Principals...
Nancy
L. Parenteau, Ph.D.
 Dr.
Parenteau is a
biotechnology pioneer and award-winning biologist with over 20 years of experience
as a senior
industry executive, including the advance of first-in-class bioscience
from concept to the market. She is the former Senior Vice President ad
CSO
of Organogenesis and was co-founder and CEO of a biotech start-up,
Amaranth
Bio,
Inc.
She
brings many years of hands-on research and management experience to the
challenge of bioscience
development, having built and managed top cross-disciplinary teams of engineers,
biochemists, cell
and molecular biologists, and immunologists.
Nancy
has
operated at technology's cutting edge throughout her career from her
academic beginnings in monoclonal
antibody research in its earliest days while at Georgetown, developing
a novel
ELISA assay commercialized while a Harvard postdoc, to pioneering the
first living
product to achieve
clinical trial success and US FDA approval. Nancy's
technology innovation and product
achievements have been recognized with the prestigious "R&D 100"
award in 1990 for a sophisticated in vitro test system and a "Best
of Biotech" award in 2000 for a tissue engineered cell therapy that
remains the leading cell therapy today after blood transfusion. She is
listed in Who's Who in America and has served on the Chemical Sciences
Roundtable of the National Research Council. She is an internationally
recognized thoughtleader in cell therapy.
Drawing
from her successful experience as a scientific innovator, she co-founded Parenteau BioConsultants
in September of 2005 to focus
on analyzing, communicating, developing and supporting industry
practices that can reduce the development risk of novel technology and
increase the efficiency and effectiveness of bioscience R&D.
Janet
Hardin Young,
Ph.D.
 Trained
as an immunologist at Georgia Tech and Harvard, Dr. Hardin Young has
experience
building and managing highly
productive basic research, preclinical and clinical research teams. During
the last
10
years she has set the bar in addressing the safety questions of new
technology. Dr. Hardin-Young is the former Senior Director of
Technology
Implementation at Organogenesis Inc.
Jan
has designed and implemented strategies for clinical immunological and
safety testing,
mechanism of action, establishment of bioequivalence, cell purity and
biological assay design and validation, as well as post marketing
clinical studies. She has worked on the safety assessment of
biomaterials to complex cellular implants.
Her
clinical testing
strategy is now a benchmark for regulatory submissions in the field of
cell therapy and tissue engineering having developed an overall
strategy and validated clinical assays to demonstrate the safety of the
first living cellular device to be approved by the US FDA and Canada.
Her
broad bench to market experience has given her
first-hand knowledge on how to make the most of basic and applied
research; how to focus efforts to achieve the information needed
for the regulatory approval process while minimizing testing and time
to approval. She knows the importance of savvy preclinical
development - that new technology needs new solutions and that even
simple biological tests can be keys to success.
As
a seasoned industry veteran and co-founder of Parenteau BioConsultants,
Jan is committed to devising realistic strategies and providing the
kind of input and support that can increase the success of innovative
bioscience from bench to market.
Consulting Services, Information
and Analysis, Coaching and Training
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