Better Data, Better Tools, Better Decisions – An Overview of the FDA's Office of Computational Science

FDA’s Office of Computational Science (OCS) provides FDA reviewers at the Center for Drug Evaluation and Research (CDER) with innovative and reliable solutions that improve and strengthen the scientific review process by integrating data, computational tools, and training. OCS helps reviewers understand, analyze, and use their data so they spend more time thinking about the results of the data analyses rather than setting up those analyses, thereby improving and expediting the review process. Join us on July 31 to hear from OCS scientists and learn how the FDA is leveraging computational tools, services and training into the scientific review process.

Where and When

Room 160, Helen Diller Bldg., UCSF Mission Bay (1450 Third St., San Francisco)
3:00 to 4:00 PM, Tuesday, July 31, 2018

About the Speakers

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Lilliam Rosario, PhD is the Director of the Office of Computational Science (OCS) in the Office of Translational Sciences, Center for Drug Evaluation and Research. OCS leads and directly supports the modernization of CDER’s scientific review capabilities. OCS innovates tools, technologies, and services specifically for drug product review and then provides these to reviewers at the right time backed up with training and support. Acknowledging that successful review starts with good data, OCS continues to support efforts to regularly achieve high quality data. OCS received the Health and Human Services Secretary’s Award for its work in developing CDER’s JumpStart program, an innovative initiative dedicated to enhancing the efficiency of CDER’s new drug development and review process. OCS continues to innovate and service reviewers as Dr. Rosario has led to the OCS to make real it’s motto: Better data, better tools, better decisions.

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Crystal Allard is the Data Quality Team Lead in the Office of Computational Science at the FDA/CDER where she leads work in study data standards, data management, and business process in support of regulatory review. Crystal also manages all collaborations with the OCS. Crystal has a bachelor’s degree in Biology from Binghamton University and is a current masters student in Information Quality at the University of Arkansas at Little Rock. She has worked at the FDA since 2008 and at the OCS since 2012.

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Qais Hatim received a dual Ph.D. degree in operation research and industrial engineering and graduate minors in statistics and high performance computing from Pennsylvania State University/University Park in 2015. In 2015, he also joined FDA. Currently Qais’s main roles as computer scientist/statistician at FDA is conducting research in statistical/operational modeling and computer science as well as supporting other activities at CDER/ Office of Translational Science (OTS)/ Office of Computational Science (OCS) in FDA. In his work, he is utilizing machine learning and data mining algorithms, natural language processing (NLP) techniques, Neural Networks procedures, and Bayesian analytics to extract meaning, patterns and hidden structures in structured and unstructured data. He is active member in several organizations within and outside FDA.

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After 7 years as a PM/BA at a software development company, Matt Steele joined FDA in 2016 as a project lead in FDA’s Office of Computational Science (OCS) for the inspectional and risk based tools. He is currently managing the effort to modernize and improve this suite of tools and is a member of multiple working groups aimed at improving the business processes and technology used across various offices within CDER.

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Kendra Worthy PharmD, is Team Leader, Tools, Technology & Innovation at OCS. She oversees a team that manages the development and maintenance of analytical tools that empower clinical reviewers to conduct their regulatory reviews with greater efficiency.

She was commissioned as a Lieutenant (O-3) in the U.S. Navy and served as a pharmacy manager at National Naval Medical Center during the Global War on Terrorism.  In 2004, she transferred to the U.S. Public Health Service (USPHS) Commissioned Corps as a Drug Utilization Analyst with the Food and Drug Administration Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology.  She’s held several leadership positions working in Risk Evaluation and Mitigation Strategies (REMS) and Medication Errors. As an officer USPHS, Kendra has deployed on missions for Hurricanes Katrina and Ike (both in Baton, Rouge, LA) as well as for the H1N1 Swine Flu outbreak.  She has also assisted the Attending Physician staff at the United States Capitol for State of the Union Addresses for President George W. Bush.

 

The Fifth Annual Rosenman Symposium on Health Technologies

The annual Rosenman Symposium is the premier event 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.

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

Agenda

Welcoming Remarks: Sam Hawgood, Chancellor, UCSF

Featured Speakers:

  • Benson Smith, Chairman, Teleflex
  • Tejal Desai, Chair, Department of Bioengineering & Therapeutic Sciences, UC San Francisco
  • Joe DeSimone, CEO & Co-Founder, Carbon
  • Jeffrey Shuren, Director, Center for Devices & Radiological Health, FDA
  • Andrew Thompson, CEO, Proteus Digital Health

 
Panel Discussion: "The Future of Innovation in Health Technologies: Aligning All the Stakeholders"

Moderator: Josh Makower, General Partner, NEA

Panel Members:

  • Tim Homer, VP Health Policy, Market Access & Government Affairs, iRhythm
  • Wende Hutton, General Partner, Canaan Partners
  • Kate Rosenbluth, CEO & Co-Founder, Cala Health
  • Jeffrey Shuren, Director, Center for Devices & Radiological Health, FDA
  • Renee Compton Ryan, VP, Venture Investments, J&J Innovation

 
With presentations by the 10 startup companies selected as the 2018 cohort of the Rosenman Innovators.
 
Reception to follow.

QB3 Seminar: Mickey Urdea, Halteres Associates. "Why Do Diagnostics Companies Fail?"

Over the last decade, several diagnostics companies that initially appeared to be on a path to success ultimately failed. The Gates Foundation asked a diagnostics consulting firm, Halteres Associates, to study the phenomenon. Classifying 28 companies as "Successes," "Failures," and "Zombies," the firm found that key indicators of success or failure emerged as companies drove their concepts toward commercialization. Want to get the details? Join us on May 15 to hear from Mickey Urdea, a diagnostics entrepreneur and founding partner at Halteres. Download the slide deck

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th Street, San Francisco)
12:00 to 1:00 PM, Tuesday, May 15

About the Speaker

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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.

Office Hours: Legal Help on Immigration in Life Science. Atessa Chehrazi & Robert Herreria, Jackson & Hertogs

Life science startups need talented employees with specialized skills--who are not necessarily US citizens or permanent residents. And US immigration law is continually in flux. If you're a Bay Area life scientist who needs legal advice on your status, or an employer seeking how to hire or retain a foreign scientist, these office hours are for you. Sign up for a 30-minute, one-on-one introductory session with lawyers Atessa Chehrazi and Robert Herreria of the San Francisco immigration firm Jackson & Hertogs. This session will be a pro bono consult, with the legal advice and relationship limited to the clinic and based on the limited information provided.

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

To hold your slot for this session, we 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 48 hours in advance. We regret that we cannot honor requests made at a later time.

Where and When

Suite 214, Byers Hall, UCSF Mission Bay (1700 4th Street, San Francisco)
9:00 AM to 12:00 PM, Friday, May 4

Reserve Your Slot

About the Experts

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Atessa Chehrazi has been a partner at Jackson & Hertogs since April 2013 and an associate/senior associate since July 2000. She was previously an associate at Maggio & Kattar in Washington, D.C. from 1996 to 2000. She has held several volunteer roles within the American Immigration Lawyers Association (AILA) during her career. For AILA’s Northern California Chapter, she has served as Chair, Vice-Chair, Treasurer, U.S. Citizenship & Immigration Service (USCIS) liaison, and Customs & Border Protection (CBP) liaison. On a national level, Atessa served on AILA’s USCIS Headquarters and Benefits, Administrative Appeals Office (AAO), and Department of Labor (DOL) liaison committee. In addition, Atessa has served on AILA’s Business Immigration Advocacy, Issues, and Due Process & Civil Liberties committees, as well as several conference committees. She has authored articles published in AILA Handbooks and has presented at national and regional AILA conferences. Atessa has served as a board member of the Iranian American Bar Association Northern California chapter since 2009, served as President of the chapter 2014-2015, and was the chapter honoree at the Bar Association of San Francisco Minority Bar Council annual unity awards event in 2014. She is a member of the National Lawyers Guild and was the NLG Immigration Project’s honoree in 2013. Atessa has been highly reviewed in legal directories, including selection as a Northern California “Super Lawyer” (2010-2012, 2015-2017), and listing in the International Who’s Who of Corporate Immigration Lawyers (2011-2015).

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Robert L. Herreria joined Jackson & Hertogs as an Associate in January 2016. He has over eight years of experience in U.S. immigration law as an attorney and case manager with business and employment immigration firms, as well as in internships with the U.S. Executive Office for Immigration Review and Immigration and Customs Enforcement. Robert has represented a wide range of small, medium, and large businesses, corporations, and organizations in identifying and executing efficient and effective immigration strategies for critical hires and valued employees. He has experience advising employers on nonimmigrant and permanent residence cases as well as immigration workplace compliance and related issues. He has also written articles on U.S. immigration topics including family and employment-based immigration and was previously a contributing editor for “Fiancé & Marriage Visas: A Couple’s Guide to U.S. Immigration”, published by Nolo.com. Robert has been admitted to practice law in California since 2011. He is a graduate of the University of San Diego School of Law and is an active AILA member.

Rosenman D-Series: David Kim, DigiTx Partners. "Investing Insights in Digital Health"

Digital health is a sector of the health ecosystem that has enormous growth potential. What’s really piquing investors’ interest these days? Are there any special factors that make certain digital health companies more attractive than others? What trends are emerging, and what major unmet needs are still crying out for a solution that would bring investors running? Join us on May 1 to get answers from David Kim of the investment firm DigiTx Partners.

Where & When

Room N-114, Genentech Hall, UCSF Mission Bay (600 16th Street, San Francisco)
5:00 to 6:30 PM, Tuesday, May 1

Agenda

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

About the Speaker

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David is the CEO of DigiTx Partners, bringing both business and clinical expertise to venture capital with an extensive background practicing medicine and building healthcare software companies. Most recently, Dr. Kim served as the COO of Lumiata, a venture-backed predictive analytics company positioned at the intersection of data science and medical science. Prior to Lumiata, he spent over a decade as an investor evaluating and growing healthcare companies at MPM Capital and Pinnacle Ventures. Before entering the business sector, David practiced as a general internist and hospitalist at Kaiser South San Francisco where he also served as the Director of Urgent Care and Assistant Chief of Internal Medicine. David completed his internal medicine residency at Harbor-UCLA Medical Center and is a graduate from the Johns Hopkins University School of Medicine (M.D), Stanford Graduate School of Business (M.B.A.), and Pomona College (B.A., Biology). In addition to leading the DigiTx fund, David serves as an active advisor to the Catalyst Program within the UCSF Clinical & Translational Science Institute.

QB3 Seminar: Jon Norris, Silicon Valley Bank. "New Investors, Valuations and Recent Exits for Diagnostics Companies"

Who's investing and acquiring diagnostics startups? What technologies are they interested in, and how are they putting valuations on the companies? Nobody has a better view of the space than Jon Norris, who analyzes healthcare VC trends for Silicon Valley Bank. Join us April 24 at UCSF Mission Bay, when Jon will tell us what happened in 2017 and what he expects to see in the year ahead.

Lunch provided, but space is limited.

Where & When

Room 212, Byers Hall, UCSF Mission Bay
Noon to 1:00 PM, Tuesday, April 24

About the Speaker

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Jonathan Norris, JD is a managing director of sales origination for Silicon Valley Bank. Norris oversees business development efforts for banking and lending opportunities as well as spearheading strategic relationships with many life science and healthcare venture capital firms. He also helps SVB Capital through sourcing and advising on limited partnership allocations.

In addition, he speaks at major investor and industry conferences and authors widely cited analyses of healthcare venture capital trends. Norris has more than sixteen years of banking experience working with healthcare companies and venture capital firms.

Norris earned a bachelor's degree in business administration from the University of California, Riverside and a juris doctorate from Santa Clara University.

Rosenman D-Series: Kirsten Carroll, Imperative Care. "How to Develop, Communicate, and Deliver on a Winning MedTech Strategy"

There is a seemingly limitless number of frameworks for strategy development. Using them well lays a critical foundation for aligning teams and investors and ensuring long term success. Kirsten Carroll will review the role strategy plays in business planning and the importance of not just developing a great one, but also communicating it effectively. She will provide examples of the frameworks that have served her particularly well in her own career with advice on when and how to use them.

Where and When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
5:00 to 6:30 PM, Tuesday, April 3, 2018

Agenda

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

About the Speaker

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Kirsten Carroll holds over 15 years of experience in product development, marketing, strategy and business development for medical devices in stroke care. In November 2017, she joined Imperative Care (an Incept Company), working under the leadership of Fred Khosravi. Prior to her new role, Kirsten was the Senior Director of Strategic Development at Stryker Neurovascular, leading business intelligence, NV services products and BD deal modeling and diligence activities. Kirsten’s first 8 years at Stryker Neurovascular (previously Boston Scientific) were spent in a succession of marketing management roles in the access and hemorrhagic stroke franchises. During that tenure she acted as marketing lead on multiple product development teams, the MAPS Trial, and ultimately the Target Coil, which went on to realize over $1B in revenue to-date and remains the #1 embolization coil in the world. Following the neurovascular division’s acquisition by Stryker in 2011, Kirsten moved into Marketing Operations, ultimately building it into a 9-person Strategic Development function that managed business development, portfolio planning and business intelligence. She holds 2 patents on pre-shaped microcatheters and is a contributing author on 3 publications in the American Journal of Neuroradiology. Kirsten earned a B.Sc. in biomedical engineering from Yale University and an MBA and MPH from the Haas School of Business at UC Berkeley.

QB3 Seminar: Jill Fuss, CinderBio. "The Science of a Startup: Applying the Scientific Method to Start a Biotech Business"

Join us March 29 at UCSF Mission Bay to hear from Jill Fuss, co-founder and CTO/COO of CinderBio. Jill, also an LBNL scientist, will frame her startup experience as an exercise of the scientific method, from testing hypotheses to dealing with unexpected results. Come meet her in person for what is sure to be a compelling talk and Q&A.

Where and When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
Noon to 1:00 PM, Thursday, March 29, 2018

About the Speaker

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Jill Fuss, PhD, is co-founder and CTO/COO of CinderBio, a company that produces extreme enzymes for industry using proprietary technologies. She is also a research scientist at Lawrence Berkeley National Laboratory, where she determines the structural biology of DNA repair enzymes. She earned her PhD in molecular and cell biology at UC Berkeley.

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.