Our Experts

Dr. Sara Armani is an expert in scientific consulting (clinical pharmacology), serving as the vital connection between our Medical Affairs and Business Development teams. Since February 2020, she has led our Medical Affairs division, applying her more than 20 years of experience in the CRO industry, including her previous role at Parexel. Dr. Armani specialises in the planning and designing of clinical trials, first-dose calculations, protocol development, and medical monitoring. As a board-certified clinical pharmacologist, she also actively participates in safety review meetings and independent data monitoring committees. Dr. Armani holds a Pharmacy degree from the Free University of Berlin, a Medical Doctor degree, and a Ph. D from Charité University Medicine and a bord Certification in Clinical Pharmacology from Berlin Physician Champer.

Professor Thomas Andreas Forst is a board accredited physician for internal medicine and endocrinology. In 1989, he started his postdoctoral clinical and scientific carrier at the German Diabetes Research Institute (German Leibnitz Institute) at the Heinrich Heine University in Düsseldorf, Germany. After changing over to the Medical Department for Internal Medicine at the Johannes Gutenberg University in Mainz, Germany in 1991, he achieved his graduation in Internal Medicine in 1996 and in Endocrinology in 1997. In 2006 Professor Forst was recognized as a Professor for Internal Medicine at the Johannes Gutenberg University Mainz, where he is still involved in the training of medical students. From 1999 until 2001, he served as a Clinical Research Physician at Eli Lilly Indianapolis where he was responsible for several clinical trials in the development and registration of new drugs for the treatment of cardiometabolic diseases. In 2001 he took over the position of the CEO and Medical Director of a clinical research organisation (Institute for Clinical Research and Development, Mainz, Germany). In 2013, Professor Forst took over the position of the CEO and Director for Medical Science at the Profil Institute Mainz, before he joined Clinical Research Services, Germany as a Chief Medical Officer in 2018.

Mariya has worked for hVIVO since 2014 in various roles including Viral Challenge Physician, Senior Physician/ Principal Investigator, Associate Medical Director and has been appointed in March 2021 as Medical Director. Since qualification in 1996 at the Medical University, Sofia, Bulgaria Mariya specialized in General (Internal) Medicine. Mariya have wide experience in oncology, hematology, rheumatology, gastroenterology, endocrinology and Chronic & Preventative Care; both in Bulgaria and the UK. She is on the GMC Specialist Register for General (Internal) Medicine, and has a current ALS certificate. Mariya is an experienced pharmaceutical physician; this expertise extends to RSV challenges, Influenza, HRV and SARS-CoV-2. As PI, Mariya has been responsible for many clinical trials including RSV, SARS-CoV-2 characterisation and vaccine trials. She has developed and overseen clinical development for clients including safety and medical monitoring. She also regularly trains, supervises and supports staff and investigators.

Maria leads the medical team at CRS Kiel, bringing extensive expertise across multiple therapeutic areas and all phases of clinical research. Before joining CRS, she served as Medical Director at Velocity Clinical Research and Head of Clinical Research at eCovery. Her previous roles also include Senior Clinical Research Physician at Parexel and Medical Site Lead at SIBAmed, where she contributed to both early- and late-phase studies. Dr. Lehretz’s clinical insight and leadership are central to delivering high-quality research at our Kiel site.

Marina serves as Medical Director at CRS Mannheim, bringing a wealth of clinical and leadership experience from her previous roles as Deputy Medical Director and senior anesthesiologist at Theresienkrankenhaus Mannheim and Kreiskrankenhaus Freudenstadt. Board-certified in anesthesiology, emergency medicine, and operative intensive care, she also has expertise in quality management and medical ethics. A graduate of Heidelberg University, Marina is committed to advancing clinical research and plays a key role in driving medical excellence at our Mannheim site.

Andrew first studied as a virologist at the University of Warwick before then furthering his education with postgraduate studies for his DPhil in influenza replication at Oxford University. Since then he has applied his scientific knowledge in a commercial setting. After working as part of a multidisciplinary R&D team developing nuclear medicine research tools at GE Healthcare, he then returned to the field of virology to work for hVIVO, an industry-leading service provider of human viral challenge studies (controlled human infection studies). Andrew is now considered an expert in human viral challenge studies and challenge agent production having played key roles in the development of numerous challenge models at hVIVO including influenza, RSV, HRV, SARS-CoV-2 and hMPV. He has overseen the design and conduct of numerous antiviral, immunomodulator and vaccine product efficacy studies and now works as the Chief Scientific Officer (CSO), leading scientific strategy for the company. A key part of his CSO role is to provide scientific consultancy both internally and externally to hVIVO’s clients and collaborators on clinical study design, laboratory sample analysis and data interpretation as well as to oversee hVIVO’s challenge agent manufacturing activities.

Bringing 25 years of strategic and operational leadership across global drug development and manufacturing enterprises, Chris has guided initiatives spanning the UK, EU, and US. His expertise lies in crafting clear business and operational frameworks and inspiring high-performance teams in dynamic, solutions-driven environments. He is passionate about forging strong client partnerships and delivering impactful therapies that meaningfully improve patient outcomes. This client-centric approach has consistently fostered shared success and long-standing relationships. In each role, Chris has demonstrated a commitment to culture, accountability, and empowerment. 360° feedback and engagement surveys frequently highlight his leadership, which is praised for authenticity, leading-by-example, and cultivating talent. Chris’s track record includes steering CMC/biosafety teams in the UK, scaling operations across Ireland/EU, and most recently, advancing growth within a major US-based organisation.

Clinical Science Director at hVIVO with 20 years’ experience in both animal and human challenge models for infectious diseases including SARS-CoV-2, influenza virus (H5N1 & H7Nx highly pathogenic avian influenza, H3N2 & H1N1), avian paramyxovirus and human respiratory syncytial virus. Grant manager for UK Research and Innovation Biotechnology and Biological Sciences Research Council (BBSRC) and Department of Environmental and Rural Affairs (Defra) grants. Oversight of the management of BSL-3 facilities and associated Health & Safety processes. Expertise also includes business development, project management, grant applications, leadership and management, infectivity, molecular and serological assay development and validation to FDA/ICH/EMA guidelines and UKAS 17025 and ISO 9001, animal models of disease (highly pathogenic avian influenza H5N1 & H7N1/H7N7; Newcastle disease) pathogenesis and transmission (pigs, poultry, ferrets), reversers genetics of both paramyxo- and orthomyxoviruses, and molecular biology including phylogenetics.

Alex Mann is a senior clinical scientist with over 25 years’ experience working in infectious and respiratory disease clinical research at hVIVO. He has significant expertise in leading the design, execution, and analysis of human challenge studies for efficacy testing, using pathogens such as Influenza, RSV, and Rhinovirus, as well as more recently clinically characterising new challenge agents such as HMPV and SARS-Cov2 variants. A major focus of Alex's research has also been collaborating with partners to mature hVIVO’s challenge and non-challenge airway disease capabilities including for asthma, COPD, bronchiectasis.

Nicolas Noulin is a virologist with over 20 years of experience in infectious and respiratory disease research. Since joining hVIVO in 2010, Nicolas has contributed to human virus challenge studies for various respiratory viruses including influenza, HMPV, RSV, rhinovirus, and SARS-CoV-2. As Director of Clinical Science, he has been involved in developing GMP viruses for Controlled Human Infection Models and analysing trials to evaluate vaccine and antiviral efficacy. An accomplished researcher, Nicolas has collaborated with academic institutions and pharmaceutical partners. He also has authored and co-authored a significant number of peer-reviewed publications and presented oral abstracts at industry conferences. Nicolas' work focuses on translational research and vaccine development, contributing to respiratory virus research efforts. He holds a PhD in Immunology and Molecular Biology from Orléans University, France, and completed post-doctoral research at the Institut Pasteur, Paris.

Over 25 years of experience in Clinical Data Management within CROs, including more than 17 years in leadership roles and 15 years at Venn. Brings a deep expertise in clinical trial data management processes, with comprehensive knowledge of ICH/GCP guidelines, CDISC standards, and GCDMP principles. Strongly committed to delivering excellence in customer service and ensuring high-quality data outcomes.

Erik Gout has over 40 years of experience in the pharmaceutical industry. He has been involved in numerous drug development projects as analytical scientist, pharmaceutical development scientist, Quality Insurance engineer and CMC project leader. His experiences also include Technology Transfers, writing, reviewing, and approving regulatory CMC documents, GMP QA audits and due diligence of various projects. He is a senior consultant in CMC and is head of the department.

An experienced clinical & IT professional with over 30 years experience in the Medical Research area and substantial knowledge of IT, statistics and methodology, having commenced his career as a statistical programmer Christian has significant experience in developing technologies and systems to enhance and improve the services offered to clients. Achievements include development of technologies to automate statistics production in ICH report, optimisation of clinical research departments, IT consultancy for a wide variety of organisations involved in clinical research (e.g. central Laboratory, CMO, CRO, Biotech and phase I units), Establishment of a clinical database management department, establishment of RTSM department. Thorough understanding of clinical trial processes together with in-depth knowledge of ICH/GCP guidelines. Organised and highly motivated team player with excellent communication skills who is committed to customer service excellence.

Teja brings 12 years’ experience of working in a number of QA GCP roles in the Clinical research & CRO industry. She has extensive experience in conducting GCP & GCLP audits, supplier audits and hosting external inspections. She has led multiple projects involving improvement of existing processes and systems, implementation of GCP compliant standards within business and regulatory gap analysis. She has worked at hVIVO since 2016 and was appointed as Head of QA in 2021. Previously she worked as a GCP Compliance manager at Institute of Cancer Research/Royal Marsden Hospital. Teja is a pharmacist and holds M. Tech degree in Bioprocess Technology and Doctorate degree in Pharmaceutical Sciences from University of Mumbai, India.

Katsuhiro Mihara, RPh, PhD is a registered pharmacist and with a PhD in pharmaceutical sciences from the University of Tokushima. He joined Venn in 2016 to lead the Clinical Development department and is currently also leading Venn’s business in the Netherlands. Before joining Venn, he held leadership and senior scientist positions in clinical development and pharmacology at Abbott, Merck Sharp and Dohme, Schering Plough and Organon, giving him over 25 years of experience in preclinical/early clinical drug development in big pharma, biotech and provider alike. He has been involved in numerous drug development projects as project leader, clinical trial manger and/or study director in multiple therapeutic areas, including, but not limited to, oncology, immunology, dermatology, urology, gynaecology and CNS from early discovery to marketing. His experiences also include due diligence of various drug development projects with primary focus on risk assessments including evaluation of regulatory documents at major milestones (e.g. pre-IND, End of Phase I/II meetings) for investors.

Alice Tourneroche brings over 20 years of experience in clinical research statistics, with a strong foundation in statistical methodology gained through her Master’s Degree from Paris XVIII University, specializing in Biomedical Research. She joined Venn in 2010 as a Senior Statistician and has led the Statistics department since 2012. As Head of Statistics for more than 15 years, Alice has overseen a wide range of projects across multiple therapeutic areas, spanning clinical phases I through III. She is well-versed in global regulatory standards, including ICH, FDA, and EMA guidelines, and has extensive expertise in implementing CDISC ADaM standards to ensure high-quality, compliant clinical data submissions.

André Wolterbeek has a PhD in Toxicology with over more than 25 years CRO experience as scientist, study director and project leader in performing and monitoring of preclinical projects for the pharmaceutical, chemical and food industry. He acquired much experience in the conduct and evaluation of preclinical IND-enabling studies for various therapeutic areas and was heavily involved in development of new methodologies. He has thorough understanding of OECD, ICH and FDA guidelines and was involved in drafting new and/or updated guidelines. He is currently senior consultant non-clinical development and is leading the non-clinical department.