Sandra Barnard, Ph.D.

• Provide strategic vision and innovative scientific and regulatory leadership in defining a comprehensive science-based, solution-oriented global regulatory development strategy for assigned projects to achieve high quality and timely submissions and effective regulatory agency interactions aligned with stakeholders needs. • Maintain collaborative interactions with the as Clinical Development, Clinical Operations, Global Safety & Pharmacovigilance, Data Management, and Biostatistics teams for INDs/CTAs. • Pro-actively establish and maintain high-quality working relationships with regulatory agencies as appropriate for assigned therapeutic areas and for Cell and Gene Therapy products. • Monitor and assess impact of relevant global regulations and the evolving regulatory, scientific, and competitive environment for Cell and Gene therapy products. • Represent Global Regulatory Affairs on assigned core product development teams and other relevant bodies. Provide regulatory expertise and guidance to product development teams and other functions of the company as needed. • Provide regulatory direction in product development to align medical need with business objectives in the context of available and expected scientific data, and regulatory guidance and precedent. Lead the planning and implementation of global regulatory filings (IND/CTAs, BLAs). • Oversees all submission activities and regulatory writing for regulatory documentation including but not limited to meeting briefing packages, requests for special designations, INDs, BLA/MAAs, and routine submissions. • Ensure consistency of evidence-based global product communication. Present regulatory plans, risk assessments and strategies, pertaining to the assigned project(s), including innovative strategic options which communicate the associated risks. • Support preparation and authoring of dossier documents for IND/CTA and BLA submissions for novel, breakthrough drug products.

• Regulatory Lead for multiple NDA preparations, submissions, and approvals. • Obtain all licenses required to enable clinical trials (as needed) as well as market commercially approved products. • Establish, align, and implement product related regulatory strategies and advise the cross-functional project teams on Regulatory considerations when developing overall strategy for project portfolio. • Planning and managing regulatory submissions for drug-device combination products in compliance with US and global regulatory requirements. • Identify potential outcomes and risks associated with interactions and/or correspondence with regulatory agencies. • Communicate and ensure alignment with direct management and cross functional, matrix teams. • Maintain an awareness of new and developing legislation, regulatory policy, and technical Regulatory guidance relating to the project portfolio. • Perform regulatory due diligence to obtain relevant histories, precedence, and other information relevant to support and enhance the project portfolio.

• Perform critical, regulatory reviews and scientific evaluations of chemistry, formulation, manufacturing and controls (CMC), drug release biopharmaceutics, the container closure system, technical aspects of labeling, and environmental impact information submitted by pharmaceutical applicants in drug applications and amendments (i.e., BLAs, NDAs, ANDAs, and INDs) and Type II, III, and IV DMFs. • Provide interpretation and regulatory guidance on the science and quality of simple and complex drug products of differing dosage forms and therapeutic categories submitted for review. • Establish clinically relevant quality standards and Identifies the critical quality attributes of drugs by providing risk based assessment and recommendations regarding the scientific and regulatory adequacy of pharmaceutical manufacturing, products’ usability, and acceptability to the patient for the drug substance and drug product. • Provide comprehensive written evaluations of the scientific data presented and make recommendations to senior management regarding scientific and regulatory acceptability for any identified deficiencies or issues, established policy, and any further requests through oral and/or written communication. • Acts as a direct liaison with stakeholders to address concerns and discrepancies encountered during the review and assessment of the proposed drug product to ensure a quality product for approval and alignment of the proposed product with ICH, USP, and EU guidance. • Review and evaluate proposed USP monographs based on approved drug products and provide revision recommendations to existing monographs to reflect the current literature and data for inclusion in official compendia.

Structural elucidation of enzymes utilized in the biosynthesis of peptidyl nucleoside biosynthesis and compounds inhibiting Mycobacterium tuberculosis. • Data mining utilizing current programs such as VNTI and Geneious software. • Isolation, cloning, and sub-cloning genes of interest. • Expression and purification of proteins in Escherichia coli and Streptomyces lividans. • Enzymatic assay development by means of HPLC, MS, and UV/Vis analysis. • Enzymatic product purification and NMR analysis of potential substrates and enzymatic products. • Crystallization of proteins for structural analysis. • Mutagenesis for identification of active site residues and development of novel compounds.

Researching the biosynthetic pathway of various peptidyl nucleoside and sideromycin antibacterial compounds. • Isolated, cloned, and sub cloned genes involved in the biosynthesis of antibacterial compound. • Expressed and purified potential enzymes in Escherichia coli and Streptomyces lividans. • Utilized mutagenesis for developing mutants of proteins for control reactions and identification of necessary residues for activity. • Developed enzyme assays by means of HPLC, MS, and UV analysis. • Directed several new and rotating graduate students as well as summer interns.

Executed and analyzed experiments involving the manipulation of plant genomes and the phenotypic results in low nitrogen content soil. • DNA and RNA extraction followed by PCR or RT-PCR for gene expression or deletion analysis in transgenic plants. • Media preparation for experiments. • Arabidopsis and maze tissue and sample preparation via sterile technique. • Yeast genomic isolation and quantification.

• Sample tissue preparation involving sterile technique and cell count for Asian Soybean Rust. • Large batch sample inoculation and cell count. • Media preparation for experiments.