Past QED talks & material

Elizabeth Iorns, Science Exchange

“From academic to entrepreneur: starting Science Exchange”
Tuesday, February 18, 2014, noon-1:00 pm
UCSF Mission Bay, Genentech Hall, Room N-114
[ slides ]


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I will share the lessons I’ve learned from my experience as a founder of Science Exchange and the Reproducibility Initiative. In particular, what made leaving academia to work on a startup seem like an attractive career choice, how to find the right opportunities, and how to be competitive in the business world.

Speaker bio

Dr. Elizabeth Iorns is co-founder and CEO of Science Exchange, the marketplace for scientific collaboration, where researchers can order experiments from the world’s best labs. The mission of Science Exchange is to improve the quality and efficiency of scientific research by using market-based incentives to promote collaboration between scientists. She has a Ph.D. in Cancer Biology from the Institute of Cancer Research in London, and a Post Doctorate in Cancer Biology from the University of Miami’s Miller School of Medicine. She has received a range of honors, including the 2012 Kauffman Foundation Emerging Entrepreneur Award, Nature Magazine’s ‘Ten People Who Mattered in 2012’, and is a graduate of the Y Combinator Summer 2011 program. Based on her own experiences as a young investigator seeking expert collaborations, Dr. Iorns co-founded Science Exchange. In 2012, after recognizing the need to create a positive incentive system that rewards independent validation of results, Dr. Iorns created the Reproducibility Initiative.

Larry Kammerer and Richard Croghan, Partners, Moss Adams LLP

“Practical Tax Filing Tips for Startups”
Tuesday, February 4, 2014, noon—1 pm
UCSF Mission Bay, Helen Diller Bldg., Room 160

Spend an hour with the experts from the CPA firm of Moss Adams to learn your tax filing requirements and practical approaches to stay in compliance.

Speaker bios


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Larry has been practicing public accounting since 1985, focusing on venture-funded technology companies and high net worth individuals. He specializes in outsourced accounting and consulting for start-up companies and personal CFO services for individuals. Larry is a frequent speaker at entrepreneur-focused events on the topic of creating and growing start-up businesses and has been recognized by the American Institute of Certified Public Accountants as a pioneer in combining cloud-based technology with outsourced accounting services to transform the way companies and individuals solve their financial challenges.





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Rich is a tax partner with over 20 years of public accounting experience, including 13 years with a Big 4 firm. He has extensive experience working with life sciences companies ranging from early stage start-ups to multi-national public entities. He assists companies with tax compliance, tax accounting and tax planning.







Antoinette Konski and Alex Nie, Foley & Lardner LLP

“Advanced Intellectual Property Strategies”
Tuesday, January 14, 2014, noon-1:00 pm
UCSF Mission Bay, Helen Diller Bldg., Room 160

Speaker bios

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Antoinette F. Konski is a partner with Foley & Lardner LLP where her practice focuses on intellectual property. She works with life science clients, creating and optimizing value in intellectual property portfolios encompassing technologies that include personalized medicine, regenerative and stem cell biology, antibodies, immunology, gene therapy, nanotechnology, diagnostics, small molecules and drug delivery. She represents public and private companies and universities. Ms. Konski currently serves as the firm’s Silicon Valley IP office chairperson and co-chair of the Life Sciences Industry Team.

Ms. Konski’s practice includes:

  • Identifying diverse commercial applications for early stage technologies
  • Developing, prosecuting and managing global intellectual property portfolios
  • Advising clients on preparing for due diligence investigations and conducting due diligence of target intellectual property
  • Providing inventorship; patent invalidity, freedom to operate and non-infringement opinions
  • Advising clients on domestic and foreign IP acquisitions
  • Assisting clients resolve intellectual property disputes in non-litigious forums

In 2013, Ms. Konski was named one of Silicon Valley’s Women of Influence by the Silicon Valley Business Journal. In 2011, she was selected as a Top 25 IP Portfolio Manager in California and one of 25 Leading Biotech Lawyers in California, each by the Daily Journal. She was recently recognized by the Legal 500 for her work in the area of health care – life sciences in 2013 and was also recognized in the Legal 500 US 2009 Edition and in the Legal 500 US: Volume II: Intellectual Property, Media, Technology, and Telecom 2007 Guide as a top attorney for patent prosecution.

Dr. Alex Nie is an associate and patent attorney with the law firm Foley & Lardner LLP. Alex’s practice focuses on patent procurement and monetization. Alex has dual technical background, and his training includes a Ph.D. degree in biochemistry, an M.S. degree in computer science and many graduate courses in statistics and engineering. Within biotechnology, Alex’s focus includes biologics, pharmaceutics, in vitro diagnostics, and stem cell technology. In high technology, Dr. Nie works with industry and academic clients in the fields of mobile technology, cloud computing, artificial intelligence, data mining and data security. Alex has extensive experience working with startup companies, helping them to secure IP protection and align it with product and market development.

Prior to his legal career, Alex was a senior scientist with Johnson & Johnson Pharmaceutical R&D, L.L.C. He has published 25 peer-reviewed scientific articles and two book chapters.


Kathryn Phillips, UCSF

“‘Show me the money’: demonstrating value and obtaining reimbursement for new technologies in a changing health care environment”
Tuesday, December 3, 2013, noon-1:00 pm
UCSF Mission Bay, Byers Hall, room 212
[ slides ]

In today’s changing health care and investor environment, it is even more critical that entrepreneurs develop a strong value proposition and reimbursement approach during the early stages of product development. This presentation will discuss how the value of new technologies can be defined and demonstrated within the broad context of payer coverage polices and health care delivery systems.

Speaker bio

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Kathryn A. Phillips, PhD, is Professor of Health Economics and Health Services Research at UCSF and Founder/Director of the UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS) in the Department of Clinical Pharmacy. Kathryn’s work focuses on the translation of new health care technologies into clinical care and health policy. Her research, focusing particularly on diagnostics and personalized medicine, has been supported by the NIH for over 20 years. Kathryn’s cross-disciplinary, cross-sector research emphasizes the “big picture,” integrating perspectives across basic, clinical, and social sciences and spanning the divide between academia, industry, government, and health care payers. Her integrative approach is illustrated by her leadership of the TRANSPERS Evidence and Reimbursement Advisory Council, which includes senior executives from the seven largest US health plans as well as thought leaders with industry, government, and Medicare perspectives. Kathryn has advised or served as a board member for more than 35 biotech/pharma companies, venture capital firms, and consulting companies, including working as advisor to Mohr Davidow Ventures for six years and an advisor to the FDA for two years.

Gary Jones, MD, C3 Research Associates

“A unique approach to clinical development”
Thursday, November 21, 2013, noon-1:00 pm
UCSF Mission Bay, Byers Hall, room 212

Clinical studies using techniques such as microdosing and accelerator mass spectrometry (AMS) are being used in many more applications, particularly in the phase 2 area to provide biometric information such as bioavailability. Developments in personalized medicine are using these techniques to provide pharmaco-phenotyping in cancer patients to determine appropriate therapies. Although phase 0 is just starting to catch on, this represents taking these same innovative techniques all the way into the pre-clinical arena to provide human derived data in ways to improve decision making prior to commitment to full clinical development.

Gary Jones, M.D. will discuss the use of microdosing and phase “0” studies combined with highly sensitive detection based on AMS to provide first-in-human data as timely and cost effective support of innovative early therapeutic development projects as well as applications during later phase clinical trials and in the post-approval marketing arena.

  • Understand basics of accelerator mass spectrometry (AMS) and microdose studies
  • Recognize preclinical, early phase development and post-marketing situations in which microdose studies using AMS may provide important data
  • Contrast preclinical data needed for, information available from as well as cost & time to results involved in exploratory IND/phase 0 microdose studies with conventional clinical development pathways

Speaker bio

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Dr. Jones applies his 25 years of experience and expertise, accumulated through his careers in academia, medical care, and clinical research, to direct involvement in the clinical development of innovative therapeutics and medical devices. He received his M.D. at the Oregon Health Sciences University (OHSU) and has had academic appointments at University of North Carolina and OHSU. Industry experience includes leadership roles in medical affairs and clinical development at Berlex and Bayer and he is a Founding Partner and Director of Clinic Development with C3 Research Associates.

C3 Research Associates is a full service CRO that conducts clinical and device trials for pharmaceutical, biotech, medical device and diagnostic companies. The C3 Research Associates team provides customized solutions for start-ups and small companies. Our goal is to help mitigate the risk of clinical trials by supporting companies early in the development process with protocol development and writing, site selection and recruitment strategy, biostatistics, cost projections and regulatory services. Over 70% of our projects have been phase I or phase II studies with innovative strategies for first-in-human studies. Experience in therapeutic areas include oncology, infectious disease, cardiology, neurology and pulmonary diseases.

Bob Lima and Darren Warren, Ricerca Biosciences

“Essential IND strategies: fundamental considerations on the road to success”
Wednesday, November 6, 2013, 1:30-5:00 pm
UCSF Mission Bay, Byers Hall, room 212

Join QB3 and Ricerca Biosciences, LLC for an afternoon workshop on strategies, requirements and approaches for drug development and IND submission for both small molecule and biologic compounds.

The workshop will consist of three 45-60 min sessions, each followed by a 15 minute question and answer session. A networking session will immediately follow the workshop.

1:30 – 2:00 pm: Registration Sign In

2:00 – 5:00 pm: Workshop Sessions

Session one: ICH guidelines, regulatory requirements, and review of strategies for preclinical drug development. Overview of regulatory guidelines and requirements for submitting an IND for FDA approval. Various approaches will be considered depending on small molecule vs. biologics as well as differences in therapeutic areas. Discussion will overview IND content needs in support of early clinical use.

Session two: Chemistry for your first API: From concept to production and how to avoid money draining pitfalls. Overview of the analytical, synthetic and process chemistries needed to manufacture your key preclinical API lots. A how-to guide with particular emphasis on how you can best contribute to the process in order to save both time to first dose and your budget.

Session three: Best practices on the road to IND submission: objectives and pitfalls to avoid in your preclinical program. Overview of drug safety and metabolism needs with emphasis on practical considerations and case studies. Understanding the pharmacology, compound target, and how this drives the preclinical and clinical program designs; PK & metabolism profiling, selecting species for toxicology studies, and designing a preclinical program to support early clinical objectives.

5:00 – 6:00 pm: Networking Session and Hors d’oeuvres

After the workshop, a networking session will be available so attendees can meet the presenters and discuss projects in greater detail.

Contact Sun Kwon (415-476-5716) with any questions.

Presenters


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Darren Warren, PhD
Dr. Warren has broad experience in nonclinical pharmaceutical development with over 23 years of industry experience that includes direct scientific, technical, project management, and strategy responsibilities within a large pharmaceutical company and at various contract research organizations. He was formally trained in Pharmacology and Toxicology, and now provides senior-level laboratory management and direction. At Ricerca he is the Head of the Drug Safety and Metabolism (DSM) division, providing leadership to the scientific departments involved in drug safety, exploratory toxicology, pharmacokinetics and metabolism, bioanalysis, ADME, pathology, and laboratory animal sciences. He leads business management activities for the DSM division and provides scientific consultation in the areas of nonclinical development designs and IND strategies. He has expertise in scientific assessment of nonclinical information with an emphasis on drug safety, and has a record of accomplishment in facilitating efficient completion of IND preclinical programs.


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Bob Lima, PhD
Dr. Lima, who joined Ricerca in 2010, is the Vice President of Strategy and Business Process and the former Business Manager of Chemical Development. Chemical Development encompasses pilot plant scale manufacturing, custom synthetic chemistry (medicinal, radiochemical and process), and analytical chemistry. The combined functions support the non-regulated, GLP and GMP processes necessary to take a new small chemical entity from discovery to commercialization. In addition, Dr. Lima is responsible for the integration of Ricerca’s business development, customer service and technical function with the purpose of delivering on-time, on-budget project execution. In addition to 8 years of CRO management Dr. Lima has a decade of experience in pharmaceutical product development. Dr. Lima has served as the CMC team leader for numerous projects and has taken products from discovery to market in North America and Europe. Dr. Lima’s technical background is in Analytical chemistry, specifically chromatographic method development. Dr. Lima has a PhD in Chemistry and an MBA with foci in Operations, Competitive Strategy and Organizational Behavior.


Tilmann Brotz, Konzept

“Got drugs? A primer on drug discovery and R&D operations for novice biotech entrepreneurs and academic researchers”
Thursday, October 31, 2013, noon—1:00 pm
UCSF Mission Bay, Byers Hall, room 212
[ slides ]

Are you ready to take your idea from the lab and turn it into a drug or product? Are you a budding biotech entrepreneur and want to better understand the R&D challenges lying ahead on the drug discovery path? This presentation aims to address some of the questions you may have such as:

  • How to make the transition into industry?
  • How does research in a company differ from an academic lab?
  • What are the key steps of the drug discovery process?
  • What are some common misperceptions, challenges and pitfalls?
  • Why do so many projects fail?
  • What is the ‘virtual company’ business model all about?
  • How do you conduct research with Contract Research Organizations (CROs)

Speaker bio

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Tilmann Brotz, PhD, is a Biopharma R&D Executive and Drug Development Consultant working with early stage biotech companies and investment funds on drug development strategy, virtual R&D operations, project management and due diligence projects. He has 20 years of research experience with over 12 years in start-ups and early stage biotech companies, where he led the development of novel therapies from discovery through Phase 2 Proof of Concept. He is also a reviewer and consultant for the T1 Catalyst program at CTSI/UCSF. Prior to his consulting practice, Tilmann was Vice President, Preclinical Research & Development at VIA Pharmaceuticals, a virtual biopharmaceutical company where he, among other projects, repurposed an asthma drug for atherosclerosis. Prior to that he held positions of increasing responsibilities at Renovis, Inc. and at the National Cancer Institute. Tilmann has extensive experience working with distributed, virtual teams and outsourcing projects to CROs and CMOs. He has technical expertise in toxicology, pharmacology, DMPK, CMC & regulatory affairs as well as translational research and biomarker development. Tilmann received his Ph.D. in Animal Physiology/Neuroscience from the University of Tübingen and completed his postdoctoral training at the University of California, Berkeley.

Event sponsors

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Ed Jameson and Tom Pistone, Jameson & Company, CPAs

“Government accounting: indirect rates & the costs of non-compliance”
Wednesday, October 23, 2013, 3:00—6:00 pm (includes happy hour 5:00—6:00 pm)
UCSF Mission Bay, Byers Hall, room 212

Non-dilutive grant & contract funding is a fantastic way for a startup to build infrastructure, but with any reward comes risk. Strings attached to free money include confusing federal regulations, increased audit oversight and severe penalties that can cause major interruptions to any good business. Meet Jameson & Company CPAs Ed Jameson and Tom Pistone to learn more about the risks and how to take advantage of the rewards.

Speaker bios
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Ed Jameson is a second-generation CEO of Jameson & Company, LLC, which was founded by his father Gordon in 1977. Ed joined the firm in 1988, having previously served as a senior consultant in the small business and tax departments at Price Waterhouse, Boston.

Ed has helped clients secure billions of dollars in government grants and contracts. He has extensive experience in the indirect rate recovery process and has settled hundreds of incurred cost submissions. In addition to overseeing all client relationships, Ed consults on cost recovery, strategic and tactical management issues, and contract and grant cost procurement.

Ed is recognized nationally for his expertise in Government Grant & Contract Cost Accounting. Ed has presented on accounting related topics to incubators, accelerators, and at conferences across the country including several appearances as an expert panelist and presenter at the National SBIR Conference.

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As Jameson & Company’s Business Development Manager, Tom Pistone oversees and coordinates all sales & marketing efforts at the firm including our website, social media and blog. Since joining us in 2009, Tom implements strategies to raise awareness of the firm’s capabilities to Government Grantees & Contractors, as well as partnering with Small Business Development Centers and Incubators around the nation.

A 2004 graduate of Bridgewater State University, with a Bachelor of Science Degree in Business Administration, Tom’s primary responsibility is to develop relationships and be the initial contact for those whom require our firm’s specialized services, leaving the Partners to focus on solving client issues. Tom has also participated as a proposal judge for Greentown Labs’ Winner of Winners Competition & The Rhode Island Economic Development Center’s Renewable Energy Early Stage Commercialization Program.

Steve Allan, Jennifer Friel Goldstein and JC Simbana, Silicon Valley Bank

“Banking and valuation 101”
Thursday, October 10, 2013, noon—1:00 pm
UCSF Mission Bay, Byers Hall, room 212

SVB Analytics will shed light on the world of financing in private innovative healthcare companies, spanning the need to know blocking and tackling areas as well as the broader landscape perspective helpful for strategic planning of future funding needs.

Speaker bios

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Steve Allan is a senior director with SVB Analytics, responsible for executing client valuation assignments and issuing valuation opinions for private companies. Allan brings a strong financial background and passion for entrepreneurship to his role at SVB Analytics.

Prior to joining SVB Analytics in 2008, Allan worked with J.P. Morgan Chase in New York for the firm’s fixed income trading business. While at J.P. Morgan, Allan worked with both the proprietary and client-focused U.S. Dollar Fixed Income Derivatives desks.

Before J.P. Morgan, Allan worked with AT&T. Joining AT&T in 2000, Allan completed the two-year rotational training Financial Leadership Program. After graduating from the program, Allan joined AT&T Consumer Services in a marketing and sales role developing models for customer acquisition and retention partnerships and strategies.

In 2006, Allan co-authored the winning business plan and best presentation award winner for the IrishAngels-sponsored University of Notre Dame McCloskey Social Business Plan Competition with a plan for a socially-focused, hybrid for-benefit organization, PEPY Tours. Allan then served as a board member and Chief Financial Officer for the organization.

Allan earned a master’s in business administration from Duke University’s Fuqua School of Business and a bachelor’s degree in finance from the University of Notre Dame. Allan has been conferred the Chartered Financial Analyst designation.

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Jennifer Friel Goldstein is based in San Francisco and is responsible for the Biotechnology and Diagnostics practice. Jennifer joined SVB after seven years at Pfizer, where she served as a Director on Pfizer’s Venture Capital team and a Senior Manager in the Portfolio and Decision Analysis group. While a consultant at Bain & Company in London, Jennifer focused on private equity deals. She has also had diverse operational and research experience at companies such as Chiron, Genelabs, and Genencor.

Jennifer brings over ten years of business development, portfolio management, and consulting experience as well as a biotechnology background to the team. She graduated magna cum laude with a BSE in Bioengineering and a Master’s of Biotechnology from the University of Pennsylvania. Jennifer was also named a Joseph Wharton Fellow while completing her MBA at the Wharton school.

In her free time Jennifer enjoys remaining involved with SpringBoard Enterprises and the Make-a-Wish foundation as well as raising her twin toddlers.



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JC Simbana leads the early-stage Life Science & Digital Health practice for SVB’s Entrepreneur Services Group, which provides banking and lending services to early-stage startups, organizes events to connect startups and VCs, and assists startups with their fundraising process.

With over fifteen years of experience in venture banking and equity research, Mr. Simbana has worked with entrepreneurs in the biotech, medical device, diagnostics, tools, and digital health sectors and has helped several startups secure angel and VC financing.

Mr. Simbana is on the board of directors of Life Science Angels, BioPacific Investors and is actively involved with Rock Health, Astia, Springboard, DC-to-VC, QB3, and the Thiel Foundation’s 20Under20 Fellowship and Breakout Labs programs as a mentor, speaker, judge and connector.

Kimberly Kovacs, executive vice-president, Solium

“The basics of corporate equity”
Tuesday, October 1, 2013, noon—1 pm
UCSF Mission Bay, Byers Hall, Room 212
[ slides ]

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This seminar will introduce you to the basics of corporate equity from early stage founders’ shares; to issuing your first employee stock options; and moving through to preferred shares and investor warrants. Learn about the various types of awards and how they impact your start-up venture, recent trends in issuing equity to employees, consultants, board members and advisors and the various regulations that are involved with each of these types of equity awards.

Solium is the leading provider of equity management and compliance tools and we support thousands of early stage companies both directly and through their law firms by keeping capitalization tables organized and equity awards accounted for accurately with our cloud-based solutions.

Speaker bio

Kimberly Kovacs was the founder and CEO of OptionEase, a leading network connector for complex equity compliance applications delivered on-demand via software-as-a-service (SaaS) which was purchased by Solium Capital (SUM.TXU) in November 2012.

Prior to the acquisition in 2012, and for the second year in a row, OptionEase was honored by INC Magazine as one of the fastest growing companies in the United States. Orange County Business Journal also honored OptionEase as one of its Fastest Growing Companies in Orange County and B2B CFO named OptionEase a winner in its Smart 25 Awards, because of its strong and sustainable growth and commitment to innovation.

Ms. Kovacs has had a distinguished career in executive leadership and finance spanning over 20 years with dozens of successful startup ventures. In addition to raising over $100M in equity capital for these entities, she secured over $50M in funding from HUD to preserve low income housing as Chairman of Alpha Project in San Diego.

Another noted accomplishment was as co-founder and CFO of ORXYE Energy she, along with leaders of the EPA and major oil testified in Congress that ultimately resulted in Ms. Hillary Clinton’s involvement and final adoption of revised Clean Energy laws in the U.S that brought in new conservation and renewable fuel standards.

Ms. Kovacs is currently on the board of the All American Boys Choir and an advisor, mentor and adjunct professor for the Ralph W. Leatherby Center for Entrepreneurship and Business Ethics at Chapman University. In addition, she is active in many industry organizations such as the Los Angeles Venture Association, OCTANE, FEI and FENG as well as the Women Presidents Organization (WPO) and the Association of Women in Technology (AWT) to promote female executive leadership and capital raising.

Other past board seats include the National Center for Employee Ownership (NCEO) and the American Coalition of Stock Plan Professionals.

Oscar Luna, Spinnaker Consulting


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“The strategist’s abacus”
Thursday, September 26, 2013, noon—1 pm
UCSF Mission Bay, Byers Hall, room 212
[ slides ]

This talk will introduce a few basic concepts of finance and marketing. These concepts are then weaved together in a simple mathematical model that can be used as road map for companies to make strategic decisions. This simple mathematical model was developed with the simplicity of an abacus as a frame of reference. The model can be used by startups as well as by established companies. The model, a single page spreadsheet, can be used to calculate the impact that strategic decisions would have on the company’s valuation.

Agenda

  • Introduction of two basic finance principles:
    • Financial Statements
    • Net present value
  • Introduction of four basic principles of marketing. The four Ps:
    • Placement
    • Product
    • Price
    • Promotion
  • Present a simple mathematical model to calculate the impact of strategic decisions in shareholder’s value or company’s valuation.

Speaker bio

Oscar Luna is a finance and management consultant. He has advised clients including PG&E, Boeing, International Paper, allrecipes.com and nonprofits such as The Nature Conservancy, I-TEHC, and others. He has taught business courses at Seattle University and UC Berkeley. Oscar graduated with an MBA from Columbia University in New York City.

Paul Stewart and Todd Rumberger, Foley & Lardner

“A legal primer on early-stage financing for your startup”
Friday, September 13, 2013, noon—1 pm
UCSF Mission Bay, Rock Hall Auditorium, room 102

Speaker bios

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E. Thom (Todd) Rumberger Jr. is a partner with Foley & Lardner LLP where he focuses his practice on private equity, mergers and acquisitions and venture capital.

Mr. Rumberger counsels his corporate clients, ranging from start-up, emerging growth stage and venture backed, to public domestic and foreign companies, on a wide variety of matters ranging from formation, capitalization, key executive employment and general employment issues, and corporate governance, to early (convertible debt and seed preferred) and later stage venture capital, debt and public equity financings and offerings, strategic partner, reseller, and similar commercial agreements. In addition, he has broad transactional experience representing public and private company, and private equity, buyers and sellers involved in mergers and acquisitions and financings.

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Paul A. Stewart is managing partner of the Palo Alto office for Foley & Lardner LLP. Mr. Stewart has over 35 years of experience in business, technology, general corporate and real estate matters.

Mr. Stewart has served as chief legal counsel for numerous private companies, ranging from start-ups to established organizations active in technology, consulting, financing, retailing, health care, real estate, and other business sectors. He has extensive experience in structuring companies, obtaining financing, negotiating contracts, private placements of securities, corporate governance, mergers and acquisitions, corporate collaborations and corporate partnering transactions, and in commercial real estate.



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David Rabuka, president, chief scientific officer and founder, Redwood Bioscience

“The trials and tribulations of a startup”
Thursday, July 25, 2013, noon—1 pm
UCSF Mission Bay, Byers Hall, Room 212

Redwood was launched based on a proprietary technology called “aldehyde tagging” developed by Carolyn Bertozzi and her research team at UC Berkeley, of which I was a part. We decided to try to commercialize the technology in 2008 and started building a company. Five years later Redwood Bioscience is continuing to grow and develop cutting edge technologies although along the way there have been many bumps and bruises. I will share some of my own experiences, both the good and the bad, and highlight some of the lessons I have learned about attempting to build a biotech startup.

Speaker Bio
David Rabuka received a PhD in chemistry at the UC Berkeley as a Chevron Fellow in the lab of Carolyn Bertozzi. His research included developing and applying Redwood’s platform technology to cell surface modification. Prior to joining Bertozzi’s lab, David worked at the Burnham Institute synthesizing complex glycans followed by Optimer Pharmaceuticals, which he joined as an early employee, focused on the development of glycan and macrolide based antibiotics. David graduated with a double honors BS in chemistry and biochemistry from the University of Saskatchewan, where he received the Dean’s Science Award, and holds an MS in chemistry from the University of Alberta. He is an author on over 20 major publications, as well as numerous book chapters and patents.

Edward Diao, orthopedic surgeon and founder and CEO, Socorro Medical and Zoe Quan, president, Qingchu Thinking

“Startups as a team sport”
Thursday, July 18, 2013, noon—1 pm
UCSF Mission Bay, Byers Hall, Room 212

Socorro Medical, Inc. is a medical device venture dedicated to developing transformative endoscopic devices for surgeons to improve patient outcomes. We will share some of the lessons Socorro is learning about the challenges confronting a start up on the road to commercialization, starting with identifying the problem to be solved, and the value of getting suitable help early and often from multiple sources, some of which come from unlikely directions.

Speaker Bios

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Dr. Edward Diao is the founder and CEO of Socorro Medical, Inc. He is a leading orthopedic surgeon with substantial hands-on experience and customer insight. He is a successful clinician, scientist, educator, and innovator, and has maintained leadership positions in major orthopedic and hand surgery societies for over 24 years. Dr. Diao is professor emeritus of Orthopedic Surgery and Neurosurgery at UCSF, where he was chief of Hand, Upper Extremity and Microvascular Surgery for 13 years. He has been the PI on multiple NIH RO1 and SBIR grants. He is currently on the SAB of NanoNerve, Inc. and founder of EndoOrthopaedics, Inc. which is a QB3 incubator company.

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Dr. Zoe Quan is president of Qingchu Thinking, LLC, a strategy evaluation firm that combines strategy, international business, and assessing technologies for their growth potential to help companies think through where they are, where they think they want to be, and what they need to do to get there. She helps ventures see patterns among seemingly unrelated pieces of information to home in on key issues, and translate vision into executable strategies. She has held senior leadership positions with large multinationals as well as entrepreneurial ventures in Asia, Europe, and North America, and is skilled at all aspects of product management, including strategy, product development, business plan development and execution, and P&L responsibility. What quickens her blood is translating between the language of business and the language of technologies to unleash the commercial potential of innovative research.


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Adam Regelmann, co-founder, Quartzy, Inc.

“Starting from scratch: How Quartzy went from an idea to a company that’s changing how science is done”
Wednesday, June 12, 2013, noon—1 pm
UCSF Mission Bay, Byers Hall, Room 212

Sections:
Pain – identifying the problems
Founders – building the core team
Technology/Product – Version 1, version 2, etc.
Money (aka more pain) – where does it come from? Where should it come from?
Marketing – Underestimate its importance at your own risk
Overall Lessons Learned

Speaker Bio
Adam Regelmann earned a PhD in cellular, molecular and biophysical studies as well as an MD from Columbia University in New York. He then went on to complete a residency in Internal Medicine at Washington University in St. Louis. While at Columbia, he co-founded Quartzy, a free online suite of lab management tools. Quartzy sprung from personal frustrations he experienced during his time at the bench, and aims to increase scientific productivity by improving the efficiency of lab operations. By the end of his residency Quartzy was used by thousands of researchers to manage their labs, and the company was accepted into the summer 2011 batch of the prestigious Silicon Valley incubator, Y Combinator. Quartzy is now a venture-backed company used by labs all over the world, in both academia and industry to manage their resources. He will discuss Quartzy’s progress from nascency to its current state and the lessons he learned along the way.


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Merv Turner, independent consultant and former CSO, Merck & Co.

“May you live in interesting times! Innovation in healthcare in a fast-changing marketplace”
Thursday, June 6, 2013, noon—1 pm
UCSF Mission Bay, Genentech Hall, room N-114
[ slides ]

The US does not have a debt problem, it has a healthcare cost problem that is eroding salaries and sucking resources from drivers of long term prosperity, while failing to provide efficient and effective care. No one can expect to invest successfully in today’s healthcare system without asking difficult questions about how products will both produce a return to investors and lower overall costs of healthcare. That is a challenge—not insurmountable—to the traditional biotech and pharma models. However, where traditional players see problems, others see opportunity, and a new ecosystem of small companies leveraging the digital revolution is looking for ways to capitalize on the need for innovative solutions to drive down the cost of delivering care.

Speaker Bio
Mervyn Turner has over 25 years of experience in pharmaceuticals drug discovery, research and development, licensing and business development, emerging markets analysis, and strategy development and implementation. He headed two of Merck’s premier research sites, in Rahway NJ, and in Montreal, Canada. He then spent seven years as head of world wide licensing and external research at Merck, during a period of rapid expansion in Merck’s partnering activities. He became Merck’s first chief strategy officer and a member of the senior executive team in 2008, before retiring from the company in 2011. He is currently an advisor to Bay City Capital in San Francisco, and also operates his own consulting business.

Kathy Ryan, CEO and CFO, RoseRyan, and Kyle Holm, Associate Partner, Radford

“Equity compensation: end-to-end strategies for private companies”
Thursday, May 30, 2013, noon—1 pm
UCSF Mission Bay, Genentech Hall, room N-114
[ slides ]

How you design and execute your equity compensation plan has significant impacts on your business, including: attracting the right talent, key employee retention, market valuation and readiness for growth.

“Equity compensation: end-to-end strategies for private companies” is a one hour seminar co-sponsored by RoseRyan and Radford, which will show you how to set your young company up for success and avoid common pitfalls.

During this session with equity experts from RoseRyan and Radford you will learn:

  • Definitions of equity vehicles
  • Founder versus non-founder distinctions
  • Equity comp strategies for early stage companies
  • How to choose the right equity comp vehicles
  • Common stock pitfalls and how to avoid them

Speaker Bios

Kathy Ryan, CEO and CFO, RoseRyan


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Kathy started RoseRyan, a finance and accounting consulting firm, on a mission to provide highly skilled finance and accounting professionals to Bay Area firms of all sizes. While building RoseRyan, she’s served as interim CFO at more than 50 emerging companies, mostly in the high-tech sector. With the keen ability to see the big picture as well as pesky details, she makes sure her employees and clients stay on top of an ever-changing regulatory landscape. Kathy was director of finance at Quantum and tax manager at Price Waterhouse before co-founding RoseRyan 20 years ago. In addition to management expertise, her skills include general and cost accounting; tax and SEC reporting; forecasting, budgeting and planning; business finance; and systems planning and implementation. She was named one of the most influential women in Silicon Valley in 2012. Kathy, formerly a Big Four CPA, holds a BS in accounting from Santa Clara University.

Kyle Holm, Associate Partner, Radford


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Kyle has over 15 years of compensation consulting experience covering executive, broad-based and Board of Director pay. His work covers all elements of compensation including base salary, annual incentives and long-term incentives. He consults on the design of cash and stock-based compensation programs for a varied range of public and private companies with a focus on high growth organizations in the technology and life sciences sectors. Prior to joining Radford, Kyle held a principal position at Hay Group and was one of the three founders of Presidio Pay Advisors, where he was instrumental in developing their pre-IPO offerings. Kyle has been an instructor for the Northern California Human Resources Association’s continuing education program. His work has been published in WorkSpan and he co-authored a chapter on initial public offerings in the recently published Understanding Executive Compensation – A Practical Guide for Decision Makers. He earned a bachelor’s degree in finance from Santa Clara University.



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Emily Walsh, Principal Consultant, Halloran Consulting Group

“Money: how to raise it and spend it wisely in your biotech startup”
Friday, May 17, 2013, noon—1 pm
UCSF Mission Bay, Byers Hall, room 212

Angel and venture capital investors alike agree on one thing: you have to have a credible plan for your company. In this short presentation, Emily Walsh, principal consultant at Halloran Consulting Group, will cover some of the basics of how to develop a fundable plan. In particular, she’ll focus on how you can develop a budget that passes both top-down and bottom-up scrutiny and manages your risk along the development path. Then she’ll describe best practices around how you keep to that budget (and avoid hidden costs along the way).

Speaker Bio
Emily joined Halloran Consulting Group in 2011. Emily is an accomplished life sciences professional with expertise managing drug discovery and clinical programs across a breadth of indications in biotech and pharma. Most recently, Emily founded Tremont Therapeutics, a small virtual biotech focused on identifying and developing promising therapeutics from academia from mid-discovery through human proof of concept.

Prior to that, Emily has held a number of roles including management and leadership responsibilities in the Novartis Drug Discovery Incubator at the Novartis Institutes for Biomedical Research. This group sought to internally “partner” high-risk discovery programs within Novartis for full clinical development. Subsequently, Emily was responsible for business, financial, alliance and scientific program management across a number of research and development programs at Alnylam Pharmaceuticals including the flagship respiratory syncytial virus therapeutics program. This Phase II clinical stage program included the use of an IDE device for the nebulized delivery of the siRNA therapeutic, ALN-RSV01.

Emily was selected one of the Boston Business Journal’s “40 under 40” honorees in 2009 and led a volunteer analytics team that won the Group Innovation Award from the Healthcare Businesswomen’s Association in 2010. Emily earned her Ph.D. from University of California, San Francisco, performed her postdoctoral work at the Broad Institute, and received her PMP certification in 2007. She sits on the Board of Trustees for the renowned Boston-based Cantata Singers.


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Eli Loots, Partner, Knobbe Martens

“Best practices following the implementation of the America Invents Act”
Friday, May 10, 2013, noon—1 pm
QB3 East Bay Innovation Center, 2929 Seventh St., Berkeley

Speaker Bio
Dr. Loots is a partner in the San Francisco office of Knobbe Martens. Dr. Loots’ practice focuses on client counseling, opinion and due diligence work, and patent preparation and prosecution in the chemical and molecular biology arts. Dr. Loots assists startup companies in developing their core IP portfolios and mapping paths for their core products to proceed through the various patent landscapes that are relevant to their technological areas. Dr. Loots also actively manages and assists Fortune 500 companies with managing and developing strategies for their key technologies. Dr. Loots also represents clients in diagnostics, stem cell technologies, medical devices, next generation sequencing, amplification technologies, and the large molecule space (including antibodies and protein engineering).

Dr. Loots obtained his Ph.D. in Molecular and Cell Biology from U.C. Berkeley, with an emphasis on neuroscience and biophysics. His research focused on the structure/function relationship of ion channel gating and involved engineering various ion channels so that various fluorescent probes could be attached to observe the structural rearrangements of the ion channel as it passed through its various states. Dr. Loots attended Boalt Hall (U.C. Berkeley) for his law degree and has an undergraduate degree in chemistry.


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Larry Kammerer, Partner, Outsourced Accounting Group, Moss Adams LLP

“Tax and accounting tips for startups”
Wednesday, February 27, 2013, noon—1 pm
UCSF Mission Bay, Genentech Hall, Room N-114
[ slides ]

In a one-hour lunch and learn session on February 27th, Larry Kammerer of Moss Adams will discuss tax and accounting matters that are relevant to startup companies. Some of the topics covered will be Delaware Corporation filings, State and Federal Tax filings as well as filings for LLCs. We will also address many accounting questions startup organizations ask as well as the common problems we see in early stage companies.

Bio: Larry has been practicing public accounting since 1985, focusing on venture-funded technology companies and high net worth individuals. He specializes in outsourced accounting and consulting for start-up companies and personal CFO services for individuals. Larry is a frequent speaker at entrepreneur-focused events on the topic of creating and growing start-up businesses and has been recognized by the American Institute of Certified Public Accountants as a pioneer in combining cloud-based technology with outsourced accounting services to transform the way companies and individuals solve their financial challenges.



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Reece Hirsch, Morgan Lewis

HIPAA issues and startups”
Thursday, February 7, 2013, noon—1 pm
UCSF Mission Bay, Helen Diller Bldg., Room 160

On January 17, the Department of Health and Human Services issued the long-awaited final omnibus regulations amending the Health Insurance Portability and Accountability Act (“HIPAA”), implementing the most sweeping revisions to healthcare privacy law in a decade. This presentation will provide an overview of the wide-ranging impact of the new HIPAA Omnibus Regulations on vendors, or “business associates,” to the healthcare industry, clinical research and security breach notification.

Reece Hirsch is a partner in the San Francisco office of Morgan Lewis specializing in privacy and security law. He advises clients from all sectors of the healthcare and life sciences industries on compliance with HIPAA and other privacy and security laws. He was named an Outstanding Healthcare Information Technology attorney by Nightingale’s in 2009 and has served on advisory committees appointed by the California Office of Privacy Protection on medical identity theft issues. Reece is a member of the editorial advisory boards of BNA’s Health Law Reporter and Healthcare Informatics. He can be reached at rhirsch@morganlewis.com or (415) 442-1442.


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Alex Tkachenko, Siluria Technologies

“Siluria Technologies: From incubation to the Holy Grail of petrochemical industry challenges”
Tuesday, January 8, 2013, noon—1 pm
UCSF Mission Bay, Genentech Hall, Room N-114

Alex Tkachenko, Ph.D., is President and co-founder of Siluria Technologies. Siluria is the first company to develop a scalable process for making gasoline, jet fuel and commodity chemicals out of natural gas, rather than out of oil, using a breakthrough catalyst technology and conventional process industry equipment. The market opportunity is vast, since oil is 2 to 5 times more expensive than natural gas. Alex developed the company’s business plan, led three rounds of venture financing totaling $63M and built Siluria’s outstanding development and commercialization team. A Ph.D. biochemist, he also holds an MBA from Harvard Business School. Earlier, Alex served as a squad leader in the Soviet Army and completed a tour of combat duty in Afghanistan.


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Corey Goodman, venBio

“Pharma, biotech, venture capital, and the search for innovation: a broken ecosystem and how to fix it”
Friday, December 14, 2012, 12:30-1:30 pm
UCSF Mission Bay, Genentech Hall, Room N-114
[ slides ]

Join the QB3 team for a special QED to mark the official launch of the QB3 Accelerator entrepreneur membership program.

12:00-12:30 pm: Lunch and Accelerator Partner meet & greet.

12:30-1:30 pm: QED with Corey Goodman.

1:30-3:00 pm: Dessert reception with Accelerator Partners.

Speaker Bio
Dr. Goodman is a renowned scientist, entrepreneur, educator, CEO, and corporate executive. He was formerly President of Pfizer’s Biotherapeutics and Bioinnovation Center, and a member of Pfizer’s Executive Leadership Team. Dr. Goodman was a co-founder of Exelixis, Renovis, Second Genome, and Ossianix, and CEO of Renovis until its acquisition by Evotec. He is a former professor at Stanford University and UC Berkeley, co-founder of Berkeley’s Wills Neuroscience Institute, an Investigator with the Howard Hughes Medical Institute, and currently an Adjunct Professor at UC San Francisco. Dr. Goodman is an elected member of the U.S. National Academy of Sciences, the American Academy of Arts and Sciences, and the American Philosophical Society. His honors include, amongst others, the Alan T. Waterman Award from the National Science Board, Canada Gairdner Biomedical Award, March-of-Dimes Prize in Developmental Biology, Reeve-Irvine Research Medal, and Trinity College Dublin Dawson Prize in Genetics. He is on the Board of the California Council on Science and Technology, the Pacific Institute, and former chair of the National Academy of Sciences’ Board on Life Sciences. He is an advisor to several university innovation centers and disease foundations. He is Chair of the Board of several companies, including Oligasis, Ossianix, and Second Genome, and a member of the Board of several others, including NeuroTherapeutics and Mirna. Dr. Goodman is located in venBio’s San Francisco office.


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Paul Burke, Burke Bioventures

“Addressing delivery barriers to enable new therapeutics”
Tuesday, November 20, 2012
UCSF Mission Bay, Genentech Hall, Room N-114

The biopharmaceutical industry productivity crisis is forcing a realignment of activity between innovation and its translation into therapeutics. This shift is impacting innovators both in industry and academia, particularly those focused on using technology to enable new medicines. A retrospective on delivery and RNAi technologies provides lessons on scientific risk and factors impacting commercial success. These lessons are applied to identify approaches important for success in the new environment.

Speaker Bio
Dr. Paul Burke is Principal of Burke Bioventures LLC, where he brings over 15 years experience launching and leading new technology initiatives for transforming discovery and preclinical pipelines. Dr. Burke recently was founding head of Pfizer’s global Center of Excellence for targeted drug delivery and imaging, and held the position of VP and Chief Technology Officer of Pfizer’s Oligonucleotide Therapeutics Unit. Previously he was Executive Director, RNA Therapeutics at Merck & Co. where he led delivery R&D, charged with developing enabling technologies for maximizing value from the company’s $1.1B acquisition of Sirna Therapeutics. The effort encompassed five Discovery and Preclinical departments and multiple external partnerships. Dr. Burke joined Merck following a decade-long tenure at Amgen, where he held positions of increasing responsibility including his most recent as Executive Director, Pharmaceutics. In this role he launched initiatives for extending product lines (including Aranesp® and Neulasta®) and for integrating drug delivery in the discovery pipeline, with a focus on enablement of new therapeutic classes. Prior to Amgen Dr. Burke held staff scientist positions at Alkermes and Mitsubishi Kasei (now Mitsubishi Tanabe Pharma). He received his B.S. in Chemistry with Distinction and Departmental Honors from Harvey Mudd College and his Ph.D. in Biological Chemistry from the Massachusetts Institute of Technology. He is an Affiliate Professor of Bioengineering at the University of Washington.



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Elaine Allen, Babson College

“Finding your direction with data: navigating from idea to proof of concept to funding”
Tuesday, October 16, 2012
UCSF Mission Bay, Byers Hall, Room 212
[ slides ]

Increasingly, angels and VCs want to see more data and a definitive proof of concept prior to funding. This talk will examine all the data you need to finish this step quickly.

  • How much data are enough? How do you design a definitive proof of concept experiment? These require a firm grounding in data analysis. A simplified template for choosing designs, analyses, and sample sizes will be covered including some case studies.
  • Part of your proof of concept includes understanding your competitors. Research synthesis using the tools of evidence-based medicine is an important component of profiling any new compound, therapy, diagnostic or app. Consulting examples will illustrate how this can help you move forward (or stop early).
  • Moving forward—it really is all about the data.

Speaker Bio
I. Elaine Allen, PhD is Visiting Professor of Biostatistics and Epidemiology at UCSF and Emeritus Professor of Statistics and Entrepreneurship at Babson College. She founded and led several biotechnology companies prior to joining Babson including ARIAD Pharmaceuticals, a gene therapy company; MetaWorks, an Evidence-Based Medicine firm; and Stat Systems, a diagnostic company. She previously held faculty positions at the University of Pennsylvania & the Medical College of Pennsylvania. She serves on the board of the Global Healthy Living Foundation, is Research Advisor to the Women’s Initiative for Self Employment in San Francisco and advises several start-ups on analytics and data science. At Babson College she received the Women Who Make a Difference Award and the Faculty Award for Outstanding Research.She is Statistical Director of the Babson Survey Research Group and is a Fellow of the American Statistical Association.

She has published widely on statistical issues in meta-analysis, analytics, survey research, and clinical research methodology as well as authoring several articles and book chapters on women’s entrepreneurship. She continues to consult in the entrepreneurship, finance, pharmaceutical, biotechnology and sports industries and has served on several NIH panels on best practices in statistics and evidence-based research.

Lindy Fishburne, Breakout Labs


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“Breakoutlabs.org: one of the newest alternative funding models for early-stage startups”
Thursday, October 4, 2012
UCSF Mission Bay, Byers Hall, Room 212

Introducing one of the newest alternative funding models for early-stage startups working on radical innovations in science and technology— Breakoutlabs.org.

Every year, hundreds of thousands of ideas and inventions are born, and new findings are established. What differentiates the ones that achieve commercial success and go on to transform sectors and societies, from those that end up on the laboratory floor? When simultaneous innovation occurs, what differentiates the market winner and the forgotten finishers?

Timothy Gardner, Amyris

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“Synthetic biology: the story of its origins and predictions for the future”
Thursday, September 20, 2012
UCSF Mission Bay, Helen Diller 160
[ podcast ]
[ slides ]

Dr. Timothy Gardner serves as the Director of Research Programs & Operations at Amyris, a company producing high-performance chemical products from the fermentation of renewable feedstocks including sugarcane and lignocellulosic biomass. At Amyris, Tim leads the R&D program for farnesene-producing microbes and manufacturing process technologies. Farnesene is Amyris’ base molecule for its renewable diesel fuel, jet fuel, lubricant, cosmetic oil and polymer products. He also previously served as the Director of Computational Biology at Amyris.

From 2003-2008, Tim was an Assistant Professor of Biomedical Engineering at Boston University where he founded a laboratory of 20 researchers focused engineer microbes to synthesize fuels, electricity and materials, and to decipher microbial mechanisms of antibiotic resistance. His laboratory pioneered new technologies in microbial genetics and physiology, multivariate statics, and computational biology with support from the Department of Defense, the Department of Energy, PhARMA foundation, the NSF and the NIH.

In the spring of 2000, he founded the world’s first “synthetic biology” company, Cellicon Biotechnologies, to develop genetic control circuit technologies for applications in gene therapy, industrial biotechnology and antibiotic development. Cellicon was formed around Tim’s pioneering genetic flip-flop technology – an invention credited by Nature as launching the field of synthetic biology (Nature 463, 269-270, 2010).

Tim received his Ph.D. in Biomedical Engineering from Boston University in 2000 and his B.S. in Mechanical Engineering from Princeton University in 1995. Tim is the recipient of a 2004 Technology Review Magazine TR100 award honoring a group of 100 creative individuals under age 35, whose research will shape how we live and work in the future. His work has also been recognized by Scientific American, the New Scientist, Technology Review, and the New York Times.

Tim currently serves on the boards of the ENIGMA project at Lawrence Berkeley National Labs, and the Boston University Alumni Leadership Council. He is an avid hockey player (still reveling in his team’s 2011 summer-season victory in the Oakland “old man’s” league), a father of 2 boys, and volunteer in several East Bay community organizations.

Christine Mason McCaull, Milsal + McCaull


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Photo by TEDx SF. CC BY-NC 2.0

“Thinking ahead to commercialization: how to transition from an idea to a company”
Tuesday, July 10, 2012
UCSF Mission Bay, Byers Hall, Room 212
[ podcast ]
[ slides ]

Every year, hundreds of thousands of ideas and inventions are born, and new findings are established. What differentiates the ones that achieve commercial success and go on to transform sectors and societies, from those that end up on the laboratory floor? When simultaneous innovation occurs, what differentiates the market winner and the forgotten finishers?

Join Christine McCaull, a 20 year tech start up veteran, and Taylor Milsal, a business development and sales executive working exclusively with new, worldchanging technologies, for a conversation on the commercial elements of bringing an idea forward and obtaining market success. What’s in the DNA of a successful startup?

Speaker Bio
Christine starts, architects and grows businesses- building teams, raising capital, crafting go-to-market strategies and building brands. She focuses on companies that can make a meaningful difference in the quality of people’s lives and experiences, working with boards and management teams to create great organizations. She runs TEDxSanFrancisco, is a Green Dot Award juror and is actively engaged in work supporting innovation, human potential and sustainability.

Colleagues and clients consider her to be a creative, high energy, hardworking and hands-on leader—someone who can go broad or dig into the details as needed.

As a company founder and CEO, Christine has built online companies from a blank sheet of paper to millions of dollars in recurring revenues. Christine founded and served as CEO and board member at venture-backedSpringCM, the leading Software-as-a-Service provider of Enterprise Content Management (that’s software provided on a subscription basis). She served on the board of MSDSOnline, an online subscription provider of compliance information, and was the founding CEO at Intellext, a contextual search technology spun out of Northwestern University. She was a cofounder at LeadAmerica and MetalMaker. In addition to her own companies, she has worked with global organizations, such as Nabisco, Omnexus, Texas Pacific Group and Alcoa, as well as the many European clients, to open new markets or solve strategy challenges. During her early career, she worked in Mergers and Acquisitions for a global consulting firm, and in established companies in consumer packaged goods and heavy industry, leading new market development, trade marketing and strategy. She is a Springboard Enterprises alumna.

In 2008, Christine began to realign her work life to a larger life mission of spreading big (culture shifting) ideas, and created the SweetMedia Network, a group of content sites serving the LOHAS market, with an emphasis on sustainability, conscious business, personal wellness and community building, and began curating/producing local communites, including TEDxSanFrancisco, LoveSpring, Exquisite and WiredSonoma.

Christine holds a MBA from the JL Kellogg School of Management at Northwestern University and is a Phi Beta Kappa graduate of Northwestern University in Political Science, with a senior thesis in Arab Nationalism. She has lived and traveled all over the world, and speaks French and German, and a smattering of other languages. Christine has received recognition for her leadership and contributions in technology, marketing, entrepreneurship and community service. She is a yogini, artist and writer, and mother of 6.




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David Kirn, Founder, President & CMO, Jennerex Biotherapeutics, Inc.

“Targeted and transgene-armed oncolytic poxviruses for cancer: clinical proof-of-concept and future directions”
Wednesday, June 13, 2012
UCSF Mission Bay, Byers Hall, Room 212
[ podcast ]

Dr. Kirn is the global leader in the clinical research and development of oncolytic viruses for cancer. He designed and led clinical development programs and trials with over 10 different agents, and with over 10 different companies and leading academic programs, involving hundreds of patients (Phase 1-3). He held academic and/or faculty positions at Harvard Medical School; the University of California, San Francisco (UCSF); and the University of Oxford. In addition, Dr. Kirn was vice president of clinical research at Onyx Pharmaceuticals. After joining Onyx as the first oncology development employee, he created and initiated clinical development plans in partnership with Bayer for Nexavar, now a marketed product for kidney and liver cancers. He also led the development of a first-in-class oncolytic virus therapeutic through to Phase 3, a corporate partnership with Warner-Lambert and an initial public offering during his tenure. He has been a consultant in cancer biotherapeutics for Pfizer, Novartis, BiogenIdec, Schering AG and other leading oncology companies. He has been an invited advisor on cancer therapy to the National Institutes of Health (U.S.), the Gene Therapy Advisory Committee (U.K.) and the European Agency for the Evaluation of Medicinal Products (E.U.). He has authored over 100 publications in peer-reviewed journals and textbooks. He completed his oncology fellowship at UCSF, his internal medicine residency at Brigham and Women’s Hospital, a teaching affiliate of Harvard and was chief medical resident (WR-VA) at Harvard Medical School. He received his MD from UCSF (AOA Honors) and his BS in physiology from the University of California, Berkeley, with departmental citation, Phi Beta Kappa.

Joseph Snyder, Kilpatrick Townsend

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“Prometheus v Mayo”
Thursday, June 7, 2012
UCSF Mission Bay, Byers Hall, Room 212
[ podcast ]
[ slides ]

Mayo Medical Laboratories v Prometheus Laboratories Inc.

Dr. Snyder will discuss the recent decision in the Supreme Court case and its implication on patentable subject matter in biotechnology. Dr. Snyder will also review earlier Supreme Court precedent in order to further explain the Court’s view on patentable subject matter and the patent laws prohibition on patenting laws of nature, natural phenomena and abstract ideas.

Joseph Snyder is the Managing Partner of the firm’s Walnut Creek office. He focuses his practice on patent prosecution and counseling, emphasizing patent drafting, patent procurement, client counseling and opinion writing, primarily in the chemical arts, biotechnology, life sciences and clean technology. He counsels clients on planning and portfolio analysis for patent protection, including strategic review of technologies’ commercial potential, enforcement of patent rights and defense of infringement allegations. Dr. Snyder represents U.S. and foreign companies, such as pharmaceutical companies, diagnostic laboratories, universities and start-ups in all areas of intellectual property counseling and protection.

He conducts and performs due diligence investigations in connection with commercial transactions, such as mergers, acquisitions and the establishment of strategic business alliances. These investigations involve intellectual property including patents, technology licenses, acquisition agreements and asset purchase agreements. Dr. Snyder advises on the creation of start-ups and their patent portfolio development. He coordinates and negotiates the transfer and licensing of intellectual property as it relates to office of technology transfer agreements, collaborative/sponsored research agreements and other transfer agreements.

His technology experience includes small molecules, pharmaceutical formulations, drug delivery technologies, medical diagnostics, nucleic acid assays, nucleic acid sequencing technologies, dyes and clean technology, such as fuel cells.

Before joining the firm, Dr. Snyder worked as a patent attorney for Zeneca Ag Products in the areas of patent drafting, patent prosecution and patent validity opinions.

Prior to joining the legal profession, he was a senior scientist in their analytical department doing organic structural analysis using NMR and mass spectrometry.




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Lila Hope, Cooley LLP

“The first deal—small contract terms with big consequences”
Wednesday, May 16, 2012
UCSF Mission Bay, Byers Hall, Room 212
[ podcast ]
[ slides ]

Dr. Hope will lay out some of the key elements in early stage licenses and research collaborations that a startup company may enter into, as well as how such terms may play out as the company seeks collaboration partners as its product and technology mature over time.

Dr. Lila W. Hope is a partner in the Life Sciences practice group and counsels life sciences clients ranging from privately-held companies to Fortune 500 companies. She specializes in transactions involving complex intellectual property, business, operational and legal issues, including strategic partnerships, discovery and option deals, and complex asset purchases. In addition, she counsels clients’ management, operational and legal teams on daily legal matters involving grant funding, licensing, supply, distribution, clinical trials, research collaborations and contract services. She is regularly involved in financing and M&A transactions where she evaluates a company’s product rights and operational risks through contract due diligence. Dr. Hope graduated with a J.D. magna cum laude from Duke University School of Law. She earned her Ph.D. in Cancer Biology from Stanford University School of Medicine. Prior to entering Stanford, she graduated with an M.S. from the Oregon Graduate Institute, and received her undergraduate education at the University of San Francisco and the University of Science and Technology of China.

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Eric Walczykowski, Deloitte Recap LLC

“Biopharma deal analysis: year in review”
Thursday, May 10, 2012
UCSF Mission Bay, Byers Hall, Room 212

Eric Walczykowski (Managing Director, Deloitte Recap LLC) has assisted emerging growth companies in many roles, including Chief Executive Officer, VP of Corporate Development, Venture Capital Investor, Board Member and Investment Banker and Auditor.

Previously, Eric was the Chief Executive Officer of Suni Medical Imaging, a medium-sized medical technology company that grew 40% under his direction. Prior to Suni, Eric spent five years in the Venture Capital Industry with Nucleus Partners and The Angels Forum/Halo Fund, where he led direct investments and served as an interim executive in certain portfolio companies.

Eric also spent six years with Anderson in both Corporate Finance and Audit. While in Corporate Finance, Eric created the Western Region internet/e commerce practice and acted as the lead financial advisor on Private Placement transactions and Mergers and Acquisitions.

This QED is sponsored by WuXi AppTec. A brief presentation will follow the talk.




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Janet Woodcock, Center for Drug Evaluation and Research, FDA

“Today’s biomedical innovation: lost in translation?”
Thursday, April 26, 2012
[ blog post ]
[ podcast ]
[ slides ]

Janet Woodcock, M.D. is the Director, Center for Drug Evaluation and Research, Food and Drug Administration (FDA). Dr. Woodcock held various leadership positions within the Office of the Commissioner, FDA including Deputy Commissioner and Chief Medical Officer, Deputy Commissioner for Operations and Chief Operating Officer and Director, Critical Path Programs. Previously, Dr. Woodcock served as Director, Center for Drug Evaluation and Research from 1994-2005. She also held other positions at FDA including Director, Office of Therapeutics Research and Review and Acting Deputy Director, Center for Biologics Evaluation and Research. A prominent FDA scientist and executive, Dr. Woodcock has received numerous awards, including a Presidential Rank Meritorious Executive Award, the American Medical Association’s Nathan Davis Award, and Special Citations from FDA Commissioners. Dr. Woodcock received her M.D. from Northwestern Medical School, completed further training and held teaching appointments at the Pennsylvania State University and the University of California in San Francisco. She joined FDA in 1986.



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Special event at the Wharton | San Francisco campus, 2 Harrison St., 6th floor, San Francisco

“Between a Rock and a Hard Place: The Biotech Startup & Walking the Line Between the University and the Venture Investor”
Wednesday, April 25, 2012

You and a guest are invited to join us for the first panel discussion of a semi-annual series that will bring together thought leaders, executives and investors in the life sciences. The presentation will offer a range of views and observations about the unique challenges facing the biotech startup where the core science emanates from the university. Our panelists—representing the point of view of the executive, the university and the venture capital investor—will comment on the tensions and competing objectives faced by the company as it seeks to secure appropriate licensing terms for the commercialization of the IP and investment terms for the foundation to fund the company’s growth.

Questions that will be addressed include:

  • What are the main parameters that influence UCSF’s OTM in licensing out core IP?
  • How much latitude does the company have in navigating between OTM’s objectives and the objectives of the venture capital investor?
  • What are the showstoppers in company organization from the investor’s standpoint?

These and other mission-critical issues will be addressed as our panel discusses investor insights, company requirements and university concerns across this challenging landscape.

Moderator: Vern Noviel, Senior Partner, Biotech Practice of Wilson Sonsini Goodrich & Rosati

Panelists:

Company perspective: Steve Engle, Former CEO, XOMA, Ltd.

University perspective: Erik Lium, Assistant Vice Chancellor of Research, UCSF

Venture capital perspective: Rowan Chapman, General Partner, Mohr Davidow Ventures



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Stephen Sherwin, Ceregene and UCSF

“The changing world of biotech startups: a three-decade perspective”
Tuesday, April 10, 2012
[ podcast ]

Dr. Sherwin plans to lead an informal discussion of the challenges faced by biotechnology startups over the years based on his three decades of experience in biotechnology and clinical medicine, beginning at Genentech in 1983, followed by the co-founding of three biotech companies, and more recently his serving on the board of several established companies in the industry.

Dr. Sherwin currently divides his time between advisory work in the life science industry and patient care and teaching in his specialty of medical oncology. He is chairman of the board of Ceregene, Inc., a company focused on neurodegenerative diseases which he co-founded in 2001, and a director of Biogen Idec, BioSante Pharmaceuticals, Neurocrine Biosciences, and Rigel Pharmaceuticals. He is also a member of the board and chairman emeritus of the Biotechnology Industry Organization and currently serves on the President’s Council of Advisors for Science and Technology (PCAST) Working Group on Advancing Innovation in Drug Development and Evaluation. Dr. Sherwin is a Clinical Professor of Medicine at the University of California, San Francisco, and a volunteer Attending Physician in the Hematology/Oncology Division of San Francisco General Hospital.

Previously Dr. Sherwin was chairman and chief executive officer of Cell Genesys, Inc., beginning in 1990 until the company’s merger with BioSante Pharmaceuticals in 2009. He was also a co-founder and chairman of the board of Abgenix, Inc, an antibody company which was acquired by Amgen, Inc. in 2006. From 1983 to 1990, Dr. Sherwin held various positions at Genentech, Inc., most recently that of vice president of clinical research. Prior to 1983, he was on the staff of the National Cancer Institute.

Dr. Sherwin holds a B.A. in biology summa cum laude from Yale University and an M.D. from Harvard Medical School, and is board-certified in internal medicine and medical oncology. He is a fellow of the American College of Physicians and a member of the American Society of Clinical Oncology and the American Association for Cancer Research.



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M. “Ken” Kengatharan, Altheos, Inc.

“Freakonomics® of factors that determine failure of a biotech company”
Thursday, April 5, 2012
[ blog post ]
[ podcast ]
[ slides ]

There are a number of ways a successful biotech company could be built (from one’s garage) provided key macro- and micro- environmental factors are in place at a particular time. However, only a handful of factors determine failure of a biotech startup company. Some of these factors are obvious and have been very well described and discussed in the past. This presentation and discussion focuses on the unconventional and non-obvious factors that determine failure of biotech startups learnt through personal experience and through studying mistakes made by other biotech pioneers.

Dr. M. (Ken) Kengatharan is a co-founder, president and CSO of Altheos, Inc., a co-founder and director of Armetheon, Inc, both biopharmaceutical companies based in South San Francisco, CA, and a general partner at Atheneos Capital, a Bay Area based biotech incubator fund. Previously, Dr Kengatharan co-founded Athenagen, Inc (later re-named CoMentis, Inc) which in 2008 completed licensing and drug development collaboration deal with Astellas Pharmaceutical worth $760+ MM with an upfront payment of $100MM. He joined the company in 2005 as VP of pre-clinical R&D and later became VP of translational research and scientific affairs. Prior to that, he was a member of staff at Stanford University School of Medicine, where he continues his affiliation as a visiting scientist and an advisor to Stanford’s technology incubator SPARK since its founding ~6 years ago. Since the late 1990s, he has been critical to technology asset licensing/acquisition, moving multiple drug candidates from idea to Phase II and for raising more than $130 MM in private equity for five start-up companies. Dr. Kengatharan obtained his Ph.D. in pharmacology at the William Harvey Research Institute with Nobel laureate Sir John Vane and an MBA (with distinction) from Durham University in England, where he focused on biotech finance and entrepreneurship.


Louis Lange, Asset Management Company


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“Scientific entrepreneurship: building a synthetic career”
Thursday, March 22, 2012
[ podcast ]

Dr. Lange will share advice and perspective from his 20+ year career, starting as one of the first academicians in molecular cardiology, to a biotech entrepreneur who took his company public, and eventually to his current work as a venture capitalist.

Dr. Lange has 22 years experience in academic medicine at Harvard and Washington University, where he served as Chief of Cardiology and Professor of Medicine at Jewish Hospital from 1985-1992 and was one of the first academicians in molecular cardiology.

He founded CV Therapeutics based on this broad field and as Chairman, CEO and Chief Scientific Officer, led the IPO in 1996 and the overall pipeline development and the initiatives for US FDA and European EMEA approval for Ranexa®, a first-in-class late sodium channel blocker and the first anti-anginal drug class approved in 30 years in the US. He also led the approval of Lexiscan®, a first-in-class adenosine A2a receptor agonist for use in myocardial perfusion imaging studies. Dr. Lange oversaw the commercial success of CV Therapeutics and its sale to Gilead in 2009 for $1.4 billion dollars.

As a member of the Board of Trustees at the University of Rochester since 1998 and as Chair of the Health Affairs committee that oversaw all of the medical operations for five years, Dr. Lange has been part of the leadership team for strategic re-invigoration of the medical center with construction of two research buildings and recruitment of over 100 faculty members. As a member of BIO Board of Directors (the trade organization of biotech companies) from 1999 to 2009, Dr. Lange led the largest committee of member companies for two years and was picked as one of two biotech executives to attend the ceremonies at the White House for the signing of the Bioterrorism bill in 2004.

Dr. Lange has been a General Partner at Asset Management since 2009, remains a senior advisor to Gilead and serves on numerous other public and private Boards in both the non-profit and for-profit arena.


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Dennis Henner, Clarus Ventures

“A current perspective on investing in the life sciences”
Tuesday, March 13, 2012
[ blog post ]
[ podcast ]

Dr. Henner will talk briefly about his experiences at Genentech and his thoughts on careers in the biotechnology and pharmaceutical industry. He will then give his perspective on the current climate for investments in Life Sciences, what venture capital firms are looking for, and what you should be thinking about if you are looking for investment capital.

Dennis Henner, PhD, has been Managing Director of Clarus Ventures since the firm’s inception in 2005. Prior to Clarus, Dr. Henner was a General Partner at MPM Capital, a healthcare venture capital firm. He has over 27 years of direct industry and investment experience within the healthcare sector.

From 1981 to 2001, Dr. Henner was an executive at Genentech where he held various positions including Senior Vice President of Research, and was a member of Genentech’s executive committee.

Dr. Henner received his PhD from the Department of Microbiology at the University of Virginia and did postgraduate training at the Scripps Clinic and Research Foundation.

Dr. Henner represents Clarus Ventures on the Board of Directors of Aerie Pharmaceuticals, Cleave Biosciences, CoMentis, Inc., FerroKin BioSciences, Proacta, Inc., and SARcode Bioscience.

In addition he is a member of the Board of Directors of Ceregene, Inc. and KaloBios, and also a member of the Board of Trustees of Reed College.

Previous directorships include Cellerant, Pelikan Technologies, Rinat (acquired by Pfizer), Rigel (NASDAQ:RIGL), Synergia, and Tercica (acquired by Ipsen).


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Pat Scannon, XOMA

“The target product profile: converting discoveries into companies”
Thursday, March 1, 2012
[ blog post ]
[ podcast ]
[ slides ]

Novel discoveries, regardless of importance, do not routinely convert themselves into commercial reality. Generation of a Target Product Profile is an accepted method for linking discoveries to commercial products. By taking into account a spectrum of post-discovery considerations, discoveries can be translated into a product format understandable by non-technical business colleagues and investors. Although a broad concept, the Target Product Profile can be customized to meet a variety of requirements, including providing a critical foundation when starting new companies.

Patrick J. Scannon, MD, PhD is XOMA’s founder, executive vice-president, chief scientific officer and a member of the board of directors of XOMA. Since 1980, Dr. Scannon has directed the company’s product identification, evaluation and clinical testing programs. He also has actively participated with senior executives in all aspects of fund raising and investor relations for XOMA, both as a private and public company. As CSO, he heads the clinical research programs and has evaluated several classes of biologic compounds and conducting clinical studies for infectious, oncologic and immunologic indications.


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John Steuart, Claremont Creek Ventures

“Secrets of early-stage life-science startup funding”
Wednesday, February 22, 2012
[ blog post ]
[ podcast ]

John Steuart has spent more than 20 years managing, building and investing in technology and life science companies and is passionate about understanding and combining powerful themes in information technology and in biology to create products that deliver better health care at a lower price. One theme is Moore’s Law, which guarantees year after year that semiconductor-based devices are smaller, faster and cheaper than their predecessors. Another is the genomics revolution, which, with the help of Moore’s Law, makes it possible to tailor an individual’s medical treatment to his particular genetic profile.

Two Claremont Creek companies that reflect these themes are Gene Security Network and AssureRx. John sits on the board of Gene Security and oversaw the firm’s investment in AssureRx. Gene Security Network provides a better and less expensive version of screening tools that allow doctors in fertility medicine to determine whether embryos have any number of conditions pre-implantation. This assures parents that their offspring won’t have a major genetic disease. AssureRx uses a clinically validated form of genetics to determine which psychiatric drugs are most likely to benefit a specific patient.

John is an Industry Fellow at the Center for Entrepreneurship and Technology at the College of Engineering and a member of the Advisory Council to the Lester Center’s Berkeley Entrepreneurs’ Forum at UC Berkeley. Early in his career, he joined Alafi Capital, an Emeryville-based venture firm specializing in early-stage biomedical companies, where he served as an officer of the General Partner. At Alafi, John lead investments in more than a dozen successful start-ups, and served as the senior executive and board member of various firms such as Tanox, Software Ventures, Lipomatrix and Megan Health.