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1 Audrey’s Life Science Meeting Picks for August 7, 2016 – October 2016 Complimentary Service of AudreysNetwork.com August 7, 2016 ************************************************************************* Bio2Device Group, Tuesday Evening, August 9, 2016 Topic: “Sooner rather than later: Payer-rationalized trial planning” Speaker: Elizabeta Gorgoska, Director, Global Life Sciences Pricing, Strategy, and Marketing Specialist, Simon-Kucher & Partners Date and Time: Tuesday Evening, August 9, 2016, 6:00 pm (buffet prior to meeting) 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 http://bio2devicegroup.org/content/sooner-rather-later-payer-rationalized-trial-planning-elizabeta- gorgoska-08092016-600pm Topic Description Too often, trial planning is focused solely on clearing regulatory hurdles, leading to reimbursement surprises at launch. Learn why, how, and when to incorporate P&MA during product development. Speaker Bio Elizabeta Gorgoska supports the successful commercialization of Life Sciences products across all stages of development, and leads engagements for the top 25 pharmaceutical, biotech and medical technology companies in domestic and international markets, including the US, EU-5 and emerging markets at Simon-Kucher & Partners. In doing her work, she draws from experience across a broad range of therapeutic areas including oncology, infectious diseases, immunology, cardiovascular and rare diseases, employing qualitative and quantitative methodologies to derive optimal solutions while guiding consulting teams through sophisticated hypothesis-driven analyses and deliver actionable recommendations to address key client challenges. She proactively drives business development initiatives for the Life Sciences practice at Simon-Kucher. Her selected experience includes: clinical trial design optimization, product value communication to key customers, business opportunity and landscape assessment, pricing, contracting and market access strategy development, and marketing and launch planning She has worked in Europe, Boston and California for Simon-Kucher and was Health Economics Consultant for Ministry of Health, Macedonia prior to that. Her education includes: BA, Biology, Computer Science from Colby College and MS, Health Policy and Management fromHarvard T.H. Chan School of Public Health. **************************************************************** WIB-San Francisco Bay Area, Wednesday Evening, August 10, 2016 Topic: “Breakthrough Discoveries in Aging Research” Panelists: Cynthia Kenyon (VP of Aging Research, Calico)

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Page 1: August 7, 2016 October 2016 Complimentary Service of … · 2016. 8. 7. · his international experience crisscrossing the globe, traveling to around 50 countries and spending over

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Audrey’s Life Science Meeting Picks for August 7, 2016 – October 2016 Complimentary Service of AudreysNetwork.com

August 7, 2016 *************************************************************************

Bio2Device Group, Tuesday Evening, August 9, 2016 Topic: “Sooner rather than later: Payer-rationalized trial planning”

Speaker: Elizabeta Gorgoska, Director, Global Life Sciences Pricing, Strategy, and Marketing Specialist, Simon-Kucher & Partners

Date and Time: Tuesday Evening, August 9, 2016, 6:00 pm (buffet prior to meeting)

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 http://bio2devicegroup.org/content/sooner-rather-later-payer-rationalized-trial-planning-elizabeta-gorgoska-08092016-600pm

Topic Description Too often, trial planning is focused solely on clearing regulatory hurdles, leading to reimbursement surprises at launch. Learn why, how, and when to incorporate P&MA during product development.

Speaker Bio

Elizabeta Gorgoska supports the successful commercialization of Life Sciences products

across all stages of development, and leads engagements for the top 25 pharmaceutical, biotech and medical technology companies in domestic and international markets, including

the US, EU-5 and emerging markets at Simon-Kucher & Partners. In doing her work, she draws from experience across a broad range of therapeutic areas

including oncology, infectious diseases, immunology, cardiovascular and rare diseases,

employing qualitative and quantitative methodologies to derive optimal solutions while guiding consulting teams through sophisticated hypothesis-driven analyses and deliver

actionable recommendations to address key client challenges. She proactively drives business development initiatives for the Life Sciences practice at

Simon-Kucher. Her selected experience includes: clinical trial design optimization, product value communication to key customers, business opportunity and landscape assessment,

pricing, contracting and market access strategy development, and marketing and launch planning

She has worked in Europe, Boston and California for Simon-Kucher and was Health

Economics Consultant for Ministry of Health, Macedonia prior to that. Her education includes: BA, Biology, Computer Science from Colby College and MS, Health Policy and

Management fromHarvard T.H. Chan School of Public Health. ****************************************************************

WIB-San Francisco Bay Area, Wednesday Evening, August 10, 2016

Topic: “Breakthrough Discoveries in Aging Research” Panelists:

• Cynthia Kenyon (VP of Aging Research, Calico)

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• Kimberly Scearce-Levie (Director of Preclinical Translational Biology, Denali

Therapeutics) • Irina Conboy (Professor, UC Berkeley)

• Judith Campisi (Professor, Buck Institute) Date and Time: Wednesday, August 10, 2016, 5:00 p.m. – 8:30 p.m. PST

Registration Deadline August 9, 2016

Location: Calico, 1170 Veterans Blvd., South San Francisco, CA 94080 Sold out as of Aug. 4, 2016

Topic Description Can scientists slow down aging? Come learn about the latest discoveries and research

in aging from expert scientists in academia and industry. Panelists will discuss cutting edge research being conducted in the field of aging,

identify important research trends and technologies used in this rapidly growing field, and speak to current and future intervention and therapeutic strategies for age-

related disorders. ***************************************************************

NCC AWIS, Saturday, August 13, 2016

Event: 10th Annual NCC-AWIS Potluck Picnic

Join us for this family friendly event on August 13th! Date and Time: Saturday, August 13th, 12:00 PM to 3:00 PM

Location: Beresford Park, 2720 Alameda De Las Pulgas, San Mateo, CA 94403

Fee: Free Register at https://www.eventbrite.com/e/10th-annual-ncc-awis-potluck-picnic-

tickets-26360273287

Event Description

This is the best opportunity to meet members of all the Northern California Chapters of AWIS (Palo Alto, San Francisco, East Bay, and Sacramento Valley). Please RSVP by August8th. Families are welcome! We will be grilling delicious tri tip and will provide drinks and games. Please bring a side dish or dessert to share with 6-8. Hope to see you there! p.s.: The Beresford Park has paths for walking, grassy and picnic areas, several playgrounds, skate park, bocce, as well as tennis and basketball courts nearby. We will be located in picnic area #2 next to the play structure. More information about the park:http://www.cityofsanmateo.org/exploreourparks/

Invite Your Friends! *********************************************************************

Bio2DeviceGroup, Tuesday Morning, August 16, 2016

Topic: “Volumetric Integral Phase-shift Spectroscopy (VIPS): A New Paradigm in Intracranial Fluid Monitoring”

Speaker: E. Mark Shusterman, MD , Chief Medical Officer , Cerebrotech Medical Systems, Inc.

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Date and Time: Tuesday, Aug. 16, 2016, 8:30am

Location: Sunnyvale City Council Chambers- 456 West Olive Ave., Sunnyvale More information coming soon at www. Bio2DeviceGroup.org

******************************************************** RAPS, Wednesday Evening, August 17, 2016

Topic: “Clinical Evaluation in the EU for Medical Devices—Changing Expectations”

Featured speaker: Keith More, PhD, vice president, regulatory compliance, Qserve Group US Inc

Date and Time: Wednesday, August 17, 2016, 5:30- 8:30 pm

Location: J&J--6500 Paseo Padre Parkway, Fremont, CA 94555 Fees:

Prior to 11 August: RAPS Members: $25

Nonmembers: $35

On or After 11 August: RAPS Members: $35

Nonmembers: $45

Register Today https://goo.gl/URiV9O

You can also register by calling +1 301 770 2920 ext. 200

Event Description Join your regulatory colleagues from across the San Francisco Bay area for an

evening of networking and an expert presentation on the changes to MEDDEV 2.7.1. This meeting is sponsored by the RAPS San Francisco Bay Area Chapter and is

intended to promote knowledge advancement and facilitate networking among local

regulatory professionals. A light meal will be available and attendees may claim two RAC recertification credits.

A new revision of MEDDEV 2.7.1 represents a complete re-write, with many new

appendices and much new guidance. This revision will lead to clinical investigations being conducted more frequently for CE Marking (probably of larger size than before)

and notified bodies will be looking more closely at how all the essential requirements are met, including those with regard to usability. The CER reports themselves will

need to be updated more frequently, written and reviewed by more highly qualified

evaluators, and more closely integrated with the various stages of the product lifecycle. With the publication of this revision, and no transition period typically being

provided for the MEDDEVs, it would be in the manufacturers best interests to start discussing with their notified bodies how they will start implementing these new

requirements and to start performing their gap assessments and resource needs-assessments now. Urgency on gap assessments is warranted, as manufacturers will

be expected to budget for additional clinical data asap; hence the assessment will need to feed into the budget plans for next year if clinical studies might need to be

initiated in 2017.

Some questions that will be answered during this presentation include:

What is the European MEDDEV 2.7.1 Rev 4 for Clinical Evaluation?

What are some of the most significant changes? When does this go into force?

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How does this align with the changes to the “MDD” (i.e., the new Medical Device

Regulations and In Vitro Diagnostic Regulation)? I’ve heard it’s demonstrating “equivalence” will now be harder, but in what ways?

How often must I update my CERs now and what qualifications must the evaluators have?

How should I prepare for the increased notified body scrutiny in this area? Do I just need to write a CER for CE Marking? If not, when else do I need to do this

and with what focus? How do I perform a clinical literature review to meet the new expectations?

***************************************************************

Bio2Device Group, Tuesday Morning, August 23, 2016

Topic: “Considerations for Launching Medical Devices in Japan” Speaker: Kirk Zeller , Managing Director and Co-Founder, MedMarket Access, LLC

Date and Time: Tuesday, August 23, 2016, 8:30 am Location: Sunnyvale City Council Chambers- 456 West Olive Ave., Sunnyvale

No fees or registration for morning meetings

Topic Description

Japan has long been and continues to be the world’s second largest market for medical devices. It has also long been considered the most challenging international market and this

talk aims to help provide a framework for companies considering entry into the Japanese market. “Consideration for Launching Medical Devices in Japan” will review the steps to

Japanese market entry and the things to consider as your company contemplates entry into the Japanese market. The presentation will cover market assessment, regulatory and

reimbursement pathway assessment, approval management options, distribution options, importance of KOL identification and management, launch management and strategies, and

effective sales management.

Speaker Bio Mr. Zeller is the Managing Director and Co-Founder of MedMarket Access, LLC, an

organization to which he brings more than two decades of experience in global medical device sales and marketing, channel management, market development, and business

development. Previously Mr. Zeller was Senior Director of International Market Development and Sales at

SI-BONE, a Bay Area start-up. Prior to that he was Director of International Market Development at Johnson & Johnson’s Codman Neuro where he successfully led the

integration of the Asia-Pacific business he built while at Micrus Endovascular (acquired by

J&J in 2010) and expanded the business into new markets. Mr. Zeller was an early employee at Bay Area start-up PneumRx where he was responsible for International Sales.

Mr. Zeller spent the first 12 years of his career working for Japanese medical device companies in various roles based in Japan, US, and Europe.

Mr. Zeller began his career selling heart valves in Japan after having spent most of his undergraduate degree studying there. He has launched many products in Japan over the

last 23 years and spent more than 10 years of his life living there. He has since expanded his international experience crisscrossing the globe, traveling to around 50 countries and

spending over a decade living, working, and studying in Asia and Europe.

Mr. Zeller’s strong desire to deepen his understanding of the medical device industry, start-ups, and international markets led him to focus his masters and doctoral study and research

on these topics. He completed an MBA with a specialization in BioPharma and Health Technology Entrepreneurship at Imperial College London with a master’s thesis on

“Financing and Beyond: The Role of Venture Capital in Silicon Valley Based Medical Device Companies.” For his Doctorate of Business Administration from the International School of

Management (ISM) he received a distinction on his dissertation entitled: “European Market

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Entry Strategies for Venture Capital Financed Medical Device Companies.” Mr. Zeller’s

executive education has included study in China, Brazil, India, South Africa, Japan, France, and England.

**************************************************************** Bioscience Forum, Wednesday Evening, August 24, 2016

Topic: "Novel Immune Therapies for Cancer--the Adenosine Pathway"

Speaker: Ian McCaffery, Ph.D., Vice President, Translational Sciences, Corvus Pharmaceuticals

Date and Time: Wednesday, August 24, 2016 6:00 PM - 9:00 PM

6 pm - 7 pm networking 7 pm - 8 pm dinner

8 pm - 9 pm presentation Location: The Holiday Inn, 275 S Airport Blvd, South San Francisco, California 94080,

USA Fee: Event Registration ($3 service fee will apply)

Pre-Registration $50.00

On-Site Registration

$60.00 Pre-Registration ends Monday, August 22nd, at 9 pm

Cash or check accepted on the day of the event $10 discount for full-time students

Register at BioSF.org Or you can pay with a check made out to "BioScience Forum" and sent to:

BioScience Forum 1442A Walnut Street, #308

Berkeley, CA 94709-1405

Please do not mail checks later than Thursday, August 18th If paying with check, do not complete online registration with Cvent

Register at

Topic Description

Development of anti-tumor immunity involves the coordinated activity of multiple immune cell types that mediate antigen presentation to effector cell populations

which then invade tumors and target tumor cells that harbor the “foreign” antigen.

Over time, suppressive mechanisms are initiated that are normally involved in regulating the extent of effector cell activity during inflammation. These self-

regulatory mechanisms are often co-opted by tumors to evade the immune system.

Therapeutic agents are being developed that stimulate activation and inhibit specific suppressive mechanisms and these agents are demonstrating robust clinical activity

in subsets of patients in multiple tumors types. Generation and release of extracellular adenosine during inflammation is known to be an important suppressive

mechanism that regulates immune responses and inflammation through activation of

receptors that are expressed on effector cells. Accumulation of adenosine in the tumor microenvironment is emerging as an important immune checkpoint, leading to

suppression of anti-tumor immunity through inhibition of function of multiple immune cell types, including NK and T cells. CPI-444 is a novel, selective inhibitor of

adenosine 2A receptor (A2AR), the key mediator of adenosine mediated immune suppression. In preclinical studies, CPI-444 demonstrated strong anti-tumor activity

as a single agent and synergy in combination with multiple immune targeted agents,

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including anti-PD-L1 antibodies. CPI-444 is being evaluated in a multicenter Phase

1/1b clinical trial in patients with various solid tumors both as a single agent and in combination with TECENTRIQTM (atezolizumab), Genentech's investigational cancer

immunotherapy that targets PD-L1. Insights into the underlying biological mechanisms of adenosine activity in tumors from ongoing preclinical and clinical

studies of CPI-444 will be discussed.

Speaker Bio Dr. McCaffery has over 15 years experience in the Biotechnology industry, leading

target, biomarker and companion diagnostic discovery and development programs in

Research and Early/Late Stage Clinical Development. Prior to his position at Corvus, Dr McCaffery led the Companion Diagnostic Development group at Genentech,

developing and clinically validating predictive and prognostic diagnostic markers across all therapeutic areas in the Genentech Research and Early Development and

Roche Product Development portfolios. Prior to Genentech, Dr. McCaffery spent eight years in the Medical Sciences Department at Amgen leading the Oncology

Therapeutic Area Biomarker Group, with accountability for all early and late stage biomarker development in Oncology.

Dr. McCaffery received his PhD in Biochemistry and Molecular Biology from the University of Leeds, UK and gained postdoctoral experience at the University of

Virginia investigating mechanisms of gene regulation.

********************************************************************* Bio2Device Group, Tuesday Morning, August 30, 2016

Topic: “Solving Back Pain through University Partnerships with NIH, NSF, NASA, and

Industry”

Speaker: Jeffrey C. Lotz, PhD, Vice Chair of Orthopaedic Research, David S. Bradford MD, Endowed Chair of Orthopaedic Surgery, University of California at San Francisco

Date and Time: Tuesday, August 30, 2016, 8:30 am Location: Sunnyvale City Council Chambers- 456 West Olive Ave., Sunnyvale

No fees or registration for morning meetings

Topic Description Low back pain is the world’s most disabling condition. Despite significant investments in

basic and clinical research, the disability rates and associated costs continue to escalate.

Studies supported by the NIH and NASA have shown that chronic pain associates with dysfunction of both passive and active spine stabilizers that atrophy and degenerate with

age and long-term exposure to gravity. Impediments to successful solutions relate to the circular reliance between sensitive/specific diagnostic tools and effective therapies: it is

often difficult to localize the pain source and even the best treatment won’t work if it is applied to the wrong patient or wrong spinal level.

Research at UCSF has uncovered the common anatomic source of pain, and partnerships with industry and the National Science Foundation have enabled the translation of these

discoveries into new tools and treatments available for clinical adoption. This presentation

will discuss these advances and the associated innovation programs that help overcome practical obstacles that often impede the clinical translation of new research findings.

Speaker Bio Jeffrey C. Lotz, PhD, holds the David S. Bradford, MD, Endowed Chair in Orthopaedic

Surgery at The University of California at San Francisco. Dr. Lotz has been director of the Laboratory for Orthopaedic Bioengineering at UCSF since 1992, and vice chair for research

in the department since 2012. His awards for spine research include the International

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Society for the Study of the Lumbar Spine (ISSLS) Prize for Low Back Pain Research (2007),

the ISSLS Volvo Award (1998), and the North American Spine Society Award (1993). Dr. Lotz also serves as a deputy editor for the journal Spine. He is the founding director of

the UCSF/NIH Core Center for Musculoskeletal Biology in Medicine, and the UCSF/NSF Center for Disruptive Musculoskeletal Innovations. He has expertise in spine biomechanics,

intervertebral disc biology, and tissue engineering. His laboratory work focuses on identifying mechanisms of intervertebral disc degeneration, developing novel diagnostics

and therapies for low back pain, and the biomechanics of spinal instrumentation.

**************************************************************** EPPIC Global, Tuesday Evening, Aug. 30, 2016

Event: Entrepreneur Spotlight: “Pre-Clinical Development Of A Humanized Anti-CD47

Antibody “ Speaker: Ravi Majeti MD, Phd, Co-Founder Of "Forty Seven, Inc."

Associate Professor Of Medicine, Division Of Hematology, Cancer Institute, nstitute For Stem Cell Biology And Regenerative Medicine

Date and Time: Tuesday, Aug. 30, 2016, 6:00 pm

6pm - 7pm Networking Mixer 7pm - 8:30pm Spotlight Speaker Presentation Followed By Q&A

Location: Offices Of Shepherd Mullin, 379 Lytton Ave, Palo Alto

Registration Is Complimentary. Please Use This Link To Register At The Earliest And Reserve

Your Spot! Https://Www.123signup.Com/Register?Id=Nzhgh

Dr. Ravi Majeti's Illustrious Bio Can Be Found At: Https://Med.Stanford.Edu/Profiles/Majetilab/Ravindra-Majeti/

EPPIC GLOBAL

Www.Eppicglobal.Org [email protected]

************************************************************** JLABS Meet with…Path, Thursday Morning, Sept. 8, 2016

Event: Meet with Path PATH Participating Representative:

David Shoultz, Ph.D., MS, MBA | Global Program Leader, Drug Development and Devices and Tools, PATH

Date and Time: Thursday, September 8, 2016 from 10:30 AM to 1:00 PM (PDT) Agenda:

10:30am | Registration Opens and Networking 11:00am | Presentation and Q&A

11:45am | Networking Lunch

1:00-5:00pm | One-on-one Meetings*

*Companies must have applied for a one-on-one meeting ahead of time and be approved. The application period ends on August 3rd.

Fees: Presentation

$25 | General Public

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$35 | Onsite

Includes presentation, Q&A, and lunch. All attendees must pay this fee, regardless of one-on-one meeting status. Pre-registration to attend the presentation, Q&A, and

lunch will remain open until noon on September 7th (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 August 3rd. Your application will be reviewed and you

will be notified of acceptance on August 19th. Acceptance of one-on-one meetings is not guaranteed as all applications must be approved.

Location: Johnson & Johnson Innovation, JLABS, 329 Oyster Point Blvd., 3rd Floor, South San Francisco, CA

Register at http://www.eventbrite.com/e/meet-with-path-tickets-23921043485?aff=weekly

Description of PATH

PATH is the leader in global health innovation. An international nonprofit

organization, PATH saves lives and improves health, especially among women and children. PATH accelerates innovation across five platforms - vaccines, drugs,

diagnostics, devices, and system and service innovations - that harness their entrepreneurial insight, scientific and public health expertise, and passion for health

equity. By mobilizing partners around the world, PATH takes innovation to scale, working alongside countries primarily in Africa and Asia to tackle their greatest

health needs.

PATH works with companies to create market-based solutions through tailored

partnership opportunities that deliver measurable impact. PATH matches each company's resources and expertise with their unique strengths to accelerate the next

generation of lifesaving innovations, creating better health and opportunity for all.

Partnering with PATH is a smart investment that can yield significant social impact. Companies choose to work with PATH because of their:

Focus on high-impact, large-scale, sustainable approaches - and measurable results. Proven technical and market expertise.

History of successful partnership with the private sector that dates from their

founding in 1977. Extensive in-country networks in more than 70 countries around the world.

International reputation as a trusted and influential convener and translator and their ability to mobilize partners across borders, sectors, and disciplines.

Major funders include the Bill & Melinda Gates Foundation; the US government; other governments, other nonprofit organizations, and multilateral agencies such as the

World Health Organization; individuals; and interest from investments.

Headquartered in Seattle, Washington, PATH has 1,300 employees, 1,400 partners

worldwide, and an annual budget of US$300 million. Visit www.path.org for more details. If your company has technologies with applications in low- and middle-

income countries, apply to meet one-on-one with PATH.

Dr. David Shoultz, program leader, Drug Development and Devices and Tools programs at PATH, will be in attendance on Thursday, September 8, to provide an

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overview presentation on PATH's areas of interest and keys to solving global health

issues.

David and other PATH representatives will meet with a handful of preapproved applicants after the presentation. To be considered for a one-on-one meeting,

complete the information required here.

Speaker Bio David Shoultz, Ph.D., MS, MBA, directs two of PATH's product development

programs: the Drug Development program, which seeks to discover, develop, and

deliver safe, effective, and affordable treatments for neglected diseases, and the Devices and Tools program, which focuses on advancing appropriate, affordable, and

accessible technologies to improve the health of underserved populations. Prior to joining PATH in 2014, Dr. Shoultz served as the director of grantee and

partner engagement and as a member of the leadership team at the Bill & Melinda Gates Foundation. In this role, he led an effort to strengthen the foundation's

relationships with its partner organizations to facilitate ongoing interactions and help achieve maximum impact. Previously, he served as a deputy director in the

foundation's Global Health Program, Infectious Disease, where he was central to

strategy, planning, and management for four strategic program teams, including malaria, enteric diseases, pneumonia, and the neglected tropical diseases.

Prior to his roles at the foundation, Dr. Shoultz worked as a member of the senior management team for a number of clinical research organizations participat ing in the

development of new medicines, including PPD Development, PRA International, and Biomedical Systems. He has been a member of the affiliate faculty for the

departments of Global Health and Epidemiology at the University of Washington since 2000 and sits on the board of the Geneva Foundation, where he also serves as the

inaugural chair of the Scientific Advisory Committee. Dr. Shoultz earned his Ph.D.

and MS from the School of Public Health and Community Medicine at the University of Washington, where he also obtained his BSN. He holds an MBA from the Albers

School of Business and Economics at Seattle University, where he is a faculty member in the Executive MBA Program.

David Shoultz leads our work in drug development and in devices and tools. ***************************************************************

RAPS, Saturday, Sept. 17, 2016

Event: “RAPS' 2016 Regulatory Convergence”

Date and Time: Saturday, Sept. 17, 2016, 8:00 am Location: San Jose, CA

Event Details: Come together with the global regulatory community at RAPS' 2016 Regulatory

Convergence, 17-20 September, in San Jose, CA.

This year's Convergence features panelists from 23andme, Verily/Google, FDA and Medtronic, plus keynote speakers R "Ray" Wang and Lori Hartwell and an exciting

lineup of informative sessions, networking opportunities and the regulatory

profession's 40th anniversary. • Design your own education agenda during Convergence—our two-day

conference packed with a variety of sessions that cover multiple areas of focus within the regulatory world.

• Add a one- or two-day intensive, interactive workshop where you can fully explore an area of interest and emerge with an advanced skillset and newly

developed strategies.

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• Enroll in the RAPS Regulatory Leadership Institute—a two-day program

designed for mid-career and senior level regulatory professionals looking to advance into leadership roles.

This is where the global regulatory community comes together. ***************************************************************

Meet with New Enterprise Associates, Tuesday Mid Day, Sept. 20, 2016

Date and Time: Tuesday, Sept. 20, 2016, 10:30 am to 1:00 PM (PDT) Agenda:

10:30am | Registration Opens and Networking

11:00am | Presentation and Q&A 11:45am | Networking Lunch

1:00-5:00pm | One-on-one Meetings* *Companies must have applied for a one-on-one meeting ahead of time and be

approved. The application period ends on August 15th. Location: JLABS @ SSF, 329 Oyster Point Blvd - 3rd Floor, South San Francisco,

California Apply today for an opportunity to meet with a representative from NEA.

Fees:

Presentation $25 | General Public

$35 | Onsite Includes presentation, Q&A, and lunch. All attendees must pay this fee, regardless of

one-on-one meeting status. Pre-registration to attend the presentation, Q&A, and lunch will remain open until noon on September 19th (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 August 15th. Your application will be reviewed and

you will be notified of acceptance on September 8th. Acceptance of one-on-one meetings is not guaranteed as all applications must be approved.

New Enterprise Associates, Inc. (NEA) has a strong track record of investing in innovative companies that are transforming the healthcare industry. NEA has nearly

$17 billion in committed capital and is currently investing $2.8 billion from their 15th Fund (NEA 15). Can you be their next investment?

Program Overview:

NEA, a global venture capital firm focused on helping entrepreneurs building transformational businesses across multiple sectors and stages, is visiting Johnson &

Johnson Innovation, JLABS (JLABS) on September 20, 2016. NEA invests in life science innovators with biopharma focus areas including clinical drug development

and drug discovery.

Since 1977, NEA has partnered with technology and healthcare companies at all

stages in a company's lifecycle, from seed stage through IPO. The firm's long track record of successful investing includes more than 200 portfolio company IPOs and

more than 320 acquisitions.

Frank Torti, M.D., Partner at NEA, will be in attendance to give an overview presentation covering key areas of interest and best practices when seeking startup

funds. Following the presentation, don't miss the opportunity to introduce yourself to

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Frank during the networking lunch. Finally, for those companies who apply online and

are approved, one-on-one meetings with NEA will provide a brief forum to further discuss your company.

NEA's healthcare investing has a focus biopharmaceuticals, healthcare services/IT

and medical devices. Leaders from the life science industry are encouraged to apply today to meet with NEA!

About NEA:

New Enterprise Associates, Inc. (NEA) is a leading venture capital firm focused on helping entrepreneurs build transformational businesses across multiple stages,

sectors and geographies. With nearly $17 billion in committed capital, NEA invests in information technology, healthcare and energy technology companies at all stages in

a company's lifecycle, from seed stage through IPO. The firm's long track record of successful investing includes more than 200 portfolio company IPOs and more than

320 acquisitions. For additional information, www.nea.com.

NEA Participating Representative Bio: Frank Torti, M.D. | Partner, New Enterprise Associates, Inc.

Frank Torti joined NEA in 2007 and focuses on investments in biopharmaceuticals, medical devices, and healthcare services. He has been actively involved in the firm's

private and public investments in healthcare, including Alimera Sciences, Cadence Pharmaceuticals (acquired by Mallinckrodt plc), CITIC Pharmaceuticals (acquired by

Shanghai Pharmaceuticals), Dermira, Galera Therapeutics, Neotract, Novast Pharmaceuticals, Peplin (acquired by LEO Pharma), Rigel, Solta Medical (acquired by

Valeant) and Tarveda Therapeutics. Prior to joining NEA, Frank worked for the Duke

University Center for Clinical & Genetic Economics, where he was involved in clinical trials research and economic evaluations of multinational clinical trials. Frank's

experience also includes public market investing at the Wasatch Advisors mutual fund family and business development work with the consumer-directed healthcare startup

Revolution Health Group. Frank received his medical degree from the University of North Carolina School of Medicine, his MBA with distinction from Harvard Business

School, and his BA with highest honors from the University of North Carolina, where he was a Morehead Scholar.

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Joint B2DG & ACRP, Thursday Evening, Sept. 22, 2016

Topic: “Strategies to Navigate Device Clinical Trials - Trends and Regulations” Date and Time: Thursday, Sept. 22, 2016, 6:00pm

Location: Cepheid - 904 E Caribbean Dr, Sunnyvale, CA 94089 Speaker: Victor Chen,The C&K Clinical Group

********************************************************** CSLA, Tuesday, Oct. 25, 2016

Event: Evening With Thought Leaders Date and Time: Tuesday, Oct. 25, 2016, 6:00 pm

Location: Sheraton Palo Alto 625 El Camino Real Palo Alto, CA 94301 Panel Discussions

Location: Sheraton Palo Alto, 625 El Camino Real, Palo Alto, CA 94301 Questions? Please contact [email protected].

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Event Description

CLSA members have come to rely on this program as a way to stay current on trends in the biomedical industry and get fresh insights from key opinion leaders on policy, economics,

business and society. Past speakers have included Former Secretary of State and Distinguished Fellow at the Hoover Institution, Stanford University, George P. Schultz, the

Dean of Scripps School of Medicine and author of The Creative Destruction of Medicine, Dr. Eric Topol, and the Distinguished Professor, from the UC San Diego Stem Cell program, Dr.

Larry Goldstein.