Susan Simmons Email and Phone Number

Regulatory strategy, early oncology development from toxicology to IND submission. Provide regulatory strategy for development of oncology candidates through regulatory discussion in multidisciplinary development intended to speed the development of the drug candidate to IND via regulatory strategy, guidance documents, and interactions with the food and drug administration.

Main responsibilities involve providing regulatory advice and consultation to clients on domestic drug/biologic/device development/strategy/submissions and documentation review for compliance with US regulations. Additional responsibilities include the generation and compilation of technical documents for submission to regulatory agencies (Briefing Documents, INDs, NDA/eCTDs etc.). US Agent services provided to companies located outside the United States (US) for over 9 years.Entirely responsible for 10 + FDA meetings and associated submissions on behalf of contracted sponsors during this timeframe.Main PPD US RA contact for company-wide inquiries regarding US FDA regulations.Responsible for generating and conducting eCTD submission training for the US RA group at PPD.Main SOP annual reviewer for US RA and eCTD procedures for the group.Wrote and submitted 9 Canadian CTAs, including basic experience with New Substance Notification assessments under the Canadian Environmental Protection Act.During this time generated and submitted 14 INDs and associated lifecycle submissions as required by FDA.Extensive work scoping and drafting the regulatory portions of PPD’s responses to sponsor Requests for Proposals (RFPs).

Contract Regulatory Affairs consulting, and medical writing

Subcontracted with Pacific link, Consulting for Regulatory Affairs Consulting, CMC sections, gap, analyses, and regulatory submission writing

Strategic regulatory input (nonclinical, clinical and CMC) for Phase III development of analgesic intravenous acetaminophen product in both adults and pediatrics. Managed transfer, assessment and CTD gap analysis for the product transfer from Bristol-Myers Squibb of 22 supporting clinical studies for inclusion in the NDA.This position also required communication and regulatory strategy defense to the Senior Leadership Team on the clinical development plan, implementation of pediatric regulatory program, CMC strategies and product development.Direct responsibility for the coordination of departments, regulatory aspects and systems implementation for the NDA/eCTD submission.Primary FDA and Health authority contact for the analgesics program. Additional requirements of the position included budget management, coordination of contractors, due diligence efforts for potential drug product acquisitions and supervision of employees.

Strategic regulatory input (nonclinical, clinical and CMC) for development of pre-IND apoptosis compound. Close-out of numerous multi-national clinical trials for histamine dihydrochloride product when the US Phase III results came back with negative results and the company was disbanded.Additional work includes feasibility review for regulatory due diligence during Maxim’s merger and acquisition activities. Responsible for regulatory assessments of various corporations and subsequent capabilities recommendations to the management team.Prior to company sale to Epicept was the departmental representative providing nonclinical, clinical and manufacturing strategies to the oral histamine dihydrochloride development team. Regulatory representative on SOP, Change Control, Materials Resource Board and Specifications Committees. Responsible for two IND activities/submissions, generating Module 3 for two marketing applications (NDA/eCTD and MAA/eCTD). Successfully navigated the EU MAA/eCTD review process with Ireland and Sweden.

Responsibilities included generation and compilation of technical documents (Module 2.3 and Module 3) for submission to regulatory agencies (NDAs, Briefing Documents, INDs, sNDAs etc.).Updated + 45 approved labels and core information dossiers for marketed products to confirm compliance with current FDA labeling regulations for the class of drug (pediatric and geriatric updates) including the assessment of clinical data to support labeling revision and supporting submissions to FDA.Additional experience consisted of providing regulatory advice and consultation to clients on domestic drug/biologic/device development/strategy/submissions, documentation review for compliance with regulations, authoring SOPs for client operations, and project and budget management for regulatory assignments.Responsible for oversight of electronic submission capabilities in the San Diego PAREXEL regulatory affairs department.

Primary company contact for regulatory agencies (domestic and international). Regulatory responsibilities included: Preparation of a 510(k), IDE and IND, internal auditing, departmental representative for internal project teams and project management for all regulatory submissions.Successfully led and managed a quality audit by TÜV (third party EU device audit).

Established and implemented systems to support the release of investigational product for clinical trials, investigational product export, domestic and international reporting of serious adverse events as well as extensive work with IND submissions.Additional time was spent in project management, organizing regulatory submissions and tracking regulatory obligations in this development-stage company.

Recruited from the manufacturing group to write the Chemistry, Manufacturing and Controls section of the Dermagraft-TC and Dermagraft manufacturing applications. Managed the submissions process for both successful manufacturing applications to FDA.Prepared all periodic reports for nine clinical protocols with multiple dermal wound care indications. Reviewed and submitted final clinical/statistical reports for all nine clinical investigations.Developed and submitted responses to FDA requests for information on both marketing applications and participated in labeling content negotiations with the Agency. Developed and reviewed post-market product labeling and promotional materials as well as performed regulatory review of all advertising and promotional materials developed for these unique combination products (biologic/device).Prepared numerous post-market submissions, including extension of expiration dating, storage conditions, additional indications, Annual Postmarket Reports (APRs), changes to the manufacturing process and safety Medical Device Reporting (MDR).Prepared international marketing applications for Australia, Canada, South Africa and Sweden for multiple products.Supervised submission compilation teams for all submissions going to regulatory authorities. Experience with the General and Plastic Surgery Devices Advisory Panel, participated in two FDA inspections (BIMO), 483 and warning letter responses.Developed and implemented regulatory strategy for clinical production to commercial level products.Cross trained in conducting product review and release for QA, served as Materials Review Board administrator, and audited GMP/Quality Systems and GCP processes.Conducted pre-approval quality system and clinical audits in preparation for FDA inspections.Primary contact with FDA for both product lines.

Recruited from the manufacturing group to write the Chemistry, Manufacturing and Controls section of the Dermagraft-TC and Dermagraft manufacturing applications. Managed the submissions process for both successful manufacturing applications to FDA.Prepared all periodic reports for nine clinical protocols with multiple dermal wound care indications. Reviewed and submitted final clinical/statistical reports for all nine clinical investigations.Developed and submitted responses to FDA requests for information on both marketing applications and participated in labeling content negotiations with the Agency. Developed and reviewed post-market product labeling and promotional materials as well as performed regulatory review of all advertising and promotional materials developed for these unique combination products (biologic/device).Prepared numerous post-market submissions, including extension of expiration dating, storage conditions, additional indications, Annual Postmarket Reports (APRs), changes to the manufacturing process and safety Medical Device Reporting (MDR).Prepared international marketing applications for Australia, Canada, South Africa and Sweden for multiple products.Supervised submission compilation teams for all submissions going to regulatory authorities. Experience with the General and Plastic Surgery Devices Advisory Panel, participated in two FDA inspections (BIMO), 483 and warning letter responses.Developed and implemented regulatory strategy for clinical production to commercial level products.Cross trained in conducting product review and release for QA, served as Materials Review Board administrator, and audited GMP/Quality Systems and GCP processes.Conducted pre-approval quality system and clinical audits in preparation for FDA inspections.Primary contact with FDA for both product lines.

Responsible for the GMP manufacture of two neonatal fibroblast cell/product lines (MCB and MWCB) as well as production of a combination product (biologic/device) for clinical investigation.Extensive GMP experience in generating and reviewing manufacturing and systems documentation and validation protocols.Responsible for generating Standard Operating Procedures for scale-up from clinical production to commercial manufacturing and participating in validation studies.Supervisory experience for Assembly/Operations group.

Development of novel diagnostic tracer methods (radiolabeled iodine and luciferase) using monoclonal antibody technology.Additional responsibilities included radiolabeling monoclonal antibodies (I125) and optimization of monoclonal antibody stability matrices in existing in-vitro diagnostic assays.