KIRILL V. KALNIN, Ph.D.
VICE PRESIDENT OF R&D
25+ years of experience strategically leading multi-disciplinary R&D organizations in the biotech and biopharma industries
Dynamic, hands-on R&D leader that leads pivotal Phase 1, 2, and 3 programs for bacterial and viral vaccines. Orchestrates strategic leadership in scientific planning, R&D pipeline management, and the identification of new research opportunities. Excels in developing comprehensive research and development proposals, including budgets and timelines. Effectively manages vaccine programs from target identification to Phase 2-3, covering market analysis, preclinical proof-of-concept, and scientific publication review. Contributed as VP of R&D and Head of the San Diego Center of Excellence and played a pivotal role in contributing to the corporate portfolio strategy and advancing vaccine product development through Phase 1-3. Gained recognition as a leader in mRNA vaccine development, particularly for COVID and flu vaccines, and successfully managed the research, development, and manufacturing processes for IND and BLA submissions. Demonstrates a consistent track record of innovation and troubleshooting, resulting in the successful development of viral and bacterial vaccine candidates and immunotherapeutic products through preclinical proof-of-concept and beyond. Utilizes strong communication and motivational skills to mentor junior staff. Develops intellectual property, conducts due diligence efforts, and performs feasibility studies on novel platform technologies.
Areas of Expertise
Research & Development (R&D)
Strategic Planning & Execution
Project Management
Clinical Trial Management
Biotech & Biopharma
Operational Excellence
Innovator
Manufacturing
Investigator
Transparent Communication
Data Analytics & Reporting
Motivational Team Leadership
PROFESSIONAL EXPERIENCE
Kalnin Consulting - San Diego, California
Founder and President
2024-Current
Please click the “About” button above to learn more about Kalnin Consulting LLC
Adiverna LLC - San Diego, California
Founder and Chief Technical Officer
2023-current
Adiverna, a pre-seed stage startup poised for groundbreaking success.
Our expertise in mRNA immunotherapy, coupled with the pressing demand for premium vaccines and therapies in the pet healthcare sector, positions us for rapid growth and unparalleled impact. We are confident that our innovative approach will revolutionize the industry, and we invite you to join us on this exciting journey towards transforming veterinary care for dogs and cats.
Emergent Biosolutions – San Diego, California
Vice President R&D & San Diego, Site Head
2021 – 2023
Strategically led a dynamic R&D site comprised of 200 employees across diverse functions that included research, analytical development, process development, and GMP/GxP.
Directed and managed various developmental and bioanalytical initiatives that played a pivotal role in supporting Phase 1-3 vaccine studies.
Significantly contributed to the reconstruction of the corporate strategy and project portfolio.
Successfully restructured the R&D division and oversaw the completion and licensing of an innovative GMP pilot plant within the San Diego Site.
Seamlessly coordinated facility operations, supply chain logistics, health and safety protocols, and quality assurance functions as part of the newly established R&D Center of Excellence by employing 6S and lean methodologies for streamlined efficiency.
Sanofi Pasteur – Cambridge, Massachusetts
mRNA Research Platform Leader
2018 – 2021
Drove translational research efforts in support of mRNA vaccine development, notably the SARS-COVID-19 vaccine.
Assumed leadership of the mRNA vaccine SARS-COVID-19 program by overseeing NHP and mouse immunogenicity studies to facilitate Phase 1 trials.
Ensured the successful submission of the IND application.
Provided crucial support for at-risk manufacturing of Phase 1-3 vaccine formulations.
Spearheaded efforts that achieved scale-up, potency, and consistency for Phase 3.
Established pioneering collaborations with TBio to develop LNP/mRNA technologies for a range of vaccine applications that included Flu, RSV, and Chlamydia.
Oversaw and led innovative collaborations focused on vaccine design, immunoprofiling, and biomarker discovery.
Served as the prominent representative of Sanofi Pasteur Research and Enabling Science. Recognized as an influenza vaccine opinion leader by both internal and external stakeholders.
Sanofi Pasteur - Cambridge, Massachusetts
Head of Biologic Design, Biochemistry,
& Formulation (BDB&F) Platform
2008 – 2018
Collaboratively led all research activities and personnel for the pre-development portfolio. Effectively managed a team of 10 direct reports.
Spearheaded the development of innovative research strategies and project plans for approximately 10 projects, consistently delivering measurable Key Performance Metrics (PKMs). Presented regular updates at Senior Management Committee meetings, Departmental Reviews, and Global Town Halls.
Successfully managed an annual budget totaling approximately $10M in operating expenses (OPEX) and $2M in capital expenditures (Capex).
Actively contributed as a member of the Translational Strategic Forum (TSF) and the New Target Committee (NTC) those were responsible for evaluating novel technologies and identifying new target opportunities.
Acambis Inc – Cambridge, Massachusetts
Director – Head of Discovery Platform Research
2004 – 2008
Served as Department Head and Budget Holder by overseeing a team of 10 full-time employees (FTEs) across three distinct disciplines.
Comprehensively managed research portfolio that included program strategy development, proposal drafting, and presentation to the Projects & Portfolio Committee (P&PC), as well as resource allocation and project implementation.
Targeted research efforts focused on infectious disease targets, including respiratory pathogens such as Influenza and Rhinovirus, bioterrorist agents like Anthrax, and emerging infectious diseases, including SARS-Coronavirus.
Acted as a member of the Operations Committee, where responsibilities included the establishment of project management oversight and metrics, as well as the review of operational requirements to align with company objectives.
Acambis Inc - Cambridge, Massachusetts
Associate Director & Group Leader – Discovery Research
2002 – 2004
Led and managed a group of three full-time employees (FTEs) that spanned two distinct disciplines.
Conducted research focused on critical infectious disease targets that included bioterrorist agents such as Anthrax and emerging infectious diseases like SARS-Coronavirus.
EDUCATION AND OTHERS
Post-Doctoral Fellowship, National Cancer Institute, NIH, Bethesda
1996-2002
PhD in Microbiology, Gamaleya Institute of Epidemiology & Microbiology, Academy of Medical Sciences – Moscow, Russia
1993
Master of Science in Genetics, Saint Petersburg State University – Saint Petersburg, Russia
1984
Awards
Sanofi Innovation Transformative Technologies Award (2019)
Sanofi Pasteur “Yes To innovation” Award (2015, 2018,)
Patents
WO2009120380 Oct 2009 Recombinant Rhinovirus Vectors
WO2008100290 Aug 2008 Recombinant Rhinovirus Vectors
WO2008057158 May 2008 Rhinovirus Immunogen
WO2004091524 Oct 2004 Respiratory Virus Vaccines (SARS)
Affiliations
American Society of Microbiology
American Society of Virology
New York Academy of Sciences
International Society for Vaccines
Selected Publications
Goldman RL, Vittala Murthy NT, Northen TP, Balakrishnan A, Chivukula S, Danz H, Tibbitts T, Dias A, Vargas J, Cooper D et al: Understanding structure activity relationships of Good HEPES lipids for lipid nanoparticle mRNA vaccine applications. Biomaterials 2023, 301:122243.
Kalnin KV, Plitnik T, Kishko M, Huang D, Raillard A, Piolat J, Anosova NG, Tibbitts T, DiNapoli J, Karve S et al: Pan-SARS neutralizing responses after third boost vaccination in non-human primate immunogenicity model. Vaccine 2022.
Kalnin KV, Plitnik T, Kishko M, Zhang J, Zhang D, Beauvais A, Anosova NG, Tibbitts T, DiNapoli J, Ulinski G et al: Immunogenicity and efficacy of mRNA COVID-19 vaccine MRT5500 in preclinical animal models. NPJ Vaccines 2021, 6(1):61
Chivukula S, Plitnik T, Tibbitts T, Karve S, Dias A, Zhang D, Goldman R, Gopani H, Khanmohammed A, Sarode A et al: Development of multivalent mRNA vaccine candidates for seasonal or pandemic influenza. NPJ Vaccines 2021, 6(1):153.
Kalnin KV, Plitnik, T., Kishko, M., Zhang, J., Zhang, D., Beauvais, A., Anosova, N.G., Tibbitts, T., DiNapoli, J.M., Huang, P-W. D., Huleatt, J., Vincent, D., Friees, K., Karve, S., Goldman, R., Gopani, H., Dias, A., Tran, K., Zacharia, M., Gu, X., Boeglin, L., Chivukula, S., Swearingen, Landolfi, V., Fu, T-M., DeRosa, F., Casimiro, D. : Immunogenicity of novel mRNA COVID-19 vaccine MRT5500 in mice and non-human primates. bioRix 2020.
Kalnin K, Cheng W, Yan Y, Tibbitts T, Shen L, Costa V, Cieszynski J, Oomen R, Almond J, Kleanthous H: Sequential Immunization Induces Broad Cross-Neutralizing Antibody Responses Across HRV types. In: 8/3/2014 2014. 2014.
Kalnin K, Tibbitts T, Yan Y, Stegalkina S, Shen L, Costa V, Sabharwal R, Anderson SF, Day PM, Christensen N et al: Low doses of flagellin-L2 multimer vaccines protect against challenge with diverse papillomavirus genotypes. Vaccine 2014, 32(28):3540-3547.
Jagu S, Kwak K, Schiller JT, Lowy DR, Kleanthous H, Kalnin K, Wang C, Wang HK, Chow LT, Huh WK et al: Phylogenetic considerations in designing a broadly protective multimeric L2 vaccine. J Virol 2013, 87(11):6127-6136.
