Outsourcing in Clinical Trials DACH 2020
Mövenpick Hotel Zürich-Regensdorf
7th-8th October, 2020
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Outsourcing in Clinical Trials DACH 2020
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7th – 8th October 2020, Zurich, Switzerland
After an incredibly successful 2nd edition, Outsourcing in Clinical Trials DACH will be taking place in Zurich for 2020.
The 3rd annual edition will focus upon the operational challenges in clinical development found within Germany, Austria and Switzerland. Over 2 days, delegates will discuss the common challenges and trends impacting the region, including steps for defining contractual relationships and getting the maximum from external providers, incentivising good relationships with CROs and constructing defined deadlines.
With ideas shared between large and small pharma alongside innovative solution providers, this event will offer interactive, knowledgeable and will be a highlight within the DACH pharma industry calendar. Delegates will enjoy an engaging programme with workshops, panel discussions, roundtables and presentations, whilst exchanging local knowledge on the opportunities for clinical trials in the region.
Registration is now open – book your 2020 ticket today!
WHAT TO EXPECT FOR 2020
Join pharma and biotech experts to discuss new trends and opportunities and learn how they optimize their clinical operations enabling you to stay ahead of the game.
Find the right solution providers to partner with, allowing you to accelerate your trial timelines.
250+
ATTENDEES
30+
SPEAKERS
20+
EXHIBITORS
75%
ATTENDEES AT
DIRECTOR+ LEVEL
WHY THIS IS YOUR UNMISSABLE CONFERENCE
NETWORK
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This is an exceptional networking opportunity for industry accelerators. Meet industry C-Suite and Director level executives and make valuable connection at this annual thought leadership platform.
LEARN
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Join like-minded peers to learn new perspectives and case studies through presentation, panel discussions, interactive round tables and workshops.
ACTION
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The conference discusses the vital connections between process, tools and techniques to manage change. Update your knowledge to create new strategies enabling you to enact change.
Marie-Eve Alary
Clinical QA Operational Project Lead,Sandoz
Biography:
Session Details: Panel Discussion: A perfect marriage! How to work in harmony – bringing sponsors and CROs together 10-10-2019, 9:45 am View In Agenda
Denise Lee
Head of Clinical Operations,Allergy Therapeutics
Biography: Denise loves to delegate! When an opportunity arose 14 years ago as Clinical Study Manager at a mid-sized pharmaceutical company with a 100% clinical trials outsourcing model, she jumped at it. In doing so, she left behind her role as Clinical Research Manager at the Technical University of Munich. Today, Denise heads up a Global Clinical Operations department, where she is dedicated to establishing the best model of outsourcing for the delivery of succinct and successful clinical trials, one that meets company culture, conditions and cash-flow. Denise’s background as clinician in occupational therapy and psychiatry, together with over 17 years of clinical research experience, has taught her that the key to success is a keen understanding of drivers behind questions, people, projects and institutions, the courage to take decision and action, and the belief that each path forward leads you to the finish line!
Session Details: Multiple Vendor Management in Clinical Trials Update: an effective model for small to medium-sized companies 10-10-2019, 12:15 pm View In Agenda
Stephan Aufhammer
Senior Manager, Global Project Management,Merz Pharma
Biography: Leading cross-functional teams within research & development, a Global Project Leader has to control several projects in a matrix organization, to report to steering committees and bring decisions to the highest management board. MERZ class III medical devices are known to improve wrinkles in several body regions. Certain formulations are under life-cycle management; safety and efficacy are to be proven in clinical programs.
Session Details: KEYNOTE: Live Cycle Management in between two regulatory environments 09-10-2019, 9:00 am View In Agenda
Laura Beni
Head of Clinical Operations,Cellestia Biotech AG
Biography: Laura Beni has over 15 years’ experience in pharma, CRO and academic setting of which 10+ years in the Clinical Operations. During her career progression she took on more and more responsibilities not solely limited to the Clin Ops. Currently, she holds the position of Head of Clinical Operations at Cellestia Biotech AG, a privately-owned clinical-stage Biopharma Company located in Basel (Switzerland) whose drug candidate platform is a first-in-class solution targeting orphan cancers. She is a hospital pharmacist by training and a strong believer that learning is a never-ending process
Session Details: INTERACTIVE ROUNDTABLE DISCUSSIONS 09-10-2019, 4:00 pm View In Agenda
Kathleen Schmidt
Clinical Project Manager,Adrenomed
Laszlo Farkas
Global Sourcing Manager,Merck
Biography: A seasoned supply chain professional specialized on clinical trial service outsourcing, supply and logistics. My current main focus is on defining Merck KGaA´s clinical innovation and digitalization strategy together with my counterparts in clinical Research & Development
Session Details: Panel Discussion: A perfect marriage! How to work in harmony – bringing sponsors and CROs together 10-10-2019, 9:45 am View In Agenda
Max Horneck
Head of Clinical Data Management and eClinical Systems,Medac
Eva Herrmann-Keiner
Clinical Operations Manager,Neurimmune AG
Biography:
Session Details: INTERACTIVE ROUNDTABLE DISCUSSIONS 09-10-2019, 4:00 pm View In Agenda
Fauzi Zakaria
Clinical Quality & GCP Audit,Debiopharm
Biography:
Session Details: Reducing the rate of failure for first time submissions – currently 50% of submissions fail 10-10-2019, 11:45 am View In Agenda
Jessica Cordes
Head of Clinical Operations,Medigene
Biography: Jessica Cordes studied Molecular Life Science in Luebeck and started her business career for 2 years at the Central Lab MDS Pharma Services as project manager. She moved then to GlaxoSmithKline where she worked as country project leader for 4 years. In 2013, she moved to MorphoSys, working for four years in an international role as clinical trial leader. 2017 she moved to Medigene headquarter as clinical trial manager and is now leading the Clinical Operations group since 2018
Session Details: Implementing effective Key Performance Indicators (KPIs) to optimise sponsor/CRO partnership 10-10-2019, 11:00 am View In Agenda
Kimi Le
QA Specialist,Bavarian Nordic
Biography: Kimi Le, QA Specialist GCP B Pharm 17 years of experience within the Pharmaceutical and Biotech Industry (Production, Clinical Trial Supply and QA) Worked for Novo Nordisk in Copenhagen, Hexal AG in Holzkirchen, Actelion in Basel and Bavarian Nordic in Munich (current position)
Session Details: INTERACTIVE ROUNDTABLE DISCUSSIONS 09-10-2019, 4:00 pm MINI WORKSHOPS: With four workshops to choose from, there is a workshop for you! Choose from one of the following workshops to suit your needs 10-10-2019, 2:45 pm View In Agenda
Bodo Lutz
Clinical Risk Management and Data Integrity QA,Novartis
Biography: Bodo Lutz holds a leading role as an expert in global clinical Data Integrity and Risk Management within Novartis Global Drug Development Quality. In this position he is currently the alliance manager for multiple partners ranging from clinical operations to external parties, as well as scouting and evaluating opportunities to improve Data Governance and Risk Management. He has 15+ years of experience in the quality environment in the pharmaceutical industry and is working for Sandoz/ Novartis since 2011. Prior to this he held several positions in clinical Quality Management functions at CROs, Biotech, Medical Device and Pharmaceutical companies. He has spoken at numerous international conferences and workshops on Data Integrity and Risk Management topics. Bodo Lutz, a Germany native, is an environmental engineer and marine biologist by education and received his doctorate of natural sciences (PhD) from the Technical University of Munich, Germany.
Session Details: Gain insight to Patient-Centric Remote Trial Conduct 09-10-2019, 3:00 pm View In Agenda
Ulrike Grimm
Vice President, Head Global Project & Alliance Management,Vifor Pharma
Biography: Ulrike is an expert in ensuring successful operational execution and excellent team performance with a track record of developing drugs from research to market launch. She has extensive experience in the leadership of multi-cultural and cross-functional project teams, within Research & Development in phase I – IV clinical studies, international product launches, portfolio and alliance management and clinical operations. Ulrike is a pharmacist by training with a Ph.D. in pharmacology. At Merck Serono KGaA she held various positions with increasing responsibilities, starting as a project manager, moving on to International Team Leader and Product Director. In 2007 Ulrike joined Fresenius Biotech with responsibility for the Global Program & Portfolio Management department. In Sept. 2010 she joined Vifor Pharma in Zürich and newly implemented the Global Project & Alliance Management Department. Her responsibilities focus on project, portfolio and change management. During 2013-15 she led the Global Clinical Operations department. As of 2019, Ulrike works as an independent consultant focusing on project and alliance management services for pharmaceutical companies to ensure operational excellence and process improvement. Ulrike is an IMPA-certified Project Director and holds a lean six sigma Black Belt
Session Details: Panel Discussion: A perfect marriage! How to work in harmony – bringing sponsors and CROs together 10-10-2019, 9:45 am View In Agenda
Jasmin Hellwig
Assoc. Director Project Management,MSD
Biography: Jasmin Hellwig graduated from the Applied Institute of Science in Muttenz, Switzerland, 2005 in Chemistry and joined Inovalab AG the same year as Study Director. In her various roles, including Business Development, Deputy of the General Management and Deputy of Test Facility Management, she enjoyed facilitating success by supporting processes, which meet high quality and business need. Since 2010 Jasmin is part of the Global Clinical Supplies department of MSD, former Schering Plough. She started as Project Lead coordinating packaging of clinical supplies and supporting integration projects. In September 2014, Jasmin joined the Comparator Sourcing and Planning group, supporting Clinical Trials by purchasing comparators on time from various sources. Besides various hobbies she cultivates, particularly horses and singing, she graduated as MSc in Management from the Lorange Business School, Zurich, Switzerland, in 2015.
Session Details: Patient Centricity - A Supply Chain Perspective 09-10-2019, 11:30 am View In Agenda
Rocco D´Ambrosio
Associate Director, Lead Study Management,Takeda
Biography:
ROLES
Takeda Pharmaceuticals International 2016 – Present
Associate Director, Lead Study Management
Medical Affairs Europe and Canada
Novocure 2015 – 2016
Clinical Trial Manager
Clinical Operations
Novartis Pharma Schweiz 2012 –2015
Project Manager, Oncology Business Unit
Celgene International 2010 – 2012
Clinical Trial Associate, Oncology Clinical Operations
Inselspital, Children’s Hospital Bern – Switzerland 2010
Research Associate – Pediatric Oncology and Hematology
Children’s Hospital Zurich 2009 –2010
Research Associate – Pediatric Oncology and Hematology
University of Naples, Italy 2005 –2008
Research Associate – Endocrinology and Oncology Department & Diagnostics, Biotechnology Department
STUDIES
University of London - Epidemiology, 2010
Federico II University of Naples
Master of Science in Medical Biotechnology, 2007 – 2008
Federico II University of Naples
Bachelor of Science in Biotechnology, 2003 – 2006
Session Details: Identifying the right CRO in the DACH region for your trials: full service CROs versus specialised area vendors – a Swiss perspective 09-10-2019, 12:15 pm View In Agenda
Cesare Spadoni
Chairman,aPODD Foundation
Biography: Cesare has more than 20 years of experience in the drug development field, in both scientific and commercial roles. He is co-founder and Chief Operating Officer of Oncoheroes Biosciences Inc., a Boston-based biotech company exclusively focused on paediatric oncology drug development. Prior to that he held senior positions at AMRI, Aptuit Laurus, ThalesNano and Auxiliis BV. Cesare started his career as research scientist in a pharmaceutical company (Eisai, London) and in academia (Institute of Enzymology, Budapest). Following the death of his first daughter Laura to cancer, Cesare set up aPODD Foundation, a London-based charity focused on accelerating paediatric oncology drug development. As aPODD’s chairman and trustee he is actively involved on a pro-bono basis in drug repurposing projects, advocacy efforts and research collaborations with other childhood cancer charities. Cesare holds an MSc in Applied Molecular Biology and a PhD in Neurosciences from UCL, University of London, as well as an MBA from the Central European University, Budapest.
Session Details: View In Agenda
Alan Kennedy
Director,Poseidon
Biography: Alan Kennedy is a specialist in supply chain dynamics who, with his extensive cross-sector experience, is focused on bringing best-collaboration practice to coldchain pharma-logistics. He is one of the principal architects behind the Poseidon program, a new logistics delivery model that has been conceived to radically transform the transportation of pharmaceutical products by sea. This is being achieved through the application of contemporary supply chain best-practice and structured, multi-party, collaboration.
Session Details: Integrating your CT supply chain - the journey towards real collaboration 10-10-2019, 9:00 am View In Agenda
Ludwig Baumann
Executive Director, Regulatory Affairs,Synteract
Biography:
Session Details: Key Regulatory Considerations to Optimize Study Start Up 09-10-2019, 9:30 am View In Agenda
Beate Hanson
Vice President, Head Global Clinical Strategy,Smith & Nephew
Biography: Beate has over 18 years of experience in leading clinical research departments. After building up and managing the AO Clinical Investigation and Documentation institute for many years, she moved to S&N in 2015 as the Regional Clinical Director for EUCAN. Beate was appointed the Head of Global Clinical Strategy, Senior Director in October 2015, and became a Vice-President in March 2016. She also serves as an Assistant Professor at the University of Washington, School of Public Health in Seattle, USA, and is a Visiting Professor at the University for Human Science in Liechtenstein. M.D. from the Benjamin Franklin University of Berlin, Germany. M.P.H. from the University of Washington.
Session Details: eTMF in Switzerland: handling shared responsibility between CRO/sponsor 09-10-2019, 2:00 pm View In Agenda
Dr. Ralf Wulkow
EVP Clinic,Nuvisan
Biography:
Session Details: Future trends in successful drug development 09-10-2019, 2:30 pm View In Agenda
Heike Schön
Managing Director,Lumis International GmbH
Biography:
Session Details: INTERACTIVE ROUNDTABLE DISCUSSIONS 09-10-2019, 4:00 pm View In Agenda
Sponsors
Metronomia is a German clinical research organization (CRO) committed to high quality, best service and outstanding flexibility. A service oriented, stable and highly skilled team provides e-clinical services,clinicaldata management and biostatistical services within phase I – IV and non-interventional studies in allmajor therapeutic areas.
Pharm-Olam International delivers cost effective, quality clinical services to pharma and biotech sponsors across all therapeutic areas in more than 40 countries. Since 1994, we have been committed to our objective: to create value for our clients by satisfying their clinical development needs with consistent and dependable solutions and services.
QPS
Industry: Healthcare,Outsourcing Clinical Trials,
SPONSORSHIP OPPORTUNITIES
To enquire about sponsorship opportunities for the conference, please contact:
Alex O’Leary
T: +44 207 936 6690
E: AlexanderOLeary@arena-international.com
SPEAKER OPPORTUNITIES
The speaking faculty for 2020 is underway. If you would like to be involved, please get in touch below.
Lu Tikrity
T: +44 161 359 5349
E: Lu.tikrity@arena-international.com

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