Tom Spitznagel Email & Phone Number

Rockville, Md, Us

Responsible for a group of ~60 including Development (Upstream, Downstream, Analytical, and Formulation), Manufacturing, Supply Chain, Facilities and Engineering. - Responsible for CMC technical content for 8+ molecules, including Antibodies and DARTs (bi-specific). - CMC leadership role for alliances with Servier, and Janssen- Oversight of internal GMP manufacturing facility for Drug Substance- Oversight of external manufacturing (DS and DP)- Led $5 MM expansion of internal manufacturing (2 x 500L SUB)- Facility management of over 100,000 sq. ft. in both Maryland and California

Rockville, Md, Us

Responsible for a group of ~50 including Development (Upstream, Downstream, Analytical, and Formulation), Manufacturing, Supply Chain, and Facilities. - Responsible for CMC technical content for 8+ molecules, including Antibodies and DARTs (bi-specific). Filed 5 new IND's in first two years- CMC leadership role for alliances with Takeda, Servier, and Janssen- Oversight of internal GMP manufacturing facility for Drug Substance- Oversight of external manufacturing (DS and DP)- Led $5 MM expansion of internal manufacturing (2 x 500L SUB)- Facility management of over 100,000 sq. ft. in both Maryland and California

Independent consultant for biopharmaceutical development, validation, and regulatory strategies. Areas of expertise include: - Comparability approaches | Stability | Process and analytical validation | Development strategies- Organizational planning | Biosimilars | IND and BLA writing | CMO selection | Formulation | QbD

Brentford, Middlesex, Gb

Facilitated integration of HGS BioPharmaceutical Development group into GSK while maintaing ongoing development and commercial programs

Rockville, Md, Us

Responsible for $20+MM annual budget and ~100 employees within 5 functional areas: Fermentation and Cell Culture Sciences, Purification Sciences, Drug Product Sciences, Analytical Sciences, and Strategic CMC Planning. These groups oversee the overall development, optimization, and validation of bulk and finished drug product manufacturing as well as analytical methods used to support testing and characterizing these productso Oversight of technical component for 20+ IND/CTA and 3 BLA/MAAo Supported global approval and launch of Benlysta® (first in class biologic for lupus) and US approval and stockpiling of Raxibacumab into the Strategic National Stockpile o Successfully won and delivered contract development services on biosimilars yielding revenue of $30MM over 3 yearso Successfully validated methods and processes for 4 biological productsDrove cross-functional and partnership decision making through leadership roles in key corporate committeeso Chair of cross-functional Pharmaceutical Development and Manufacturing Committee. Responsible for oversight of all CMC project goals, timelines, and dispute resolutiono Chaired Joint Development Committee between HGS and FivePrime. Responsible for overall corporate development plan for HGS1036 (FGFR1 fusion protein being developed in oncology)o Member of Joint Steering and Development Committees for CMO partnerships, GSK, Novartis, and Morphotek collaborations. o Corporate HGS officer and member of Operating CommitteeEstablished and nurtured a culture of innovation and scientific development o Created 2 cycle platform antibody process development trajectory. Reduced time to IND by > 25%o Member of sub-visible particulate industry consortium and established internal monitoring programo Implemented QbD development approach, including CQA determination, risk assessment, and design space mappingo Development team averaged over 25 presentations and publications per year since 2005

Rockville, Md, Us

Led two separate departments overseeing both Pharmaceutical Sciences (described below) and Global Project Managemento Responsible for overseeing and coordinating all project team activities, including project team goals, timelines, and resource utilization.o Developed company-wide metrics and dashboards to facilitate uniformity and visibility to key program activitieso Chaired corporate Operating Committee

Rockville, Md, Us

Managed combined departments of Drug Product Sciences and Analytical Developmento Developed, qualified, validated, and transferred analytical release methods for 15 programs o Developed analytical characterization program to support comparability assessments and health authority filingso Responsible for formulation and fill/finish process development and transfer for 15 programso Led team responsible for commercial development of a dual-chamber pen delivery system

Rockville, Md, Us

Established department to develop formulations for protein pharmaceuticals. o Recruited more than 40 individuals to oversee the formulation development of 16 novel proteins. o Management of cGMP clinical release and stability programs o Developed topical delivery device for multi-dose protein pharmaceutical. o Designed and produced PEGylated proteins to increase serum half-life. o Managed numerous collaborations to develop pulmonary and controlled release formulations.

Responsible for development, scale-up, and transfer of purification processes for polysaccharide-protein conjugates. Work included writing SOPs and batch records, developing in-process assays, and the manufacture of Phase 1 clinical material. Additional responsibilities included formulation and analytical method development of immunoglobulin products.

• Manager of Process Engineering Group. Developed validation protocols and documentation for processes involved in finished drug product manufacturing to support commercialization of BeneFIX®. Coordinated the production of toxicology and pre-clinical drug product. Designed and optimized the formulation and delivery system for a protein absorbed onto a collagen matrix to support INFUSE® (rhBMP-2). Authored documentation for FDA submissions.• Manager of Formulation Group. Responsible for developing formulations for recombinant human proteins. Activities include method development for stability indicating assays, solubility mapping, and stability testing. Developed, scaled, and transferred all final UF/DF formulation steps. Designed and optimized lyophilization cycles.

Doctor Of Philosophy (Ph.D.), Chemical Engineering

Bachelor Of Science (Bs), Chemical Engineering