Rona LeBlanc, Ph.D.

•Led the Generics program area: responsible for regulatory strategy, gap analyses, and a variety of submission types. Authored and submitted Controlled Correspondence, authored pre-ANDA meeting requests and led discussions with the FDA, authored eCTD Module 1 Administrative (including labeling), Module 2 Summaries and Module 3 Quality sections. Submitted original ANDAs, amendments, supplements, annual reports, and other required regulatory submissions. Performed QC checks of eCTD submissions. Supported due diligence review of potential assets for clients. •For innovator products, supported clients with project management, pre-IND meeting requests, IND submissions/amendments, NDA supplements/annual reports/PADERs. Performed QC checks of eCTD submissions. Supported due diligence review of potential assets for clients.

Led the Generics program area: responsible for regulatory strategy, gap analyses, and a variety of submission types. Supported clients with pre-ANDA meeting requests and led discussions with the FDA. Authored eCTD Module 1 Administrative (including labeling), Module 2 Summaries and Module 3 Quality sections.

Responsible for establishing, managing, and leading an efficient and effective post approval team. Lifecycle management of sterile products for the US market from multiple global manufacturing sites. Evaluate regulatory issues and provide accurate and timely recommendations and alternatives. Establish regulatory strategies for submissions and manage deliverables to ensure submission targets/KPIs are met to support continuity of commercial supply, while adhering to appropriate statues, regulations and guidances.

•Responsible for post approval submission activity for sterile products on the US market from 3 European sites. •Recognized as a subject matter expert for parenteral products. •Provide secondary review of change controls, annual reports and supplements. •Provide specific training to global sites in the area of microbiology/sterility assurance. •Develop and implement regulatory strategy for all post-approval regulatory submissions. •Critically evaluate changes to regulatory documents and formulate a strategy to ensure proper filing category. •Serve on various inter-departmental project teams to provide regulatory strategy •Oversee staff productivity and implement strategic decisions to meet department and company objectives. •Provide regulatory guidance to business, research and operations staff. •Provide training and mentoring to direct reports and other department members

•Formulate regulatory strategy for the sterile products portfolio of the US Generics business unit. •Conduct process remediation by harmonizing regulatory best practices across 6 global manufacturing sites. •Critically review, assess and provide corrective measures for the sterility assurance packages of new ANDA submissions from multiple global manufacturing sites. •Represent the Regulatory Affairs department on project teams. •Provided regulatory strategy on cGMP documents for new products (i.e. change controls, batch records, packaging orders, protocols, methods, product development reports). •Minimize regulatory issues and help prevent unnecessary regulatory delays. •Evaluate pre-approval changes to regulatory documents and formulate a strategy to ensure proper filing categories. •Manage direct reports in the preparation, compilation, and submission of high quality submissions (ANDAs, NDAs, INDs, amendments, etc.) to FDA.

•Provided regulatory strategy on cGMP documents for new products (i.e. change controls, batch records, packaging orders, protocols, methods, product development reports). •Authored regulatory filings as needed (INDs, ANDAs, amendments) for parenterals, ophthalmics, nasal sprays, tablets, capsules, and oral solutions. •Brought in several ANDAs ahead of schedule, thus allowing earlier submission to the FDA. •Scheduled/prioritized tasks, critically evaluated work, and trained direct reports. Managed up to 6 direct reports. •Served as point of contact with the FDA. Reviewed incoming FDA correspondence to coordinate responses to deficiency letters and information requests. •Reviewed outgoing submissions to the FDA for completeness and adherence to FDA regulations, company commitments, and guidance documents. •Increased departmental efficiency and consistency of submissions through the use of document templates. Formatted eCTD templates to be company-specific training guides. •Interfaced with various Lannett departments, raw material vendors, contract packagers, etc. to provide regulatory strategy for filings.

•Authored FDA regulatory filings for non-sterile and sterile products, both pre and post approval (INDs, ANDAs, amendments, supplements, and PADERs) in eCTD format. This included CMC and labeling. •Served as project manager to coordinate submission activities with multiple contract manufacturers (US and foreign). •Reviewed/edited annual reports prior to filing with the FDA. •Prepared field alert and recall summaries for internal annual product reviews (over 70 products). •Created an ANDA filing checklist for sterile products to enhance completeness of submissions and minimize FDA comments. •Created process to streamline PADER submissions. •Effectively presented information to managers, working partners, and government agencies.

•Provided critical, independent, sterility assurance review and approval for abbreviated new drug applications (ANDAs) and drug master files (DMFs). Identified and issued technical deficiencies, and requested corrective actions from the applicants. •Reviewed and evaluated manufacturing procedures and process validation for aseptically filled/terminally sterilized drug products. Including, but not limited to: container closure integrity testing, filter validation, media fills, environmental monitoring, endotoxin and sterility method validation, chemical sterilization, gamma irradiation. •Wrote technical reports and communicated findings with supervisor and fellow members of the department. •Guest speaker at two GPhA-FDA sterility assurance workshops (2005 and 2006). Topics covered included facilities, overall manufacturing process, and in-process controls. •Independently created internal regulatory review templates for the department to increase efficiency and consistency of ANDA reviews.

•Conducted independent CMC review, including validation of viral clearance, of Investigational New Drugs (INDs; Phases 1 to 3) and Biologics License Applications (BLAs). Identified and issued technical deficiencies, and requested corrective actions from the applicants. •Represented CBER in meetings with sponsors (End of Phase 2, Pre-Phase 3, pre BLA submission) •Wrote technical reports and communicated findings (oral, written) with supervisor and fellow members of the department. •Served as a Product Specialist consultant on multiple FDA inspections.

•Studied the entry, tropism and reactivation of Herpes Simplex Virus (HSV) types 1 and 2 using cell culture and animal models. •Studied the effects of gene mutations and drug therapy on HSV reactivation. •Developed protocols and methods, including a new method for reactivating latent virus. •Published research in peer-reviewed scientific journals. •Presented research at major global virology conferences. •Trained summer interns and new hires in various laboratory procedures.