From Bench to Bedside and Beyond: Shaping the Future of Early-Phase Clinical Pharmacology at CPDD

Abstract

It is with both gratitude and enthusiasm that I assume the role of editor-in-chief for Clinical Pharmacology in Drug Development (CPDD), one of the 2 premier translational journals of the American College of Clinical Pharmacology (ACCP). CPDD occupies a distinctive place in scientific publishing, focusing on the practical applications and translational nature of clinical pharmacology and grounded in the values of scientific practice, mentorship, and integrity that define the ACCP community.

As the landscape of drug development grows increasingly complex—shaped by emerging therapeutic modalities, integration of real-world evidence, artificial intelligence (AI), and precision medicine, our journal has a vital role to play. We are uniquely positioned to be the publishing home for translational clinical pharmacology research, first-in-human studies, drug-drug interaction assessments, negative early-phase studies, modeling and simulation, regulatory science innovations, and more. Our vision is to be the premier forum for practical advances in clinical pharmacology—widely read, frequently cited, and globally recognized.

We are committed to building upon the strong foundation established by our founding editor, Dr David Greenblatt, along with the dedicated Editorial Board and team who have elevated CPDD to its current stature as a leading journal in the field.

I am delighted to extend a warm welcome to our new associate editors, Dr Michael Fossler and Dr Vijay Upreti, both of whom are highly respected authorities in clinical pharmacology. Their expertise and leadership will be invaluable as we work together to advance the journal's mission.

Our Editorial Board is composed of distinguished leaders in the field who play a crucial role in shaping the direction of the journal. They provide expert guidance, collaborate in identifying timely and impactful content, and dedicate their time to the thorough review of manuscripts, ensuring the highest standards of scholarly excellence.

A key member of our editorial team, Managing Editor Angelique Ly, brings exceptional organizational skills to the journal's daily operations. She ensures a smooth peer-review process and fosters effective communication among authors, reviewers, and editors, all while maintaining the journal's commitment to excellence and integrity. Her dedication is crucial to CPDD’s ongoing success.

I look forward to a productive and collaborative partnership with this outstanding team.

CPDD has long stood apart by offering a practical, translational focus on early clinical studies and the application of pharmacologic science in the development of new therapeutics. A hallmark of CPDD is our commitment to publishing methodologically sound, innovative, and relevant research—including negative or inconclusive early-phase trial results. By sharing these often-overlooked findings, we contribute valuable lessons and a more comprehensive understanding to the broader scientific community, ultimately accelerating progress in drug development and clinical care. Our core mission remains unchanged: to provide timely, accurate, and accessible insights that bridge the preclinical-clinical interface, advance the design of early-phase trials, and provide valuable negative or inconclusive data to guide regulatory and therapeutic decision making.

But the contours of this mission are evolving.

Where once clinical pharmacology was grounded in traditional pharmacokinetic/pharmacodynamic models and empirical dose finding, today it is interwoven with computational modeling, digital biomarkers, and AI-driven analytics. It is no longer sufficient to describe a drug's behavior in isolation—we must now characterize it in the context of complex, multidimensional data spanning genomics, behavior, environment, and clinical outcomes.

Our journal must adapt to reflect these changes while remaining true to our core purpose.

The clinical pharmacology toolbox is expanding, and so is our editorial scope. We are at the threshold of a new era in drug development, defined by advanced analytics, integrated data sets, and model-driven approaches.

AI is being harnessed to model pharmacokinetics, predict adverse events, optimize trial protocols, and mine real-world data. At CPDD, we are committed to becoming a home for robust, transparent, and reproducible novel applications of AI/machine learning in early-phase drug development. We will prioritize papers that go beyond simply novelty to demonstrate how new AI/machine learning models enhance decision making in real-world drug development scenarios. We also recognize the importance of ethics, transparency, and validity in this space. As such, we will be introducing updated author guidelines to ensure that AI-based submissions are accompanied by clear descriptions of data sets, algorithms, and validation processes.

Model-informed drug development has moved from a niche methodology to a central tool for regulatory and industry strategies. We will continue to welcome high-quality research that applies population modeling, physiologically based pharmacokinetic modeling, and quantitative systems pharmacology to inform clinical and regulatory decisions.

Advances in pharmacogenomics, molecular diagnostics, and biomarker science are enabling personalized therapeutic strategies. CPDD will invite work that elucidates the pharmacologic underpinnings of individualized treatment—whether through genotype-informed dosing, patient stratification strategies, or early-phase trials in targeted subgroups.

As the ways in which readers consume science evolve, so too must the way we present it. CPDD will adopt new formats and tools to make our content more discoverable and engaging. A few of the innovations we have in mind include:

Graphical and video abstracts: Select articles will feature enhanced summaries to increase visibility and understanding, particularly for multidisciplinary readers.

Special theme issues on emerging topics: Planned thematic issues will focus on AI in pharmacology, regulatory innovation, negative early-phase trials, clinical trial decentralization, international early-phase drug development, global harmonization, and many more.

We will amplify the voice of CPDD’s burgeoning international community, spotlighting submissions that exemplify our expansive global impact.

As a fellow of ACCP, I have witnessed the College's long-standing dedication to mentorship and education. In alignment with ACCP's mission, CPDD will launch a series of initiatives to support early-career professionals:

Early career in-training Editorial Board: An inaugural group of early-stage professionals (eg, post-docs, junior faculty, early-stage industry and regulatory professionals) will join the editorial process—learning firsthand about peer review, editorial decision making, and scientific publishing.

Rising star author recognition: Each year, we will highlight top first-author papers by early-career scientists in a special CPDD feature.

Educational features: We will collaborate with ACCP committees and our sister journal, The Journal of Clinical Pharmacology (JCP), to publish review articles, primers, and tutorials on emerging topics (eg, regulatory pathways, pharmacometrics, trial design) that support career-long learning and professional development.

These initiatives will ensure that CPDD is not only a platform for established experts but also a launchpad for the next generation of clinical pharmacologists.

As editor-in-chief, I see this journal not merely as a publication but as a vibrant community—a community of clinicians, scientists, pharmaceutical industry developers, regulators, educators, and trainees, all united by a shared commitment to advancing the safe, effective, and rational use of therapeutics.

That vision is deeply aligned with the ACCP's own values and strategic plan, and it will guide every decision we make in the years ahead.

As we embark on this new chapter, I extend an open invitation to our readers, authors, reviewers, and colleagues: Help us shape the future of CPDD. Whether you are a long-time contributor or a first-time author, your voice, insights, and science matter. Submit your best work. If you are conducting innovative early-phase research, CPDD is your journal. Join us as a reviewer. We need your expertise to maintain high-quality peer review and support growing submissions. Propose ideas for special issues. Share your insights and perspectives, and help us foster a journal that is rigorous, responsive, and relevant to the challenges and opportunities of 21st-century drug development.

CPDD’s success is built on the dedication and innovation of our contributors, reviewers, and readers. Your research, your feedback, and your passion are what drive our field forward. Together, we can make CPDD a global leader in applied clinical pharmacology—where innovation meets integrity and science meets impact.

On behalf of the entire editorial team and the ACCP, I thank you for your continued support. I look forward to working with each of you in the exciting years ahead.

The author declares no conflict of interest.

No funding was obtained for this work.