Your Milestone, Our Mission

D2V Clinical is the early oncology, hematology and rare disease development partner for biopharmaceutical sponsors in the US and China. We are a full-service global CRO offering deep clinical development insight with world-class quality and investor value creation.

When it comes to oncology, hematology and rare disease drug development, we know what works – and what doesn’t.

As seasoned clinical drug developers, we’ve been in your shoes and have robust solutions for investor value creation.

Learn about our therapeutic experience

D2V Clinical leaders have been accountable for critical global development decisions and successful outcomes

80+

FDA Reviews

65+

Early-Phase Clinical Development Programs

5,700+

Patients

1,200+

Sites

Our Solutions

Powered by industry-leading technology combined with robust global expertise

Speed to

signal

pathway

patient

Leadership Team

Decades of experience paired with exceptional poise and oncology / rare disease knowledge

Amanda Fu, M.D., M.S., MBA

CO-FOUNDER AND CHIEF EXECUTIVE OFFICER

Walt Cao, Ph.D.

Co-Founder, President and Regulatory Officer

Vijay Reddy, M.D.

Chief Medical Officer

Jeffery Roe

Executive Vice President, Human Resources

Marwa Noaman

Clinical Operations Director

Amanda (Meng) Fu, M.D., M.S., MBA CO-FOUNDER AND CHIEF EXECUTIVE OFFICER

Amanda is the Co-founder and Chief Executive Officer of D2V Clinical. She brings to the position a passion for driving significant growth in global clinical development for oncology, hematology and rare disease. Amanda has extensive international management experience in strategy, corporate development, and strategic planning. In addition, she has more than 20 years of experience as an outstanding strategic group leader in clinical development and clinical strategy. She has planned and executed global clinical trials from Phase I - IV on four continents and in more than 30 countries.

From 2015 to 2019, Amanda served as Vice President of Clinical Development at 3D Medicine and Senior Clinical Operation Lead and Clinical Scientist in Oncology at MedImmune, where her focus on both clinical development and operations was invaluable. In 2015 she served in Project Management at Pharmacyclics, an AbbVie-owned company, and was the Clinical Surveillance Team Lead for INC Research from 2010 to 2015. From 2008 to 2010, she was Team Lead for GE Healthcare, Diagnostic Cardiology, and Clinical Research Site Director for Complete Healthcare for Women. In addition, Amanda was General Manager and head of Clinical Development at Gleneagles CRC in Beijing, China, from 2004 to 2008 and an attending physician at Beijing General Hospital from 2000 to 2002.

She earned her Medical Degree from Jilin University, Norman Bethune Medical School, in China, and her MS in Health Services Research and Technology Assessment from the University of Sheffield in Sheffield, UK. Amanda also earned an MBA from Ohio University.

Amanda (Meng) Fu, M.D., M.S., MBA

CO-FOUNDER AND CHIEF EXECUTIVE OFFICER

Xianhua (Walt) Cao, Ph.D., PRESIDENT AND REGULATORY OFFICER

Xianhua (Walt) Cao, Ph.D., is the founder and President of D2V Clinical, where he provides more than 20 years of experience in drug discovery and development in both the pharmaceutical industry and the U.S. Food and Drug Administration. During this time, he worked extensively with NME NDA/BLA applications and more than 500 IND Phase I-III clinical trial protocols. Additionally, he worked on drug development and marketing application for both new chemical entities and new biological entities. Walt has invaluable experience in cell and gene therapy, early-stage project optimization and clinical translation, translational sciences, clinical pharmacology, pharmacometrics, clinical study design, and global regulatory strategies for new drug marketing applications.

Walt served six years as Senior Clinical Pharmacologist for the FDA from 2013 to 2019. Previously, he served as Senior Scientist II/III at Abbot/AbbVie from 2010 to 2013 and Senior Scientist at Boehringer Ingelheim, from 2007 to 2010.

Walt earned his B.S. in Microbiology and Immunology from the Department of Microbiology and Immunology, School of Life Sciences, at Wuhan University in Wuhan, P.R. China. He also earned an M.S. in Microbiology from the Institute of Microbiology, Chinese Academy of Sciences, in Beijing, P.R. China, and a Ph.D. in Pharmaceutics at the Division of Pharmaceutics, School of Pharmacy, at Ohio State University in Columbus, OH.

Xianhua (Walt) Cao, Ph.D

CO-FOUNDER, PRESIDENT AND REGULATORY OFFICER

Vijay Reddy, M.D., Ph.D., CHIEF MEDICAL OFFICER

Vijay Reddy, MD, Ph.D., is the Chief Medical Officer of D2V Clinical.

Vijay has more than 25 years of clinical practice and biotechnology pharmaceutical industry experience in hematology, oncology and immuno-oncology. His background includes medical affairs leadership, clinical leadership of Phase I first-in-human trials for solid tumors, and the publication of more than 50 original research publications in high-impact peer-reviewed journals.

Vijay is responsible for medical oversight of protocol, site initiation, education and training of principal investigators; assessment of efficacy; data entry within D2V; development of study-specific manuals and plans; maintaining quality standards, support of all aspects of IRB/ERC and Regulatory Agency submissions; clinical input in interactions between the sponsor, the site and the FDA; and medical input internal audit and inspections.

Prior to his work with D2V, Vijay served as Vice President of Clinical Development for Actinium Pharmaceuticals from 2018 to 2022, Senior Medical Director of Medical Affairs at Pharmacyclics LLC from 2016 to 2018, Medical Director of Early Clinical Development for Medimmune, Astra Zeneca from 2015-2016, and Medical Director of Janssen Scientific Affairs for Johnson & Johnson from 2013 to 2015. He has served as a Professor in the College of Medicine at the University of Central Florida since 2012.

Vijay earned his M.B., B.S. (M.D. equivalent) from Madras Medical College in India and his Ph.D. in Immunology from the Memorial University of Newfoundland, St. John’s, in Newfoundland, Canada. He also attained Specialty Board Certification in Hematology from the American Board of Internal Medicine, Internal Medicine and Hematology Fellow of the Royal College of Physicians and Surgeons of Canada, and Internal Medicine from the American Board of Internal Medicine.

Vijay Reddy, M.D., Ph.D.

CHIEF MEDICAL OFFICER

Jill Loftiss, MHS, CHIEF DEVELOPMENT OFFICER

Jill Loftiss, MHS, is the Chief Strategic Officer at D2V Clinical. She brings more than 25 years of experience as an R&D Clinical Operations Leader in pharma, managing clinical operations specialists and clinical scientists. Over those two decades, Jill built a flexible, scalable outsource model with leading CROs to meet internal project demands and led teams to multiple successful BLAs, NDA, and sNDAs in Oncology.

Prior to joining D2V, Jill served as Director and Senior Director in Oncology Development at MedImmune/AstraZeneca from 2014 to 2020, where she was responsible for the execution of a diverse portfolio of immunomodulators, monotherapy, and novel-novel combinations, as well as other biological therapies. She also gained significant outsourcing expertise to manage a wide range of clinical CROs using the model she created. In addition, Jill spent 15 years with GlaxoSmithKline as Director of Global Clinical Operations in the Oncology Business Unit from 1999 to 2014. She got her start at BMS as a Clinical Research Scientist and at Quintiles as a Clinical Research Associate from 1996 to 1999.

Jill earned her BSN in Nursing at Indiana University and went on to earn her MHS in Public Health at Duke University.

Jill Loftiss, MHS

CHIEF DEVELOPMENT OFFICER

Jeffrey Roe, MBA , EXECUTIVE VICE PRESIDENT, HUMAN RESOURCES

Jeffrey Roe, MBA, is the Executive Vice President, Human Resources for D2V Clinical. He is a highly accomplished and results-oriented global HR executive with over 25 years of experience leading change and increasing organizational effectiveness within dynamic life sciences organizations. As a strategic business advisor, Jeffrey brings vast experience across multiple corporate functions, including HR, Finance, IT, Administration, M&A, Integration, and Facilities. He is skilled in performance management, leadership development, diversity and inclusion, talent acquisition, employee engagement and retention, and compensation and benefits planning.

Before joining D2V Clinical, Jeffrey served as Head of HR at M3 Wake Research during 2022, where he implemented strategies that increased diversity and inclusion by 15% and improved employee engagement by 20% and productivity by 10%. As Head of HR at Velocity Clinical Research from 2020 to 2022, he implemented succession planning and talent acquisition programs which resulted in a 20% increase in new hire retention. Jeff spent four years as Human Resources Executive Consultant for JMR Consulting from 2016 to 2020, and was the Vice President of Human Resources for Clinipace Worldwide from 2009 to 2016. Jeff served as Vice President, Human Resources for Transamerica from 2005 to 2006. His earlier career included HR roles at IQVIA and BTI.

Jeffrey holds an MBA in Business Administration from Baker University and a BA in Human Resources from Mid America Nazarene University.

Jeffrey Roe, MBA

EXECUTIVE VICE PRESIDENT, HUMAN RESOURCES

Marwa Noaman, CLINICAL OPERATIONS DIRECTOR

Marwa Noaman, MBA, is the Clinical Operations Director at D2V Clinical. She brings more than 16 years of experience as a clinical research professional, managing research facilities, sites, and clinical trials. During her time in project management, Marwa has built long-lasting client relationships and successfully managed and overseen trials from start-up to trial publishing.

Prior to joining D2V Clinical, Marwa served as Head of Center of Excellence in Oncology and Project Director at ProPharma Group and Veristat from 2020 to 2023, where she was responsible for building site networks to support sponsor needs. Her experiences gained in those roles include the management of solid tumor trials and combination device trials. She earned a significant portion of her expertise by conducting project management at IQVIA/IQVIA Biotech from 2012 to 2020. In addition, Marwa spent much of her earlier career with direct patient care supporting Phase I-III clinical trials from 2007 to 2012.

Marwa earned her B.S. in Behavioral Neuroscience at the University of Kansas and went on to earn her MBA in Project Management at Capella University.

Marwa Noaman, MBA

CLINICAL OPERATIONS DIRECTOR

INSIGHTS

Latest News and Updates

Video

Enhancing Data Quality: Instream Data Cleaning

Join our Director of Clinical Operations, Marwa Noaman, and our Chief Medical Officer, Vijay Reddy, M.D., Ph.D, as they explore the game-changing practice of instream data cleaning. Noaman, a seasoned industry professional, emphasizes real-time data cleaning’s impact on crucial milestones, while Dr. Reddy highlights its…

Blog

Reaching Your Milestones: D2V Clinical’s 2024 Mission

DURHAM, NC – As 2024 begins, D2V Clinical stands firmly committed to our core ethos: ‘Your Milestone. Our Mission.’ This guiding principle is the driving force behind our strategic expansions and enhancements in key areas. We’re broadening our therapeutic focus to encompass diverse medical fields,…

Event

Connect with D2V Clinical at ASH 2023

Connect with D2V Clinical at ASH 2023 Stop by booth #3446 at ASH 2023 to meet the D2V Clinical team and discover how we can help you achieve milestones in your early-phase hematology program. Backed by leadership with 20+ years of drug development and senior FDA review experience, our agile approach eliminates surprise…

Video

Project Optimus: Challenge vs. Opportunity

Join our Chief Medical Officer, Vijay Reddy, M.D., Ph.D., as he shares a perspective on Project Optimus, an FDA initiative revolutionizing oncology treatment development. Explore the shift from “more is better” dosing to optimized doses, maximizing efficacy, safety, and tolerability through pharmacokinetic and…

Video

Unlocking Insights: Strategic Positioning of the PK Package

Join D2V Clinical’s Chief Development Officer, Jill Loftiss MHS, as she shares valuable insights on strategically positioning PK packages within NDAs. With 22+ years of drug development experience, Jill provides expert guidance on leveraging the timing of your PK package to enhance the likelihood of successful…

Video

Modern Therapies: Inside Early-Phase ADC Development

Join our Chief Medical Officer, Vijay Reddy, M.D., Ph.D, as he explores the vital role of early-phase design in antibody drug conjugates (ADC) development. With a wealth of experience in drug development, Dr. Reddy’s career in ADCs began during his Ph.D. research, where he pioneered monoclonal antibodies targeting…

Press Release

D2V Clinical: Raising the Bar for Early-Phase Oncology

DURHAM, NC – Dose2Value Clinical (D2V Clinical) is a full-service global CRO addressing the challenges of early-phase oncology studies faced by biotech companies. Founded by seasoned veterans from the industry and the FDA, D2V Clinical focuses on asset value creation for sponsors. The company offers vast knowledge and…

Insights from Former FDA Insights Graphic min -

Blog

Insights from a Former FDA Reviewer on the Latest FDA Draft Guidance Regarding Dosage Optimization in Oncologic Clinical Development

Insights from a Former FDA Reviewer on the Latest FDA Draft Guidance Regarding Dosage Optimization in Oncologic Clinical Development DURHAM, N.C. (May 16, 2023) – The U.S. Food and Drug Administration (FDA) and the National Cancer Institute collaborate on the Oncology Center of Excellence (OCE) Project Optimus, which aims…

Your Milestone, Our Mission

When it comes to oncology, hematology and rare disease drug development, we know what works – and what doesn’t.

D2V Clinical leaders have been accountable for critical global development decisions and successful outcomes

Powered by industry-leading technology combined with robust global expertise

Speed to

signal

pathway

patient

Decades of experience paired with exceptional poise and oncology / rare disease knowledge

Amanda Fu, M.D., M.S., MBA

Walt Cao, Ph.D.

Vijay Reddy, M.D.

Jeffery Roe

Marwa Noaman

Amanda (Meng) Fu, M.D., M.S., MBA CO-FOUNDER AND CHIEF EXECUTIVE OFFICER

Xianhua (Walt) Cao, Ph.D., PRESIDENT AND REGULATORY OFFICER

Vijay Reddy, M.D., Ph.D., CHIEF MEDICAL OFFICER

Jill Loftiss, MHS, CHIEF DEVELOPMENT OFFICER

Jeffrey Roe, MBA , EXECUTIVE VICE PRESIDENT, HUMAN RESOURCES

Marwa Noaman, CLINICAL OPERATIONS DIRECTOR

Latest News and Updates

About D2V Clinical