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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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Sandra J. Hecker, RAC, is
President of Hecker & Associates, LLC,
a drug development consulting group
incorporated in 2001. Sandy’s specialty is
strategizing for and managing production
of global drug and biologic clinical trial
and marketing applications filed to FDA.
With more than 25 years of experience with
FDA and Health Canada she recommends
regulatory strategy, and identifies FDA
data and documentation “red-flags” for her
clients, so the issues can be explained /
eliminated prior to submission, thus
shortening time to market for a successful
medicinal product. Sandy’s network of
expert colleagues around the world,
provides her clients access to detailed
regulatory drug development strategy and
requirements in other world regions as
well.
Indications
Sandy’s main medical interests / project
experience are oncology, neurology/CNS, and
cardiology. She has also worked on rare
disease and gene therapy projects. For her
client Amgen, Sandy supported regional
oncology cooperative groups to accurately
summarize results of new uses of marketed
products, ensuring better medical care for
cancer patients and better feedback for
biotech / pharma companies developing new
cancer drugs.
IND/CTA and NDA/NDS/MAA Experience
Sandy’s more than 30 years’ experience with
basic and medical research, medical writing,
and regulatory strategy, culminated in her
establishing her own firm. To date, Sandy has
worked on 35 clinical trial applications/INDs
and 22 marketing applications for biologic and
small molecule projects, such as Genentech’s
Pulmozyme for CF, Pfizer’s Celebrex for
arthritis, and Otsuka/Bristol Myers Squibb’s
Abilify for schizophrenia and other
psychiatric disorders. A good reputation with
FDA is imperative for Sponsor success, so
Sandy ensures FDA filings are appropriate.
Thus, none of Sandy’s IND filings were put on
clinical hold and none of Sandy’s marketing
applications resulted in a “Refuse to File” or
“Complete Response.”
Sandy ensures data and information FDA
expects, nothing more, organized in a way that
FDA can review it easily/quickly, is filed.
Project Management / Regulatory
Experience in Industy and NIH
Prior to starting Hecker and Associates in
2001, Sandy was Director of Drug Development
for Commonwealth Biotechnologies, Inc. (CBI),
and for SRA Life Sciences (SRA). Before that,
she was Director, Regulatory Affairs, for SRA,
from 2000 to 2001.
From 1996 to 2000, Sandy managed medical
writing and regulatory submissions groups at
Quintiles (now called IQVIA). At Quintiles she
was Associate Director, Regulatory Affairs,
from 1997 to 2000.
Before Quintiles, Sandy worked for the
National Institute of Allergy and Infectious
Diseases (NIAID) at NIH, first (1986 to 1989)
as a press officer and member of NIAID’s
Institutional Review Board (IRB) evaluating
potential new drug development projects and
later (1994 to 1995) as scientific assistant
to the director in the early days of AIDS.
In 1990, Sandy was hired by Genentech, Inc.,
South San Francisco, CA, to create its medical
writing department and devise a harmonized
international marketing application format
prior to the establishment of the
International Conference on Harmonisation, and
its guidance for the Common Technical Document
(CTD), a global marketing application format.
This effort resulted in Genentech’s first
nearly simultaneous marketing application
submission that resulted in getting Pulmozyme,
for cystic fibrosis, on the markets in the US,
Canada, and Europe in a shorter time frame
than previously accomplished for a Genentech
product.
Academic Training and Professional
Society Activities
Sandy received a BA in Biology with honors
from Amherst College in Massachusetts, where
her research thesis was in population
genetics. She completed graduate work in
medicinal chemistry, molecular genetics, and
molecular immunology at George Washington
University in DC and at the National
Institutes of Health.
Since 1998, Sandy has been active in her main
professional society, the Drug Information
Association (DIA). Since 2001 she has been on
the Core (Management) Committee of DIA’s
Medical Writing (i.e., regulatory submissions)
Community. She has also been active for many
years in the DIA Regulatory Affairs, Clinical
Safety and Pharmacovigilance, and Clinical
Trial Disclosure communities.
Her interest in fostering drug development
efficiency led Sandy to work on a 2010 US
Office of Management and Budget / White House
effort to streamline the drug development
process by identifying issues that if
addressed, could facilitate faster and less
expensive–though still as safe for patients as
possible–drug development
Hecker & Associates’ Goals and
Clients
Sandy’s focus throughout her career has been
to encourage more efficient work processes
(despite individual team members having
differing goals) to ensure, if possible,
medicinal product development achieves success
in a global team-oriented, time-sensitive,
cost-effective manner.
Sandy’s clients (most of whom include
confidentiality clauses in their contracts;
she can’t name them) are biotech and pharma
companies, as well as academic or venture
capital groups based in the US, Canada, New
Zealand, Europe, or Asia. She enjoys coaching
novice groups about efficient drug development
processes to ensure they work well with FDA to
develop drugs and biologics successfully.
Sandy often finds that sponsor-reported
“problems with FDA” were caused by not
understanding how to work effectively with the
agency, or not following current regulations
and guidelines. And particularly with novice
sponsors, Sandy has found they do more work
than needed, or expensive but incomplete work
that must be redone before consulting her,
because they did not know the “real world”
(unwritten) expectations of FDA that Sandy
knows from frequent interaction with FDA and
through her network.
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