Gopi Shankar Email and Phone Number
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Charismatic R&D executive with demonstrated success in leading science and operations, creating and implementing fit-for-purpose strategies that drive scientific and business solutions. Significant experience in research and preclinical development of mAbs, bispecifics, fusion proteins, and cell therapies, regulatory compliance, and due diligence for licensing and acquisition.An inspiring ambassador for organizational mission, products, pipeline, and culture. Persuasive communicator, known for simplifying complex concepts and developing clear and compelling value propositions. Builds and develops infrastructure by matching strong skills and talent with opportunities to drive highly efficient and productive R&D engine. Servant leader, engaging and empowering cross-generational employees to create innovative solutions and maximize team potential. Reputation as an authentic, level-headed leader who operates with integrity and high ethical standards in science, management, and corporate responsibility. Passionate about translating basic science into patient impact.► Immunogenicity | Pharmacology | Bioanalytical | Regulatory Compliance► Vision | Ideation | Strategy | Management | Value Proposition► Workflows and Infrastructure Development | Mentor, Coach and Develop Talent
Larimar Therapeutics Inc.
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Chief Development Officer (Cdo)Larimar Therapeutics Inc. Feb 2023 - PresentBala Cynwyd, Pa, UsBuilding and leading Larimar’s R&D organization comprising Discovery, Toxicology, Clinical & Translational PK/PD, Biostatistics & Programming, Data Management, Bioanalysis, Clinical Operations and CMC. Driving strategy creation, overseeing implementation of plans, development of robust data and analytical packages, and hiring talent with necessary skills and leadership competencies. As a member of Larimar’s executive management team, working in collaboration with the CEO, CMO and CFO on portfolio strategy and business operations.
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Adjunct ProfessorUniversity Of Tennessee-Health Science Center College Of Medicine 2021 - PresentMemphis, Tennessee, UsFor over 10 years I have been a lecturer in the PK/PD of Protein Therapeutics course, on the topic of Immunogenicity. -
Vice President & Head, Biologics Development SciencesThe Janssen Pharmaceutical Companies Of Johnson & Johnson Apr 2018 - Apr 2022Raritan, New Jersey, UsLed global group of ~175 scientists to elucidate pharmacological parameters to guide discovery of biologic molecules, preclinical PK/PD, and drug development strategies. Enabled investigational new drug applications (IND) for 1st-in-human trials of mAbs, bispecifics and CAR-Ts in multiple therapeutic areas. Led clinical immunogenicity, PK/PD bioanalysis, reagents manufacture, lab automation and GLP quality compliance. Managed operating budget of $26M. Turned-around stagnated organizational status quo by defining culture of excellence in R&D, significantly improving in nimbleness, operational efficiency, accountability, performance management, empowerment, and talent development. Managed team’s contribution to 60+ INDs BLAs/MAAs globally. Formed Translational PK/PD Research team and directed integrated strategic product development plans partnering with stakeholder departments, producing decision-enabling data and driving intended business outcomes. Delivered technical management review, guidance to due diligence team members, and recommendations to upper management on 75+ licensing and acquisition (L&A) opportunities. -
Senior Director & Head, Bioanalytical Sciences & ImmunogenicityThe Janssen Pharmaceutical Companies Of Johnson & Johnson May 2011 - Apr 2018Raritan, New Jersey, UsDelivered technical and business leadership to group of 100+ scientists contributing nonclinical and clinical assay development, validation, and bioanalysis for PK/PD and immunogenicity. Contributed to all therapeutic area projects for immunogenicity strategy, risk assessment, bioanalytical laboratory testing, regulatory submissions, and related communications. Drove workforce planning, externalization, and developed/implemented lab automation strategies. Improved data integrity and regulatory compliance, including building workflows and research infrastructure. Led team contribution to over 60 BLA/MAA (US, EU, Japan, LATAM, China). Published 2 key industry-health authority white papers on clinical immunogenicity, combined total of 230 citations to date.
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Director, Immune Response Assessment & ResearchCentocor R&D Jun 2007 - Apr 2011Oversaw clinical and non-clinical immunogenicity operations (method development, validation, and bioanalysis) for all biologic drug products. Produced immunogenicity text in clinical reports, INDs, BLAs and MAAs, and reviewed study protocols and bioanalytical reports. Fielded questions related to regulatory filings from US FDA and global health authorities.
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Principal Research Scientist & Assistant Director, Clinical & Nonclinical ImmunogenicityCentocor R&D Aug 2006 - Jun 2007
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Senior Research Scientist, Clinical ImmunogenicityCentocor R&D Feb 2003 - Aug 2006
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Manager, Quality Control And Immune MonitoringNorthwest Biotherapeutics Sep 2000 - Oct 2002Bethesda, Md, Us -
Scientist, Vaccine ResearchNorthwest Biotherapeutics Mar 1999 - Sep 2000Bethesda, Md, Us
Gopi Shankar Skills
Gopi Shankar Education Details
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Drexel University'S Lebow College Of BusinessLeadership & General Management -
University Of KentuckyImmunology
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Oklahoma State UniversityMolecular And Cell Biology
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Saint Mary'S UniversityBiology
Frequently Asked Questions about Gopi Shankar
What company does Gopi Shankar work for?
Gopi Shankar works for Larimar Therapeutics Inc.
What is Gopi Shankar's role at the current company?
Gopi Shankar's current role is Biotechnology R&D Executive ✦ Creates & Delivers Scientific & Operational Strategies that Maximize Business Outcomes.
What is Gopi Shankar's email address?
Gopi Shankar's email address is ri****@****hoo.com
What schools did Gopi Shankar attend?
Gopi Shankar attended Drexel University's Lebow College Of Business, University Of Kentucky, Oklahoma State University, Saint Mary's University.
What skills is Gopi Shankar known for?
Gopi Shankar has skills like Monoclonal Antibodies, Immunology, Biotechnology, Biopharmaceuticals, Drug Development.
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