Cécile Rousseau
Leader of the In Silico Application Working Group
VCLS, Senior Director, Nonclinical
As Senior Director in the Regulatory Nonclinical / Clinical group at VCLS, Dr. Cécile Rousseau brings more than 15 years of experience in the biotech industry. At VCLS, Cécile is responsible for working closely with clients in the management of complex projects involving cell, gene and tissue-based medicinal products (“ATMPs”), medical devices, combination products, in vitro diagnostics and microbiome products, from nonclinical to clinical phases, in both Europe and the US. Dr. Cécile Rousseau is also the Leader of the Avicenna In Silico Application (ISA) Working Group representative and active contributor to the Avicenna Alliance Policy Development Working Group (including Notified Bodies Task force, Good Simulation Practice (GSP) Task Force, EMA/VPHi/AA Task Force, Pharmaceutical Strategy Task Force and Public & Patient Involvement Task Force), the International Working Group (including Global Harmonization Task Force), and the Research Technology Working Group within the Alliance. Cécile leads the VCLS In Silico Task Force and actively supports VCLS's activities around in silico medicine by preparing regulatory and technical briefing packages including digital evidence for interactions with both FDA and EMA. VCLS received the TOPRA Innovation Award 2021 for the in silico activities that Cécile has been undertaking on behalf of VCLS and the Avicenna Alliance.
Cyrille Thinnes
Chair of the Public & Patient Involvement Task Force
National University of Ireland, Galway NUI Galway
Cyrille Thinnes is a co-chair of the Public & Patient Involvement (PPI) taskforce of the Avicenna Alliance Policy Development working group. Currently based at the National University of Ireland, Galway, he is the Engagement Manager for the Virtual Metabolic Human (VMH) where he strives to accelerate Digital Health research outcome into societal benefit through systematic stakeholder involvement. He designed and leads Virtuome, the fully virtual VMH flagship undergraduate summer research programme in Digital Health with Engaged Research as a core pillar, now counting 56 alumni in 2 years from all across Ireland and 513 community contributors in summer 2021 alone. Cyrille is also a member of the School of Medicine, Nursing & Health Sciences Civic Engagement Committee, the national PPI Ignite network working group on establishing PPI in the lab-based environment, and an academic mentor for the Irish University of Sanctuary network. Cyrille holds a doctorate in Chemical Biology from the University of Oxford and an Executive MBA from NUI Galway and has worked in Ireland, the UK, the USA, and Luxembourg.
Emmanuelle Voisin
Leader of the In Silico Application Working Group
VCLS, Founder & CEO
Dr. Emmanuelle Voisin founded Voisin Consulting Life Sciences (VCLS) in 1997. The firm has become a leading advisor to Biotech, Pharma and Medtech manufacturers for the development, registration and launch of innovative medical technologies across international Advis.
Dr. Emmanuelle Voisin has a particular interest in the in silico clinical development leading to expedited approval of drugs and biologics. Emmanuelle also provides strategic advice for interacting with FDA and EMA. She participates in due diligences and negotiations for licensing and acquisitions.
Emmanuelle holds a pharmacy degree and was a Resident in the Paris Hospital Authorities (Ancien Interne des Hôpitaux de Paris). She published a number of articles in international peer-reviewed journals, covering various scientific and regulatory aspects of innovative drug development, as well as global challenges of the biotechnology industry.
Emmanuelle is a member of the Avicenna Alliance and co-leads the In Silico Application (ISA) Working Group of the Alliance, together with Cécile Rousseau. She is a member of organisations of professionals in Regulatory (Eucope, TOPRA, RAPS, DIA,…), as well as an active member of France Biotech and other industry associations.
She is a member of the Advisory Board of the Swiss-based biopharmaceutical company, leader in Alzheimer’s disease, AC Immune. Dr Voisin is also on the Board of Endodiag, developing an innovative diagnostic for endometriosis.
Dr. Voisin is regularly invited as a key expert speaker at international conferences.
Liesbet Geris
Leader of the Research & Technology Working Group
VPHi Director
Liesbet Geris is Research Professor in Biomechanics and Computational Tissue Engineering at the University of Liège and KU Leuven in Belgium. Her research focusses on the multi-scale and multi-physics modeling of biological processes. Together with her team and their clinical and industrial collaborators, she uses these models to investigate the etiology of non-healing fractures, to design in silico potential cell-based treatment strategies and to optimize manufacturing processes of these tissue engineering constructs. Liesbet is scientific coordinator of the Prometheus platform for Skeletal Tissue Engineering (50+ researchers). She has edited several books on computational modeling and tissue engineering. She has received 2 prestigious ERC grants (starting in 2011 and consolidator in 2017) to finance her research and has received a number of young investigator and research awards from the in silico and regenerative medicine communities. She is a former member and chair of the Young Academy of Belgium (Flanders) and member of the strategic alliance committee of the Tissue Engineering and Regenerative Medicine Society. She is the current executive director of the Virtual Physiological Human Institute (VPHi) and in that capacity she advocates the use of in silico modeling in healthcare through liaising with the clinical community, the European Commission and Parliament, regulatory agencies (EMA, FDA) and various other stakeholders. Besides her research work, she is often invited to give public lectures on the challenges of interdisciplinary in research, women in academia and digital healthcare.
Marc Horner
Chair of the Global Harmonization Task Force
Senior Principal Engineer at Ansys
Dr. Marc Horner is a Senior Principal Engineer leading technical initiatives for the healthcare industry at Ansys. Marc joined Ansys after earning his Ph.D. in Chemical Engineering from Northwestern University in 2001. Marc currently holds a number of industry leadership positions, with a focus on model credibility frameworks, regulatory science, and clinical applications. These include Vice Chair of the ASME V&V-40 Sub-Committee and Avicenna Alliance Global Harmonization Task Force Leader. Lastly, Marc is an Executive Committee Member of the IMAG/MSM Credible Practice of Modeling & Simulation in Healthcare project, which aims to establish a task-oriented collaborative platform that outlines credible practices of simulation-based medicine.
Martha De Cunha Maluf-Burgman
Leader of the Policy Development Working Group
Director Regulatory Affairs Digital at Edwards
Martha De Cunha is Mechanical Engineer with B. Political Sciences, MBAs in International Relations and Marketing Management (SUNY-USAL), and post-grade in (Tele) Communications Regulations, International, Institutional and Governmental affairs, Satellite regulations, and advocacy on Radiocommunications and wireless technologies, Telemedicine, eHealth, Artificial Intelligence, Interoperability and Cybersecurity, and in silico technologies. She is also innovator and inventor.
Currently she works for Edwards Lifesciences as Director Regulatory Affairs for EMEA, Canada and LATAM (EMEACLA). Martha represents Edwards in MedTech Europe, participating actively in its Digital Health Committee. Martha is a very active member of the Alliance and collaborate in different Working Groups and Task Forces. She is the Policy Development WG Leader, Co-Chair of the EMA Task Force and a member of the Avicenna Board.
Roberta Maggi
Avicenna Alliance Office Manager
In her role as Avicenna Alliance Office Manager, Roberta works closely with the Secretary General, the Treasurer and the Working Groups and Task Forces to ensure optimal organization of meetings and proper management of the various administrative tasks, web page and social media. She speaks 4 languages, Italian and Spanish as mother tongues and English and French fluently.
Roberta Maggi has a Degree in Foreign Languages and Literatures by the University of Bergamo and a Master in HR Management. She also spent 1 year at the prestigious University of Deusto of San Sebastian.
Along her over than 20 years of experience as Executive Assistant and HR Manager, Roberta worked in different Companies and fields, including Administration, Sales and Marketing.
Steven Levine
Chair of the Public & Patient Involvement Task Force
Director of Virtual Human Modeling at Dassault Systèmes
Steven M. Levine, PhD is the Sr. Director of Virtual Human Modeling at Dassault Systèmes. Dr. Levine has more than 30 years of experience in the development of computational scientific and engineering tools and is the Founder / Executive Director of the Living Heart Project.
He oversees incubators for healthcare startup companies as well as Educational centers of excellence and serves on several company boards. Dr. Levine was elected into the College of Fellows in the American Institute for Medical and Biological Engineering (AIMBE) and holds a PhD in Materials Science from Rutgers University. He began is career in health tech at the San Diego based startup Biosym that went public as Accelrys in 2004 and acquired by Dassault Sysèmes in 2014. Steve is also co-chair of the Avicenna Public & Patient Involvement Task Force.
Thierry Marchal
Secretary General, Avicenna Alliance
Program Director for Healthcare Solution, ANSYS, Inc.
As the Secretary General of the Avicenna Alliance, a global organization advocating for the regulation and exploitation of in silico technology, Thierry Marchal built his vision of Personal Digital Avatar through close collaborations with industrial innovators, academic leaders and regulatory authorities. Thierry is also the ANSYS Program Director for Healthcare Solutions leading the medical devices, pharmaceutical and biotech strategy of Ansys through the in silico and personalized medicine evolution.. In 2020, Thierry has been nominated as a member of the European Commission eHealth Stakeholder Group and a member of the EMA (European Medicine Agency) Stakeholders Group.
