In this webinar, ICON we will provide insights on scientific considerations, regulatory requirements and study design approaches in drug development programs. This aim of this webinar, is to build a deeper understanding of the role of preclinical sciences and clinical pharmacology in early development and how novel study design approaches can be used to streamline drug development.
This webinar will be hosted by KoNECT.
|Early Oncology approaches||How study design helps to understand risk/benefit in oncology||Andreas Dreps|
|Preclinical development||Understand IND (FDA) requirements||Fiona Diamond|
|Use of Synthetic or historical controls||Review how and when synthetic arms can be used in development programs||Will Maier|
|First time in Humans (FIH)||Review different approaches to FIH studies||Ewoud-Jan van Hoogdalem|
|Predicting Drug induced liver Injury||How preclinical approaches can help de-risk development programs||Guy Webber|
Andreas Dreps, PhD
Senior Vice President, Oncology Drug Development, ICON
Dr. Dreps has over 25 years of clinical research and development experience in a variety of solid tumours and haematology diseases including, breast, NSCLC, SCLC, pancreatic, gastric, ovarian, colorectal, head & neck and prostate cancers. He is co-author of the EMA submission dossier of Paclitaxel for ovarian cancer and the FDA /EMA Taxotere submission dossier for breast cancer and NSCLC.
Prior to joining ICON, Andreas held positions at BMS, Aventis Medical, Merck/Serono and was responsible for the clinical development of Taxol®, Taxotere®, Campto® and Gliadel®. Dr. Dreps was instrumental in the clinical development of several targeted therapies including 2 EGF-R antibodies (Erbitux® and EMD 72.000), angiogenesis inhibitors (Cilengitide) and vaccines (BEC-2, Theratope and BLP-25).
Dr. Dreps completed his post-doctoral fellowship at Beckman Research Center, Stanford, CA, and at Sugen Inc., Redwood City, CA.
William C. Maier, MD, PhD
Vice President, Rare Disease, Drug Development Sciences, ICON
Dr. William C. Maier, MD, PhD is Vice President, Center for Rare Diseases at ICON. He has over 25 years of experience in drug development and commercialisation at pharmaceutical companies in Europe, Canada, the US and Asia. At ICON he works with pharmaceutical companies throughout the world to provide regulatory, strategic, and scientific guidance on medical treatment development and commercialisation. He is a member of the EMEA’s European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (www.encepp.eu). In addition, he is a frequent speaker at medical conferences, has had academic appointments in the UK (Dundee) and the US (North Carolina) and is a member of the Royal Society of Medicine in the UK.
Ewoud-Jan van Hoogdalem, PharmD PhD
Vice President, Clinical Pharmacology, ICON
Ewoud-Jan van Hoogdalem, PharmD PhD, is Vice President Clinical Pharmacology in ICON. His team advises on strategic early clinical drug development and clinical pharmacology program design in all therapeutic areas including orphan drug indications, executed by the ICON clinics in the EU or USA, or in clinics elsewhere. He has over 30 years of drug development experience with small biotech and large pharma companies including JNJ and Yamanouchi (now Astellas). He is a board-certified clinical pharmacologist and licensed pharmacist with a PhD in pharmacology from Leiden University. He is member of various professional organizations, co-organizer of various scientific conferences, and is first author/co-author in over 35 publications in peer-reviewed journals or book chapters.
Guy Webber, BSc (Hons), MSc
Senior Director, Preclinical/Nonclinical Consulting (NC)
In his role as Senior Director, Guy is responsible for providing strategic and technical advice on all aspects of pharmacokinetics and ADMET. He is an experienced DMPK scientist and consultant who has worked in drug metabolism for over 25 years. Guy’s focus is in understanding the biotransformation and drug-drug interaction (DDI) potential of new molecular entities and applying this knowledge to discovery and development programmes, advising on lead selection, applying metabolism-driven de-risking strategies and IND-enabling requirements. He holds a BSc in Chemistry and an MSc in Medicinal Chemistry and Drug Metabolism both from Loughborough University in the UK. Prior to joining ICON, Guy spent time at GSK conducting metabolism and in vitro ADMET screening studies, before taking several senior DMPK leadership roles within various contract research organisations including holding the role of Chief Scientist for In Vitro and DDI Sciences at Quotient for over 10 years. He has contributed to several successful New Drug Applications (NDAs) to date, providing the crucial DMPK (ADME, MIST) and DDI data sets required for regulatory review and approval. Guy has regularly attended the major worldwide metabolism and toxicology focussed conferences (ISSX, SOT, DMDG) giving presentations and presenting new work on many different aspects of DMPK. He has also given numerous webinars and published white papers on DDI, DILI and MIST assessment.
Fiona Diamond, BSc, MSc, DABT, ERT, MRSB
Senior Director, Head of Preclinical/Nonclinical Consulting, Drug Development Services
Fiona currently heads up the Nonclinical Drug Development team at ICON, where she provides expert advice on the safety evaluation of pharmaceuticals and biopharmaceuticals.
Fiona has over 30 years of experience in drug development. Before taking up her role as a toxicology consultant within Fulcrum Pharma in 2006, Fiona spent 16 years in various Contract Research Organizations (CROs), gaining in depth practical knowledge of preclinical drug development. After initially gaining hands-on experience in radiolabelled ADME studies, she moved into the field of Toxicology, becoming a Study Director in 1996. Since 2006, Fiona has gained extensive experience as a Study Monitor, and has conducted many technical audits of suppliers worldwide. She has directed a variety of projects, in a broad range of indications, and has compiled the nonclinical sections of many successful regulatory submissions, from First Time in Human through to Marketing Authorisation. Fiona has also interacted with the FDA, EMA and various member countries through written responses and meeting attendance.
Fiona holds a BSc in Life Sciences from Napier University, Edinburgh, an MSc (with distinction) in Applied Toxicology from the University of Surrey and is a Board certified toxicologist in the US (Diplomate of the American Board of Toxicology (DABT)) and Europe (European Registered Toxicologist (ERT)). She is also a Member of the Royal Society of Biology (MRSB).