Ryan Pierce, Nine, Rock Health, & Stanford: "The First Dollar: Strategies and Ethics of Seed-Stage Fundraising"

Ryan Pierce, Nine, Rock Health, & Stanford: "The First Dollar: Strategies and Ethics of Seed-Stage Fundraising"

What is the right way to raise a seed round?  Even as founders strive to focus on innovation and execution, they must make myriad decisions, big and small, on fundraising.  Whom should I pitch first?  What's the smallest check I should accept?  Do I price the round or raise on a convertible note, and on what terms?  Join us as healthcare product designer, entrepreneur, and investor Ryan Pierce tests conventional wisdom against a survey of his peers, considers the ethics of taking early-stage money, and shares his own lessons from both sides of the table.

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
5:00 to 6:30 PM, Tuesday, December 11

Agenda

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

About the Speaker

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Ryan Pierce is Co-Founder and CEO of Nine, Entrepreneur-in-Residence at Rock Health, and Lecturer in Bioengineering at Stanford, where he teaches BIOE 70Q: Medical Device Innovation.  He has served as VP of Design and Innovation at Ventus Medical, VP of Business Development at Loma Vista Medical, a healthcare investor at De Novo Ventures, and a product designer at Concentric Medical and The Foundry/Zephyr Medical.  An inventor on over two dozen issued U.S. patents, he has designed FDA-cleared devices to treat sleep apnea and stroke.  Ryan holds mechanical engineering degrees from MIT and Stanford, and an MBA from Harvard Business School.

Rajan Patel, iO life science. "Learn About Experience Design for Medical Devices"

Rajan Patel, iO life science. "Learn About Experience Design for Medical Devices"

If your product addresses a viable market, it will have competition. Your commercial success can depend to a large extent on the good or bad experience that users--clinicians and patients--have while using your device or system. How can you ensure that users have a good experience? Join us to learn from Rajan Patel, founder and CEO of the firm iO life science. (Speaker info has been updated from the original)

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
Thursday, November 29, 2018, 5:30 to 6:30 PM

Agenda

5:30 - 6:15 PM: Talk
6:15 - 6:30 PM: Q&A

About the Speaker

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Rajan Patel is founder and CEO of io life science. He is a medical device executive who partners with healthcare brands to transform their design & development practices. After 30+ years of medical device development across drug delivery, diagnostic systems, surgical devices and digital medicine, Rajan knows what truly drives innovation of smart, connected and patient-centric devices. It’s about collaborating with partners who are dedicated to creating breakthrough therapeutic solutions to unmet patient needs. Rajan has held senior positions across such companies as Minimed, Heartport, Aerogen, M2 Medical, Cirtec Medical and Lunar, leading programs to develop & commercialize medical products. Rajan’s commitment over the past 15+ years has been to organizations dedicated to transforming lives through revolutionary drug delivery and medical device technologies. Rajan has led numerous research & development and manufacturing teams to successful execution and launch of life-impacting devices. Rajan holds a B.S. in Mechanical Engineering from MS University of Baroda and M.S. in Biomedical Engineering from UC Davis/CSUS.

Johnny Lam & Kyung Sung, FDA-CBER. "Meet the FDA: Regulatory Science Insights into Cell-Based Products"

"Meet the FDA: Regulatory Science Insights into Cell-Based Products"

Kyung Sung, Ph.D., Principal Investigator

Johnny Lam, Ph.D., Staff Fellow

Cellular and Tissue Therapies Branch, Division of Cellular and Gene Therapies, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research

This event is held in partnership with UCSF-Stanford CERSI.

Where & When

Room 2103, Mission Hall, UCSF Mission Bay (550 16th St., San Francisco)
2:00 to 3:00 PM, Friday, November 9

As described in the 21st Century Cures Act, products eligible for Regenerative Medicine Advanced Therapy (RMAT) designation include cellular therapies, therapeutic tissue engineered products, human cell and tissue products, or any combination products that use such therapies or products. Multipotent stromal cells (MSCs) and induced Pluripotent Stem Cells (iPSCs) have been popular sources for manufacturing RMAT products due to their ability to undergo lineage-specific differentiation. Despite great promise, successful clinical translation of such cell-based products is often hindered by manufacturing challenges and the lack of reliable markers that can predict the products’ in vivo performance. For instance, MSCs are very heterogeneous and responsive to their surrounding environment, resulting in distinct subpopulations of cells with potentially different amounts of qualities needed for product potency. Since there are numerous biochemical and biomechanical factors regulating the functions of MSCs, it is critical to develop reliable high-throughput assays that enable the efficient exploration of large and complex parameter spaces for evaluating cellular function. Microscale in vitro systems offer the practicality to fulfill this unmet need. Several simple microfluidic channel arrays have been successfully implemented in screening the influence of paracrine mediators and various tissue microenvironment components in the regulation of cellular functions. In addition, microphysiological three-dimensional organoids and tissue-like structures such as chondrogenic cell aggregates and blood vessels have been incorporated into high-throughput, cell-based screening platforms in efforts to provide functionally relevant in vivo-like conditions. This presentation will give an overview of practical microscale technologies that are simple to operate while enhancing throughput, relevance, and reliability. How such technologies could be employed in the assessment of cell-based products will be discussed.

About the Speakers

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Dr. Johnny Lam is a biomedical engineer with expertise in biomaterials and in developing practical microscale in vitro tools for medical and biological applications. Dr. Lam’s main research interests involve studying multipotent stromal cells (MSCs, otherwise known as mesenchymal stem cells) and how their quality attributes relate to their functional potential using physiologically relevant, higher-throughput platforms. Dr. Lam received his Ph.D. in Bioengineering in 2015 at Rice University, where he developed and evaluated injectable multi-layered hydrogel composites for cell and controlled growth factor delivery for in vivo cartilage tissue repair. Following his graduate studies, Dr. Lam joined the Center for Biologics Evaluation and Research at the FDA as a post-doctoral researcher, where he now works as a Staff Fellow. His research now focuses on the development and adaptation of wide-ranging microphysiological platforms to evaluate various functional outcomes of MSCs toward improving the quality and potency of manufactured cell-based products.

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Dr. Kyung Sung is a biomedical engineer with expertise in developing functional and practical microscale in vitro tools for medical and biological applications. Dr. Sung’s main research interests lie in studying cell-materials interactions and exploring cell behavior in various tissue microenvironmental conditions. Dr. Sung received her Ph.D. in Chemical Engineering in 2007 at the University of Michigan, and worked as a post-doctoral researcher in the Department of Biomedical Engineering at the University of Wisconsin-Madison, where she also worked as a Principal Investigator before she joined the FDA in 2015. She also worked as a patent examiner in Biotechnology at the US Patent and Trademark Office. During her previous research, she used principles from tissue and microsystems engineering to develop tissue-like structures such as blood vessels and mammary ducts in microfluidic channels to develop new practical tools to conduct cancer research in vitro. The microscale in vitro systems provide unique capabilities when studying complex interactions occurring in tissue microenvironment, by providing more precise controls of biochemical and biomechanical factors than traditional platforms. She has been able to create innovative opportunities and strategies for researchers to explore biology in different ways – particularly in understanding the role of the tissue microenvironment in regulating cellular functions.

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.

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.

Conversation: 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.

Interview: Justin Klein, NEA

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

Agenda

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

6:00 pm onward: Networking

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.