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Audrey’s Life Science Meeting Picks for Feb. 21, 2016 – August 2016
Complimentary Service of AudreysNetwork.com
Feb. 21, 2016
******************************************************************* Bio2Device Group, Tuesday Morning, Feb. 23, 2016
Topic: “Applying the powerful silicon platform for breakthrough medical and life science
products”
Speaker: Winny Tan, Ph.D., Partnerships Manager, Nanoelectrics R&D Institute
Date and Time: Tuesday, Feb. 23, 2016, 8:30 am
Location: Sunnyvale City Council Chambers, 456 West Olive Ave., Sunnyvale, CA
There is no registration or fee for morning meetings.
Topic Description
Imec is a nano electronics R&D institute that is leveraging silicon technology and
manufacturing to enable breakthrough medical and life science products. This presentation
will explain how to access silicon technology through Imec, what is in the toolbox, and why
it is poised to disrupt the medical and life science markets.
Dr. Tan will talk about 2 Imec programs for health and life science applications:
Imec Wearable Health Solutions - This program includes Imec’s advanced wearable health
sensors, electronics, and systems with the aim of putting medical quality data in everyone’s
hands. Keywords: health patch, EEG headset, smart band
Imec Life Science - This program includes Imec’s advanced life science prototypes and
highly complex biochips, which integrate entire molecular and cellular workflows and
detectors on chip. Keywords: PCR on-chip, cell sorter, holographic imagin
Speaker Bio
Winny Tan, PhD is a Partnerships Manager for Imec, a nanoelectronics R&D institute in
Belgium; with a focus on the Life Science, Medical Device and Healthcare segments. In her
previous role, she spent 4 years consulting on business strategies for the market leaders in
diagnostics. She enjoys roles that bring advanced technologies to market and successfully
developed business plans to raise funding for spinouts from UCLA and Caltech in a start-up
incubator based in Los Angeles. Winny received her PhD from UCLA in which she conducted
bio-microfluidics research.
****************************************************************************** BioScience Forum, Wednesday Evening, Feb. 24, 2016
Topic: "Leveraging Polymer Science to Advance the Treatment of Hyperkalemia"
Speaker: Lance Berman, M.D., Senior Vice President and Chief Medical Officer, Relypsa
Date and Time: Wednesday, February 24th, 2016, 6:00 -9:00 pm
6:00 PM - networking
7:00 PM - dinner
8:00 PM - presentation
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Location: The Holiday Inn, 275 S Airport Blvd, South San Francisco, CA 94080
Price: $50 before 9PM, Monday, Feb. 22nd; $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
Details and registration at http://biosf.org/
Topic Description
Hyperkalemia is a serious condition that can result in life-threatening cardiac arrhythmias.
Patients with compromised renal potassium excretion, primarily patients with chronic kidney
disease (CKD), are most at risk of hyperkalemia. Hyperkalemia frequently occurs where the
underlying disorder is persistent and generally progressive. Thus, treatment may be needed
for long periods of time and/or may need to be repeated. Current options for the ongoing
management of recurrent or persistent hyperkalemia have limited utility and include dietary
potassium restriction, diuretics, sodium bicarbonate and the cation exchange resins sodium
and calcium polystyrene sulfonate.
Until recently, sodium polystyrene sulfonate (Kayexalate®), approved by the FDA in 1958,
was the only medication in the US specifically indicated for the treatment of hyperkalemia.
Since effective lowering of serum potassium with sodium polystyrene sulfonate may take
hours to days, treatment with this drug alone may not be sufficient to rapidly correct severe
hyperkalemia associated with the rapid tissue breakdown or marked hyperkalemia
considered to be a medical emergency. Warning and Precautions added to the Kayexelate
label in 2009 and 2011 may also limit its use.
Relypsa applied its polymer technology with the intent to design an orally administered,
non-absorbed potassium binder with physicochemical characteristics that would provide
effective and sustained reductions in serum potassium and with a safety and tolerability
profile that would support long term chronic use. VELTASSA® (patiromer) for oral
suspension was recently approved by FDA for the treatment of hyperkalemia (given its
delayed onset of action, it should not be used as an emergency treatment for life-
threatening hyperkalemia). The active moiety, patiromer, is a sodium-free, non-absorbed
polymer that binds potassium in exchange for calcium in the gastrointestinal tract,
increasing fecal potassium excretion and lowering serum potassium levels. A comprehensive
nonclinical and clinical testing program was conducted to support the development of the
product for its intended use in humans for the treatment of hyperkalemia. The primary
objectives of the clinical development program included: the evaluation of safety and
efficacy in subjects with underlying conditions that are common causes of hyperkalemia in
the clinical setting; a reduction in serum potassium to within the normal range; and an
assessment of safety and tolerability, particularly in support of repeated and long term use.
This talk will provide perspectives on the mechanism of action and clinical development
program used to develop patiromer from preclinical to use in patients today.
Speaker Bio
Lance joined Relypsa in December 2011 as Senior Vice President, Commercial Strategy and
Medical Affairs and was promoted in October 2012 to Senior Vice President and Chief
Medical Officer. Most recently, he was Chief Medical Officer of CPEX Pharmaceuticals where
he was responsible for the clinical development of the Company’s late stage clinical product
as well as its in-licensing and acquisition strategies. Prior to that, he served in various
medical leadership roles at Pfizer Inc. from June 2003 to January 2009, where he was
responsible for atherosclerosis, hypertension and endocrinology products serving at various
times as US or Global Medical Team Leader.
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Previously, Lance held roles of increasing responsibility at Schering-Plough Corporation
(merged with Merck) and Janssen Pharmaceuticals, Inc. (Johnson & Johnson).
Lance received his Bachelor of Medicine and Bachelor of Surgery at the University of Cape
Town in Cape Town, South Africa, and holds a Masters Degree in Pharmaceutical Medicine. **********************************************************************************************
ASQ, Wednesday Evening, Feb. 24, 2016
Topic: “Human Factors Engineering in Medical Devices”
Speaker: Mark Moyer is the Administrative Director of the USF Health CAMLS Innovation
Cente
Date and Time: Wednesday, February 24, 2016, 7:00 to 9:00 pm
Moderator: Barry Craner, retired, former Vice President of Quality and Regulatory,
Stellartech Research Corporation.
Location: Stellartech Research Corporation, 560 Cottonwood Dr, Milpitas, CA 95035 Click
here for map and directions.
Food: Snacks equivalent to a light meal and beverages are provided at each event at no
additional cost.
Registration Link: NCDGfeb2016.eventbrite.com
ONLY Check or Credit Card accepted at door
Email: To be added to or removed from our email list, contact George Marcel
Topic Description
This discussion will help the medical device professional identify practical
implementations of usability engineering subsystems and development projects for
conformance to FDA and EU regulations. The discussion is intended to help visualize
human factors engineering & usability engineering (HFE/UE) as part of a compliant
design control process.
Discussion Areas:
The IEC 62A/JWG 4, Medical devices- general requirements for safety and
essential performance – Usability and the AAMI HE, Human Factors Engineering
Committee, EN 62366:2009 / IEC 62366:2015-1
Proposed AAMI TIR ”Integrating human factors into design controls”.
High fidelity simulated use environments
Speaker Bio
Mark Moyer is the Administrative Director of the USF Health CAMLS Innovation Center.
The Innovation Center is an environment for physician and technologist collaboration.
From concept design, (modeling and engineering) to final verification, validation, and
regulatory body acceptance, the Innovation Center works closely with clients to provide
useful, timely, cost effective and innovative healthcare solutions. Mark began his career
in the aerospace industry and has spent over 20 years providing leadership in new
product development, manufacturing, compliance, quality/regulatory affairs, and
change control with both domestic and off-shore partners. Mark has been awarded
multiple design patents.
As an ASQ certified auditor, Mark works with the society’s Learning Offerings
group as one of the faculty deploying the Biomedical Body of Knowledge (BoK).
He has trained industry professionals as well as regulators both internationally
and domestically. A past chair of ASQ’s Biomedical Division, he currently serves
on the society’s Technical Communities Council, co-chairs the Performance and
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Recognition Committee, and was recently elected to the society’s Board of
Directors. Mark also serves as a representative on the AAMI HE, Human Factors
Engineering Committee
Questions: For information about this session, contact Barry Craner
Formal discussion and questions will end between 8:30 - 8:45 pm to allow time for
networking after the roundtable presentation.
Materials: Handouts provided. Please limit distribution to immediate personal professional
use only.
********************************************************************************************** BVS, 3rd SF Biotech Community Event at Dominic’s, Wednesday Evening, Feb. 25,
2016
Date and Time: Thursday, February 25, 2016 from 5:00 PM to 8:00 PM (PST)
Location: Dominic’s at Oyster Point –360 Oyster Point Boulevard South San Francisco, CA
94080
Register at https://www.eventbrite.com/e/3rd-bvs-sf-biotech-community-event-at-
dominics-at-oyster-point-tickets-21639999822
Details at bit.ly/1PN51TR
Event Description
Please join us for a fun night of networking, great food and great cutting edge suppliers with
local life science companies and institutes in the area.
Our last two events were a great success and we would like to personally invite you to
attend this one!!
This will be a wonderful way for fellow entrepreneurs and scientists to connect and network
with each other along with learning about the newest innovation and technologies out there.
Complimentary to life science job related employees (including executives, purchasing,
scientists, clinical, manufacturing, etc.) at life science companies and research institutes.
Product and Service providers that sell to the life science community, BVS suppliers,
lawyers, consultants, etc. will pay a $50.00 fee to attend.
Pam Gardner
President and CEO
Biotech Vendor Services, Inc.
858-349-8375
******************************************************************************************* JLABS, Thursday, Feb. 26, 2016
Topic: “Meet with….Sofinnova Ventures”
Speaker: Mike PowellSofinnova Ventures Participating Representative
Date and Time: Thursday, Feb. 26, 2016; 10:30 am to 1:00 pm
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*
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*Companies must have applied for a one-on-one meeting ahead of time and be
approved. The application period ends on January 25th, 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 February 24th, 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 January 25th, 2016. Your application will be reviewed
and you will be notified of acceptance by February 11th, 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-sofinnova-ventures-tickets-
18715680103?aff=blast
Topic Description
Are you Sofinnova material? Sofinnova Ventures, a leader in funding for life sciences
companies, is visiting Johnson & Johnson Innovation, JLABS. With $2 billion under
management and a recent $500 million fund, Sofinnova is looking to invest in life
science innovators. Focus areas include clinical drug development and drug
discovery.
Since 1974, Sofinnova has partnered with entrepreneurs to secure initial funding,
build successful management teams, form impactful corporate al liances, win key
customers, and navigate acquisitions and IPOs. Sofinnova applies capital and
expertise to guide start-up companies to successful exits. Recent exits include Labrys
Biologics, Tesaro, and Spark.
Representatives from Sofinnova will be in attendance to give an overview
presentation about the company's key areas of interest and best practices when
seeking startup funds. Following the presentation, don't miss this opportunity to
introduce yourself to Mike Powell, General Partner, during the networking lunch. And
finally, for those companies who apply online and are approved, one-on-one meetings
with Sofinnova will provide a forum to discuss your company.
Speaker Bio
Mike Powell, Ph.D. | General Partner, Sofinnova Ventures
Mike joined Sofinnova in 1997, and SVP IX ($510M) is his sixth Sofinnova fund. He
has 32 years of experience, including 15 years of R&D before venture. Mike has been
involved in more than 50 clinical programs, and is the author of 90 publications and
books, including a 1,000-page treatise on vaccine design. He was the initial venture
investor of: Actelion (ATLN), Intermune (ITMN), Orexigen (OREX), Seattle Genetics
(SGEN), Threshold (THLD), and Trius (TSRX) and other public and private companies
such as Intellikine (sold to Millennium-Takeda), Mirna and Labrys Biologics (sold to
Teva). Mike was the first person in the biotech industry to be honored by the
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American Association of Pharmaceutical Scientists as an AAPS Fellow. He has also
served on the journal editorial boards of Journal of Pharmaceutical Sciences and the
Journal of Controlled Release. He has been the Board President of the AIDS Vaccine
Advocacy Coalition, as well as advisor to the Institute for One World Health, IAVI,
and the Bill and Melinda Gates Foundation. Mike is also Adjunct Associate Professor in
the Department of Pharmaceutical Chemistry at the University of Kansas, one of the
top US pharmacy schools. Before joining Sofinnova, he was group leader of drug
delivery at Genentech. During his tenure there, he and colleagues spun off VaxGen,
an AIDS vaccine company. Prior to Genentech, he helped start Cytel as the Director
of Product Development. Before this he was Senior Scientist and Project Team Leader
at Syntex Research. Mike received his PhD in Chemistry from the University of
Toronto and carried out postdoctoral studies in bio-organic chemistry at the
University of California as a National Science and Engineering Research Council
Scholar. Mike and his wife Tana live in San Francisco, and they enjoy flying, skiing,
diving and flyfishing.
Connect with Mike: Connect on LinkedIn
*****************************************************************
CIE, Saturday, Feb. 27, 2016
Event: Chinese Institute of Engineers (CIE) 37th Annual Conference-- Conference Theme:
Innovation
Date and Time: Saturday, Feb. 27, 2016
Afternoon Technical Programs (FREE): We are Makers!
1:00 pm - 5:00 pm
1:00 pm: Registration and Networking
1:30 pm: Event Starts. Speakers:
Mr. Dale Dougherty, Chairman of Maker Media
Dr. Weixun Cao, CEO of Bitlab
Zach Supalla, Founder and CEO of Particle
Sandra Madrigal, Founder and CEO of ProtoCafe
Steven Si, Technical Director at MediaTek
Arnie Chencinski, Wen Chu
5:00 pm: End of the afternoon program
Those who are interested can register at the following link.
https://www.eventbrite.com/e/chinese-institute-of-engineerscie-sf-37th-annual-conference-
tickets-20828492582
Dinner Banquet and Keynote Speech
6:00 pm: Registration and networking
6:30 pm: Banquet Seating
7:15 pm: Keynote speech: My Encounters with Innovation, Prof. Chenming Hu, recipient of
2016 National Medal of Technology and Innovation
8:00 pm: Awards and Scholarship
9:00 pm: Entertainment
Dinner Banquet and Keynote Speech ($100)
6:00 pm - 10:00 pm
Location: Computer History Museum, 1401 North Shoreline Boulevard, Mountain View,
CA 94043 *********************************************************************
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PBSS, Monday, Feb. 29, 2016
Workshop: Advanced LC/MS Practices
Speakers: Jack Henion, Ph.D. Emeritus Professor of Analytical Toxicology, Cornell University
Date: Monday, February 29, 2016, 8:45-17:00
Location: SF Bay Area: Foster City Crowne Plaza
Registration fee (US$): Regular: $195; For unemployed & students: $30; For major-sponsor
rep (incl lunch): $0; For vendor-show rep: $35; For others, details available upon online
login.
Registration: http://www.PBSS.org
Further Information:
Registration deadline: 2/26/2016 (it will close sooner if the seating cap is reached)
About the Topic
Course Objective:
Learn effective LC/MS techniques for analyzing complex samples and characterizing organic
compounds
Who Should Attend:
Experienced LC/MS researchers and practitioners, or others involved in identifying or
measuring organic compounds in real-world samples including drugs and metabolites within
or for the pharmaceutical industry, and who work with HPLC and MS techniques. Prior HPLC
and/or LC/MS experience and understanding is assumed.
Key Topics You'll Learn About:
Principles and preferred practices for APCI LC/MS
Fundamentals and practices for optimal electrospray ionization
Principles of multiple charging in electrospray mass spectra of biomolecules
Strategies for characterizing small molecules contained in biological samples via
electrospray LC/MS and LC/MS/MS.
Sample preparation optimized for LC/MS and LC/MS/MS analyses
Initial strategies for interpreting collision-induced dissociation (CID) mass spectra of
small pharmaceutical molecules.
About the Speakers
Jack Henion is Professor Emeritus of Toxicology at Cornell University in the Analytical
Toxicology.. He is also a co-founder, Chairman, and CSO of Advion BioSciences, Inc.,
located in Ithaca, New York. Prof. Henion’s work in LC/MS relates to the analysis of real-
world samples common to pharmaceutical, environmental, and biochemical problems. The
instructor has published extensively in the areas of conventional capillary GC/MS as well as
LC/MS, SFC/MS, IC/MS, and CE/MS using atmospheric pressure ionization (API)
technologies with quadrupole, ion trap, FTMS, and time-of-flight mass spectrometers.
******************************************************************
Swedish Consultancy, Tuesday Morning, March 1, 2016
Event: “Opportunities for US Medical Device and Biotech Companies in the Changing EU
Clinical and Regulatory Environment”
Speakers: Elisabeth Liljensten, DDS, PhD, founder and CEO of Swedish CRO DEVICIA, Åsa
Runnäs, CEO at Symbioteq a Swedish Regulatory Affairs Consultancy and Tomas Camnell,
founder of Symbioteq
Date and Time: Tuesday, March 1, 2016, 8:00 am
Program outline
08.00 Continental breakfast and registration
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09:00 Introductions and presentations
11:00 Panel with Elisabeth Liljensten, Åsa Runnäs and two US experts
12:00 Lunch and networking
12:45 Concluding remarks
- Different kinds of clinical trials and registries in the EU.
- How European clinical data can support US market entry.
- Handling of data and statistics.
- Ongoing changes in EU regulations. CE marking of medical devices – requirements and
how to fulfill them.
- Changed requirements in ISO 13485:2016.
- Panel discussion. Q&A.
Location: K&L Gates, 4 Embarcadero Center, San Francisco, CA 94111
A seminar presented by REGISTER HERE
https://events.r20.constantcontact.com/register/eventReg?oeidk=a07ec6i5v...
Register at : https://goo.gl/F668tN
Topic Description
To generate clinical data and get approval with a CE-mark provide a number of
opportunities for US Medical Device and BioTech companies. Currently there is a
comprehensive change of the regulatory environment in the EU. The requirements are
getting stricter and there is a heavy focus on clinical data that support safety and efficacy.
This development has an impact on products already CE-marked and new products that are
to be CE-marked. The changing regulatory landscape presents both opportunities and
challenges for US Medical Device and BioTech companies. The seminar will address how to
navigate this new and changing environment, and what is to be expected over the next few
years.
Who should attend?
Executives of medical device and biotech companies who:
- market their products in Europe
- are planning to enter the EU market
- look to perform clinical trials in environment that offer flexibility and cost efficiency
Speakers
Dr Elisabeth Liljensten is the CEO of the medical device CRO Devicia AB/Devicia Inc. She
has +20 years experience of medical device clinical trials and has had several senior
positions in medical device developmental companies. Dr Liljensten is a Doctor of Dental
Surgery with a PhD degree in Biomaterials research.Fredrik Hansson is VP of the medical
device CRO Devicia AB. He has close to 30 years experience in statistics and data
management within the life science industry in different senior positions. Fredrik holds a
M.Sc. in statistics from University of Lund, Sweden.
Åsa Runnäs is part owner and CEO of Symbioteq. Åsa also works as consultant and training
officer with a focus on quality assurance and regulatory compliance for the medical device
industry and has had several senior QA/RA positions in medical device companies. Åsa holds
a M.Sc from the Royal Institute of Technology, Sweden.
Tomas Camnell is the founder of Symbioteq and has been working in the life science
industry for more than 30 years. The past 20 years as consultant at Symbioteq, with QA/RA
consultation and training, in several cases also acting as QA Manager in Medical Device
companies.
*********************************************************
Medtech Frontiers, Thursday Evening, March 3, 2016
Topic: “Human Factors -- What Does this Really Mean for Medical Devices? “
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Speaker: Shannon Clark
Date and Time: Thursday, March 3, 2016, 6:00 pm – 9:00 pm (presentation begins at
6:45pm)
Location: Triple Ring Technologies 39655 Eureka Drive Newark, CA 94560
Cost: The seminar is free of charge, but advance registration is required.
On-Site registration: A limited number of on-site registrations may be available.
Seminar Description
February 3, 2016 was an important date in the history of medical device usability. On this
day, the FDA issued the guidance, "Applying Human Factors and Usability Engineering to
Medical Devices," which emphasized the importance of designing usable medical devices.
The guidance outlines the FDA's recommended process for developing usable medical
devices.
Shannon Clark's talk will describe what "Human Factors" means to the FDA, why Human
Factors has become such a popular topic in the field of medical device development, and
what usability engineering process needs to be followed when developing new medical
devices. Shannon will share her experience conducting usability testing for medical devices,
and she will discuss how to identify and assess use-related risks for medical devices.
Speaker Bio
Shannon Clark, is founder and CEO of UserWise, a consultancy that helps medical device
manufacturers and start-ups to design safe and easy-to-use medical devices. The
consultants at UserWise conduct usability testing for a variety of medical devices ranging
from surgical robots to home-use injection platforms. UserWise consultants also perform
safety assessments to comply with U.S. and international regulations related to Human
Factors.
Before UserWise, Shannon was a Human Factors Engineer at Intuitive Surgical, where she
worked on da Vinci surgical systems, instruments, and accessories including the da Vinci Xi
System.
In 2012, Shannon completed Abbott Laboratories' Professional Development Program,
working in various supervisory, R&D, Quality and Regulatory functions in divisions including
Abbott Vascular, Abbott Diagnostics, Abbott Diabetes Care, and Abbott Medical Optics.
Shannon graduated in 2010 from UCLA with a B.S. in Mechanical Engineering and a
technical breadth in Technology Management. In addition, Shannon is a Certified
Processional Industrial Engineer, holds two patents, and has written and published three
books.
**************************************************************
RAPS, Friday, March 4, 2016
RAPS San Francisco Chapter – “How to Avoid 483 Observations and Audit Non-
Conformities: Lessons from the Trenches”
Speakers:Eric Anderson, supervisory consumer safety office, Food and Drug
Administration and Bradley Chen, managing director, TUV-USA/Nord Industry
representatives to be announced
Date and Time: Friday, March 4, 2016
7:30–8:30 am Registration Check-in and Networking Breakfast
8:30–12:00 pm AM Presentations and Panel Discussions
12:00–1:00 pm Luncheon
1:00–4:15 pm PM Presentations and Panel Discussions
4:30 pm Closing and Adjourn
Location: Crowne Plaza Foster City, 1221 Chess Drive, Foster City, California 94404
Registration: RAPS and ASQ Members: $175 Nonmembers: $200
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Details and registration at
http://www.raps.org/EventDetail.aspx?id=23946&utm_source=Email&utm_medium=I
nformz&utm_campaign=Informz%2DEmails
Event Description
Join your quality and regulatory colleagues from ASQ Northern California Biomedical
and the RAPS San Francisco Bay Area Chapter for a lively and informative workshop
that explores effective methods for avoiding common 483 observations and Notified
Body audit non-conformities.
Food and Drug Administration, Notified Body and industry presenters will take a deep
dive into key areas where device and diagnostic companies often have compliance
struggles. Interactive sessions will highlight GMP systems, with particular focus on
CAPAs, Complaints, Design Control, and Risk Management, and use these as a
framework for discussing what’s not working and best practices for how to get it
right. In a bonus segment, a Notified Body Director will provide insight into an
auditor's focus during the MDSAP process.
This workshop will benefit regulatory, quality and R&D personnel from device and
diagnostic companies.
Local Contacts:
Barry Craner, ASQ Biomedical Division
Shaalini Doan, RAPS SF Chapter
Michelle Ragozzino, RAPS SF Chapter
Registration Questions:
Shweta Kaushik, RAPS SF Registration Chair
Wesley Carr, RAPS
********************************************************************
Clark Center Seminars, Wednesday Mid Day, April 7, 2016
Topic: “Optical Control and Interrogation of Protein Activity Using Engineered
Photoreceptors “
Pre seminar speaker: Bianxiao Cui, Department of Chemistry; Seminar Speaker: Chandra
Tucker, University of Colorado at Denver
Date and Time: Wednesday, 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 AT12:15pmPRE-SEMINARS IN
CLARK CENTER ROOM S361; SEMINARS IN CLARK CENTER ROOM S360
***********************************************************************
Palo Alto AWIS, Wednesday Evening, March 7, 2016
Topic: “The Journey of a Leader: How to Find Your Path to Success in Science” Speaker: Maria Grazia Roncarolo, MD, Prof. of Pediatrics, Chief of the Division of Pediatric Translational and Regenerative Medicine and Co-Director of the Institute for Stem Cell Biology and Regenerative Medicine, Stanford
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Date and Time: Wednesday, March 7, 2016, 7 - 9 PM
7:00-7:30: Networking dinner
7:30-7:45: Announcements
7:45-9:00: Seminar
Location: PARC Auditorium, 3333 Coyote Hill Rd, Palo Alto, CA 94304
Fees: Palo Alto AWIS Members: FREE; Pre-registered Non-Members: $10
Fee at Door: $15
Register at http://www.brownpapertickets.com/event/2511532
Topic Description
Are you pursuing a leadership position in academia or industry? Do you sometimes
feel overwhelmed with obstacles?
AWIS Palo Alto has invited Maria Grazia Roncarolo to inspire you. You will hear how
this leading scientist has surmounted hurdles in her career to become a world leader
in stem cell and gene therapy at Stanford University.
Speaker Bio
Dr. Roncarolo’s stellar career is an inspiration to women scientists. She rose through
the academic ranks to become the co-director of the Institute for Stem Cell Biology
and Regenerative Medicine, chief of the Division of Pediatric Stem Cell
Transplantation and Regenerative Medicine, and co-director of the Bass Center for
Childhood Cancer and Blood Diseases.
Dr. Roncarolo has dedicated her career to studying inherited immune diseases, stem
cell transplantation, and gene therapy. After training as a pediatric immunologist in
Turin, Italy, she studied severe inherited metabolic and immune diseases in Lyon,
France, where she was a key member of the team that carried out the first stem cell
transplants given before birth to treat these genetic diseases. Thereafter, Dr.
Roncarolo has continued to pioneer discoveries and therapies that have benefited
patients with immune diseases and leukemia. As co-director of the Stem Cell
Institute, she will drive the translation of basic science discoveries into patient
treatments by building the teams and infrastructure to move stem cell and gene
therapy to the clinic quickly.
*******************************************************************
Stanford Medicine | American India Foundation Symposium And Reception,
Tuesday Afternoon, March 8, 2016
Topic: “Maternal And Newborn Survival: Research, Technology Driven Innovation, And
Action”
Date And Time: Tuesday, March 8, 1–6 P.M.
Symposium And Reception
Agenda
1:00 - 1:10 P.M. Welcome
LLOYD MINOR, MD, DEAN, STANFORD MEDICINE, AND LATA KRISHNAN, CFO, SHAH
CAPITAL PARTNERS AND CHAIR, AIF
1:10 - 1:30 P.M. Maternal And Newborn Survival: Our Journey Thus Far
GARY DARMSTADT, MD, MS, ASSOCIATE DEAN FOR MATERNAL AND CHILD HEALTH,
PROFESSOR OR DEVELOPMENT PEDIATRICS, STANFORD MEDICINE
Prof. Darmstadt Will Take Us Through The History -- Through The Challenges And Solutions
To The Issues Facing Mothers And Newborn Children In India. He Will Speak About Some Of
The Goals Of This New Initiative And Collaboration Between Stanford Medicine And AIF And
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Also Examine Potential Metrics Of Success. In Addition, He Will Speak About The Differences
And Similarities Of The Issues Around The Globe.
1:30 - 1:45 P.M. AIF MANSI Program: Video And Introduction
AIF's Maternal And Newborn Survival Initiative (MANSI) Has Been One Of The Most
Successful Maternal And Newborn Programs Across The Globe, Significantly Improving
Maternal And Infant Mortality Rates And Showing Tremendous Scale. The Program Has
Impacted The Lives Of Over One Million Marginalized People Spread Over 1,379 Villages In
India. Training Over 98 Sahiyas (The Village Health Worker Who Assists With Childbirth And
Maternal Health Issues), The Program Has Leveraged Resources Provided By Both The
Communities And Local Government To Create A Scalable Solution.
1:45 - 2:00 P.M. The Sahiya: A Day In The Life
An Actual Sahiya From A Village In Jharkand, India Where MANSI Has Been Implemented
Will Speak About Her Experiences, Challenges, And Issues On The Ground.
2:00 - 2:20 P.M. Keynote Speaker
PROF. K. SRINATH REDDY, PRESIDENT, PUBLIC HELATH FOUNDATION OF INDIA
As Part Of His Work At The Public Health Foundation Of India (PHFI), Prof. Reddy Has A
Great Deal Of Experience In Understanding The Issues On The Ground, As Well As How
Training, Innovation, Research, And Advocacy Can Lead To Better Capacity Building And
Scale In Public Health. Using Actual Examples Of Such Efforts, Prof. Reddy Will Share Deep
Insights Into How A Multi-Pronged Approach Is Needed To Arrive At Scalable Solutions To
Address Such A Vast Problem.
2:20 - 2:40 P.M. Keynote Speaker
RAKESH KUMAR, MD, JOINT SECRETARY TO THE GOVERNMENT OF INDIA, MINISTRY OF
HEALTH AND FAMILY WELFARE (REPRODUCTIVE & CHILD HEALTH PROGRAM)
2:40 - 3:10 P.M. Networking Break
3:10 - 3:30 P.M. Keynote Speaker: Maternal And Newborn Health: State Of Research
DAVID K. STEVENSON, MD, PROFESSOR OF PEDIATRICS AND SENIOR ASSOCIATE DEAN OF
MATERNAL AND CHILD HEATH, STANFORD MEDICINE
Dr. Stevenson Will Draw From His Many Years Of Involvement In Stanford Medicine's
Research Programs On Maternal And Child Health To Speak To The Areas Of Research
Currently Underway At Stanford. Dr. Stevenson Will Speak To How Such Research Often
Leads To Ground Breaking Innovations In The Field.
3:30 - 4:15 P.M. (Panel) Innovation, Scale, Impact On The Ground
SPEAKERS: KRISTA DONALDSON, CEO, D-REV AND JOSH NESBIT, CEO, MEDIC MOBILE
DISCUSSION PANELISTS: NABIHAH KARA, HARVARD PUBLIC HEALTH AND BRIGHAM
WOMEN'S, BETTER BIRTH AND S.V. MAHADEVAN, ASSOCIATE PROFESSOR OF EMERGENCY
MEDICINE, STANFORD MEDICINE
MODERATOR: HAYAGREEVA RAO, PHD, PROFESSOR OF ORGANIZATIONAL BEHAVIOR AND
HUMAN RESOURCES, STANFORD GRADUATE SCHOOL OF BUSINESS AND CO-AUTHOR,
SCALING UP EXCELLENCE
Profile Of Two Companies That Have Applied Innovations In The Field Of Maternal And
Newborn Health And Have Had A Great Impact On The Ground Achieveing Scale. Each
Speaker Will Give A 10-Minute Presentation, Followed By A Full Panel Discussion.
4:15 - 5:00 P.M. (Panel) Startup Spotlight
PRESENTERS: EDITH ELLIOTT, CEO, NOORA HEALTH; PUSHKAR INGALE, INDUSTRIAL
DESIGNER, LAERDAL GLOBAL HEALTH; RAJAN PATEL, FOUNDING TEAM MEMBER,
EMBRACE; JOHN KUCHARCZYK, SECURESCAN
DISCUSSION PANELIST: DIAZ NESAMONEY, SERIAL ENTREPRENEUR AND FOUNDER/CEO,
JIVOX AND BOARD MEMBER, AIF
MODERATOR: IMMANUEL THANGARAJ, MANAGING DIRECTOR, ESSEX WOODLANDS
Profile Of Four Startups That Are Changing The World Of Maternal And Newborn Health.
Each Startup Will Give A 7-Minute Presentation, Followed By A Panel Discussion.
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5:00 - 5:45 P.M. (Panel) Investments And Business Models In Maternal And Newborn
Health And Ngos
PANELISTS: KATHRYN GLEASON, CO-FOUNDER, TEAMFUND; TIMOTHY RING, CHAIRMAN
AND CEO, C.R. BARD (A GLOBAL MEDTECH COMPANY); SWETA RAWAT, CHAIRPERSON,
HANS FOUNDATION (SPONSOR OF AIF'S MANSI PROGRAM IN UTTARAKAND); VINOD
BHUTANI, PROFESSOR OF PEDIATRICS (NEONATOLOGY), STANFORD MEDICINE
MODERATOR: ASH LILANI, MANAGING PARTNER AND CO-FOUNDER, SAAMA CAPITAL
5:45 - 6:00 P.M. Ongoing Engagement: Be Part Of The Solution
DIAZ NESAMONEY, FOUNDER/CEO, JIVOX AND BOARD MEMBER, AIF; CHRIS DAWES, CEO
AND PRESIDENT, LUCILE PACKARD CHILDREN'S HOSPITAL STANFORD
6:00 - 8:30 P.M. Networking Reception
Location: Berg Hall, Li Ka Shing Center, Stanford Stanford University School Of Medicine,
291 Campus Dr., Palo Alto, CA 94305,USA
To Register And Learn More, Please Visit: Http://Med.Stanford.Edu/Aif/About.Html
Topic Description
Join leaders in academia, philanthropy, and industry to share ideas, spark partnerships, and
identify opportunities to improve maternal and newborn health in India and other nations in
the developing world. Sponsored by Stanford Medicine and the American India Foundation,
this symposium is open to all researchers, entrepreneurs, policy makers, and students
interested in India or issues related to cost-effective innovation in the area of maternal and
newborn health.
************************************************************************************************
Bio2Device Group, Tuesday Evening, March 8, 2016
Topic: “Change at the FDA: How the current regulatory environment impacts device
development “
Speaker: Lisa Olson, MBA, President, RCRI, Inc.
Date and Time: Tuesday Evening, March 8, 2016, 6:00 pm
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
Register at www.Bio2DeviceGroup.org
Speaker Bio
Lisa Olson has over 20 years of experience in the medical device and biologics industries
providing contract research services to start-up through Fortune 100 companies. She has
extensive technical experience in pre-clinical research, including in vitro and in vitro
biocompatibility, genotoxicology and toxicology models.
Lisa’s work now centers primarily on strategic leadership for a regulatory consulting and
clinical research organization that helps medical device manufacturers bring products to
market. Lisa received a B.S. degree in microbiology from the University of Minnesota and
her Masters of Business Administration from the University of St. Thomas. She has co-
authored numerous ISO Biocompatibility Standards, served as a co-chair of the AAMI/ISO
Technical Advisory Group on Cytotoxicity, and sat on working groups related to materials
safety for the Association for the Advancement of Medical Instrumentation (AAMI) and the
American Society for Testing and Materials (ASTM).
14
Event Description
In response to public and legislative pressure over the past several years, the FDA has been
actively working to evolve to meet expectations for safer devices while supporting device
innovation. To make the change, the FDA is starting by examining its very foundations,
evaluating how it operates, developing quality systems, and working to effectively manage
talent. Further, the agency is continually evaluating how it regulates medical products.
While all signs point to a more progressive and effective organization, the constant change
leads to a lack of transparency that can mean getting clearances and approvals difficult to
get.
This session will focus on FDA strategic priorities, what changes are pending and what these
events mean to device manufacturers. ********************************************************************************* sfAWIS, Wednesday Evening, March 9, 2016
Topic: “"Strategic Transitioning: Methodical Job Hunting in Biotech"
Speaker: Mary Arcana, President, Biotecher
Date and Time: Wednesday, March 9, 2016, 6:30 pm – 8:30 pm
Location: Women's Building - Audre Lorde Room, 2nd floor. 3543 18th St. San
Francisco 94110 - View Map
Fees: Members-free; non-members, $11.49
Register at https://www.eventbrite.com/e/strategic-transitioning-methodical-job-hunting-
in-biotech-tickets-21062216657?ref=ebtn
Description: Learn a simple but effective method to bounce back from a layoff or
simply find a more fulfilling role. Mary Arcana will show you how to market yourself
or “self-present” through a straightforward process that, if followed, has proven to be
highly effective. For example, recently a principal scientist called Mary in tears
having just moved his family to the Bay Area only to be laid off within weeks. He was
highly cooperative in following Mary’s suggestions. Two months later, he had
received three offers. Others have come to Mary out of frustration having repeatedly
applied to positions for which they knew they were well qualified, but had
consistently received no response. With a few suggested alterations in their resume
and approach, they resubmitted to the same companies for the same positions and
were called in to interview. Through Mary Arcana’s professional experience as a
recruiter, she has found that few professionals, no matter how senior, skilled or
savvy, are given any practical orientation on how to control their destiny in the job
market. Mary will show you how during this presentation!
Speaker Bio: Mary Arcana, President, Biotecher With16 years of biotech-industry
recruiting experience, Mary Arcana has earned a reputation for swift delivery of
difficult-to-find scientific and managerial talent. Her diverse clientele has included
drug development and medical device companies and ranged from early startups to
global industry leaders. Prior to starting Biotecher, Mary served for six years at a Bay
Area biotech office of Management Recruiters International where she rapidly
advanced to Director of Research and Development responsible for all R&D
recruitment and business development efforts. This initial concentration in R&D gave
her keen insight into the science and the business of product lifecycles and provided
a big-picture perspective of the biotech industry as a whole, insights that have
benefited her many clients over the years. Mary founded Biotecher in 2004 to expand
her talent-delivery services beyond R&D to encompass and facilitate hires all along
the product development pathway: from early discovery, through preclinical and
clinical stages, to include product launches and post-commercialization. Prior to her
tenure in biotech, Mary held leadership positions in several industries including IT,
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media relations, restaurant-ownership, and film. During her eclectic career, she
successfully built and managed multi-disciplined teams of up to 40 people. A
seasoned business leader and hiring manager with broad exposure to diverse
business models, she is able to quickly grasp complex employer needs and
consistently deliver rare talent within aggressive deadlines.
*****************************************************
JLABS, Thursday Morning, March 10, 2016
Topic: “Meet with... National Cancer Institute “
Date and Time: March 10, 2016, 10:00am
Location: JLABS @ SSF, 329 Oyster Point Blvd., 3rd Floor,South San Francisco, CA
Fees: $25 | Presentation and Q&A
FREE | 1-on-1 application
Register at http://www.eventbrite.com/e/meet-with-national-cancer-institute-tickets-
21343593262?aff=blast
Program overview
This is a time of remarkable opportunity in cancer research. Armed with broad knowledge
about how various kinds of cancers arise and with powerful new research tools, the research
community, under the leadership of the National Cancer Institute (NCI), is poised to reduce
the burden of cancer in this country and around the world at an accelerated pace.
************************************************************
Stanford, Thursday Mid Day, March 10, 2016
Topic: “Discerning Rare Disease Biomarkers By Micro- And Nanotechnologies”
Date And Time: Thurday, March 10, 2016, Noon
Pre-Seminars In Clark Center Room S361; Seminars In Clark Center Room S360
Small Lunch Served At 12:00pm; Lectures Begin At12:15pm
Pre-Seminars In Clark Center Room S361; Seminars In Clark Center Room S360
March 8, 2016
Pre-Seminar Speaker: Joe Liao, Department Of Urology
March 10, 2016
Seminar Speaker: Jeff Tza-Huei Wang, Johns Hopkins University
Discerning Rare Disease Biomarkers By Micro- And Nanotechnologies
***************************************************************
GGPF, Friday Evening, March 11, 2016
Topic: Designing Simple Polymers with Protein-like Activity: Advanced materials and new
therapies
Speaker: Gregory N. Tew, Professor in the Polymer Science and Engineering Department at
the University of Massachusetts, Amherst
Date and Time: Friday, March 11
6 PM social hour
7 PM dinner
8 PM lecture
Location: Michael's Restaurant at Shoreline Park, 2960 N. Shoreline Park, Mountain View,
CA 94043
Cost:
Employed/postdoc Student/unemployed/retired
16
Early Registration $30 $15
Registration $35 $20
Walk-in (not guaranteed) $40 $25
Lecture-only is free.
Deadline for registration:
11:59PM, Thursday, March 3 for early registration discount.
5PM, Thursday, March 10 for regular registration
Registration: http://ggpf.org
Topic Description
Our primary research aim is to create new materials using a combination of principles,
many of which are inspired by biology. In addition, the design of simple molecules that
mimic the complex structures and functions of biology is at the heart of our work. In this
presentation, we will illustrate some of these principles including novel networks with high
resilience and new delivery agents inspired by protein transduction domains (PTDs).
Coupling high efficiency click chemistry with telechelic polymer design generates new phase
separated networks that are highly elastic and have bicontinuous morphologies over a very
wide compositional range. PTD designs rely on synthetic approaches that easily allow
doubling the density of guanidine functional groups, which increases the transduction
efficiency of the sequences. Cellular uptake studies on three different cell lines (HEK 293T,
CHO, and Jurkat T cells) confirm that these synthetic analogs are highly efficient novel
protein transduction domain mimics (PTDMs), that are more effective than TAT49-57 and
nonaarginine (R9) and also highlights the usefulness of polymer chemistry at the chemistry-
biology interface.
Speaker Bio
Gregory N. Tew, Professor in the Polymer Science and Engineering Department at the
University of Massachusetts, Amherst, has more than a decade of experience transitioning
bio-inspired design concepts to practice.
He received a B.S. in Chemistry from North Carolina State University in 1995 performing
undergraduate research with Prof. D. A. Shultz and interning at Burroughs-Wellcome
Pharmaceutical. In 2000, he earned his Ph.D. from the University of Illinois-Urbana under
Prof. Samuel Stupp in Materials Science after which he joined the Faculty at the Polymer
Science and Engineering Department at the University of Massachusetts, Amherst. Before
starting there, he spent one year in William DeGrado's laboratory at the University of
Pennsylvania Medical School.
His current research interests include bioinspired and biomimetic macromolecules,
molecular self organization, nano-medicine, and materials-immunology. Greg received
every young investigator award offered by the Federal Government including the
Presidential Early Career Award for Scientists and Engineers (PECASE) which is the highest
honor recognized by Federal Funding Agencies for young faculty and presented by the White
House. He was elected as a member of the Defense Science Study Group, founding
member of the ACS Polymer Chemistry Division Fellows program, and served as board chair
of the ACS Division of Polymer Chemistry. More recently he has elected fellow of the ACS
and AIMBE. He has published over 150 peer-reviewed papers and serves as chair of the
SAB for PCCL, Polymer Competence Center Leoben, Austria. Greg remains interested in
technology transfer activities and mentorship. He was a scientific and original co-founder of
PolyMedix; a clinical-stage biotechnology company which has raised over $150M as well as
founding mentor of Future Faculty Workshop: Diverse Leaders of Tomorrow.
17
***********************************************************************************************************
NCC AWIS, Saturday, March 12, 2016
NCC AWIS Winter Workshop
Speakers: Debbie Rocco and Betina Schonberger, Senior Consultants at Interaction
Associates and Ariana Newcomer – The Voice Coach’s Voice Coach and international best-
selling author
Date and Time: Saturday, March 12, 2016, 8:30 am to 2:00 pm
Location: Genentech, Inc. (35-1A), 1475 Grandview Drive., South San Francisco
Event Description
Can you control a room? Influence others? Do you have a "place at the table"? And if you
do, are you comfortable there? We will unlock the mysteries of Executive Presence through
use of voice and other techniques
Debbie Rocco and Betina Schonberger, Senior Consultants at Interaction Associates, partner
with multi-national corporations, non-profits, and educational institutions to develop and
support women leaders around the world. In this workshop, they will help us learn what it
takes to make a positive impact.
Ariana Newcomer – The Voice Coach’s Voice Coach and international best-selling author.
Ariana will help you unlock the secrets of your voice so you can command a room, increase
your influence and effectiveness, and step into authentic leadership.
More details and ticket ordering information will be sent out soon.
Join a supportive group of women to:
-Explore your Field of Authentic Leadership as the core of your personal power
-Unlock the secrets of your voice to increase your influence and effectiveness
-Utilize wholeheartedness as a source of renewed energy **********************************************************************************************
NCC, AWIS, Saturday Evening, March 12, 2016
Event: “NCC AWIS Winter Workshop: Brand you! Techniques to help you feel comfortable in
leadership roles”
Speakers: Debbie Rocco and Betina Schonberger, Senior Consultants at Interaction
Associates and Ariana Newcomer – The Voice Coach’s Voice Coach
Date and Time: Saturday, March 12, 8:30 am - 2:00 pm
Location: Genentech, Inc. (35-1A),1475 Grandview Drive., South San Francisco
Cost: $20 AWIS member, $40 non-member
For more information and to register, go to
http://www.brownpapertickets.com/event/2499977
Join a supportive group of women to:
Explore your Field of Authentic Leadership as the core of your personal power
Unlock the secrets of your voice to increase your influence and effectiveness Utilize wholeheartedness as a source of renewed energy
Can you control a room? Influence others? Do you have a "place at the table"? And if you
do, are you comfortable there? We will unlock the mysteries of Executive Presence through
use of voice and other techniques
18
Debbie Rocco and Betina Schonberger, Senior Consultants at Interaction Associates, partner
with multi-national corporations, non-profits, and educational institutions to develop and
support women leaders around the world. In this workshop, they will help us learn what it
takes to make a positive impact.
Ariana Newcomer – The Voice Coach’s Voice Coach and international best-selling author.
Ariana will help you unlock the secrets of your voice so you can command a room, increase
your influence and effectiveness, and step into authentic leadership.
Call for Nominations for NCC Banquet
Respond by Feb 25th, 2016
Do you know a woman who has helped you or others in personal career development?
Nominate her for an award!
Each year NCC-AWIS presents awards to women who have combined their professional
activities with support of other women in science. In honoring individual women, AWIS
recognizes the importance of mentoring and of teaching and sharing with others more than
just the content and techniques of our science.
Awards are given at the Annual Banquet in late April/early May held in South San Francisco.
The recipient should be able to attend the banquet and will be asked to speak for about 10
minutes on the general topic of mentoring and supporting other women in career
development. These personal observations and motivations are always the highlight of the
evening.
Currently we are soliciting nominations for the following awards:
Ellen Weaver Award: To recognize a woman, who is early in her career, and working to
advance research or technology in academia or industry. Sherrie Wilkins Award: To recognize a woman using her science away from the bench Nominating someone is easy. Please write a brief letter explaining how this person has helped you and/or other women develop professionally and a brief resume or CV giving the nominee's educational background and professional history. Submit nominations by February 25th, 2016 to Mary Alice Yund at [email protected] If you know a deserving recipient, don't delay!
***************************************************************** 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:
19
$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
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
20
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
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.
***********************************************************************************************************
JLABS, Tuesday Morning, March 15, 2016
21
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
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
22
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. *************************************************************************************************************
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.
******************************************************************************************************
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
23
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
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.
*************************************************************************
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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
**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.
25
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
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.
26
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
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:
27
• 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
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
28
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.
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
****************************************************************
BioX Program Stanford, Thursday Mid Day, April 7, 2016
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 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
29
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
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
30
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)
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
31
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
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.
32
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?
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
33
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
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
34
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'
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
35
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.
**************************************************************
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
********************************************************
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
***************************** sfAWIS, Wednesday Evening, May 11, 2016
Topic: "The Conflict Shift: from Conflict to Cooperation"
Speaker: Susan Berstein, MBA, PhD
Date and Time: Wednesday, May 11, 2016, 6:30 pm,:
36
******************************************************************* 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.
**************************************************************** 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
37
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.
********************************************************************** BIO International Conference, June 6 – 9, 2016
Dates: June 6 – 9, 2016
Location: Moscone Convention Center, North, South and West Halls
38
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!
*********************************************************************
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.
39
Payment must be made by check or credit card payable in US Dollars and drawn on a US bank (no bank wire transfers).
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
[email protected] www.HPLC2016.org
***********************************************************
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
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
40
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.
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