Chair of the UK Insilico Regulatory Task Force
University of Leeds
Prof. Alejandro Frangi is the Diamond Jubilee Chair in Computational Medicine and a Royal Academy of Engineering Chair in Emerging Technologies at the University of Leeds. He is the Director of the Centre for Computational Imaging & Simulation Technologies in Biomedicine (http://www.cistib.org/) and the Leeds Centre for HealthTech Innovation (https://www.leeds.ac.uk/centre-for-healthtech-innovation). He holds joint appointments in the Schools of Computing and Medicine. He received the 2021 IEEE EMBS Technical Achievement Award “For pioneering contributions in model-based image computing and image-based computational modelling in medicine with clinical and innovation impact”. He is the Chair of the Avicenna Alliance Taskforce on UK Regulatory Science and Innovation and leads the InSilicoUK Innovation Network (www.bit.ly/InSilicoUK) funded by InnovateUK and supported by Innovate KTN. He published one of the most comprehensive evaluations of in silico trials for endovascular repair of brain aneurysms https://vimeo.com/578167974.
Angel Guzman Rodriguez
S&C Project Engineer Advisor
Standardization and Testing
Angel Guzman Rodriguez is Project Engineer Advisor at ASME. He graduated from Hofstra University in 2004 with a degree in Industrial Engineering. Started working for ASME shortly after graduating. Responsible for the ASME VVUQ Subcommittee 40 on Verification, Validation, and Uncertainty Quantification in Computational Modeling of Medical Devices as well as many other committees.
University of Oxford
"Big data, AI and in silico trials based on multiscale modelling and simulation"
Blanca Rodriguez is Professor of Computational Medicine and Welcome Trust Senior Research Fellow at the University of Oxford. She leads the Computational Cardiovascular Science team, with a key focus on its members’ career development, and a large network of collaborators in industry, hospitals, academia and with regulatory bodies. Her research is on human in silico trials to investigate the response of human diseased hearts to therapies, through computational modelling and simulation augmenting experimental and clinical methods. She is also Head of the Computational Biology and Health Informatics Theme in the Department of Computer Science at Oxford and holds leadership and advisory positions in several national and international organizations. Blanca has been awarded generous funding by research councils, charities, industry and the European Commission.
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 VCLS 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.
Chair of the Clinical Community Outreach Task Force
Research Fellow at GOSH, UK
After graduating at Politecnico di Milano (Milan, Italy), Claudio Capelli moved to London at UCL & Great Ormond Street Hospital where he started his PhD project in Biomedical Engineeringg under the supervision of Prof Philipp Bonhoeffer, Prof. Andrew M. Taylor and Dr. Silvia Schievano. During his PhD project Claudio had the chance to conduct multidisciplinary research. In addition, he had the possibility of an internship at Medtronic Inc (Mounds View, Minnesota, USA).
In 2012, after completing his PhD, Claudio Capelli continued to work as a post-doc research fellow at UCL Institute of Cardiovascular Science. Dr. Capelli currently collaborate with several research groups within UCL, other academic centres in Europe and US and industry for simulation software development and medical devices. He sits in the Board of Directors of the VPH Institute and committed to the activities of the outreach to the clinical community.
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.
Leader of the Policy Development Working Group
VCLS, Founder & CEO
“Adoption of in silico methods for European Regulatory Activities”
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 leads the Policy Development Working Group of the Alliance. 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.
Chair of the Pharmaceutical Strategy Task Force
University of Catania
Prof. Francesco Pappalardo is Deputy Director of Department of Drug and Health Sciences, at University of Catania, Italy. He is involved in several multi-institutional funded projects in Europe and USA. He holds computer science professorship appointment at University of Catania and he is visiting professor at the Boston University and Health Informatics Research Lab, Computer Science Department, USA. In addition, he is the founder of the COMBINE research group (https://www.combine-group.org/). Research activity of Francesco Pappalardo is focused on the application of computational models in the field of systems biomedicine. He is one of the pioneers of in silico trials, where he currently also deals with regulatory aspects with the European authorities. The most visible projects from his group are (1) scientific coordination of the “In Silico World” funded project with the aim of lowering barriers to ubiquitous adoption of In Silico Trials; (2) development of in silico trials framework for immunotoxicity risk assessment of chemicals evaluating the potential for unintended effects of chemical exposure on the immune system; (3) scientific coordination of the “STriTuVaD” project where an in silico trial computer model is being developed to drastically reduce the cost of innovation in tuberculosis care; (4) in silico vaccine developing for prompt actions against SARS-CoV-2; and (4) development of immune system in silico trial modeling and simulation suite to support specific research on immunotherapies. In addition, his group also specializes in molecular modeling and biological pathway analysis with specific interest in precision medicine. Professor Pappalardo has published more than 150 articles in international journals and conferences. He serves the scientific community as president and member of the program commissions for prestigious international conferences and is a member of editorial boards for major bioinformatics journals.
Chair of the Artificial Intelligence Task Force
Johnson & Johnson
Gordon Johnston is Chartered Engineer at Johnson & Johnson. Based in Edinburgh, Scotland. He has a Bachelor of Engineering by the Albertay University. Gordon has worked in a number of Medical Device and Pharmaceutical industry positions for over 25 years. Currently supporting digital healthcare innovation and innovators with risk-based solutions and strategies that enable adoption. Passionate about the development of novel technologies, especially in the areas of healthcare, computational modeling, digital twins, artificial intelligence/machine learning, DevOps/MLOps, digital architectures, and developing associated standards and guidance.
Chair of the Artificial Intelligence Task Force
Universitat Pompeu Fabra
Jérôme Noailly did his PhD at the Universitat Politècnica de Catalunya (UPC), where he explored the mechanical communications within the lumbar spine through finite element modelling and addressed model reliability issues. From 2007 to 2011, he was a Marie Sklodowska-Curie postdoctoral fellow, first at the AO Research Institute and then at the Eindhoven University of Technology, where he focussed on computer models applied to tissue engineering and multi-physics modelling, respectively. In 2012, he became the head of the group of Biomechanics and Mechanobiology at the Institute for Bioengineering of Catalonia (IBEC) and started to combine systems biology and physics-based models and simulations. In 2015, he moved to the Universitat Pompeu Fabra (UPF) and merged his expertise with medical image analysis and machine learning, at the BCN MedTech research unit. In 2016 he was awarded a Ramon y Cajal Fellowship by the Spanish Government and in 2019, he became Tenure Track Faculty at UPF. Jérôme is the current coordinator of the H2020 EU project Disc4All. He is regularly involved in clinical and technology transfer activities, with hospitals and companies. He co-chairs the Student Committee and the AI Task Force for the Virtual Physiological Human Institute and Avicenna Alliance, respectively.
Team Manager Health
DIN - German Institute for Standardization
Klaus Zeir has a more than 10 years carreer at DIN, the German Institute for Standardization. Since 2012 Klaus Zeier works as Committee Manager of ISO committees and Secretary of CEN committees related to medical devices, e. g. ISO/TC 150 “Implants for surgery“ and CEN/TC 285 “Non-active surgical implants”. Along his career he has been moderating discussions on dozens of medical device standard projects, including aspects such as risk management, biological evaluation, material specifications, coatings, cleaning, test design and requirements, additive manufacturing, clinical investigations, labelling and information provided by the manufacturer. Klaus also advises International, European and German medical device standards committees on strategic as well as procedural matters. He is involved in policy discussions regarding the interaction between regulations and standards, particularly in Europe and is cooperating closely with medical device experts from industry, test labs, academia as well as regulatory authorities from all over the world.
Leader of the Research & Technology Working Group
“The future in Research”
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.
Chair of the Good Simulation Practice Task Force
Luca Emili is an entrepreneur and investor, founder and current CEO of InSilicoTrials Technologies, the first global platform that is making easy-to-use modeling and simulation to accelerate the pace of innovation in the healthcare and life science industry. From 2001 to 2010 he was CEO of Emaze, a cybersecurity company that became one of the market leaders in Italy by automating security analysis for complex networks and devices. He is a member of the Cloud Security Consultative Group in EMA and is responsible for the RCA Research Collaboration Agreement between InSilicoTrials and the FDA. He is also a member of the Board of Avicenna Alliance, and a member of the committee for the adoption of the In Silico Medicine of the Italian Ministry of Health. Luca also worked in M&A and his many passions brought him to be a journalist, an entrepreneur in the internet services business, a startup investor and an IT lecturer at the MIB School of Management of Trieste. He has a degree in Economy and Business from the University of Trieste, Italy, where he still lives when he’s not traveling across the USA and Europe.
Chair of the Global Harmonization Task Force
Senior Principal Engineer at Ansys
“Towards Global Harmonization - A Framework that Makes the Game Work”
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.
Leader of the International Affairs Working Group
Research Director at Medtronic
“Sharing the progress on in silico with the world”
Mark Palmer, MD, PhD is a Research Director in the Corporate Strategic Scientific Operations group at Medtronic where he leads an internal team of experts that collaborate across the global enterprise on advanced applications of modeling and simulation. Intramurally, Mark serves on the Enterprise AI Working Group and leads the Enterprise Modeling and Simulation Working Group where he regularly reports to the R&D Council, Clinical Research Council, Executive Committee and the Board of Directors on the long-range R&T Strategy for Modeling & Simulation. Extramurally, Mark serves on the NAFEMS Business Impact Working Group and Industry Advisory Boards for ASME and CompBioMed. He also represents Medtronic on the ASME Verification & Validation 40 Standard for Modeling and Simulation and the ASME Verification and Validation 70 Standard for AI and Machine Learning. In 2020, Mark was named a Medtronic Technical Fellow for his outstanding contributions to the company’s technical excellence.
Treasurer of the Avicenna Alliance
Biomedical engineer by training, Mathieu Rimaud started his career, working with surgical robots and then surgical navigation both in Orthopedics. It was in 2000, and such innovations were not common as they are now. After various positions in start-ups, he then widens his experience in a more established international group (Tornier, bought by Wright, and then Corin Group) with marketing positions in the knee portfolio. After some months of brainstorming, it came to evidence that simulation and in silico were the way to go to be able to impact the journey of care and improve patient satisfaction and their clinical results. This needed disruption motivated the establishment of TwInsight in March 2020 by its 4 cofounders, including Mathieu as the CEO. Coordinating the team expertise and technology of more than 10 years of research, Mathieu is dedicating his energy and experience to answer current musculoskeletal clinical needs. The route is now clear with the mission and ambition of TwInsight to make digital twins essential to personalize and improve orthopedics surgery.
Health Innovation Lead at Innovate UK
Michael Kipping is a Health Innovation Lead at Innovate UK and responsible for the Biomedical Catalyst grant funding programme that supports UK life science SMEs. He has experience in supporting companies to access funding, navigation of regulatory pathways and different approaches to commercialisation. He has a keen interest in regulation having worked at MHRA in the Devices Division and is currently on the advisory board of The Organisation for Professionals in Regulatory Affairs (TOPRA). After completing his Ph.D. in Biomedical Engineering (orthopaedic implants) he spent 10 years in industry in a range of commercial roles with Guidant, Boston Scientific and BIOTRONIK where he was responsible for commercial operations in UK & Eire.
Chair of the Avicenna Alliance Tissue Characterization Task Force
Tenure track research professor, KU Leuven.
“C4Bio – Community Challenge towards Consensus on the Characterization of Biological Tissue”
Since 2018, she is a tenure track research professor at the Department of Mechanical Engineering, KU Leuven where she heads the Soft Tissue Biomechanics Group.
She chairs the Avicenna Alliance Tissue Characterization Task Force and she is also leading the C4Bio initiative, an international Community Challenge towards Consensus on Characterization of Biological Tissue.
The overall aim of her research is to develop optimal solutions for biological soft tissue injury prevention, soft tissue injury repair and soft tissue replacement.
US Food and Drug Administration
“Modeling and Simulation at the FDA”
Dr. Pras Pathmanathan is a senior scientist at the Office of Science and Engineering Laboratories (OSEL), the regulatory science research Office within FDA’s Center for Devices and Radiological Health (CDRH). His research focuses on methods for establishing the credibility of computational models, covering the wide range of models relevant to medical devices, with a focus on physiological models including computational cardiac models. He leads or collaborates in numerous initiatives advancing computational modeling in healthcare, including co-founding and co-Chairing FDA’s Modeling and Simulation Working Group, and leading OSEL’s regulatory science program on Credibility of Computational Models. He received a BA in mathematics from Cambridge University and an MSc and PhD in computational cardiology from Oxford University.
Associate Director, Guidance and Scientific Policy, Office of Clinical Pharmacology
OTS / CDER / FDA
"Role of Modeling & Simulation in Drug Development and Regulatory Decision-Making"
Rajanikanth (Raj) Madabushi has over 15 years of regulatory experience. As a Pharmacometrics Reviewer and Clinical Pharmacology Team Lead, Dr. Madabushi has played a key role in the advancement and application of MIDD approaches for regulatory decision making and addressing various drug development issues. He currently serves as the Associate Director, Guidance and Scientific Policy in the immediate Office of Clinical Pharmacology. Dr. Madabushi plays an instrumental role in FDA’s PDUFA VI MIDD initative and is the CDER Point-of-Contact for the MIDD Paired Meeting Pilot Program. Dr. Madabushi is also involved in global harmonization activities as the Rapporteur for ICH M12 Expert Working Group – Drug Interaction Studies. Dr. Madabushi received his PhD. in Pharmaceutical Sciences from Birla Institute of Technology and Sciences (BITS), Pilani, India.
Randall L Schiestl
Vice President, R&D
Global Technology & Services
Boston Scientific Corporation
“Creating a Modeling-Based Culture”
Randall L. Schiestl, PMP, is Vice President, R&D, Global Technology & Services at Boston Scientific Corporation where he leads a team driving the development and sustainment of minimally invasive medical devices. He has global responsibility for building technical community, centralized R&D services, enabling technology partnerships, driving R&D globalization, leading product security and data governance, and implementing global R&D systems. Engineering teams that he directs are located across multiple facilities both US and OUS and he leads the cross-divisional Technical Executive Committee within Boston Scientific.
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.
Chair of the Avicenna Alliance Notified Bodies Task Force
CEO and Co-Founder, Virtonomy.
“Engaging with Notified Bodies and other European Stakeholders”
Dr. Simon Sonntag holds a PhD in medical engineering and has more than 10 years of experience in computer-aided simulation for cardiovascular medical device development and regulatory. In 2019, he co-founded Virtonomy as CEO with the mission of accelerating clinical trials using data-driven virtual patients and simulations. In addition, he is a board member of various societies and associations, including the European Society of Artificial Organs, and heads the NB task force as part of the Avicenna Alliance to engage with notified bodies for the adoption of in silico medicine.
Steven M. Levine, PhD
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 scienctific 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 Systèmes in 2014. Steve is also co-chair of the Avicenna Public & Patient Involvement Task Force.
Secretary General, Avicenna Alliance
Program Director for Healthcare Solution, ANSYS, Inc.
“The Avicenna Alliance Journey towards the large scale adoption of In Silico methods”
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.
Walter Schmidt is a managing Chief Engineer in Stryker’s Joint Replacement Division, where he has served since 2001. Walter graduated with a Master of Science degree in Civil Engineering & Engineering Mechanics from Columbia University. He began his career with a focus on civil / structural modeling & simulation applications, during which time he received his Professional Engineer license. Today, Walter manages a Modeling & Simulation team whose mission is to develop and deploy industry leading in-silico technologies which transform implant designs and enhance surgical technique to deliver superior clinical outcomes. Walter has been co-chair of ASTM’s “FEA in Orthopedics” subcommittee since 2005 where he had led computational simulation standards development efforts. Walter was a vocal advocate for Stryker’s Avicenna Alliance corporate membership in 2019.