EAGLE ROCK LIFE SCIENCES - Key Persons

Anja Wiersma is a medical biologist by training with a PhD in the NeuroPharmacological -Behavioural - Physiology field. After working for 8 years at a multinational Pharmaceutical company (Organon), first as scientific researcher and later as a Strategist in Strategy and Business Development department, she started to work for a Notified Body in the field of Medical Devices and In Vitro Diagnostic Medical Devices. She was working for this notified body for 6.5 years. She is fully qualified as a notified body auditor for both the Medical Device Directive (MDD 93/42/EEC) and the In Vitro Diagnostic Device Directive (IVDD 98/79/EC) . She has full scope qualifications including Annex II and from low Class I, to high risk Class III devices, with her special expertise on borderline products for MDD as well as full scope qualifications for the IVDD including Annex IV. Additional she is a lead auditor for the QMS standard ISO 9001 and ISO 13485, including the requirements needed for Canadian approval (CMDCAS) and Taiwanese compliances. Since 2010 she is a RA/QA consultant for medical device and in vitro diagnostic device manufacturers, and she remains a contractor for several notified bodies executing design dossier reviews and CE audits. She is also specialized regulatory and QMS consultant with regard to the medical device regulatory requirements for FDA. (510(k) DHF approvals and compliance to 21CFR820). Anja is an associate partner of Eagle Rock Life Sciences with focus on medical devices/IVD's regulatory compliances as well as medical device quality management systems and auditing for CE-marking and FDA compliance (QSIT-21CFR820). Expertise Regulatory (Medical Devices)

Bernard Mulder has over 14 years of experience in medical, marketing, sales and management positions in the pharmaceutical industry. He worked for Organon in Asia, Europe and the USA. As Medical Director Asia-Pacific, he was responsible for phase IV clinical trials and medical training. He was speaker at numerous congresses and KOL meetings. He continued his career in France directing sales forces and marketing teams. In the USA, he was responsible for the global commercialization of asenapine in an alliance with Pfizer. Most recently, he was VP Sales and Marketing at Avantium Pharma. Bernard received his MD degree from Leiden University, the Netherlands, and his MBA from New York Institute of Technology, USA. He is founding partner of Eagle Rock Life Sciences, focussed on Marketing & Sales, Medical Affairs and Management. Expertise Strategy & Business Development Marketing & Sales

Carl Thys has over 30 years of international experience in the pharma industry. He started his career in Manufacturing and via Strategic Planning, Licensing & Business Development became responsible for Organon's Marketing & Sales operations in The Netherlands. He subsequently held Sr. VP positions for Global Marketing, Area Asia Pacific and later Area South Europe, Middle East and Africa. He received his degree in Pharmacy at Leiden University. He is a founding partner of Eagle Rock Life Sciences and specialized in Marketing & Sales and Business Development. Expertise General Management Strategy & Business Development Marketing & Sales

Job Titles:

• Board Certified Toxicologic Pathologist

Eric van Esch is a Board Certified Toxicologic Pathologist with over 30 years of experience in the field of toxicologic pathology in the pharmaceutical industry and in various CRO settings. He did manage a wide variety of scientific challenges in toxicological pathology that has deepened his knowledge, expertise and insights. His ideas and approaches to toxicological pathology are innovative and he is always eager to take the data into perspective by considering possible mechanistic implications as well as the overall human risk relevance. He particularly likes the motto of the famous American cell biologist Daniel Mazia: "Think with the eyes and see with the brain". For many years he has served as senior expert pathologist (with specialty in the field of the female and male reproductive system) and as head of a pathology group in the pharmaceutical industry. As a consultant he now supports various clients by a/o microscopic slide readings of investigative, non-, and full GLP toxicity studies, by performing peer reviews and by writing regulatory expert reports on specific problematic pathology cases. He has served on several international pathology expert working groups. Expertise Toxicologic pathologist

Job Titles:

• Certified Biostatistician

Gonnie van Osta is a certified biostatistician with over 30-year experience in clinical development. She studied mathematics at the University of Amsterdam She worked at Organon as a senior statistician and biometrics manager for a variety of indications (Women's Health, CNS (Psychosis, Sleep), Rheumatoid Arthritis). During that time, she was a member of the Dutch pharmaceutical statistics and data management (PSDM) working group and council member of the EFPSI (European Federation of Statisticians in the Pharmaceutical Industry). She has a broad understanding of the drug development (regulatory) requirements, extensive knowledge of ICH, EMA and FDA guidelines and hands-on experience in applying these guidelines. Following the Schering-Plough merger, she broadened her scope and responsibilities in various clinical, regulatory and pharmaceutical development functions. From 2014 onwards she works as a statistical consultant, providing input and statistical design justifications for a variety of clinical trials, as well as leading integrated statistical analyses for regulatory filings. Gonnie is an associate partner of Eagle Rock Life Sciences with focus on Statistics. Expertise Women's health

Jolanda Elbers studied Biological Health Sciences at the Maastricht University and has more than 20 years experience in clinical research. She received her PhD degree in Medicine at the Division of Endocrinology/Andrology of the Vrije Universiteit in Amsterdam in 1999. One year earlier, she joined Organon as a Clinical Research Scientist at the Global Clinical Development Department. Since then, she has played a leading role in several clinical research projects on male and female hormone therapy. Her experience covers all aspects of late-stage clinical development, from protocol design to clinical reporting and providing scientific input to regulatory documents. She is an associate partner of Eagle Rock Life Sciences with a focus on clinical development in the area of (late-onset) male hypogonadism, menopausal health and infertility treatment. Expertise Women's Health

Martin Smit has 20 years experience in drug discovery. He has been instrumental in introducing early ADME and toxicology in research and has been heading teams in lead finding and optimisation projects in a range of therapeutic areas, before he became head of Molecular Pharmacology at Organon (Schering-Plough/MSD). He received his PhD in biochemistry in Groningen. Currently he is director of the Graduate School of Medical Sciences at the University Medical Center Groningen and Program Manager Life Sciences of the Healthy Ageing Network Northern Netherlands. He is associate partner of Eagle Rock Life Sciences with focus on Molecular Pharmacology. Expertise Molecular Pharmacology

Job Titles:

• Associate
• Partner
• Pharmacist and Certified Clinical Pharmacologist

Mireille Gerrits is a pharmacist and certified Clinical Pharmacologist with more than 25 years clinical drug development experience. She has worked as a pharmacist and project manager for a phase I CRO before joining Organon, Schering Plough and Merck/MSD as Director Clinical Pharmacology. Mireille worked on different therapeutic areas, amongst others Women's Health, CNS, pain and immunology and she contributed to several regulatory filings. Mireille is an associate partner of Eagle Rock Life Sciences with a focus on designing programs for new drugs in early stage development, from first-in-human up to proof-of-concept, as well as on clinical pharmacology/pharmacokinetic programs during late stage development. Expertise Clinical pharmacology

Peter Chung has a vast experience in the Hong Kong pharmaceutical industry, both in ethical as well as OTC business. He held General Management position in both and was a Board member of the Hong Kong Association of the Pharmaceutical Industry for more than 10 years. He is an external lecturer on Bio-technology Business for Master degree graduates at the Hong Kong University of Science and Technology. Peter has an excellent network in China. His educationalbackground includes Electrical engineering in the Hong Kong Polytechnic and MBA at Oklahoma University.cHe is associate partner of Eagle Rock Life Sciences with focus on implementation of new businesses in China and Hong Kong Expertise Strategy & Business Development Marketing & Sales

Renato de Leeuw is Medical Biologist by training with a PhD in Reproductive Endocrinology. He served for 24 years at Organon, Schering-Plough and Merck in several R&D functions, from Research in Endocrinology to Project Management of Hormone Replacement Therapy projects and for over 10 years in Regulatory Affairs. He has contributed successfully to the development and registration of a wide range of products in Contraception, Fertility and HRT. Since 2007 he was Executive Director and Global Regulatory Head for the Women's Health portfolio of Schering-Plough and Merck. Renato joined Eagle Rock Life Sciences early 2013 as associate partner with focus on (pre)clinical development and registration in the area of reproductive medicine Expertise Women's Health

Job Titles:

• Design

Willem Daniels has a vast experience of more than 25 years in the pharmaceutical industry. He started his career at Organon International in various marketing and sales functions which developed over time in general and senior management positions. More specifically he has held Managing Director positions in Asia, Europe and the Middle East. Since 2004 he is based in Cyprus from where his focus has been on the Middle East, Near East and North Africa. A turbulent area which is very well known to him and he has a very vast network of excellent business contacts as well as solid business partners in the field of commercialization of pharmaceutical and semi-pharmaceutical products.Willem received his MBA degree from Erasmus University in Rotterdam and Technical University Delft. He is an associated partner of Eagle Rock Life Sciences with focus on implementing new businesses in the MENA Region. Expertise Strategy & Business Development Marketing & Sales