Capitol with hecker associates logo
Split World Map

Hecker & Associates, LLC

Product Development Experience
Regulatory Strategy
US Agent
Seminars and Events

307 North Garfield St.
Arlington, VA 22201-1261



Facebook Logo


Picture of Sandra J Hecker
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.


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.