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I am currently employed with Regeneron Pharmaceuticals and not available for a fee for service consulting engagements.
Still, I always welcome and encourage you connecting with me for a friendly and honorarium free conversation!
Practical Guidance for Challenging Assays
During my tenure at Wyeth, Pfizer, Sana, and Regeneron I have cultivated substantial expertise in strategically approaching the bioanalysis of biotherapeutics. I was fortunate to support development of monoclonal antibodies (mAb), antibody drug conjugates (ADC), enzyme replacement (ERT), fusion proteins, adeno-associated virus delivery (AAV), chimeric antigen receptor T-cell (CAR-T), siRNA and other modalities of biotherapeutics. I had opportunity to experience and apply bioanalytical approach that is anchored in considerations such as the developmental phase of the compound, the modality type, the clinical indication, and the regulatory landscape. Key questions revolve around determining the optimal PK assay, fine-tuning the timing and nature of immunogenicity assessments for various biotherapeutic modalities, preparing comprehensive regulatory submissions, and crafting thorough responses to regulatory inquiries.
I have also gathered an array of pragmatic solutions designed to streamline the process of PK, anti-drug antibody (ADA) and neutralizing anti-drug antibody (NAb) detecting assay development, transfer, and validation. These encompass guidelines for discerning assay readiness for production or identifying the need for adjustments. Over the years, my involvement has been pivotal in assessing immunogenicity risk factors and orchestrating data-driven strategies for immunogenicity assessment. My leadership of the Immunogenicity Expert Working group within the organization has afforded me a unique vantage point, exposing me to diverse biotherapeutic modalities, indications, and associated risks.
Leveraging my extensive network within the industry, forged through direct engagements and active participation in esteemed organizations such as AAPS, EBF, EIP, and Industry IQ, I have consistently seized opportunities to contribute, co-lead, and spearhead initiatives aimed at advancing the frontiers of bioanalysis science.
I possess a determined and dynamic personality, characterized by visionary leadership and an unwavering passion for ongoing enhancement. My approach to communication is transparent and direct, geared towards achieving straightforward and efficient solutions.
My role as a lab head has equipped me with the readiness to offer essential support across diverse facets of laboratory operations. This includes adeptly managing vendor relationships, facilitating seamless technology transfers, driving process optimization, and fostering innovation in science and technology.
My substantial publication history underscores my expertise in a multitude of areas within Biotherapeutic Bioanalysis.
Boris Gorovits
Strategic and Practical solutions for Bioanalysis of Biotherapeutics aiming to enable development of innovative and breakthrough compounds to help patients and clients to succeed
Keywords: immunogenicity, bioanalysis, assay development, assay validation, assay troubleshooting, PK assay, ADA, NAb, immunogenicity of gene therapy, immunogenicity of cell therapy, translational strategy for gene therapeutics, translational strategy for cell therapeutics