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Audrey’s Life Science Meeting Picks for Feb. 2014 - June 2014

Complimentary Service of AudreysNetwork.com Feb. 9, 2014

************************************************************ BioCentury This Week, See new program Webcast Starting Sunday, Feb. 9, 2014, www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT Date: Original broadcast Sunday, Starts Feb. 9, 2014

Watch the Broadcast 8:30 - 9:00 a.m. EDT

WUSA Channel 9 in Washington, D.C.

Watch on the Web Any Time www.biocenturytv.com Continuously available starting at 9:00 a.m.

Topic: “Chronic Challenges: Multiple Diseases” Speakers: Dr. Anand Parekh, deputy assistant secretary for health at HHS; Dr. Robert Temple, deputy director of FDA’s Center for Drug Evaluation and Research; and Myrl Weinberg, CEO of the National Health Council, a patient advocacy organization Topic Description Twenty-five percent of American adults have two or more chronic conditions, a number that increases to 68% for seniors in Medicare. Patients with more than one chronic disease account for two-thirds of America’s healthcare bill. But modern medicine traditionally treats one disease at a time. Physicians specialize in particular diseases, and clinical trials of new drugs often exclude patients with multiple diseases. Are modern medicine and drug development failing patients with multiple chronic diseases? How can care be improved for these patients? On Sunday, February 9, BioCentury This Week television examines the challenges posed by multiple chronic conditions and searches for ways to improve care, with: • Dr. Anand Parekh, deputy assistant secretary for health at HHS • Dr. Robert Temple, deputy director of FDA’s Center for Drug Evaluation and Research • Myrl Weinberg, CEO of the National Health Council, a patient advocacy Organization ********************************************************************* Bio2Device Group, Tuesday Evening, Feb. 11, 2014 Topic: Magellan Robotics, Catheter System Speaker: Francis Macnamara, Hansen Medical Date and Time: Tuesday, Feb. 11, 2014, 6:00 pm Location: Wilson Sonsini Goodrich & Rosati, 650 Page Mill Road, Palo Alto CA 94304-1050 Cost: Cost: $6 - Students/In-transition - Members only until Feb 10 at 12:01am $11 - Early-bird Registration - Members only until Feb 10 at 12:01am $20 - Registration for Non-Members and Members after Feb 10 at 12:01am $25 - Walk-ins- Check or cash only Register at www.bio2devicegroup.org or go to http://goo.gl/OLu2NH Payment Options We use PAYPAL to process your online payment. Print and bring a copy of your online receipt with you. If you prefer to pay at the door, please pay $25 in cash or with a check.

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To register now, please select the appropriate registration level and your meal preference from the pull-down menus below and enter the name and email of the attendee. Then click on the "Pay Now" button. This will take you to the PayPal payment page. Each attendee must be registered separately. Please register a non-member by logging out first. Make sure you enter the attendee's meal choice, name, and email address. Register at www.Bio2DeviceGroup.org a week prior to event Speaker Bio Francis Macnamara is vice-president of Advanced Technology at Hansen Medical Inc. in Mountain View. Before joining Hansen Medical five years ago, he was with Boston Scientific for the eleven years, serving in various R&D roles, first in Ireland and then in Boston. He has launched eight medical devices ranging from coronary stents and disposable endoscopes to robotic catheter systems. He is the named inventor on five patents. He holds an MBA from Santa Clara University and a degree in mechanical engineering from the University of Limerick in Ireland. ************************************************************ SF AWIS, Wednesday Evening, Feb. 12, 2014 Topic: “Science and Entrepreneurship” Speaker: Akhila Satish, CEO of CyberDoctor Date and Time: Wednesday, Feb. 12, 6:30-8:30 pm 6:30-7:00 pm Networking with light dinner 7:00-8:00 pm Presentation 8:00-8:30 pm Q&A and networking Location: UCSF Mission Bay Campus, Genentech Halll N114, 600 16th Street, San Francisco, CA 94158 Cost: Online registration: $5 AWIS members/students* or $10 non-members At the door: $8 members/students or $15 non-members *UCSF students are free. Funding is provided by WILS for the first 40 UCSF attendees. RSVP by Monday February 10th for online rate. Register at https://www.eventbrite.com/e/sfawis-and-wils-presents-science-and-entrepreneurship-tickets-10019956961?ref=enivtefor001&invite=NDk5MzYzMS9hdWRyZXllcmJlc0Bhb2wuY29tLzA%3D&utm_source=eb_email&utm_medium=email&utm_campaign=inviteformalv2&utm_term=attend&ref=enivtefor001 Topic Description Have a venture idea but don’t know how to start? Curious about what it takes to start and run your own business? Looking for an inspiration? sfAWIS and UCSF WILS presents Akhila Satish, CEO of CyberDoctor, a digital platform designed to improve healthcare. PatientPartner, their first breakthrough product, was shown to improve patient adherence to medication, diet, and exercise recommendations. All are welcome! Speaker Bio Akhila has a Bachelor’s degree in Neuroscience and graduate degree from the University of Pennsylvania. She was named one of the top five women CEOs in digital health to watch. She began her entrepreneurial journey as an undergraduate spending late nights researching her idea.

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********************************************************** UC Berkeley Extension, Thursday Evenings, Feb. 13-27, March 6-13 and 27 Topic: “Life Science Product Marketing: It’s All in the Plan” Required course for Professional Program in Life Sciences Business (see flyer at http://extension.berkeley.edu/upload/lifesciences_business.pdf) Instructor: Audrey S. Erbes, Ph.D. Guest Speakers:

• Deb Donovan, Director of Marketing at Avantis Medical Systems • Stanley Skrzypczak, M.S., M.B.A., Senior Director, Commercial Development,

Genomic Health • Charles Versaggi, President, Versaggi Biocommunications • Steven Wong, Senior Consultant, Plan A • John M. York, Pharm.D., Principal and CEO, Akita Biomedical

Dates and Time: Thursdays, Feb. 13-27, March 6-13 and 27; 6:00 – 9:00 pm Location: Downtown University of California, Berkeley Extension, 425 Market St., 8th Floor, San Francisco, CA 94105 Cost: Fee is $695 Course identifier is BUS ADM X442.5. See more details and register at http://tinyurl.com/k2aq8nr Course Description This science product marketing course introduces industry-relevant product planning knowledge and skills required for successfully marketing life science products and, specifically, explores the development of strategic and tactical marketing programs for their launch. Topics include learning about different market research approaches; information resources critical for developing a successful plan, product strategy and positioning with differentiated claims; and how to identify the most lucrative target audience. Course activities include a team-developed preliminary marketing plan. The course is appropriate for professionals at all levels in life science marketing research, product planning and management, product sales, promotion, business development and licensing, public and corporate relations, as well as other company functions involved in the development and commercialization of a product and its labeling, including clinical and regulatory. Course participants will learn about the development of a marketing strategy, product positioning, differentiated claim structure and selection of target audience as members of a class-based product team that replicates a company-based team. They will understand what goes into successful tactical marketing and promotional programs and gain insights into what it takes to gain management approval and resources for implementation. Course Instructor Audrey Erbes, Ph.D., Principal, Erbes & Associates and www.audreysnetwork.com, is a life-science business development and marketing consultant and developer of customized executive education. With more than 30 years of managerial experience in the biotech and pharmaceutical industry, she was Executive Vice President and cofounder of Kowa Research Institute, a biopharmaceutical licensing and investment subsidiary of Kowa Company Ltd., Japan and before that held U.S. and global management positions at Syntex Corp. (acquired by Roche) in market research, product management, strategic marketing and planning, and business development. Guest Speakers and Their Topics

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Debbie Donovan, B.A., an expert in medical device marketing, is focused on developing digital marketing programs for medical technology companies—including the integration of social media channels. Currently, Debbie is the Director of Marketing at Avantis Medical Systems supporting market adoption of Third Eye® Retroscope. Previously, she was a Senior Manager at Intuitive Surgical and, addition, had experience serving Ob/Gyn, Orthopedics/Spine and ENT physicians at Conceptus, Kyphon and Somnus. Her expertise is in developing effective strategies and leading teams in marketing communications, public relations and event programs. Before heading to the client side, Debbie began her career at a medical advertising and public relations agency. “e-Marketing: Connecting with Providers and Patients” Stanley Skrzypczak, M.S., M.B.A., currently leads Business Development at Invitae across the U.S. and ex-US markets. He has over 25 years of business experience across commercial and product development while at Genentech (biotechnology) and Genomic Health (gene expression profiling). Prior to Invitae, Stan was Sr. Director for Breast Cancer Marketing and led the Breast Cancer Core Team for Global Strategy and Lifecycle Management at Genomic Health. He has held leadership roles and led teams across marketing, commercial development, managed care and market access, sales management, government affairs, pricing, and reimbursement. He holds a B.A. in Biology, an M.B.A. in Marketing, and an M.S. in Immunology & Microbiology. “Product Management 101 – Developing/Executing The Tactical Plan” Charles S. Versaggi, Ph.D., is President, Versaggi Biocommunications®, a marketing consultancy specializing in corporate and marketing communications for the global life-science industry. Based in the San Francisco Bay Area, the firm serves clients in every stage of development — from seed funding through research and development, clinical trials, regulatory approval and worldwide product marketing. With nearly 30 years of strategic marketing and communications experience, Dr. Versaggi has directed marketing and communications initiatives for life science companies ranging from startups to Fortune—100 global leaders. These include the launch of the first genetically engineered vaccine and genomic disease management products, and the first applications of minimally invasive surgery. "Building Value through Strategic Marketing Planning and Communications." Steven Wong, B.A., is a Senior Consultant at Plan A, a strategic marketing consulting firm servicing biotechnology and pharmaceutical companies. He specializes in developing patient-based forecast models and prioritizing marketing opportunities in therapeutic areas such as oncology and infectious diseases. At Plan A, he has directed numerous consulting engagements, including opportunity assessments, complex population modeling, and therapeutic area strategy. Additionally, Mr. Wong co-authored several editions of Plan A’s ONCOSight and Innovations in Anticancer Drugs multiclient report series. "Market Research Information Resources” John M. York, Pharm.D., Principal and CEO, Akita Biomedical brings over 25 years of biopharma experience. After receiving his Pharm D from the Univ. of Michigan, he became the 1st Rutgers Industry Fellow. His corporate career includes stints in medical, sales, marketing, and management at BMS, Amgen, and Allergan. Since 2002, he has run Akita Biomedical, a medical communications and consulting firm. He is presently a MBA candidate at Indiana University’s Kelley School of Business in addition to his work at AKITA and at Cancer Control, H. Lee Moffitt Cancer Center’s journal, where he is an associate editor. “Helpful Tips to Successfully Navigating Course Assignment” Course Content Outline Strategic Marketing Research, Analysis and Creativity

• Marketing plan outline • Market research tasks and methodology for implementation • Analysis of market research results for input to planning • Development of market strategy

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• Selection of best market segment and target audience focus • Development of product positioning and claim structure

The Marketing Program • Development of tactical marketing program: steps and content • Development of information about the product and its competitive market needed for

hiring vendors and providing direction that would assist in selection and implementation of tactical programs

• Selection of tactical marketing activities and programs for plan implementation Writing the Product Marketing and Sales Plan

• Putting all the elements together in draft plan • Writing final preliminary plan for implementation • Selling the plan and obtaining prospective “company commitment” to proposed

plan, marketing programs and related budget with guest Marketing Committee Presentation of Team Marketing Plans ******************************************************************* HBA, Thursday Evening, Feb. 13, 2014 Topic: “Regulatory and clinical challenges and opportunities in orphan drug development” Speakers: Michelle Rohrer. Vice president regulatory - Genentech Inc.; Jeffrey Siegel, Senior group medical director -Genentech Inc.; Jorge Tavel, Medical director - Genentech Inc. Date and Time: Thursday, February 13, 2014, 5:30 -7:45 PM PST 5:30 PM - 6:15 PM Registration & Networking 6:15 PM - 6:30 PM Welcome/introductory remarks 6:30 PM - 7:10 PM Panelist presentations by Jeffrey Siegel and Jorge Tavel 7:10 PM - 7:30 PM Moderated Q&A with Michelle Rohrer 7:30 PM - 7:45 PM Closing remarks Location; Genentech Inc, 651 Gateway Blvd, Building 81, Pacific Heights (81-15A), 15th Floor Reception Area , South San Francisco, 94080 Cost: Event is open to: HBA members and nonmembers Online Registration deadline: February 10, 2014 Onsite (walk-in) registration: Is allowed Member rate: $35 until February 10, 2014; $40 after February 10, 2014 Nonmember rate: $45 until February 10, 2014; $52 after February 10, 2014 Other rate: Student $ 25 until February 10, 2014; $ 30 after February 10, 2014 Register at https://netforum.avectra.com/eweb/DynamicPage.aspx?WebCode=LoginRequired&Site=HBA Registration Information Event is open to: HBA members and nonmembers Online Registration deadline: February 10, 2014 Onsite (walk-in) registration: Is allowed Member rate: $35 until February 10, 2014; $40 after February 10, 2014 Nonmember rate: $45 until February 10, 2014; $52 after February 10, 2014 Other rate: Student $ 25 until February 10, 2014; $ 30 after February 10, 2014 Topic Description Orphan drug development is a major growth area for pharmaceutical companies. We have an incredible panel of senior clinical and regulatory experts to discuss the opportunities and challenges in orphan drug development. This is the first program in a two-part orphan drug

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series and the second program taking place on March 30 will build on the first part by exploring the commercial challenges and opportunities in this space. Please join us for an engaging panel discussion. 1. Discuss the regulatory framework that makes orphan drugs appealing investments to pharmaceutical companies: • Accelerated approval pathway • Regulatory exclusivity (7 years of orphan drug protection) • Clinical trial costs can be lower with smaller clinical trails • Line extension opportunities 2. And challenges in orphan drug development: • Difficult to enroll clinical trials due to small total number of patients • Poorly studied epidemiology • Limited understanding of clinical natural history makes it more difficult to design successful trials 3. Orphan development case studies: • Acromegaly • Congenital cytomegalovirus (CMV) Please submit any questions/comments you might have for the speakers ahead of time (all questions will remain anonymous) to Elena@kearnyvp.com or marcya@gene.com Learning Objectives 1. Receive an overview of orphan drug development. 2. Develop an understanding of orphan drug development through two case studies. 3. Benefit from networking with peers and senior executives. Cancellations/Refunds Is this event refundable? Yes If yes, must be submitted in writing to events@hbanet.org by February 6th, 2014; no refunds are available after this date. Event Questions/Support - Program contact for event details: Contact email marcya@gene.com and/or phone 650-521-5093 - Membership questions: membership@hbanet.org or 973-575-0606 - Trouble with online registration: events@hbanet.org or 919-890-5230 ****************************************************************** Bio2Device Group, Tuesday Morning, Feb. 18, 2014 Topic: " Home Use Medical Devices: Evolution and Future Wireless (Mobile Cloud) Trend" Speaker: Sanjiv Tanna, Chief Technology Officer, Intanna Medical Devices Labs Date and Time: Tuesday, Feb. 18, 2014, 8:30am – 10:30 am Location: Sunnyvale City Council Chambers, 456 West Olive Ave., Sunnyvale, CA No registration required Topic Description With rising cost of health care, aging population, technology advancement and patient's desire to stay in homes - health care is increasingly moving from medical facilities into homes. This seminar takes a deep dive into design criteria, human factor, hardware, environment requirements for Home Use Medical Devices. On September 25, 2013, FDA issue Guidance for Mobile Medical Application (apps). According to industry estimates, 500 million smartphone users worldwide will be using a health care application by 2015, and by 2018, 50 percent of the more than 3.4 billion

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smartphone and tablet users will have downloaded mobile health applications by professionals, consumers and patients. We will review about FDA oversight of mobile medical application in relation to Home Use Medical Devices. In addition we will briefly review on Mobile Cloud System platform and future trend. Speaker Bio Sanjeev Tanna is a founder and Chief Technology Officer of Intanna Medical Devices Labs, Milpitas, California (www.intanna.com). Graduated from University of Massachusetts with MS degree, Sanjeev has developed and successfully launched many programs and products into production. Some of devices Sanjeev has worked: therapeutics, surgical, capsule endoscopy, Dental Tissue Management, Infusion pumps, Inhaler and many more. Since 2006, Intanna has served startups to public companies. Prior to founding Intanna, Sanjeev had worked for Aerogen, Omron, Honeywell (North Safety). You can reach to Sanjeev at samt@intanna.com ******************************************************************** Janssen Labs, San Francisco Innovation Center, Tuesday Morning, Feb. 18, 2014 Topic: “The Road to the Biologic IND: Best Practices When Filing Biologic Investigational New Drug Applications” Speakers: Barry Springer, PhD | VP of Technology, Strategy & Operations, Biotechnology Center of Excellence, Janssen R&D; Steven Lang, PhD, MBA | Director, Biologics Research Analytical Discovery, Cell Line Development, Biotechnology Center of Excellence, Janssen R&D; Pauline Martin, PhD | Senior Scientific Director, Biologics Toxicology, Biotechnology Center of Excellence, Janssen R&D; Hugh Davis, PhD | VP and Head of Biologics Clinical Pharmacology, Biotechnology Center of Excellence, Janssen R&D; and Salvatore Morello | Director Global Regulatory Affairs, Janssen R&D Date and Time: Tuesday, Feb. 18, 2014, 8:30 am – 11:30 am Agenda 8:30 AM |

Registration, Breakfast, and Networking

9:00 AM |

Development of a Process Suitable for Manufacturing a Biologic Drug

- Cell culture - Protein purification - Product characterization - Formulation & stability - Fill/Finish

9:30 AM |

Toxicology of Biotechnological Products

- Goals of preclinical toxicology evaluations - Why biopharmaceuticals are different from small molecule drugs - a toxicology perspective - Unique considerations for biologics Typical First-in-Human Program

-Preclinical toxicology program objectives, endpoints, findings of concern - Factors to consider for biotechnology products: Species specificity, Immunogenicity, Antibody response -Testing considerations

10:00 AM |

Biologics Clinical Pharmacology

- Determination of the starting dose for the First-in-Human study using MABEL, PK/PD, allometric scaling and common drug approaches - Immunogenicity Risk Assessment and Determination: preclinical and clinical

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Location: UCSF - Rock Hall, 1550 4th St., San Francisco, CA 94158 Fees: $20 | Student/Academic, $35 | General Public Register at http://www.eventbrite.com/e/the-road-to-the-biologic-ind-tickets-10272008855?aff=blast

Program Description

Janssen Labs, the San Francisco Innovation Center and the Biotechnology Center of Excellence, Janssen R&D, Pharmaceutical Companies of J&J, invite you to an in-depth look into the process of filing a biologic Investigational New Drug (IND) application and the procedures necessary for advancing your company's early-stage drug development program. Whether your goal is to develop a pipeline through commercial launch, or partner as early as possible, submitting an IND is a critical early milestone for every biotech company. With big Pharma and VC firms competing for the most promising compounds, startups are expected to demonstrate a solid plan for achieving IND acceptance. Join us for a series of short presentations exploring the basic requirements and considerations necessay to achieve a successful biologic IND submission. The presentation will highlight the following:

• Key components of the Chemistry/Manufacturing/Controls section • Expression, Purification, Analytics, Formulation, Fill/Finish • Preclinical study design, species selection, material requirements, and timelines • Regulatory requirements, strategies to minimize costs and timelines while balancing

risk

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Palo Alto AWIS, Wednesday Evening, Feb. 19, 2014 Topic: “Lessons from starting a non-profit” Speaker: Tzipor Ulman, Ph.D. Executive Director of Science is Elementary Date and Time: Wednesday, February 19, 2014, 7:00 pm Location: Xerox PARC Auditorium, 3333 Coyote Hill Road, Palo Alto, CA Pricing: Non-members $10 plus fees, free for Palo Alto Chapter members; $15 at the door for non-members Register at http://www.brownpapertickets.com/event/556538

impact 10:30 AM |

Regulatory - Satisfy Statutory Legal Requirements for Testing in Humans

- Strategy - Data requirements: CMC, safety, clinical plan - eCTD - Pre-IND meetings

11:00 AM | 11:30AM Close

Discussion and Q&A

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Speaker Bio Dr. Ulman founded Science is Elementary (SiE), a non-profit whose mission is to inspire a passion for science in children by increasing knowledge and interest in science at the elementary school level. Tzipor has grown SiE from a 2 classroom pilot to a program that serves over 1500 students in the Bay area and 150 students in a new site in Buffalo, NY. She has recruited and trained over 400 scientists and engineers to serve as classroom facilitators and mentors to low-income youth. In 2014, SiE will offer professional development in STEM to elementary school teachers in the Mountain View-Whisman school district. ****************************************************************** BayBio Lunch and Learn, Wednesday Morning, Feb. 19, 2014 Topic: “Strategies for Protecting Biomarket Innovation in the U.S. and Abroad” Speaker: Django Andrews Date and Time: Wednesday Morning, Feb. 19, 2014 11:00am – 11:30am: Registration and Networking 11:30am – 12:30pm: Program Location: HCP/BayBio Event Center, 250 East Grand Ave. – Suite 26, South San Francisco, CA 94080 United States Cost: Members: Free, Non-members: $75 Register https://m360.baybio.org/event.aspx?eventID=93005 • Early registration is highly advised as space is limited and there will be no on-site

registration • Late arrivals will not be admitted after 11:30AM • Pre-registered attendees will receive an immediate receipt/confirmation after

submission • Please print this receipt/confirmation and bring it with you to receive your conference

credentials • Photo ID (driver’s license or passport) will be required at check-in • All sales are final

Please mail your event-related questions to: registration@baybio.org or you can contact us via phone: 650-871-3257. Attire: Business Attire Suggested Topic Description Methods of assessing drug treatment efficacy by measuring metabolite levels are not eligible for patent protection. From these decisions, it’s become clear that the hard work of identifying a gene, or set of genes, which are correlated with a disease state is not enough to receive patent protection in the US. In contrast, isolated DNA is eligible for patent protection in many jurisdictions outside the US, such as Europe. Moving forward, companies will likely consider innovation protection strategies which include some mix of patent and trade secret protection. • Insight regarding the impact of these decisions and strategies for protecting

biomarker innovation in the US and abroad • Understanding which biomarker innovations are patent-eligible in the US and abroad • Information enabling companies to craft a global innovation and protection strategy

***************************************************************** EMBS, Wednesday Evening, Feb. 19, 2014 Optional dinner location: Stanford Hospital Cafeteria, 6:15 PM (no host, no reservations)

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Topic: “The Development of A Wearable Cardiopulmonary Sensor System” Speaker: Dr. Sam Eletr, Acting CEO, Rhythm Diagnostic Systems, Inc. Date and Time: Wednesday, February 19, 2014, 7:30 PM Location: Room M-114, Stanford University Medical School No cost or registration Topic Description Rhythm Diagnostic Systems, Inc. began operations in August 2012, in the San Francisco Bay Area. It aims to offer very light, wearable, unobtrusive, band-aid-like, optionally reusable MultiSenseTM Strips that measure and record (and eventually transmit) a number of cardiopulmonary physiological parameters, as well as the wearer's relative physical exertion data. A proprietary design minimizes power consumption and thus reduces battery bulk to enhance comfort and wearability. A company-owned manufacturing facility is currently producing, for an upcoming clinical trial, a run of recording Strips of about 100x27x3 mm, weighing less than 16g, and capable of detecting and recording up to ten days' worth of: Heart Rate, clinical quality ECG, Oxygen saturation, Respiratory Rate, relative respiration depth, relative level of physical exertion, and temperature, as well as positional information. Examples of these data will be shown. The recording Strip may be read directly following an ambulatory testing period, and its data interpreted within minutes in the physician's office using software available on a laptop or tablet. A real time transmitting version of this Strip is under development. These MultiSenseTM Strips potentially address a number of applications and markets. These vary from the diagnoses of intermittent and asymptomatic/symptomatic arrhythmias in patients suspected of cardiac disorders, to the wireless monitoring of ICU/CCU patients and ambulatory in-hospital or in-hospice patients. Other applications include the screening of patients with sleep disorders, the monitoring of progress of athletes in training, or the watching over of a variety of professionals in stressful or risky situations." Speaker Bio Dr. Eletr was a co-founder and first CEO of Applied Biosystems, Inc., whose DNA sequencers first enabled the sequencing of the human genome. He was also a co-founder of Lynx Therapeutics and a Board member of Solexa, the companies that gave birth to the other dominant DNA sequencing technology. More recently he was involved in the seeding of Population Genetics Technologies and Domain Therapeutics, companies whose Boards he chairs, and in the seeding and financing of Andrew Alliance, a pipetting automation robot company on whose Board he sits. ****************************************************************** BioScience Forum, Wednesday Evening, Feb. 19, 2014 Topic: "The Challenges of Building Shareholder Value in a Growing, Platform-Based Therapeutics Company" Speaker: Edward Lanphier, President and CEO, Sangamo BioSciences, Inc. Date and Time: Wednesday, Feb. 19, 2014, 6:00 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 Franicisco, CA 94080 Event Registration ($3 service fee will apply) General Pre-Registration $45.00 General On-Site Registration $55.00 Student Pre-Registration $35.00

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Student On-Site Registration $45.00 Pre-Registration ends Monday, Feb. 17, at 9 pm Cash or check accepted on the day of the event Register at http://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, Feb. 13th If paying with check, do not complete online registration with Cvent Topic Description Building a successful company based upon a novel DNA binding protein technology platform has required numerous resource prioritizations and strategically aligned business decisions over the past 18 years at Sangamo BioSciences. The technology, based upon naturally occurring zinc finger proteins (ZFPs), can be used to generate ZFP transcription factors (ZFP TFs) to selectively activate or repress gene expression, and ZFP Nucleases (ZFNs) that allow precise gene-editing to correct, disrupt or modify a specific targeted gene. The ability to drive the development of this novel therapeutic approach was shaped and governed, in part, by access to non-dilutive capital and private and public equity financing alternatives. Effective management of financial and scientific opportunities and risks has allowed Sangamo to attract the capital necessary to evolve from a technology platform company into an emerging pharmaceutical company, working in areas including AIDS, Huntington’s disease, and hemophilia. Edward Lanphier will address the challenges companies such as Sangamo may face, and his experience in building a company that has become a recognized leader in the field of genome engineering. Speaker Bio Edward Lanphier is the founder of Sangamo BioSciences, and has served as President, Chief Executive Officer and a member of the Board of Directors since the company’s inception in 1995. He has over 30 years of experience in the pharmaceutical and biotechnology industry including senior management positions at Somatix Therapy Corporation, BioGrowth, Inc., Biotherapeutics, Inc., and Synergen, Inc. Before joining Synergen, he was employed by Eli Lilly and Company in the strategic business planning-biotechnology group. Mr. Lanphier currently serves on the Board of Directors of The Biotechnology Institute, is the Vice Chairman of the Board of Trustees of The Buck Institute for Research on Aging, serves on the Board and Executive Committee of the Alliance for Regenerative Medicine, is a member of the Industry Advisory Board for the California Institute for Regenerative Medicine, and is on the Dean’s Advisory Board of the University of Michigan School of Public Health. Mr. Lanphier has a B.A. in biochemistry from Knox College. **************************************************************************************************************** BOLD, Thursday Late Afternoon, Feb. 20, 2014 Topic: “Science Trends, Issues and Advances that will Impact the Life Sciences Industry” Speaker: Karin Lucas, Director of Training and Education at BioTech Primer Date: February 20th, 2014 Time: 4:00 - 6:30 pm Location: Exelixis, 210 East Grand Avenue, South San Francisco, CA 94080 Pre-Register: (by February 18th) http://annualforumfeb202014.ezregister.com BOLD Members: $20.00 Non Members: $35.00

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BOLD Members are welcome to pre-register one guest at the member price. For membership information, please visit the BOLD website or email info@growbold.com Topic Description With the IPO window open for biotech start-ups in 2013, 2014 will bring exciting innovations. Progress in DNA sequencing, companion diagnostics, and mobile medical technology are changing the way medicine is practiced. Research and clinical development in stem cell therapy will bring us closer to the era of regenerative medicine. Biofuels and industrial enzymes promise to free us from dependence on fossil fuels and lessen our carbon imprint. All of these advances require and are enabled by collaboration between experts from diverse fields. Learn about the most exciting advances of the past year from the experts who translate today’s breakthroughs for the non-scientist professional. Attend this workshop and you will:

· Learn how DNA sequencing is redefining translational medicine · Understand the important and increasing role of companion diagnostics in drug development · Be excited about your intestinal bacteria · Be amazed at the advances in autologous stem cell therapies · Have hope for the future of alternative energy

**************************************************************** Janssen Labs, Thursday Afternoon, March 20, 2014 Topic: “Show Me The Money: Alternative Sources of Capital” Speaker: Bob More, Head of Venture Investing, Bill & Melinda Gates Foundation Panelists: Bob More | Head of Venture Investing, Bill & Melinda Gates Foundation Todd Meyerrose, PhD | Portfolio Manager, Poliwogg Melissa Stevens | Deputy Executive Director, FasterCures Una Ryan, PhD, OBE | Member, Astia Angels; and Managing Director, Golden Seeds (Silicon Valley) Date and Time: Thursday, March 20, 2014, 3:00 pm 3:00pm | Registration & Networking 3:30pm | Introductions 3:35pm | Panel Presentation 5:00pm | Networking Reception 6:30pm | Close Location: TRES - San Francisco, 130 Townsend St., San Francisco, CA 94107 Fee: $20 | Student/Academic $40 | General Public Register at http://www.eventbrite.com/e/show-me-the-money-alternative-sources-of-capital-tickets-10272612661?aff=blast Topic Description When building a biotech company you need buckets of cash for development, but where can one find the cash and is all money created equally? While venture capital is the traditional source of capital there are alternative funds for your biotech company and some sources have the added benefit of being non-dilutive whilst remaining core to your mission. There may be a time and a place for venture capital, but at the early stages of development leave no stone unturned. Join our panel to hear from a diverse set of funding sources such as innovative grant programs, government agencies, foundations, angel investors, patient advocacy groups and crowd funding platforms that have funding opportunities for your

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company. Our panel discussions are candid, interactive and informal. We hope you walk away with the real story behind how things work so you can make it happen for yourself. This panel will be followed by a networking reception. Speaker Bio Bob More is the head of venture investing for the Bill & Melinda Gates Foundation and leads the Global Health Venture Initiative. Prior to his current position, More was a general partner at Frazier Healthcare and a member of the firm's Biopharma Venture Team. His other previous positions include partner at Domain Associates, a Kauffman Fellow, chief operating officer of Small Molecule Therapeutics, and positions at Pharmacia Biotech, Somatogen, and MedVest. More serves as an advisory board member for Greenspring Associates, Okapi Ventures, BioMed Realty Trust, The Medical Industry Group of the NVCA, and The Sulpizio Family Cardiovascular Center. He received a master of business administration degree from the Darden School of Business Administration at the University of Virginia and a bachelor of arts from Middlebury College. ***************************************************************** Bio2Device Group, Tuesday Morning, Feb. 25, 2014 Topic: “Myths and Challenges of Cloud-based eClinical Systems: The Story of CloudClinica” Speaker: Ale Gicqueau, CEO & President, Clinovo Date and Time: Tuesday, Feb. 25, 2014, 8:30am – 10:30 am Location: Sunnyvale City Council Chambers, 456 West Olive Ave., Sunnyvale, CA No registration required Topic Description The “Cloud” is expected to reach $72.8 billion of cumulated sales by 2015, all industries combined, according to a recent IDC study. With a CAGR of 21% per year from 2011 to 2015, it is growing three times faster than traditional IT infrastructures. Cloud-based systems are gaining momentum in a number of industries: High tech, manufacturing, business intelligence, to name only a few. However, this innovative technology remains largely misunderstood in the clinical trial industry. According to the research company Datamonitor, 80% of clinical trials are still done on “paper”, which actually means Excel or non-compliant eClinical system. Clinical trial data collection solutions (EDC systems) today have very high licensing fees and high cost of programming resources (up to $300K+/study), inaccessible for startup medical device companies, early phase clinical trials, universities and hospitals. In addition to cost, sponsor companies are struggling with study build complexity, long implementation cycle time, and IT dependency. Clinovo is building a disruptive cloud-based solution, CloudClinica, that will empower end users to build studies themselves during the clinical trial process, remove IT dependency, and eliminate barrier of entry. This presentation will go over 5 essential rules for any eClinical system to be defined as cloud-based, and tackle a number of common myths around the “Cloud”. Finally, it will determine where there are barriers to the use of cloud-based eClinical systems, and where there are solutions to overcome those barriers. Speaker Bio Ale Gicqueau founded Clinovo in 2003, with the vision of bringing medical innovations faster to market by running clinical trials more effectively and leveraging latest cost-efficient technologies. Over the last 8 years, Ale grew Clinovo organically from a small SAS consulting firm to a leading open source EDC vendor. Ale is an entrepreneur at heart and he is a strong supporter of open source, web 2.0

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technologies and global standards to accelerate clinical trials. Ale started his career at IBM. Prior to founding Clinovo, Ale worked in healthcare informatics in companies such as Axolotl (acquired by Ingenix) to develop advanced Clinical Networking solutions to meet the diverse and changing needs of physicians, hospitals, RHIOs and statewide HIEs to achieve interoperability across entire medical trading areas. Ale is actively participating in a PhUSE workstream aiming at "lowering barriers to the adoption of cloud technology". PhUSE is an independent, non-profit global platform for the discussion of topics encompassing the work of Data Managers, Biostatisticians, Statistical Programmers and eClinical IT professionals. Ale is also involved with the CDISC organization, a non-profit that aims to establish and implement industry wide standards to help life science companies run their clinical trials efficiently. *************************************************************** NCCACRP, Tuesday Evening, Feb. 25, 2014 Topic: “Re-thinking Protocol and Site Feasibility Processes: How to Ensure Complex Protocols Can Be Executed Flawlessly” Speaker: Beth D. Harper, BS, MBA, President, Clinical Performance Partners, Inc., Encore Speaker from 2013 Date and Time: Tuesday, February 25, 2014, 6:00 – 9:00 PM 6:00 – 7:00 PM Registration, Networking, & Dinner Buffet 7:00 – 7:30 PM President’s Welcome, Raffle, Open Mic 7:30 – 8:45 PM Educational Presentation 8:45 – 9:00 PM Networking 1:1 with speaker Location: BioMarin Pharmaceutical, Inc. San Rafael Campus, 770 Lindaro Street, San Rafael, CA, 94901 Topic Description The term “feasibility” in clinical research conjures up images of lengthy study questionnaires for clinical research site candidates. This is typically the sponsor’s primary data collection strategy during protocol development and site selection. Has this effort translated into effective, efficient protocols, better enrollment, or better site performance data? The resounding answer from sponsors, CROs, and sites is NO! Protocols have become increasingly complex, costly, and with tight timelines for study execution from first subject enrolled to data lock. An effective feasibility strategy is critical to successful study execution. This interactive, thought provoking and enjoyable presentation includes several real world strategies, tools, and a case study. Some content was presented at an ACRP Global Conference, and in an article in The Monitor. We will explore essential questions for planning an effective feasibility strategy including: ► What does “feasibility” mean? ► What feasibility questions aren’t being asked that should be? ► What’s a better approach to feasibility assessment (sponsor, CRO, site perspectives)? ► How can sponsors, CROs, and sites adopt more effective feasibility strategies? Learning Objectives:

1. Explain why a paradigm shift is needed in the way the industry approaches protocol and site level feasibility assessments

2. Describe the role, value and importance of operational review conversations as a more effective alternative to traditional site and protocol feasibility questionnaires

3. List the three most powerful questions to ask during the feasibility assessment process that can have the greatest impact on study implementation success

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Speaker Bio: Beth presented Trouble Shooting Enrollment and Retention- Prevention or Rescue? at our 2013 North Bay Chapter Event to rave reviews. She’s President of Clinical Performance Partners, Inc. a clinical research consulting firm specializing in enrollment and site performance management. Previously she was the Chief Clinical Officer of Centerphase Solutions, Inc., a technology-enabled consultancy specializing in protocol optimization services as well as Sr. Vice President at D. Anderson and Company a firm specializing in patient recruitment and retention. In addition to Beth’s 28 years of clinical research experience, she is an Adjunct Assistant Professor at the George Washington University. She has published and presented extensively in the areas of study feasibility, site selection, patient recruitment and protocol optimization. She’s a member of the Editorial Advisory Board for ACRP’s The Monitor. Beth received her B. S. in Occupational Therapy from the University of Wisconsin and an M.B.A. from the University of Texas. Target Audience: Clinical Research Professionals

• Sponsors • Study Sites • Physicians • Nurses • Students • Vendors/Service Providers/CROs, Consultants • Institutional Review Boards • Related–Clinical Quality Assurance, Project Management, Account Rep, HR,

Recruiters/Staffing, Finance, Biometrics, Regulatory ************************************************************************* BayBio Lunch and Learn, Wednesday Morning, Feb. 26, 2014 Topic: “Compensation for Private Companies: The Ins and Outs of Equity” Speakers: Kelley Wall, Director RoseRyan, Kyle Holm, Associate Partner, Radford Date and Time: Wednesday Morning, Feb. 19, 2014 11:00am – 11:30am: Registration and Networking 11:30am – 12:30pm: Program Location: HCP/BayBio Event Center, 250 East Grand Ave. – Suite 26, South San Francisco, CA 94080 United States Cost: Members: Free, Non-members: $75 Register at https://m360.baybio.org/event.aspx?eventID=97891

Attire: Business Attire Suggested • Early registration is highly advised as space is limited and there will be no on-site

registration • Late arrivals will not be admitted after 11:30AM • Pre-registered attendees will receive an immediate receipt/confirmation after

submission • Please print this receipt/confirmation and bring it with you to receive your conference

credentials • Photo ID (driver’s license or passport) will be required at check-in • All sales are final

Please mail your event-related questions to: registration@baybio.org or you can contact us via phone: 650-871-3257. Topic Description

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Equity-based compensation is a must-have for attracting and retaining top talent at Bay Area companies, but determining the right compensation philosophy is anything but straightforward. Many companies fail to adequately consider the full array of compensation choices and the financial impact of each one, including changes to their valuation. During this luncheon you will learn: • Prevalent equity vehicles and which one to use when • Key milestones from start-up to a liquidity event • The difference between private and public company equity compensation

philosophies • How to avoid stock compensation issues • Crucial equity considerations before IPO

*********************************************************************** ASQ Biomedical Division, Wednesday Evening, Feb. 26, 2014 Topic: “February Roundtable – Design and Development Planning (Design Control Series – Session #2) Date and Time: Wednesday, February 26, 2014 from 7:00 PM to 9:00 PM (PST) Triple Ring Technologies, 39655 Eureka Drive, Newark, CA 94560 Cost: Online registration Feb 26, 2014 $30.00 $0.00 Student/Unemployed Feb 26, 2014 $20.00 $0.00 Walk-in (Registration at the door) Not Started $40.00 $0.00 N/A NCDG Board member Feb 26, 2014 $0.00 $0.00 Register at https://www.eventbrite.com/e/february-roundtable-design-and-development-planning-design-control-series-session-2-tickets-10265844417 Topic Description This is the second in the series of Design Control Roundtable presentations for the 2014 NCDG year, the February session will cover Design and Development Planning. Each of us as a device manufacturers is required to create a Design and Development plan that guides our development activities and responsibilities for carrying out them out. Our speaker has 15 years’ experience in this area and in his presentation this evening, he will share some requirements, how to implement them, and some helpful nuances in this important part of device design sequencing.” In the next few months, specific Design Control topics will be discussed in greater detail. Also, for the benefit of the attendees, a binder will be provided to collect the presentations and notes from these Round Table sessions and discussions. **************************************************************** Golden Gate Polymer Forum Dinner Lecture, Wednesday Evening, Feb. 26, 2014

Topic: "Draping Materials: Enabling Advanced Adhesives and Multifunctional Technologies" Speaker: Prof. Alfred J. Crosby, Polymer Science & Engineering Department, University of Massachusetts, Amherst Date and Time: Wednesday, Feb. 26, 2014, 6:00 pm 6:00 PM social hour 7:00 PM dinner 8:00 PM presentation Location: Michael's Restaurant at Shoreline Park, Mountain View, 2960 N Shoreline Blvd. Cost: Employed/postdocs: $30 early registration, $35 regular registration

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Unemployed/retired/students: $15 early registration, $20 regular registration Free if you attend just the lectures at 8:00 PM (but please let us know for headcount) After deadline: Registration not guaranteed, so contact us Late fee applies if space available -- $40 regular/employed, $25 unemployed/student/retired Because we must pay the restaurant for the ordered meal, we must ask no-shows to pay for their reservation. However, penalty-free cancellations are allowed up until the deadline for reservations the day before the event. Register at www.GGPF.org

PLEASE NOTE: We accept cash or checks, but are unable to accept payment by credit card at this time. You may pay at the door. Checks may be made to "GGPF" Please register on the web page Or, if necessary, contact: Lothar Kleiner lothar_kleiner@hotmail.com 650-492-9400 You should receive confirmation of your registration; if not, please contact us again. Registration Discounted Advance Registration Ends 5pm Tuesday Feb. 18 Final Registration Ends 5pm Tuesday Feb. 25 Topic Description Many materials in nature demonstrate a unique ability to gently conform to complex topology while maintaining extreme robustness in mechanical strength. In a similar fashion, one of the oldest forms of synthetic materials, fabric, displays the same balance of properties that are virtually unmatched in any other mass-produced continuous material. Key to the presentation of such properties is the creation of materials with structural hierarchy, discretized combinations of lengths and angles, and interactions between flexible, yet stiff, components that permit rotational freedom. Although the use of fabric and fibers in technological solutions is not new, recent demands for new material functionality combined with lessons learned from inspirational biological examples have led to new questions and opportunities for furthering our understanding and guided-development of fabric-like materials. In this presentation, we describe the development of a gecko-inspired adhesive material, called Geckskin™, which can sustain large forces, permit easy release, and be reused without loss in performance. Building upon a scaling design principle, we demonstrate how the same balance of materials properties and geometry that controls draping leads to a unique set of interfacial properties. Furthermore, this link provides new understanding of how adhesion-based locomotion has developed in organisms ranging from insects to large lizards. We finish by highlighting recent efforts to assemble tailored nanoparticles into materials structures that possess fabric-inspired attributes on both sub-10nm as well as multi-centimeter length scales. These structures represent a new materials paradigm, possessing the functionality of inorganic cores with unique nanoscale properties combined with macroscale properties similar to fabric. Overall, these stories will provide insight into how we think as a group and learn from nature, without losing focus on the importance of fundamental materials principles and engineering design.

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Speaker Bio Prof. Crosby is a Professor in the Polymer Science & Engineering Department at the University of Massachusetts Amherst. Crosby received his B.S. degree in Civil Engineering and Applied Mechanics at the University of Virginia and his Ph.D. in Materials Science and Engineering at Northwestern University. He was awarded a National Research Council Research Fellowship to conduct postdoctoral research in the Polymers Division at the National Institute of Standards and Technology. In 2002, he joined the faculty at UMass and has received many awards for his research, including the NSF CAREER Award, the ARO Young Investigator Award, the Adhesion Society Outstanding Young Scientist Award, the Rohm & Haas New Faculty Award, the ACS Rubber Division’s Sparks-Thomas Award, and the College of Natural Sciences Outstanding Research Award. His research has been covered extensively in the popular media, including Discovery Channel, Popular Science, CNET, NPR, and CNN Money, which named the Geckskin™ project one of the Top 5 Science Breakthroughs of 2012. His research interests include mechanics of hierarchical structures, polymer adhesion, biomimetic materials design, responsive surfaces and materials, elastic instabilities in polymer networks, deformation and fracture of thin films, polymer patterning, nanoparticle-polymer assemblies, and nanocomposites.. *************************************************************** CACO, Friday Mid Day, Feb. 28, 2014 Luncheon Topic: “PK/PD in forensic science: the science of anesthesiology in the court case of Michael Jackson's propofol overdose” Speaker: Professor Steven Shafer (Stanford University) Date and Time: Friday, Feb. 28, 2014, 11:00 am – 1:30 pm Location: SF Bay Area: Foster City Crowne Plaza Register at http://www.pbss.org/aspx/login01.aspx?iURL= ************************************************************** Bio2Device Group, Tuesday Morning, March 4, 2014 Topic: “The Histone Code as a Driver of Clinical Outcome: An Epigenetic Revolution Reveals a New Face of Cancer as a Metabolic Disease” Speaker: Babak N. Alizadeh, Ph.D. Co-founder & Chief Operations Officer, PrognosDx Health Inc. Date and Time: Tuesday, March 4, 2014, 8:30am – 10:30 am Location: Sunnyvale City Council Chambers, 456 West Olive Ave., Sunnyvale, CA No registration required Topic Description A revolution in epigenetics is forming with histone biomarkers as key drivers of clinical outcome in multiple major cancers. For many years histone proteins were solely recognized as spools around which cellular DNA wraps and studies conferring function from chemical modifications that occur on histones were focused on gene promoter regions. While examining histone modifications across entire genomic DNA (predominantly non-genic regions referred to as “global modifications”), PrognosDx’s scientific founders for the first time revealed that acetylation and methylations occurring at specific amino acids on core histones, act as prognostic markers across multiple cancers and are predictive of response to 5-Fu chemotherapy. This work was published in Nature, JCO and featured on the cover of the American Journal of Pathology. Today, more than 24 publications from around the

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world have confirmed global histone biomarkers as prognostic in more than 14 cancers and drug response predictive for several other important oncology drugs. This talk will provide a brief overview of the field of epigenetics and focus on the utility of global histone modifications for effective clinical decision making in oncology. A brief overview of the metabolic mechanisms governing histone modifications as drivers of cellular autonomy and aggressive disease behavior, controlling genomic instability, androgen/estrogen receptor activation, and folate pathway metabolites will be presented. Concluding comments will review new evidence from PrognosDx’s scientific founders published in Molecular Cell, hailed as “major finding” by the American Association for Cancer Research revealing tumor pH as a major driver of histone acetylation and its implications for diagnostic and therapeutic development. Speaker Bio Dr. Alizadeh is a cancer biologist and entrepreneur who has held a wide range of management positions in R&D, operations, business development and corporate venture capital fund management in some of the most significant areas of the biotech industry at inception of commercial applications including epigenetics, circulating tumor cells, RNA interference, chip-based genome sequencing, personalized medicine and biomarker discovery. Earlier in his career he conducted 22 years of research studies on leukemia, breast, colon, liver and bone cancers.

He completed his M.S., Ph.D. and post-doctoral studies in Biological Sciences and Cancer Biology at Stanford University after gaining a B.S. degree in Cellular and Molecular Biology at the University of Michigan at Ann Arbor. He has served as a member and treasurer of the Board of Governors of the Stanford University Medical Center Alumni Association. He is the recipient of multiple honors including the UC Berkeley Haas Business Plan Writing Competition finalist and BayBio Fellowship. He has been a cancer patient advocate and volunteer aid to uninsured or late stage patients for more than 2 decades.

************************************************************* RAPS, Friday Evening, March 7, 2014 Topic: “EU Device Regulations, Unannounced Visits and Key Compliance Requirements–NB Expectations” Speakers: Paul Brooks, senior vice president, healthcare solutions, BSI Healthcare; Laurel Macomber, MS, PMP, RAC, product expert, BSI Healthcare ; Ronald Rakos, PhD, RAC, team leader, vascular devices, BSI Healthcare; Ibim Tariah, PhD, technical director, BSI Healthcare Date and Time: 7 March 2014, 7:30 am-4:15 pm 7:30 am - Registration and Breakfast 8:45–11:30 am - Morning sessions 11:30 am–12:30 pm - Lunch 12:30–3:15 pm - Afternoon sessions 3:15–4:15 pm - Q&A session Location: Biltmore, 2151 Laurelwood Road, Santa Clara, CA 95054 Cost: List Price:$150.00, Member Price:$125.00 Find registration details at http://www.raps.org/membership-amp-benefits/chapters/raps-san-francisco-chapter-7-march-2014.aspx Topic Description

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Join the RAPS San Francisco Bay Area chapter for a full day of regulatory sessions related to the EU parliament’s latest decisions on the future of medical devices regulations in Europe, the EU commission’s recommendation and guidelines on unannounced visits and key requirements critical to demonstrating compliance to both existing MDD and the impending Medical Devices regulations. Presentations will include: MDD Revisions Will discuss the draft regulations including highlights of recent amendments compromise and those under further consideration. Unannounced Visits Will discuss what companies need to do differently to prepare and what to expect from Notified Bodies. Technical Files and Design Dossiers Will confirm current regulatory requirements and interpretations of key sections such as Essential Requirements, Risk Management, Supplier management, PMS and PMCF. Understanding Clinical Equivalence Will discuss how you can demonstrate clinical equivalence, which is critical in conducting clinical evaluations and determining whether new investigations are required versus drawing from pertinent data of comparable device(s). Risk Management Will discuss understanding ISO 14971:2012 and what manufacturers need to consider doing differently from a practical standpoint. *************************************************************** CACO-PBSS Workshop, Monday, March 10, 2014 Topic: “Clinical Trials Design & Management Intensive Workshop” Date and Time: Monday, March 10, 2014, 8:30 am -5:30 pm See details at http://www.caco-ca.org/aspx/homeSF.aspx when they appear **************************************************************************************************************** CACO-PBSS Workshop, Monday Afternoon, March 17, 2014 Workshop: “Drug-Device Combination Products” Speakers: Deepa Deshpande (Universal Regulatory, Inc.), Ed Smith (Zogenix), Igor Gonda (Aradigm Corporation), Peter Staehr (Abott Vascular Inc.) Date and Time: Monday, March 17, 2014, 12:45-17:30 Location: SF Bay Area: Foster City Crowne Plaza Registration fee (US$): Regular: $105; For vendor-show reps: $25; For unemployed: $20; For others, details available upon online login. Registration: http://www.PBSS.org Registration deadline: 3/14/2014 (it will close sooner if the seating cap is reached) Topic Description We have scheduled the following Workshop and would like to invite you to register at the CACO-PBSS website. Over the past decades, drug-device combination products of increasing complexity are being developed and commercialized. Regulatory authorities have reacted and developed specific processes, and regulations to facilitate the increasing integration of drugs and devices. For example, the Food and Drug Administration (FDA) established the Office of Combination Products in 2002, according to the Congress enactment. Combination products present new technological and organizational challenges: they require new product

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development strategies and a different regulatory approach compared to traditional combination products, drugs, and devices. This short course will provide the audience with an understanding of the regulatory frameworks for drug/device combinations. It will focus on the differences between device and drug development processes and regulations, and will highlight development challenges facing developers through presentation of case studies. FDA will provide updates on regulatory developments and guidance. Session 1: Introduction to Drug-Device Combinations, Overview of Regulatory Landscape and GMP development considerations Deepa Deshpande, PhD, RA, President, Universal Regulatory, Inc Session 2: Needle-free Injection devices Ed Smith, PhD, RAC, Vice President, Regulatory Affair, Zogenix Session 3: Development of Inhaled Drug Device Combination Product Igor Gonda, PhD, CEO, Aradigm Corporation Session 4: Beyond Drug-Eluting Metallic Stents: the next generation of a fully Bioresorbable Vascular Scaffold System Peter Staehr, MD, Senior Director, Worldwide Clinical Science, Abott Vascular Inc. Panel Discussion **************************************************************** Janssen Labs, Thursday Afternoon, March 20, 2014

Topic: “Show me the Money: Alternative Funding Sources” Panelists to be announced soon. Date and Time: Thursday, March 20, 2014 from 3:00 PM to 6:30 PM (PDT) 3:00pm | Registration & Networking 3:30pm | Introductions 3:35pm | Panel Presentation 5:00pm | Networking Reception & Tours of Janssen Labs 6:30pm | Close Location: San Francisco, CA, address to be announced soon. Fees: $40 General Public, $20 Student/Academic,$50 Onsite Register at http://www.eventbrite.com/e/show-me-the-money-alternative-funding-sources-tickets-10272612661?aff=blast Program Description While venture capital is a traditional source of funding in the biotech industry, there are many alternative opportunities for financing for your company. Join our panel to hear from government granting agencies, foundations, angel investors and crowdsourcing organizations that have funding opportunities for your company. Our panel discussions are candid, interactive and informal. We hope you walk away with the real story behind how things work so you can make it happen for yourself. This panel will be followed by a networking reception. ***************************************************************** BioDesign, Wednesday Evening, March 26, 2014 Topic: “From the Innovator’s Workbench” Speaker: André Michel Ballester, Chief Executive Officer, Sorin Group

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Date and Time: Wednesday, March 26, 2014, 5:30 - 7:00 pm Location: Frances C. Arrillaga Alumni Center, McCaw Hall, 326 Galvez Street, Stanford, CA 94305 Cost: General Admission: $45/$60 at door Stanford Alumni: $35/$40 at door Biodesign Alumni: $25 For registration information: http://biodesign.stanford.edu/bdn/networking/workbench.jsp For directions to Arrillaga Alumni Center: http://biodesign.stanford.edu/bdn/networking/workbench.jsp#parking For further information please contact: Mary Gorman Biodesign Program (650) 736 1161 marygorman@stanford.edu http://biodesign.stanford.edu/ *************************************************************** CACO, Monday, March 31, 2014 Workshop Topic:” Applications of PK-PD and TK-TD Modeling in Drug Discovery and Development” Speakers: Wade Adams, Harvey Wong (Genentech), Weijan Pan (Alexion) Date and Time: Monday, March 21, 2014, 12:45 pm – 5:30 pm Location:: SF Bay Area: Foster City Crowne Plaza See details at http://www.caco-ca.org/aspx/homeSF.aspx as they are announced ************************************************************* UC Berkeley Extension Course, Thursday and Friday, April 10-11, 2014 Course: “Life Science Business and Marketing: Their Integral Role for Success” Applies for credit toward Professional Program in Life Sciences Business (see flyer at http://extension.berkeley.edu/upload/lifesciences_business.pdf) Dates and Time: Thursday and Friday, April 10-11, 2014; 8:30 am – 5:00 pm for classroom intensive and balance of term for working on term project Location: Downtown University of California, Berkeley Extension, 425 Market St., 8th Floor, San Francisco, CA 94105 Fee: $795, course ID is BUS ADM X442.4 See more details and register now. You can locate course online and register at http://tinyurl.com/kqbu2rx Course Description The life science industry presents very different challenges found in other industries and requires specialized knowledge and skills to navigate the unique regulatory path requirements, lengthy development times, expensive clinical trial process, FDA control of advertising and labeling, and impact of managed care on reimbursement and pricing. This course conveys the foundational research and analysis skills needed on the job to make good marketing and business recommendations and decisions across company functions.

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Course includes two days of intensive classroom work and mentoring by instructor available for balance of term while completing optional term project. Students will learn how to research and analyze markets and environments for making recommendations and decisions useful for all professional functions in bioscience companies. They will learn how to do typical business and marketing assignments common to the workplace and receive templates/outlines for documents. In the process students will develop a basic understanding of the role and benefits of various business and marketing functions involved in company’s success, underscoring their roles across all stages of company and product lifecycle. Participants will learn what makes the industry “tick,” identify challenges and opportunities critical to the success of a company and its products that might otherwise be overlooked until too late in the development process. Students will complete business investment analysis of a company and its technology/products of their choice for term project. Deliverables Students receive an extensive student reader with lecture slides for note taking, lists of Internet-accessible information resources and gratis access to selected otherwise paid Elsevier subscription databases to assist in researching their optional term project. Who Will Benefit from This Course Experienced and newer business and marketing professionals--as well as scientific, clinical, regulatory, and legal professionals--can benefit from this introduction to the important business and marketing aspects of the life science industry and how to research and develop solutions to handle its challenges. Course Director Audrey Erbes, Ph.D., is a global life-science business development and marketing consul-tant, industry blogger at www.AudreysNetwork.com, organization leader, public speaker and developer of customized executive education. She is known for her industry blog publications on Audreysnetwork.com. She had 25 years of corporate managerial experience in the biopharmaceutical industry including Executive Vice President and Cofounder of Kowa Research Institute, a biopharmaceutical licensing and investment subsidiary of Kowa Company Ltd., Japan. Before that she held both U.S. and international management positions at Syntex Corp. (acquired by Roche) in market research, product management, strategic marketing, and business development with a special emphasis on Europe and Asia/Pacific/Canada. Guest Speakers and Their Topics Joyce L Chiarenza, Chiarenza Consulting, L.L.C. is a regulatory affairs, labeling expert and clinical compliance certified professional with over 40 years of pharmaceutical and biotech experience. She held managerial positions in quality control, quality assurance, compliance and regulatory affairs. After more than 16 years at Genentech, Inc., she became a regulatory affairs consultant, specializing in labeling, advertising and promotion, and clinical compliance. Prior to Genentech she worked in quality with Abbott Laboratories and for three years worked in area of vitamins, food supplements and cosmetics. Joyce holds a B.S. degree in Child Psychology and Special Education Credentials from California State University at Northridge. In 2010, she received her certification as a Clinical Compliance Professional. Topic: “Operating in the U.S. Regulatory Environment: Is Product Approvable” Linda L. Schock is the Director of Commercial Compliance & Government Programs at Compliance Implementation Services (CIS) and responsible for opening the CIS West Coast

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office in Burlingame, California. Ms. Schock brings over 20 years of industry experience ranging from distribution, pricing, Commercial and Government contracting, reimbursement and Patient Support Programs. Prior to joining CIS, Ms. Schock worked at NeurogesX as Director, Commercial Operations from 2009-2011 and CV Therapeutics from 2005 2009. From 2001 to 2005 Ms. Schock was Associate Director, Distribution and Reimbursement within Commercial Operations at Actelion Pharmaceuticals where she was involved in the launch of Tracleer® and the risk management program T.A.P. Ms. Schock began her career at Genentech, Inc. where she worked in Commercial Operation positions of increasing responsibility from 1987 to 2001. Topic: “Building Effective & Compliant Commercial and Government Contracting Operations: A Case Study”

Bev Hudson, MBA, is Executive Director/SVP of Clinical Research, Oklahoma Foundation for Cardiovascular Research (OFCR). Previously, she was Senior Vice President, Business Development, Omnicomm Systems, Inc., a Web-based electronic data capture (EDC) and eClinical (eClinical) software and services company; VP and General Manager of Clinical Research Services at MedPoint Communications, Inc.; and earlier ran sales and operations for Mayo Clinical Trial Services. She spent eleven years at Genentech in sales and marketing management roles. Topic: "The Impact of U.S. Health Care System on Marketing Life Science Products" Julie Tompkins, MBA, is Sr. Vice President at Timely Data Resources (TDR), a healthcare market research and consulting firm. She has more than 30 years experience in the pharmaceutical and biotech arenas, including 12 years in industry and more than 20 years in market research consulting, and has worked with pharmaceuticals, diagnostics, and drug delivery systems. At Syntex (acquired by Roche), Julie worked in both R&D and Marketing, including positions as Analytical Chemist, Market Research Analyst, Manager of New Product Planning, and Manager of Market Analysis. She spent most of her time in Marketing as the primary liaison between Marketing and R&D, serving as a key member on multi-disciplinary project teams and strategic planning committees. After leaving Syntex, Julie was President and Founder of MedSearch, a primary market research company that merged with TDR in January 2000. She holds a B.A. in Human Biology from Stanford University and an MBA from Santa Clara University. Topic: “The Role of Market Research in Product Planning, Development and Marketing" Course Content Outline

The Discipline of Marketing in the Bioscience Industry • Unique bioscience industry marketing characteristics • The core marketing functions • Pivotal documents associated with marketing functions • The critical role of marketing at all stages of a product’s development

Marketing Research and Analysis • Use of market research to optimize product planning, development and marketing • Role of market research throughout development of company and product • Defining the objectives, planning and implementation of the research • Types of market research and methodologies

Impact of Managed Care System on Marketing Bioscience Products • Review healthcare industry trends/data that impact cost and reimbursement • Define “who/what is the U.S. healthcare system” and how it influences the

commercialization process • Define reimbursement from Managed Care perspective

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Success Parameters for Products and Companies

Dealing with regulatory Environment and Product’s Approvability

The Role, Function, Objective of Selected Major Marketing Functions • Business Development and Licensing Process, Contract and Terms • Product/Technology Opportunity Assessment Research and Recommendation • Strategic Planning and Strategic Plan • Product Management and Product Marketing Plan • Sales and Distribution

************************************************************************* CACO-PBSS, Wednesday, April 23, 2014 Topic:”Nano-therapeutics: Pharmacokinetics, Pharmacology, New Technologies and Clinical Development for Cancer Targeting” Date and Time: Wednesday, April 23, 2014, 12:45 pm – 5:30 pm Location: SF Bay Area: Foster City Crowne Plaza See details at http://www.caco-ca.org/aspx/homeSF.aspx as they are announced ************************************************************************* CACO-PBSS Luncheon, Friday Mid Day, May 16, 2014 Topic: “3-D printing in the creation of functional human tissues: advances and potential applications in medical research, drug discovery, preclinical drug evaluation and the future of patient care” Speaker provided by Organovo Date and Time: Friday, May 16, 2014, 11:00 am – 1:30 pm Location Crowne Plaza Hotel, Foster City, CA See details at http://www.caco-ca.org/aspx/homeSF.aspx as they are announced ******************************************************************** PBSS, Wednesday Afternoon, May 28, 2014 Topic: BCS system / Dissolution and Solid Form Technologies: Advances, Impact on Drug Absorption, and Applications in Drug Development” Speakers: Gordon Amidon, Gregory Amidon (U Michigan), Larry Wigman (Genentech) Date and Time: Wednesday, May 28, 2014, 12:45 -5:30 pm Location: Crowne Plaza Hotel, Foster City, CA Registration fee (US$): Regular: $105; For vendor-show reps: $25; For unemployed: $20; Webcast: $250; For others, details available upon online login. See details at http://www.caco-ca.org/aspx/homeSF.aspx as they are announced *************************************************************************PBSS, Friday Afternoon June 13, 2014 Topic: “Transporter ITC update: latest development in transporter science” Speakers: Kathy Giacomini (UCSF), Xiaoyang Chu (Merck), Maciej Zamek-Gliszczynski (Lilly) Date and Time: Friday, June 13, 2014, 12:45 pm – 5:30 pm Location: Crowne Plaza Hotel, Foster City, CA Registration fee (US$): Regular: $105; For vendor-show reps: $25; For unemployed: $20; For others, details available upon online login. Registration: http://www.PBSS.org *****************************************************************