Scott Hallam Email and Phone Number

I led operational activities to support commercial registration of Molgramostim Nebulizer Solution, including process development, characterization, technology transfer, and scale-up. I also established and managed global strategic partnerships with CMOs for development and validation of Molgramostim Drug Substance and Drug Product. Additionally, I:• Collaborated with Quality Assurance to establish QMS and Regulatory Assurance to craft global CMC regulatory strategies, authoring CMC modules for regulatory submissions.• Expedited PPQ and comparability activities within 6-month timeframe, addressing critical need due to decommissioning of CDMO's filling line.• Established fully redundant manufacturing supply chain for Molgramostim Drug Product by transferring technology to second CDMO in just 8 months.• Developed initiatives that drove innovation and contributed to milestones in manufacturing of Molgramostim.• Established internal procedures and process, enhancing quality and regulatory compliance.

I managed strategic partnerships with external contract manufacturing organizations for the development and distribution of clinical and commercial products. Additionally, I:• Led operational activities for the commercial registration of Tilsotolimod, ensuring end-to-end solutions were established and managed efficiently. • Developed global CMC regulatory strategies, embedding CMC regulatory expertise across the portfolio to support growth and new product development. • Oversaw process development, process characterization, and technology transfer, scaling up activities to meet production demands.• Transferred API manufacturing process to a new CDMO, securing a secondary source and reducing COGs by 40%.• Negotiated with FDA on oligonucleotide impurity identification and thresholds, enabling manufacturing of registrational batches.• Led process development and technology transfer activities, ensuring scalability and efficiency in production.• Oversaw operational activities for Tilsotolimod's commercial registration, streamlining end-to-end solutions.

I orchestrated global strategic partnerships with CDMOs for the end-to-end production, testing, and release of biopharmaceuticals, including monoclonal antibodies and antibody drug conjugates. • Managed technology transfer initiatives, routine manufacturing oversight, and process enhancements to bolster commercial readiness. • Authored, reviewed, and defended critical CMC documentation to support regulatory submissions across clinical and commercial stages. • Conducted due diligence and quality audits, enhancing vendor qualification and PAI readiness.• Successfully transferred key late-stage asset to a new commercial CMO, streamlining the process from proof of concept to the first GMP lot production within one year.• Drove ~30% reduction in COGs while concurrently advancing PAI readiness, improving timelines by three months.• Led process characterization and validation activities, for commercial launch preparedness of multiple products.

I managed all aspects of clinical and commercial production for Gattex/Revestive and Natpara/Natpar, utilizing fully external manufacturing model. Additionally, I:• Orchestrated technology transfers, process qualification, and inspection readiness, culminating in the approval of two products across US and EU markets. • Directed preapproval inspection readiness and managed inspections across the CMO network. • Led technical operations for post-marketing commitment requirements and manufacturing process modifications post-approval.• Led successful validation and commercial launch of Gattex and Natpara, achieving market introduction for both products within three-year period.• Implemented redundant CMOs for lifecycle management, ensuring robust supply chain and mitigating risk within six months of initial product approval.• Drove 35% cycle time reduction from manufacturing to market release, enhancing product availability.• Coordinated preapproval inspection activities, achieving great outcomes across external manufacturing network.

• Responsible for Manufacturing of Afrezza inhalation powder for the treatment of Diabetes • Led Technical Operations Team responsible for the Fill and Finish operations in both Clinical Production and Commercial Production overseeing a staff of 30+ employees.• Team Member involved with Design, Build and Layout of 12 Fill and Finish Production Lines for an estimated Annual Yearly Production of 1 Billion units. All Equipment was of Custom Design and Build. • Led Facility and Equipment Design, Installation, Qualification Programs for associated Fill and Finish Operations including, Dry Powder Filling, Thermoformed Pouching, Blister Packaging, Over-Wrapping and Cartoning• Technical Lead for all Biologics Projects. Acquired the rights for the production of Insulin and performed Preliminary IP and Tech Transfer from External Manufacturer into MannKind Corporation.• Project Lead to evaluate costs associated with manufacturing of Insulin (CMO vs Internal)

• Responsible for the Development and Teaching of Curricula in the Areas of Biotechnology, Biochemistry, Microbiology, Industrial Pharmaceuticals, Regulatory Compliance, Quality Systems throughout Colleges, Universities and Private Industries within North Carolina• Responsible for the development of Workforce Education and Training Programs for North Carolina Biotechnology and Pharmaceutical Industries.• Deliver State of the Art Hands on Training in Principles of Biotech and Pharmaceutical Processing in both a university setting and also from a Mobile Laboratory Capable of delivering Training On Site. Delivered Programs for Biogen, Merck, Novartis, Talecris, Wyeth, Covance and numerous others.• Led Programs related to Economic Development and Industrial Support both in NC and across the US promoting what the State of NC was doing for the Bio and Pharma Industry