Speakers & Abstracts

Dr. Kern Rei Chng is a Specialist Team Lead in the Singapore Food Agency’s National Center for Food Science (NCFS/SFA). He leads the Biological Research Team in the Research & Exposure Science Department. His team develops and evaluates biotechnologies and computational analytics to enhance SFA’s capabilities in ensuring microbiological food safety and supporting foodborne outbreak investigations. Prior to him joining SFA, he has held research appointments in the National University of Singapore and Genome Institute of Singapore, working on cancer genomics, microbial genomics, microbiome genomics, genome informatics and the development of genomics technologies. His current research interests focused on the development and application of genomics tools and analytics for foodborne outbreak infection prevention and control. His recent works seek to realise the potential in coupling state-of-the-art DNA sequencing methodologies to metagenomics analytics for microbial safety of food, water and the environment.   read more...   read less

Dr. Zhichao Liu is the technical leader at Artificial Intelligence Research Force (AIRForce) at Division of Bioinformatics & Biostatistics, FDA/NCTR. Dr. Liu's background spans the fields of chemistry, biology, and computer science. He led many cutting-edge projects in the past decade by designing, implementing, and deploying AI/machine learning solutions for advanced regulatory sciences. Specifically, Dr. Liu developed the standard pipeline with the AI-powered drug repositioning to help the industry seek the optimal route to accelerate the drug-development efficacy from an advanced regulatory-sciences perspective. Furthermore, Dr. Liu unleased the AI/machine learning solutions for promoting predictive toxicology with a few successful models adopted by the industry and regulatory process. His accomplishment was reflected by 5 FDA-wide Awards, 9 NCTR level Awards, 2 Scientific community level awards, and more than 80 peer-reviewed publications.   read more...   read less

Prof. Francesco Pappalardo is Deputy Director of Department of Drug and Health Sciences at the 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 (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 5) 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.   read more...   read less

Dr. Monica Da Luz Carvalho-Soares is a pharmacist with a Ph.D. in Biological Science from the Carlos Chagas Filho Biophysics Institute at the Federal University of Rio de Janeiro (IBCCF/UFRJ) and a master’s degree in Biophysics from IBCCF/UFRJ; she is also an expert in International Health with a degree from São Paulo University (USP) and an expert in Health Surveillance with a degree from Oswaldo Cruz Institute (FIOCRUZ).
Dr. Carvalho-Soares has worked as a Health Regulatory Expert at the Brazilian Health Regulatory Agency (Anvisa), where she has held various leadership positions, since 2005. From 2009 to 2011, she was Head Manager of Pharmaceutical Technology Management, where she coordinated technical and regulatory activities regarding the registration and post-approval changes of generic and herbal drugs. During this period, she was also a member of the Multidisciplinary Commission for Updating the List of Essential Medicines in Brazil. In 2011, she was the Coordinator of Generic Drug Registration and published a study about Regulatory Efficiency: Generic Drug Registration Time in Brazil. In 2009, Dr. Carvalho-Soares coordinated the work: Review of Post-Approval Procedures for Drugs in Anvisa that was selected among the most important initiatives for Public Administration in Brazil and received an award in Federal Public Management Innovation.
Dr. Carvalho-Soares was a member of the Deliberative Council and Coordinator of the Brazilian Pharmacopoeia from 2011 to 2015. She was also the Anvisa coordinator at the Mercosur Pharmacopeia. At the time, Dr. Carvalho-Soares was an advisor to the World Health Organization (WHO) on matters relating to interchangeability of multi-source products (generics), pre-qualification of medicine guides and specifications for pharmaceutical preparations. In 2016, Dr. Carvalho-Soares was at the University of Maryland Baltimore County (UMBC) as a Postdoctoral Fellow, where she worked with new data analysis to predict critical post market risks for biological products. From 2017 to 2018, she was a member of the drug-induced liver injury (DILI) work group of the Council for International Organizations of Medical Sciences (CIOMS).
Since 2019, Dr Carvalho-Soares has been General Manager of Knowledge, Innovation and Research at Anvisa and a member of the Real-World Data and Real World Evidence work group of CIOMS.   read more...   read less

Dr. Patrick Beeler studied medicine and has long been interested in the advantage of processing and analyzing “big clinical data” for research purposes. He programs SQL and R to transform large, routinely collected data into clinically meaningful results. He applies a variety of techniques, for example, multivariable regression modeling, electronic phenotyping, and cluster analyses – and furthermore, he often develops novel approaches to tackle problems related to the inherently complex nature of real-world clinical raw data. The goal of his research is to better understand clinical problems and ultimately to improve patient safety, diagnostics and quality of care.   read more...   read less

Dr. Diamond is the Chief Medical Officer for Digital Health at FDA's Center for Devices and Radiological Health (CDRH). At the CDRH Digital Health Center of Excellence, Dr. Diamond serves as the senior clinical expert for digital health medical devices and provides leadership for digital health policy development for emerging technologies including artificial intelligence. Dr. Diamond has also served as a leader on CDRH’s COVID-19 response team. Prior to joining the Agency, Dr. Diamond served on leadership teams of large and small technology companies, including as Chief Medical Officer at Nokia, and as Medical Director at Fossil Group and the startup Misfit Wearables. He was Vice Chair of the Consumer Technology Association (CTA) Health & Fitness Technology Board of Directors, where he promoted public health applications of mobile technology and established an ANSI-accredited standardization committee to develop standards in digital health for wellness-related hardware and mobile applications. Dr. Diamond served on numerous advisory boards including at the Center for Personalized Health Monitoring at UMass Amherst and for the venture firm NGP Capital. He earned his MD and PhD (biophysics) from the Mount Sinai School of Medicine, and he is board certified in rehabilitation medicine and sports medicine and certified in medical acupuncture. A faculty member at NYU, Dr. Diamond is passionate about helping people improve their mobility and performance through a holistic approach to rehabilitation and technology that promotes wellness.   read more...   read less

Didier Verloo is working for the European Food Safety Authority (EFSA) since 2005 where he is heading the Assessment and Methodological Support Unit since 2008. This multidisciplinary unit leads and supports the development, implementation and review of evidence based risk assessment and decision support approaches in all fields within EFSA’s remit (food safety, feed safety, animal health, plant health and nutrition) and was responsible for the development and implementation for the EFSA guidance on Systematic Review in food and feed safety risk assessment, the EFSA guidance on Expert Knowledge Elicitation and the EFSA framework for Promoting Methods for Evidence Use in Scientific assessments underpinning the science quality system. Building on this sound basis several feasibility studies were executed around artificial intelligence/machine learning and crowdsourcing in risk assessment and since two years the unit initiated, created and manages the continuously growing knowledge community on the implementation of AI with other EU agencies such as EMA, ECDC, EUIOPO, EUROFOND, CdT.
Didier started his professional career at the Institute of Tropical Medicine in Belgium being confronted with the reality of decision making under uncertainty by working on evidence based medical decision making in human and animal trypanosomosis (sleeping sickness) and worked before joining EFSA for the Belgian government as an epidemiologist and Risk Assessor mainly in the area of antimicrobial resistance and infectious diseases. Over the years he built up academic and hands on experience in biostatistics, epidemiology, risk analysis, statistical process control, test validation and provided risk analysis consultancy in public health, construction, finance and engineering.   read more...   read less

Binay Panda is a Professor of Biotechnology in Jawaharlal Nehru University, New Delhi, India. He studied, lived and worked in the UK, USA, and Japan before moving back to India in 2010. Binay received his Doctorate Degree from the University of Oxford, UK, Post-Doctoral training at the Scripps Research Institute, La Jolla, California, USA with a Fellowship from the American Cancer Society, and was a Visiting Researcher of Genome Science at the University of Tokyo, Japan. His group’s main interests are data integration and genomic medicine, and building and optimizing computational tools for high-throughput and imaging data. In disease genomics, the main thrust of research in his lab has been understanding head and neck squamous cell carcinoma using integrated analysis of heterogenous data.   read more...   read less

Dr. Miquella “Kelly” Rose joined the Burroughs Wellcome Fund in January 2019 and oversees the Interfaces in Science and Regulatory Science programs that invest a combined $10 million a year in biomedical research. Dr. Rose serves on the Committee of Inclusive Excellence for the National Organization of Research Development Professionals and is co-chair of the Diversity, Equity and Inclusion Working Group for the Health Research Alliance. Prior to BWF, Dr. Rose was Executive Director for the Research Triangle Material Research Science and Engineering Center (RT-MRSEC), and coordinated research, education, and outreach activities between four partner universities in the Research Triangle area (Duke, UNC-CH, NC State and NC Central). Before moving to North Carolina, Dr. Rose was the program coordinator for the California Institute of Regenerative Medicine Bridges to the Baccalaureate Program for Berkeley City College. She completed a postdoctoral fellowship at the University of California-San Francisco (UCSF) that was funded through a National Institute of Health (NIH) Institutional Research and Academic Career Development Award (IRACDA). At UCSF, she worked on a joint project in the Departments of Bioengineering and Craniofacial Biology, and her work focused on bioengineering a stem cell niche for tooth regeneration with Drs. Tejal Desai and Ophir Klein. She earned her PhD in Biomedical Sciences from the University of New Mexico in the laboratory of Dr. Laurie Hudson in the College of Pharmacy. Her PhD project focused on the dynamics of cell-cell junctions during epidermal wound healing.   read more...   read less

As Lead Data Scientist in the Analytics Centre of Excellence, Joaquim develops and delivers new applications and services where analytics has a big impact on the Agency’s operations. Leads the development and execution of ACE’s Strategy and Roadmap in support of an overall EMA digitalisation strategy advising and driving innovation through delivering new processes and digital solutions in collaboration with EMA’s ecosystem of users and stakeholders.
The Analytics Centre of Excellence (ACE) is a cross-agency initiative led by the Digital Business Transformation Taskforce. ACE explores how data analytics - including Artificial Intelligence, Machine Learning and Robotics – can be used to build pragmatic solutions to existing EMA business needs with the main objective of gaining efficiency. ACE team works in parallel on a variety of digitalisation projects. These projects have in common that they contribute to achieving EMA’s digital ambition through the use of analytics or machine learning and/or AI.   read more...   read less

Dr. Ayako Furuhama is a Senior Staff Scientist at the Division of Genetics and Mutagenesis, National Institute of Health Sciences (DGM/NIHS), Japan. Her background is in theoretical chemistry, including quantum chemistry and in silico toxicity modeling. At the Department of Chemistry, Faculty of Science, Ochanomizu University, Tokyo, Japan, her bachelor and master research involved quantum chemistry: the molecular orbital studies of tetra-aza macrocycles and their lithium complexes. She received her doctorate from Nagoya University, Nagoya, Japan, where she studied theoretical chemistry, focusing on the development of distributed partial wave integral equation theory and its application to molecular liquids. After graduation, Dr. Furuhama became a Japan Society for the Promotion of Science (JSPS) research fellow at the University of Tokyo, Japan, and a long-term visitor at the Pacific Northwest National Laboratory, USA, where she did a direct ab initio dynamics study of ionization in a (H₂O)₁₇ cluster. Also, as a JSPS postdoctoral fellow at Imperial College London, UK, she worked on Quantum Mechanics/Molecular Mechanics calculation for photoactive yellow protein.In 2008, she started (eco)-toxicity QSAR studies at National Institute for Environmental Studies as well as NIHS; she has more than 10 years of experience developing in silico models, including models for predicting both fish and Daphnia magna chronic toxicities of chemicals from D. magna acute toxicities. When combined with structural and physicochemical descriptors, activity data were efficient for estimating chronic toxicities. Estimation of such chronic toxicities will play an important role in the screening assessment of chemicals under the Japanese Chemical Substances Control Law. Presently, Dr. Furuhama is a member of the 2nd AMES/QSAR International Challenge Project at DGM/NIHS.   read more...   read less