FUTURE MEANS CREATIVITY

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1 START-UP & ACADEMICS THEORY & PRACTICE IN DRUG DEVELOPMENT 1 EARLY PHASE DRUG DEVELOPMENT COURSE MAY 9 TH ANTWERP FUTURE MEANS CREATIVITY VENUE: LINDNER HOTEL LANGE KIEVITSTRAAT 125 BE-2018 ANTWERP, BELGIUM SPONSORED BY:

2 START-UP & ACADEMICS THEORY & PRACTICE IN DRUG DEVELOPMENT 2 This course aims to provide participants with a strong insight in how drugs are developed, and how you can successfully make the transition from lab to clinic. This meeting encompasses a theoretical plenary morning session with expert lectures and discussions, and in the afternoon, practical workshops where the participants will apply the lessons learned on actual case studies. This meeting will address: The common hurdles and challenges in early phase drug development Which regulatory aspects you need to take into account when moving through the different phases of drug development How early data analysis through pharmacokinetic and modeling & simulation can optimize decision making AGENDA 9:00-9:30 REGISTRATION AND WELCOME COFFEE 9:30 OPENING 09:35-10:20 OPTIMIZING EARLY CLINICAL DRUG DEVELOPMENT IN THE 21 ST CENTURY Dr. Katrien Lemmens Medical Director Early Phase 10:20-11:05 HOW CLINICAL PHARMACOLOGY AND PHARMACOKINETICS EXPERTISE CAN SUPPORT THE EARLY CLINICAL DEVELOPMENT OF NEW DRUGS: FROM THEORY TO PRACTICE Nariné Baririan PK and Clinical Pharmacology Expert 11:05-11:15 COFFEE BREAK 11:15-12:00 INFORMED DECISIONS FOR TARGET SELECTION: HOW CAN PK/PD MODELING & SIMULATION CONSULTANCY HELP? Ruben Faelens Scientist Exprimo 12:00-12:45 FROM LAB TO MARKET: WHAT DO REGULATORS EXPECT? Bruno Speder Head Clinical Regulatory Affairs & Consultancy 12:45-13:30 LUNCH BREAK 13:30-14:30 WORKSHOPS & CASE STUDIES 14:30-14:50 COFFEE BREAK 14:50-16:00 CONCLUSION & CLOSING The venue is the Linder Hotel in Antwerp (Kievitplein, 2000 Antwerp), conveniently located near the Antwerp Central Railroad station. The hotel also has a car park, located in the Van Immerseelstraat. Lunch and refreshments throughout the day are foreseen. The training is free of charge, however registration is mandatory. Register yourself by sending an to Christina.Abts@sgs.com before 1 May. A certificate of attendance will be provided to the participants.

3 START-UP & ACADEMICS THEORY & PRACTICE IN DRUG DEVELOPMENT 3 SPEAKER S & BIOGRAPHIES OPTIMISING EARLY CLINICAL DRUG DEVELOPMENT IN THE 21 ST CENTURY DR. KATRIEN LEMMENS Medical Director Early Phase Over the past three decades, costs of drug development have risen sharply, while the likelihood for a new compound to make it to the market declined. This discrepancy reveals the need to rethink the traditional clinical development model. Recent advances in science and technology pave the way for sophisticated and innovative approaches. For example, better understanding of diseases at the molecular level leads to the development of molecularly targeted therapies. Also, a patient s response to treatment in terms of safety and efficacy can be better predicted upon their molecular and genetic profile. This presentation focuses on the critical role of the early clinical development process. Modernizing and optimizing early phase clinical studies is paramount for late phase success. Therefore, early phase clinical trials, such as the first-in-human trials, need to be designed in a smart way to gain crucial information on the new compound as early as possible. Implementing innovative tools, such as biomarkers, aids to improve safety/efficacy testing methods and provides the possibility to improve success rates and shorten timelines. During the workshop, a practical exercise will be provided to reflect on possible tools and designs that can be used to optimize the trial. Dr. Lemmens obtained her MD in 2000, and a PhD in 2006 from the University of Antwerp. She started her medical career as a clinical cardiologist, before undertaking a post-doctoral position at the physio-pharmacology laboratories at the University of Antwerp. Dr. Lemmens went on to join Janssen Pharmaceuticals where she was Medical Director of its Clinical Pharmacology Unit in Merksem, before rejoining the University of Antwerp as Associate Professor of Pathophysiology and Pharmacology. From Oct 2016, Dr Lemmens joined as Medical Director Early Phase. HOW CLINICAL PHARMACOLOGY AND PHARMACOKINETICS EXPERTISE CAN SUPPORT THE EARLY CLINICAL DEVELOPMENT OF NEW DRUGS: FROM THEORY TO PRACTICE NARINÉ BARIRIAN, PK and Clinical Pharmacology Expert Animal and other forms of laboratory research provide the foundation for human studies. Before proceeding to early human testing, investigators and reviewers must determine whether the preclinical scientific foundation is adequate. This is a complex and valueladen task. First in Human (FIH) clinical trials are part of the exploratory phase of drug development and represent a significant milestone in the clinical development of new drugs. When only preclinical data are available to guide dose-selection, population, study design, safety monitoring and appropriate expertise are all critical to maximise the safety of the study subjects and the quality of the data. In choosing design options for FIH and other Early Phase clinical trials, it is important to consider factors linked to the compound pharmacological (PK and PD) characteristics. This presentation will discuss how Clinical Pharmacology and Pharmacokinetics expertise are crucial to find the best clinical trial design which will be acceptable for appropriate Health Authorities and will bring valuable results. Some practical examples of drug-drug interaction and hepatic/renal impairment study designs will be discussed during the workshop.

4 START-UP & ACADEMICS THEORY & PRACTICE IN DRUG DEVELOPMENT 4 After obtaining a University degree in Pharmaceutical Sciences, Nariné has started the Research Master in UCL (Belgium) in Cellular and Molecular Pharmacology orientation. The research experience was continued by a PhD in Pharmaceutical Sciences at UCL and St Luc Hospital (Bruxelles) in Clinical Pharmacology and Pharmacokinetics orientation. By doing PhD, Nariné performed her own research clinical trials in the Unité de Pharmacologie Clinique at St Luc Hospital and therefore obtained the first knowledge and experience in Clinical Pharmacology applied to Clinical Trials, which was further continued at. 10 years ago Nariné joined as Pharmacokineticist, then she worked as a PK team Coordinator and now as PK and Clinical Pharmacology Expert. In her function, Nariné is a part of consultancy/experts team supporting/advising the clients in the study designs and Clinical Development plans of their new compounds. INFORMED DECISIONS FOR TARGET SELECTION: HOW CAN PK/PD M&S CONSULTANCY HELP? RUBEN FAELENS Scientist Exprimo In this talk, Ruben Faelens from Exprimo will show how we can make better decisions in drug development, through the use of Modeling & Simulation. Strategic decisions in drug development can be of vital importance to a company. In , the Likelihood of Approval from Phase 1 was only 9.6%. Only 1 in 10 promising drugs get approved for use in humans. The attrition rate for Phase 2 is the highest, with 69.3% of Phase II trials failing. To fix this, we need to make better decisions. We need better information. Authorities agree, and promote Model-Informed Drug Development as one of the tools to discover early on if compounds will fail in later phases. In this talk, we present a concrete case study for Phase 2 trial design in Parkinson s Disease. Using publicly available information, we show how we designed the study, and how we optimized information discovery during the trial. Afterwards, a practical session will allow you to simulate several trial design options for yourself, using a demo compound. Together, we will decide the next step for your compound, allowing you the best chances of market approval. Ruben is a Scientist at Exprimo. He obtained a Master s degree from the KULeuven (Belgium) in Computer Science in He also studied abroad in Stockholm (Sweden) for 6 months. Ruben joined Altran, a software consultancy firm, in late 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 strong interest in the field of pharmacometrics with his passion for IT. Ruben focuses on simulation projects (clinical trial optimization, power calculation, therapeutic drug monitoring), as well as the internally developed pharmacometric simulation software.

5 START-UP & ACADEMICS THEORY & PRACTICE IN DRUG DEVELOPMENT 5 FROM LAB TO MARKET: WHAT DO REGULATORS EXPECT? BRUNO SPEDER, Head Clinical Regulatory Affairs & Consultancy Bringing a compound from the lab to the market is a long and winding road with a great number of potential pitfalls. During drug development it is very important to have a clear view on the expectations of Regulatory Authorities at each stage of drug development. During this talk we will highlight the most common regulatory issues that may arise through a number of illustrated case studies and how you can make sure you keep your development on track. Bruno is Head Clinical Regulatory affairs & Consultancy at Clinical Research. Bruno is pharmaceutical engineer and has almost 10 years experience in drug development. He supports pharmaceutical and biotech companies in designing their regulatory strategies and supports them in the interactions with regulators like EMA and FDA. He is member of the advisory board of several biotech companies and guest lectures on clinical research in the honours Program of the Ghent University. He is also member of the clinical trial steering group of TOPRA, the European Organisation for Regulatory Affairs. ABOUT LIFE SCIENCES is a leading life science CRO providing clinical research, biologics characterization, biosafety, and quality control testing. Delivering solutions in Europe and in the US, provides clinical trial management (Phase I to IV) services encompassing clinical project management and monitoring, data management, biostatistics, medical writing, pharmacovigilance, PK/PD Modeling & simulations and regulatory consultancy. has its own clinical unit with a total of 88 hospitalization beds in Belgium and has a wealth of expertise in FIH studies, human viral challenge testing, biosimilar and complex PK/PD trials, as well as other regulatory and exploratory trials. has a large database of investigators and key opinion leaders with therapeutic focuses in Infectious Disease, Vaccines, Oncology, and Respiratory. CONTACT US VENUE ADDRESS CONTACT COST & ACCOMMODATION Lindner Hotel Lange Kievitstraat 125 BE-2018 Antwerp, Belgium Christina Abts Christina.Abts@sgs.com The seminar is offered free of charge. However, only pre-registered attendees will be admitted.

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