Rosenman D-Series: Sherry Parker, WuXi Apptec. "The Changing Landscape of Medtech Regulation"

From the FDA’s Guidance on ISO10993 to the EU Medical Device Regulation, there have been some significant changes lately that affect pre-clinical safety testing for combination products or medical devices. Staying up-to-date is crucial to moving your product to market. As WuXi AppTec’s Director of Technical and Regulatory for Medical Devices/Combination Products, Sherry Parker is a leading expert on regulation. She will speak about recent regulatory changes and resulting trends that she is seeing emerge. Bring your questions; there will be plenty of time for Q&A.

Where and When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
5:00 to 6:30 PM, Thursday, March 1

Agenda

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

About the Speaker

Sherry Parker.jpg

Dr. Parker has over 19 years of toxicology and medical device research experience, and is an expert in analytical, pharmacological, and toxicological evaluations of devices and novel combination products. After receiving her Ph.D. in Molecular and Cellular Pharmacology from the University of Miami, Dr. Parker spent 10 years in toxicology research for the University of Miami, the U.S. EPA (Neurotoxicology Division) and RTI International before moving into the medical device industry, where for more than six years she was involved with device development, safety and efficacy testing and regulatory submissions for OrbusNeich Medical. In her current position as WuXi AppTec’s Director of Technical and Regulatory for Medical Devices/ Combination Products, Dr. Parker provides manufacturers with guidance on global regulatory and technical requirements and testing program design. Dr. Parker is currently an internationally recognized expert by ISO and US Delegate for TC 194, the technical committee for ISO 10993. She is currently the Vice President-Elect for the Medical Device and Combination Products Specialty Section of the Society of Toxicology.

SBIR Workshop, UC Berkeley (four sessions from Feb. 14 to Mar. 14)

"The Art, Science, and Politics of Writing a Successful SBIR Proposal"

Schedule

Location is 177 Stanley Hall, UC Berkeley. All classes are on Wednesdays. Class dates: Feb. 14, Feb. 21, Mar. 7, Mar. 14

The chances of your SBIR 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 process, and unsure about how to interact with funding agency staff.

This workshop will help you develop a compelling, well-organized research plan, and to 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.

The workshop will consist of four 2.5 to 3 hour sessions. Specific topics to be covered will include:

  • Introduction to the NIH and NSF SBIR funding processes
  • Identifying funding opportunities
  • Developing a logical, compelling Research Plan
  • Facing and conquering the blank page
  • Writing for your reviewers
  • Instructor and peer feedback on your Specific Aims
  • Making the most of graphics
  • Electronic registration and submission
  • Communicating with NIH and NSF staff

This class is designed for applicants planning to submit for the April 5, 2018 NIH deadline. The science writing skills taught in this class will serve you well in writing not only grant applications, but also manuscripts and public relations materials.

Fee Structure
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

gabrielle.png

Gabrielle G. Leblanc, Ph.D. is a grant consultant and science writer with over 15 years of previous experience as both an NIH grant program director and an NIH- and NSF-funded PI. She has worked with numerous grant applicants in both academia and biotech, and as a science writer for NIH institutes, non-profit foundations, and the popular press. She has a B.A. in Biology from Harvard University and a Ph.D. in Neuroscience from Stanford University.

SBIR Workshop, UC San Francisco (six sessions from Feb. 1 to Mar. 29)

Schedule

All classes are on Thursdays, 1:00-4:00 pm in Room S202, Genentech Hall.
Class dates: Feb. 1, Feb. 8, Feb. 15, Mar. 1, Mar. 15, Mar. 29

This workshop will take you through all the steps necessary to successfully file a well-written NIH SBIR/STTR grant application for the April 5, 2018 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.

(Feb. 15 class is guest talk & interactive workshop on 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

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
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

shauna.jpg

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: Dan Widmaier, Bolt Threads. "Synbio from Chemistry to Couture"

Dan Widmaier with Stella McCartney & models at Fashion Week, Paris, October 2017

Dan Widmaier with Stella McCartney & models at Fashion Week, Paris, October 2017

How did Dan Widmaier, CEO of synbio company Bolt Threads, end up backstage in Paris at Stella McCartney's Spring 2018 Ready-to-Wear runway show?

Bolt has had the most remarkable trajectory of any company in the QB3 network. Widmaier (CEO), David Breslauer, and Ethan Mirsky launched Bolt in 2010 at the QB3 Garage@UCSF to develop synthetic spider silk based on their graduate research. Initially they aimed at military applications, but soon pivoted to the fashion industry. Under Widmaier's leadership, Bolt has raised multiple rounds of funding, acquired NYC's Best Made, and partnered with Patagonia. Bolt is now front and center of the green fabric fashion movement.

Wednesday, December 13 at UCSF Mission Bay, Widmaier will tell the inside story of Bolt's founding and growth, and answer your questions. Join us for what is sure to be a terrific event.

Where and When

Noon to 1:00 PM, Wednesday, December 13
Byers Auditorium, Genentech Hall, UCSF Mission Bay (600 16th St., San Francisco)

Eventbrite - Dan Widmaier, CEO, Bolt Threads

About the Speaker

About_Vert_Dan_300.jpg

Dan is fascinated by finding the right conditions to grow things, whether he’s cultivating the broccoli in his vegetable garden, yeast in his microbrews or the people at Bolt Threads. He’s carefully tended our growth since 2009, using his passion and expertise to lead the company through technology development, expansion, and financing. He earned his Ph.D. in Chemistry and Chemical Biology from UC San Francisco, where his graduate research involved designing genetic circuits to control microbial organelles. He’s also passionate about the growth of something over which he has less control: the progress of the Seattle Seahawks. [Bio courtesy Bolt Threads]

Rosenman D-Series: Adam Schoen, Brown Rudnick. "How to Build a Commercially Valuable, Unassailable Patent Portfolio"

A secure IP position is absolutely essential for a bioscience startup. It's a key factor in helping you win investment. But how exactly do you build commercial barriers to prevent competitors from entering your space? Join us to get the whole picture from IP attorney Adam Schoen of Brown Rudnick. Adam will cover what investors and strategics are looking for in IP diligence; how that frames portfolio development; classic pitfalls to avoid; and much more.

Where and When

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

Eventbrite - Rosenman D-Series: Adam Schoen. How to Build a Patent Portfolio

About the Speaker

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Adam Schoen advises life science and medical device companies regarding implementation of a patent strategy to further business objectives and business goals. Adam’s practice encompasses patent preparation and prosecution, portfolio development, product clearance, freedom to operate analysis and intellectual property due diligence. Adam works with public and private companies, investors, and academic institutions.

Adam has experience with a variety of technologies, such as next generation sequencing technologies, droplet based technologies, cancer diagnostics, medical device technology (ophthalmology, cardiology, orthopedics, neurology, spine) and medical imaging technology (IVUS and OCT), mass spectrometry, small molecule therapeutics, digital health, near field communication technology, and semiconductor technology. He manages patent portfolios of all sizes and develops strategies to maximize and protect intellectual property rights in both the United States and foreign jurisdictions.

Prior to law school, Adam was a scientist of analytical chemistry for ArQule Inc., a combinatorial chemistry and drug discovery company.

QB3 Seminar: Eric Hobbs, Berkeley Lights. “'Destroyer of Obstacles': Going from Startup to a Commercial Organization"

Eric Hobbs leads Berkeley Lights, an East Bay company developing nanofluidic technology that enables cell selection for drug discovery, cell line development, and cell therapy manufacturing. The SF Business Times recently profiled Hobbs as a "destroyer of obstacles." Under his leadership, Berkeley Lights has hit revenue and budget targets, despite having lost 40 staff just before Hobbs took the helm. How does he face and overcome such challenges, and what has his professional journey been like? Join us November 16 to hear for yourself.

Where and When

Noon to 1:00 PM, Thursday, November 16
Room 160, Helen Diller Bldg., UCSF Mission Bay (1450 Third St., San Francisco)

Eventbrite - QB3 Seminar: Eric Hobbs, Berkeley Lights. “'Destroyer of Obstacles': Going from Startup to a Commercial Organization"

About the Speaker

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Eric D. Hobbs joined Berkeley Lights in May 2013 and was appointed Chief Executive Officer in March 2017. Prior to becoming CEO, Eric held various senior management roles, including most recently, Senior Vice President of Operations and Consumables. Prior to Berkeley Lights, Eric led the design, development, and launch of 3 new product architectures at FormFactor, Inc. as a senior member of both R&D and Operations organizations. He holds more than 62 U.S. and International patents. Eric has lectured both at UC Berkeley and Stanford speaking on Engineering Design, Invention, and Optimization Algorithms. Eric earned his Ph.D. & M.S. in MEMS Design and Microfluidic Devices at UC Berkeley. He received a B.S. in Mechanical Engineering from U.S.C.

Rosenman D-Series: Matt Likens, GT Medical Technologies

Join us on Thursday, November 9, when Rosenman Institute Director Christine Winoto will interview Matthew Likens, a serial startup CEO with a track record of impressive success. How do you lead a startup from its founding to IPO or acquisition? How do you keep investors on your side through the hard times? We look forward to seeing you at the next D-Series.

Where and When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
5:00-6:30 PM, Thursday, November 9

Eventbrite - Rosenman D-Series: A Conversation with Matt Likens

Agenda

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

About the Speaker

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Matthew Likens is currently President and CEO of GT Medical Technologies, the makers of GammaTiles, with the goal of improving the lives of brain tumor patients.

After graduating cum laude from Kent State University, Mr. Likens began his professional career with Johnson & Johnson Corporation. He then spent more than twenty years in domestic and international sales, marketing and general management roles at Baxter Healthcare Corporation, culminating in the position of President, Baxter Biotech North America, followed by President of Baxter’s Renal Division in the U.S.

In July of 2006, Mr. Likens became President and CEO and the second employee of Ulthera, Inc., a venture capital-backed start-up company in energy-based aesthetics in Phoenix, AZ. After filing for an initial public offering in early 2014, Ulthera was acquired by Merz Pharma GmbH for $600M, an amount representing 6.6x trailing 12-months’ revenue. The Arizona Association for Corporate Growth (ACG) recognized this as Transaction of the Year for 2014.

Phoenix Business Journal honored Mr. Likens in 2012, naming him one of Arizona’s Most Admired CEOs.
In June of 2015, Ernst & Young presented Mr. Likens with the Entrepreneur of the Year for the Mountain Desert Region Award.

Mr. Likens is a member of the board of directors of Luma Therapeutics, an early-stage company with a promising treatment for psoriasis, and an adviser to Genteract, an early-stage genetics company. He is a member of the Greater Phoenix Economic Council Healthcare Innovation committee and a member of the City of Mesa Economic Development Council.

Introduction to the Science Exchange Marketplace at QB3

Startups moving toward a lean, virtual research model must negotiate contracts as they outsource, spending time that they otherwise could have devoted to innovation. To eliminate busywork and help our startups become more efficient, QB3 has partnered with Science Exchange, an online marketplace. Science Exchange offers a single access point to more than 2,500 qualified service providers, all with pre-established contracts in place to protect client intellectual property and confidentiality.

Join this introductory session to learn how your company can access Science Exchange through QB3's marketplace, and get concierge service from full-time staff who can ensure that you connect with the right providers.

Where and When

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

Eventbrite - Introduction to the Science Exchange Marketplace at QB3

Meet Your Science Exchange Contacts

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Nolan McDonnell is the Director of Business Development at Science Exchange where he works closely with R&D organizations to help increase access to innovation, reduce administrative friction, and enhance spend visibility. Prior to joining Science Exchange, Nolan worked at Deloitte Consulting where he drove technology strategy and implementation to enable organizations to achieve key business objectives, including merger and acquisition; pipeline development; commercialization; IPO. Nolan received his BS in biomedical engineering from California Polytechnic State University and is passionate about enhancing R&D with innovative technologies.

Nolan McDonnell, Director of Business Development
Nolan@scienceexchange.com
818.723.1545

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Dr. Zev Wisotsky is a Senior Scientist / Research & Development Specialist at Science Exchange where he works closely with scientists to understand their research goals and expedite their outsourcing projects by connecting them with expert service providers. Prior to joining Science Exchange, Zev worked as a postdoctoral researcher at Stanford studying the role of brain regions involved in fear memory and drug withdrawal through silencing different brain circuits by optogenetics. Zev received his PhD in neuroscience from the University of California, Riverside and works hard to provide researchers access to expert scientific service providers.

Zev Wisotsky, PhD, Senior Scientist / Research & Development Specialist
Zev@scienceexchange.com
925.434.5888

QB3 Seminar: Carley Jacobson & Maaike Doyer, Business Models Inc. "Business Model Innovation: Designing Strategies for the Future"

Startups need creative business models to attract investors and industry partners and for ultimate profitability. And business models must often evolve as companies develop. In conceiving business models, entrepreneurs can think as designers: use visual tools, consider scenarios, generate options, and test prototypes. Carley Jacobson and Maaike Doyer of Business Models Inc. are experts in applying design thinking to help companies succeed. Join us Tuesday, October 10 to learn how they operate.

Where and When

Room HD-160, Helen Diller Bldg., UCSF Mission Bay (1450 Third Street, San Francisco)

12:00-1:00 pm, Tuesday, October 10

Eventbrite - "Business Model Innovation: Designing Strategies for the Future." Carley Jacobson & Maaike Doyer

About the Speakers

Carley Jacobson is a Strategy Designer at Business Models Inc. Through Business Models Inc she supports organizations with strategy, business model generation and validation, and value proposition design. For 6 years prior, Carley helped grow Autodesk's maker community Instructables.com. With over 115 do-it-yourself tutorials, Carley has gained over 13 million page-views and recognition from major publications such as The Huffington Post, GQ Magazine, Popular Mechanics, and more. She uses her experience in online community building, hackathons, content creation, and customer development to build new innovative strategies. Carley holds a degree in Computer Science and Visual Art from Union College and an MBA in Design Strategy from California College of the Arts.

Maaike Doyer supports (inter)national organizations with the development and improvement of business models and the embedment of business models throughout the organization. Maaike’s specialization is strategy and business modeling, supporting organizations in realizing their vision and achieving sustainable business. She has a proven record in strategy and implementation of mergers and acquisitions. She has extensive experience in the Automotive and Financial Services Industry. Maaike is an expert in business design, design thinking and strategic visioning. She runs global projects, with a focus on the Americas. Maaike is very pragmatic and has a startup mindset. Maaike is the Global CFO of Business Models Inc and a professor at the California College of the Arts where she teaches design thinking in practice.

SBIR Workshop, UC Berkeley (4 sessions from Oct. 4 to Nov. 1)

"The Art, Science, and Politics of Writing a Successful SBIR Proposal"

Schedule (all classes are on Wednesdays. Location is 177 Stanley Hall, UC Berkeley)

Oct. 4, 2 - 5 pm
Oct. 11, 2 - 5 pm
Oct. 25, 2 - 5 pm
Nov. 1, 2 - 5 pm

Eventbrite - QB3 SBIR workshop at Berkeley, Fall 2017

The chances of your SBIR 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 process, and unsure about how to interact with funding agency staff.

This workshop will help you develop a compelling, well-organized research plan, and to 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.

The workshop will consist of four 2.5 to 3 hour sessions. Specific topics to be covered will include:

  • Introduction to the NIH and NSF SBIR funding processes
  • Identifying funding opportunities
  • Developing a logical, compelling Research Plan
  • Facing and conquering the blank page
  • Writing for your reviewers
  • Instructor and peer feedback on your Specific Aims
  • Making the most of graphics
  • Electronic registration and submission
  • Communicating with NIH and NSF staff

This class is designed for applicants planning to submit for the December 2017 NSF deadline, the January 5 2018 NIH deadline, or later deadlines. The science writing skills taught in this class will serve you well in writing not only grant applications, but also manuscripts and public relations materials.

Fee Structure
General Admission: $750
Startup in a Box members: $100

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

gabrielle 200.png

Gabrielle G. Leblanc, Ph.D. is a grant consultant and science writer with over 15 years of previous experience as both an NIH grant program director and an NIH- and NSF-funded PI. She has worked with numerous grant applicants in both academia and biotech, and as a science writer for NIH institutes, non-profit foundations, and the popular press. She has a B.A. in Biology from Harvard University and a Ph.D. in Neuroscience from Stanford University.

QB3/CERSI Seminar: Ying Huang & Jakob Reiser, FDA/CBER. "Safety Considerations for Gene Editing and Other Gene Therapy Products: An FDA Perspective"

Join us to hear from two experts at the FDA's Center for Biologics Evaluation and Research (CBER). Dr. Ying Huang will discuss regulatory considerations for gene therapy products involving gene editing technologies. Dr. Jakob Reiser will describe ongoing work in his laboratory dealing with safety issues pertaining to lentiviral vectors. Seminar hosted by QB3 and UCSF/Stanford CERSI.

Abstract

FDA/CBER has a long history of regulating gene therapy products, including genetically modified cellular products that are generated using integrating viral vectors. Development of HIV-1-based gene therapy vectors to deliver therapeutic genes into humans with various medical conditions has been ongoing over the past two decades. The risks associated with these promising vectors include activation of oncogenes during random integration of the vectors into the genome and the ability to spread from cell to cell through the formation of replication-competent lentivirus. This experience has contributed to CBER’s understanding in the regulation of products that incorporate use of gene editing (GE) technologies to generate investigational therapies intended to treat a disease.

The regulatory review of gene therapy products uses a science-based approach that considers the risks and benefits of each investigational product in the framework of the respective clinical trial. We will describe the safety concerns associated with gene therapy products, including those that incorporate GE technologies, in the context of our research efforts aimed to improve the safety profile of HIV-1-based lentiviral vectors.

The introduction of GE technologies to generate gene therapy products raises unique concerns regarding whether the GE component is appropriately designed and optimized for specificity, and how the gene editing process may impact the product safety profile. CBER’s considerations for the preclinical evaluation of gene therapy products involving GE technologies build upon the extensive scientific and regulatory history that exists for gene therapy products. Specific safety concerns include the potential for gene editing events at off-target sites, chromosomal translocations, and genomic instability. We will discuss CBER’s preclinical expectations for gene therapy products with a focus on the products that incorporate GE technologies.

Where and When

Room N-114, Genentech Hall, UCSF Mission Bay (600 16th St., San Francisco)

4:00-5:00 pm, Tuesday, October 3

Eventbrite - Ying Huang & Jakob Reiser, FDA/CBER: “Pre-Clinical Evaluation of Gene Therapy Products Including Products Obtained Using Gene Editing Technologies”

About the Speakers

Ying Huang sq.jpg

Dr. Ying Huang has been a Pharm/Tox master reviewer at FDA/CBER/OTAT/DCEPT since 2004. She is responsible for the review of the preclinical evaluations for proof-of-concept and safety related to cell and gene therapies, and gene editing derived gene therapy products on oncology and non-oncology diseases. Her review activities have been involved in submissions of Investigational New Drug (IND) including pre-preIND and pre-IND, and Biologics License Application (BLA). In addition to her review work, she is one of the representatives for the US FDA in the International Pharmaceutical Regulators Forum (IPRF) / Gene Therapy Working Group (GTWG). She was the co-representative for FDA/CBER in the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) during 2006 – April 2017. Prior to the FDA, Dr. Huang received her Ph.D. degree in Pharmacology and Toxicology at the University of Toronto, Canada, and subsequently an NIH IRTA fellowship at NIH/NIDDK before became a senior scientist at Genetic Therapy Inc., a Novartis Company.

Jakob Reiser sq.jpg

Dr. Jakob Reiser received a Ph.D. in Biochemistry from the University of Basel in Switzerland. He then did postdoctoral work in Virology and Protein Chemistry in the Department of Biochemistry, Stanford University School of Medicine as an American Cancer Society Junior Fellow and at the Imperial Cancer Research Fund Laboratories in London. At Stanford he helped develop the Western Blot technique and was instrumental in setting up the original chromatin immunoprecipitation method.

Dr. Reiser was a group leader and lecturer in Biotechnology at ETH (Swiss Federal Institute of Technology) in Zürich, Switzerland between 1986 and 1994. His work there focused on quorum sensing in Pseudomonads.

Dr. Reiser joined the NIH in Bethesda, MD in 1994 to gain experience in the emerging field of gene therapy. He worked with HIV-1-based lentiviral vectors since 1995. The group was among the first to develop such vectors.

Dr. Reiser moved to the Louisiana State University (LSU) Health Sciences Center in New Orleans in 1999 to join the Gene Therapy Program as Associate Professor of Medicine and as the Director of the Gene Therapy Vector Core. At LSU he gained experience applying such vectors in the context of in vitro, ex vivo and in vivo applications. Past in vivo applications included the delivery of therapeutic genes to the brains of mice afflicted with globoid cell leukodystrophy. This work was supported by R21 and R01 grants from the NIH on which he was a PI.

Dr. Reiser moved to FDA/CBER in 2008 as a PI. His laboratory at CBER uses genetic engineering methods to improve the safety of HIV-1-based lentiviral lentiviral vectors. He spends 50% of his time as a CMC reviewer of gene therapy files.

SBIR Workshop, UCSF (6 sessions from Sept. 26 to Dec. 19)

Schedule (all classes are on Tuesdays. Location is 212 Byers Hall, UCSF Mission Bay)

Sept. 26, 11 am – 2 pm
Oct. 10, 1 pm – 4 pm **Note different time slot!**
Oct. 24, 11 am – 2 pm Optional session on Specific Aims
Nov. 7, 11 am – 2 pm
Dec. 12, 11 am – 2 pm
Dec. 19, 11 am – 2 pm

Eventbrite - QB3 SBIR workshop at UCSF, Fall 2017

This workshop will take you through all the steps necessary to successfully file a well-written NIH SBIR/STTR grant application for the January 5, 2018 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 five working sessions and a pre-submission review of specific aims by our course instructors.

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

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
General Admission: $750
Startup in a Box members: $100

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.

Meet the FDA. Focus: Genomic Medicine

Space is limited. Please only register if you are sure you can attend!

We're pleased to welcome four representatives of the FDA's Center for Devices & Radiological Health, specialists in genomics, for an open roundtable discussion. These FDA scientists work on investigational biomarker tests, molecular testing for genetic diseases, oncology molecular tests, companion diagnostics, and next generation technologies. This is an opportunity for entrepreneurs to interact with officials responsible for regulating commercial technologies, help them understand startups' perspective, and make the regulatory process smoother.

Where and When

4:00-6:00 PM, Wednesday, September 20

Room 2103, Mission Hall, UCSF Mission Bay (550 16th St., San Francisco)

Eventbrite - Meet the FDA. Focus: Genomic Medicine

ABOUT THE SPEAKERS

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Dr. David Litwack received a B.S. in Chemistry from the University of Chicago, and a Ph.D. in Biology from MIT. After postdoctoral studies at the Salk Institute for Biological Studies, he joined the faculty of the University of Maryland School of Medicine as an Assistant Professor in the Department of Anatomy and Neurobiology and a member of the Program in Neuroscience. In that role, Dr. Litwack directed an NIH-funded lab that studied the role of transcription factors in neurogenesis in the mammalian brain and in human embryonic stem cells, and was a founding member of the School’s Center for Stem Cell Biology and Regenerative Medicine. In 2010, Dr. Litwack was awarded an AAAS Science and Technology Policy Fellowship in NCI’s Office of Biorepositories and Biospecimen Research. During this fellowship, he led several efforts to develop policy and programs to advance the use of biobanking for personalized medicine. In 2012, Dr. Litwack joined the Personalized Medicine Staff of the Office of In Vitro Diagnostics and Radiological Health at the FDA, where he develops policies to guide the review of investigational biomarker tests, companion diagnostics, and next generation technologies.

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Dr. Hisani Madison is a Senior Scientific Reviewer in the Office of In Vitro Diagnostics and Radiological Health (OIR) at the Center for Devices and Radiological Health (CDRH) in the Food and Drug Administration (FDA). Dr. Madison leads the review of submissions in the Molecular Pathology and Cytology Branch as part of the Division of Molecular Genetics and Pathology (DMGP). The Molecular Pathology and Cytology Branch is responsible for reviewing a wide range of devices including next generation sequencing technologies and hybridization-based molecular techniques to detect genetic alterations associated with cancer. Dr. Madison specializes in review of devices intended to aid in selection of therapy for patients with solid tumors.

Prior to her current position, Dr. Madison was a postdoctoral fellow in the Hormonal and Reproductive Epidemiology Branch of the Division of Cancer Epidemiology and Genetics at the National Cancer Institute where she conducted molecular epidemiologic research focusing on breast cancer etiology and heterogeneity. Dr. Madison obtained her Ph.D. in Pathology from Duke University, where her doctoral research focused on identifying and characterizing genetic and epigenetic markers for the early detection, prognosis and prediction of breast and ovarian cancer. She also has an M.P.H. from Johns Hopkins Bloomberg School of Public Health where she trained in epidemiology and biostatistics and received a Certificate in Health Disparities and Health Inequality.

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Dr. Reena Philip currently holds the position of Director in the Division of Molecular Genetics and Pathology in the Office of In Vitro Diagnostic Devices and Radiological Health, at Center for Devices and Radiologic Health at the FDA. At the FDA, she has been involved in many diverse activities including premarket clearance/approval, manufacturer assistance, post market regulatory compliance actions, and an ongoing participant in FDA multi-center reviews in companion diagnostics.

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Brittany Schuck, Ph.D. is a Senior Staff Fellow in the Division of Chemistry and Toxicology Devices in the Office of In Vitro Diagnostics and Radiological Health (OIR) at the FDA. In her current position, Dr. Schuck contributes to regulatory review of in vitro diagnostic devicesto assure that patients have access to safe, effective, and high quality medical devices.  Dr. Schuck is also involved in OIR’s efforts to foster innovation and advance regulatory science of in vitro diagnostic devices. Dr. Schuck’s regulatory review interests include genomics, proteomics, and microfluidic devices for use in specialized chemistry and cardio-renal diagnostic devices.

Prior to joining the FDA, Dr. Schuck completed her Ph.D. in Pharmaceutical Sciences at the University of North Carolina at Chapel Hill Eshelman School of Pharmacy and then completed a postdoctoral fellowship at the National Institutes of Health’s National Center for Advancing Translational Sciences.

QB3 Seminar: Zach Serber, Zymergen. "CSO: Point of the Innovation Spear"

Maintaining a competitive edge in technology is key to startup success. The chief technology or science officer keeps that edge sharp by conceiving and developing new innovations, often managing a team of scientists and engineers. So what's it like to have that responsibility? Join us on September 19 to find out. We'll hear from Zach Serber, CSO at Zymergen, which was recently profiled by Science for its application of robotics and machine learning to the refinement of industrial microbes.

Where and When

Room 160, Helen Diller Bldg., UCSF Mission Bay (1450 Third St., San Francisco)

12:00-1:00 pm, Tuesday, September 19

Eventbrite - Zach Serber, Zymergen. "CSO: Point of the Innovation Spear"

About the Speaker

Dr. Zach Serber is a scientist and entrepreneur devoted to using bioengineering to drive the next industrial revolution. In 2013, Dr. Serber co-founded Zymergen, a technology company unlocking the power of biology by combining biology with technology such as robotics and machine learning. Today, he is the company’s Chief Science Officer and Vice President of Development overseeing scientific direction, new products, and development teams.

Dr. Serber was previously the Director of Biology at Amyris where he worked on manufacturing bio-derived transportation fuels, on lowering the cost of the antimalarial drug, Artemisinin, and on developing advanced tools for engineering biology. He has been PI on multiple DARPA contracts including an $8M contract devoted to improving the genome engineering cycle and, currently, a $31M contract to develop 360 microbes, each producing a novel molecule with the potential to generate innovative polymers and materials.

Dr. Serber has 17 peer-reviewed publications in journals such as Cell and Science, multiple patents, and has worked as a research fellow at Stanford University Medical School. He has a PhD in Biophysics from University of California San Francisco, a MSc in Neuroscience from the University of Edinburgh, and a BA from Columbia University.

Zach lives with his wife, two children, and dog on a sailboat in Sausalito, CA.

Rosenman D-Series: Justin Klein, New Enterprise Associates

Join us Tuesday, September 12, when venture capitalist Justin Klein of New Enterprise Associates (NEA) will give us an inside view on the current state of healthcare investing. Christine Winoto, director of the Rosenman Institute, will interview Justin.

Where and When

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

5:00-7:00 pm, Tuesday, September 12

Eventbrite - An Interview with Justin Klein of New Enterprise Associates

About the Speaker

Justin Klein joined NEA in 2006 and is a Partner on the healthcare team. He focuses on medical device, healthcare technology, and biopharmaceutical company investments. He serves as a director of Advanced Cardiac Therapeutics, Cartiva, ChromaCode, FIRE1, Intact Vascular, Personal Genome Diagnostics, PhaseBio Pharmaceuticals, Relievant Medsystems, Senseonics (NYSE: SENS), VertiFlex, Vesper Medical, and VytronUS. Justin’s past board memberships and investments include CV Ingenuity (acquired by Covidien), Nevro (NYSE: NVRO), Topera (acquired by Abbott), TriVascular (NASDAQ: TRIV), and Ulthera (acquired by Merz). He is also a member of the advisory boards for the National Venture Capital Association’s Medical Industry Group and its Medical Innovation and Competitiveness Coalition (MedIC), as well as a member of AdvaMed's Business Development Committee.

Prior to NEA, Justin worked for the Duke University Health System—reporting directly to the hospital CEO on health system strategy, finance and clinical service unit operations—as Duke built one of the nation's first and largest healthcare integrated delivery systems. Justin concurrently earned his MD from the Duke University School of Medicine and his JD from Harvard Law School. He has also served as a member of the Board of Trustees of Duke University, where he earned his AB in Economics and his BS in Biological Anthropology and Anatomy.

QB3 Seminar: "Research in Space to Benefit Life on Earth," Liz Warren & Miki Sode, Center for the Advancement of Science in Space

Have you thought about the effect of gravity’s influence on your research? Gravity is a controlled variable on the International Space Station. Many researchers, biotech and pharmaceutical companies and entrepreneurs have been conducting breakthrough research on the ISS National Lab to take advantage of its unique environment. Liz Warren and Miki Sode from Center for the Advancement of Science in Space (CASIS) will present opportunities available for you to bring your science and innovation to higher potential, located 250 miles above Earth. Come join us on August 10th to learn more and start thinking about what science you would do onboard the ISS NL.

Where and When

Noon to 1:00 PM, Thursday, August 10

Room N-114, Genentech Hall, UCSF Mission Bay

Eventbrite - QB3 Seminar: "Research in Space to Benefit Life on Earth," Miki Sode & Liz Warren, CASIS

About the Speakers

Liz Warren, Ph.D., Associate Program Scientist, CASIS

Liz Warren, Ph.D., Associate Program Scientist, CASIS

Liz was born and raised in the San Francisco Bay Area, and attended the University of California at Davis for both her undergraduate and doctoral degrees in physiology. For her doctoral work, she investigated the effects of gravity as a continuum on energy balance in rats. She completed post-doctoral work in the San Francisco Veterans Affairs Laboratory of Cell Growth, and the Neuroscience Laboratory at NASA’s Johnson Space Center. She performed a variety of roles at NASA, including serving as Deputy Project Scientist for the NASA Bed Rest and Artificial Gravity Projects. Liz also spent several years as an Operations Lead in Mission Control for the ISS Medical Project. She joined CASIS in June of 2016. Liz enjoys travel, running, and learning to play the ukulele.

Miki Sode, Ph.D., Commercial Innovation Program Manager, CASIS

Miki Sode, Ph.D., Commercial Innovation Program Manager, CASIS

Miki combines her multi-disciplinary background and passion for space to advocate for utilizing the orbital environment to advance science and technology. Her curiosity about nature, particularly gravity (and the lack thereof), drove her to obtain a BA in Physics from UC Berkeley, a MS in Aerospace Engineering from San Jose State University and a Ph.D. in Bioengineering from UCSF & Berkeley's joint program. It was her work on bone loss in astronauts while at NASA Ames Research Center that motivated her to pursue her doctoral work on imaging and analysis of trabecular bone structure due to varying mechanical loading. Miki spent several years as a scientist at a clinical research organization helping pharmaceutical companies run clinical trials for FDA approval, mainly for therapeutics for musculoskeletal systems. Born in Tokyo, Japan, Miki calls the San Francisco Bay Area her home. Miki enjoys cooking, baking, arts & craft, skiing, and ballet, but most of all, spending time with her family to explore more of the beautiful Bay Area.

The Fourth Annual Rosenman Symposium

At the Rosenman Institute we’re here to support medtech startups. We connect entrepreneurs to the resources and expertise they need to commercialize their technologies. Helping innovators forge connections is why we’ve brought our legendary symposium back for a fourth year. Join us in San Francisco on June 21 to learn from leaders in the field, meet CEOs of exciting early-stage companies, and get insight on how industry forms strategic partnerships with startups.

Agenda

1:00 pm Registration

1:30 pm Welcome: Christine Winoto, Deputy Director, QB3; Director, Rosenman Institute

1:35 pm Steve Hetts, UCSF: "Hitting Cancer Hard While Limiting Collateral Damage"

1:55 pm Showcase: 2017 Rosenman Innovators

2:05 pm Justin Roberts, Medtronic: "TAVR: Developing and Cultivating a Breakthrough Therapy"

2:25 pm Showcase: 2017 Rosenman Innovators

2:35 pm Break

3:00 pm Robert Gaunt, University of Pittsburgh: "Wired Brains: Technology & Neuroscience for Rehabilitation"

3:20 pm Showcase: 2017 Rosenman Innovators

3:30 pm Richard Rapoza, Abbott Vascular: "Unexpected Consequences in Clinical Trial Design"

3:50 pm Showcase: 2017 Rosenman Innovators

4:00 pm Break

4:30 pm Panel Discussion: "Game of Thrones: Strategic Acquisition in Medtech"
Lisa Suennen, GE Ventures (moderator)
Jennifer Kozak, Johnson & Johnson
Chris Eso, Medtronic
Virginia Giddings, Stryker

5:30 pm Reception

QB3 Seminar: Meytal Waiss, FreeMind. "Beyond the SBIR: Non-Dilutive Funding for Your Startup"

Billions of non-dilutive dollars are awarded annually across scientific fields, mainly from NIH, DOD, and other government sources. In 2016 alone, domestic for-profit organizations received approximately $2.7 billion from awards ranging from $200k to multi-millions; ~$2 billion came from non-SBIR funders. In this presentation, Meytal Waiss of the FreeMind Group will give an overview of the non-dilutive funding landscape with an emphasis on NIH, DOD, and BARDA. She will discuss alternatives to SBIR/STTR, and describe the various mechanisms and pockets of money available, potential for funding, and means to maximize your chances of winning an award. Download the slide deck

Watch the YouTube video

Where and When

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

12:00-1:00 pm, Thursday, June 15

Eventbrite - QB3 Seminar: Meytal Waiss, FreeMind. "Beyond the SBIR: Non-Dilutive Funding for Your Startup"

About the Speaker

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Meytal Waiss, Director of Business Development at FreeMind, has spent most of her career as a part of the scientific community. Previously a Senior Project Manager in FreeMind’s Professional Department, Meytal has helped clients manage the complex application production process, submit, and win, and is now utilizing her strong background in the life sciences, grant writing, and understanding of non-dilutive funding to guide potential clients through the first stages of the process. Meytal holds a Master’s degree in Cellular and Developmental Biology from the Hebrew University of Jerusalem, where she specialized in Neurodegenerative Diseases and Microscopy.

Rosenman D-Series: Marijke Annis, Ruckus Partners. "Reimbursement 101 for Medtech Startups"

Regulatory approval no longer guarantees market access. Payers control the health care dollar and ultimately if and how patients access new technologies. Understanding the reimbursement challenges your technology may face and setting a strategy early in the product development process will help ensure you can navigate payer challenges. Attendees will leave with an understanding of the current U.S. reimbursement system and how to navigate coding, payment and coverage.

Where and When

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

5:00-7:00 pm, Thursday, May 18

Eventbrite - D-Series: Marijke Annis, Ruckus Partners. "Reimbursement 101 for Medtech Startups"

Agenda

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

6:00 pm onward: Networking

About the Speaker

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Marijke Annis, MSPH, Founder, is a reimbursement expert whose work has realized multiple, positive coverage and payment decisions for innovative medical solutions across devices and diagnostics. Having worked in payer relations for integrated health delivery systems, she offers a unique ‘inside-payer’ perspective that serves to shape these successful strategies. Prior to founding Ruckus Partners, she held leadership positions for companies and health care providers across the market - hospital and physician groups, diagnostics and medical devices and she knows cardiology, women’s health, oncology, hematology, pulmonology, and ophthalmology. Her former roles include reimbursement leadership for CardioDx, Abbott Vascular, and Guidant, and in managed care for Tenet Health Care.

Marijke received a MSPH from the University of North Carolina Chapel Hill and a BA from Emory University.

Leadership in Biopharma: a Conversation with John Milligan, CEO, Gilead Sciences

Gilead Sciences is a Bay Area titan, a life science leader known for its pipeline of antivirals and Hepatitis C therapeutics. Its CEO is John F. Milligan, PhD, a former UCSF postdoc, who joined the company in 1990 as its 32nd employee. Join us on May 11 when Barry Selick, CEO of Threshold Pharmaceuticals and himself a former UCSF postdoc, will engage Milligan in a conversation touching on topics such as Milligan's career path from postdoc to CEO of a major biotech, his experience leading it, and how Gilead feeds its pipeline of innovation and develops new products.

Brook Byers, a Founding Partner of Kleiner Perkins Caufield & Byers and a member of the UCSF Board of Overseers, will provide introductory remarks.

Where and When

Byers Auditorium, Genentech Hall, UCSF Mission Bay (600 16th St., San Francisco)

4:00-5:00 pm, Thursday, May 11

Eventbrite - A Conversation with John Milligan, CEO, Gilead Sciences

Agenda

4:00 pm Introduction: Brook Byers, Partner, Kleiner Perkins Caufield & Byers

4:00-5:00 pm Remarks from John Milligan, Gilead Sciences, followed by audience Q&A and a conversation moderated by Barry Selick, Threshold Pharmaceuticals

5:00-6:30 pm Reception

About the Speakers

Dr. John F. Milligan joined Gilead Sciences in 1990 and was appointed Chief Executive Officer in March 2016. He began his career at Gilead as a research scientist, and subsequently held leadership positions in project management and corporate development before being named Chief Financial Officer in 2002. He was appointed Chief Operating Officer in 2007 and President in 2008.

During his tenure at Gilead, Dr. Milligan has led teams that have developed, manufactured and commercialized more than 20 new therapies for significant unmet needs. He has managed multiple transformative acquisitions, licensing agreements and financings, helping the company grow into a worldwide organization reaching more than 10 million patients. He is a member of the board of Pacific Biosciences of California, Inc. and a Trustee of Ohio Wesleyan University.

Dr. Milligan received his BA from Ohio Wesleyan University, his PhD in biochemistry from the University of Illinois and was an American Cancer Society postdoctoral fellow at the University of California at San Francisco.

Harold E. "Barry" Selick, Ph.D. joined Threshold as Chief Executive Officer in June 2002. Between June 2002 and July 2007, Dr. Selick was also a Venture Partner of Sofinnova Ventures, Inc., a venture capital firm. From January 1999 to April 2002, he was Chief Executive Officer of Camitro Corporation, a biotechnology company that was acquired by ArQule. From 1992 to 1999, he was at Affymax Research Institute, the drug discovery technology development center for Glaxo Wellcome plc, most recently as Vice President of Research. Prior to working at Affymax he held scientific positions at Protein Design Labs, Inc. and Anergen, Inc. As a staff scientist at Protein Design Labs, he co-invented the technology underlying the creation of fully humanized antibody therapeutics and applied that to PDL's first product, Zenapax, which was developed and commercialized by Roche for the prevention of kidney transplant rejection. Dr. Selick received his B.S. and Ph.D. from the University of Pennsylvania and was a Damon Runyon-Walter Winchell Cancer Fund Fellow and an American Cancer Society Senior Fellow at the University of California, San Francisco.

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Brook Byers is a Founding Partner of Kleiner Perkins Caufield & Byers. A venture capital investor since 1972, Brook has been closely involved with more than 60 new technology-based ventures, many of which have become public companies. He formed the first life sciences practice group in the venture capital profession in 1984 and led KPCB to become a premier venture capital firm in the medical, healthcare and biotechnology sectors. KPCB has invested in and helped build more than 170 life sciences companies that have developed hundreds of products to treat underserved medical needs for many millions of patients. Brook was the founding president and then chairman of four biotechnology companies that were incubated in KPCB’s offices and went on to become public companies with an aggregate market value of more than US$8 billion. He serves on the board of directors of Cell Design Labs, Enjoy, Newsela and Zephyr Health. Brook is also a Lifetime Director on the UCSF Board of Overseers. Full bio on KPCB website