Mary Lou is Regulatory Advisor for Valaria Technical Consultants (VTC) and subcontractor to VTC clients. Her responsibilities are to provide regulatory guidance for pre-clinical , clinical, product and process development and stages through to scale-up, validation and commercialization, and the designation and preparation of Meeting packages for FDA Review Divisions, as needed. Over a period of several years, acting as a member of the Executive Advisor Group (EAG), she worked with the Department of Defense and Nanotherapeutics on MCM initiatives, including the construction of the Advanced Development and Manufacturing (ADM) facility. She mapped the procedure for distributing MCMs to the strategic national stockpile (SNS) with the FDA/DoD; and, evaluated stability data as justification for product expiration dating. She provided regulatory oversight for MCMs developed under the “Animal Rule”, and negotiated study designs to support MCM initiatives with the FDA. Her work encompassed research and regulatory strategy for the development of: vaccines, biologics; monoclonal antibody medical device diagnostics for screening monoclonal antibody clones; dry powder inhalants for post-exposure and prophylaxis of and treatment of aerosolized pneumonic plague and tularemia; ETI-204 monoclonal antibody anti-anthrax toxin; combination products for the expeditious neutralization of the dirty bomb decorporation and several radioactive materials (americium and cesium) in the dirty bomb; cidofovir dry powder inhaler for post- exposure prophylaxis and treatment of smallpox.
Prior to joining Nanotherapeutics her accomplishments for various clients included: As Senior Quality Engineer and Project Leader for Johnson and Johnson’s, Ethicon-her team developed the Intraluminal Stapler (ILS), a critical medical device. She transformed a desk top stapler company (Senco) into a GMP facility for the production of the ILS. She holds a patent for the processing of ILS double row staples. As Senior Scientist for Ortho Pharmaceuticals she successfully developed and characterized monoclonal antibodies for infectious disease diagnostics (ELISA). For Biocraft Laboratories (now owned by Teva) she negotiated with the FDA Compliance Division to accept the regulatory strategy proposed to verify the validation of several antibiotic manufacturing processes for 5 production facilities, thereby, removing the company from the “Alert List” and reinstated product approvals for submissions in the pipeline; further, correcting all Biocraft’s compliance violations, the FDA rescinded all senior executives’ 305 subpoenas to appear in court. As Executive Senior Director of Regulatory Affairs and QA Compliance at NovaDel Pharma, sublingual sprays, Nitromist (cardiovascular) and Zolpimist (neurological) were approved for manufacture and distribution for sale in the US and Europe; and, the proposal to produce, distribute and sell ondansetron under a Regional European Registration was successfully negotiated with the Swedish Advisory Committee. As a CMC expert, she successfully submitted responses to global registration needs (ANDAs; amendments) for Pfizer’s veterinarian antibiotics used in domestic and farm animal treatments.
In the past 20+ years scope of her regulatory submissions encompassed: Pre-INDs, NDAs, sNDAs, OPD & Grant reporting, IDEs, PMAs, ANDAs, 505(b)(2)s, 510ks, EU, EU-like, non-EU, and Combination Products: eSubmission task force with CDER and CBER. Regulatory oversight for therapeutic areas: cardiovascular, wound healing, neurological, depression, intractable cancer pain, bacterial infections, anthrax infection, irradiation poisoning, lupus erythematosus, lupus nephritis, dental carries, periodontitis and gingivitis, female sexual and male erectile dysfunction, osteoporosis, rheumatoid arthritis, smoke cessation, oral mucositis, generics, and pediatric product approval and labeling, diabetes, benign prostatic hyperplasia, liver cancer.; DNA antibody to CCR5 for the treatment of HIV; small molecule treatment of hepatitis C.
She obtained her BS in Medical Technology from Marywood University (Scranton, PA); MS in Medical Technology-Immunology from Fairleigh Dickenson University (Rutherford, NJ); MBA for Executives from Fairleigh Dickinson University (Rutherford, NJ); All But Dissertation (TP5 for Immunoregulation of Systemic Lupus Erythematosis; (Rutgers, Newark, NJ), and PhD in Management of Organizational Systems (Technology Transfer Effectiveness in the Biotechnology Industry)