4th ANTWERP BIOPHARM DAY SAFETY & EFFICACY CLINICAL TRIALS SOLUTIONS DATE: OCTOBER 29, 2015

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1 4th ANTWERP BIOPHARM DAY SAFETY & EFFICACY CLINICAL TRIALS SOLUTIONS DATE: OCTOBER 29, 2015 VENUE: LINDNER HOTEL LANGE KIEVITSTRAAT 125 BE-2018 ANTWERP, BELGIUM

2 2 Join the 4 th one-day seminar to discuss advances in R&D biopharmaceutical development. Learn recent solutions to optimize your clinical development processes and achieve reliable results. This seminar will discuss upstream regulatory & clinical trial considerations but also clinical trial management for patients & special populations background. It will include a selection of scientific talks, case studies and face-to-face meetings with some of our experts and key industry players. PROGRAM REGISTRATION BREAKFAST - WELCOME AND OPENING SESSION 9:00 9:30 Jean-Luc Marsat Managing Director REGULATORY DUE DILIGENCE, USING REGULATORY AFFAIRS TO MAXIMIZE THE VALUE OF A COMPOUND WITH INVESTORS IN EARLY PHASE 9:30 10:00 Bruno Speder Head Clinical Regulatory Affairs TRANSLATING BASIC RESEARCH INTO LICENSABLE COMPOUNDS, DIAGNOSTIC ASSAYS AND BIOMARKER ASSAYS KEY TO DRUG DEVELOPMENT 10:00 10:30 Ingeborg Heirman Business Development Manager VIB vzw WRITING A PHASE I PROTOCOL: A MULTIDISCIPLINARY TEAM APPROACH 10:30 11:00 Dr. Steven De Bruyn Medical Director Early Phase COFFEE BREAK 11:00 11:30 Rabia Hidi Haiko Pillu IMPACT OF SAMPLE HANDLING AND PROCESSING ON BIOANALYTICAL OUTCOME 11:30 12:00 Director Biomarkers & Biopharmaceutical Testing - Laboratory Services Head Technical Operations - Clinical Research HYPNOTIC DRUG SAFETY COGNITIVE ANALYSIS, CLINICAL TRIAL CASE STUDY ON DRIVING ABILITY 12:00 12:30 Dr. Gary Kay CEO Cognitive Research Corporation EARLY PHASE CLINICAL TRIALS IN PATIENTS WITH HEPATIC OR RENAL IMPAIRMENT: FROM DESIGN TO DATA ANALYSIS 12:30 13:00 Nariné Baririan, Pharm.D PK Expert, Head TK NETWORKING LUNCH BREAK 13:00 14:00 EVOLUTION OF DRUG DEVELOPMENT IN INFECTIOUS DISEASES: HISTORY OF THE DEVELOPMENT OF NITAZOXANIDE 14:00 14:30 Dr. JF. Rossignol Chief Scientific Officer and Chairman Romark Laboratories A CONSIDERATION OF H1N1 2009PDM AND NEW VARIANT H3N FOR VIRAL CHALLENGE TRIALS 14:30 15:00 Dr. Adrian Wildfire Project Director, Infectious Diseases and Human Challenge Unit PATIENTS PHASE I CLINICAL TRIALS SECURED MULTI SITE MODEL FOR KEY POPULATIONS RECRUITMENT 15:00 15:30 Dr. Istvan Udvaros Medical and Project Director Oncology EARLY PHASE PHARMACODYNAMIC MODELS FOR RESPIRATORY DRUG CANDIDATES 15:30 16:00 Dr. Robert Lins Senior Consultant Q&A CLOSING REMARKS 16:15 16:30 Jean-Luc Marsat Managing Director TOUR OF THE CLINICAL PHARMACOLOGY UNIT (ON DEMAND) 16:15 18:00 Annick van Riel CPU Antwerp Director

3 3 SPEAKER S REGULATORY DUE DILIGENCE, USING REGULATORY AFFAIRS TO MAXIMIZE THE VALUE OF A COMPOUND WITH INVESTORS IN EARLY PHASE BRUNO SPEDER Head Clinical Regulatory Affairs Developing a new drug is a costly undertaking, which can cost several hundreds of millions. Except for the largest Pharma companies, any other company will need external funding at some stage in the development of a drug. A solid regulatory strategy in early phase clinical research is essential to convince your investors to further fund the clinical development of your compound. Depending on your compound (chemical, biotech product, advanced therapy) and the type of investors (private investors, government funding bodies or a larger pharmaceutical company), different aspects of the regulatory strategy need to be more developed. The main aspects of such an early phase regulatory strategy will be discussed and illustrated with a number of case studies such as the development of a regulatory strategy for a bacteriophage and discussions with Health Authorities. TRANSLATING BASIC RESEARCH INTO LICENSABLE COMPOUNDS, DIAGNOSTIC ASSAYS AND BIOMARKERS KEY TO DRUG DEVELOPMENT INGEBORG HEIRMAN Business Development Manager VIB vzw Drug development strategies continue to undergo major changes and partnership between pharma and academia/start-up biotech companies offers many solutions: pharma companies significantly rely on licensing, co-development and acquisitions to fill up their pipeline. introducing biomarkers as early as possible during the clinical phase of drug development is key for early GO/NO GO decisions. An increased complexity of compounds being developed may translate into an increased complexity of the biomarker development. drug development s focus moves towards personalized medicine, the development of (companion) diagnostics to select the right population for participation in clinical trials and/or to receive treatment is gaining attention from regulatory bodies but is an extra level of investment for drug development companies. Flanders has been proven to be a tremendous resource of top research academia and successful start-up biotech companies, which can play a key role in addressing these three challenges and be a key partner for drug development. VIB plays a crucial role in bridging academia with pharma/biotech companies and clinical research organisations to drive development of innovative drugs and biomarkers/diagnostic assays. As such, VIB has co-founded 11 companies in Flanders, is executing over 110 partnerships with pharma/ biotech companies per year and has a patent portfolio of over 240 patents.

4 4 WRITING A PHASE I PROTOCOL: A MULTIDISCIPLINARY TEAM APPROACH Dr. STEVEN DE BRUYN Medical Director Early Phase A well-written and thought-out protocol is essential for achieving a high quality research study. To write this complete protocol, one must involve multiple key players from different disciplines, including: pharmacokinetics, toxicology, statisticians, modeling and simulation, and a biomarkers specialist. This approach will take additional time and resources, however the time spent on writing a detailed protocol will help to avoid problems and delays during the study conduct and will make publishing the results easier. A complete protocol is also essential for the study to be approved by the ethics committee. This presentation will explain the important roles of each team member in writing an early phase protocol. IMPACT OF SAMPLE HANDLING AND PROCESSING ON BIOANALYCIAL OUTCOME RABIA HIDI Director Biomarkers & Biopharmaceutical Testing Laboratory Services HAIKO PILLU Head Technical Operations - Clinical Research Data from clinical assays (biomarkers, PK, PD, and immunogenicity) are often key outcomes from clinical trials. Implementing these endpoints in clinical trials is very costly and also time - and resource-consuming. Therefore, ensuring that appropriate measures are taken from the collection of samples until the completion of laboratory testing is paramount. The purpose of this presentation is to discuss the challenges and potential pitfalls of sample collection, processing, and storage on the final bioanalytical endpoints and laboratory assays. Key parameters affecting various assay endpoints will be discussed and illustrated with specific examples, highlighting the SGS approach to handling and controlling these critical activities for the successful delivery of these studies outcomes. HYPNOTIC DRUG SAFETY COGNITIVE ANALYSIS, CLINICAL TRIAL CASE STUDY ON DRIVING ABILITY Dr. GARY KAY CEO Cognitive Research Corporation The presentation will cover the 2015 Draft FDA Guidance on evaluating drug effects on driving and answers to the following questions: What drugs need to be evaluated? What methods need to be employed to assess drug effects on driving? At what phase in drug development should screening for impairment of driving be initiated? What is the state-of-the art in driving simulation? The presentation will close with a case study describing the investigation of the acute and steady-state effects of flibanserin on next-day driving.

5 5 EARLY PHASE CLINICAL TRIALS IN PATIENTS WITH HEPATIC OR RENAL IMPAIRMENT: FROM DESIGN TO DATA ANALYSIS NARINÉ BARIRIAN Pharm.D, PK Expert Pharmacokinetic studies in renal or hepatic impaired subjects are often part of the Early Phase Clinical Pharmacology trial portfolio. For most of the drugs that are likely to be administered to patients with renal or hepatic impairment, including drugs that are not primarily excreted by kidney or primarily eliminated by hepatic metabolism/excretion, pharmacokinetics should be assessed in patients with renal or hepatic impairment to provide appropriate dosing recommendations. EMA and FDA guidances are there to support study design, conduct and data analysis, and should be viewed as recommendations. However, in practice, some key questions about design must still be discussed taking into consideration the detailed properties of the investigational drug. This presentation will discuss how the expertise and feasibility analysis are crucial to get valuable results and perform these trials in time. EVOLUTION OF DRUG DEVELOPMENT IN INFECTIOUS DISEASES: HISTORY OF THE DEVELOPMENT OF NITAZOXANIDE Dr. JEAN FRANÇOIS ROSSIGNOL Chief Scientific Officer and Chairman Romark Laboratories Dr. Rossignol has had a very distinguished career in developing new drugs for treating infectious diseases. He will describe the history of clinical development of nitazoxanide, a broad-spectrum antiviral agent for treatment of influenza, and will discuss the evolution of clinical trials and clinical development programs for treating infectious diseases, challenges encountered during clinical development, and the role of viral challenge studies. A CONSIDERATION OF H1N1 2009PDM AND NEW VARIANT H3N FOR VIRAL CHALLENGE TRIALS Dr. ADRIAN WILDFIRE Project Director, Infectious Diseases and Human Challenge Unit The use of live virus in human challenge models to give early predictors of drug and vaccine efficacy is becoming accepted by regulatory Authorities (FDA guidance April 2011 for Industry Influenza: Developing Drugs for Treatment and/or Prophylaxis) as a valid bridge between animal modelling, first-in-human (FIH) studies and early phase field trials. The selection of an agent to use in the model may depend on its relative impact on society. Specifically for influenza, the prevalence of Influenza A, H1N1/09 has fallen over the past five years as a result of immunisation and natural attenuation. An additional pressure on H1N1/09 has been the rapid, global spread of a new Influenza A H3N2 variant. The new variant A/Switzerland/ /2013 fulfils many of the requisites for an ideal challenge agent but offers some distinct advantages over previous H3N2 strains and the pandemic H1N1/09. The case for using the new variant H3N2 will be discussed in the light of current practice with reference to comments and statements from the regulatory authorities.

6 6 PATIENTS PHASE I CLINICAL TRIALS SECURED MULTI SITE MODEL FOR KEY POPULATIONS RECRUITMENT Dr. ISTVAN UDVAROS Medical and Project Director Oncology Patient trials are receiving more focus in the early phase landscape. SGS strategy is to create robust and transparent capabilities to offer customized solutions for a wide range of patient trial requests. Enrollment potential, operational, excellence and completeness in control are the key concerns for sponsors in this field. Beyond our CPU capabilities, we employ a network of Phase I Patient Units. These units are located in hospitals both in Belgium and in the CEE region, where SGS own medical and support staff are present to ensure quality and professionalism in trial execution and SOPs are harmonized for full-scope transparency. Additional or alternative solutions involve our regular cooperation and partnership with carefully selected recruitment expert CROs in order to access highly challenging patient pools or unique geographical locations. EARLY PHASE PHARMACODYNAMIC MODELS FOR RESPIRATORY DRUG CANDIDATES Dr. ROBERT LINS, MD, PhD Senior Clinical Adviser The prevalence of respiratory diseases is increasing worldwide. The most common types are asthma and chronic obstructive pulmonary disease (COPD). Enlarged exposure to certain risk factors and the aging population are responsible for this increase. The large majority of treatments in this therapeutic area consist of inhalation therapy. One of the causes of the rising cost for development of new drugs and the high failure rate is the lack of sensitivity of pharmacodynamics techniques used in translational medicine. In this presentation an overview of current techniques in early development will be given. There will be a special attention for the study of drug disposition in the bronchial tree with techniques like local bronchial pharmacokinetics. Bronchoalveolar lavage may be a promising technique for evaluating drug concentrations and biomarkers in alveolar lining fluid.

7 7 ABOUT SGS LIFE SCIENCE SERVICES is a leading CRO providing clinical research, biologics characterization, biosafety, and quality control testing. Delivering solutions in Europe and in the US, SGS provides clinical trial management (Phase I to IV) services encompassing clinical project management and monitoring, data management, biostatistics, medical writing, pharmacovigilance, PK/PD Modeling & simulation and regulatory consultancy. SGS has its own clinical unit with a total of 88 hospitalization beds in Belgium and has a wealth of expertise in: FIH studies, viral challenge testing, biosimilars and complex PK/PD studies. SGS has large data base of investigators and key opinion leaders with a high therapeutic expertise in Infectious Disease, Vaccines, Oncology and Respiratory. CONTACT US VENUE ADDRESS CONTACT SGS COST & ACCOMMODATION Linder Hotel Lange Kievitstraat 125 BE-2018 Antwerp, Belgium Ms. Marijke Vanderauwera Phone: marijke.vanderauwera@sgs.com The seminar is offered free of charge. However, only pre-registered attendees will be admitted. For information on travel and discounted accommodation please contact Ms. Marijke Vanderauwera REGISTER :

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