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Hecker &
Associates, LLC
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307 North Garfield St.
Arlington, VA 22201-1261
202.297.7708
sandy@hecker-associates.com
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Drug/Biologic Development
Experience
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Sandy’s interest in drug
development began in 1988 when she was
appointed to an Institutional Review Board
(IRB) for the National Institute of Allergy
and Infectious Diseases (NIAID), at NIH.
Along with the other IRB members she
reviewed a large number of clinical trial
protocols and investigator brochures for
scientific merit and patient safety. In 1990
when she joined Genentech to create the
medical writing/submissions department, her
experience reading those documents was put
to good use creating submission templates.
After Genentech, she moved back east and
back to NIAID, where she was Scientific
Assistant to the Director, but she missed
the business side of promising scientific
research, as demonstrated by Genentech’s
unofficial motto: “Do it better, faster,
cheaper!” So she went back to industry, this
time into the Contract Research Organization
(CRO) world, managing a succession of
regulatory submissions writing groups, first
in Medical Affairs, and then in Regulatory
because she wanted to work on entire
applications, and be part of identifying and
implementing a project’s big picture
strategy to achieve client goals.
At Genentech she oversaw contract workers
supporting her department’s submissions, and
at CROs, she worked as a contractor for
sponsors. Sandy cares as much about the
success of the client’s project, as the client
does, as a reliable, always available team
member. Her approach has led multiple clients
to transfer other work to her too, because she
is “so quickly responsive.”
Sandy’s experience coaching teams and filing
strategic submissions as efficiently as
possible was put to use helping clients when
she started her own business in 2001. From her
experience managing contractors, Sandy
understands that the contractor must be
reliable, accessible, anticipate and prevent
any wrinkles in the drug development process,
and keep executives advised about options for
addressing issues that may arise, so they can
be dealt with before they become problems.
Since 1990, Sandy has worked on 35 clinical
trial applications filed to FDA and/or Health
Canada. Of these, only one was put on Clinical
Hold by FDA and Health Canada, because a
clinical trial run by a different sponsor
treating similar patients with a related
product, had safety problems. Working with FDA
and Health Canada, Sandy and her client team
convinced the US and Canadian agencies to
allow the trial to proceed and the study was
successfully completed.
Also since 1990, Sandy has worked on 22
marketing applications, filed to FDA, Health
Canada, and various agencies in Europe.
Working on marketing applications, Sandy likes
to integrate herself into the sponsor team,
and has typically been responsible for a
particular area, such as managing the review
and finalization of 75 clinical study reports
by a global team based in Japan, the US, and
Europe, or shepherding a problem safety
summary through review and finalization. Her
marketing application support includes
responding to questions from FDA, Health
Canada, or EMA, sometimes on a very tight
timeline. Some of her proudest accomplishments
were helping get on the market in multiple
regions Genentech’s Pulmozyme for cystic
fibrosis, Pfizer’s Celebrex for arthritis, and
Otsuka/BMS’s Abilify for schizophrenia.
Meeting or hearing about patients whose lives
were saved or improved by these products,
makes the hard work and long hours worthwhile.
The majority of Sandy’s regulatory submissions
have been for CNS, oncology, and
cardiovascular projects. Her work as a
contractor since 1996 enables her to quickly
assess the status of a project she’s asked to
facilitate, and get up to speed on its
scientific and regulatory issues rapidly.
Her clients have included small or novice
companies in the US, Europe, Canada, New
Zealand, and Asia, academic groups in the US,
venture capitalists, and biotech/pharma
companies that needed help with a particular
project where she became part of or led a
global team. Sandy particularly loves working
cross-culturally and as US Agent to FDA for
foreign companies without a presence in the
US.
Because drug development regulations,
guidelines, and best practices are constantly
changing, Sandy is active in management of the
Drug Information Association (DIA), her main
professional society, where she is a member of
management committees focused on regulatory
submission strategy and global submission best
practices. She has also been on the Program
Committee or a speaker or session chair at
numerous DIA and Regulatory Affairs
Professionals Society (RAPS) meetings since
1999. Her topics have included Global
Submission Best Practices, US Agent Best
Practices, Effective Submission
Content/Management, Successful Global Team
Project Management, and Career Development
topics for regulatory staff, medical writers,
and project managers.
Through her former project teams and her
professional societies, Sandy maintains a
large network of individuals with extensive
expertise—from subspecialties in chemistry and
manufacturing, to nonclinical regulatory
knowledge supporting various product types and
clinical pharmacology, to medical experts on a
wide range of indications. She confidently
recommends these individuals to her clients
because she has worked successfully with them
on prior projects and knows them to be
knowledgeable, reliable contractors.
Sandy regards drug development as like a
steeplechase on horseback—“you never know what
you’ll have to jump next—how far or how wide,”
but with her extensive experience, an
entrepreneurial problem-solving outlook, and a
determination that her clients will succeed if
at all possible, Sandy loves helping client
teams learn and navigate the complex drug
development pathways, so as to get ever better
products on the US market, as time- and
cost-effectively as possible.
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