Biotech Start-ups from the Inside Out—An Unconventional Story of 3 Decades in the World of Emerging Companie-David DeNola-04/20/2010 - 8:30am

Event Information
Event Topic: 
Biotech Start-ups from the Inside Out—An Unconventional Story of 3 Decades in the World of Emerging Companie
Event Date: 
04/20/2010 - 8:30am
Event Location: 
Sunnyvale City Council Chambers, 456 W. Olive St., Sunnyvale
Speaker Information
Event Speaker: 
David DeNola
Event Speaker Title: 
Consultant
Event Speaker Company: 
Biotechnology Emerging Company Consultant
Event Speaker Bio: 

David has broad experience working with biotech and life sciences start-ups, preparing them for rapid growth in global markets. As a senior executive in operations and product development, he has served with a number of companies in both the U.S. and Israel. He is dedicated to preserving a culture of innovation, while building flexible infrastructure for growth. Orchestrating cross-departmental communication is a central part of his leadership style and ensures that decision making and strategic focus permeate organizations. With his focus on start-ups and emerging companies, he emphasizes fast product development turn around by identifying and fixing bottlenecks, as well as leading with a “fail fast” approach, cutting development time and time-to-market.
David has served as Chief Operating Officer (COO) for Cobalt Biofuels, a CleanTech start-up company, developing technologies for commercial production of biobutanol as a next generation transportation fuel. In prior roles he served as COO of Arbor Vita, a diagnostics and drug development company and VP of Operations for Xenogen, a company operating in the area of biophotonic real-time in vivo imaging and genetic modification. For 5 years Mr. DeNola served as VP of Operations and Product Development for Ciphergen Biosystems, a proteomics company that achieved revenues of $58M within 3 years.
During his time in Israel, David spent over ten years developing, building, and operating systems for mammalian cell culture microfiltration, as well as virus-free plant cell fermentation and production. Experience with these systems, as well as experience directing contract manufacturing of pharmaceuticals, has given David a thorough knowledge of clean room infrastructure and operating methods. As COO for Gamida-Cell of Jerusalem, David concentrated on formulating and writing the business plan, and constructing a regulatory and operational infrastructure for this early-stage start-up in the area of umbilical cord blood stem cell expansion. At Diagenetics, he oversaw the research-to-market commercialization, within 1.5 years, of a molecular biology based in vitro diagnostic for Gaucher Disease for markets in Israel and Europe.
David has extensive experience with Regulatory Affairs and has represented several companies in discussions and submissions to FDA. He has installed QA programs in the majority of the companies he has worked with, establishing and overseeing GMP, QSR, and ISO systems to meet both U.S. and EU standards.
David has a post-graduate degree in Business Administration from Technion College, Israel and received his B.A. from the University of California, Berkeley. He is a co-inventor for patents pertaining to automated tissue culture for mass propagation in clean rooms.

Event Details
Cost: 
$0
Event Details: 

Bio2Device Group, Tuesday Morning, April 20, 2010
Topic: “Biotech Start-ups from the Inside Out—An Unconventional Story of 3 Decades in the World of Emerging Companies”
Speaker: David DeNola
Date and Time: Tuesday, April 20, 2010, 8:30 – 10:30 am
Location: Sunnyvale City Council Chambers, 456 W. Olive, Sunnyvale, CA (across the street from Sunnyvale Public Library)
Cost: Free, no registration required at morning meetings
Parking: On street and in NOVA and library parking lots across the street.

Topic Description
Start-ups, especially as they emerge from early stage development and drive toward commercialization, have their own unique characteristics and idiosyncrasies. Often, the whole team is on a steep learning curve, and some of the lessons are harsh. There is the unrelenting need to raise money, the challenge of understanding what the customer really wants, the effort to navigate a clear and affordable way through the twisted pathways of product development, and so much more. As in any organization the human element takes center stage, such that good leadership, communication, and judgment come into play. The speaker has spent 3 decades in this environment, straddling just about every sector of the life sciences. This talk is meant to give some of the flavor of that experience through a progression of stories from the “inside” that highlight some of the more thought provoking and interesting experiences of a long career. The idea is not so much to teach, but to tell.

Speaker Bio
David has broad experience working with biotech and life sciences start-ups, preparing them for rapid growth in global markets. As a senior executive in operations and product development, he has served with a number of companies in both the U.S. and Israel. He is dedicated to preserving a culture of innovation, while building flexible infrastructure for growth. Orchestrating cross-departmental communication is a central part of his leadership style and ensures that decision making and strategic focus permeate organizations. With his focus on start-ups and emerging companies, he emphasizes fast product development turn around by identifying and fixing bottlenecks, as well as leading with a “fail fast” approach, cutting development time and time-to-market.
David has served as Chief Operating Officer (COO) for Cobalt Biofuels, a CleanTech start-up company, developing technologies for commercial production of biobutanol as a next generation transportation fuel. In prior roles he served as COO of Arbor Vita, a diagnostics and drug development company and VP of Operations for Xenogen, a company operating in the area of biophotonic real-time in vivo imaging and genetic modification. For 5 years Mr. DeNola served as VP of Operations and Product Development for Ciphergen Biosystems, a proteomics company that achieved revenues of $58M within 3 years.
During his time in Israel, David spent over ten years developing, building, and operating systems for mammalian cell culture microfiltration, as well as virus-free plant cell fermentation and production. Experience with these systems, as well as experience directing contract manufacturing of pharmaceuticals, has given David a thorough knowledge of clean room infrastructure and operating methods. As COO for Gamida-Cell of Jerusalem, David concentrated on formulating and writing the business plan, and constructing a regulatory and operational infrastructure for this early-stage start-up in the area of umbilical cord blood stem cell expansion. At Diagenetics, he oversaw the research-to-market commercialization, within 1.5 years, of a molecular biology based in vitro diagnostic for Gaucher Disease for markets in Israel and Europe.
David has extensive experience with Regulatory Affairs and has represented several companies in discussions and submissions to FDA. He has installed QA programs in the majority of the companies he has worked with, establishing and overseeing GMP, QSR, and ISO systems to meet both U.S. and EU standards.
David has a post-graduate degree in Business Administration from Technion College, Israel and received his B.A. from the University of California, Berkeley. He is a co-inventor for patents pertaining to automated tissue culture for mass propagation in clean rooms.