Rosenman D-Series: Eric Stone, Velano Vascular. "Innovating the Obvious: The Complex Value of Simple Ideas"

Join us on Thursday, March 8, to hear from Eric Stone, CEO and co-founder of Velano Vascular. Under Eric's leadership, Velano's PIVO™ needleless blood draw technology won FDA approval; the company raised $17 million this past March; and Velano has just been named to the 2017 Fierce 15 in Medtech.

 

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
5:00 to 6:30 PM, Thursday, March 8

Agenda

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

About the Speaker

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Eric M. Stone is the Chief Executive Officer and co-founder of Velano Vascular. A patient advocate and serial healthcare entrepreneur, Stone currently serves as National Trustee and a Committee Chair of the Crohn's and Colitis Foundation of America (CCFA). Prior to Velano, he served as Vice President of Sales and Marketing for Molecular Health, and earlier in his career launched a series of pioneering interventional cardiology devices for Abbott while based in Brussels, Belgium and California. Stone was a founding member of Model N's (NYSE: MODN) Life Sciences division, where he led marketing and business development. Stone began his career in Marketing with Trilogy Software, and has since co-founded social sector programs at Harvard and Wharton. He served for a decade on Harvard University's Alumni Association (HAA) Board of Directors. Stone is a Director of Vigilant Biosciences and an Advisor to multiple healthcare upstarts. Stone received an MBA from The Wharton School, a Master's from Harvard University, and a BA from the University of Pennsylvania. He lives with his wife and daughter in San Francisco.

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

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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.

QB3 Seminar: Eric Hobbs, Berkeley Lights. "Destroyer of Obstacles": Going from a 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 to hear for yourself.

Where and When

Room N-114, Genentech Hall, UCSF Mission Bay (600 16th St., San Francisco)
Noon to 1:00 PM, Thursday, February 22, 2018

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: Sean O'Donnell, Experien Group. "They're Not Optional: Quality Management Systems for Startups"

A Quality Management System (QMS) is a crucial part of a medtech startup's path to market. It demonstrates to the FDA that your company can provide safe and effective devices that meet all regulatory requirements and customer needs. A QMS comprises many interconnected elements. Do you know what they all are? Join us at this talk to get an overview from Sean O'Donnell, Chief Quality Officer at Experien Group, a consulting firm specializing in QMS, Regulatory, and Clinical support. Sean will detail the composition of QMS, explain how they interact with regulatory affairs, and describe how US agencies enforce compliance.

Where and When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
5:00 to 6:30 PM, Tuesday, February 13, 2018

Agenda

5:00 to 5:30 PM: Registration & Networking
5:30 to 6:30 PM: Talk and Q&A

About the Speaker

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Sean O'Donnell is the Chief Quality Officer for Experien Group, a medical device consulting firm headquartered in northern California that helps companies develop and execute successful FDA and international regulatory programs.  In addition to managing the Quality team, Sean holds particular expertise in software-based technologies as well as usability engineering standards for complex medical devices. He supports clients’ U.S. and international regulatory submissions and functions as Experien Group’s interface with regulatory agencies through audits and inspections. Sean has completed AAMI Certification for Mastery of the Quality System Regulation and a Lead Assessor Program for ISO 9000 with emphasis on ISO 13485. He was a certified instructor on Process Validation for Siemens Medical Solutions and Boston Scientific and a course instructor for De Anza College Center for Applied Competitive Technology. Sean achieved a B.S. from San Jose State University in Chemical Engineering.

QB3 Seminar: Ben Stern & Brandon Service. "How to Find the Right Lab Space for Your Startup"

So you're looking for lab space for your startup to do R&D. Depending on what you need, you may have to make some hard choices. What is most important--location, space, or facilities? What about future expansion? How best to compare sites, and come to a rational decision? On Thursday, February 1, Ben Stern from the commercial real estate firm Newmark Knight Frank will give us a primer for life science entrepreneurs.

Where & When

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

About the Speakers

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Ben Stern: One of the most active tenant representation agents in the San Francisco Bay Area, Ben Stern is a top producing agent for Newmark Knight Frank (formerly Cornish & Carey), the largest commercial brokerage in Northern California (330 agents/13 offices). With an expertise in the life sciences his clients include Fortune 500 companies and startups looking for their first facility. Mr. Stern has directly managed the successful completion of over 900 headquarter leases, ground leases, build-to-suits, sales and acquisitions for corporate users (11 million square feet/$2B+ in consideration).

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Brandon Service: Specializing in representing tenants (startups and large corporate users) on the development and execution of real estate strategies throughout the Bay Area. Prior to joining Newmark Knight Frank, Brandon Service worked as a senior construction project manager for high-growth technology and life science companies. In this capacity, Mr. Service managed all aspects of corporate headquarters relocations, vendor negotiations, timelines and budgets. He also managed the construction of tenant improvements for projects ranging from small start-ups to multi-building campus headquarters comprising 300,000 square feet or more.

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

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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: 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

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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

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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.