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Lead Editorial

Eisai’s SVP of Biostatistics on the Bayesian Trial for Early Alzheimer’s Disease

Eisai’s SVP of Biostatistics on the Bayesian Trial for Early Alzheimer’s Disease

Eisai’s Bayesian Phase IIb study dose-ranging lecanemab led to the design of the Phase III Clarity AD trial to verify the drug’s clinical efficacy and safety in early Alzheimer’s Disease. Shobha Dhadda, SVP of Biostatistics and clinical development operations for Neurology at Eisai, describes the unique hurdles that accompany Bayesian designs.

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Featured Editorial

Wake Forest on Building Community Trust

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Astellas Pharma on Next Steps for Patient Engagement in Pharma

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MGH Cancer Center Breaks Down the T Cell to Better Understand Immuno-Oncology

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Exosome Delivery: The Past and Future

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Editorial by Category

Clinical Trial Operations

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Sponsors are Making Headway with Sites, but Blind Spots and Burdens Remain
Sponsors are Making Headway with Sites, but Blind Spots and Burdens Remain
The Operations Behind the First ALS Platform Trial, at Massachusetts General Hospital
The Operations Behind the First ALS Platform Trial, at Massachusetts General Hospital
Why Innovative Trial Designs Matter, with Janssen
Why Innovative Trial Designs Matter, with Janssen

Immuno-Oncology and Cell Therapy

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UPenn's Dr Bruce Levine on Advancements in Cell Therapy Manufacturing
UPenn's Dr Bruce Levine on Advancements in Cell Therapy Manufacturing
How the NYU Genome Center is Making Better Cell Therapies
How the NYU Genome Center is Making Better Cell Therapies
Developing MSK's First Gene Transfer Clinic, Expediting Cell Therapy
Developing MSK's First Gene Transfer Clinic, Expediting Cell Therapy
Finding Career Fulfillment Working in Immune Diagnostics
Finding Career Fulfillment Working in Immune Diagnostics

Drug Delivery

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Partnering Advice from the Eli Lilly Genetic Medicines Search & Evaluate Team Lead
Partnering Advice from the Eli Lilly Genetic Medicines Search & Evaluate Team Lead
Bringing the User Experience to Drug Delivery Devices – An Untapped Opportunity For Pharma
Bringing the User Experience to Drug Delivery Devices – An Untapped Opportunity For Pharma
How AstraZeneca is Solving Delivery Challenges for mRNA Therapies
How AstraZeneca is Solving Delivery Challenges for mRNA Therapies
How Chiesi Evaluates Cell & Gene Delivery Technologies
How Chiesi Evaluates Cell & Gene Delivery Technologies

Patients as Partners in Clinical Research and Patient Access

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Novartis’ Bold Vision to Change How the Entire Sector Engages Patients
Novartis’ Bold Vision to Change How the Entire Sector Engages Patients
How Pfizer Builds Patient Centricity Across the Entire Company
How Pfizer Builds Patient Centricity Across the Entire Company
Parexel’s First Patient Ambassador on Being a Voice for Patients
Parexel’s First Patient Ambassador on Being a Voice for Patients
Centering the Patient in Plasma-Based Therapy Development at Takeda
Centering the Patient in Plasma-Based Therapy Development at Takeda

Biotech CMO/R&D Leadership

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How Simulation-Guided Trial Design Can Take Predictions of Your Drug For a More Optimized Clinical Trial Design
How Simulation-Guided Trial Design Can Take Predictions of Your Drug For a More Optimized Clinical Trial Design
How Biotech CMOs Can Prepare for M&A with Pharma
How Biotech CMOs Can Prepare for M&A with Pharma
CEO Perspective on Ensuring a Successful Merger
CEO Perspective on Ensuring a Successful Merger
The Role of the CMO in Successful Biotech-Pharma Partnerships
The Role of the CMO in Successful Biotech-Pharma Partnerships

CRAACO: Clinical Research as a Care Option

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How Duke Is Improving Clinical Research Workforce Retention
How Duke Is Improving Clinical Research Workforce Retention
Investing in Patient and Physician Engagement to Improve Access to Clinical Research
Investing in Patient and Physician Engagement to Improve Access to Clinical Research
How Merck is Increasing the Representation of Diverse Patient Participants and Clinical Staff
How Merck is Increasing the Representation of Diverse Patient Participants and Clinical Staff
Johns Hopkins Works to Make Clinical Research as Reality for Community Physicians
Johns Hopkins Works to Make Clinical Research as Reality for Community Physicians

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