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Irina Koroleva, Ph.D.

Chief Translation & Strategy Officer

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MISSION: Accelerating innovative medicine to clinics, patients, and the market by balancing speed with scientific rigor. 

My Story

Dr. Irina Koroleva is a biopharmaceutical executive with over 17 years of scientific and operational expertise advancing innovative therapeutic programs across the drug development process: from pre-clinical research, clinical development, registration, approval, and lifecycle management. 

Her breadth of knowledge combines developing small molecules, biologics, cell and gene, microbiome, and RNA therapeutics and transitioning more than 16 programs into the clinic in multiple therapeutic areas, including autoimmunity, inflammation, immuno-oncology, infectious, gastrointestinal, neurological, musculoskeletal, and genetic diseases. She developed and executed translational research and biomarker strategies, including precision medicine and diagnostic tools to accelerate drug development

Irina has played critical roles in building clinical organizations, translational medicine, and other functions across multiple therapeutic areas, and has managed key partnerships with large pharma for fast-growing portfolios in two start-up biotechnology companies and the transition of companies post-IPO, namely, Rubius Therapeutics (2018-2019) and Finch Therapeutics (2019-2022). 

Dr. Koroleva rose through the ranks of the Novartis Institutes for Biomedical Research (NIBR) transitioning from Biomarker Expert to Portfolio Strategy Leader (2006-2018). At NIBR, Irina improved strategic decision-making, developing integrative cross-functional portfolio management and review processes that strengthened operational management, financial planning, and compliance including regulatory reporting. She led transformative system change and process development that streamlined biomarker clinical contributions, optimizing operational resources by integrating multiple stand-alone systems into the program lifecycle from drug candidate selection to registration and into the enterprise planning system. 

Irina led the successful operational execution supporting Cosentyx® biomarker and clinical pharmacology reporting, resulting in submission and successful approval for the treatment of psoriasis, psoriatic arthritis, and ankylosing spondylitis. Irina contributed to 57 studies on Cosentyx® (AIN457) and a follow-up compound as well as 10 studies on Bimagrumab (BYM338), leading to the eventual spin out to a new company for the development of obesity and type 2 diabetes (diabesity) indications.

Irina began her career in academia at the Danish Academy of Sciences, Denmark researching mammalian genome mapping and at the University of Iowa Hospitals and Clinics, heading the cross-departmental functional genomics team focused on biomarker discovery to understand disease mechanisms and discover new drug targets.  She holds a Ph.D. from the Institute of Cytology and Genetics (Novosibirsk, Russia), and advanced management training from Bentley University (Essentials of Management/Executive Education). Irina is a Founding Member of the Boston chapter of CHIEF.

Dr. Irina Koroleva's Strong record in accelerating translation to the clinic

  • Global scientific and technical expertise leading the discovery and development of new drug products delivering over $8B in revenue.

  • Advance drug development programs and big pharma partnerships through pre-clinical research and clinical trials. 

  • Apply deep experience in therapeutics and modalities to inform and execute translational research and biomarker strategies. Lead the generation of high-quality data for internal decisions and build a pipeline for regulatory submissions and approvals. 

  • Develop innovative translational strategies to support clinical studies that accelerate the clinical development processes and speed to market. 

  • Drive operational excellence by defining, refining, aligning, planning, and executing implementations of translational sciences and biomarker requirements to accelerate development phases.  

  • Collaborate smoothly with C-suite, investors, and boards to advance mission-critical initiatives. Foster a collaborative culture of accountability, open communication, innovation, and excellence. 

Selected Publications

  • Krueger J, Wharton JK, Schiltt T, Suprun M, Torene RI, Jiang X, Wang C, Fuentes-Duculan J, Hartmann N, Peters T, Koroleva I, Hillenbrand R, Letzkus M, Yu X, Li Y, Glueck A, Hasselberg A, Flannery B, Suarez-Farinas, Hueber W. IL-17A inhibition by secukinumab induces early clinical, histopathological, and molecular resolution of psoriasis. Journal of Allergy and Clinical Immunology, May 2019.

  • Gerwien R, Tarasow TM, Melnick J, Lei A, Kinhika A, Duecet J, Kazma R, Maguire P, Koroleva I, Macchiarella G, Avrameas A, Valentin MA, Oliver S, Vitaliti A. Immunosignature-based diagnosis, and prediction of therapeutic response enables retrospective patient stratification in a phase IIa clinical trial for VAY736 in primary Sjogren. Arthritis & Rheumatology, Oct 2017.

  • Kolbinger F, Bruin G, Valentin MA, Peters T, Khokhlovich F, Jiang X, Koroleva I, Lee D, Sinner F, Pieber T, Dragatin C, Bodenlenz M, Loesche C. Secukinumab treatment rapidly leads to positive proteomic and transcriptional changes in psoriatic skin. Journal of Dermatological Science, Oct 2016.

  • Loesche C, Kolbinger F, Valentin M-A, Jarvis P, Ceci M, Wieczorek G, Khokhlovich E, Koroleva I, Bruin G, Patel D. IL-17A blockade with secukinumab results in decreased neutrophil infiltration in psoriasis: minimally invasive measurement by tape stripping. Advances in Precision Medicine. Advances in precision medicine Vol 1, N2, 1-9, Oct 2016.

  • Burmester G, Durez P, Shestakova G, Genovese MC, Schulze-Koops H, Li Y, Wang A, Lewitzky S, Koroleva I, Bemeis A, Lee D, Hueber W. Association of HLA-DRB1 Alleles with Clinical Responses to the Anti-Interleukin-17A Monoclonal Antibody Secukinumab in Active Rheumatoid Arthritis. Rheumatology (Oxford), 12 pii: kev258, Aug 2015.

  • Kolbinger F, Bruin G, Malentin M, Peters T, Khokhlovich E, Jiang X, Koroleva I, Lee D, Sinner F, Pieber T, Dragatin C, Bodenlenz M, Loeshe C. Secukinumab rapidly reduces markers of both keratinocyte proliferation and skin integrity in psoriasis. Journal of the American Academy of Dermatology, May 2015.

  • Krueger J, Wharton K, Fuentes-Duculan J, Wang C, Hillenbrand R, Li Y, Koroleva I, Lee D, Hueber W. Secukinumab reverses disease-defining psoriasis histopathology while retaining full T-cell activation potential. British Journal of Dermatology, Vol 171, Issue 6, Dec 2014.

  • Hueber W, Patel DD, Dryja T, Wright AW, Koroleva I, Antoni C, et al. Effect of AIN457, a fully human antibody to Interleukin-17A, on psoriasis, rheumatoid arthritis, and uveitis. Science Translational Medicine 2, 52ra72, Oct 2010.

  • Wier AW, Nyholm S, Mandel M, Massengo-Tiassé R, Schaefer A, Koroleva I, Durant SS, Brown B, Manzella L, Snir E, Almabrazi H, Scheetz T, Bonaldo MF, Casavant T, Soares M, Cronan J, Reed J, Ruby E, McFall-Ngai M. Transcriptional patterns in both host and bacterium underlie a daily rhythm of anatomical and metabolic change in a beneficial symbiosis. PNAS, 107(5): 2259-64, Feb 2010.

  • Chun CK, Troll JV, Koroleva I, Brown B, Manzella L, Snir E, Almabrazi H, Scheetz TE, Bonaldo MF, Casavant TL, Soares MB, Ruby EG, McFall-Ngai MJ. Effects of colonization, luminescence and autoinducer on host transcription during development of the squid-vibrio association. PNAS 15 (32), 11323-11328, Aug 2008.

  • Morris KA, Snir E, Pompeia C, Koroleva IV, Kachar B, Hayashizaki Y, Carninci P, Soares MB, and Beisel KW. Differential Expression of Genes within the Cochlea as Defined by a Custom Mouse Inner Ear Microarray. Journal of the Association for Research in Otolaryngology (JARO) Mar 2005.

  • Huang J, Kao HC, Koroleva I, Zhang CH, Soares MB. A semi-liner model for normalization and analysis of cDNA microarray data. Department of Statistics and Actuarial Science, University of Iowa. 2003.

  • Ivanova EV, Koroleva IV, Kuznecov SB, Aksenovich TE, Svischova GR, Mal’chenko SN, Bendixen C, and Zhdanova NS. Radiation mapping of the short arm of swine chromosome 2. Genetika Feb; 37(2):230-7. 37 (2), 168-174. Translated from Russian, Feb 2001.

  • Ivanova V, Koroleva IV, Malchenko SN, Kuznetsov SB, Bendixen C & Zhdanova NS. Regional mapping of pig Chr 2 on the basis of RI hybrids. Chromosome Research, 2000.

  • Koroleva IV, Malchenco SN, Shukri NM, Ivanova EV, Kuznetsov SB, Zhdanova NS, Bendixen C. Assignment of five porcine genes by pig-mink cell hybrids to pig chromosomes 2, 5, 8, 12. Mammalian genome 9 (11), Nov 1999.

  • Matyakhina LD, Koroleva IV, Malchenko SN, Bendixen C, Cheryaukene OV, Pack SD, Borodin PM, Serov OL, and Searle JB. Chromosome location of sixteen genes in the common shrew, Sorex Araneus L. (Mammalia, Insectivora). Cytogenetic and Genome Research 77, 201-204, 1997.

  • Malchenko SN, Koroleva IV, Brusgaard K, Matyakhina LD, Colonin MG, Pack SD, Searle JB, Borodin PM, Serov OL and Bendixen C. Chromosome localization of the gene for growth hormone in the common shrew (Sorex Araneus). Heredias 125, 243-245, May 1996.

  • Koroleva IV, Malchenko SN, Khlebodarova TM, Brusgaard K, Zakian SM. Chromosomal localization of the genes for growth hormone, somatostatin peptide, ornithine transcarbamylase, and prion protein in silver fox (vulpis fulvus). Mammalian Genome 7(11); 860-862, Nov 1996.

  • Adkison LR, Koroleva IV, and Zakian SM. Mapping of the alpha-subunit of the fox fibronectin receptor (FNRA) to chromosome 8. Mammalian Genome 5, 119-120, Feb 1994.

  • Nesterova TB, Koroleva (n.e. Nikitina IV), Zakian SM, Rubtsov NB, Matveeva VG, Radjabli SI. Mapping of silver fox genes: Chromosomal localization of the genes for GOT2, AK1, ALDOC, ACP1, ITPA, PGP, and BLVR. Cytogenet. Cell Genet. 56, 185-188, 1991.

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