Katie McGuire

Clinical Trials - Oncology

Clinical Trial Trends Late Phase Oncology

Clinical Trials - Oncology

Clinical Trial Trends: Antibody-Drug Conjugates

Clinical Trials - Oncology - Rare Diseases

Clinical Trial Trends: Early Phase Rare Oncology 

Clinical Trials

Custom FSP Models That Help Biotechs Scale Smarter

Manufacturing

Chevron Deference: A New Era for Biotech

Clinical Trials

Protocol Study Design: Bridging Clinical Goals with Patient Needs

Translational Research - Biomarkers - Assays

Optimizing Immunohistochemistry Validation and Regulatory Strategies

Expediting Clinical Trial Study Start-up in Australia

Clinical Trials

Rescuing a Complex Hematology Oncology Trial: Case Study in Precision

Clinical Trials

Lean Authoring: Bringing Efficiency and Speed to Clinical Study Reports

Clinical Trials - Regulatory

What Is an FDA Breakthrough Therapy Designation?

Clinical Trials - Translational Research

Women Leaders Share Raw Truths About Leadership in Life Sciences

Manufacturing

Challenges & Opportunities in Cell and Gene Therapy

Clinical Trials - Oncology

How European Oncology Site Networks Streamline Clinical Trial Site Selection

Clinical Trials - Early Phase Research - Oncology

Clinical Trial Trends: Early Phase Oncology

Clinical Trials - Oncology

The Dose Dilemma: Lessons from Sotorasib and the Future of Oncology Drug Optimization

Clinical Trials - Oncology

Why Antibody-Drug Conjugates Are Revolutionizing Precision Oncology

Regulatory - Gene Therapies

Therapeutic Genome Editing – Reshaping the Landscape of Advanced Therapies

Clinical Trials - Oncology

Clinical Trial Trends: Non-Hodgkin’s Lymphoma

Manufacturing

US Crackdown on Chinese Clinical Trials: What’s at Stake for Biopharma?

Clinical Trials

Safety isn’t a Milestone but a Mindset in Clinical Research

Manufacturing

Will BIOSECURE Boost US Pharma?

Clinical Trials

Advancing Equity in Clinical Trials: Unpacking the FDA’s Diversity Guidance

Clinical Trials

Case Study: Effective Management of a Rescue Study

Clinical Trials - Oncology

Case Study: A Double Rescue in Advanced Solid Tumor Clinical Trials

Clinical Trials

How South Korea Became a Leading Destination for Clinical Trials

Translational Research - Biomarkers - Assays

Immunohistochemistry in Precision Medicine: From Biomarker to Clinical Trial Assay

Manufacturing

The Bottom Line on Chevron's Overturn

Clinical Trials - Oncology

Clinical Trial Trends: Multiple Myeloma

Oncology - Rare Diseases

Clinical Trial Trends: Rare Oncology vs Non-Oncology

Clinical Trials

AI's Role in Reshaping Drug Development: FDA Workshop Recap

Oncology

Clinical Trial Trends: Ovarian Cancer

Rare Diseases

Lessons Learned from a Rare Pediatric Case Study

Clinical Trials

Inside a CRO: Operational Strategy and Excellence

Oncology - Cell Therapies

FDA Approves Breakthrough Cell Therapy for Synovial Sarcoma

Regulatory - Oncology

FDA ODAC Vote: Key Changes for Perioperative Cancer Trials

Clinical Trials - Oncology

Top Clinical Research Organizations for Oncology in 2024

Manufacturing

Perspectives on the Future of the BIOSECURE Act

Manufacturing

Bracing for Impact of BIOSECURE Act

Rare Diseases

Clinical Trial Trends: Rare Cardiovascular

Rare Diseases

Clinical Trial Trends: Rare Autoimmune

Rare Diseases

Clinical Trial Trends: Rare Oncology

Rare Diseases

Clinical Trial Trends: Rare Metabolic

Clinical Trials - Oncology

Clinical Trial Trends: Radiopharmaceuticals

Rare Diseases

Clinical Trial Trends: Rare Pediatric

Translational Research - Lab Services - Biomarkers

Protein Assays: Choosing the Most Effective Method for Biopharmaceutical Development

Clinical Trials

Clinical Trial Trends: Rare CNS

Oncology

Case Study: Streamlining Radiopharmaceutical Clinical Trials

Regulatory

Navigating Site Activation Strategy Under the EU Clinical Trials Regulation

Clinical Trials - Regulatory

Considerations for Your Pre-IND Meeting With the FDA

Translational Research - Biomarkers - Rare Diseases

Precision Medicine in Pediatrics: Biomarkers and Assay Development

Regulatory - Oncology

FDA Draft Guidance Encourages Broader Inclusion Criteria in Oncology Trials

Manufacturing

When Should Biopharma Companies Buy, Partner or Develop Innovative Assets?

Manufacturing

Strategic Portfolio Management in Cell and Gene Therapy: Keys to Growth and Impact

Translational Research

Companion Diagnostics: Key Considerations for Registrational Studies and Effective Co-Development with Therapeutics

Clinical Trials - Oncology

Optimizing Investigator Databases for Oncology Trial Enrollment

Manufacturing

Why Smaller M&A Deals Boost Biopharma Growth

Clinical Trials - Oncology

Case Study: AML Phase 1-2 Trial

Manufacturing - Cell Therapies - Gene Therapies

Navigating Cell and Gene Therapy Acquisitions: A Strategic Blueprint

Clinical Trials - Oncology

Why Select a Specialized Oncology CRO?

Clinical Trials - Oncology

Clinical Trial Trends: Acute Myeloid Leukemia (AML)

Manufacturing

Patient-Focused Precision Manufacturing

Clinical Trials

Leveraging Australian R&D Tax Credit Program

Clinical Trials

Administering Event-Driven Clinical Trials: A Biostatistical Analysis

Clinical Trials

Streamlining Clinical Trials in an Age of Complexity: Insights from Sofia Baig

Clinical Trials

Inside a CRO: The Impact of a Biostatistician in Clinical Research

Clinical Trials - Oncology

Clinical Trial Trends: Breast Cancer

Clinical Trials

Strategies to Elevate Your Study at Saturated Sites

Translational Research - Gene Therapies

Companion Diagnostics: Strategies for Biomarker Development and Early Phase Clinical Studies

Clinical Trials - Cell Therapies

Clinical Trial Trends: Cell Therapies

Translational Research - Gene Therapies

8 Best Practices for Immunogenicity Assay and Companion Diagnostic Development in AAV Gene Therapy

Manufacturing

Biopharma Manufacturing and Supply: Where Experts Predict We’re Headed

Clinical Trials - Regulatory - Early Phase Research

Inside a CRO: The Critical Role of Regulatory and Startup Specialists in Clinical Research

Clinical Trials - Oncology

Case Study: International Phase 1 Non-small Cell Lung Cancer (NSCLC) Trial

Clinical Trials - Oncology

Clinical Trial Trends: Non-small Cell Lung Cancer (NSCLC)

Translational Research - Biospecimens - Data Intelligence

Empowering Clinical Operations with Enhanced Biospecimen Lifecycle Management

Clinical Trials

Inside a CRO: Essential Insights from Medical Monitoring

Regulatory

Unpacking FDA’s Draft Guidance on Psychedelic Research for Clinical Success

Clinical Trials

Inside a CRO: The Pivotal Role of Clinical Trial Manager in Clinical Research

Clinical Trials

Best Practices for Biostatisticians: Preparing for Interim Analysis in Clinical Trials

Clinical Trials - Early Phase Research - Rare Diseases

Clinical Trial Patient Recruitment: Why Concierge Services are a Game-Changer

Clinical Trials - Early Phase Research

CROs in Clinical Trials: Keys to Successful Sponsor-CRO Partnerships

Clinical Trials - Translational Research - Regulatory

Conducting Pediatric Studies: Addressing Ethical and Clinical Challenges

Clinical Trials - Early Phase Research - Oncology

Phase I Clinical Trial Designs: Backfill i3+3 (Bi3+3)

Clinical Trials - Oncology

Driving Oncology Trial Execution with Novel Data-Driven Approaches to Site and Patient Identification

Clinical Trials - Regulatory

Case Study: An Advanced Approach to Integrated Summary of Safety Studies

Clinical Trials - Data Intelligence

Inside a CRO: The Critical Role of Clinical Data Managers in Clinical Research

Clinical Trials

Inside a CRO: The Essential Role of a Clinical Project Manager

Manufacturing - Cell Therapies - Gene Therapies

Scaling Hope: The Growth of Allogeneic Cell Therapy Sector

Clinical Trials

Phase III Case Study: Adapting in the Face of Adversity

Translational Research

High-Quality Biospecimens in Therapeutic & Diagnostic Development: A Comprehensive Guide from Concept to Cloud

Clinical Trials - Regulatory

Controlled Substances in EU Clinical Trials

Clinical Trials

Incorporating Decentralized Clinical Trial Strategies into CNS Studies

Clinical Trials - Regulatory - Rare Diseases

FDA Guidance on Pediatric Drug Development

Oncology - Cell Therapies

Navigating the Complex Ecosystem of Cell Therapy Clinical Trials

Clinical Trials - Regulatory - Rare Diseases

Overcoming Hurdles in Rare Disease Research and Development

Translational Research - Biomarkers - Assays

Choosing the Optimal Sample Type for Flow Cytometry: Key Considerations and Case Studies

Clinical Trials - Regulatory - Oncology

FDA Accelerated Approval for Oncology Therapeutics: Clinical Trial Considerations

Translational Research

Methods for a Comprehensive Characterization of the Tumor Microenvironment

Clinical Trials - Rare Diseases

Decentralized Clinical Trials: Strategies that Work in Rare Diseases

Translational Research - Biomarkers - Assays

Moving from Exploratory to Clinical Flow Cytometry Assays: 3 Critical Considerations

Clinical Trials - Manufacturing - Gene Therapies

Next in Gene Therapy: Trends, Innovations, and Challenges

Clinical Trials

Centralized vs Decentralized Raters: When to Use Which in CNS Trials?

Clinical Trials - Early Phase Research - Oncology

Optimizing Inclusion and Exclusion Criteria in Early Phase Oncology Clinical Trials

Translational Research

Guiding Precision Medicine with Liquid Biopsy: Circulating DNA vs Circulating Tumor Cells

Manufacturing - Cell Therapies - Gene Therapies

Cell & Gene Day 2023

Translational Research - Biomarkers - Assays

Harnessing the Power of Flow Cytometry in Biomarker-Driven Clinical Trials

Clinical Trials

Pros and Cons: Innovative Study Designs vs. Traditional FIH

Clinical Trials

Overview: Innovative Study Designs vs. Traditional FIH

Clinical Trials - Early Phase Research - Oncology

Phase I Clinical Trial Designs: Modified Toxicity Probability Interval

Clinical Trials - Early Phase Research - Oncology

How Biomarkers Impact Clinical Trial Study Start-up

Clinical Trials - Biomarkers

Advancing the Use of Biomarkers in CNS Drug Discovery and Development

Translational Research

Precision for Medicine Selected as an Akoya Biosciences Certified Partner for Multiplex Immunofluorescence Tissue Profiling

Translational Research

How Translational Central Lab Services Facilitate Creative Solutions for Biomarker-Driven Studies

Clinical Trials - Regulatory - Oncology

Five Considerations for Global Phase 3 Trials in Oncology

Using electronic patient-reported outcome (ePRO) technology to address key challenges in CNS trials

Clinical Trials

Leveraging German R&D Tax Credit Program

Clinical Trials

Leveraging Canadian R&D Tax Credit Program

Clinical Trials

R&D Tax Incentive Program Support

Clinical Trials

Leveraging French R&D Tax Credit Program

Clinical Trials - Oncology

Increased Complexity and Therapeutic Combinations Pave the Way in Immuno-oncology

Critical Strategies for Patient Advocacy Collaboration in Rare Disease Clinical Trials

Clinical Trials - Rare Diseases

FDA Procedural Guidance: Expansion Cohorts in FIH Oncology Clinical Trials

Clinical Trials - Early Phase Research - Oncology

Phase 1/2 Combination Studies: Best Practices When Moving from Escalation to Expansion

Translational Research

Maximizing the Scientific Value of Tissue Biomarker Analysis: Case Studies in Immuno-Oncology and Dermatology

Clinical Trials - Oncology

Taking the Right Approach to Data Integrity in Rescue Studies

Clinical Trials

Key Considerations for Selecting a CRO Partner

Translational Research

Characterizing a Central Switch of Immune Suppression: Monitoring Treg Cells in Clinical Studies

Clinical Trials

Leveraging UK R&D Tax Credit Program

Clinical Trials

Why Caregivers Are the Key to Patient-Centric Clinical Trials

Clinical Trials - Regulatory

5 Considerations for Managing DEA-Controlled Substances in CNS Clinical Trials

Clinical Trials

Effectively Managing Rater Training and Consistency in CNS Trials

Translational Research

Developing an Immunohistochemistry Assay for Human Spermine Oxidase to Evaluate Human Cancer Tissues

Biomarkers - Oncology - Rare Diseases

Streamlining Recruitment in Biomarker-driven Oncology and Rare Disease Studies

Clinical Trials - Oncology

Breast Cancer Clinical Research Trends According to Citeline Data (JAN 2017–OCT 2022)

Clinical Trials - Biomarkers

Shifting the Paradigm in Personalized Medicine Clinical Trials

Clinical Trials - Early Phase Research - Rare Diseases

Leveraging genetic laboratories in rare disease patient identification

Clinical Trials

Best Practices for Database Transfer in a Rescue Study

Clinical Trials

Transitioning a Rescue Study: Data Management Considerations

Clinical Trials

Improving Data Quality with Clinical Science Analytics & Insights

Translational Research

Advancing Clinical Development of Immuno-modulatory Therapies with Flow Cytometry-Based Receptor Occupancy Assays

Clinical Trials - Cell Therapies

Current Trends in Cell Therapy According to Citeline Data (JAN 2017–AUG 2022)

Translational Research - Gene Therapies

Monitoring Immune Responses in Gene Therapy Clinical Trials Using ELISpot

Clinical Trials - Gene Therapies

Current Trends in Gene Therapy According to Citeline Data (JAN 2017–AUG 2022)

Translational Research

Solving the Unique Central Lab Services Challenges of Precision Medicine Trials

Translational Research

Using Epigenetic Immunophenotyping to Explore Potential Biomarkers in Hepatocellular Carcinoma

Clinical Trials - Early Phase Research

Technologies Advancing Patient Identification, Site Selection and Clinical Trial Recruitment