Selected references for further in-depth reading are provided with first author and title, including a link to the publisher site. In the case that the PDF is available, a link is provided as well.

CLINICAL TRANSLATIONAL PHARMACOLOGY AND ITS EVOLUTION

• Miller RR. History of clinical pharmacy and clinical pharmacology
• Sjöqvist F. The past, present and future of clinical pharmacology
• Aronson, J.K. Clinical Pharmacology: Past, Present, and Future (PDF)
• Dollery CT. Clinical pharmacology – the first 75 years and a view of the future (PDF)
• Waldman SA. Clinical Pharmacology & Therapeutics: Past, Present, and Future (PDF)
• Zineh I. What's Past Is Prologue: Clinical Pharmacology at the Intersection of Science, Policy, and Patients (PDF) 
• ASCPT’s History: ASCPT History
• FDA’s CDER History: A Brief History of the Center for Drug Evaluation and Research | FDA
• Critical Path Initiative Background: Challenge and Opportunity on the Critical Path to New Medical Products
• Critical Path Initiative Opportunity list: Critical Path Opportunities List

TRANSLATIONAL SCIENCE, BIOMARKERS, NOVEL MODALITIES & PRECISION MEDICINE

• Wagner JA. The Future of Translational Medicine: Accelerating Open Convergence (PDF)
• Satam H. Next-Generation Sequencing Technology: Current Trends and Advancements (PDF)
• Pacanowski M. Precision Medicine 2030 (PDF)
• Peck RW. Precision Dosing: An Industry Perspective (PDF)
• Tyson RJ. Precision Dosing Priority Criteria: Drug, Disease, and Patient Population Variables (PDF) 
• Pacanowski M. A Multistakeholder Perspective on Advancing Individualized Therapeutics (PDF)
• Naik K. Current Status and Future Directions: The Application of Artificial Intelligence/Machine Learning for Precision Medicine (PDF)
• Darwich AS. Model-Informed Precision Dosing: Background, Requirements, Validation, Implementation, and Forward Trajectory of Individualizing Drug Therapy (PDF) 
• Choi Y. Novel Therapeutic Modalities: The Future is Now (PDF)
• Mody H. Best Practices and Considerations for Clinical Pharmacology and Pharmacometric Aspects for Optimal Development of CAR-T and TCR-T Cell Therapies: An Industry Perspective (PDF)
• Mitra A. Model-Informed Approaches and Innovative Clinical Trial Design for Adeno-Associated Viral Vector-Based Gene Therapy Product Development: A White Paper (PDF)
• Abdelhady AM. Clinical Pharmacology and Translational Considerations in the Development of CRISPR-Based Therapies (PDF)
• Zhou J. Model-Informed Drug Development Applications and Opportunities in mRNA-LNP Therapeutics (PDF)
• Ribba B. Digital Therapeutics as a New Therapeutic Modality: A Review from the Perspective of Clinical Pharmacology (PDF)
• Benefits and Risks of New Drug Modalities | BCG
• In 2023, Personalized Medicines Topped One Third of New Drug Approvals for Fourth Year in a Row - The Personalized Medicine Coalition
• Table of Pharmacogenomic Biomarkers in Drug Labeling | FDA

CLINICAL RESEARCH

• Shahin MH. The Patient-Centered Future of Clinical Pharmacology (PDF)
• Park JJH. Systematic review of basket trials, umbrella trials, and platform trials: a landscape analysis of master protocols (PDF).
• Papachristos A. Dose Optimization in Oncology Drug Development: The Emerging Role of Pharmacogenomics, Pharmacokinetics, and Pharmacodynamics (PDF)
• Korn EL. Dose optimization during drug development: whether and when to optimize
• Nikanjam M. At the right dose: personalised (N-of-1) dosing for precision oncology (PDF)
• Maass KF. Leveraging patient-centric sampling for clinical drug development and decentralized clinical trials: Promise to reality (PDF)
• Zhu R. Clinical Pharmacology Applications of Real-World Data and Real-World Evidence in Drug Development and Approval-An Industry Perspective (PDF)
• Kluwe F. Perspectives on Model-Informed Precision Dosing in the Digital Health Era: Challenges, Opportunities, and Recommendations (PDF)
• Dibbets AC. Barriers and Facilitators for Bringing Model-Informed Precision Dosing to the Patient's Bedside: A Systematic Review (PDF)
• CDER Patient-Focused Drug Development | FDA
• FDA In Brief: FDA Takes New Steps Aimed at Advancing Development of Individualized Medicines to Treat Genetic Diseases | FDA

QUANTITATIVE MEDICINE

• Morgan P. Can the flow of medicines be improved? Fundamental pharmacokinetic and pharmacological principles toward improving Phase II survival 
• Milligan PA. Model-based drug development: a rational approach to efficiently accelerate drug development (PDF)
• Mentré F. Pharmacometrics and Systems Pharmacology 2030 (PDF)
• Nayak S. Getting Innovative Therapies Faster to Patients at the Right Dose: Impact of Quantitative Pharmacology Towards First Registration and Expanding Therapeutic Use (PDF)
• Gupta N. Transforming Translation Through Quantitative Pharmacology for High-Impact Decision Making in Drug Discovery and Development (PDF)
• Cucurull-Sanchez L. An industry perspective on current QSP trends in drug development (PDF)
• Neves-Zaph S. Quantitative Systems Pharmacology Models: Potential Tools for Advancing Drug Development for Rare Diseases (PDF)
• Terranova N. Artificial Intelligence for Quantitative Modeling in Drug Discovery and Development: An Innovation and Quality Consortium Perspective on Use Cases and Best Practices (PDF)
• Kaddi C. Quantitative Systems Pharmacology-Based Digital Twins Approach Supplements Clinical Trial Data for Enzyme Replacement Therapies in Pompe Disease (PDF)
• Shahin MH. Agents for Change: Artificial Intelligent Workflows for Quantitative Clinical Pharmacology and Translational Sciences (PDF)
• Foundational Research Gaps and Future Directions for Digital Twins | The National Academies Press 

GLOBAL HEALTH

• Blaschke TF. The World Health Organization Prequalification Program and Clinical Pharmacology in 2030 (PDF)
• Wenning L. Clinical Pharmacology Worldwide: A Global Health Perspective (PDF)
• McNair D. Use of RWE to Inform Regulatory, Public Health Policy, and Intervention Priorities for the Developing World (PDF)
• Sawant-Basak A. Role of Clinical Pharmacology in Diversity and Inclusion in Global Drug Development: Current Practices and Industry Perspectives: White Paper (PDF)

EDUCATION

• Brouwer KLR. Clinical Pharmacology Education - The Decade Ahead (PDF)
• What is Clinical Pharmacology
• What is Translational Science
• Translational Science Principles | National Center for Advancing Translational Sciences (NCATS)
• Core Competencies in Clinical and Translational Research (ITHS)