seminar

Rosenman D-Series: Nada Hanafi, Experien Group. "Critical Success Factors for Regulatory Strategy"

Set yourself up for success in your startup's approach to effectively navigate the regulatory pathway to market and maximize your interactions with FDA. Join this seminar to hear from Nada Hanafi, Chief Strategy Officer of Experien Group, headquartered in San Jose, CA. This discussion will focus on the critical success factors that go into a comprehensive regulatory strategy and the benefits of FDA’s Q-Submission process for state-of-the-art medical devices and innovative technologies.

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
5:30 to 6:30 PM, Tuesday, April 23, 2019

About the Speaker

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As Chief Strategy Officer at Experien Group, Nada combines her institutional knowledge with innovative approaches to help companies develop actionable premarket strategies to guide programs through successful submission. Nada joined Experien in 2017 after dedicating 12 years at FDA’s Center for Devices and Radiological Health (CDRH). At CDRH, Nada led cross-Center and Agency programs for the advancement of FDA’s mission, including the Health of Women program, the Network of Experts program and the Patient Preference Initiative. She was the CDRH Liaison and Subject Matter Expert to FDA’s Office of Women’s Health and the Office of Minority Health. Nada holds an MS in Biomaterials, a BEng in Biomedical Materials Science & Engineering from Queen Mary College, University of London, and her MPH from Johns Hopkins Bloomberg School of Public Health.

QB3 Seminar: Kris Corzine. "Customer Discovery and Go-to-Market Strategy"

Many life science startups have innovative IP but learn from investors that they have not fully thought out the market for their product or service, nor identified the right value proposition. How can they address these challenges and win over investors? Join us to learn from Kris Corzine, an entrepreneur and consultant specializing in customer discovery and go-to-market strategy for early-stage startups. View the slide deck from Kris’s talk

Where & When

Room 160, Helen Diller Bldg., UCSF Mission Bay (1450 Third St., San Francisco)
Noon to 1:00 PM, Thursday, April 11

About the Speaker

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Kris helps companies innovate and grow. She is an energetic Operations/Product/Growth generalist passionate about helping early stage startups grow to scale. As head of growth she’s assisted companies move toward operational excellence and grow revenue. As a product and UX leader, she has worked with big companies (eBay, Wells Fargo, Autodesk), mid-stage startups (Marin Software, Twist Bioscience) and early stage startups (Mapcat founder, DeNA Global).

Rosenman D-Series: Kevin Chu, F-Prime Capital. "How a VC Sees the Current Medtech Landscape"

Kevin Chu, F-Prime Capital. "How a VC Sees the Current Medtech Landscape"

By being in a position to see hundreds of pitches a year, VCs benefit from the opportunity to formulate a unique view of the needs, opportunities, trends, and emerging technologies in a market. Want to get a VC’s perspective on the current state of the medtech landscape and how he anticipates making investment decisions in this environment? Join us on March 26 to hear from Kevin Chu of F-Prime Capital.

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
5:30 to 6:30 PM, Tuesday, March 26

About the Speaker

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Kevin Chu is an Associate on the healthcare team at F-Prime Capital Partners. Prior to F-Prime Capital, Kevin was an Associate Consultant with IMS Consulting Group in New York, where he advised biopharmaceutical clients on development and commercial strategy across multiple therapeutic areas. Kevin currently works across the healthcare sub-sectors including therapeutics, med tech, and healthcare IT and services, and also works closely with Eight Roads Ventures China healthcare team to manage F-Prime’s existing and new investment efforts in China.

Kevin received his B.S.E. in Biomedical Engineering from the University of Pennsylvania.

QB3 Seminar: Gina Poon, Covered California. "Healthcare Plans for Small Business"

If you’re founding a company, where are you and your employees going to get health insurance? Join us for an overview of healthcare plans available under Covered California Small Business.

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
Noon to 1:00 PM, Thursday, March 21

About the Speaker

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Gina Poon is Regional Sales Executive - Covered California for Small Business.

Covered California for Small Business offers small businesses a variety of affordable health coverage options for its employees. Small employers participating in CCSB will be able to provide their employees with a broader choice of health plans that generally has only been available to large employers. All plans will provide a standardized set of benefits and cost sharing to make it easy for employers and employees alike to make apples-to-apples comparisons.

Certain small businesses — those with 25 or fewer full-time equivalent employees paid an average annual wage of less than $50,000 — may be eligible to receive up to 50 percent small business health care tax credit for coverage purchased through CCSB.

QB3 Seminar: Sushmita Venkatraman, Linus Group. "Persuading Scientists: A Strategic Marketing Model"

How do you persuade skeptical scientists that your product or service is worth their time and money? Join us to learn from Sushmita Venkatraman, Lead Strategist at Linus, a strategic marketing agency that specializes exclusively in life science and healthcare marketing. Sushmita will describe the "Persuading Scientists" model that Linus uses to influence scientists and clinicians to take action. She will present selected case studies on how companies have obtained catalytic results using the model along with proven story-telling techniques.

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
Noon to 1:00 PM, Thursday, March 14

About the Speaker

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Sushmita Venkatraman is Head of Strategy at the Linus Group.

As a Client Strategist, she works with inspiring visionaries in Fortune 500 companies to help accelerate their marketing goals by turning consumer data, audience research and trends into creative and actionable messaging and positioning insights supporting the execution of content-centric marketing campaigns for brands and products.

Rosenman D-Series: Natalie Wisniewski. "Empowered Health Through Biomaterials Innovation: Tissue-Integrating Sensors for Mobile Health Monitoring at Profusa"

Natalie Wisniewski, PhD, is co-founder and CTO of Profusa, which develops and markets real-time biosensors that provide unprecedented insights into our overall health status. Together, she and her co-founders, executive team, collaborators and advisors built the company road map, enlisted top talent, secured funding and turned innovative concepts into products. Join us to hear the lessons she has learned as a health tech inventor and entrepreneur.

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
Tuesday, March 12, 2019

About the Speaker

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Dr. Wisniewski’s research focuses on biomaterial-tissue interactions, specifically the foreign body response and how it affects implanted sensors. Her novel work on tissue-integrating sensors expands the paradigm of biocompatibility beyond surface chemistry to biomechanics and bioelectronics to enable long-term continuous sensors in the body. Dr. Wisniewski co-founded Profusa, Inc., a company that is revolutionizing continuous monitoring of body chemistries through in vivo biosensors and mobile health. Profusa has developed this technology from concept to clinic with tissue-integrating sensor in humans functioning for a landmark of 4 years. She is the Principle Investigator on $29M of NIH and DARPA research grants, and has over 100 papers, patents and invited lectures on biosensors, diabetes, tissue hypoxia, and implantable devices. She was awarded the NIH Transformative Research Award for her work on multi-analyte in vivo sensing for mobile health applications.

Dr. Wisniewski earned engineering degrees from Purdue University (B.S. in Chemical Engineering) and Duke University (Ph.D. in Biomedical Engineering. For her graduate work, she taught biomaterials and researched the mechanisms and effects of biofouling and the foreign body response on implantable biosensors). She worked in R&D and manufacturing for consumer products at Kimberly-Clark Corporation and in management consulting with McKinsey & Company. Before starting Profusa, she ran her own consulting firm in the San Francisco Bay Area specializing in technical, clinical and regulatory strategy. She currently serves on the Board of Directors and as Chief Technology Officer at Profusa.

QB3 Seminar: Serge Saxonov, 10X Genomics. "Building Technologies to Resolve Biology"

Serge Saxonov is co-founder and CEO of 10X Genomics. The Pleasanton-based company is only six years old but has already launched multiple breakthrough products revolutionizing many fields of biology. It has ushered in the age of single cell genomics, achieved over $100M in annual revenue and raised $243M in venture funding. Join us to hear what Serge has learned as leader during this explosive period.

Where & When

Room N-114, Genentech Hall, UCSF Mission Bay (600 16th St., San Francisco)
Noon to 1:00 PM, Thursday, February 21

About the Speaker

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Serge Saxonov co-founded 10x Genomics in 2012 and has served as the CEO since its inception. He defined vision and strategy, contributed to core inventions, and led the company through multiple phases of rapid growth. In 2016, he was honored as one of Goldman Sachs 100 Most Intriguing Entrepreneurs of the Year. Prior to 10x Genomics, Serge was VP of Applications at QuantaLife, where he was responsible for building content, driving new applications, and identifying key diagnostics opportunities for the core ddPCR technology. Before QuantaLife, Serge was Founding Architect and Director of R&D at 23andMe. There he defined the initial conception of the product, built many elements of the technology, and drove strategy and execution of R&D functions as the company scaled. Serge received a Ph.D. in biomedical informatics from Stanford University and an A.B. in applied mathematics and biology from Harvard College.

QB3 Seminar: Sofie Qiao, Vivace Therapeutics. "Tackling Novel Drug Targets at a Virtual Startup"

Creating a virtual startup is an option for a seasoned pharma scientist who wants to develop drugs on a lean budget. In the past this has only been feasible when going after a known target. Now, however, improved CRO capabilities in biology make it possible to launch a company that explores the science of a pathway while simultaneously developing drugs to target that pathway. A prime example of such a company is Vivace Therapeutics, co-founded and led by Sofie Qiao. Interested in hearing Vivace's story? Join us on February 7.

Where & When

Room N-114, Genentech Hall, UCSF Mission Bay (600 16th St., San Francisco)
Noon to 1:00 PM, Thursday, February 7

About the Speaker

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Dr. Qiao is the founding president and CEO of Vivace Therapeutics, and a member of the board of directors. Prior to co-founding Vivace, she served as managing director of WuXi ventures, the corporate venture arm of WuXi AppTec. Dr. Qiao co-founded the chemistry-driven drug discovery company LEAD Therapeutics in 2006, assembled the management team and played a central role in raising $17 million in Series A financing. The company was acquired in 2010 by BioMarin for up to $97 million, primarily for its PARP inhibitor (Talazoparib), then in preclinical development. Dr. Qiao began her industry career at Genzyme as a medicinal chemist, and later moved into business roles with McKinsey & Company, Syrrx (now Takeda California) and Discovery Partners International (now Galapagos). She holds a doctorate in organic chemistry from Massachusetts Institute of Technology and an A.B. in chemistry from Harvard University.

Rosenman D-Series: Ali Samiian, Abbott. "How to Adapt to a Changing Market Environment"

If you are to succeed in commercializing a medical device, you need a clear path to reimbursement. However, the path is often nonintuitive, and increasing globalization has complicated matters. Payers now reference prices from around the world and employ health economics and cost containment tools first seen in pharma. Some companies have adapted by seeking revenue for services beyond the physical product. Join us to get the full briefing from Ali Samiian, Global Head of Market Access, Health Economics and Pricing at Abbott Diabetes Care.

Where & When

5:30 to 6:30 PM, Tuesday, February 5, 2019
Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)

About the Speaker

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A lawyer by training, Ali has worked in government in the healthcare sector providing policy advice to the Minister of Health in Ontario, Canada on Pharmaceuticals, Diagnostic devices, and physician negotiations. He has over 10 years of experience working in the pharmaceutical and medical device sector in several roles of increasing responsibility, including market access, sales, and strategic planning in global, regional and country affiliate organizations.  He has launched products in Canada, Europe, US and several Asia Pac markets. 

Ali holds a JD from Osgoode Hall Law School, an MBA from the Schulich School of Business in Canada, and a MSc in Health Economics, Policy and Management from the London School of Economics.

He is currently the global head of Market Access, Health Economics and Pricing at Abbott Diabetes Care, managing a team to ensure global reimbursement of a new glucose sensing category.  He is a proud husband and father of 2.

QB3 Seminar: Jennifer Doudna, UC Berkeley & Caribou Biosciences

Where & When

Noon to 1:00 PM, Thursday, January 31
Room N-114, Genentech Hall, UCSF Mission Bay (600 16th St., San Francisco)

About the Speaker

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Jennifer Doudna is the Li Ka Shing Chancellor’s Chair in Biomedical and Health Sciences at UC Berkeley and an Investigator of the Howard Hughes Medical Institute. Prof. Doudna’s research seeks to understand how RNA molecules control the expression of genetic information. Her research led to insights about CRISPR-Cas9-mediated bacterial immunity that showed how this system can be harnessed for efficient genome editing in animals and plants, creating a transformative technology that is revolutionizing the fields of genetics, molecular biology and medicine. She is a member of the National Academy of Sciences, the American Academy of Arts and Sciences, the National Academy of Medicine and the National Academy of Inventors. She is a recipient of many awards including the Breakthrough Prize in Life Sciences, the Princess of Asturias Award (Spain), the Gruber Prize in Genetics, the Heineken Prize (Netherlands), the Gairdner Award (Canada), the Tang Prize (Taiwan), the Warren Alpert Foundation Prize, the L’Oreal-UNESCO International Prize for Women in Science and the Japan Prize (Japan).

Rosenman D-Series: Caroline Corner, Westwicke Partners. "How to Position Your Story to Connect with the Right Investors"

It's important not just to get funding for your venture but also to ensure that you engage the right investors--people who genuinely want to help you grow and succeed. An expert in investor relations, Caroline Corner is Managing Director at the SF office of Westwicke Partners, a strategic capital markets advisory firm. Join us January 17 to learn what to include in your pitch deck, how to build credibility, and how to connect with quality investors.

Where & When

Room 212, Byers Hall, UCSF Mission Bay
5:30 to 6:30 PM, Thursday, January 17

About the Speaker

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Caroline Corner, Ph.D., joined Westwicke Partners in 2016 as a Managing Director leading our San Francisco effort in Medical Technology. Caroline’s focus is working with both public and private companies in the medical device and diagnostics areas. Her expertise and extensive C-level industry relationships stem from more than 12 years working in sell-side equity research, various roles within device and healthcare companies, as well as her academic training in biochemistry, engineering and nanobiotechnology.

QB3 Seminar: Lance Kizer. "Success in the Foodtech Space at Ripple"

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
Noon to 1:00 PM, Tuesday, January 15

About the Speaker

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Lance Kizer, PhD, is VP of Science and Technology at the Production Board in Oakland, CA.

Lance has provided technical leadership in a wide range of industries throughout his career.

Prior to joining The Production Board, Lance was Vice President of Research and Development at Ripple Foods. He joined Ripple as the first employee creating prototypes in his home kitchen. Lance ultimately led the development of novel ingredient and product technologies that enabled Ripple to create delicious, dairy-free foods that disrupted an industry which is one of the largest emitters of greenhouse gases in the world. RIpple's product line includes plant-based milks, creamers, yogurts, high protein drinks and nutritional powders which are currently available at over 13,000 locations in the US and Canada.

Before starting up Ripple, Lance led research and development projects at Amyris, Inc. where he scaled and commercialized biochemicals produced via fermentation processes. Some product highlights included an anti-malarial compound that is now used to make more than 100 million treatments annually and sustainable cosmetic ingredient alternatives that were Amyris’ first profitable product lines.

Lance also served in the U.S. Navy, where he operated and repaired nuclear power plants at shore- and sea-based commands. He holds a Bachelor of Science in Chemical Engineering from the University of Washington and a Ph. D. in Chemical Engineering from the University of California, Berkeley.

Rosenman D-Series: Terrie Firestone, BNY Mellon. “How to Maximize the Value of Your Business, Whether You are Building to Scale, Sell, or Merge”

To maximize value for stakeholders--and themselves--founders need to make the right decisions concerning financial and legal issues such as capital structure, transactions, scaling, possible exits and personal financial planning. The choices they make today, for example, may have unanticipated consequences with respect to capital raises, taxable income, and income taxes. Join us to hear from this panel of financial and legal experts as they discuss what founders should do to achieve the best possible outcome.

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
5:30 to 6:30 PM, Tuesday, February 12, 2019

About the Speakers

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Terrie Firestone (moderator) is a senior wealth director for BNY Mellon Wealth Management. In this role, she is responsible for new business development in the Northern California region, and works with individuals and families to identify how BNY Mellon’s investment and wealth management capabilities can help them reach their overall financial goals and life goals.

Terrie Firestone has more than 20 years of experience in the investment and financial services industry. Previously, she was a Senior Vice President at US Trust in Private Wealth Management. Prior to that, Terrie was a Managing Director with Smith Barney, where she led the Software and Networking Investment Research Teams. She was a nationally ranked Technology Analyst on the Wall Street Journal All Star Team and the Institutional Investor Magazine All American Team for many years. Terrie brought over 25 companies public, including Cisco Systems.

Terrie received a Bachelor of Science degree from Brown University in Applied Math and Economics and a Masters in Business Administration from the Stanford University Graduate School of Business. She is a board member of the Palo Alto Financial Planning Forum, a member of the Santa Clara Estate Planning Council, a member of the UCSF Foundation Wellness Committee and the San Francisco City College auxiliary. In the past she has served on the UCSF Cancer Council, the Teach for America Gala Committee, and the Hillsborough Foundation Parent Giving Campaign.

 
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Carolyn Amster is a Partner of Tax at BPM. She has over thirty years of experience in tax planning, research and tax compliance. She focuses her practice on minimizing federal and state tax liabilities, stock option planning, estate planning, preparation of tax projections, analyzing alternatives, identifying and researching complex tax issues, and representing clients before the IRS and Franchise Tax Board. She represents individual, trust, estate, nonprofit, corporate and pass-through entities in industries ranging from public charities and private foundations to software, professional services, high-tech, biotech, venture capital and real estate management.

 
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James Huie is a corporate and securities partner in Wilson Sonsini Goodrich & Rosati's San Francisco office. James advises life sciences and technology companies on general corporate matters, mergers and acquisitions, initial public offerings, strategic partnerships, and private equity and debt financings. He also has extensive experience in representing venture capital firms and other investors in private equity and debt financings.

 

As a national wealth strategist at BNY Mellon Wealth Management, Justin Miller works collaboratively with other advisors to provide comprehensive wealth planning advice to clients and their families. He also is an adjunct professor at Golden Gate University School of Law, a Fellow of The American College of Trust and Estate Counsel (ACTEC), and a sought-after speaker on tax, estate planning and family governance topics for leading conferences throughout the country, including events hosted by the AAML, the ABA, ACTEC, CalCPA, Santa Clara University, Stanford University, the State Bar of California, the State Bar of Georgia, the State Bar of Texas, STEP, UCLA, the University of Notre Dame, Vistage International, the Washington State Bar Association, and YPO. In addition, he has published numerous articles in publications such as the California Tax Lawyer, the California Trusts and Estates Quarterly, State Tax Notes, Tax Notes, and Trusts & Estates, and he is frequently quoted as an industry expert in the media.

Justin has served as an executive committee member of the State Bar of California Taxation Section, an executive committee member of the Los Angeles County Bar Association Taxation Section, the chair of the Century City Bar Association Taxation Section, and the editor-in-chief of the California Tax Lawyer. Prior to joining BNY Mellon, he was an attorney at a major law firm, where he advised wealthy families, senior corporate executives and closely-held business owners regarding tax-efficient estate and business succession planning, trust law and management, and asset preservation.

 
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Scott Taylor is a Partner in Assurance at BPM. He has over twenty-seven years of public accounting and private industry experience, including 10 years with a Big Four accounting firm. He provides both public and private technology, biotechnology, and healthcare, and nonprofit a variety of accounting and tax services, including financial statements, audit reviews, compilations, agreed-upon procedures and internal control evaluations. Scott also consults with management on complex accounting, tax, and SEC reporting matters.

 
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Julie West chairs BPM's Corporate Tax Practice and the Firm's Life Science Industry Group. She was named one of San Francisco Business Times' 150 Most Influential Women professionals in 2012.

Julie works closely with biotech, pharmaceutical, medical device, software, social media, communications, and manufacturing companies. She began her career at Deloitte and understands the complex business needs of pre-revenue startups to consolidated publicly-traded companies.

She has over 14 years of experience in public accounting and deals extensively with tax provisions (FAS 109/ ASC 740), FIN 48 analysis for uncertain tax positions, Section 382 studies to determine limitations on tax attributes, and sales tax exposure. She has advised companies involved in a wide arena of transactions, including mergers, asset and stock acquisitions, tax-free reorganizations and foreign expansion. She consults and reviews a variety of tax returns with multi-state and international filings, and helps guide her clients through financings and IPOs. Julie is passionate about building and mentoring her team of outstanding professionals.

Rosenman D-Series: Ryan Pierce, Nine, Rock Health, & Stanford: "The First Dollar: Strategies and Ethics of Seed-Stage Fundraising"

What is the right way to raise a seed round?  Even as founders strive to focus on innovation and execution, they must make myriad decisions, big and small, on fundraising.  Whom should I pitch first?  What's the smallest check I should accept?  Do I price the round or raise on a convertible note, and on what terms?  Join us as healthcare product designer, entrepreneur, and investor Ryan Pierce tests conventional wisdom against a survey of his peers, considers the ethics of taking early-stage money, and shares his own lessons from both sides of the table.

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
5:00 to 6:30 PM, Tuesday, December 11

Agenda

5:00 - 5:30 pm: Networking
5:30 - 6:30 pm: Talk and Q&A

About the Speaker

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Ryan Pierce is Co-Founder and CEO of Nine, Entrepreneur-in-Residence at Rock Health, and Lecturer in Bioengineering at Stanford, where he teaches BIOE 70Q: Medical Device Innovation.  He has served as VP of Design and Innovation at Ventus Medical, VP of Business Development at Loma Vista Medical, a healthcare investor at De Novo Ventures, and a product designer at Concentric Medical and The Foundry/Zephyr Medical.  An inventor on over two dozen issued U.S. patents, he has designed FDA-cleared devices to treat sleep apnea and stroke.  Ryan holds mechanical engineering degrees from MIT and Stanford, and an MBA from Harvard Business School.

QB3 Seminar: Wendell Lim, UCSF. "Cell Design Labs from Launch to Acquisition"

Wendell Lim, a leader in synthetic biology, chairs the Department of Cellular and Molecular Pharmacology at UCSF. He co-founded Cell Design Labs in 2015 with Brian Atwood of Versant Ventures. Cell Design Labs, developing two technologies in the CAR-T cell cancer immunotherapy space, made such rapid progress that it was acquired two years later by Gilead for $567 million. Join us to hear about Wendell's experience launching Cell Design Labs and the lessons he learned commercializing a cutting-edge technology.

Where and When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
Noon to 1:00 PM, Thursday, December 6

About the Speaker

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Wendell Lim is the Byers Distinguished Professor and Chair of the Department of Cellular and Molecular Pharmacology at the University of California San Francisco, and an Investigator of the Howard Hughes Medical Institute. He received his A.B. in Chemistry, summa cum laude, from Harvard College, his Ph.D. in Biochemistry and Biophysics at the Massachusetts Institute of Technology and completed his postdoctoral training at Yale University. His research focuses on the design principles of molecular circuits that govern cell decision-making and responses. His lab has made contributions in understanding the molecular machinery of cell signaling and how molecular modules have been used in evolution to build novel new behaviors. Most recently he has been a pioneer in the emerging field of synthetic biology, exploring how these design principles can be harnessed to engineer cells with customized therapeutic response programs. He is an author of the textbook, Cell Signaling (Garland Science 2014) and was the founder of the cell therapy biotech startup, Cell Design Labs, which was acquired by Gilead Biosciences in 2017.

Rosenman D-Series: Sanaz Saatchi, CrownPoint Medical: "Approaches to Innovation: From Strategics to Start-Ups"

How are areas of opportunity for medtech invention discovered? Is there a single optimal approach to healthcare innovation or are there multiple approaches that work equally well? Do global healthcare companies use the same framework for innovation as start-up companies? Join us on October 30th to hear Dr. Sanaz Saatchi’s perspective and recommended methodologies to drive innovation. Previously, Dr. Saatchi led the development of cardiovascular medical devices from inception to commercial launch at Medtronic and helped multiple start-up companies determine the strategic product-market fit for novel technologies.

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
5:00 to 6:30 PM, Tuesday, October 30

Agenda

5:00 - 5:30 pm: Networking
5:30 - 6:30 pm: Talk and Q&A

About the Speaker

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Sanaz has a unique combination of technical leadership and marketing expertise. While at Medtronic as an R&D Engineering Manager, she led a cross-company team to develop two cardiovascular medical devices through all phases of innovation - from inception to commercial launch. This includes needs finding, concept generation, device design, product development, high volume manufacturing, and global commercial launch. Medtronic's decision to invest in the coronary therapy delivery space with the development of these two new products stemmed directly from a global needs finding initiative led by Sanaz in partnership with IDEO. She played a critical role in conducting the research, synthesizing a strategy, and gathering organizational support to create multiple new product development programs.

Beyond her technical leadership capabilities, Sanaz also has a critical understanding of the medical device industry business needs, customer interface, and commercialization process. As a Product Marketing Manager at Medtronic, Sanaz helped drive the global launch of these two cardiovascular medical devices with a $250M market size. In addition to engineering, marketing, and leadership roles in public companies, including Medtronic and Becton Dickinson, Sanaz also has experience in technical and strategic consulting to start-ups, venture capital firms, and non-profit organizations.

Sanaz has expertise in the Stanford BioDesign Process to identify unmet healthcare needs and develop solutions. Sanaz holds a Ph.D. in Bioengineering from Stanford University, a M.S. in Mechanical Engineering from MIT, and a B.S. in Bioengineering from UC Berkeley. She is an inventor and published author on 10 patents and scientific publications, and an invited speaker at various conferences, including Cardiovascular Research Technologies and MedTech Vision highlighting female leaders within the medtech industry.

Rosenman D-Series: Rajan Patel, iO life science. "Learn About Experience Design for Medical Devices"

If your product addresses a viable market, it will have competition. Your commercial success can depend to a large extent on the good or bad experience that users--clinicians and patients--have while using your device or system. How can you ensure that users have a good experience? Join us to learn from Rajan Patel, founder and CEO of the firm iO life science. (Speaker info has been updated from the original)

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
Thursday, November 29, 2018, 5:30 to 6:30 PM

Agenda

5:30 - 6:15 PM: Talk
6:15 - 6:30 PM: Q&A

About the Speaker

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Rajan Patel is a medical device executive who partners with healthcare brands to transform their design & development practices. After 30+ years of medical device development across drug delivery, diagnostic systems, surgical devices and digital medicine, Rajan knows what truly drives innovation of smart, connected and patient-centric devices. It’s about collaborating with partners who are dedicated to creating breakthrough therapeutic solutions to unmet patient needs. Rajan has held senior positions across such companies as Minimed, Heartport, Aerogen, M2 Medical, Cirtec Medical and Lunar, leading programs to develop & commercialize medical products. Rajan’s commitment over the past 15+ years has been to organizations dedicated to transforming lives through revolutionary drug delivery and medical device technologies. Rajan has led numerous research & development and manufacturing teams to successful execution and launch of life-impacting devices. Rajan holds a B.S. in Mechanical Engineering from MS University of Baroda and M.S. in Biomedical Engineering from UC Davis/CSUS.

QB3 Seminar: Amy Trejo, P&G: "Partnering, Business Models, and Consumer Insight at P&G"

The consumer products company Procter & Gamble maintains a strong initiative in innovation, developing new products to meet consumer needs. Partnership, licensing, and acquisition are all active options. P&G actively seeks startups with technologies in areas of Life Science (including microbiome and aging), Chemistry, Materials Science, Smart Products (including AI) and Advanced Packaging. Join us to hear from Amy Trejo, Open Innovation Manager at P&G, about the company’s perspective and insights on innovation in consumer products. View the P&G one-page needs statement

Interested in meeting one-on-one with Dr. Trejo before her talk to discuss partnering with P&G? Apply for a timeslot

Where & When

Tuesday, November 27, 2018
Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)

About the Speaker

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Amy Trejo received her BSc. in Biology from Smith College in Northampton, MA and PhD in Cell and Molecular Biology from Northwestern University in Chicago, IL. She started with The Procter & Gamble Company in Cincinnati, OH in 1998 with responsibility for developing up-stream skin care technology for P&G’s Olay skin care brand. From there she moved on to manage upstream technology in the Health Care category working on digestive wellness brands with focus on the Align probiotic product. She then moved into product development managing new product innovation for Head & Shoulders. For the past 4 years Amy has worked as part of the Corporate Open Innovation Team, working to bring the best of external technologies into P&G to accelerate and strengthen their R&D programs.

Meet the FDA: Kyung Sung & Johnny Lam, FDA-CBER. "Regulatory science insights into cell-based products and practical microscale technologies for their assessment"

"Regulatory science insights into cell-based products and practical microscale technologies for their assessment"

Kyung Sung, Ph.D., Principal Investigator

Johnny Lam, Ph.D., Staff Fellow

Cellular and Tissue Therapies Branch, Division of Cellular and Gene Therapies, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research

This event is held in partnership with UCSF-Stanford CERSI.

As described in the 21st Century Cures Act, products eligible for Regenerative Medicine Advanced Therapy (RMAT) designation include cellular therapies, therapeutic tissue engineered products, human cell and tissue products, or any combination products that use such therapies or products. Multipotent stromal cells (MSCs) and induced Pluripotent Stem Cells (iPSCs) have been popular sources for manufacturing RMAT products due to their ability to undergo lineage-specific differentiation. Despite great promise, successful clinical translation of such cell-based products is often hindered by manufacturing challenges and the lack of reliable markers that can predict the products’ in vivo performance. For instance, MSCs are very heterogeneous and responsive to their surrounding environment, resulting in distinct subpopulations of cells with potentially different amounts of qualities needed for product potency. Since there are numerous biochemical and biomechanical factors regulating the functions of MSCs, it is critical to develop reliable high-throughput assays that enable the efficient exploration of large and complex parameter spaces for evaluating cellular function. Microscale in vitro systems offer the practicality to fulfill this unmet need. Several simple microfluidic channel arrays have been successfully implemented in screening the influence of paracrine mediators and various tissue microenvironment components in the regulation of cellular functions. In addition, microphysiological three-dimensional organoids and tissue-like structures such as chondrogenic cell aggregates and blood vessels have been incorporated into high-throughput, cell-based screening platforms in efforts to provide functionally relevant in vivo-like conditions. This presentation will give an overview of practical microscale technologies that are simple to operate while enhancing throughput, relevance, and reliability. How such technologies could be employed in the assessment of cell-based products will be discussed.

Where & When

Room 2103, Mission Hall, UCSF Mission Bay (550 16th St., San Francisco)
2:00-3:00 PM, Friday, November 9

About the Speakers

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Dr. Johnny Lam is a biomedical engineer with expertise in biomaterials and in developing practical microscale in vitro tools for medical and biological applications. Dr. Lam’s main research interests involve studying multipotent stromal cells (MSCs, otherwise known as mesenchymal stem cells) and how their quality attributes relate to their functional potential using physiologically relevant, higher-throughput platforms. Dr. Lam received his Ph.D. in Bioengineering in 2015 at Rice University, where he developed and evaluated injectable multi-layered hydrogel composites for cell and controlled growth factor delivery for in vivo cartilage tissue repair. Following his graduate studies, Dr. Lam joined the Center for Biologics Evaluation and Research at the FDA as a post-doctoral researcher, where he now works as a Staff Fellow. His research now focuses on the development and adaptation of wide-ranging microphysiological platforms to evaluate various functional outcomes of MSCs toward improving the quality and potency of manufactured cell-based products.

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Dr. Kyung Sung is a biomedical engineer with expertise in developing functional and practical microscale in vitro tools for medical and biological applications. Dr. Sung’s main research interests lie in studying cell-materials interactions and exploring cell behavior in various tissue microenvironmental conditions. Dr. Sung received her Ph.D. in Chemical Engineering in 2007 at the University of Michigan, and worked as a post-doctoral researcher in the Department of Biomedical Engineering at the University of Wisconsin-Madison, where she also worked as a Principal Investigator before she joined the FDA in 2015. She also worked as a patent examiner in Biotechnology at the US Patent and Trademark Office. During her previous research, she used principles from tissue and microsystems engineering to develop tissue-like structures such as blood vessels and mammary ducts in microfluidic channels to develop new practical tools to conduct cancer research in vitro. The microscale in vitro systems provide unique capabilities when studying complex interactions occurring in tissue microenvironment, by providing more precise controls of biochemical and biomechanical factors than traditional platforms. She has been able to create innovative opportunities and strategies for researchers to explore biology in different ways – particularly in understanding the role of the tissue microenvironment in regulating cellular functions.

QB3 Seminar: Lindred Greer, Stanford. "How to Build a Resilient, Winning Team"

A startup’s chances of success depend critically on the people who make up the founding team. Some conflict is inevitable, but different outlooks and temperaments among founders can ultimately make a company stronger or destroy it. What should you think about when looking for co-founders? Join us to learn from Lindred Greer, associate professor of organizational behavior at the Stanford Graduate School of Business. Professor Greer’s work focuses on the impact of team composition on intragroup conflict and team performance. She has a particular interest in how early-stage startup teams are composed in terms of power, status, and leadership structures, and when and why these structures may fuel power struggles and conflicts.

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
Noon to 1:00 PM, Tuesday, November 6, 2018

About the Speaker

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Lindred L. Greer is an Associate Professor of Organizational Behavior and she teaches the core Groups and Teams course in the MBA program. Professor Greer’s work focuses on the impact of team composition on intragroup conflict and team performance. She has a particular interest in how teams, particularly early stage start-up teams, are composed in terms of power, status, and leadership structures, and when and why particular forms of team composition may fuel power struggles and conflicts. When investigating teams, she often adopts a multi-level theoretical approach in understanding how individuals within the same team may differentially experience team structures and processes. In carrying our her research, she employs a variety of methods, including field (ranging from survey to quasi-experimental studies), laboratory, and archival research. Her research appears in academic journals such as the Academy of Management Journal, Journal of Applied Psychology, Organizational Behavior and Human Decision Processes, and Science.

Professor Greer is on the editorial boards at the Academy of Management Journal, Administrative Science Quarterly, Journal of Applied Psychology, Journal of Experimental Social Psychology, Journal of Personality and Social Psychology, and Organizational Behavior and Human Decision Processes, and served as Associate Editor of the journal Small Group Research (2011-2015).

Professor Greer joined the Stanford Graduate School of Business in 2013. She received her BS at the Wharton School of Business at the University of Pennsylvania and her PhD in Social and Organizational Psychology at Leiden University in the Netherlands.