PROFILES OF OUR EXPERTSAdvanced Pharmacokinetic and Pharmacodynamic (PK/PD) and drug-disease modeling requires specific knowledge and experience. Below are brief CVs for our professional consultants and scientists at SGS Exprimo.

■ Andreas Lindauer ■ Per Olsson Gisleskog ■ Isabelle Delor ■ Marc-Antoine Fabre ■ Ruben Faelens

■ Enrica Mezzalana ■ Philippe Jacqmin ■ Koen Jolling ■ Quentin Leirens ■ Bernardo de Miguel Lillo

■ Eric Snoeck ■ Belén Valenzuela ■ Daniel Röshammar ■ Nancy Smets

Per Olsson Gisleskog is a Principal Consultant and one of the founders of Exprimo. He was born in 1960 in Sweden. Per obtained his M.Sc. in pharmacy and his PhD from the University of Uppsala, his PhD focused on population PK/PD modelling. He initially worked within pharmaceutical development and pharmacokinetics at Pharmacia in Sweden. Thereafter, he worked for Glaxo/GSK in the UK, where he held several positions within the Clinical Pharmacology division, being responsible for pharmacokinetics, population pharmacokinetics, modelling and simulation in several therapeutic areas. He was also appointed clinical development team leader. Prior to joining Exprimo Per worked for Pharsight, where he was a scientific consultant, working with modelling of pharmacokinetics, pharmacodynamics and clinical endpoints, and clinical trial simulation. He has over 15 years experience of pharmaceutical drug development and more than 10 years consultancy experience. He is author of several original research papers in the fields of pharmacokinetic/pharmacodynamic modelling. His current research interests focus around the use of modelling and simulation approaches to provide a rational basis for decision making in drug development. Per lives in the UK.

PER OLSSON GISLESKOG Principal Consultant

Andreas Lindauer is a Senior Consultant at SGS Exprimo. He was born in 1980 in Germany and studied pharmacy at the University at Bonn where he obtained his license in 2006. Thereafter he started his PhD research at the Department of Clinical Pharmacy at the same university, focusing on the PK/PD modelling in oncology and the CNS. He completed his research with his thesis entitled: “Pharmacokinetic/Pharmacodynamic Modeling and Simulation of Biomarker Response to Venlafaxine and Sunitinib Admin-istration”. In 2009, he moved to Barcelona where he joined Ferrer Internacional, as a pharmacometrician in the Department of Drug Metabolism and Pharmacokinetics. At Ferrer he was mainly working on the development of anti-infective agents and drugs for the treatment of sleep disorders. In 2011, Andreas joined Merck, Sharp & Dohme in Oss, The Netherlands. There he worked in several multi-disciplinary clinical development teams (early stage) where he was responsible for the planning and conduct of PK/PD and M&S related activities. In addition he performed M&S analysis in several therapeutic areas including oncology, CNS, infectious diseases, cardiovascular diseases and hematology. Andreas joined Exprimo in 2014 and lives in Germany.

ANDREAS LINDAUER Senior Consultant

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Isabelle Delor is an external consultant, working for SGS Exprimo on specific projects. Isabelle obtained a pharmacy degree from the University of Louvain, Belgium in 1986 and a bachelor of Natural and Applied Sciences, Immunology and Genetics section in 1987. She received her Ph.D. in pharmaceutical sciences in 1992 with a thesis entitled: “Nucleotide sequence of yst gene, encoding the Yersinia enterocolitica heat-stable enterotoxin and its role in Yersinia infections”. This research work resulted in several publications in peer-reviewed journals in the area of Infection, Microbiology and Molecular Biology. In 1996, Isabelle joined the Department of Clinical Pharmacokinetics of Janssen Research Foundation, Beerse, Belgium, as support scientist, actively involved in the clinical development of products in the areas of psychiatry, antidepressants and oncology. From 2001, Isabelle worked as a scientist in early clinical development in various therapeutic areas. In this position she provided scientific and technical support to early development projects with respect to the applicability of biomarkers, exploring and validating innovative ad-vanced PK-PD modelling methodologies and characterising the benefits and limitations of PK/PD modelling and simulation in support of early decision making. Isabelle joined Exprimo in 2005 and lives in Belgium.in 2005 and lives in Belgium.

ISABELLE DELOR Senior Scientist (External)

Marc-Antoine Fabre is a Consultant at SGS-Exprimo. He graduated from a top French Engineering School in Scientific Computing at ENSHEEIT (Toulouse). He got his first experience in M&S at Vatech Hydro, Vevey, Switzerland, and he improved his skills in M&S in Belgium at IMEC, where he developed, and optimized models and put forward solutions for marketing purpose. Willing to apply his competences in pharmacometrics, he went back to the University for a one-year training in pharmacokinetics (Marseilles) and attended the basic pharmacokinetics workshop of University of Manchester (Arosa, Switzerland) to understand underlying physiological processes. Since 2004, he was a junior consultant in Clinical Pharmacology&Pharmacometrics at EMF Consulting, and became a Senior Consultant in 2007. During this time he ensured state of the art of M&S from early to late phase in clinical development programs in different therapeutic areas such as CNS, R&I, and oncology. From 2010 to end 2015 he joined AstraZeneca, where he was one of the lead pharmacometricians. In this job, he was also a representative in the IMI, DDMORE European consortium. Marc-Antoine lives south of Manchester, UK.

MARC-ANTOINE FABRE Consultant (on leave for PhD-studies)

Ruben Faelens is an IT Scientist at SGS Exprimo. He obtained a Master’s degree in Computer Science in 2010. He also studied abroad in Stockholm (Sweden) for 6 months to work on his thesis: “An open, portable AST for software engineering tools”. Ruben joined Altran, a software consultancy firm, in late 2010. There, Ruben was involved in the development of business software for (primarily) pharmaceutical companies as the lead of a team of programmers. This allowed him to become acquainted with a variety of subjects: pharmacoeconomics, pharmacometrics, production planning for oil fields, HR planning, failure testing of engine components and simulation of distributed heating plants. In September 2013, Ruben joined ONE Agency as a Technical Sales and Bid Manager. In March 2014, Ruben joined Exprimo, where he can combine his passion for IT with his strong interest in the field of pharmacometrics. He focuses on simulation projects (clinical trial optimization, power calculation, therapeutic drug monitoring), as well as the internally developed pharmacometric simulation software.

RUBEN FAELENS IT Scientist

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Enrica is a biomedical engineer working as Scientist at SGS Exprimo. She obtained her MSc degree from the University of Padova, Italy in 2010. During this period, she had the opportunity to spend some months within the Clinical Pharmacology Modelling&Simulation group of GSK in Verona, Italy, where she first became passionate about pharmacometrics by applying markov-chain models to categorical data. Thereafter, she started her PhD research at the University of Pavia, Italy with a project focused on mechanism-based PKPD modelling of biologics showing target mediated drug disposition. In 2014 she completed her research with a thesis entitled: “A target mediated drug disposition model for Otelixizumab binding on T lymphocytes”. Then, she worked as a postDoc researcher in the BMS laboratory of the University of Pavia, where she supervised students in their bachelor’s/MSc programs and contributed to the IMI, DDMORE project. From 2015, Enrica worked as scientist in the Clinical Pharmacology and Pharmacometrics division of Menarini Ricerche, Florence, Italy being responsible for population pharmacokinetic and pharmacodynamic modelling and simulation in different therapeutic areas. Enrica joined Exprimo in January 2017 and lives in Verona, Italy.

ENRICA MEZZALANA Senior Scientist

Philippe Jacqmin is one of the founders of Exprimo and is now working for SGS Exprimo as an external consultant on specific projects. He was born in 1956 in Belgium and obtained his Pharm.D. degree from the University of Louvain in 1979 and his Ph.D. degree in Pharmaceutical Sciences from the same University in 1984. From 1984 to 1988 he was successively assistant and first assistant at the Department of Pharmacology at the University of Louvain and was responsible for the Therapeutic Drug Monitoring Unit at the St. Luc University Clinics. From 1988 to 1993 Philippe worked as Group Leader Pharmacokinetics and Drug Metabolism at the Searle European Development Centre in Belgium. From 1993 to 2000 he held several positions within the Departments of Non-clinical and Clinical Pharmacokinetics at the Janssen Research Foundation (a Johnson & Johnson company) in Belgium where he was one the initiators of the Exploratory Development group. From 2000 to 2002, he worked for Pharsight Corporation as Consultant within the European Scientific Affairs Group. Philippe has 15 years of preclinical as well as clinical drug development experience. He is author or co-author of more than 35 original research papers and approximately 60 scientific abstracts and contributed to six textbooks dealing with pharmacokinetics and PK/PD modelling. He also contributed to several registration dossiers for new drug applications. Philippe lives in Belgium.

PHILIPPE JACQMIN Principal Consultant (External)

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Bernardo de Miguel Lillo is a Consultant at SGS Exprimo. He was born in 1978, and obtained MSc degrees in Statistics from the University Complutense of Madrid and Marketing Research from King Juan Carlos University of Madrid in 2003 and 2007 respectively. He completed his research with a thesis entitled “Pharmacokinetic and Pharmacodynamic Population Modeling of a new anticancer drug” in 2015 from University of Valencia. After 4 years of working as research statistician in AC Nielsen and PRA Health Sciences, Bernardo joined PharmaMar in 2004 in Madrid, Spain, where he started as a biostatistician. He moved to Clinical Pharmacology Department in 2007, contributing to the clinical development of trabectedin, the first anticancer agent being approved for a Spanish company. He also provided the PK/PD modeling support for several anticancer agents such as plitidepsin, kahalalide F, ES-285, Zalypsis, elisidepsin, tryptamicidin and PM060184 and has experience with other anticancer compounds including doxorubicin, sorafenib, bevacizumab, carboplatin, cisplatin, oxaliplatin, gemcitabine, docetaxel, erlotinib and capecitabine. He specialized in phase I oncology trials, where he provided PK/PD modeling support from the start of pre-development to dose optimization. His main focus of interest is the contribution of Pharmacometrics to the decision making process for drug development. Additionally Bernardo provided consultancy during several Due-Diligence activities and served as independent statistician for the Independent Data Monitoring Committee of phase III oncology trials. He is coordinator and professor of a Master Course on Clinical Development in Faculty of Health Sciences of King Juan Carlos University. Bernardo joined Exprimo in 2015 and lives in Spain

BERNARDO DE MIGUEL LILLO Consultant

Koen Jolling is a Senior Scientist at SGS Exprimo. Koen obtained a M.Sc. in Biology from the Catholic University of Leuven (Belgium) in 2001 and his PhD, entitled “Chronic exposure of mice to cadmium: toxic effects on the renal proximal tubule”, from Hasselt University in 2008. In between his studies, Koen worked for approximately 2 years (2002-2004) as a data analyst in the department of Global Clinical Pharmacokinetics and Clinical Pharmacodynamics of Johnson & Johnson Pharmaceutical Reasearch and Develoment, Beerse, Belgium. In this role he contributed to Phase I through III development programs for PK and PK/PD work in various therapeutic areas. In 2009 Koen joined SEPS Pharma where he was responsible for all PK and PK/PD related work of in vitro, ADME and toxicokinetic studies. Furthermore, he was, amongst others, co-responsible for strategic planning of in vitro and (pre)clinical in vivo research including design/optimization of target product profiles and decision trees, mapping out of (pre)clinical drug development programs (infectious disease, gastro intestinal tract and virology), CRO selection and writing grant applications. In 2010 Koen started at SGS life science services as head of the pharmacokinetic and toxicokinetic department. In 2013 Koen moved within SGS and joined Exprimo. Koen lives in Belgium.

KOEN JOLLING Senior Scientist

Quentin Leirens is an IT scientist at SGS Exprimo. He was born in 1988 in Belgium and obtained a Master degree in Electrical Engineering in 2011 with options in electronics, biomedical engineering and information & signal processing. His master thesis was made in collaboration with an SME and was about solving specific communication problems between remote devices and medical implants. Quentin joined Exprimo in 2011 to follow up the development of Simulo, a clinical trial simulator for the pharmaceutical industry. He is also involved in the maintenance of IT infrastructure and in several simulation projects where Simulo is extensively used. Quentin lives in Belgium.

QUENTIN LEIRENS IT Scientist

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Dr Eric Snoeck is one of the founders of Exprimo and is now working for SGS Exprimo as an external consultant on specific projects. He was born in 1961 in The Netherlands. He obtained his Ph.D. degree from the University of Leiden with emphasis on mechanism-based PK/PD modelling and his M.Sc. degree in Biochemistry from the University of Nijmegen, The Netherlands. Eric has worked for the Janssen Research Foundation, a J&J company, in Belgium. While at Janssen, he held a variety of posts within the Pharmacokinetics and Drug Metabolism Department and the Central Clinical R&D Organisation. Prior to leaving he served as the Global Development Project Team Leader for one of the oncology compounds in development. After Eric joined Pharsight in 1999 he served as Senior Director and was responsible for the European consultancy group and the management of European modelling and simulation projects. Eric has 15 years of drug development experience and more than 10 years of consultancy experience. His current main research interests include mechanism-based pharmacokinetic-pharmacodynamic modelling and clinical trial simulations. He is interested in all aspects of change management related to the full integration of the clinical trial simulation technology into the drug development process. He is an author of more than 35 original research papers and contributed to three textbooks dealing with pharmacokinetics and PK/PD modelling. He also contributed to several registration dossiers for new drug applications. Eric lives in Belgium.

ERIC SNOECK Principal Consultant (External)

Belén Valenzuela is a Consultant at SGS Exprimo. Belén obtained a Pharmacy degree with special excellence award from the University of Valencia in 1998 and her Pharm.D. degree from the same University in 2002. She also obtained a M.S. degree in Statistics for Health Sciences from the University of Barcelona in 2014. In 2002, Belén joined Pharmacy and Pharmaceutical Technology Area of the Miguel Hernandez University (UMH). She was the first full-time professor in this area and the Head of the Pharmacy and Pharmaceutical Technology Area for seven years. During this period, her research was focused on the population pharmacokinetic modelling applied to methadone, salbutamol, and antagonists of the TRPV1 channel. In 2009, Belén joined Quiron Torrevieja Hospital as Head of the Personalized Pharmacotherapy Service, inside the Platform of Oncology. In this position, she performed TDM and provided clinical support to the Clinical Oncology Department in order to personalize patient´s dosing schedule applying population PKPD models and simulations. In addition, she has performed population PKPD analysis of different oncology drugs under development. Her pharmacodynamic modelling experience is related to hematological, muscular and hepatic toxicities. Belén has been research co-director of 5 PhD Thesis successfully defended (University of Valencia and UMH). Belén joined SGS Exprimo in 2017 and lives in Alicante, Spain.

BELÉN VALENZUELA Consultant

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Daniel Röshammar is the Director of Exprimo. Daniel obtained a M.Sc. in Pharmaceutical Sciences in 2003 followed by a postgraduate Master’s program in clinical drug development (2003-2004) at Uppsala University, Sweden. After studying quantitative clinical pharmacology aspects of antiretroviral therapies, he received his PhD in Medical Sciences in 2009 from the Sahlgrenska Academy at Gothenburg University, Sweden. Daniel has had various expert and managing positions in the pharmaceutical industry at AstraZeneca, Sweden (2009-2013, 2014-2016) and at Ferring Pharmaceuticals, Denmark (2013-2014), including an internship at Servier, France (2002-2003). He has worked across a range of therapeutic areas (infectious diseases, cardiovascular, respiratory, urology, oncology, intensive care, and reproductive health) and he has also contributed to the filing and subsequent approval of new drug applications.Daniel has successfully supervised 2 PhD students (Gothenburg University, Sweden and Roskilde University, Denmark). He is especially passionate about how modelling and simulation can inform the design and evaluation of clinical studies at all stages of development and how it may add value to the decision making process in an easy communicable way. Daniel joined Exprimo in2016 and lives outside of Gothenburg, Sweden.

DANIEL RÖSHAMMAR Director of Exprimo

Nancy Smets is the administrative and program manager for SGS Exprimo. She was born in 1969 in Belgium and graduated from high school having specialized in modern languages. In 1988 she joined Alphadent NV, a dental depot supplying dentists and dental laboratories in Belgium and The Netherlands, starting as allround secretary/receptionist and finishing as responsible for acquisition and sales assistant. In 2007 she joined SGS Belgium NV, working as Clinical Trial Assistant. End 2012 she moved to the contracts department and in March 2015 she started working for the SGS Exprimo team where she’s responsible for all administrative procedures as well as contract and project management. Nancy speaks Dutch, French, English, German and some Spanish. Nancy lives in Belgium.

NANCY SMETS Administrative Manager

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7SGS EXPRIMO: PROFILES OF OUR EXPERTS

CONTACT USSGS Exprimo NVGeneraal De Wittelaan 19A Bus 5B-2800 Mechelen, Belgium

Phone: +32 15 27 32 45E-mail: life.exprimo.info@sgs.com

www.sgs.com/Exprimowww.exprimo.com

EXPRIMO IS PART OF SGS, THE WORLD’S LEADING INSPECTION, VERIFICATION, TESTING AND CERTIFICATION COMPANY.