Our inclusive approach drives success, allowing us to serve clients globally with tailored clinical development solutions and effective partnerships
Dr. Stephen B. Shrewsbury joined Alpha Clinical Development Limited as our esteemed scientific advisor, bringing years of impactful experience. As the Founder and Chief Medical Officer at Shrewd Consulting LLC, Dr. Shrewsbury’s journey began at the UK’s University of Liverpool, 13 years working in the UK’s National Health Service and subsequent over 31 years in the global pharmaceutical industry.
He played a pivotal role at Glaxo and Sarepta Therapeutics, especially in launching Seretide/Advair for asthma and developing EXONDYS51 for Duchenne Muscular Dystrophy. At Impel Pharmaceuticals, he led the Precision Olfactory Delivery clinical programs, the first potential ‘Nose-to-Brain’ drug delivery system, resulting in the groundbreaking US approval of Trudhesa in 2021. An accomplished author of “Migraine Pain Management” and many other publications, Dr. Shrewsbury is celebrated for his visionary work in inhaled and intranasal drug therapies, with numerous patents to his name.
Maria Shabe joined Alpha Clinical Development Limited as our Clinical Quality Assurance Advisor, bringing over 25 years of experience in the pharmaceutical, biotechnology, and medical device industries. With 18 years in senior Quality Assurance and Compliance roles, she also has experience in clinical operations and data management.
Maria has led quality assurance initiatives in various startups around San Francisco and has worked as a Clinical Research Associate in the medical device field. She holds a BS in Management from Philippine Women’s University and co-founded the Bay Area Clinical/Regulatory Roundtable (BACRR), promoting industry education and collaboration. Her expertise plays a vital role in enhancing our clinical trials.
Dr. Rakesh Dixit, Ph.D., DABT, joined Alpha Clinical Development Limited as our distinguished Scientific Advisor, bringing over 30 years of extensive experience in the biotechnology and pharmaceutical industries. As the co-founder, President, and CSO of Regio Biosciences, he is dedicated to developing innovative therapies for cardiovascular disease. With a proven track record at AstraZeneca and Merck, Dr. Dixit has played a crucial role in the marketing approval of multiple blockbuster biopharmaceuticals. He is recognized for his leadership in biologics safety assessment and drug development, having successfully contributed to over 100 INDs and 15 BLAs/NDA submissions. His expertise and insights will be invaluable in advancing Alpha’s mission in clinical development.
Adrian Whitford joined Alpha Clinical Development Limited (ACDL) as our esteemed Strategic Advisor, bringing a wealth of expertise in surgical robotics, medical devices, biotech, and digital health. Previously, Adrian served as President of the Monarch Endoluminal Robotic Platform at Johnson & Johnson, where he significantly enhanced global sales and profitability. His remarkable journey includes spearheading the blockbuster launch of AstraZeneca’s Fasenra and pioneering AI-enabled solutions to improve patient outcomes and streamline clinical trial recruitment. With a strong commitment to fostering innovation, Adrian is dedicated to guiding ACDL in delivering cutting-edge solutions for the future of healthcare.
Dr. Steffen W. Ernst is working as a Strategic Advisor to Alpha Clinical Development Limited (ACDL). As the CEO and founder of Xzencis AB, Dr. Ernst is an internationally recognized expert in Translational Safety, leveraging nearly 30 years of experience in the pharmaceutical industry. His extensive background includes key leadership roles at major companies such as AstraZeneca, Pfizer, and Boehringer Ingelheim, where he has championed innovative approaches to drug development and safety strategy.
Dr. Ernst holds a medical degree, a PhD in Toxicology, and an MBA, along with an active medical license in Sweden and board certification in the US. He is also a European Registered Toxicologist. Renowned for his problem-solving skills and crisis management during clinical trials, Dr. Ernst is dedicated to advancing our mission at ACDL by enhancing safety protocols and optimizing R&D processes.
Introducing Claire Weber, our esteemed Clinical Operations Advisor at Alpha Clinical, bringing over 25 years of unparalleled expertise to the team. Based in Moraga, California, Claire's impressive career includes pivotal roles at renowned companies such as Genentech and Chiron Corporation. With a strong foundation in Good Clinical Practices and a knack for implementing global trials, Claire demonstrates exceptional proficiency in conducting quality clinical studies. Her extensive qualifications include an MBA and professional training across GCP, ICH, GLP, HIPAA regulations, project management, and compliance audits. Moreover, Claire excels in medical technical writing, pharmacovigilance audits, gap analysis, and SOPs, enhancing our capabilities in biologics and pharmaceuticals. Her comprehensive experience promises to elevate our operations to new heights.
Introducing Dr. Iftekhar Khan, our esteemed Statistician, Regulatory Scientific & Health Solutions (RSS) and Advisor at Alpha Clinical. With over 20 years of experience in academia, regulatory affairs, and industry, Dr. Khan specializes in statistics, health economics, and real-world data. Based in London, he has significantly contributed to impactful projects, including advanced device studies like shoulder implants.
Holding a PhD in Statistical Methods in Health Economic Modelling from University College London, Dr. Khan has nearly 100 peer-reviewed publications and has played a key role in writing important guidelines for medical devices and AI/ML applications. As an Expert Statistical Assessor at the MHRA and the European Medicines Agency, he brings deep regulatory insight to our team. Dr. Khan's leadership in these areas positions Alpha Clinical at the forefront of healthcare advancement.
