Lieve Wierinck, Member of the European Parliament
Lieve Wierinck is a Flemish politician for the liberal Open VLD party. Mrs. Wierinck holds a pharmaceutical degree from the VUB (Vrije Universiteit Brussel). In addition, she obtained a Post-graduate degree of Pharmaceutical management in 2006 at the University of Hasselt. In line with her academic background, she owned and managed a pharmacy for nearly 30 years.
Before joining the European Parliament, Lieve was leader of the party fraction in Zaventem, followed by her twelve-year presidency of the OCMW (Public Centre for Social Welfare), where she managed a staff of 150 people. She combined this with her obligations as a fulltime member of the City Council of Zaventem. From December 2011 until June 2014, she was a member of the Belgian Federal Parliament, where she was a member of the Committee for Public Health, Environment and Social Renewal, and of the Advisory Committee on Societal Emancipation.
In May 2016, Lieve replaced Mr. Philippe De Backer as a Member of the European Parliament, where she is a full member of the Industry, Technology, Research and Energy Committee (ITRE) and a substitute Member of the Committee on Economic and Monetary affairs (ECON). Lieve also works on topics surrounding healthcare, as she strives for a progressive and affordable healthcare in Europe.
Ingrid Klingmann, MD, PhD, FFPM, FBCPM
European Forum for Good Clinical Practice (EFGCP), PHARMAPLEX bvba
Physician, specialized in General Medicine, Clinical Pharmacology and Pharmaceutical Medicine with over 30 years of experience in different senior medical, operational and managerial functions in pharmaceutical industry, CROs and clinical trial sites with focus on clinical trial design and management, ethical and regulatory aspects.
Since January 2003 she has her own pharmaceutical development and site management support consulting company.
Dr. Klingmann is Chairman of the Board of the European Forum for Good Clinical Practice (EFGCP). On behalf of EFGCP she was and is involved in different FP7- and IMI-funded projects (ICREL, PatientPartner, PharmaTrain, EUPATI, Combacte-Magnet) and with her company in the FP7-funded paediatric LENA project and the IMI-project SPRINTT. Her broad professional background as physician with experience in patient care, clinical development, site management and patient engagement enables Dr. Klingmann to bridge the gaps between the interests and skills of all different stakeholders in medicines development with the aim to develop new patient-relevant treatments more efficiently.
Dr. Klingmann is also President of PharmaTrain Federation and teaches different medicine development topics in diploma and master courses at the University of Bonn, Germany, University of Basel, Switzerland, and the Université Libre de Bruxelles, Belgium.
Adriano Henney, PhD
Chairman of the Board of the Avicenna Alliance
Dr Henney has a PhD in Medicine with research interests cardiovascular disease at the pathological, cellular, molecular and genetic level. After an academic career in laboratories in London, Cambridge and Oxford, he moved into industry, spending 13 years with AstraZeneca.
Ultimately leading global programmes exploring strategic improvements aimed at reducing drug failure in development, he created and headed a new department that focused on pathway mapping and modelling, which evolved to establish the practice of Systems Biology, supporting projects in discovery and development. Dr Henney has extensive experience in directing and managing large, complex teams across disciplinary, cultural and geographic boundaries, latterly in the area of Systems Biology and Systems Medicine. His experience in this area led to an invitation to direct the major €50M German national flagship programme, The Virtual Liver Network, at the time the largest Systems Biology programme in Europe, involving the management of over 200 contributing scientists from a range of disciplines, including clinicians, in 36 independent institutions, including industry, located across Germany.
Following the end of the VLN Programme, Dr Henney was elected to be part-time Executive Director of the Virtual Physiological Human Institute, a not-for-profit organisation promoting the use of computational modelling and simulation to interpret quantitative biological information and understand the dynamics of biological and physiological function. As part of that role, he was responsible for establishing a new partnership with industry, the Avicenna Alliance for Predictive Medicine.
Michael R.S. Hill, PhD, MBA
Vice President Corporate Science, Technology and Clinical Affairs, Medtronic
Michael Hill joined Medtronic in July 1992 as a Scientist in the Cardiac Rhythm Management division of Medtronic in Minneapolis, MN. He has served in research, clinical, program, international and management roles over his tenure at Medtronic. He is a Technical Fellow (1998) and Bakken Fellow (2001). He was awarded a CRDM Star of Excellence award in 2011. In 2012, he was inducted as Fellow of the American Institute of Medical and Biological Engineering. In 2013, he was awarded the Distinguished Engineering Alumni award from Duke University. He was awarded the Medtronic Patent of Distinction Award in 2014. He currently leads the global Corporate Science, Technology and Clinical Affairs organization. He holds over 60 patents, has authored several manuscripts and abstracts, and often is an invited lecturer at international cardiac-related conferences and university events.
A native of Jackson, Tennessee, Dr. Hill received his BSE [Biomedical and Electrical Engineering] and BS [Mathematics] Degrees from Duke University, MS and PhD [Biomedical Engineering] Degrees from Case Western Reserve University, and MBA [Management] Degree from the University of St. Thomas.
Global Head of Integrated Product Development, Cipla
Geena Malhotra is the Global President of Integrated Research & Development and also is a part of Management Council of Cipla Ltd the leading pharmaceutical company in India, with an annual turnover of over $2 billion in sales. Cipla is the third largest company in India, with anti-HIV and respiratory as its main forte. Cipla has over 70 % market share in Respiratory space in India and is a formidable force to reckon with.
Geena Malhotra completed her bachelor’s degree in pharmacy in 1985 in Mumbai and an pursued Executive MBA from Washington University, St. Louis in 2017.
Geena has been the pillar of research and development for Cipla for over 3 decades, a company that started as an API manufacturer and diversified to over 40 dosage forms, enabled singularly by Geena’s leadership over the last three decades, touching almost every product and device that Cipla has in the market today. She has changed the trajectory of the company by introducing and delivering complex generics based on technology of nano particles, liposomes and the world’s first-in-class range of respiratory products and drug device combinations, all in the environment of Quality by Design. Geena is a technologist at heart, and her passion has led her to develop not just pharmaceuticals but even the machines behind it. She has been instrumental in bringing the science of efficient drug delivery systems such as drug device combinations for respiratory therapeutics, targeted drug delivery using simulation tools etc. at Cipla. She has to her credit 300 patents filed in the areas of formulation development and technology in solid oral dosage forms, topical delivery systems and inhalation medical devices. She is responsible for providing technical leadership to multi-disciplinary R&D teams as well as operate within a cross functional environment to build and deliver a high throughput R&D with technology being the core focus. To her credit she has been constantly reinventing and repurposing to keep the momentum of research of her teams to adopt computational sciences and simulations to improve the quality and speed of development, keeping the needs of patients above all and fulfill the purpose of “caring for Life”.
Secretary General of the Avicenna Alliance, ANSYS Global Industry Director
As the ANSYS Global Industry Director since 2006, Thierry Marchal leads the medical devices, pharmaceutical and biotech strategy of ANSYS through the in silico and personalized medicine evolution by closely interacting with industrial innovators and SMEs, academic leaders and governmental and regulatory authorities such as the FDA and the EMA. In his 25+ years of professional experience, Thierry has worked as the Global Materials Market Segment Manager with Fluent and Product Manager for Polyflow. Thierry holds a degree in Mechanical Engineering from UCL.
Tina Morrison, PhD
Deputy Director, Division of Applied Mechanics and Chair of FDA's Modeling and Simulation Working Group
Dr. Morrison is the Chair of the new FDA-wide working group on Modeling and Simulation, sponsored by the Office of the Chief Scientist, which launched in the Fall of 2016. She has been serving as the Regulatory Advisor of Computational Modeling for the Office of Device Evaluation since 2011. In that capacity, she leads the Regulatory Review of Computational Modeling working group at CDRH, which has developed guidance documents on the use of modeling and simulation in the regulatory evaluation of medical devices. She dedicates much of her energy towards advancing regulatory science through modeling and simulation because she believes the future of medical product design and evaluation, and thus enhanced patient care, lies with computation and enhanced visualization.
She serves as Chair of the ASME Committee on Verification and Validation of Computational Modeling, as well as the subcommittee (V&V40) on Computational Modeling of Medical Devices, where she is leading the development of a strategy to assess the credibility of computational models. She is working with a team at CDRH to implement this strategy into the review of premarket submissions that leverage computational modeling. For seven years, she was a scientific reviewer on a variety of medical device premarket submissions in Cardiovascular Devices.
Dr. Morrison is a mechanical engineer who studied Cardiovascular Biomechanics as a post-doctoral fellow at Stanford University. During that time, she investigated the in vivo biomechanics of the aorta using gated CT imaging; those data are now used as boundary condition inputs for computational modeling and bench-testing of endovascular devices in premarket submissions. She received her PhD in Theoretical and Applied Mechanics from Cornell University in 2006.