EXPERIENCE

INDEPENDENT CONSULTANT, Framingham, Massachusetts 2018-PRESENT

President, Founder, Senior Consultant, Kovalchin Bioconsulting, LLC (2025-Present)

President, Co-Founder, Senior Consultant, IND Bioconsulting, LLC (2025-Present)

• Worked with over 6 foundations, venture capital, or biotechnology start-up companies as independent consultant.

• Acted as temporary “full-time” employee to manage/oversee bioanalytical, discovery, toxicology, and strategic functions.

• Strategic guidance/corporate deck creation for start-up biotechnology companies.

• Developed stratified nonclinical program to IND/beyond along with CRO selection, high-level budget creation, and timeline for seed funding/Series A fund raising efforts.

• Performed initial due diligence on several potential in-licensing opportunities on a wide array of treatment indications and treatment modalities for clients (foundations, venture capital companies, and start-up biotechnology companies) to broaden pipeline/solidifying company formation in accordance with client goals.

• Reviewed existing toxicology data for a client to provide strategic next steps/positioning of data to regulatory agencies.

• Served as member of scientific advisor board for client.

• Authored nonclinical sections of IND and reviewed reports for successfully submitted IND for client.

MERIDA BIOSCIENCES INC., Cambridge, Massachusetts 2024-2025

Vice President, Preclinical Development (2024-2025)

• Head of Preclinical Development Department: responsible for advancing lead asset MER511 toward IND along with initiating IND-enabling strategies for pipeline programs.

• Mentored first -time industry and/or first IND submission PhD level scientists in report writing, scientific strategic thinking, and data interpretation.

• Preclinical representative member of Research Leadership, Asset Development, and Development Candidate sub-Teams.

• Design and execution of IND-enabling non-GLP dose range finding studies, GLP toxicology and safety pharmacology of lead asset MER511.

• Design and execution of characterization studies for a novel transgenic mouse to support its use as toxicology species for MER511 and other development candidates.

• Preclinical development risk identification and mitigation strategies with effective communication to appropriate leadership and project teams.

• Budgeting/project management/stratifying preclinical development activities for lead asset MER511 in addition to pipeline development candidates.

• GLP validation of PK, ADA, and DFA of lead asset MER511 necessary for IND-enabling work along with clinical PK and ADA assay development strategy.

• Authorship of relevant documents or sections of documents for regulatory submissions.

• Maintained development timeline to keep corporate goals.

• Maintained key relationships with vendors and consultants.

ALLIEVEX CORP., Boston, Massachusetts 2019-2024

Vice President, Research (2023-2024) Executive Director, Research (2019-2023)

• Transitioned all nonclinical information/data/samples from BioMarin for the in-licensed four programs: MPS IIIA, MPS IIIB (lead program AX 250), GM1, and GM2.

• Managed the method transfer of validated clinical assays for the assessment of PK and immunogenicity of AX 250 to CROs from BioMarin Bioanalytical Services.

• Responsible for writing/reviewing critical documents for regulatory submissions (such as toxicology/safety pharmacology/GLP assay validation/sample analysis reports, reproductive and developmental study designs/strategy, and briefing documents) and interacting with appropriate divisions of the FDA and EMA.

• Assisted in the writing of scientific findings for publication to enrich the field as a whole and giving Allievex visibility as a leader in the field.

• Conducted competitive intelligence research on clinical assets in MPS IIIA and MPS IIIB space.

• Performed initial due diligence on potential in-licensing opportunities in the area of rare pediatric indications.

• Developed and integrated timelines for in vivo activities with overall company timelines and corporate goals, in close coordination with CMC and regulatory groups and external global consultants/CROs/academic collaborations.

• Day to day management and execution of all non-clinical in vivo and bioassay development/validation.

AMATHUS THERAPEUTICS INC., Cambridge, Massachusetts 2017-2019

Senior Director, Translational Pharmacology (2017-2019)

• Drove all in vivo/ex vivo activities in the company to identify small molecule development candidate(s) which modulate protein chaperones. Responsible for early discovery and proof of concept in vivo efficacy studies in two lead therapeutic indications: lysosomal storage disorders (Fabry disease and Niemann-Pick disease type C) and Parkinson’s disease (genetic and toxin induced models). These lead to critical “go/no go” decisions for the company which help lead to a partnership with Merck.

• Lead initial pharmacokinetic screening of lead series of compounds for CNS penetrance, preliminary formulation development, and tissue binding/distribution.

• Developed translation biomarkers that had utility in the clinic: which included LC/MS and ELISA based methods to measure markers of oxidative stress in various biological matrices, positron-emission tomography (PET) imaging using novel tracer used to measure oxidative stress in the CNS, and lipidomic analysis.

• Developed and integrated timelines for in vivo activities with overall company timelines and corporate goals, in close coordination with medicinal chemistry and in vitro pharmacology groups and external global consultants/CROs/academic collaborations.

COLUCID PHARMACEUTICALS INC., Cambridge, Massachusetts 2015-2017

Director, Head of Research (2015-2017)

• Reported directly to CEO in a company of 7 employees and solely responsible for nonclinical research updates to senior management and the board of directors. Involved with due diligence and transition of all non-clinical activities to Eli Lilly for lasmiditan (which recently approved by the FDA, Reyvow®).

• Strategically planned, project managed, executed, and/or contract negotiated/budgeted all non-clinical activities (including carcinogenicity, drug:drug interaction, drug abuse potential, phototoxicity, and genotoxicity/genotoxic impurities) of lead small molecule therapeutic, lasmiditan, which was in Phase 3 clinical trials.

• Responsible for daily oversight of consultants/CROs/academic collaboration activities to ensure quality results were delivered on time and within budget. This included study design, protocol development, coordination of study materials, data interpretation, report review and approval.

• Developed and integrated timelines for non-clinical activities with overall company timelines and corporate goals, in close coordination with CMC, Clinical, Regulatory groups and external global consultants/CROs/academic collaborations.

• Responsible for writing/reviewing critical documents for regulatory submissions (such as toxicology/safety pharmacology/GLP assay validation/sample analysis reports, briefing documents, bridged the electronic IND of oral lasmiditan administration to the electronic IND intravenous lasmiditan administration, and pediatric study plan) and interacted with appropriate divisions of the FDA.

• Assisted in business development opportunities at scientific conferences.

ELEVEN BIOTHERAPEUTICS INC, Cambridge, Massachusetts 2010-2015

Associate Director, Head of Pharmacology/Non-clinical Development (2012-2015)

Senior Scientist, In vivo Pharmacology (2010-2012)

• Interacted with key opinion leaders in support of strategic planning for non-clinical in vivo models of ocular diseases (environment-induced dry eye, experimental autoimmune uveitis (EAU), and laser-induced choroidal neovascularization (CNV) models) for lead biologic therapeutics (EBI-005 and EBI-031) and pipeline assets.

• Managed leased animal facility space and 2 personnel to conduct non-GLP in vivo efficacy models and developed in vitro/ex vivo nonclinical assays (including PK/TK, PD, potency and immunogenicity assays) following ICH guidelines.

• Vetted and selected CROs/academic collaborators for non-GLP in vivo efficacy models, GLP toxicology, GLP safety pharmacology, GLP assay validation, and GLP testing of clinical samples used in First in Human clinical trials through Phase 3 clinical trials.

• Responsible for daily oversight of consultants/CROs/academic collaboration activities which ensured quality results were delivered on time and within budget.

• Responsible for writing/reviewing critical documents for regulatory submissions (such as internal study reports, toxicology/safety pharmacology/GLP assay validation/sample analysis reports, briefing books, and non-clinical sections of IND) and interacted with appropriate regulatory agencies.

PEPTIMMUNE INC., Cambridge, Massachusetts 2006-2010

Senior Scientist, Pharmacology/Immunology (2007-2010)

Research Scientist, Pharmacology/Immunology (2006-2007)

• Trained and managed a 5 member pharmacology/immunology team which was responsible for bioassay development, ex vivo biomarker analysis, and in vivo PK/PD/Tox/Pharmacology.

• Showed lead compound was efficacious in the weekly treatment of experimental autoimmune encephalomyelitis (EAE), the mouse model of multiple sclerosis, developed other animal models of autoimmune disease (rheumatoid arthritis (CIA) and crohn’s disease (IBD)), and showed the lead compound can be used for other indications other than multiple sclerosis.

• Tested amino-acid copolymers developed using a proprietary platform for immunogenicity/adjuvanticity.

• Worked cross-departmentally to develop a proprietary pharmacokinetic assay, which is the first of its kind for copolymer-based immunotherapies.

• Analyzed data from the Phase Ia and Ib clinical trials and identified biomarkers, which are important for the mechanism of action in mice, are also modulated in humans. This data was used for the dose selection for the Phase II clinical trial.

• Involved in writing critical documents submitted to the FDA in response to a clinical hold which was subsequently lifted.

• Prepared and published findings from the Phase Ia and Ib clinical trials as well as pre- clinical findings in peer-reviewed journals.

AGENUS INC., (formerly Antigenics Inc.) Lexington, Massachusetts 2005-2006

Scientist, Tumor Immunology (2005-2006)

Post-Doctoral Fellow, Tumor Immunology (2005)

• Established and optimized several syngeneic tumor models (models: B16- melanoma, 4T1- breast, SM1- breast, RENCA- renal, Meth A- fibrosarcoma, CT26- colon, D122- lung, spontaneous tumor of unknown origin arising in NOD/LtJ mouse).

• Developed survival surgery techniques for naturally metastasizing cancer models (models: 4T1- breast and D122- lung) and subsequent training to animal laboratory personnel.

• Conducted in vivo translational oncology efficacy studies of lead cancer immunotherapeutic, oncophage (Vitespen®), and its’ combination with other immunotherapeutics.

• Collaborated with multiple departments and consultant for the autoimmune program.

• Performed in vitro cell culture for cell bank generation and in vivo transplantation.

• Cultured hybridoma cell lines for antibody production.

UNIVERSITY OF CONNECTICUT HEALTH CENTER, Farmington, Connecticut 2003-2005

Post-Doctoral Fellow, Center for Immunotherapy of Cancer and Infectious Diseases (2003-2005)

• Established in vivo and in vitro models to test the effects and understand the possible mechanism of heat shock proteins in wound healing (models: normal, diabetic, and radiation).

• Developed in vivo and in vitro models to test the effects and understand the possible mechanism of high dose gp96 immune suppression in autoimmunity (model: type 1 diabetes (NOD/LtJ)).

• Established an in vivo model to test the effects of high dose gp96 immune suppression in graft rejection (skin graft transplants- male vs. female, secondary graft rejection, and allo- rejection).

• Performed antibody and heat shock protein purification, quantification, and qualification using basic chromatography and analytical methods.

EDUCATION

KENT STATE UNIVERSITY, Kent, Ohio 1998-2003

Ph.D. in Cellular/Molecular Biology: Major in Immunology

Dissertation: Factors that impact the immunogenicity of heat shock protein, gp96: relevance to cancer immunotherapy.

NORTHEASTERN OHIO MEDICAL UNIVERSITY, Rootstown, Ohio 1997-1998

M1 Basic Sciences Curriculum

YOUNGSTOWN STATE UNIVERSITY, Youngstown, Ohio 1994-1997

B.S. in Combined Sciences

PROFESSIONAL MEMBERSHIPS/AWARDS/ACCOMPLISHMENTS

American Association of Immunologists (AAI) American College of Clinical Pharmacology (ACCP)

• McKeen Cattell Memorial Award (2012)

Cell Stress Society International (CCSi) BioSafe General Member