bit.bio is a synthetic biology company providing human cells for research, drug discovery and cell therapy. The company applies a patented safe harbour gene-targeting approach (opti-ox™; Pawlowski 2017) to inducibly express transcription factor combinations that reprogram human induced pluripotent stem cells (iPSCs) into highly defined and mature human cell types.
The required transcription factor combinations are discovered using high throughput screens and advanced data analysis (bit.bio discovery platform). The company is currently building a clinical pipeline and marketing a wide range of cells and disease models for research and drug discovery under its ioCells brand including nerve cells, immune cells and muscle cells.
The company was spun out of the University of Cambridge in 2016 and has since raised $150M capital from Arch Ventures, Foresite Capital, Milky Way, Charles River Laboratories, National Resilience, Tencent, and Puhua Capital among others.
The company has expertise in the underpinning science of synthetic biology and stem cells and also in manufacturing, and clinical translation. The board is chaired by serial entrepreneur Dr Hermann Hauser and includes Sir Gregory Winter (Nobel Prize for medicine), biotech veteran Alan Roemer (co-founder Roivant and Pharmasset) and the company's CEO and scientific founder Dr Mark Kotter.
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 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 member of the EMA Executive Board from 2013 until she retired in 2020.
In this roles, Dr Alteri was part of many high impact EMA’s 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 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.
Marie-Claire is a pioneering international expert in sustainability, entrepreneurship, law and public policy. An award-winning expert jurist, executive and professor specialised in corporate social responsibility, climate law and governance, trade and investment, and research ethics, she also serves as Senior Director of the global Centre for International Sustainable Development Law (CISDL), advising the United Nations and key countries, and leading purpose-led companies on ethics and the UN Sustainable Development Goals
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. Before coming to 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
Mark Kotter | MD, PhD, Founder | CEO