Archives: Speakers

Tim Akers is a Subject Matter Expert at Medidata, focusing in Clinical Trial Innovation. His background surrounds various roles within the lifecycle of clinical research. He has vast experience as a monitor on multiple late stage trials primarily in Oncology. He also has experience as a Project manager in Early Clinical Development. During his time at a large CRO, he helped develop strategic Vendor Management initiatives focusing on controlling and improving how business is conducted with 3rd party vendors in an outsourced clinical trial.  Tim has unique experience as he transitioned to a commercially focused role, focused on helping biotech and mid-market customers graduate through IND enabling and into First in Human trials. During his time at Medidata, Tim has played a leadership role in the development of Medidata’s vision for CTMS, eTMF,  and RBQM by helping clients redesign their Platform model and innovative approaches to Study team workflows. He now leads a team of SME’s focused on Central Data aggregation, standardization, and analytics.

Mark Kalhøj Andersen is a leader with extensive experience in technology and commerce. With a foundation in Chemistry and Environmental Engineering from Aalborg University, blended with strategic business education of a Graduate Diploma in Business Administration (GDBA) in Organization and Leadership, focusing on Marketing Management.

April 2024, Mark has taken a new role as CEO of Lyras A/S, with a continued focused effort on driving growth, improving order intake, and boosting revenue.
• Our mission is to serve customers around the world in the food, beverage, dairy processing, and fermentation industries to enable energy and water reduction.
• Value creation at our customers is key and our systems will secure profitability and short return on investment alongside the positive sustainability impact.
• Our strategy for the next three years is based on strengthening our position in key industries while focusing on elements to accelerate growth, profitability and serve our clients.

Since 2022, Mark has been leading commercial operations at Lyras A/S, serving as the Chief Commercial Officer actively generating a comprehensive global sales and marketing strategy. Mark’s responsibilities extended across the establishment and management of global sales offices, the creation and maintenance of distributor networks, and fostering productive relationships with engineering and OEM partners.

Previously Mark worked as the Technical Director at DESMI Ocean Guard A/S. There, he led the commercial and technical sides of the business, overseeing technical functions, managing customer projects, and steering organizational development. His role prior to that as Technical Manager highlighted his capabilities in project preparation, product development, and managing critical customer projects. Mark’s career trajectory is characterized by a blend of technical depth and commercial insight, positioning him as a key figure in shaping the future of the current organization and the industry.

Kathleen Greenough, Vice President of Marketing & Commercial Operations at 4G Clinical, has decades of experience in life sciences spanning Clinical Operations, Finance, and IT. Her wide range of solutions implementation expertise includes RTSM, CTMS, trial costing tools, OLAP financial suites and patient enrollment planning. Kathleen has also spent many years as a Clinical Financial Planner and Analyst at a major biotech in Cambridge, MA, gaining a broad and deep understanding of the challenges inherent in Clinical Development. Specializing in software adoption and a frequent speaker at industry conferences, Kathleen is most in her element when working within a user community to facilitate solutions that are insightful and truly helpful.

Dr. Gerald Y. Minuk, Professor Emeritus at the University of Manitoba in Winnipeg, Canada, is the founder of Refuah Solutions Ltd. Dr. Minuk has over 40 years of experience in the medical field and is highly qualified as an experienced clinical trials investigator and clinician. At Refuah, Dr. Minuk and his global colleagues have applied their vast experience in clinical medicine to assisting other investigators in their efforts to improve patient recruitment/retention, limit screen failures, maximize study awareness and generate high quality data.

Carleen joined Gravitas Medical as the Clinical Operations Lead in March 2023 after three years at Verily Life Sciences, where she quickly advanced from coordinator to Clinical Trial Manager for medical devices. She currently oversees all aspects of Clin Ops at Gravitas, including the conduct of multiple NIH-funded multisite studies.  Carleen also spearheaded Gravitas’ receipt of two FDA Breakthrough Device Designations in 2023 for the Gravitas Feeding Tube System. Carleen regularly draws from her clinical and patient care experience as an EMT and Clinical Research Coordinator at Stanford to develop and operate efficient in-hospital studies. Carleen attended University of Washington, where she studied Medical Anthropology & Global Health and Spanish, and continues to be passionate about improving public health and addressing health disparities. In her freetime, Carleen is a Pure Barre instructor and enjoys traveling.

Francis P. Crawley is a philosopher with a career in bioethics and expertise in research policy, regulation, ethics, integrity & methodology as well as in data/AI/virtual twins ethics and law with particular attention to the life sciences: clinical trials, genomics/omics, new technologies. Expertise in EU, US, international and country-specific ethics, law, and patient and community interests in health-related research. Strong experience working closely with patients, communities, researchers, and policymakers across disciplines. domains, and geographic regions in establishing consortia, developing patient registries, contributing to the development of biobanks, drafting data management and data protection plans, and contributing to building data repositories. A strong background in the methodologies for designing and reviewing health-related research supported by effective communication and leadership skills as well as diplomacy with the ability to influence changes in bioethics and law. Additional strong background in the development of research, guidance, and ethics related to global diseases affecting resource-poor settings and orphan diseases in the context of leading and/or contributing to challenging projects. Wide experience (e.g., UNAIDS, WHO, UNESCO, European Commission, Council of Europe, and others, including local organizations and industry) in developing health-related research projects, collaborative engagements, regulatory and policy outreach, and education and training in Europe, Africa, Asia, the Americas, and Eastern Europe & Central Asia. Leading roles in the development of international and national guidelines, capacity-building, empowerment, and education programmes for health research; including GCP, ethics review systems, genetics and biobanks, and data privacy & management (a GDPR DPO), with expertise in the ELSI aspects of data AI, digital twins, and organoids. Since January 2020 highly active in the research, ethics, data sharing, and policy discussions on COVID-19, particularly in the areas of vaccines, repurposed medicines, and genetic modelling, having organised more than 40 global webinars and coordinating research across HICs and LMICs. Recently engaged in the policy, ethics, and regulation of data and AI in times of crisis. Founded and coordinates the Ukraine Clinical Research Support Initiative (UCRSI) in cooperation with leading Ukrainian, European, and international organizations. He is at the forefront of the European and global movement to reform and advance research assessment in the universities and other research institutions, with a particular emphasis on research ethics and research integrity in developing policy for data and AI in the research assessment process.