Leading the Global Regulatory Strategy group

Leading the Regulatory Affairs CMC group.

-Lead the Regulatory CMC group for gene therapy products which includes products in early development through products preparing to be submitted for licensure. This team includes multiple direct reports and various team members lead their own gene therapy programs. -Provide regulatory strategic feedback for the CMC gene therapy programs for various Agency interactions to allow for successfully moving the development of the programs forward. -Leading the advanced gene therapy program planning on being submitted for licensure. Working the CMC and clinical teams as well with external partners on this program to allow for rapid development of the product.

-Global Regulatory CMC Liaison, responsible for leading new biologic global marketing applications. Lead the CMC topics for all pre-submission Health Authority meetings, which included discussions on drug substance and drug product comparability, drug product scale and site changes, analytical testing strategy, shelf life extensions and overall dossier content. During the pre-submission meetings, obtained agreement from various Health Authorities for the CMC topics allowing for a more harmonized global dossier.-Lead efforts for the accelerated dossier creation by collaborating with CMC team members to expedited global submissions. The team implemented numerous new strategies for the dossier that were not previously utilized at Novartis to allow for a more streamlined dossier.-Implemented day-to-day strategies to allow for the CMC dossier and administrative document completion within the deadlines and the dossier included two drug product presentations. In addition, provided clear direction to teams to allow the rapid creation of various country specific customization of documents. This allowed for the US Biologics License Application (BLA), the EMA Marketing Authorization Application (MAA) and first ROW application to be filed within two days. In addition, the application was filed in seven additional countries, within 8 weeks, which included major markets. -Lead the CMC responses to health authority inquiries for a US BLA under priority review. Over a three-month period collaborated with 10 teams to meet internal accelerated timelines to respond to six health authorities. The outcome led to an approved BLA and early approvals or positive opinions from multiple countries.

-Established the regulatory strategy for the pipeline in multiple solid tumor oncology indications, from Phase 1 studies with indication specific expansion studies through Phase 3 studies decisions with the purpose of registration. These strategies were developed to align with the board and executive management team goals. -Improved regulatory governance and increased compliance by implementing regulatory IT systems for a regulatory archive, document management system, tracking regulatory submissions and approvals. Responsible for negotiated the contracts and terms with vendors, managing the project budget through implementation. - Lead the company in filing two Investigation New Drugs (IND) within six months for two different monoclonal antibodies mixtures. Each of these compounds were manufactured using a polyclonal cell bank, which included from two up to six different cell lines. Also, lead the company in filing multiple Clinical Trial Application’s (CTA) in Europe and Asia for various clinical studies. -Collaborate with Business Development on due-diligence activities for the company’s products in development. Contributed to the regulatory portions of contacts during the negotiation process. -Responsible for department budget, resource allocation and regulatory vendor management. Manage regulatory associates and consults and external publishers to ensure all regulatory activities based on company goals.-Responsible for revising and implementing standard operating procedures to ensure regulatory compliance.- Lead regulatory development, and streamlined processes for regulatory documents.

-Global CMC product leader for three commercial products and two programs in clinical development. These marketed biological enzyme replacement therapies are registered in over 60 countries, including multiple emerging markets in South America, Asia Pacific, India and China. -Manage four regulatory affairs associates who are responsible for seven additional products including both clinical and commercial small molecule/biological. -Primary FDA contact for two BLA applications and two IND applications. Interactions with global health authorities include; leading CMC discussions at formal global health authority meetings for US FDA, EMA, China FDA and Health Canada and preparing correspondence for global health authorities for example; AVISA, TGA, and PMDA.-Responsible for preparing the global regulatory strategy to support submissions and health authority inquires for development and commercial products, examples of submissions include; IND; CTA, new marketing applications; scaling up a manufacturing process, manufacturing site, analytical method; changes to release and stability specifications; drug substance (upstream and downstream) and drug product process changes. -Develop global regulatory strategies by applying ICH guidelines and country specific regulations for proposed and implemented manufacturing changes for marketed products by identifying priority submissions and obtaining global approvals. -Regulatory CMC leader for the first biological product to be approved in China using the clinical trial waiver pathway. -Present regulatory CMC benefit/risk scenario’s for manufacturing to senior management and internal governance commitments in order to assist in program decisions. -Support manufacturing sites for PAI and routine cGMP inspections for US FDA and global health authorities. -Regulatory affairs CMC representative on program management teams, project core teams, technical and analytical life cycle management teams for multiple products.

-Author and prepare global regulatory submissions for clinical and commercial biological products in Common Technical Document (CTD) format or country specific formats as needed. -Responsible for preparing FDA meeting requests and briefing documents and advising Subject Matter Experts (SME’s) on the product manufacturing teams. -Responsible for preparing responses to health authority inquires and coordinating reviews with project team members -Manage global GMP renewals for marketed products and coordinate the submissions for paper based inspections of the manufacturing facilities-Prepare regulatory submissions such as new marketing applications and post approval changes as well as provide continuous management for global submissions in major and emerging markets -Manage the global change control system for marketed products by coordinating with the manufacturing site and working with local regulatory representatives to obtain submission assessments on the proposed changes

-Complied regulatory strategies for oncology indications in development compounds as well as supportive documentation for three sBLA filings in new and expanded oncology indications. -Assisted in the initial filing of IND’s as the clinical liaison by supporting core teams and ensuring cross functionally reviews of regulatory documents while overseeing regulatory sub-team meetings. -Reviewed initial and final responses to global health authorities, protocols for global submissions and investigational brochures. -Prepared global CMC dossiers for scaling up manufacturing processes which included comparability analysis for multiple monoclonal antibodies entering Phase 1 through Phase 3 clinical trials.

-Conducted independent research in molecular and cellular biology pertaining to angiogenesis and metastasis in both in vitro and in vivo cancer models to complete a doctoral dissertation titled; The Effects of KTS Disintegrin on Endothelial Cells. -Awarded a pre-doctorial NIH grant from the National Heart, Lung and Blood Institute to conduct research for the characterization of small proteins motifs on cellular receptors and relationships effecting cardiac angiogenesis. -Produced recombinant proteins in Eukaryotic cell lines (Chinese hamster ovarian cells) and Prokaryotic models and purified the recombinant proteins for future experiments. These proteins where then characterized in vitro and in vivo using multiple biological method to determine the function of the protein in targeted cell lines. -Teaching assistance for the biology department and responsible for teaching undergraduate biology at Temple University.