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  • Regulatory Strategist and Drug/Biologics Innovator

    Min Young, PhD, RAC

    15 years of experience 0 projects USA Research & Development
    Regulatory Regulatory Affairs and Strategy
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    A strategic thinker with extensive hands-on experience (15+ years) developing new medicines for rare diseases or areas with high unmet medical needs. Highly regarded as a dedicated, passionate and innovative Regulatory Affairs Leader throughout career. Contributed to successes of a number of development organizations.

     Led and/or contributed to global licensing of 9+ products and development of 21+ products o Solid US, EU and global RA (GRA) working experience managing full-spectrum product development, marketing applications (NDAs/BLAs/MAAs: NMEs, 505(b)(2), hybrid), approvals…

  • Regulatory Strategist and Drug/Biologics Innovator

    Meredith Brown-Tuttle

    30 years of experience 0 projects USA Research & Development
    Regulatory Regulatory Affairs and Strategy
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    Strategy, Intelligence and Product Development: • Member of core/executive drug development teams and/or Program Team Lead • Created and managed multiple global strategies for drugs, biologics, biosimulars and combination products • Conducted regulatory research and intelligence on a global basis for various therapeutic indications/areas • Performed gap analyses to identify potential challenges to successful IND, NDA, MAA, BLA and NDI/DS filings

    Scientific Advice Meetings: • Wrote, managed and compiled associated packages for FDA/EU/EMA/Health Canada scientific advice meetings • Conducted in-person…

  • lisa barbadora

    0 years of experience 0 projects USA Research & Development
    Clinical AffairsClinical Operations Publications
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    1200 word content write up of 2023 Decentralized Clinical Trials predictions.  Primary input- interview of thought leader, plus individual DCT trends research.  To be published in pharmaceutical trade journal.

  • Regulatory Strategist

    Mark Mariani, M.S.

    30 years of experience 0 projects USA Research & Development
    Regulatory Regulatory Affairs and Strategy
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    Over 30 years of experience in pharmaceutical Regulatory Affairs responsible for INDs, NDAs, and FDA liaison in the therapeutic areas of Rare Disease (Transplantation, Neuroinflammation, Hematology, Renal), Dermatology, Ophthalmology, Oncology, Allergy/Asthma, and Women’s Health. Highly experienced in developing regulatory strategies in support of global development programs for small molecules and biologic products, analysis of regulatory precedent and health authority policy, and preparation for meetings with the US FDA. Skilled in the evaluation of issues across clinical and nonclinical functions and…
  • Pulmonologist, Investigator, and Clinical Development SME

    Bernt van den Blink, MD PhD

    20 years of experience 0 projects The Netherlands Research & Development
    ClinicalClinical development planKOL LiaisonMedical AffairsPharmacovigilance
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    Clinical research professional with 20+yrs academic and biotech/pharmaceutical industry experience. M.D. Ph.D. pulmonologist with expertise in (rare) respiratory, auto-immune, inflammatory and fibrotic diseases. Physician-scientist bridging basic and clinical science, thrilled to guide new discoveries through clinical development.

  • Project Leader

    Gergely Balint

    25 years of experience 0 projects USA Market Research, Research & Development
    Project/program leadership Clinical OperationsCMCDeviceMarket StrategyProject managementRegulatoryResearch and Development Advisory CommitteeAlliance ManagementAutoimmune diseaseBfArMBiologicBudget planning & managementChange controlClinicalClinical development planClinical OperationsClinical Program ManagementCNSDue DilligenceFDALifecycle managementMarket landscape / opportunityPulmonary diseasesRare diseasesRegulatory Affairs and StrategyRheumatologyRisk Managementsubmission planning and trackingsubmission readiness
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    Highly accomplished leader of pharmaceutical industry with wide range of experience in project and organizational leadership. 20+ years of international drug development expertise coupled with strategic, operational and management experience.

    ◄ Core competencies include ► ★ In-depth Biopharmaceutical Industry Experience ★ Extensive Drug Development/Life Cycle Management ★ Product Development Plan Creation & Prioritization ★ Hands on Project & Program Leadership ★ US, EU, & International Experience ★ Strategic Alliance Experience

    ◄ Key Accomplishments ► ★ Developed asset for Phase…

  • Clinical Operations Consultant

    Nneamaka Ndukwe

    11 years of experience 0 projects USA Research & Development
    Clinical AffairsClinical OperationsDevicePharmbio Start UpQualityRegulatory 21 CFR Part 11AE/SAE ReportingAnnual ReportBioclinicaCentralized MonitoringCLIAClinical contractsClinical documentationClinical OperationsClinical Project ManagementClinical QualityClinical Trial DocumentationClinical Trials.govCNSCOACRF annotationCRF completion guidelinesCRO OversightData cleaningData CollectionData EntryDatabase lockDocument QCDocumentation and other deliverablesEarly- Phase 1 or 2eCOAeConsentEDCEHR/EMRElectronic document managementeProeSignaturesEssential documentsFDAFeasibilityGCPGCP trainingICH E6 (r2)Inform/Oracle ClinicalInformed ConsentInterim MonitoringInvestigator Site FileIRB & ethics committeeIxRSLate (Phase 2 or 3)Site managementSite Qualification and TrainingSmall pharma experienceTrial Master File remediationVeeva Vault
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    I love everything about Clinical Research. Most of all, I am passionate about getting Clinical Research Sites that are struggling or research naive back on track and audit ready. I went from doing lab work at the bench to researching the effects of the drugs made at the bench in people. If you are looking for a passionate, enthusiastic and high-performing Clinical Operations Consultant and Clinical Research Associate, look no further. I specialize in Site Management and Monitoring, Study Start-up,…

  • Yael Gozin

    0 years of experience 0 projects USA Research & Development
    Research and Development NonclinicalPharmacologyToxicology
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    Technical and Scientific Nonclinical Writing, Team Lead, Director

    At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global…

  • Nonclinical & Toxicology Consultant

    Charlene Barroga, PhD, DABT

    20 years of experience 0 projects USA Research & Development
    PreclinicalProject managementRegulatory & Medical WritingToxicology
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    As a Professional Nonclinical & Toxicology Consultant and Diplomate of the American Board of Toxicology, I provide professional strategic IND-enabling and NDA-program planning and execution for drug development with focus on small molecules and peptides for Oncology in solid and hematologic cancers, neurodegeneration, osteoarthritis, IPF (idiopathic pulmonary fibrosis), obesity, dermal (AGA, atopic dermatitis, psoriasis and tendinopathy) and multiple other indications. Regulatory writing for IND/NDA nonclinical documents as subject matter expert (SME), review of Pharmacology/PK/Tox reports, IND timeline management, Integrated Risk…

  • Preclinical Safety Assessment Scientist and Project Manager

    Caroline Bell, PhD

    30 years of experience 1 project USA Market Research, Research & Development
    Project management Drug SafetyPharmacodynamicsPharmacologyPreclinicalProject managementToxicology
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    Preclinical Safety Assessment Scientist and Project Manager with 30+ years of Medical University and Global Pharmaceutical industry experience. Specializing in Toxicology and Core Safety Pharmacology studies, Pharmacodynamics/Pharmacokinetics/Metabolism, IND-enabling Services, Proof of Concept and Candidate Selection, Strategic Program Management, Investigative and Regulatory Cardiovascular and Renal Safety Pharmacology, CRO Selection, Audit and Monitoring, Preclinical Safety Assessment, Market Analysis, Business Opportunity Assessment and Safety Pharmacology Training Workshops. Expert in strategic planning of preclinical drug development programs, protocol design to provide…

  • TMF Consultant

    Jessica Green

    11 years of experience 0 projects USA Research & Development
    TMF system (VV and TI) training development and process improvements AdministrationClinical OperationsRegulatorySafety & Pharmacovigilance Change controlComplianceConfigurationContent ManagementData migrationDocument QCEDMSImplementationMS OfficeMS WordPatient narrativesPharmacovigilanceProcess developmentProgram ManagementProject managementRecords ManagementSafety Case ProcessingSafety Patient NarrativesSOP development and writingTemplatesTMF Reference ModelTrackwiseTraining developmentTraining execution/managementTraining plansTransperfect Trial InteractiveTrial Master File ProcessingTrial Master File remediationVeeva Quality VaultVeeva TMF VaultVeeva VaultVendor ManagementVendor oversight and management
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    Hello,

    I am Jessica Green. Owner of Crystalline Pharmacare, LLC. I am just starting my journey of independent consulting. I have 5 years experience in Safety and 10 years experience in TMF. In Safety I was a case processor and then moved on to write narratives. During my time in Safety I found my love of improving processes. In TMF, I started as a TMF Lead, managing projects and TMF Health. I spent my last 5 years creating and implementing…

  • Assistant Professor

    Charles Williams

    20 years of experience 0 projects USA Research & Development
    Pre-INDZebrafish Pharmbio Start Up Academic experienceAssay developmentAssay validationBiochemistryBiopharm Start UpCardiovascularCell BiologyCollaboration technologiesData scienceDiscoveryDrugDrugDevEHR/EMRFeasibilityGenetic diseaseGrant Writingliterature searchesManuscriptsMicrosoft WordMolecular BiologyMS OfficeMS WordOrganoidsOrganoids/TumoridsPre-INDPublicationsRare diseaseResearchTraining developmentTraining execution/managementTraining plans
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    Assistant professor with multiple patients well versed in tech transfer and business management and pre-IND drug discovery/development.  Phenotype Evangelist,

  • LifeSciHub, LLC

    0 years of experience 0 projects USA Research & Development
    Administration Administrative
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    help for bookkeeping and quickbooks

  • Jeanette Towles

    0 years of experience 0 projects Research & Development
  • Communications Project Manager

    Carrie Leonard

    10 years of experience 0 projects USA Market Research, Research & Development
    Project management Project management
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    General Manager and Visionary Pace-Setter with progressive experience delivering incredible growth results for companies ranging from entrepreneurial start-ups to global Fortune 500 enterprises. Careerlong record of success launching new products, crafting compelling brand stories, building best-inclass business development functions, innovating new marketing and sales vehicles, and facilitating multimillion-dollar M&A transitions and exits. Incredibly diverse career includes both senior marketing and sales experience at life sciences, technology, financial services, luxury, and major media companies.

  • Researcher, Writer, Expert

    Bharathi Hattiangady, Ph.D

    19 years of experience 0 projects USA Research & Development
    CNSPublicationsRegulatory & Medical WritingToxicology
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    §  A team player with ability to perform a deep literature search and understand complex scientific topics, enthusiastic collaborator experienced in setting strategies, meeting deadlines and milestones to reach ambitious goals as evidenced by successful completion and delivery of NIH, DOD and VA funded projects and multiple collaborative projects.

    §  Expertise in writing manuscripts, study reports, IACUC and IRB protocols and driving the document review process from start to…

  • Science, Business and Patient Outcomes Expert

    Chirag Kariya, PhD

    15 years of experience 0 projects USA Market Research, Research & Development
    Clinical OperationsCommercialMarket StrategyMedical AffairsModerating / interviewingPharmbio Start UpProject managementRecruiting AdministrativeAlliance ManagementBiopharm Start UpBudget planning & managementBusiness IntelligenceClinicalClinical contractsClinical development planClinical OperationsClinical Program ManagementClinical Trial ManagementCorporateDue DilligenceKOL LiaisonMarket researchMedical AffairsNonclinicalOncologyPre-INDShared Investigator PlatformSmall pharma experienceToxicologyVendor oversight and managementWomen's health
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    Life sciences professional with an entrepreneurial mindset and experience in supporting scientific and business needs. Experience in managing preclinical and clinical drug development programs. Demonstrated strength in proactively identifying business opportunities and facilitating strategic partnerships and collaborations with stakeholders in the industry, academia, and government. Adept at implementing business strategies, conducting due diligence, and developing solutions to resolve challenges. Passionate about working at the intersection of science and business to improve patient outcomes.

  • Rong Wang

    0 years of experience 0 projects Research & Development
    Regulatory Regulatory Affairs and Strategy
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    A small, Arizona based sponsor currently in Phase II with a leading candidate in oncology, among others, looking to explore with FDA their Phase II as a transformational trial, protocol amendment/s, etc. as they move towards study start up.

  • Study Start Up Expert

    Swadesh Sharma

    25 years of experience 0 projects USA Market Research, Research & Development
    Clinical OperationsLife Sciences IT Clinical OperationsClinical Trial ManagementFeasibilityLife Sciences ITMonitoringRegulatoryScreeningStudy start up
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    A proven operational leader who offers a record of success in introducing strategies that drive growth, define short-and  long-term  strategic  vision,  and  create  a  positive  company image.  Builds productive internal and external relationships to advance corporate revenue  achievements,  while delivering significant time  and cost savings. Hires, trains, mentors, and leads teams across multiple disciplines.

  • Medical editing and content

    Lyra Fiske

    19 years of experience 0 projects USA Research & Development
    Scientific content editing CommercialMedical Affairs EditingMedical Affairs
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    Medical editing and content management system experience

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