Pharmaceutical & Biotechnology Industry
Dr. Gordon is responsible for developing, directing and implementing the global regulatory strategy, objectives, policies and programs pertaining to the development of drug and biological products. As a global regulatory lead for many of her clients, she is responsible for life cycle support, which includes the leadership of regulatory strategy for multiple programs that extend globally.
Dr. Gordon acts as a liaison with regulatory health authorities (FDA and other global authorities) on behalf of client pharmaceutical and biotechnology companies to develop effective professional relationships and to convey a positive company image. Technical areas of expertise include: preparation and/or evaluation of pre-clinical and clinical data; quality/chemistry, manufacturing, and controls information; and pharmacology and toxicology data submitted to the health authorities to support the safe and effective use of drug and biological products specified by Investigational New Drug (IND), Clinical Trial Application (CTA), Biologics License Application (BLA), and New Drug Application (NDA) requirements. She is responsible for the preparation of all types of regulatory submissions to health authorities, including briefing packages to support communications and meetings with the regulatory authority, CTA, and IND, BLA, and NDA submissions in electronic Common Technical Document (eCTD) format, amendments, supplements, and advisory committee briefing packages. She also provides expert medical writing services including clinical protocols, Investigator Brochures, clinical study reports and other scientific reports.
Dr. Gordon has in-depth knowledge of FDA programs to facilitate and expedite development of new drugs to address unmet medical needs in the treatment of serious and life-threatening conditions and rare diseases. She has experience in applications for fast track designation, breakthrough therapy designation, accelerated approval, priority review designation, expanded access programs and other treatment options, and orphan product designation. Each of these programs are intended to help ensure that therapies for serious or rare conditions are approved and available to patients as soon as results support that the therapies’ benefits justify their risks.