Past QED talks & material

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.

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.

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.

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.

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.

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.

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

“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

“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

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.

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

“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.

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.

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.

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.

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

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.

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

“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.

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).

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.

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.