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

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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

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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.

Fall 2019 SBIR Workshop at Berkeley

The chances of your SBIR or STTR proposal getting funded are vastly improved if your proposal is well written and packaged. In fact, many great ideas fail to get funded simply because of poor “grantsmanship.” In addition, first-time applicants are often daunted by the intricacies of the grant submission and review processes, and are unaware that they can improve their chances of getting funded by communicating directly with funding agency program and review staff.

This workshop will help you develop a compelling, well-organized research plan, and explain your ideas in clear, engaging writing that will win over your reviewers. We will focus on the Research Plan sections of NIH and NSF SBIR proposals, and one full session will be devoted to helping you craft your Specific Aims (the most important section of your application). We will also provide guidance on filling out your budget, Biosketch and other forms, and tips on how to most effectively navigate the NIH and NSF application and review processes.

Where & When

177 Stanley Hall, UC Berkeley
All classes are on Wednesday afternoons. Classes are 1:00 to 4:00 PM on Oct. 2, Oct. 16, and Nov. 6, and 1:30 to 5:00 PM on Nov. 20.

Topics Covered

  • What are SBIRs and STTRs, and which should you apply for?

  • Finding a “home” for your proposal (funding agencies, study sections, and topic-specific funding opportunities)

  • Sussing out your competition

  • Interacting with funding agency staff

  • Developing a logical, fundable Research Plan and assembling your project team

  • Logistics of the application process (electronic submission, deadlines, timelines to funding, agency requirements)

  • Major components of SBIR/STTR Research Plans and what to include in each

  • Facing and conquering the blank page

  • Writing and packaging your proposal for maximum impact

  • How to avoid common mistakes

  • Individualized feedback on your Specific Aims

  • Developing your Budget

  • Filling out forms

  • Review and award processes

  • The workshop will consist of four 3-hour sessions. There will be time during and at the end of each session for class participants to consult with the instructors about their own applications.

Session 1: Introduction to SBIRs and STTRs; identifying appropriate funding agencies and targeted funding announcements; mechanics of applying

Session 2: Developing your Research Plan; grantsmanship and writing tips (i.e., how to best pitch your proposal to your reviewers)

Session 3: Individual feedback from the instructors on your Specific Aims; help with filling out forms

Session 4: The review and award processes and how to maximize your chances of success; resubmissions and Phase II applications

This class is designed for applicants planning to submit for the next NIH and/or NSF grant deadlines (Jan 2020 and Dec 2019, respectively). However, the basic principles to be covered also apply to other federal SBIR funding agencies (DoD, DoE, etc.). Importantly, the science writing skills taught in this class will serve you well in writing not only grant applications, but also scientific journal articles and company public relations materials.

Fee Structure for New and Returning Participants

General Admission: $750
Startup in a Box members: $150

Note: Startup in a Box fee for UC founder: $250, non-UC founder: $350. More information on the program is available here.

Email Ioana Aanei with any questions.

About the Instructor

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Gabrielle G. Leblanc, Ph.D., is a professional grant consultant and writer with 11 years of experience as an NIH Program Director, and many years of prior experience as a research scientist and lab PI. During her academic career, she was an Assistant Professor at Oregon Health Sciences University, where her laboratory studied early nervous system development. As a lab PI, Dr. Leblanc was successful in winning grants from NIH, NSF, and many other government and non-profit funding agencies. As a Program Director at the National Institute of Neurological Disorders and Stroke at NIH, she oversaw multimillion dollar portfolios of grants and contracts in basic and clinical science, provided grantsmanship advice to scores of both junior and senior investigators, and led major funding initiatives in neuroscience, developmental biology, and genomics. In her subsequent 10 years as a freelance grant consultant/writer, she has provided scientific strategic consulting and grant-writing support to biotechnology industry and university investigators in a wide range of fields, from trypanosome pharmacogenomics to cancer drug development to medical applications of virtual reality. Dr. Leblanc has a B.A. in Biology from Harvard University and a Ph.D. in Neurosciences from Stanford University School of Medicine.

Fall 2019 SBIR Workshop at UCSF Mission Bay

Where & When

All classes are on Thursdays, 1:00-4:00 pm in Room 215, Byers Hall, UCSF Mission Bay.
Class dates: Sept. 26, Oct. 24, Nov. 14, Nov. 21, Dec. 5, Dec. 19

This workshop will take you through all the steps necessary to successfully file a well-written NIH SBIR/STTR grant application for the Jan. 2020 deadline. Taking the workshop you will learn how to craft an appropriate research plan, obtain persuasive letters of support, develop an efficient budget, and anticipate reviewers’ comments. We will help you speed through the application instructions, saving you hours of time. Results from past attendees indicate that taking this course triples your chances of success. The workshop culminates in a submission clinic that will ensure your application is correctly filed.

One or more team members (up to 3) from the company should be prepared to attend every session. Remember to bring your laptop; these will be working sessions.

The course includes six working sessions and a pre-submission review of your Specific Aims page by our course instructors.

(The Oct. 24 class will have a guest speaker on the topic of IP and confidentiality.

The Nov. 14 class is a guest talk and interactive workshop on the Specific Aims page.)

Topics

  • Understanding the eligibility requirements of an SBIR grant

  • Preparing to apply for an SBIR (company formation, registration at all required websites, identifying the best PI)

  • Assembling all the necessary parts of the application (letters of support, sub-contract quotes and letters, facilities description, research plan, etc.)

  • Strategies for designing your specific aims

  • Budget strategies and restrictions

  • Complete and convincing budget justifications

  • Documentation required to use human samples, human subjects and vertebrate animals

  • What makes a competitive proposal

  • Common mistakes that applicants make

  • Filing in forms and submission process

  • Re-submission if your grant is not funded

  • Phase II SBIR applications

  • Searching for program announcements and finding non-dilutive funding opportunities

Sessions

  1. Registration, eligibility, NIH/NSF program overview

  2. IP confidentiality, overview of all the sections of a NIH proposal, Phase 2 proposals

  3. Specific Aims Workshop with Kaspar, NSF workshop (Pt 1)

  4. Details on all the sections of a NIH proposal, NSF workshop (Pt 2)

  5. Details on budget and forms, resubmission (NIH)

  6. Questions, forms and submission (NIH)

Instructors

Shauna Farr-Jones, PhD, UCSF/QB3 grant writer
Ioana Aanei, PhD, Entrepreneurship Program Manager, QB3
Kaspar Mossman, PhD, Director of Marketing & Communications, QB3

Fee Structure for New and Returning Participants

General Admission: $750
Startup in a Box members: $150

Note: Startup in a Box fee for UC founder: $250, non-UC founder: $350. More information on the program is available here.

Email Ioana Aanei with any questions.

About the Instructor

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Shauna Farr-Jones, Ph.D., has a record of writing successful government grant and contract proposals on diverse life science topics, providing strategic input on both research and business plans. She has helped companies secure over $200 million in grant and contract funding from numerous government and philanthropic organizations, including BARDA, NIH, DTRA, USDA, DARPA and the Bill and Melinda Gates Foundation. For 17 years, she has consulted for life science companies and universities, identifying funding opportunities, preparing research plans, marketing plans, technical reports INDs, NDAs, white papers and proposals. She is also the Project Manager of the Antibody Technology Research Center at UCSF. Previously, she was Senior Writer at BioCentury Publications, where she analyzed and wrote about the biotechnology industry. She was a post-doctoral fellow at UCSF and has a Ph.D. in Biochemistry from Tufts University.

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

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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/UC Hastings FTO Application Fall 2019

Patenting your invention is just one step in being able to commercialize a technology. Just being granted a patent does not guarantee that you will ultimately be successful. You need to make sure that you are not infringing on existing patents that could limit your ability to apply your technology. Ensuring that you have "Freedom to Operate" (FTO) can take many hours of a patent attorney's time.

To provide FTO analysis to selected startups at no charge, QB3 has partnered with UC Hastings. For companies accepted to the program, a team of law students with technical backgrounds will perform an FTO analysis under the supervision of an experienced attorney. The company has to interact with the students weekly to ensure progress of the project.This is a selective program. Approximately four applications will be chosen based on a match with the law students' technical background and interests. Strong preference will be given to incorporated companies with issued patents.

To apply via our platform on SurveyMonkey Apply, click the button below. If you have not previously used SurveyMonkey Apply, there is a quick registration stage before you can fill out the form.

The deadline to apply is 5 PM on Thursday, August 8, 2019.

Office Hours: Mickey Urdea, PhD. Diagnostics

Would you like expert advice on diagnostics from Mickey Urdea, PhD, Founder & Partner at Halteres Associates?

Our office hours are hosted by leading experts who have generously offered their services pro bono to our entrepreneurs.

If you choose a timeslot, we will require a $100 credit card deposit. The deposit will be refunded the day after you attend. No-shows will not receive a refund. Please be punctual; arrivals late by more than 15 minutes will be considered no-shows.

If you find that you are unable to attend, you may request a refund up to 5 days in advance. (This will give us time to offer the slot to the first person on the waitlist.) We regret that we cannot honor requests made at a later time.

Where & When

Suite 214, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
Tuesday, June 25, 2019

Applications are now closed.

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Dr. Mickey Urdea is Founder and Partner for Halteres Associates. He also founded and served as Chief Executive Officer of Tethys Bioscience, a proteomics-based diagnostics company that has been involved in the prevention of type-2 diabetes (assets acquired by HDL), and was CEO of Quantum Dots Corporation (assets acquired by Life Technologies). Additionally, Dr. Urdea is a founder and the Chairman of Catalysis Foundation for Health (CFH), a non-profit organization addressing gaps in global healthcare caused by inefficiencies in disease diagnosis and monitoring; CFH is developing potential biomarkers for tuberculosis bacterial load with a grant for the Bill & Melinda Gates Foundation. Dr. Urdea is a member of the University of California at San Francisco Leadership Council for Global Health. He serves as a consultant to the life sciences industry and is on the scientific advisory boards and boards of directors of a number of biotechnology and diagnostics companies. Prior to his current activities, Dr. Urdea founded the Nucleic Acid Diagnostics business at Chiron Corporation, where he pioneered viral load assays for the human hepatitis B, hepatitis C and immunodeficiency viruses; his team introduced the first commercial viral load assays for all three viruses. Dr. Urdea also headed the Oncology Diagnostics business unit at Chiron. He then became business head of the Molecular Diagnostics group and Chief Scientific Officer at Bayer Diagnostics. He has served as an advisor to the Bill & Melinda Gates Foundation for over ten years. Dr. Urdea is an author on over 200 peer-reviewed scientific publications and has more than 125 issued and pending patents. He received his BS in Biology and Chemistry from Northern Arizona University, his PhD in Biochemistry from Washington State University, and had an NIH postdoctoral fellowship at the University of California at San Francisco.

The Sixth Annual UCSF Rosenman Symposium

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Join us Wednesday, June 19, 2019 at UCSF Mission Bay for the Rosenman Symposium, the premier conference for the San Francisco Bay Area's health technology community. Join us to learn from leaders in the health technology industry, meet dynamic startups, and connect with hundreds of players in the Bay Area ecosystem. The event runs 1:30 to 5:30 PM with a reception to follow.

For full information and registration, visit the symposium webpage on the UCSF Rosenman Institute website.

Agenda

Lightning pitches by the 2019 Rosenman Innovators startup cohort featured throughout.

1:30 PM Christine Winoto, Rosenman Institute: Welcome & Introduction

1:40 PM Marie Johnson, AUM Cardiovascular: "Commercializing an Acoustic Device to Detect Coronary Artery Blockage"

2:05 PM Fireside Chat: “A New Approach to Early-Stage Medtech Innovation and Investment: NXT Biomedical”
Andrew ElBardissi, Deerfield Management
Stanton Rowe, NXT Biomedical

-- Break --

3:20 PM John Groetelaars, Hill-Rom: “Advancing Connected Care”

3:45 PM Tippi Mackenzie, UCSF: "Fetal Stem Cell Transplantation"

-- Break --

4:35 PM Panel: “Advances in the Diabetes Space”
Casper de Clercq, Norwest Venture Partners (Moderator)
David Conn, Glooko
Sean Duffy, Omada Health
Harith Rajagopalan, Fractyl
Ruchita Sinha, Sanofi Ventures

-- Reception --

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.

Office Hours: Caleb Bates, JD, PhD. IP Strategy

Would you like expert advice on IP strategy from Caleb Bates, JD, PhD, Associate at Fish & Richardson?

Our office hours are hosted by leading experts who have generously offered their services pro bono to our entrepreneurs.

If you choose a timeslot, we will require a $100 credit card deposit. The deposit will be refunded the day after you attend. No-shows will not receive a refund. Please be punctual; arrivals late by more than 15 minutes will be considered no-shows.

If you find that you are unable to attend, you may request a refund up to 5 days in advance. (This will give us time to offer the slot to the first person on the waitlist.) We regret that we cannot honor requests made at a later time.

Where & When

Suite 214, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
Wednesday, June 12, 2019

Applications are now closed.

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Dr. Caleb Bates is an associate in Fish & Richardson’s Silicon Valley office. His practice focuses on intellectual property law, with emphasis on patent prosecution, strategic counseling, and worldwide patent portfolio management in the pharmaceutical, nutraceutical, and biotechnology fields. Caleb advises and counsels diverse clients, including early stage and established companies, research institutions, and venture capital and investment firms on how to best develop and leverage their IP assets. Caleb has extensive experience in international patent prosecution, having prosecuted applications in over 40 jurisdictions worldwide. In addition to advising clients on IP strategy, Caleb has counseled clients in licensing, investor and company side due diligence, freedom-to-operate and patentability analyses, and in market clearance.

Prior to joining Fish, Caleb practiced patent law at Knobbe Martens.  His graduate research in Medicinal Chemistry at the University of Michigan involved the design, synthesis, and mechanistic evaluation of small molecule modulators of eukaryotic gene transcription.

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

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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.

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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

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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.

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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.

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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.


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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.


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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

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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.

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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.

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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.

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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

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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.


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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.


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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.


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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.

Meet one-on-one with Bio-Rad at QB3

Bio-Rad, a leader in products for life science research and clinical diagnostics, and based in the Bay Area community of Hercules, continually seeks to increase its portfolio of innovative technologies.
 
Bio-Rad is interested in meeting startups in the QB3 ecosystem. To facilitate mutually beneficial partnerships, we are coordinating a partnering session Thursday, May 30 at UCSF Mission Bay.
 
Space is limited. If you see an opportunity in partnering with Bio-Rad, please apply thru May 9.

Areas of Interest

Before you apply, please note that Bio-Rad is interested in technologies whose applications fall in the following areas:

In life science research:

  • Single cell biology (genomics and proteomics)

  • Protein characterization

  • Digital genomics and translational research

  • New generation sequencing technology

In clinical diagnostics:

  • Microbiome

  • Point of care technologies

  • Microbiology, including antibiotic susceptibility

  • New biomarkers

  • Food safety

  • Wearables, mHealth

Download the full scope document

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

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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.

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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.

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

Biographical info to come

NSF I-Corps program at UCSF Mission Bay

Have a product idea, but unsure about whether there’s a market for it?

The NSF I-Corps short course program may be just right for you. Based on the Lean LaunchPad Method, which uses the Business Model Canvas and customer discovery, you’ll be able to significantly de-risk your venture, we promise.

Teams that complete the program and receive instructor endorsement are eligible for the national program that includes grant awards up to $50,000.

Where & When

UCSF Mission Bay
6:00-9:00 PM on Monday 4/29, Wednesday 5/1, and Monday 5/6

There is no charge for the course.

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).