Protocol amendments are up 60% since 2015, and 38% of sites now name protocol complexity as their top operational challenge, ahead of staffing and resources. In this on-demand panel, Citeline’s Skye Hodson, PhD is joined by Rob Goodwin, Chief Operating Officer at Parexel, Jonathan Crowther, Head of the Operational Design Centre at Merck KGaA, and Craig Granowitz, MD, PhD, Chief Medical Officer at Lexicon Pharmaceuticals.
Together they work through where protocol bloat originates, what the revised GCP standards expect of design decisions, and where AI is earning its place in trial planning. One question runs through the whole hour: what do you take out?
Watch the full discussion on demand.
Skye Hodson, PhD
Vice President, Clinical Solutions
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Vice President, Clinical Solutions
Citeline
Skye is a Biochemist with over 10 years of life sciences CRO and CCO experience, delivering tangible business outcomes across strategy, product development, clinical operations, commercialization and growth. He focuses on leveraging enabling technologies to accelerate the development of new medicines, having seen firsthand how data-driven insights and advanced analytics/AI can unlock real value for patients and companies. He is passionate about disrupting the status quo and advancing holistic health agendas, engaging with the community as a speaker, mentor and advocate for innovation in life sciences.
Skye is a Biochemist with over 10 years of life sciences CRO and CCO experience, delivering tangible business outcomes across strategy, product development, clinical operations, commercialization and growth. He focuses on leveraging enabling technologies to accelerate the development of new medicines, having seen firsthand how data-driven insights and advanced analytics/AI can unlock real value for patients and companies. He is passionate about disrupting the status quo and advancing holistic health agendas, engaging with the community as a speaker, mentor and advocate for innovation in life sciences.
Craig Granowitz, MD, PhD
Senior Vice President and Chief Medical Officer
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Senior Vice President and Chief Medical Officer
Lexicon Pharmaceuticals
Craig Granowitz, M.D., Ph.D. has been our senior vice president and chief medical officer since July of 2021. Dr. Granowitz previously served as chief medical officer of Amarin Corporation plc since January 2016. Prior to joining Amarin, Dr. Granowitz served as senior vice president and head of global medical affairs, global human health of Merck & Co., Inc. and in a variety of medical and commercial management positions for Schering‐Plough Corporation. Dr. Granowitz received his B.A. from Dartmouth College and his M.D. and Ph.D. from Columbia University.
Craig Granowitz, M.D., Ph.D. has been our senior vice president and chief medical officer since July of 2021. Dr. Granowitz previously served as chief medical officer of Amarin Corporation plc since January 2016. Prior to joining Amarin, Dr. Granowitz served as senior vice president and head of global medical affairs, global human health of Merck & Co., Inc. and in a variety of medical and commercial management positions for Schering‐Plough Corporation. Dr. Granowitz received his B.A. from Dartmouth College and his M.D. and Ph.D. from Columbia University.
Jonathan Crowther
Head of Operational Design Centre
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Head of Operational Design Centre
Merck KGaA
Jonathan Crowther specialises in pharmaceutical and healthcare data strategy, driving forward-thinking solutions by leveraging real-world insights for optimal analytics outcomes. He advocates that a wealth of data, without a clear strategy, is a missed opportunity. His approach centres on enhancing organisational performance through data-driven decision-making. Utilising advanced tools such as data science, quantum computing, and generative AI, Jonathan is committed to shaping the 2030 vision for healthcare companies.
Jonathan Crowther specialises in pharmaceutical and healthcare data strategy, driving forward-thinking solutions by leveraging real-world insights for optimal analytics outcomes. He advocates that a wealth of data, without a clear strategy, is a missed opportunity. His approach centres on enhancing organisational performance through data-driven decision-making. Utilising advanced tools such as data science, quantum computing, and generative AI, Jonathan is committed to shaping the 2030 vision for healthcare companies.
Rob Goodwin
Chief Operating Officer
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Chief Operating Officer
Parexel
Rob Goodwin is the Chief Operating Officer of Parexel. In this role, he is responsible for leading the core clinical functions, specifically, project management, clinical and data operations, inclusive of early phase clinical units, real world research, and the operational excellence office.
Rob Goodwin is the Chief Operating Officer of Parexel. In this role, he is responsible for leading the core clinical functions, specifically, project management, clinical and data operations, inclusive of early phase clinical units, real world research, and the operational excellence office.
Rob has over 30 years of industry experience in clinical operations, safety and regulatory. Most recently, he was Senior Vice President of Clinical Development and Operations at Pfizer, where he was responsible for establishing, maintaining, and overseeing the global clinical development and operational capabilities required to develop Phase I through Phase IV study protocols and plans, execute clinical trials and deliver post marketing studies to support the introduction of new therapies for patients.
In 2021, Rob was recognized by PharmaVoice magazine as one of the top 100 most influential leaders in healthcare.
Rob earned a Master of Business Administration in Pharmaceutical and Chemical Studies from Fairleigh Dickinson University, a Master of Science in Research, Measurement and Evaluation from Southern Connecticut State University and a Bachelor of Science in Psychology from Eastern Connecticut State University.
