Revolution Slider Error: The param width not found in slider params.

Background

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. Her more than 25 years of experience with FDA and Health Canada enables her to recommend regulatory strategy, and identify data and documentation “red-flags” for her clients, so the issues can be explained / eliminated prior to submission, thus minimizing the number of regulatory agency questions, and hastening the 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, cardiology, infectious disease, immunology, and internal medicine. She has also worked on ophthalmology, endocrinology, and gastrointestinal-related projects. For her client Amgen, Sandy supported regional oncology cooperative groups, such as Georgia Cancer Specialists, to accurately summarize results of their research or marketed product treatment protocols, 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 25 years’ experience with basic and medical research, medical writing, regulatory strategy, culminated in her establishing her own firm. To date, Sandy has worked on 35 clinical trial applications/INDs and 20 marketing applications for biologic and drug projects, such as Genentech’s Pulmozyme for CF, Searle’s (now Pfizer’s) Celebrex for arthritis, and Otsuka/Bristol Myers Squibb’s Abilify for schizophrenia and other psychiatric disorders. None of Sandy’s INDs have been put on clinical hold because of  project flaws. None of Sandy’s marketing applications has resulted in a “Refuse to File” or a “Complete Response.”

Sandy files appropriate submissions, including all the data and information FDA expects, but nothing more, organized in a way that FDA can review it easily/quickly.

Project Management / Regulatory Experience in Industy and NIH

Prior to starting Hecker and Associates, 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, the multinational drug development Contract Research Organization. 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 as a member of NIAID’s Institutional Review Board (IRB) evaluating potential new drug development projects at NIAID and later (1994 to 1995), when she returned from California, as scientific assistant to the director.

In 1990, Sandy was hired by Genentech, Inc., in 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 much shorter time frame than had previously been 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 (Submissions) Special Interest Area Community (SIAC) a special interest group, and she has been active for many years in the DIA Regulatory Affairs, Clinical Safety and Pharmacovigilance, and Clinical Trial Disclosure special interest groups.

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. Her other activities include program committee work for Regulatory Affairs Professionals Society (RAPS) meetings, and giving talks to Washington, DC law firms with pharmaceutical industry clients, as well as to groups of visiting foreign lawyers and judges (e.g., from Argentina and Chile, about the differences between drug development in their countries vs. the US), about US drug development regulatory requirements. Sandy also gives many talks at drug development professional society meetings.

Hecker & Associates’ Goals and Clients

Her focus throughout her career, whether for clients or through her professional societies, outreach efforts or speaking engagements, has been to encourage drug development teams to devise more efficient work processes (despite individual team members having sometimes differing goals) to ensure medicinal product development achieves quality results in a global team-oriented, time-sensitive, cost-effective manner. This approach also saves valuable time for frantically busy, overworked regulatory authority agency reviewers—a good thing!

Sandy’s clients have included small and large biotech and pharmaceutical companies as well as academic and venture capital groups based in California; on the US east coast, in the Midwest; and in Canada, New Zealand, and Europe. She particularly enjoys working with small or novice groups to coach them through what they need to know to set up an efficient drug development process, and to ensure they work well with the regulatory authorities—particularly FDA and Health Canada—to develop drugs and biologics successfully. Sandy finds all too often, that sponsor-reported “problems with regulatory agencies” were caused by the sponsor not understanding how to work effectively with the agency, or not following appropriate procedures in the drug development process. Sometimes too, Sandy finds that sponsors have done more work than they needed to, or expensive but incomplete work that must be redone, because they did not know the “real world” application of regulations and guidelines, i.e., the unwritten expectations of FDA or Health Canada that are only known from frequent interaction with those agencies.