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Drug/Biologic Development Experience

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 found 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 at various CROs, 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 NIH she worked with drug and vaccine sponsors on press releases about joint projects with NIAID, at Genentech she oversaw contract workers supporting her department’s submissions writing work, and at CROs, she worked on the contractor side for sponsors. From this experience, Sandy’s view of the best way to be a contractor is to care as much about the success of the client’s project, as the client does, and to be a reliable, always available team member.

Sandy’s experience working with various groups to write and file 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, but 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; the study then was successfully completed.

Also since 1990, Sandy has worked on 20 marketing applications, filed to FDA, Health Canada, and various agencies in Europe, including the central European Medicines Agency (EMA). 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, GD Searle’s (now 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, cardiovascular, immunologic, infectious disease, and endocrine 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 and New Zealand, academic groups in the US, venture capitalists, and mid-size and large pharmaceutical 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 two main drug development professional societies: the Drug Information Association (DIA), and the Regulatory Affairs Professionals Society (RAPS), where she is a member of management committees relating to regulatory strategy and global submission best practices. She has also been on the Program Committee or a speaker or session chair at numerous DIA and RAPS meetings since 1999. Her topics have included Global Submission Best Practices, US Agent Best Practices, Effective Submission Content/Management, Electronic Submissions, Successful Global Team Project Management, and Career Development topics for submission regulatory staff, medical writers, and project managers.

Through project teams going back to 1990 and her professional societies, Sandy maintains a large network of individuals with extensive expertise—from various subspecialties in chemistry and manufacturing, to nonclinical regulatory knowledge supporting various project types and clinical pharmacology, to medical experts on a wide range of indications—any of whom might be needed for a client project. She confidently recommends these individuals to clients who may need their support, because she has worked successfully with them on prior projects and knows them to be knowledgeable and reliable contractors. Sandy regards her area of 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 market.