bit.bio expands independent ethics and sustainability board
Dr Enrica Alteri has extensive experience in drug discovery and clinical safety and worked at the European Medicines Agency for 8 years, serving on its Executive Board
- Prof Jeffrey Skopek is Associate Professor of Law at the University of Cambridge and Deputy Director of its Centre for Law, Medicine and Life Sciences.
CAMBRIDGE, UK, 00:01, Tuesday 25 October 2022 - today bit.bio welcomes two new members to its independent Ethics and Sustainability Board to further support the company’s commitment to being a purpose led, ethical organisation. bit.bio is working towards a future in which precision engineered human cells enable biomedical innovation (UN SDG9) and a new generation of cures (UN SDG3).
The new advisors will provide important and independent guidance as bit.bio scales their proprietary synthetic biology cell identity coding platform, creating products and solutions based on human cells that can transform healthcare from basic research and drug discovery to next generation cell based therapies.
New board member Dr Enrica Alteri spent 7 years in drug discovery and 5 years in clinical safety at Ciba-Geigy/Novartis and then went on to lead the Pharmacovigilance and Risk Management team at Serono in Geneva. In 2012 she joined the European Medicines Agency, where she held various senior positions and was a member of the Executive Board until 2020.
“Working with the European regulatory agency allowed me to see ideas turning into products and helping patients. This is a remarkable journey and needs to be done not only with passion and with purpose, but also respecting and understanding societal needs and ethical boundaries that guide research focused on humans. I am excited to bring this mindset to bit.bio."
Dr Enrica Alteri
Ethics and Sustainability Board member
New board member Jeff Skopek is an Associate Professor of Law at the University of Cambridge and Deputy Director of its Centre for Law, Medicine and Life Sciences. His research explores the normative and conceptual foundations of health law, focusing in particular on controversies about what harms and benefits count.
“What I find really exciting and important about this board’s work is that law and ethics are built on assumptions about the nature of the world. But the nature of the world is being transformed through advances in medicine and the life sciences. . We are confronted with new types of entities and questions about whether and how we should fit them into our existing legal and ethical frameworks. That's why I think this is just such a fascinating and challenging area to be working in and why I’ve joined this board.Working with the European regulatory agency allowed me to see ideas turning into products and helping patients. This is a remarkable journey and needs to be done not only with passion and with purpose, but also respecting and understanding societal needs and ethical boundaries that guide research focused on humans. I am excited to bring this mindset to bit.bio."
Prof Jeffrey Skopek
Ethics and Sustainability Board member
The Ethics and Sustainability Board is chaired by Professor Marie-Claire Cordonier Segger, an international expert in sustainability, law and public policy. It was established by Prof Cordonier Segger in the early days of bit.bio. The board’s role is to review company strategy, from R&D and clinical translation to commercialisation and operations and provide guidance and recommendations as well as align it with UN sustainable development goals.
“bit.bio is a purpose led company that is committed to making a sustainable impact on patients’ lives and to adhering to the highest ethical standards. As creators of new technology, we are also committed to understanding its potential impact and risks, to creating robust mitigation strategies, and defining clear boundaries within which we will operate. In this spirit, I welcome Enrica and Jeff to our board, which will ensure that our ambitions and daily operating procedures adhere to the highest levels of scrutiny.”
bit.bio CEO and founder
Jeffrey Skopek is an Associate Professor of Law at the University of Cambridge and Deputy Director of its Centre for Law, Medicine and Life Sciences. His research explores the normative and conceptual foundations of health law, focusing in particular on controversies about what harms and benefits count.
He has served on the Research Ethics Committee of the University of Cambridge’s School of Humanities and Social Sciences, the Animal Welfare Ethics Review Board of AstraZeneca, and the Health and Social Care Advisory Panel of the UK government's Centre for Digital Ethics.
Before joining the University of Cambridge, he was an Academic Fellow at Harvard Law School’s Petrie-Flom Centre for Health Law Policy, Biotechnology, and Bioethics. Prior to that, he served as a law clerk to Chief Judge Lynch of the United States Court of Appeals for the First Circuit. He holds an A.B. in History from Stanford University, a Ph.D. in the History and Philosophy of Science from the University of Cambridge, and a J.D. from Harvard Law School.
After completing her medical studies in Rome and a post-doctoral fellowship focused on cellular immunology at the National Cancer Institute in Bethesda (USA), Dr Alteri spent 7 years in drug discovery and 5 years in clinical safety at Ciba-Geigy/Novartis in Basel. She was involved in major projects that yielded important drugs such as Gleevec for myeloid leukaemia, Coartem for malaria and Reyataz for HIV-AIDS. In 1998 she joined Serono in Geneva where she led the Pharmacovigilance and Risk Management team. At Serono, Dr Alteri was instrumental in establishing the company’s pharmacovigilance processes, as well as implementing the entire portfolio’s safety risk management strategy.
In 2012 she joined the European Medicines Agency, where she was Head of the Safety and Efficacy Sector for one year, being later promoted to Head of the Human Medicines Evaluation Division, and then to Head of the Human Medicines R&D Support Division.
She was a member of the EMA Executive Board from 2013 until she retired in 2020. In these roles, Dr Alteri was part of many high impact EMA initiatives, from the transparency of clinical trial data to the development of regulatory science strategy to 2025.
Dr Alteri has been consulting for the Swiss regulatory agency (Swissmedic), and is currently a member of the Scientific Committee and faculty of the Master Course in Drug R&D of the University of Geneva. Dr Alteri regularly gives lectures on various aspects of R&D at the Universities of Rome, Cattolica and LUISS, and at the European Course in Pharmaceutical Medicine at the University of Basel. Moreover, she is member of the CIOMS Working Group XIII (Real World Data/Real World Evidence), and the CIOMS Working Group Education. Most recently, she has been appointed as Core Member of the Proposal Review Committee of Unitaid for a 3-year period.