPO as well as the key
differences between M&A and IPO exits. Key focus areas include:
• What are the key decisions you need to make and when do you need to make
them?
• When is the right time to develop your exit strategy?
• Key considerations and differences between M&A and IPO exits
• Job Act requirements
• SEC requirements for IPO and post IPO
• Key stakeholders to manage through the IPO process
• Company’s internal processes pre- and post-IPO
Deloitte will share their experiences working with startup life sciences companies
through the IPO process and beyond. The skills learned during this program are
valuable to all young companies whether or not they eventually go through an IPO.
This "How to... Workshop" is geared towards life sciences startups.
As with all of our events, the "How to... Workshop" is interactive and informal so
bring your questions with you!
Speakers' Bios
Matthew is the BioPharma segment leader for Deloitte’s Life Sciences practice sector.
He speaks frequently about such topics as fostering innovation, personalized
19
medicine, the use of technology for innovating clinical research, finance
transformation, manufacturing and quality, regulatory compliance, and supply chain.
Matthew is the executive sponsor of Deloitte’s unique innovation collaboration with
the University of California, and is the Lead Client Service Principal for the California
Institute for Quantitative Biosciences (QB3). He is a member of the Board of
Directors of BIOCOM and of the Bay Area BioEconomy Initiative, and a faculty
member and executive sponsor of the UC Berkeley BioExec Institute.
Angela has 20 years of experience serving both public and private companies with a
focus on the life sciences industry. She works with companies in all stages of growth,
from start-ups to SEC registrants. Her technical background includes complex
accounting issues such as revenue recognition, equity, derivatives, stock-based
compensation, and acquisitions. Angela has been involved in financing and M&A
transactions, including initial public offerings, offerings in leveraged buyouts, and
several secondary shares offerings. She has extensive international experience and is
a certified public accountant in the United States and the United Kingdom. Angela
also served as a CFO before returning to public accounting in 2003.
********************************************************************
7th Annual Bay Area Biomedical Device Conference, Wednesday , March 30, 2016
Date and Time: Wednesday, March 30, 2016, 8:30 am
Location: Student Union Ballroom at San Jose State University.
Registration information at www.biomedconference.org.
Conference Information
The 7th Annual Bay Area Biomedical Device Conference, hosted by the Biomedical
Engineering Society at San Jose State University (SJSU), will be held on Wednesday March
30th, 2016 in the Student Union Ballroom on campus. This year's conference theme is
Medical Innovations in Silicon Valley.
Our morning Plenary Speakers are Richard Roth, who is the Chief Strategic Innovation
Officer at Dignity Health, and Dr. Hanmin Lee, who is the Surgeon-in-Chief at the UCSF
Benioff Childern's Hospital. There will be special sessions focusing on the Unmet Medical
Device Needs in Developing Countries, Human Factors Requirements for Medical Device
Design, Nanoscale Applications in Medicine, and Web-Connected Medical Devices, with
presentations from industry professionals and researchers in the forefront of their fields.
The afternoon plenary sessions will feature two panels: an Industry Panel on How to Build a
Medical Device Company from Scratch, and a CEO Panel that will focus on the Exit
Strategies for Medical Device Companies. Students from universities will be presenting their
research posters throughout the day. A Wine and Cheese Networking Reception is planned
for 5:15 to 7:00 p.m.
Further information about the conference, including registration information, can be found
at the conference website www.biomedconference.org.
Early registration for the conference ends Thursday, March 17th, 2016. Please register as
early as possible to take advantage of the reduced registration rate and to enable us to
make adequate preparations for hosting you.
If you have any questions or if your company is interested in being a sponsor, please email
us at [email protected].
We appreciate you forwarding this email and the attachment to any of your colleagues and
friends who may be interested in this conference or can benefit from it.
20
Guna Selvaduray, Ph.D.
Interim Chair, BCME Department
Director, Biomedical Engineering Program
Professor, Materials Engineering
College of Engineering
San Jose State University
San Jose, CA 95192-0082
Phone: (408) 924-3874
http://bcme.sjsu.edu/profile/guna-selvaduray
****************************************************************
ACRP Virtual Career Fair, Thursday Afternoon, March 31, 2016
Event: “Where Clinical Research Talent Meets Opportunity”
Date and Time: Thursday, March 31, 2016, noon til 4:00 pm Eastern Daylight Time
Register at
https://app.brazenconnect.com/events/ACRP033116#!eventLanding;eventCode=ACRP0331
16
This Online Career Fair will connect you directly with employers with open career
opportunities from the comfort of your home, office, smartphone or tablet.
As an attendee, you have the ability to explore employer information and opportunities.
Choose which employers you want to interact with and then engage in one-on-one text-
based conversations directly with a recruiter at those organizations. You can share your
background, experience, resume and ask questions. Maximize your time in the event by
getting in line to chat with representatives from more than one company at a time.
This Online Career Fair connects you in real time with employers seeking to recruit top
talent.
Who should attend:
Professionals seeking new career opportunities or exploring career options
Professionals who are ready to begin their careers
Professionals seeking to learn more about the various nationwide opportunities
Get a Reminder
Register Now
REGISTER
OR
REGISTER WITH LINKEDIN
Already registered? Login.
Are you an employer?
HOW THIS ONLINE EVENT WORKS
1
Register
Create your account and fill out the event registration form
2
Explore
Login anytime before the event to learn more about participating employers
3
Attend
On the event date and time, login and join the live session from anywhere
4
Connect
During the live event, you'll be matched in one-on-one timed chats with participating
employers
EDT)
21
********************************************************************
South Bay HBA, Saturday, April 2, 2016
Location: Shoreline Lake American Bistro - 3160 N Shoreline Blvd., Mountain View, CA
To RSVP or for more information, please contact Meggin Taylor or Mary Dosunmu
*************************************************************
Bio2Device Group, Tuesday Morning, April 5, 2016
Topic: “Microvolution’s Technology Empowers Scientists to Accelerate Medical Research with
Greater Accuracy”
Speakers: Cassandra Boyer and Marc Bruce, CEO & Co-Founder and CTO & Co-Founder,
Microvolution
Date and Time: Tuesday, April 5, 2016 - 8:30am
Location: Sunnyvale City Council Chambers, 456 West Olive Ave., Sunnyvale
No registration or fees for morning meetings
Topic Description
Medical research discovery often lacks accuracy. It is also a very slow process. Currently,
scientists can wait days to get their microscopy images deconvolved (focused) via CPU-
based software; hence, productivity is lost, plus, failure rates are high because scientists
cannot make adjustments to their experiments in real-time. Advancements in software and
technology are poised to change that. Microvolution's real-time GPU accelerated
deconvolution software has the unique ability to offer accurately focused images from
fluorescence microscopes in seconds. What used to take one week to complete with a failed
outcome, can now be completed in one hour, with success.
Invented by Microvolution’s CTO while studying immunology at Stanford, this new
technology accelerates medical research up to 200 times faster and enables scientists to
make adjustments to their experiments in real-time. Data sets improve because more
images can be captured in less time. Additionally, the unique algorithms incorporated into
Microvolution’s software deliver enhanced accuracy for medical discovery. Microvolution
empowers scientists to accelerate their discovery with greater accuracy and can help them
decrease costs as they produce successful results.
Speaker Bios
Cassandra Boyer, MT (ASCP), CEO & Co-Founder drives the commercialization efforts and
operations at Microvolution. She’s also an Advisor for Stanford’s Medical School’s think-tank
called SPARK. At Microvolution, Cassandra implements lessons learned from having over 25-
years of success as a proven top-tier commercial leader at GE Healthcare and Beckman
Coulter in both the life sciences and clinical markets. She is also a board certified Medical
Technologist by the American Society of Clinical Pathology with experience in clinical
hematology.
Marc Bruce, PhD, CTO & Co-Founder invented Microvolution’s technology as a PhD student
at Stanford University while studying immunology. During his studies, Marc gained a unique
insight into bridging advanced wet lab techniques with computation and invented the
software technology to solve challenges in analyzing microscopy problems in immunology
and cell biology research. Marc published: Bruce MA, Butte MJ, Real-time GPU-based 3D
Deconvolution, Optics Express, 2013; 21(4): 4766. After finishing his PhD in September
2014, Marc developed this software into a viable commercial product via his extensive
experience in software development in C++, Java, CUDA, and other programming
languages.
****************************************************************
BioX Program Stanford, Thursday Mid Day, April 7, 2016
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Topic: “Optical Control and Interrogation of Protein Activity Using Engineered
Photoreceptors”
Speaker: Speaker: Bianxiao Cui, Department of Chemistry
Thursday, April 7, 2016, 12:00 pm
Location:
PRE-SEMINARS IN CLARK CENTER ROOM S361; SEMINARS IN CLARK CENTER ROOM S360
SMALL LUNCH SERVED AT 12:00 pm LECTURES BEGIN AT12:15 pm
PRE-SEMINARS IN CLARK CENTER ROOM S361; SEMINARS IN CLARK CENTER ROOM S360
*************************************************************
JLABS, Thursday, April 7, 2016
Event: “Meet with…Sanderling Ventures”
Sanderling Representative: Timothy MillsTimothy Mills | Managing Director,
Sanderling Ventures
Date and Time: Thursday, April 7, 2016
Agenda:
10:30am | Registration Opens and Networking
11:00am | Presentation and Q&A
11:45am | Networking Lunch
1:00-5:00pm | One-on-one Meetings*
*Companies must have applied for a one-on-one meeting ahead of time and be
approved. The application period ends on March 9th, 2016.
Location: Johnson & Johnson Innovation, JLABS, 329 Oyster Point Blvd - 3rd Floor,
South San Francisco, California
Fees:
Presentation & Lunch
$25 | General Public
$35 | General Public Onsite
Includes presentation, Q&A, and lunch. All attendees must pay this fee, regardless of
one-on-one meeting status. Registration to attend the presentation, Q&A, and lunch
will remain open until April 6th, 2016 (or sold out).
One-on-One Meeting
FREE | Application
FREE | Accepted Companies
Companies must have applied for a one-on-one meeting ahead of time. The one-on-
one application period ends on March 9th, 2016. Your application will be reviewed
and you will be notified of acceptance by March 24th, 2016. Acceptance of a one-on-
one meeting is not guaranteed as all applications must be approved.
Register at http://www.eventbrite.com/e/meet-with-sanderling-ventures-tickets-
19488598924?aff=weekly
Topic Description
Sanderling is investing in today's seeds for tomorrow's harvest; is your technology
the next bumper crop?
Since 1979, Sanderling has been dedicated to building new biomedical companies,
utilizing a unique approach of specialized investment focus, active managing and long
term commitment. Sanderling has supported over 90 biomedical companies from very
early stage start-ups, through commercial development.
23
Investments are made at all stages with a focus on ground breaking early stage
technologies that reduce costs in hospitals. Currently they are investing Sanderling
VII which closed in 2015. Investment areas include:
Vaccines
Drug delivery
Research tools
Platform technology
Medical devices
Diagnostics
Imaging agents/devices
Digital/eHealth
Sanderling Ventures Managing Director Timothy Mills will be in attendance to give an
overview presentation about the company's key areas of interest. Following the
presentation, don't miss this opportunity to introduce yourself to Timothy during the
networking lunch. And finally, for those companies who apply online and are
approved, one-on-one meetings with Sanderling will provide an intimate forum to
discuss your company.
Sanderling Ventures Representative Bio
Timothy Mills has over twenty-five years of experience in biomedical research,
corporate management and venture capital investing. Dr. Mills joined Sanderling as
an Operating Partner in July 1998, was promoted to Managing Director in 2000 and
currently serves as the Chairman of the Investment Committee. At Sanderling, Dr.
Mills has focused on early stage investments in Medical Devices, Biotherapeutics, and
i-Health. His active roles within Sanderling's portfolio companies include Chairman,
CEO, Director, and management team member. Portfolio companies previously
served include Stereotaxis (NASDAQ: STXS), Stentor, acquired by Royal Philips
Electronics (NYSE: PHG, AEX: PHI), CardioNet (NASDAQ: BEAT), Taligen
Therapeutics, acquired by Alexion Pharmaceuticals (NASDAQ: ALXN), Neomend,
acquired by C.R. Bard (NYSE: BCR), Sotera Wireless and InfraReDx (acquired by
Nipro Corporation). Currently, his roles also include Chairman of Torax Medical,
Pulsar Vascular and AdMIRx. Prior to joining Sanderling, Dr. Mills served as the
Corporate Vice President of New Business Development and Chief Scientific Officer of
Target Therapeutics, a medical device company that was acquired by Boston
Scientific (NYSE: BSX) in 1997 for $1.3 billion. From July 1994 to July 1997, he was
a Director for Prograft Medical, a Target affiliate that was acquired by W.L Gore &
Associates. Before joining Target in 1994, Dr. Mills served as Director of Business
Development and Advanced Research & Development in the Interventional Cardiology
Division of Baxter Healthcare, now Edwards Life Science (NYSE: EW). Dr. Mills'
previous academic appointments included Director of the Artificial Heart Program at
the University of California, Irvine Medical Center and faculty member at the
University of California, San Francisco Radiology Department. Dr. Mills received his
Ph.D. in Bioengineering from the University of California, Berkeley & San Francisco
School of Medicine. He also received a M.S. in Electrical Engineering & Computer
Science from the University of California, Berkeley, and a B.S. in Electrical
Engineering from the University of Colorado, Boulder. In addition, he is an advisory
board member of the University of Colorado Technology Transfer Office and a
program faculty member of the Stanford University Biodesign program.
******************************************************
PBSS, Friday, April 8, 2016
Seminar luncheon: “Drug Repurposing for Unmet Medical Needs “
24
Speakers: Kevin Grimes, MD, MBA (Stanford University)
Date and Time: Friday, April 08, 2016, 11:00-13:30
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor: Vendor show vendors registered to date: (6)Agilent; Cardinal Health;
Corning Life Sciences; DyChrom; Shimadzu Scientific Instruments, Inc; Thermo Fisher
Scientific, SID
Registration: http://www.PBSS.org
Registration deadline:4/6/2016 (it will close sooner if the seating cap is reached)
About the Topic
Drug repurposing, the development an existing drug for a new clinical indication, can be a
faster, less risky, and more cost-effective path for bringing a new therapy to patients in
need. The repurposed drug may already be approved for its original clinical indication or it
may have stalled in clinical development for lack of efficacy, unacceptable side effects, or
commercial reasons. In either case, the repurposing candidate has typically been
extensively studied in humans and should have a known safety profile. Drug repurposing
candidates may be identified in multiple way, for example: i) validating that the drug’s
original target is important in your disease of interest; ii) demonstrating that the drug has
activity against your new target through conducting a high throughput screen; iii) in silico,
by matching opposite gene expression signatures between the disease of interest and
known drug profiles; iv) through astute clinical observation and exploitation of known or
unanticipated side effects. Some drug repositioning programs can be commercially
attractive if they have intellectual property claims that block competitors (e.g., new
formulation, dosing regimen, route of administration) or can take advantage of privileged
regulatory status, such as orphan disease designation. Drug repurposing can be particularly
attractive for academics and other not-for-profit drug developers who are committed to
finding cures for patients, but have limited financial resources. Over the past nine years, the
Stanford SPARK program has moved over thirty repurposed compounds into clinical study.
About the Speakers
Kevin Grimes, MD, MBA is the Co-director of the SPARK Program in Translational Research
and an Associate Professor in the Department of Chemical and Systems Biology at the
Stanford University School of Medicine. He received his MD from Brown University and
completed his residency in internal medicine at Stanford University. He became a Clinical
Assistant Professor of Medicine at Stanford, where his primary duties included the teaching
and practice of internal medicine. Grimes received a Hartford Foundation Fellowship to study
health economics at the Stanford Graduate School of Business and obtained an MBA. He
was subsequently selected as a White House Fellow and assigned to the Department of
Defense, where he served as Special Assistant to the Secretary. He spent fifteen years in
industry, working in the medical device, life science consulting, and biotechnology sectors
prior to returning to Stanford to co-direct SPARK. In addition to SPARK, Grimes teaches
graduate student courses on drug discovery and development and continues to teach and
practice internal medicine. He has received the David Rytand Award for Excellence in Clinical
Teaching and the Faculty Award for Excellence in Graduate Teaching.
SPARK’s two-fold mission is to advance promising research discoveries into the clinic as new
therapeutics and diagnostics, and to educate faculty, post-doctoral fellows and students
regarding the translational process. SPARK participants receive modest funding, education
regarding translational research, and targeted mentorship on their specific projects. Over
fifty volunteers from the local biotechnology, pharmaceutical, and health care investment
community serve as advisors and mentors. SPARK is now in its ninth year. Approximately
60% of projects completing the program have been licensed and/or advanced to clinical
trials.
*************************************************************************
*************************************
25
QB3, Tuesday Mid Day, April 12, 2016
Topic: "Friends in Low Places: How I Leveraged Everyone I Know to Start a
Company"
Speaker: Colleen Cutcliffe, Whole Biome.
Date and Time: Tuesday, April 12, 2016 from 12:00 PM to 1:00 PM (PDT)
Location: Room 160, Helen Diller Bldg., 1450 3rd Street, San Francisco, CA 94158
Fee: $10 – general admission
Register at https://www.eventbrite.com/e/qed-colleen-cutcliffe-whole-biome-friends-
in-low-places-how-i-leveraged-everyone-i-know-to-start-a-tickets-
21392423314?mc_cid=e93dc63d3c&mc_eid=cb4c38a44a
Topic Description
To start a company, you have to solve challenges that range from the advanced, such
as technical innovation, to the mundane, such as opening a bank account. You must
overcome all the obstacles, but each requires a different skill set. On April 12,
Colleen Cutcliffe, co-founder and CEO of Whole Biome, will share stories of key
hurdles that she and her team ran into and the people who helped them succeed.
Everyone knows Step 1 is to have a great idea and Step 2 is to find funding. But
what about steps 1a. through 1z.? It’s always about who you know...but when you're
starting a company, the most helpful people are often not those you might have
predicted!
Speaker Bio
Colleen Cutcliffe is a Biochemist and Molecular Biologist with 10 years of experience
managing and directing fundamental biology research teams in the academic,
pharmaceutical and biotech sectors. Prior to co-founding Whole Biome, Colleen
served as the Senior Manager of Biology at Pacific Biosciences where she met and
collaborated with her fellow co-founders, John and Jim. Before her role at Pacific
Biosciences, Colleen served as a Scientist in the Parkinson's Disease discovery group
at Elan Pharmaceuticals. Colleen completed her postdoctoral research under
Elizabeth Perlman at Children's Memorial Hospital in Chicago, IL, her Ph.D in
Biochemistry and Molecular Biology under Cecile Pickart at Johns Hopkins University
and her B.A. in Biochemistry from Wellesley College.
**************************************************************
JLABS Bay Area, Wednesday Mid Day, April 13, 2016
Topic: “Inspiring Leaders: Derek Herrera - Rebuilding Mind, Body and Business”
Speakers: Derek Herrera | CEO, Spinal Singularity [interviewer]; Renee Ryan | Vice
President, Venture Investments, Johnson & Johnson Innovation - JJDC
Date and Time: Wednesday, April 13, 2016 from 11:15 AM to 12:45 PM (PDT)
Agenda:
11:30 AM | Registration Opens, Lunch, and Networking
12:00 PM | Presentation, Interview and Q&A
1:00 PM | Program Close
Location: Plug and Play Tech Center, 440 N. Wolfe Rd, Sunnyvale, California
Fees:
$35 | General Public
$20 | Academic/Student Rate
$45 | At the door
Details and registration at http://www.eventbrite.com/e/inspiring-leaders-derek-
herrera-rebuilding-mind-body-and-business-tickets-21028235017?aff=weekly
26
Parking:
Plug and Play Tech Center onsite, additional parking in the Lowes parking lot.
Event Description
Being an entrepreneur takes resilience, perseverance, determination - all qualities
that a decorated, Marine Special Operations Team Leader would embody. Meet Derek
Herrera, Marine Captain turned entrepreneur - a man who epitomizes the idea of
turning a problem into an opportunity, and a truly inspiring leader. In June 2012,
after a six year career building and leading teams of Marines all over the world,
Captain Herrera was shot and paralyzed by enemy small arms fire while leading his
Marine Special Operations Team on patrol in Afghanistan. Derek returned to work
just 7 months after his injury, and 4 months after that completed his first para-
triathlon.
In true entrepreneur fashion Derek "pivoted," and after pursuing an MBA from UCLA
founded Spinal Singularity, who's first product, the Connected Catheter™, is the
world's first semi-permanent, fully internal, smart catheter system. Derek has led the
Spinal Singularity team to win numerous business plan competitions including being a
top 20 finalist in the MedTech Innovator program and winner of the primeUC
competition.
Join us for a fireside chat with Derek and experience the lessons he's learned about
selflessness, resilience and recovering from seemingly insurmountable odds.
The Inspiring Leader Series provides unrivaled access to been there done that
industry leaders in an intimate and unique setting. The highly sought after, featured
speakers share their forecasts and vision for the future as well as lessons learned
from the trenches. The series is designed to be an interactive and highly educational
experience for all who attend.
Speakers' Bios
Derek Herrera | CEO, Spinal Singularity
In November 2014, Captain Derek Herrera medically retired from Active Duty in the
US Marine Corps after 8.5 years of service as an Infantry and Special Operations
Officer. After graduating from the US Naval Academy in 2006, he has spent his first
six years in the Marine Corps building and leading teams of Marines, Sailors and
Soldiers all over the world. In June 2012, Derek was shot and paralyzed from the
chest down while leading his Marine Special Operations Team on patrol in the
Helmand River Valley, Afghanistan. He's received numerous personal decorations
including the Purple Heart, Combat Action Ribbon, Bronze Star (with combat
distinguishing device), Navy and Marine Corps Commendation Medal and the Navy
and Marine Corps Achievement Medal.
Captain Herrera graduated from the UCLA Anderson School of Management where he
earned an MBA, with a certificate in Entrepreneurship in 2015. While at UCLA, Derek
was awarded the John Wooden Global Leadership Fellowship for exceptional
leadership and was recognized by Poets and Quants as one of the top 50 EMBA
students of 2015.
Recently, he founded Spinal Singularity, a company that designs medical devices to
improve the quality of life for people with Spinal Cord Injury and Disease (SCI/D). In
May 2015, Derek led the Spinal Singularity team to win the UCLA Knapp Business
Plan Competition and the UCLA Student Engineering Venture Competition. Spinal
Singularity was a finalist in the MedTech Innovator program (top 20/292 companies)
27
and was awarded the Johnson & Johnson JLABS innovation award.
Derek has shared his story with the hopes of advocating for the Special Operations
and Paralysis communities and has spoken for many different groups and been
featured on National Media Outlets. He has also worked to support non-profit
organizations that he's passionate about including involvement on the Boards of The
MARSOC Foundation, American Technion Society and Renovating Hope.
[interviewer] Renee Ryan | Vice President, Venture Investments, Johnson & Johnson
Innovation - JJDC
Renee Compton Ryan joined Johnson & Johnson Innovation - JJDC, Inc. (JJDC) in
2011. She is based in Silicon Valley, California and primarily supports the strategic
investment activities in medical devices and diagnostics.
Mrs. Ryan's background includes over 20 years of healthcare investment banking.
Most recently, she ran the medical device investment banking effort at R.W. Baird &
Co. Previously, she lead the West Coast medical device group at Jefferies & Co. and
was in the healthcare investment banking groups at Goldman Sachs and Credit
Suisse.
Mrs. Ryan received an MBA from Columbia Business School and a Bachelors degree
from Georgetown University.
*********************************************************************
**************************************
Concord sfAWIS Networking Event , Wednesday Evening, April 13, 2016
Date and Time: Wednesday, April 13, 2016 - 6:00pm
Location: Valencia & Kebab Restaurant in San Francisco
Join SFAwis members for a fun evening of networking.
Event is free to attend but please register by April 6TH at eventbrite.com
search for "Concord Sfawis Networking Events."
Join sfAWIS members for a fun evening of networking! Event is free to attend but please
RSVP.
This is a great way to meet new people or strengthen existing relationships, hone your
“elevator pitch,” share advice, learn about career opportunities, hear new perspectives, and
learn more about AWIS.
*****************************************************
JLABS, Wednesday, April 20, 2016
Event: WORKSHOP 2 | IPO Readiness Bootcamp | April 20
Date and Time: Wednesday, April 20, 2016, 8:00 am
Agenda:
Event starts at Genentech Hall / Byers Auditorium
8:00 AM | Registration, Networking and Breakfast
9:00 AM | Welcome and Event introduction
Move to Mission Hall / Assigned rooms
9:40 AM | Get to your breakouts
9:50 AM | Breakout 1
10:50 AM | Get to your breakouts
11:00 AM | Breakout 2
12:00 PM | Lunch
12:50 PM | Breakout 3
1:50 PM | Coffee Break
2:00 PM | Get to your breakouts
2:10 PM Breakout 4
3:20 PM | Program Close
28
Facilitators:
Investment Banker:
Jennifer Jarrett | Managing Director , Citigroup's Health Care Investment Banking
Group
Attorneys:
Michael Tenta | Partner, Cooley LLP
Carlton Fleming | Associate, Cooley LLP
D&O Insurance:
Steve Sawyer | Partner & Executive Vice President, Woodruff-Sawyer &Co
Priya Cherian Huskins | Partner & Senior Vice President, Woodruff-Sawyer &Co
Auditors:
Angela Rusakova | West Region Life Sciences Audit Partner, Deloitte & Touche LLP
Jason Richter | National Federal Tax Services Transaction & Integration
Services, Deloitte Tax LLP
David Lyness | Director, Deloitte Tax Services
Locations:
UCSF Genentech Hall / Byers Auditorium: 600 16th St, San Francisco, CA
UCSF Mission Hall: 1599 4th St, San Francisco, CA
Day 2 Fees:
$65 | General Public (limited availability)
No Onsite Registration!
Register at http://www.eventbrite.com/e/how-to-ipo-series-tickets-
20106147027?aff=blast#Day1
Event Description
Are you on IPO watch? Whether IPO starts are up or down, and they will be up and
down, the most important time for your company to be IPO ready is now. Expertise
learned by being IPO ready benefits your firm regardless of your final go/ no-go IPO
decision. Join us for the ultimate IPO crash course to learn directly from the pros.
There are many stakeholders to manage when you prepare your company for an IPO
exit, including your investors, bankers, attorneys, auditors and insurance advisors.
We invited them all to share their insights, real stories, case studies and to answer
your pressing questions. Don't miss this opportunity to enhance your knowledge and
understanding of the step by step IPO process during our day-long program.
The Bootcamp features small group sessions with investment bankers, attorneys,
insurance and auditors/tax professionals to provide focus on individual needs.
Through direct interactions with these professionals, you will become confident in
building your IPO readiness plan as well as learn from group member experiences
and questions.
Key questions about preparing for the IPO process through IPO pricing and closing
will be answered including:
When and how to start IPO readiness process?
Are your investors and internal processes ready for the IPO?
Who from your company will be involved in the process and how much time
does it take?
How to manage your relationships with auditors during the process and what
to expect and when?
When and how to engage and choose your bankers?
What to expect from banker's due diligence?
29
IPO process detailed steps and timing
Registration statement drafting - who is involved, how long does it take, what
it includes and who will help with draft creation?
SEC review process of the registration statement
Roadshow - how to be best prepared for it?
IPO pricing and IPO closing - who is involved and what are their roles?
What do you need to know about D&O insurance? - Who sues you, and for
what, as a public company?
What are three pillars of protection to mitigate D&O risk?
What is the timeline for D&O Insurance for an IPO, including what are private
companies' transition issues?
Also, bring your own questions to receive direct, practical responses from our group
of professional advisors. The more you know, the better prepared your internal
resources and processes are to meet IPO challenges. After this program, you will be
equipped to build stronger and more efficient relationships with all stakeholders,
improve your IPO plan and more efficiently manage your IPO costs.
2016 Global sciences outlook: Moving forward with cautious optimism
Speakers' Biographies
Jennifer Jarrett | Managing Director , Citigroup's Health Care Investment Banking
Group
Jennifer is a Managing Director in Citigroup's Health Care Investment Banking Group.
At Citi, Jennifer focuses on raising capital for and advising companies in the
biotechnology sector. Prior to joining Citi in 2010, Jennifer was the Head of U.S.
Biotechnology at Credit Suisse where she spent 12 years. Jennifer started her career
working at Kidder Peabody and Merrill Lynch and has now spent almost 20 years in
investment banking, 16 of these years focused on the biotechnology sector. Since
Jennifer joined Citi in 2010, she has raised over $5B of capital for biotechnology
companies including several in the oncology sector. These companies include Ambit
Bio, Amgen, Epizyme, Five Prime, Halozyme, Jazz Pharmaceuticals, Medivation,
Mirati, Onconova, Puma Biotechnology and Tesaro. Jennifer has advised on a number
of M&A transactions over the course of her career. Jennifer is on the board of the
Clearity Foundation, a non-profit organization focused on improving treatment
options for ovarian cancer, and has organized several events to raise funds for
Clearity. Jennifer was elected to San Francisco Business Times Most Influential
Women in Business in 2014. Jennifer graduated from Dartmouth College, cum laude,
with a BA in Economics and received her MBA from the Stanford Graduate School of
Business. Jennifer is a native of Houston, Texas but has been in the Bay Area since
1996. In her free time, Jennifer enjoys golfing, skiing and running.
Michael Tenta | Partner, Cooley LLP
Michael E. Tenta is a partner in the Cooley Business department. He joined the Firm
in 2000 and is resident in the Palo Alto office. Mr. Tenta practices corporate and
securities law, representing public and private companies, investors and investment
banks in a variety of matters, including securities offerings, mergers and
acquisitions, and general corporate and commercial law. Prior to joining Cooley, Mr.
Tenta was an associate at the law firm of Lawson Lundell in Vancouver, Canada,
where he advised both public and private companies in the technology,
manufacturing and resource sectors. Mr. Tenta graduated from the University of
Victoria Faculty of Law in 1997. During his legal studies, he spent a term working at
30
the Intellectual Property Policy Directorate of the Government of Canada and at the
University of the South Pacific Department of Law. Mr. Tenta graduated from Simon
Fraser University with a BS (Biology) in 1993. Mr. Tenta is a member of the State Bar
of California, the American Bar Association and the Law Society of British Columbia.
Mr. Tenta is not admitted to practice in Washington state.
Carlton Fleming | Associate, Cooley LLP
Carlton Fleming is an associate in Cooley's Business department and a member of the
Public Companies, Capital Markets and Emerging Companies practice groups. He
joined the Firm in 2012 and is resident in the Palo Alto office. Carlton practices
general corporate and securities law, representing both public and private companies
in a wide range of matters, including formation and financing activities, SEC
reporting and compliance, corporate governance and mergers and acquisitions. He
also represents investment banks and venture capital firms in public offerings and
private placements of equity and debt securities. Since 2012, Carlton has been
involved in over 25 IPOs and other public offerings, raising over $3 billion. Carlton
received a JD and an LLM in International and Comparative Law in 2007 from Duke
University School of Law. He received a BA in German and History in 2004 from Duke
University. Mr. Fleming is a member of the State Bar of California and the State Bar
of North Carolina.
Steve Sawyer | Partner & Executive Vice President, Woodruff-Sawyer &Co
A trusted advisor to Silicon Valley companies and beyond, Steve's creativity and
passion for solving clients' most complex risk challenges has led him to become an
industry innovator. Steve has been partnering with technology and life sciences
clients since joining the firm in 1981. He launched its Life Sciences Practice in 1991—
today one of the nation's largest. Under Steve's leadership, Woodruff-Sawyer as the
Biotechnology Industry Organization's (BIO's) as its West Coast risk management
partner. Steve works with organizations from new venture formation through IPO,
commercialization and international expansion. In addition to P&C, he has extensive
experience addressing D&O liability needs of public company clients. Steve also
founded Woodruff-Sawyer's CleanTech Practice in 2008. He worked with global
insurers to create innovative Performance Warranty programs for solar and other
clean tech projects, providing customized financial backstops to facilitate
"bankability" for securing financing for various projects. Steve is on Woodruff-
Sawyer's Board of Directors and has served on the board for BayBio, the
biotechnology trade organization for Northern California. He is active in various non-
profits and missions committed to pressing needs in our community and around the
world. Steve has a bachelor's degree from Stanford University and an MBA from
Northwestern University's Kellogg Graduate School of Management. He is a
designated Chartered Property and Casualty Underwriter (CPCU).
Priya Cherian Huskins, Esq. | Partner & Senior Vice President, Woodruff-Sawyer &Co
Priya Cherian Huskins is a recognized expert in D&O liability risk and its mitigation.
In addition to consulting on D&O insurance matters, she counsels clients on corporate
governance matters, including ways to reduce their exposure to shareholder lawsuits
and regulatory investigations. Priya is a frequent speaker on D&O issues and a
regular guest lecturer at Stanford's Directors' College, among others. She is also the
author of the D&O Notebook, a blog that monitors, curates and summarizes issues as
they arise in the areas of D&O liability, insurance and corporate governance. Priya
serves on the board of directors of Realty Income Corporation (NYSE: O) as well as
the Advisory Board for the Stanford University Rock Center for Corporate
Governance. Priya is also on the board of the of the Silicon Valley Directors'
31
Exchange (SVDX). Priya was listed as one of the "Most Influential Women in Bay Area
Business" by the San Francisco Business Times in 2012. She was a judge for the
prestigious Ernst & Young Entrepreneur of the Year award in Northern California from
2009-2011. Priya was named one of the "Top 100 Women of Influence in the Silicon
Valley" in 2009 by the San Jose/Silicon Valley Business Journal. Prior to joining
Woodruff-Sawyer, Priya practiced corporate and securities law at Wilson Sonsini
Goodrich & Rosati. Priya has worked with both public and private technology
companies through all stages of their development. Priya was awarded her juris
doctorate with honors from the Law School at the University of Chicago. She earned
her undergraduate degree with high honors from Harvard University. Priya is a
member of the California Bar.
Angela Rusakova | West Region Life Sciences Audit Partner, Deloitte & Touche LLP
Angela has 20 years of experience serving both public and private companies with a
focus on the life sciences industry. She works with companies in all stages of growth,
from start-ups to SEC registrants. Her technical background includes complex
accounting issues such as revenue recognition, equity, derivatives, stock-based
compensation, and acquisitions. Angela has been involved in financing and M&A
transactions, including initial public offerings, offerings in leveraged buyouts, and
several secondary shares offerings. She has extensive international experience and is
a certified public accountant in the United States and the United Kingdom. Angela
also served as a CFO before returning to public accounting in 2003.
Jason Richter | National Federal Tax Services Transaction & Integration Services,
Deloitte Tax LLP
Jason is a Senior Manager with National Federal Tax Services (Transaction &
Integration Services), Deloitte Tax LLP, and has over 14 years of professional
experience specializing in corporate tax matters including merger and acquisition
related due diligence, tax structuring, and tax modeling. Jason is primarily involved
in providing Section 382 and NOL consulting services including the day to day
management of the preparation of full Section 382 ownership change studies and the
computation of the related annual limitations. Jason is also responsible for the
preparation and review of quarterly Section 382 update analyses and the review of
studies in support of tax return preparation and financial statement reporting and
disclosure. Jason is frequently involved in providing Section 382 services as part of
due diligence for merger and acquisition transactions as well as NOL planning and
structuring. He serves a variety of public and private company clients. Jason has
been providing Section 382 services for over eleven years, authored several articles
in this area, and has appeared as a guest lecturer on the topic.
David Lyness | Director, Deloitte Tax Services
David leads Deloitte's Silicon Valley R&D tax credit practice. Over the past 20 years,
David has specialized in serving life science and other technology companies. Primary
focus areas include developing R&D tax credit claims and representing clients before
the IRS and state tax authorities. David is a member of the New York Bar, and has
degrees in accounting and law, including an LL.M (Tax) from New York University
School of Law.
**************************************************************
West Coast Chapter PDA, Thursday, April 21, 2016
Event: “Women in the Biopharmaceutical Industry:A Panel Discussion and Networking with
Company Leaders”
Date and Time: April 21 , 2016,6:00-9:30 PM
32
Agenda
6:00pm Registration and Networking
7:00pm Dinner
7:45pm Announcements
8:00pm Presentation and Discussion
9:30pm Closing
Location: Dominic's at Oyster Point | So. San Francisco, CA
Topic Description
Come hear the career stories, challenges and successes of our esteemed panelists as they
discuss their personal journeys into the biopharmaceutical industry. They'll discuss the
challenges women can expect to face upon entering the job market as well as share general
advice for women (and men) hoping to build their careers in the industry.
Registration
Pre-registration is $50 for PDA members and $60 for non-members (Credit/Cash/Check)
Additional $5 for Walk-in/At-Door registration.
There is a $15 discount for Government Employees and Students
PDA members: Please include your member ID number (after your name) in your
registration.
Use the following link to register.
If your device or email does not support registration/payment through the PayPal link, you
can submit registration requests via e-mail to [email protected] with "WCC PDA Dinner
RSVP" as the subject line. Indicated name and company affiliation for each registrant. If
you provide your information, a seat will be reserved for you.
Reserved 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.
Speaker Bios
Melissa Morandi (Moderator) is currently the VP of Global Quality for Aegerion
Pharmaceuticals, and international company focused on the development and
commercialization of orphan drugs. Previously, she was VP of Quality at Acceleron Pharma,
and Vice President of Quality at Anesiva. Prior to joining Anesiva, Ms. Morandi held director
and managerial positions at Biogen, Genentech and Amgen. She holds a B.A. degree from
the University of California at Santa Barbara and a M.S. degree in Immunology from
California State University at Northridge.
Maura Lynch is the Director of business Development for Delta Project Management where
she oversees the business development and personnel management for the company. With
over 8 years of experience in the biotechnology and pharmaceutical industries, Ms. Lynch
has worked with many clients throughout the Bay Area including Genentech, Bayer,
Novartis, BioMarin and Boehringer-Ingelheim. She grew up in San Francisco, graduated
from the University of San Francisco and now calls Oakland home.
Sara Brien is currently Director of Technical Operations for Dynavax Technologies where she
is responsible for global project management and planning of CMC related product/process
development activities. Ms. Brien has 15 years of experience in pharmaceutical and
biotechnology manufacturing and supply chain operations. She has previously worked at
Grifols and Novartis where she held positions of increasing responsibility. Prior to joining
Novartis Ms. Brien worked at Enzo Life Sciences, Assay Designs and Sanofi Pasteur.
33
Elizabeth Leininger is a consultant for Regulatory Affairs and Quality with more than 18
years of diverse experience. Previously she was VP Regulatory Affairs, Quality Assurance
and Clinical Operations at StemCells and VP of Regulatory Affairs and Quality at BAS
Medical. Formerly a consultant with The Biologics Consulting Group, Dr. Leininger has also
worked for the U.S. Food and Drug Administration, Chiron, and GlaxoSmithKline.
Elaine Eborall is currently Executive Director, Quality and Compliance for Ultragenyx
Pharmaceutical. Previously she has been with Genentech for 15 years where she was
responsible for the Global GMP Audit Program in the Americas and Asia Pacific regions.
Elaine holds a Bachelor’s of Science in Biology with a minor in Chemistry. She is certified as
a Quality Auditor by ASQ and holds an Advanced Certificate in Regulatory Affairs from the
University of San Diego. Prior to joining Genentech Elaine held positions at Astra-Zeneca
and Centaur Pharmaceuticals in Quality and Regulatory Affairs.
*********************************************************************
Bio-X Frontiers, Tuesday, April 26, 2016
Topic: “Integration Of Systems Biology, Tissue Engineering, And Microdevices For Drug
Development”
Pre-Seminar Speaker: Ovijit Chaudhuri, Department Of Mechanical Engineering
April 28, 2016
Seminar Speaker: Linda Griffith, Mit --Integration Of Systems Biology, Tissue Engineering,
And Microdevices For Drug Development
Date And Time: Tuesday, April 26, 2016, Noon
Location:
Pre-Seminars In Clark Center Room S361; Seminars In Clark Center Room S360
Small Lunch Served At 12:00��; Lectures Begin At12:15��
Pre-Seminars In Clark Center Room S361; Seminars In Clark Center Room S360
********************************************************
Naturejobs Career Expo, Wednesday, April 27,2016
Event: Career Expo
Date and Time: Wednesday, April 27, 2016l, 10 AM - 5 PM
Location: Contemporary Jewish Museum (736 Mission St, San Francisco, CA 94103)
Find details and registration at http://www.nature.com/naturejobs/career-
expo/event/naturejobs-career-expo-san-francisco/
Event Description: The Naturejobs Career Expo is the global career fair and conference for
the science community from Naturejobs and Natureconferences. The Naturejobs Career
Expo 2016, hosted for the first time in San Francisco, offers talented researchers an
excellent opportunity to meet a diverse selection of national and international employers
from academic institutions and scientific industries, such as pharmaceutical organizations,
digital technology companies, science publishing and more.
* Attend all conferences and workshops for free
* Meet employers face-to-face
* Benefit from one-to-one resume checking
* Network with leading scientific institutions
* Learn how to enhance your employability
* Maximize your career prospects
**************************************************************
34
Bio-X, Saturday, May 7, 2016
In vitro Vascularized Constructs as Models of Metastatic Cancer
Date and Time: Saturday, May 7, 2016, noon
Location:
PRE-SEMINARS IN CLARK CENTER ROOM S361; SEMINARS IN CLARK CENTER ROOM S360
SMALL LUNCH SERVED AT 12:00��; LECTURES BEGIN AT12:15��
PRE-SEMINARS IN CLARK CENTER ROOM S361; SEMINARS IN CLARK CENTER ROOM S360
Pre-Seminar Speaker: Alexander Dunn, Department of Chemical Engineering
May 19, 2016
Seminar Speaker: Roger Kamm, MIT
In vitro Vascularized Constructs as Models of Metastatic Cancer
*****************************
CABS, Saturday, May 7, 2017
Save the Date: 2016 BioPacific Conference
Date and Time: Saturday, May 7, 2016, 8 AM- 9 PM
Location: San Mateo Marriott, 1770 South Amphlett Blvd, San Mateo, CA 94402
Description:
Our meeting will showcase:
Winner of 2016 CABS K. Fong Award in Life Sciences
Most promising areas in life sciences
Opportunities and challenges for developing biopharmaceuticals in China
Cross border financing and entrepreneurship
Success stories of entrepreneurs and emerging companies
Confirmed Speakers and Panelists include:
Hari Kumar, CEO, Adheron Therapeutics
Piers Whitehead, EVP & CBO, PaxVax
Mark Selby, Ph.D., Senior Director of Immuno-Oncology, Bristol- Myers Squibb
Edward F. Chang, M.D., Associate Professor of Neurological Surgery and Physiology,
Co-Director, Center for Neural Engineering and Prostheses at UC Berkeley and UCSF,
New York Stem Cell Foundation- Robertson Investigator University of California,
San Francisco
Lei Stanley Qi, Ph.D., Assistant Professor, Department of Bioengineering and of
Chemical and Systems Biology, faculty fellow in the interdisciplinary Institute for
Chemistry, Engineering, and Medicine for Human Health
Shawn Qian, Ph.D., CEO, Neupharma
Xiaodong Yang, M.D., Ph.D., President and CEO, Apexigen
Xian-Ping Lu, Ph.D., Co-Founder, CEO and CSO, Chipscreen Biosciences
Dan Zhang, M.D., Ph.D., CEO, Fountain Medical Development
Yongmei "Alexis" Ji, Ph.D., MBA, Principal, WuXi Ventures
James Zhao, M.D., M.S., MBA, Founding Partner, LYFE Capital
Yuwen Liu, MBA, MS, Founding Partner, BoHe Angel Fund
Min Cui, Ph.D., Founding Partner and Managing Director, Decheng Capital
This highly anticipated full day event is expected to attract over 600 life science
professionals from San Francisco Bay Area as well as Pacific Rim countries.
Contact for Sponsorship/Exhibition Opportunities: [email protected]
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*
sfAWIS, Wednesday Evening, May 11, 2016
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Topic: "The Conflict Shift: from Conflict to Cooperation"
Speaker: Susan Berstein, MBA, PhD
Date and Time: Wednesday, May 11, 2016, 6:30 pm,:
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Stanford Medicine, Saturday, May 14, 2016
Topic: “Health Matters 2016”
Date and Time: Saturday, May 14, 9:00 a.m. – 2:00 p.m.
Location: Li Ka Shing Center for Learning and Knowledge, 291 Campus Drive, Stanford
Registration opens on April 1.
Details at http://healthmatters.stanford.edu/
Podcasts and videos of the 2015 event are also listed.
Topic Description
health matters is a free community event hosted by Stanford Medicine that explores the
latest advancements in medicine and the health topics that matter most to you and your
family.
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JLABS, Thursday, May 19, 2016
Event: “WORKSHOP 3 | Lessons Learned: The IPO process from battle tested
Veterans”
Speakers:
Linda Bain | Chief Financial Officer, Codiak BioSciences read bio»
Isaac Ciechanover | President & CEO, Atara Biotherapeutics read bio»
[moderator] Angela Rusakova | West Region Life Sciences Audit Partner, Deloitte &
Touche LLP
Date and Time: Thursday, May 19, 2016, 8:15 am
Agenda:
8:15 AM | Registration Opens, Breakfast and Networking
9:00 AM | Panel and Q&A
10:30 AM | Closing remarks and networking
11:00 AM | Program Close
Location: JLABS @ SSF, 329 Oyster Point Blvd - 3rd Floor, South San Francisco, CA
Day 3 Fees: $20 | General Public: $35 | At the door
Register at http://www.eventbrite.com/e/how-to-ipo-series-tickets-
20106147027?aff=blast#Day3
Event Description
There is nothing like experience! The final event in our 3 part IPO series with Deloitte
& Touche, LLP brings in two high profile C-level executives. They have gone through
the IPO experience and as IPO journey's go, their paths were different.
This breakfast event will take a look at two companies that recently went through
successful IPO's. The company leaders will share their insights from firsthand
experience on issues ranging from preparation to execution.
Topics include:
Hiring the right professional team
Managing the Board
The roadshow
Pricing, timing and market conditions
The surprises, pitfalls and lessons learned
36
With plenty of time for Q&A
Join us for an insider's look at the IPO!
Speakers' Biographies:
Linda Bain | Chief Financial Officer, Codiak BioSciences
Linda Bain joined Codiak from Avalanche Biotechnologies where, as chief financial
officer, she led a successful IPO and follow-on financing. She previously served as
vice president of finance, business operations and treasurer at Bluebird Bio. Ms. Bain
has held senior roles at Genzyme Corporation, including vice president of finance,
global manufacturing and operations and vice president of finance of Genzyme
Genetics. Earlier in her career, she served in senior finance roles at Fidelity
Investments and AstraZeneca Pharmaceuticals and as an auditor at Deloitte &
Touche.
Isaac Ciechanover, M.D. | President & CEO, Atara Biotherapeutics
Dr. Isaac Ciechanover is a physician, investor and entrepreneur driven by a passion
to improve the practice of medicine. Motivated by the belief that the majority of
medical discoveries still lie ahead, he has dedicated the past 20 years to working
with entrepreneurs and life sciences organizations to advance medicine through
innovation and technology. He founded Atara Biotherapeutics in August 2012.
Previously, he was a partner in the life sciences practice at Kleiner Perkins Caufield &
Byers. Earlier as Celgene's Executive Director for Business Development, he
spearheaded the company's venture capital efforts and led licensing and M&A
activities with an aggregate value of more than $6.7 billion. Also at Celgene, he was
Global Project Leader for the company's first clinical-stage biologic therapy. Isaac has
also held business development and venture capital roles at Amylin Pharmaceuticals,
Pequot Ventures' healthcare practice and Pfizer. Intellectually curious (and
undeterred by student debt), Isaac holds a B.A. from Stanford University, an M.Phil.
in Epidemiology from Cambridge University, an M.D. from Weill Cornell Medical
College and an M.B.A. from Harvard Business School. For fun, he enjoys cycling,
scuba diving and building Lego with his two children. His all-time favorite albums are
Pink Floyd's "The Dark Side of the Moon," Radiohead's "OK Computer" and Ruggero
Leoncavallo's Italian opera, Pagliacci, with Herbet Von Karajan conducting.
Angela Rusakova | West Region Life Sciences Audit Partner, Deloitte & Touche LLP
Angela has 20 years of experience serving both public and private companies with a
focus on the life sciences industry. She works with companies in all stages of growth,
from start-ups to SEC registrants. Her technical background includes complex
accounting issues such as revenue recognition, equity, derivatives, stock-based
compensation, and acquisitions. Angela has been involved in financing and M&A
transactions, including initial public offerings, offerings in leveraged buyouts, and
several secondary shares offerings. She has extensive international experience and is
a certified public accountant in the United States and the United Kingdom. Angela
also served as a CFO before returning to public accounting in 2003.
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South Bay HBA, Saturday, June 4, 2016
Event: South Bay Coffee Chat
Location: Shoreline Lake American Bistro - 3160 N Shoreline Blvd., Mountain View, CA
To RSVP or for more information, please contact Meggin Taylor or Mary Dosunmu
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37
BIO International Conference, June 6 – 9, 2016
Dates: June 6 – 9, 2016
Location: Moscone Convention Center, North, South and West Halls
Fees: Convention Access - $1,200, Members and 1,450, Non Members before April 16;
$1,400, Members and $1,750 for nonmembers after April 16 (see other package pricing at
http://convention.bio.org/register/)
*****************************************************************
BIO Career Fair, Thursday Afternoon, June 9, 2016
Event: BIO Career Fair
Date and Time: Thursday, June 9, 2016, 2:00 – 7:00 pm
Cost: Free
Details and registration at http://convention.bio.org/careerfair-jobseekers/
BIO is proud to announce the 2016 BIO Career Fair, Thursday June 9 from 2:00 - 7:00 pm.
As an extension of BIO’s online job board—Bio Jobs—the Career Fair will provide an
opportunity for meeting participants and top employers to discuss career opportunities..
The BIO Career Fair (is free) and will allow you access to many of the world’s leading life
science companies. A minimum of a 4-year life science degree OR a community college
biotech degree is recommended and military veterans are encouraged to apply. Details at
More information coming soon!
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HPLC, Sunday, June 19, 2016
Topic: “HPLC 2016 - 44th International Symposium and Exhibit on High Performance Liquid
Phase Separations and Related Techniques”
Date and Time: Sunday, June 19, 2016 , 8:30 am
Location: Mariott San Francisco Marquis
The goal of HPLC 2016 is to bring together scientists who use and develop
HPLC, capillary electrophoresis, supercritical fluidic chromatography, microfluidics, and mass
spectrometry to exchange ideas, best practices, and
latest developments. The conference program is guided by emerging trends in
separations technology and their impact on science and society.
THREE SESSION TRACKS AT HPLC 2016:
Technology: Better, Faster, Quantitative Separations
Interface to MS: Improving Information Content
BioAnalysis and Applications: Impacting Science and Society
Topics include column and stationary phase technology, interface to mass spectrometry,
microfluidic systems, capillary electrophoresis, LCxLC, QA&QC methods, QbD in separations,
and application to real world problems. A special emphasis in applications will be on
bioanalysis including:
pharmaceuticals, antibody-drug conjugates, antibody characterization, biotechnology,
proteins and proteomics, glycomics, metabolomics and lipidomics, food and nutrition, well-
characterized biologicals, biofuels, environment, and toxicology.
Also Featuring:
Tutorials, Short Courses, User Group Meetings, and Lunch Technical Sessions
For more information, visit: www.hplc2016.org
http://www.hplc2016.org/index.html
Type of Registration: Fees are posted under the "Online Registration" tab located at
www.HPLC2016.org.
Payment must be made by check or credit card payable in US Dollars and drawn on a US
bank (no bank wire transfers).
38
Registration is not accepted or acknowledged until payment is received.
By submitting this registration, you authorize the HPLC 2016 meeting to share your
information with attendees, etc.
Student Registrants: In order for the student rate to be accepted, must submit proof of
current full-time graduate or undergraduate, not postdoctoral, status at an academic
institution by providing both a copy of your Student I.D and a letter on university stationery
from your department chair along with the department chair contact details and email.
Email the letter and copy of the Student ID to [email protected].
All Oral and Poster Presenters: In order to present, the presenting author of each lecture
and poster must be registered as a conference attendee (not booth staff) and must
complete the registration process by paying online by April 18 to confirm intent to attend
and present at the meeting. If fees are not paid, submissions from that author will be
removed from the program.
Refund Policy: A processing fee of 20% will be collected on cancellations on or before April
1, 2016, after which the fees are non-refundable. Registration is transferable; must contact
Symposium Manager by no later than one week prior to the conference to transfer and
receive confirmation of the transfer of the registration ([email protected] or
telephone 301-668-6001).
HPLC 2016 Symposium/Exhibit Manager
Ms. Janet Cunningham
Barr Enterprises
www.LinkedIn.com/in/BarrEnterprises
phone 301-668-6001
www.HPLC2016.org
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PBSS Workshop, Monday, June 27, 2016
Workshop
Topic: “UHPLC in Biopharmaceutical Analysis: Benefits, Practices, Issues and
Implementation”
Speakers: Dr. Michael W. Dong, MWD Consulting
Date and Time: Monday, June 27, 2016, 8:45-12:30
Registration fee (US$): (USD$)Regular: $125; For vendor-show reps: $25; For unemployed
& students: $20; For major-sponsor rep (incl lunch): $0;
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor: (1)Agilent
Vendor show vendors registered to date:
Registration: http://www.PBSS.org
Registration deadline:6/23/2016 (it will close sooner if the seating cap is reached)
About the Topic
Ultra-high-pressure liquid chromatography (UHPLC) is the new standard HPLC platform
delivering higher performance with small-particle columns used on low-dispersion systems
with pressure limits of 15,000 – 23,000 psi. This intermediate-level 1/2-day training
workshop will provide a critical overview the fundamental concepts, benefits, potential
issues, and best practices of UHPLC in pharmaceutical analysis of small molecule drugs and
recombinant biologics (monoclonal antibodies, mAbs)
Who Should Attend
This workshop is intended for analysts, managers, and researchers wishing to have a
thorough understanding the fundamentals and practices of UHPLC in pharmaceutical
analysis. A basic knowledge of HPLC is assumed and some practical hands-on experience is
highly recommended.
39
Workshop Agenda
UHPLC 1: Concept and Benefits
1. Overview and perspectives, Glossary, the modern HPLC platform with higher
performance, UHPLC concepts (the need for high pressure, void volume, peak
volume, instrumental bandwidth), UV flow cell design, dwell volume.
2. Benefits and case studies: Very fast separations with good resolution, very high
resolution analysis of complex samples, facilitating rapid method development,
flexibility to customize resolution, a modernized generic method for most drugs, a
greener HPLC platform.
UHPLC 2: Potential Issues, Practices, and implementation
1. Potential issues and how to mitigate (viscous heating, operating nuances,
compatibility to existing methods, injection precision, detector sensitivity vs. mixing
volumes.
2. Method translation (transfer) issues: method portability, method conversion
(translation), “What is method transfer?”, need for partial method validation, case
studies.
3. How to transition from HPLC to UHPLC, end-fittings, system performance tradeoffs,
Myths in UHPLC, references.
Learning Outcomes UHPLC in Biopharmaceutical Analysis
The attendee will learn the benefits, best practices and potential issues of UHPLC in
pharmaceutical analysis including method translation and how to get started in UHPLC.
About the Speakers
Dr. Michael W. Dong is a principal consultant in MWD Consulting focusing on consulting and
training services on HPLC/UHPLC, pharmaceutical analysis and drug quality. He was
formerly Senior Scientist in Analytical Chemistry and Quality Control at Genentech,
Research Director at Synomics Pharma, Research Fellow at Purdue Pharma, and Senior Staff
Scientist at Applied Biosystems / Perkin-Elmer. He holds a Ph.D. in Analytical Chemistry
from the City University of New York, and a certificate in Biotechnology from U. C. Santa
Cruz. He has 100+ publications including a bestselling book on chromatography (Modern
HPLC for Practicing Scientists). He is an editorial advisory board member of LCGC magazine
and American Pharmaceutical Review.
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PBSS, Friday MidDay, July 29, 2016
Seminar luncheon
Topic: “CRISPR gene editing platform development for drug discovery and validation”
Speakers: Benjamin Haley, PhD (Genentech)
Organizers:
Date: Friday, July 29, 2016, 11:00-13:30
Registration fee (US$): (USD$);
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor:
Vendor show vendors registered to date:
Registration: http://www.PBSS.org
Registration deadline:7/27/2016 (it will close sooner if the seating cap is reached)
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Bio2Device Group, Tuesday Evening, August 9, 2016
Topic: TBA
Speaker: Dr. Allison Dupuy, Partner, Simon-Kucher
Date and Time: Tuesday, Aug. 9, 2016, 6:00 pm
Date and Time: Tuesday, Oct. 13, 2015, 6:00pm
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Location: Wilson Sonsini Goodrich & Rosati, 650 Page Mill Road, Palo Alto CA
Cost:
$6 - Students/In-transition - Members only
$11 - Early-bird Registration - Members only
$20 - Late Registration and Non-Members
$25 - Walk-ins (as space permits)
Register at www.Bio2DeviceGroup.org
Speaker Bio
Dr. Allison Dupuy is a Partner in the Life Sciences division of Simon-Kucher & Partners in
San Francisco and leads the company’s life sciences practice on the west coast of the
US. She joined the team in San Francisco in August 2012 after spending 5 years in
Simon-Kucher’s Boston office.
In her work at Simon-Kucher, she focuses on strategic pharmaceutical marketing, value-
to-customer, market entry strategies, pricing and market access strategies, innovative
pricing strategies, product lifecycle strategies, licensing and valuation, market
forecasting and value communication, including global value story development and
implementation. She is a trusted advisor of leading pharmaceutical and biotech
companies across a wide range of therapeutic areas in all major healthcare markets
across the globe.
Dr. Dupuy received her Ph.D. and M.Phil. in Molecular Biophysics and Biochemistry from
Yale University and a B.A. in Physics with honors from Wellesley College where she was
a Goldwater Scholar and a Schiff Fellow.
She is the author and coauthor of several scientific publications and has research
experience in theoretical and experimental physics, biophysics, cell biology, cancer
biology, genomics, proteomics, bioinformatics and biochemistry.