QB3 Seminar: "Machine Learning in Science: Lessons Learned at Riffyn," Tim Gardner, CEO & Founder, Riffyn.

Tim Gardner founded and leads Riffyn, a global provider of Software-as-a-Service for scientific process design and data analytics. The Oakland-based startup recently closed a $15 million Series B round and announced a collaboration with BASF. At this talk, Tim will relate his motivation for starting Riffyn and discuss challenges he and his team have faced and overcome.

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
Noon to 1:00 PM, Thursday, December 5, 2019

This is a brown bag event.

About the Speaker

Timothy Gardner is the Founder and the CEO of Riffyn. He was previously Vice President of Research & Development at Amyris, where he led the engineering of yeast strain and processes technology for large-scale bio-manufacturing of renewable chemicals. Earlier, he was an Assistant Professor of Biomedical Engineering at Boston University, the Founder of Cellicon Biotechnologies, and a Programmer at ALK Associates. Tim has been recognized for his pioneering work in Synthetic Biology by Scientific American, the New Scientist, Nature, Technology Review, and the New York Times. He also served as an advisor to the European Union Scientific Committees and the Boston University Engineering Alumni Advisory Board. He holds BS in Mechanical Engineering from Princeton University and a PhD in Biomedical Engineering from Boston University.

About Riffyn

Riffyn provides cloud-based process design and data analytics to R&D organizations in biotech, pharmaceutical, food and chemical industries. Riffyn’s cloud-based Scientific Development Environment (Riffyn SDE) gives customers the power to achieve repeatable outcomes, faster discoveries, and right-first-time technology scale-up. Riffyn serves enterprise R&D customers across the US, Asia, Europe and South America, and has headquartered in Oakland, CA. For more information, visit: www.riffyn.com.

QB3 Seminar: Jennifer Kenny. "How to Be an Entrepreneur and a Leader"

As an entrepreneur you are not just building a company. You are also leading people and creating partnerships. You can improve your chances of leadership success by applying "Human Innovation," a process that integrates design thinking, systems thinking, and human cognition and language. Human Innovation enables entrepreneurs to leverage the innovative capacity of their teams and the ecosystem so they can thrive. Join us November 14th to learn more from Jennifer Kenny, a mentor and trainer who specializes in advising CEOs on leading innovation in complex technical environments.

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
Noon to 1:00 PM, Thursday, November 14, 2019

This is a brown bag event.

About the Speaker

Jennifer Kenny speaks, mentors, trains and facilitates on Human Innovation, with a specific focus on two of the big levers of innovation: technology and gender diversity. Her work is founded on Systems Thinking and Language Action Design/Human Centered Design.

Jennifer has held senior consulting positions with Accenture, Booz Allen and Gartner, senior executive roles with Wells Fargo and Cisco, and was CIO, SRI International (formerly Stanford Research Institute) where she designed and led the enterprise’s IT transformation program.

Jennifer was most recently honored at the 2019 Silicon Valley Global Awards. She was awarded the internationally acclaimed IDG DEMO Entrepreneurship Award and won the Intel/University of California Business Plan Award. Jennifer is on the Board of Directors of Global Women's’ Leadership Network and is a Fellow of the Irish Computer Society. Jennifer holds a M.Sc. (Hons.), in Engineering Geology, Imperial College, University of London, a B.Sc.(Hons), in Geology and Chemistry from University College, Dublin. She currently lives in San Francisco.

QB3 Seminar: Tito Serafini, Atreca. "Lessons Learned at Atreca from Founding Through IPO"

Redwood City-based Atreca ("BCEL" on Nasdaq) is developing novel therapeutics based on a deep understanding of the human immune response. In June, Atreca's IPO raised $125 million. Tito Serafini led Atreca as CEO from inception through 2018. Join us on October 31 to get Tito's insights and reflections on the company's founding and growth.

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
Noon to 1:00 PM, Thursday, October 31, 2019

This is a brown bag event.

About the Speaker

Dr. Serafini is one of the three principal founders of Atreca and was CEO from the Company’s inception in 2010 until 2018. In his role as Chief Strategy Officer, Dr. Serafini is responsible directly for research, preclinical development, technology, and intellectual property. Before co-founding Atreca, he was Chief Scientific Officer of Nuon Therapeutics, a development-stage biotechnology company. Previously, Dr. Serafini was a founder of Renovis, a public biotechnology company, where he served as an executive officer in multiple technical and business management roles, including leading the research and M&A functions. Prior to founding Renovis, Dr. Serafini was an award-winning faculty member in the Department of Molecular and Cell Biology at the University of California, Berkeley, where he established the university’s Functional Genomics Laboratory.

Dr. Serafini received a BS in biochemistry from Case Western Reserve University and a PhD in biochemistry from Stanford University (advised by Dr. James Rothman), and he performed postdoctoral research at the University of California, San Francisco in the laboratory of Dr. Marc Tessier-Lavigne.

Rosenman D-Series: James Eadie, MD, Santé Ventures. "Investing in Early-Stage Life Science and Healthcare"

This will be an interactive conversation between Dr. Eadie and Christine Winoto, Director and Founder of the UCSF Rosenman Institute. When you register, please let us know what questions you would most like answered.

Where & When

Tuesday, October 22, 2019, 5:30 to 6:30 PM
Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)

About the Speaker

James Eadie, MD, is Partner at Santé Ventures. He joined the firm in 2010. Previously, James served in the Air Force and was the medical director and Vice-Chair of Emergency Medicine at Wilford Hall Medical Center, an academic level-one trauma center in San Antonio. He completed two tours in Iraq as a critical care transport team chief and as the emergency department commander. He separated honorably as a Major in 2008. James received his MBA from the University of Texas McCombs School Of Business, his MD from Harvard Medical School, and a BS in bioengineering, Summa Cum Laude, from the University of Michigan. He is board certified in emergency medicine and completed his residency at Massachusetts General Hospital and Brigham and Women’s Hospital.

Rosenman D-Series: Neil Tiwari, dRx Capital. "Investing in Digital Innovation at Novartis"

This will be an interactive conversation between Neil and Christine Winoto, Director and Founder of the UCSF Rosenman Institute. When you register, please let us know what questions you would most like answered.

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
5:30 to 6:30 PM, Thursday, October 10

About the Speaker

Neil is a General Partner at dRx Capital and sits in the Novartis Chief Digital Office. He is a healthcare technology leader with 10+ years of experience developing life sustaining medical devices, diagnostic devices, drug-device combination products and digital health products. His background in product development has allowed him to foster the growth of early stage companies and products in the startup, academic and corporate environments. Prior to dRx, Neil led a digital health product development team at Novartis developing Software as a medical device products (SaMDs) and was a systems engineering manager for drug-device combination products. Prior to Novartis, Neil led a systems engineering team at Baxter Healthcare developing home dialysis devices, cloud based telemedicine solutions, and other medical products. He is an inventor on 6 patents from his work in these areas.

Neil holds a BS cum laude and MS in Biomedical Engineering from Northwestern University where he focused in an electrical engineering/computer science track. He also holds a MBA from the Berkeley Haas School of Business with a focus in venture capital.

QB3 Seminar: David Spellmeyer. "Score! How Your SBIR/STTR Application is Reviewed and Scored"

The SBIR/STTR grant review process can be extremely frustrating and opaque. But if you understand how the reviewers operate, you can improve the chances that your application will succeed. On October 3, David Spellmeyer, an expert SBIR consultant, will reveal the inner workings of an SBIR/STTR Study Section Review Panel. David’s talk will cover panel composition, review assignments, meeting mechanics, critiques, and the scoring process. Join us to learn several ways that you can make your application stand out.

Following David’s talk there will be an extended Q&A session, up to 90 minutes, so we can be sure all questions have been answered.

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
Thursday, October 3, 12:00 to 1:00 PM

This is a brown bag event.

About the Speaker

Dr. Spellmeyer is a biotechnology executive with 25 years of broad experience in the life sciences industry. He regularly participates in NIH SBIR/STTR Study Sections as both a panel reviewer and as Chair. He currently serves as CSO at Circle Pharma, as an Executive-in-Residence at ShangPharma Innovation, and heads Interlaken Associates where he advises early-stage companies and investors on corporate and technical strategy, product development, and commercialization. He previously served in research leadership roles at both large and small companies. Dr. Spellmeyer received his BS in computer science and chemistry from Purdue University and his PhD in theoretical organic chemistry from UCLA. He completed postdoctoral training in pharmaceutical chemistry at UCSF, where he is an adjunct Associate Professor.

QB3 Seminar: Ira Mellman, Genentech. "Drug Discovery & Development in Cancer Immunology"

Ira Mellman, PhD, is Vice President of Cancer Immunology at Genentech, a world leader in this vital, complex, and exciting field. Join us on Tuesday, September 17 to learn how an understanding of the basic science can inform the quest to discover and develop novel, effective therapies for cancer. Dr. Mellman will also contrast the differing approaches to R&D in industry, academia and startups.

Where & When

Byers Auditorium, Genentech Hall, UCSF Mission Bay (600 16th St., San Francisco)
Tuesday, September 17, 2019, noon to 1:00 PM

About the Speaker

Ira Mellman came to Genentech in the Spring of 2007 as Vice President of Research Oncology, after more than 20 years as a faculty member at the Yale University School of Medicine, where he was chair of his department (Cell Biology), a member of the Ludwig Institute for Cancer Research, scientific director of the Yale Cancer Center, and Sterling Professor of Cell Biology and Immunobiology. Dr. Mellman has a BA from Oberlin College & Conservatory and a PhD in Genetics from Yale. He was a Postdoctoral Fellow at the Rockefeller University with Ralph Steinman, who received the Nobel Prize for the discovery of dendritic cells. His laboratory is known not only for advances in fundamental cell biology particularly in the area of membrane traffic (including the discovery of “endosomes”) but also for applying these insights to understanding the cellular basis of the immune response, especially dendritic cell function. He was also the founder of CGI Pharma, which was recently purchased by Gilead. Ira ran all of oncology research at Genentech until the end of 2013 when he decided to concentrate his efforts on the rapidly developing area of cancer immunotherapy and became Vice President of Cancer Immunology. Ira is a member of the National Academy of Sciences, American Academy of Arts & Sciences, the European Molecular Biology Organization, and the former Editor in Chief of the Journal of Cell Biology. He has also served on the editorial boards of Cell, the Journal of Experimental Medicine, EMBO Journal, among others. He also serves on the boards of the Society for the Immunotherapy of Cancer, the American Society for Cell Biology, and the Cancer Research Institute. He remains a frustrated composer and songwriter, and has recorded two CDs in the little-known genre of “bio-rock”.

QB3 Seminar: Dennis Schwartz, Repositive. "How to Access Genomic Data for Cancer Therapeutic Discovery"

Cancer drug targets are now largely determined by mutations, rather than tumor tissue. This shift in focus has introduced new challenges for scientists identifying targets. First they must choose the right genomic datasets from disconnected sources; then make aggregate data comparable despite different platforms or analytical pipelines. Human data protection also adds layers of security and legal complexity. In this seminar, we will examine how to overcome these challenges and plan for validating potential targets at the preclinical stage. Download Dennis’s slide deck

Where & When

Room N-114, Genentech Hall, UCSF Mission Bay (600 16th St., San Francisco)
Noon to 1:00 PM, Thursday, June 13

About the Speaker

Dennis Schwartz, Bioinformatics Software Developer, Repositive

Dennis is a software developer and bioinformatician with a keen interest in genomic data sharing and open source software. After earning a BSc (Tübingen University) and MSc (TU & LMU Munich) in Bioinformatics he started working for Repositive in 2016. He spent the majority of the past two years working to better understand the needs of Pharma researchers and how they use genomic data in their search for cancer models in drug target validation. His focus is mainly on untangling the often jargon based requirements of biologists, oncologists and pharmacologists into comparable molecular characteristics which can be detected in next generation sequencing data from a variety of sources. Outside of his role at Repositive he is a contributor and maintainer with the BioJS open source project for the visualisation of biological data on the web. Through his open source work he has spoken at and partially organised multiple workshops, talks and a MOOC (as part of a team at TUM) about Javascript and data visualisation.

Rosenman D-Series: Piers Blewett & Doug Portnow, Schwegman Lundberg & Woessner. "Understanding IP Due Diligence from the Investor’s Point of View"

Early-stage companies will have to obtain funding or go through an exit process at some point in time. Since intellectual property (IP) often represents the bulk of an early stage company’s assets, investors will typically conduct due diligence on the IP during their evaluation process. Key areas that are evaluated include ownership of the IP, strength of the company’s IP, and freedom-to-operate. Join us May 30 to get a primer on how to prepare for IP due diligence from Douglas Portnow and Piers Blewett from the IP law firm Schwegman Lundberg & Woessner.

Where & When

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

About the Speakers

Piers Blewett is a patent attorney and principal at Schwegman Lundberg & Woessner. He is a former Chief Patent Counsel (International), Vice President and associate General Counsel at Kimberly Clark Corporation. His practice includes strategic IP counseling, patent prosecution (US and foreign), patent validity, infringement and clearance analysis and opinions, global patent litigation, and IP due diligence work.

Doug Portnow is a registered patent attorney and a Principal of Schwegman Lundberg & Woessner. His practice focuses on patent preparation and prosecution, IP due diligence and strategic counseling in the medical device and mechanical technologies. Prior to joining Schwegman, Doug was a Member at Wilson Sonsini Goodrich & Rosati and an associate at Townsend and Townsend and Crew LLP (now Kilpatrick Townsend & Stockton). Before entering the legal profession, Doug worked for over a decade in the medical device industry holding engineering and management positions at start-ups and publicly traded companies commercializing critical care products, vascular grafts, surgical instruments, stents, stent delivery systems, RF ablation catheters, embolic protection devices, and heart failure implants. Doug has been recognized as a Rising Star by Northern California Super Lawyers.

QB3 & UCSF Innovation Ventures Seminar: The Nuts & Bolts of Licensing UCSF Technology

The Nuts and Bolts of Licensing UCSF Technology
How UCSF, Third Rock, and Pliant Negotiated a Deal for a Potential Lung Fibrosis Therapy

Listen to the podcast episode produced by UCSF Innovation Ventures

Intellectual property is key to success in commercializing life science. When a startup wants to license university IP, how exactly does the process work? In this panel discussion we'll take a panoramic look at the negotiations by which Pliant Therapeutics, a company built by Third Rock Ventures, licensed a discovery made by UCSF professors. This event is jointly hosted with UCSF Innovation Ventures.

Participants:

• Bill DeGrado, PhD, Professor, UCSF School of Pharmacy; Scientific Co-Founder, Pliant

• Dean Sheppard, MD, Professor, UCSF School of Medicine; Scientific Co-Founder, Pliant

• Neil Exter, Partner, Third Rock Ventures; Board Member, Pliant

• Gemma Rooney, PhD, Licensing Officer, Office of Technology Management, UCSF

• Kaspar Mossman, PhD, Communications & Marketing Director, QB3 (Moderator)

Coffee and networking to follow.

Where & When

Byers Auditorium, Genentech Hall, UCSF Mission Bay (600 16th St., San Francisco)
10:30 to 11:30 AM, Thursday, May 23

About the Speakers

Bill DeGrado, Ph.D., is a Professor in the Department of Pharmaceutical Chemistry at UCSF, where he is also a member of the Cardiovascular Research Institute. Dr. DeGrado’s work focuses on the design of small molecule drugs, peptides, proteins and peptide mimetics. Before joining UCSF in 2011, he was a member of DuPont Central Research and DuPont Merck Pharmaceutical Company and the George W. Raiziss Professor in the Department of Biochemistry and Biophysics at the University of Pennsylvania. Dr. DeGrado is a member of the National Academy of Sciences, the National Academy of Inventors, the American Academy of Arts and Sciences, and a fellow of the American Association for the Advancement of Science. He is also a past President of the Protein Society and was the scientific founder of PolyMedix, which discovered brilacidin. Brilacidin, currently licensed to Cellceutix, is now in Phase 3 clinical trials for drug-resistant Staphylococcal aureus infections. Some of Dr. DeGrado’s research interests include de novo design of proteins and peptides; peptide mimetics; structure/function of membrane proteins, including integrins and viral ion channels; small molecule drug design; and bioinorganic chemistry.

Dr. DeGrado graduated from Kalamazoo College and holds a Ph.D. in organic chemistry from the University of Chicago. He joined DuPont Central Research without an intervening postdoctoral position.

Dean Sheppard, M.D., holds a variety of positions at UCSF, including Chief of the Division of Pulmonary, Critical Care, Allergy and Sleep Medicine, Professor of Medicine and a member of the cell biology, biomedical sciences, immunology and pharmaceutical sciences, and pharmacogenomics graduate programs. His research focuses on the molecular mechanisms underlying pulmonary (and other organ) fibrosis, asthma and acute lung injury. One aim of his research is to identify new therapeutic targets to ultimately improve the treatment of each of these common diseases. The work begins with basic investigation of how cells use members of the integrin family to detect, modify and respond to spatially restricted extracellular clues and how these responses contribute to the development of common lung diseases. Utilizing mice with global or conditional knockouts of four integrins, the epithelial-restricted integrin, avß6, and the widely expressed integrins a9ß1, avß1, avß5 and avß8, Dr. Sheppard’s lab has identified important roles for these integrins in models of each common lung disease and key steps upstream and downstream of the integrins that provide potential therapeutic targets.

Dr. Sheppard holds an A.B. in social studies from Harvard College and an M.D. from SUNY at Stony Brook. He trained in internal medicine at the University of Washington in Seattle and in pulmonary medicine at UCSF. He has been on the faculty of UCSF since 1980, and was appointed the Founding Director of the Lung Biology Research Center in 1986.

Neil Exter brings to the company more than 20 years of business development, leadership and strategic experience facilitating the successful development and implementation of operations and collaborations across the spectrum of newly emerging and established biotechnology companies. As a Partner of Third Rock Ventures since 2007, Mr. Exter plays an integral role in the formation, development and business strategy for Third Rock’s portfolio companies and has served in key leadership roles in several portfolio companies, including REVOLUTION Medicines, Cibiem, CytomX Therapeutics, Element Science, Rhythm Pharmaceuticals, bluebird bio, Constellation Pharmaceuticals, Foundation Medicine, Lotus Tissue Repair (sold to Shire) and Seventh Sense Biosystems.

Prior to joining Third Rock, Mr. Exter was Chief Business Officer of Alantos Pharmaceuticals, leading the sale of the company to Amgen, and earlier, served as Vice President for Millennium Pharmaceuticals, directing in-licensing and M&A. Earlier in his career, he held various executive and senior management roles within the high technology industry, including tenures at Hewlett Packard and Wang Laboratories. He is a member of the Research Committee of Children’s Hospital Boston, a member of the Investment Committee of the Innovation Research Fund and Innovation Advisory Board at Partners Healthcare and the treasure and a member of the Board of Directors of the New England Venture Capital Association. In addition, Mr. Exter serves as a member of the Advisory Council of the Electrical and Computer Engineering Department at Cornell University and the board of visitors of Columbia College.

Mr. Exter holds an MBA as a Baker Scholar from Harvard Business School, an M.S. from Stanford University and a B.S. from Cornell University.

As a Licensing Officer, Gemma Rooney has over 5 years of experience in licensing and business development. Gemma is responsible for evaluating and managing new technologies, determining the commercial and patenting strategy, engaging with faculty, building new relationships with industry partners and early stage investors, and negotiating license agreements, as well as the intellectual property terms in sponsored research agreements. Gemma and her colleague, Cathy Smith, manage the licensing internship program, which provides early career scientists a unique opportunity to learn about university technology commercialization and intellectual property management.

Gemma holds a Ph.D. in Neuroscience and Stem Cell Biology from the National University of Ireland, Galway, and a B.Sc. in Neuroscience from University College Cork, Ireland. She received postdoctoral training from the University of California, San Francisco and the Mayo Clinic College of Medicine. Her research focused on neurological applications of stem cell therapies.

Gemma is passionate about guiding UCSF investigators in realizing the fullest commercial potential of their innovations. She loves working at the interface between academia and industry, establishing partnerships that have the potential to benefit patients worldwide.

Kaspar Mossman engages internal and external stakeholders in QB3’s mission to support research and commercialization in quantitative biosciences. He manages the QB3 website, newsletter, email and event marketing, multimedia, social media, and print publications. Previously, he worked on the media staff at Proceedings of the National Academy of Sciences and held an AAAS mass media fellowship at Scientific American. He earned a PhD in biophysics from UC Berkeley.

QB3 Seminar: Tara Kochis-Stach, Slone Partners. "How to Build a Great Company Culture"

A startup's culture affects its reputation and ability to recruit and retain talent. Culture starts at the top, but must be embodied at every level. To learn more, join us Thursday, May 16th, when a panel of Bay Area HR experts, moderated by Tara Kochis-Stach, President of executive search consultancy Slone Partners, will cover topics such as how to create a thriving culture in a growing company; how to make core values meaningful & actionable; how diversity in leadership benefits everyone; and how to involve people at all levels in building and sustaining a great company culture.

Where & When

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

About the Speakers

Tara Kochis-Stach joined Slone Partners as President in 2004, bringing to the company over a decade of healthcare experience. Her successful sales career with industry leaders such as VERSYSS, American Medical Laboratories, and Quest Diagnostics covered a wide variety of healthcare segments, including information technology, medical records, and the diagnostic and laboratory testing industry.

Prior to healthcare, Tara recruited executive and management talent in the banking and finance sector. Tara’s executive abilities and business acumen have been instrumental in building Slone Partners into the successful and growing company it is today. Tara drives business development strategies, creating strong partnerships with new clients and strengthening relationships with existing clients. She is a tremendous resource for clients and prospects alike.

Through her partnership with Springboard Enterprises, she is an advisor to Blumio, a startup company focused on building sensors and systems to improve health and wellness, as well as a frequent panelist and speaker at industry conferences and a participant in select industry committees; activities that provide continuing opportunities to expand Slone Partners’ knowledge and expertise in the industries we serve.

Tara graduated cum laude from Boston College, receiving a Bachelor of Science with a concentration in Human Resources Management.

Wendy Lukas helps companies innovate, collaborate and grow. Through individual and team coaching, Wendy works with innovators and their teams, empowering them to rapidly come together and perform in the face of complexity and uncertainty. For over 25 years, she has developed trusted partnerships with C-Suite leaders and technical professionals involved in high stakes product development. Known as a people-centered HR leader, Wendy has designed and implemented high impact HR programs for all aspects of the employee life cycle. She has held HR leadership roles in emerging startups as well as leading global companies in the Life Sciences, Financial Services and High Tech sectors. Wendy completed the Berkeley Executive Coaching Institute Intensive through the Haas School of Business and holds a BA from UC Berkeley.

Wendy has a passion for fostering collaboration and creativity among multi-disciplinary teams and their senior level stakeholders as they work together to build vibrant organizations and deliver game-changing products that make the world a better place.

Eric Schlezinger is the Head of Human Resources for Vir. Previously, Eric led the human resources and facilities functions at Tessera Technologies where he helped manage the company through a complete transformation of board, senior leadership, organizational focus, culture and values.

Prior to joining Tessera, Eric held positions leading both the legal and human resources functions at various technology and pharma/biotech companies in the Bay Area.

Eric holds an JD from Washington University in St. Louis and an AB in Asian Studies from Dartmouth College.

Adrienne Seal is Founder and Principal Consultant at Spirit Tree Consulting. She has worked collaboratively with leaders to deliver solutions that improved how organizations function at the individual, group and organizational level, transforming their culture to be more inclusive and innovative. Companies include Blue Shield of California, Tessera Inc., Xperi, Handtmann Inc, Cisco, The Clorox Company, Flex Products, Hewlett Packard, The East Bay SPCA, NAMI; National Association of Mental Illness, and The City of Oakland. Her capability and versatility in culture transformation, organization design, strategic change, executive coaching and leadership development have resulted in many successful assignments.

Graduating college with a BA in Cultural Anthropology from SFSU gave her the skills of observation and exploration necessary to understand cultures and climates. She worked in the political arena, rose through the ranks of Price Club from hourly/union to management and leadership development. She has an MA in Psychology and Organization Development from Sonoma State.

Rosenman D-Series: Finding Unmet Needs in Pulmonary/Critical Care Medicine

This is the first in a series of events in which we bring clinicians and medical device engineers to discover unmet needs in a specialized area of medicine. In this event physicians will describe how they treat conditions, some of the challenges they face in delivering quality medical care, and possible solutions; engineers will discuss what is feasible and suggest alternative approaches. Join us for an intensely interactive session focused on pulmonary and critical care medicine.

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
5:00 to 6:00 PM, Thursday, May 9

About the Speakers

Ajay Dharia, MD, Principal, Medtech Venture Partners

Ajay received his medical degree from the David Geffen School of Medicine at UCLA after obtaining his engineering degree from UC Berkeley. He completed his residency and fellowship in internal medicine and pulmonary/critical care at UCSF Medical Center. After completing his fellowship, Ajay transitioned into a medical device lab working on the development of artificial organ technology. He continues to practice clinically during extended hours in two ICUs in the San Francisco Bay Area.

---

Nicholas Kwaan, MD, Pulmonary Medicine, Kaiser Vacaville Medical Center

Nicolas received his medical education from Albert Einstein College of Medicine in New York. From there, he went on to internal medicine training at UCLA and later to a pulmonary and critical care fellowship at UCSF. His goal is to ensure all of his patients receive quality care and to help them achieve their medical goals.

---

Aartik Sarma, MD

Aartik is currently a fellow in pulmonology and critical care medicine at UCSF. He studied biomedical engineering and public policy at Brown before completing his medical degree at Harvard and internal medicine residency at Massachusetts General Hospital. While at MGH, Aartik worked with MIT's Hacking Medicine to develop a framework for design thinking in healthcare, and helped organize a series of workshops and hackathons that have led to the creation of multiple venture-backed companies.

---

Sujith Shetty, MBBS, Executive VP at Maxis Medical, and Acting VP, Clinical and Regulatory, BioCardia

Suji is current EVP at Maxis Medical, and Acting VP Clinical and Regulatory at BioCardia after more than 15 years working in clinical research and regulatory at a number of small companies. He holds and MBBS from KempeGowda Institute of Medical Science and worked as a research fellow for 4 years at USC Keck school of medicine in Cardiology and Pulmonary and Critical Care. After moving to Industry, he has participated in development of novel technology in Cardiology (Vascular Dynamics, Inc.), Pulmonary (Asthmatx and Pulmonx), and Neuro (Micrus Endovascular and Codman Neurovascular) and has provided significant strategic, scientific, and clinical leadership in all these fields. While working with the FDA on many projects, he has extensive experience in the breakthrough programs the FDA has offered over the past 10 years and has worked on projects through the EFS program, EAP process, Payor Communication Task Force, and multiple IDE projects.

QB3/CERSI Seminar. Meet the FDA: Biostatistics & Epidemiology/CBER

The FDA BEST System: Leveraging EHR Data and Innovative Approaches for Surveillance of Biologic Products

In 2016 the FDA Center for Biologics Evaluation and Research (CBER) launched the BEST (Biologics Effectiveness and Safety) Initiative to build an active surveillance system better able to evaluate the safety and effectiveness of biologic products including vaccines; blood and blood products; and advanced therapeutics. BEST is part of the Sentinel initiative and advances beyond FDA’s current claims data-based systems. It offers new electronic health record (EHR) data sources, uses new innovative approaches such as artificial intelligence (AI), natural language processing (NLP) and automation. At its core, BEST’s primary function is to conduct routine surveillance activities such as queries and epidemiological studies for more than 100 million patients that address timely regulatory questions concerning biologic product safety and effectiveness. To enhance BEST’s basic operational capabilities, we are in the early phases of using NLP and AI to improve, expedite and semi-automate medical chart review for use in outcome validation. FDA also considers other sources of data such as passive or spontaneous reporting in regulatory decision-making concerning safety. However, passive reporting of adverse events (AE) for biologics is voluntary and usually suffers from underreporting. To address these and other limitations BEST is beginning to use NLP and AI to identify and mine biologic product AE information from EHRs, with the goal of populating the fields of an AE report form and automatic submission to FDA. Automated reporting is expected to supplement current reporting and is in its very early stages. But it has the potential to transform the current landscape by providing additional, potentially higher-quality real-world evidence to inform regulatory decision-making. This presentation will provide context for the development of the BEST system, discuss relevant legislative and regulatory mandates, some preliminary findings and future directions for the program.

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
4:00 to 5:00 PM, Tuesday, May 7

About the Speakers

Steve Anderson, Ph.D., M.P.P., Director, Office of Biostatistics and Epidemiology, FDA Center for Biologics Evaluation and Research (CBER)

Steve Anderson, Ph.D., M.P.P., is currently the Director of the Office of Biostatistics and Epidemiology (OBE) at the FDA Center for Biologics Evaluation and Research (CBER). He provides leadership for all CBER statistical, epidemiological and benefit-risk assessment programs and has led numerous important benefit-risk assessment and epidemiological studies of vaccines, tissues, and blood products using the FDA Sentinel and CMS data. Most recently Dr. Anderson’s office established the Biologics Effectiveness and Safety (BEST) system, CBER’s new postmarket risk identification and analysis system that engages new data sources, tools and experts to further enhance biologic product effectiveness and safety surveillance.

Dr. Anderson earned a Master’s Degree in Public Policy (MPP) at Georgetown University and while there developed the first quantitative risk assessment for antimicrobial resistant pathogens in livestock. Dr. Anderson received his PhD from the University of Cincinnati where he worked on biochemistry, drug resistance and ion pumps, pathogenicity and genomics of unique tropical disease pathogens. He has published a number of articles in biologic product safety, risk assessment, epidemiology, infectious diseases, biologics safety, and genomics.

Gregory Pappas, MD, PhD, Associate Director for National Surveillance, FDA-CBER

Dr. Pappas recently joined CBER to help build networks that brings together data from registries, claims, and other electronic records to address information needs of the many stakeholders in the medical product ecosystem. Dr. Pappas works to build sustainable health data networks that answer questions today and in the future about the safety and efficacy of biological.

Dr. Pappas was previously the Associate Director with the CDRH, FDA providing leadership for development of NEST (National Evaluation System of health Technology.

Dr. Pappas served as the Senior Deputy Director of HAHSTA (HIV/AIDS, Hepatitis, STD, and TB Administration) for the District of Columbia, Department of Health where he manages a budget of $90 million and a staff over over 150. New HIV diagnoses in DC fell by half over a five years and disparities decreased.

He has worked professionally in over 30 countries.

Barbee Whitaker, PhD, Director, Research & Data Analysis, AABB

Biographical info to come

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

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

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

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

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

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

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

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.