Thomas Nikolai Email & Phone Number

North Chicago, Illinois, Us

• Leadership role in Drug Product Development group responsible for AbbVie's New Biologic Entity (NBE) pipeline candidates from discovery through late-stage development, submission and market authorization • Management of high-performing team responsible for drug product preformulation, formulation and process development of NBE candidates, including mAbs, ADCs, bispecifics and fusion proteins, as well as NCE parenteral development projects.

New York, New York, Us

• FDA BLA approvals of RETACRIT® (epoetin alfa-epbx), a biosimilar to Epogen® and Procrit® (epoetin alfa), the first and only biosimilar erythropoiesis-stimulating agent (ESA) to be approved in the U.S.; and NIVESTYM™ (filgrastim-aafi), a biosimilar to Neupogen (filgrastim); significant leadership contributions in bioprocess development, regulatory strategy, authoring and approval process over multiple years• Leadership role in successful integration of Hospira’s biosimilar R&D organization into Pfizer, including platform technology evaluation, knowledge transfer and business process harmonization • Successful advancement of additional Pfizer biosimilars assets through key development continuum milestones; both new early monoclonal antibody (mAbs) biosimilar candidates and product enhancement (LCM) initiatives for the late stage biosimilars portfolio• Leadership appointment to Pfizer’s Biologics Management Team, a governance forum for Pfizer’s entire late stage biologics development portfolio, with modalities including mAbs, vaccines, fusion proteins, gene therapy and cell-based therapy • Successful design, construction, qualification and startup of a new non-GMP Pilot Plant Facility in Chennai, India, on-time and under budget, adding significant new capabilities to the Biosimilars business

Lake Forest, Il, Us

• Progressive series of R&D leadership roles in the advancement of Hospira’s growing biosimilars pipeline. Initial responsibilities for External Partnerships and Collaborations, managing the network of partners and vendors supporting external R&D efforts. Role expanded in 2012 to include Drug Product & Combination Product responsibilities, as well as interim co-leadership of the Adelaide GMP biologics manufacturing site for 9 months (Manufacturing and Engineering functions). Role expanded in 2013 to include Drug Substance responsibilities• Championed R&D organizational transformation for the Bioprocess R&D group across sites in the US, India and Australia. • Completed submission of EPO BLA to US FDA, with successful PAI inspections of the drug substance and drug product sites• Contributed to successful Celltrion partnership outcomes as R&D representative supporting the Joint Steering Committee between the two companies.• Championed staff hiring and laboratory start-up of drug product capabilities at the Chennai, India site for expanded capabilities and favorable cost position for biosimilar formulation development activities.• Leadership role in integration planning (pre-close) for Pfizer acquisition of Hospira’s biosimilars R&D group , involving organizational design options, platform technology and capabilities assessment, and go-forward implementation planning for integration actions.

Abbott Park, Illinois, Us

• Global technical operations leader for commercial and late‐stage biologic drug products including Humira and ABT‐874. Responsible for strategic direction and execution of continuous improvement activities including new technology identification, process development, validation, regulatory submission requirements and commercial implementation. Extensive experience in scale‐up and technical transfer of biologic manufacturing processes to both internal and contract manufacturing facilities. Key manufacturing representative on global clinical project & CMC teams for pipeline NBEs and LCM programs. • Built a technical support organization for commercial biologic drug products, including formulation, bioanalytical, stability and device expertise, with locations in US, Germany and Puerto Rico. • Implemented multiple quality improvements, new indication launches, and capacity increases for risk management of a rapidly growing blockbuster biologic drug product. • Leadership role in strategic partnership with Vetter Pharma as main technical representative for drug product commercial manufacturing support and process improvement initiatives, spanning 8 years.• Directed continuous improvement projects with annualized savings of > $10 million, including batch size increases, yield improvements and PAT applications.• Championed new technology identification and implementation, including non‐invasive silicone oil detection/control and automated visual inspection (AVI) for prefilled syringes.

Abbott Park, Illinois, Us

Abbott Park, Illinois, Us

Abbott Park, Illinois, Us

Abbott Park, Illinois, Us

Bs, Chemical Engineering, Biochemistry

Mba, Business Administration

Ms, Biochemical Engineering