ECNE Research Leadership Team
Elizabeth Weathers, PhD, RN, RGN, FAAN Founder & CEO of ECNE Research
Dr. Elizabeth Weathers is a clinician, researcher, and clinical regulatory strategist with almost 20 years of experience.
As Founder and CEO of ECNE Research, she helps pharmaceutical and medical technology companies establish clinical value, develop evidence strategies, and navigate global regulatory requirements.
A former associate professor at University College Dublin, she holds a PhD in Medicine and Health and has authored more than 50 peer reviewed publications across her career.
Nicole Darling, PhD, EIT Senior Manager, Projects / Operations, ECNE Research
Dr. Nicole Darling is a clinical scientist and biomaterials engineer with experience in device research, clinical evaluation and regulatory evidence generation.
At ECNE, Nikki manages multidisciplinary projects spanning systematic literature reviews, clinical and regulatory documentation, and post-market evidence strategies.
In her prior role at Terumo BCT, she supported clinical and regulatory activities across more than 23 medical devices and solutions. She holds a PhD in Chemical and Biomolecular Engineering from UCLA, with research spanning biomaterials, tissue repair and regenerative therapies.
Frank McCarthy Chief Commercial Advisor, ECNE Research
Frank McCarthy is Chief Commercial Advisor to ECNE Research, supporting commercial strategy, business development, and client engagement.
Working with ECNE in an independent advisory capacity, he helps connect healthcare innovators with clinical evidence, regulatory and scientific communications support tailored to their development priorities.
His focus is on building partnerships and aligning ECNE’s expertise with clients’ needs, helping translate complex development challenges into practical opportunities for collaboration.
ECNE Senior Advisors
Dr. Carole Chrvala
Dr. Carole is an accomplished epidemiologist and medical strategist with more than 30 years of experience supporting biotech, pharmaceutical and medical device organisations. Her expertise spans health economics and outcomes research, competitive intelligence and strategic medical communications across therapeutic areas.
Robert Steele BA Eng. CEng. Mi Mech E. MCQI. MASQ
Robert is a Chartered Engineer and RAQA professional with extensive experience in medical device design, quality and regulatory affairs across US, European and Asian markets. He has supported the approval of numerous medical technologies through EU MDR CE marking, FDA 510(k) submissions, and PMA applications.
Aoife McAuliffe
Aoife is a pharmaceutical consultant and founder of AUREUM PHARMA with over 25 years’ industry experience. A pharmacist and IPHA Code expert, her expertise spans medical affairs, market access, governance, and compliance. She helps organizations translate scientific innovation into improved patient access through strategic, ethical, and patient-centered healthcare solutions.
Dr. Sheela Devi, PhD, PMP
Dr. Sheela Devi is a scientific and medical affairs leader with nearly 20 years’ experience across the Asia-Pacific region. Her expertise spans clinical research, medical affairs strategy, commercialisation and operational excellence. She advises healthcare and life sciences organisations on market expansion, digital transformation, and integrating AI into clinical settings.
Bhaveeka Dattani
Bhaveeka is a regulatory affairs and quality assurance executive with over 20 years’ international experience in medical devices, pharmaceuticals, and combination products. She helps organisations shape regulatory strategy, maintain compliance, and access global healthcare markets while supporting innovation, quality, and sustainable business growth.
Katie Cooney
Katie is a learning and development specialist and executive coach with over 24 years’ experience in life sciences. Her expertise spans instructional design, leadership development, and organisational culture. Having worked with Boston Scientific, Integer, and Astellas Pharma, she transforms complex regulatory and technical topics into practical, engaging learning experiences.
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