External advisory board

The External Advisory Board (EAB) has been appointed and steered by the General Assembly. The main goal for the EAB is to help create a widespread impact of the project results and to advice on the direction that the project takes. It consists of international leaders in scientific and medical issues relating to corneal transplantation (from outside of Europe), an expert in regulatory issues for medical devices and therapies in the EU from industry, and an independent ethics advisor for clinical trials with expertise in human ethics.

Members of the External Advisory Board are:

Reza Dana (male) – M.D., M.P.H., M.Sc., Claes Dohlman Professor of Ophthalmology, Harvard Medical School

rezaProf Dana is a cornea expert and ocular immunologist and graduate of Johns Hopkins and Harvard, who holds the Claes Dohlman Chair in Ophthalmology at Harvard Medical School. He is Director of the Cornea Service at the Massachusetts Eye and Ear, Senior Scientist at the Schepens Eye Research Institute/Mass Eye and Ear, and a member of the Harvard Medical School Graduate Program in Immunology (‘Committee on Immunology’). Dr. Dana studies the molecular and cellular mechanisms of ocular inflammation with applications in autoimmunity, transplantation, dry eye disease, and angiogenesis. A ‘Gold Fellow’ of ARVO, he has authored over 270 peer-reviewed articles and over 120 reviews and book chapters, and has delivered more than 200 invited and named lectures worldwide. His published work has been cited more than 17,000 times (h-index=67). He has been the recipient of multiple awards, including the RPB Special Scholar Award, RPB Physician-Scientist Award, and the Senior Scientific Investigator Award from Research to Prevent Blindness, the Cogan Award from ARVO, the LSU Chancellor’s Award in Neuroscience and Ophthalmology, the Alcon Research Institute Award and the Endre A. Balazs Prize from the International Society for Eye Research. Dr. Dana is Associate Editor of IOVS, and is on the editorial board of the journals Cornea, Scientific Reports (Nature Group), The Ocular Surface, Ophthalmologica, and UpToDate Rheumatology, among others. In addition to his basic laboratory investigations, he leads a translational research program at Mass. Eye and Ear that has received 9 IND permits from the United States FDA in just the last few years. Dr. Dana has trained over 100 fellows and graduate students from 32 countries in his laboratory to date, and in 2014 was recipient of the A. Clifford Barger Excellence in Mentoring Award at Harvard Medical School.

Heather Draper (female) – PhD, Professor of Biomedical Ethics, Chair of Bioethics in the Medical School, University of Warwick, the UK

SONY DSCProf Draper research is in bioethics. Professor Heather Draper was recently appointed to the newly founded Chair of Bioethics in the Medical School, University of Warwick. She publishes on widely in bioethics including papers on research ethics and the ethics of transplantation and tissue donation. She an experienced PI and PhD supervisor and has received research funding from National Institute for Health Research (Research for Patient Benefit), European Union (FP7), EPSRC, ESRC and the AHRC. Professor Draper is particularly interested in interdisciplinary research, and she uses ‘empirical bioethics’ methods alongside more traditional ethical analyses of issues.  She is part of several different research teams in the UK and across Europe. She is a member of the UK Defence Medical Services Professional Conduct Committee, NHS BT’s Deceased Donor Family Tissue Advisory Group and currently serves as an ethics expert on three hospital clinical ethics committees. She was a member of the UK Donation Ethics Committee and was twice co-opted onto the UK Human Genetics Commission. She is a member of the Donation Committee of University Hospitals Birmingham NHS Foundation Trust. She has nearly three decades of experience teaching ethics to undergraduate medical students and healthcare professionals (Universities of Birmingham and Liverpool). She has also been invited by the Human Regulatory Authority to run ethics workshops for research ethics committee members. She has twice been invited to design and deliver courses on research ethics in Saudi Arabia, to support the research ethics scrutiny processes and ethical conduct of research in the Kingdom.

Maria E Donawa (female) – MD, President and founder of Donawa Lifescience Consulting Srl (DLC), Rome, Italy

maria-1Dr Donawa has over thirty years of regulatory experience. From 1980 to 1986, she worked with the United States (US) Food and Drug Administration (FDA) in the area of medical device regulation. In 1986, after moving to Rome, Italy, she founded two consecutively operating consulting companies, which have now become Donawa Lifescience Consulting, with headquarters in Rome, Italy and operations in the UK and the US. The firm provides medical device, in vitro diagnostic device and combination product clinical study services (DLC is a full-service CRO specializing in medical devices), regulatory assistance, quality system auditing and support to life science companies that need to meet US and European requirements, European clinical study services, European Authorized Representative services to medical device companies, and US Agent services. Dr. Donawa has worked with a wide range of life science companies to ensure compliance with US and European clinical study, regulatory and quality system requirements. Dr. Donawa is an active member of the international standards group responsible for the development and revision of ISO 14155, Clinical investigation of medical devices for human subjects – Good clinical practices, which has been harmonized in Europe and published as EN ISO 14155. For over 25 years until closure of the publication, she was the regulatory affairs columnist for European Medical Device Technology; many of these articles can be found on the DLC website at www.donawa.com. She is also a former member of the ISO TC 210 Working Group 1, which is responsible for the development and revision of the ISO quality system standard for medical devices and a former member of the Global Harmonization Task Force Study Group 3 (quality management system requirements). She has also served as a United Kingdom Institute of Quality Assurance registered lead auditor and provided Notified Body auditing services to a German Notified Body for five years. Dr. Donawa is also a former Member of the Board of Directors of the Regulatory Affairs Professionals Society. She holds US degrees in pharmacy and medicine, with a post-doctoral specialty in clinical and anatomical pathology.

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