Immunologist, infectious disease, scientist

J O C E L Y N J A K U B I K, P h . D .

( ***) ***- 2352 [ M ] j akubik.j o c e l y n@y ahoo.c om h t t p : / /www.l i n k edin.com/i n / j o c e l ynjakubik S U M M A R Y

Translational immunologist with process development, CMC manufacturing & clinical experience with multiple platforms. P R O F E S S I O N A L E X P E R I E N C E

MESO SCALE DISCOVERY, Rockville, MD 2024 – present Develop, manufacture, and commercialize innovative assays for multiplex biomarker measurements Director, New Product Development, Assay Development Apply CRO outsourcing experience & knowledge to achieve a 20% increase in new serology bioservices via creative kit designs Lead teams to launch 8 new multiplex V-PLEX products ($1M/yr new sales) offering >80 new proteins, standards & controls

• Increased MSD portfolio to include >150 variants, shipped >3,000 customized antigen panels, reagents & kits to customers

• Generated 20 assay services & bioanalytical customer contracts for epidemiology, vaccine evaluation & surveillance SABIN VACCINE INSTITUTE, Washington D.C. 2020 – 2024 Enable innovation in vaccine assay design, manufacturing, formulation, delivery & clinical trials for immunization success Sr Director, Analytical Testing and Translational Immunology Led global Phase II trials based on confirmed safety & binding IgG increased Day 29 levels for new Adenovirus vectors in Ph I trials

• Proactively completed review of CMC batch records, regulatory filings, ELISA validations & sample collections to gain >$200 million in BARDA funding to stockpile 200,000 doses, evaluate formulation buffers, respond to outbreaks & run Africa trials

• CMC strategy award: resolved aggregation CAPA failures by spectral scan & UPLC to pass drug product specifications for release PRECISION FOR MEDICINE, Frederick, MD 2018 – 2020

Translational informatics support for life science clients to conquer product development and commercialization challenges Vice President, Immunology, Translational Medicine Research Biomarker operational lead for Phase I-III clinical trials to support custom bioassay development & testing for >30 customers

• Validated virus neutralization for a gene therapy IVD, fresh PBMC flow cytometry receptor occupancy for oncology, ELISpots for T cell interferon response, molecular Nanostring, ddPCR & cytokine storm for endocrine/inflammation therapies

• Led >30 protocol executions, >14 R&D/qualification scientists, wrote >50 reports with test data analytics & hosted >25 client audits

• Investigated >5 complaints, resolved patient cryopreserved cell shipments to achieve >70% viability upon thaw before testing PHARMACEUTICAL PRODUCT DEVELOPMENT (PPD), Richmond, VA 2011 – 2018 Comprehensive development & testing services to speed the introduction of life-changing vaccines (Prevnar13, Trumenba) Associate Director, Laboratory Operations, Vaccines Sciences Department Analytically led 100,000 opsonophagocytosis (OPA) titers/year for Pfizer, GSK, Sanofi alliance partner support ($20M/year)

• Phase I, IIb, III, IV through post-approval high-throughput validated robotic assays for GLP & GMP in vivo potency testing

• Managed 150 scientists using soft skill promotions, raises, performance reviews & awards for Pneumo, MenB & MRSA/Staph o Teamwork Excellence Award: Prevnar Team Lead, Pfizer CAPITA Trial (NCT0074426) E D U C A T I O N

Ph.D., Immunology & Microbiology, RUSH UNIVERSITY MEDICAL CENTER, Chicago, IL B.S., Biochemistry, UNIVERSITY OF ILLINOIS, Chicago, IL P R E S E N T A T I O N S, P A T E N T, P U B L I C A T I O N S Recent Key Note Presentation

VIRAL STRAIN SEROLOGY ASSAYS

Publication Listing

R E C E N T P R E S E N T A T I O N S

• Multiplexed Serology Assays for Detection of IgG Antibodies against Mpox and Vaccinia Viruses. 2024. International Vaccines Conference, Baltimore, MD

• A Novel Multiplex Serology Assay to Evaluate Immune Response to RSV, SARS-CoV-2 and Influenza. 2024. International Vaccines Conference, Baltimore, MD

• Multiplexed Assays for Detection of IgG Antibodies against AAV Serotypes. 2024. AAPS, Salt Lake City, UT

• Validation of Novel Multiplexed Serology Assays for Detection of IgG Antibodies against SARS-COV-2 Key Variants. 2023. World Vaccine Congress, DC

• Immunobridging, Protocol for Clinical Trials & Assay Development for Single-Shot ChAd3-MARV Vaccine in Modified Formulation Buffer. 2022. WHO Strategic Agenda for Filovirus Research and Monitoring (AFIRM); R&D Blueprint. Filovirus vaccines and outbreaks

• Challenges in Production of High Purity Marburg Recombinant Glycoprotein for ELISA. 2021. Immunogenicity & Bioassays Summit. Optimizing Bioassays, DC

• An Update on Marburg Virus Vaccines & Therapeutics. 2022. World Health Organization R&D Blueprint, Expert Consultation on Marburg Virus Vaccines

• SARS-CoV-2 Detection Using Saliva Specimen. 2020. BioPharmaceuticals R&D Global Science Symposium, AstraZeneca

• Assay Optimization and Method Transfer of the Microcolony Opsonophagocytic Assay (mcOPA) for the Streptococcus pneumonia serotype 3 (Pn3). PPD, Richmond VA. Pfizer R&D Scientific Conference, Pfizer Vaccine Research, Pearl River, NY

• Multi-faceted program improvements result in enhanced viral safety profile for the third generation B-Domain Deleted Recombinant Factor VIII (Albumin-Free). PDA/EMEA European Virus Safety Forum, Langen, Germany

• WNV Inactivation by the S/D Step of 2nd & 3rd Generation Manufacturing Processes for B-domain Deleted Recombinant Factor VIII. Biological Safety & Production

(BSP)/Plasma Protein Therapeutics Association, Reston, VA

• Performance of a novel Viresolve® Normal Flow Retrovirus filter. Viral Clearance Symposium, BSP USA, Washington DC

• Virus retention by the retrovirus membrane filter. Pharmaceutical & Viral Safety Conference. Institute Pasteur, Paris, France P U B L I C A T I O N S

Safety, tolerability, and immunogenicity of two investigational monovalent chimpanzee adenoviral vectored filovirus vaccines, cAd3-EBO-S and cAd3-Marburg, in healthy adults: a phase 1b, open-label clinical trial. 2025. E Vert-Wong; M Stevenson; R Rustomjee; C Finch; J Jakubik; T King. Submitted to The Lancet. Single-Shot ChAd3-MARV Vaccine in Modified Formulation Buffer Shows 100% Protection of NHPs. 2022. Vaccines. 2022 Nov 15;10(11):1935. Doi: 10.3390/vaccines10111935. C Finch, T King, K Alfson, K Albanese, J Smith, P Smock, J Jakubik, Y Goez-Gazi, M Gazi, J Dutton, E Clemmons, M Mattix, R Carrion, T Rudge, A Ridenour, S Woodin, R Hunegnaw, N Sullivan, R Xu. An introduction to the Marburg virus vaccine consortium, MARVAC. 2022. PLOS Pathogens, Oct 13;18(10):e1010805. doi: 10.1371/journal.ppat.1010805. R Cross, I Longini, S Becker, K Bok, D Boucher, M Carroll, J Díaz, W Dowling, R Draghia, J Duworko, J Dye, M Egan, P Fast, A Finan, C Finch, T Fleming, J Fusco, T Geisbert, A Griffiths, S Günther, L Hensley, A Honko, R Hunegnaw, J Jakubik, J Ledgerwood, K Luhn, D Matasov, E Nelson, C Parks, R Rustomjee, D Safronetz, L Schwartz, D Smith, P Smock, Y Sow, C Spiropoulou, N Sullivan, K Warfield, D Wolfe, C Woolsey, R Zahn, A Henao-Restrepo, C Muñoz-Fontela, A Marzi. Discovery of the Aryl-phospho-indole IDX899, a Highly Potent Anti-HIV Non-nucleoside Reverse Transcriptase Inhibitor. 2016. J Med Chem 59, 1891-8. Dousson C, Alexandre FR, Amador A, Bonaric S, Bot S, Caillet C, Convard T, da Costa D, Lioure MP, Roland A, Rosinovsky E, Maldonado S, Parsy C, Trochet C, Storer R, Stewart A, Wang J, Mayes BA, Musiu C, Poddesu B, Vargiu L, Liuzzi M, Moussa A, Jakubik J, Hubbard L, Seifer M, Standring D. Synthesis and biological evaluation of aryl-phospho-indole as novel HIV-1 non-nucleoside reverse transcriptase inhibitors. 2011. J Med Chem 54, 392–395. Alexandre FR, Amador A, Bot S, Caillet C, Convard T, Jakubik J, Musiu C, Liuzzi M, Roland A, Seifer M, Standring D, Storer R, Dousson CB. In Vitro Activity of IDX320, A Novel and Potent HCV Protease Inhibitor. 2010. Journal of Hepatology. 52, 298-299. L.B. Lallos, J. Mccarville, B. Li, J.P. Bilello, M. Lacolla, J. Jakubik, M.A. Soubasakos, J. Gillum, I. Serra, L. Hubbard, A. Bonin, M. Seifer, M. Liuzzi, C. Parsy, D. Surleraux, D.N. Standring. In Vitro Activity of IDX320, A Novel and Potent HCV Protease Inhibitor. 2010. European Association for the Study of the Liver (EASL), Vienna, Austria. L.B. Lallos, J. McCarville, B. Li, J.P. Bilello, M. Lacolla, J. Jakubik, M.A. Soubasakos, J. Gillum, I. Serra, L. Hubbard, A. Bonin, M. Seifer, M. Liuzzi, C. Parsy, D. Surleraux, D.N. Standring.

Viral clearance studies on new & used chromatography resins for Bone Morphogenic Protein-2, rhFactor VIII and Factor IX: critical review of a large dataset. 2008. Biologicals 36:88-98. Kelley, BD, Jakubik, J., Vicik, SM. Genotypic Resistance and Phenotypic Cross-Resistance Profile in vitro for a Novel NNRTI: IDX899. 2008. 15th Conference on Retroviruses and Opportunistic Infections

(CROI); Boston, MA. Richman DD, Jakubik J, Chapron C, et al. In vitro cross-resistance profile, antiviral activity, safety and pharmacokinetics in HIV-1-infected patients of IDX899, a novel HIV-1 NNRTI with high barrier to resistance. 2008. 17th International HIV Drug Resistance Workshop; Sitges, Spain. Murphy R, Zala C, Jakubik JJ, et al. West Nile Virus inactivation by the solvent/detergent steps of the second & third generation manufacturing processes for B-domain deleted recombinant factor VIII. 2004. Haemophilia 10:1-6. Jakubik, JJ, Vicik, SM, Tannatt, MM, Kelley, BD. Performance of a novel Viresolve Normal Flow Retrovirus filter. 2002. Biotechnology Progress 18:782-95. Brough H, Antoniou C, Carter J, Jakubik J, Xu Y, Lutz Immune complexes containing human immunodeficiency virus type 1 primary isolates bind to lymphoid tissue B lymphocytes & are infectious for T lymphocytes. 2000. Journal of Virology 74:522-555. Jakubik, JJ, Saifuddin, M, Takefman, DM, Spear, GT. B lymphocytes in lymph tissues & peripheral blood are important for binding immune complexes containing HIV-1. 1999. Immunology 96:612-619. Jakubik, JJ, Saifuddin, M, Takefman, DM, Spear, G.T.

S E L E C T E D P A T E N T

Co-Inventor: VIRAL STRAIN SEROLOGY ASSAYS. International Application No. PCT/US2023/068614, filed June 16, 2023. Jacob N. WOHLSTADTER, George SIGAL, James WILBUR, Jeffery DEBAD, Hans BIEBUYCK, Priscilla KRAI, Alan KISHBAUGH, Leonid DZANTIEV, Christopher SHELBURNE, Christopher CAMPBELL, Anastasia AKSYUK, Seth B. HARKINS, John FULKERSON, and Jocelyn Jean JAKUBIK. MESO SCALE TECHNOLOGIES, LLC.

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