Outsourcing in Clinical Trials DACH 2022

Biography:

Session Details: View In Agenda

Biography: Pavlina Walter is the Global Clinical Operations Lead, with expertise in rare disease (PW, HIO) pediatrics and medical devices.  For 15 years, Pavlina has been responsible for management of Central & Eastern European region and USA in regard to projects set up, execution, oversight and reporting, providing local strategic planning and organization to achieve successful studies completion. Pavlina holds an Executive MBA. Managing Director and owner of Shasta medical company, providing consulting for American biotech companies in CEE.

Session Details: View In Agenda

Biography: I am a Pharmacologist by training and highly motivated team player with over 21 years’ experience in Clinical Research and Drug development within industries, from fundamental research; non-clinical and Clinical studies (phase 1 to 4). Following my Post doctorate, I worked for various CRO as non-clinical and clinical project manager, where I had a full responsibility for deliverables, timelines, resources and budget oversight. I am a Pharmacologist by training and highly motivated team player with over 21 years’ experience in Clinical Research and Drug development within industries, from fundamental research; non-clinical and Clinical studies (phase 1 to 4). Following my Post doctorate, I worked for various CRO as non-clinical and clinical project manager, where I had a full responsibility for deliverables, timelines, resources and budget oversight. I Joined Polyphor in December 2017 from Vectura, where I held various positions including Associate Director for the management of global clinical development programs and senior Clinical Pharmacologist and Operational Excellence Manager. During that time I have highly contributed to a development program that have resulted in the approval anti asthmatic drug “Fluiform”. The combine CRO and biotechnology experience has provided a strong leadership experience in cross functional management in multi-cultural environment; to achieve strategy and business objectives. My Pharmacology background allows understanding of science in several therapeutical area. The 12 years’ spent with a Biotech company has strengthen my experience in all aspect of the drug development including preclinical, CMC, Regulatory, pharmacovigilance and essential document writing, outsource management.  My inborn calmness makes me a good listeners a strong communicator and allow good productivity under stress full conditions.

Session Details: View In Agenda

Biography:

Session Details: View In Agenda

Biography:

Session Details: View In Agenda

Biography: Max Horneck has been the programmer and developer of one of the first EDC and IRT systems in the young internet-era in the 90s. For more than 25 years he worked in clinical IT and data management. He has a PhD in linguistics, philosophy and computer science. Currently he holds a position as head of clinical data management and eClinical systems at medac GmbH a midsize pharmaceutical manufacturer. With more than 20 years of CRO background, 10 years business consultancy and 5 years in pharmaceutical industry he combines the perspective of a CRO with that of a sponsor organization.

Session Details: View In Agenda

Biography: Agata Wiesiołek is a graduate of the Intercollegiate Faculty of Biotechnology of the University of Gdańsk, Poland. She has been working in the area of clinical trials and with AstraZeneca since 2006. Agata’s current role is Senior Director, Study Management Late-Phase Development in Respiratory & Immunology area, supporting AstraZeneca clinical operations worldwide. Agata’s  global experience includes strict project management in clinical trials & leading non-drug project initiatives leading to improvements and optimization ways of working in various Therapeutical Areas for different stages of trials. Agata has been involved in managing and leading clinical research projects for more than 15 years and she also took a part of shaping and transforming AstraZeneca’s global Clinical Trials Site in Warsaw.

Session Details: View In Agenda

Biography:

Session Details: View In Agenda

Biography: Jennifer C. Smith is Senior Editor for GlobalData’s investigative, science journalism team based in New York and London. An award-winning healthcare journalist with a deep knowledge of the US and European pharmaceutical, regulatory and pricing/reimbursement sector, Jennifer works closely with other management on editorial strategy and output, mentors and trains junior reporters and is responsible for wide-ranging editorial projects. Her passion for healthcare and science-related news, with a particular focus on government and public and social policy, has led to diverse reporting experience across the US and internationally over the past decade.

Session Details: View In Agenda

Biography: After  25+ years’ experience in the digitalization of clinical trials, the active participation of Benoît in the public-private consortium EHR4CR (Electronic Health Record for Clinical Research) has made him realize that there is a lot of value in all the data collected in the routine clinical setting and we should really maximize such usage in the best interest of medical research and thus the patients. Nevertheless, that is only achievable if we involve the patients in the most trustable, transparent and privacy respectful way.  Through his participation to Partners for Patients,  Benoît ambitions to promote the various approaches going in such a direction.

Session Details: View In Agenda

Biography: Stefania is a Digital Orchestrator and Omnichannel Marketing Manager in Daiichi Sankyo Italy, also driver of the  Digital Transformation at European level for the country. She established strong digital marketing, social media and digital strategy experience. In her role, Stefania has developed her ability to translate theory into action in the context of change control and mind process. At Daiichi Sankyo Italy, Stefania is responsible for digital & omni-channel strategy, the planning of local and regional initiatives, evaluating the impact of multi-channel marketing and digital strategy to the integration of on-and offline services and initiatives to open up cross-functional opportunities. She has gain several awards for innovative projects in the digital and multichannel field and has been a guest speaker at various Italian and international conferences. Stefania has over 10 years of pharmaceutical, marketing, communications and digital experience in different company. She is also a journalist with several experience in radio, TV and magazines publishing several articles and nowadays she writes articles on innovation and digital transformation topics.

Session Details: View In Agenda

Biography: John Shillingford, PhD is an experienced clinical researcher whose career in the Pharmaceutical, Medical Device and CRO industries has stretched over 40 years.  John has both lived and worked in a number of European Countries as well as the USA.   He is now lives in Germany. His wide experience of Drug and Medical Device Development in Europe and the USA has been acquired during the management of both Clinical and Data Operations for major Global Programmes. John has held senior positions in Management, Clinical Operations and Project Management for, Aptiv Solutions, Averion International (a Medical Device Research Company), PRA International and Imform GmbH. Currently John is Clinical Operations Director and a member of the Board of Afon Technology Ltd, a UK based Medical Device Company, Consultant to International Research Companies  and additionally continues to run a number of training courses in Vendor and Project Management.

Session Details: View In Agenda

Biography: Luke Rogers is the Senior Director of Business Partnerships at Within3. Luke's background includes degrees in Business, Science & a Masters' in Health Economics. He's worked for almost 15 years in Life Sciences in Live Events, including Running & Moderating Advisory Boards, Investigator Meetings, Payer Panels & Large Congresses. Luke's role is to assist Life Sciences clients of all sizes and scopes to operationalize their digital strategy, particularly around Stakeholder Engagement.

Session Details: View In Agenda

Biography: Marcel Besier has spent the last 20 years of his career in professional services and program management teams working with global clients implementing IT solutions.  As Director of Services Delivery, he oversees the professional services team responsible for project management, account management, and IRT services delivery for Suvoda’s customers in Europe. Marcel holds a dual degree in International Business Administration and General Management.

Session Details: View In Agenda

Biography: Federico is an experienced Design Consultant based in Suvoda’s Barcelona office. Federico has designed and overseen the development of over 50 IRT builds in a variety of therapeutic areas such as oncology and rare diseases in all phases. With a focus on providing excellent service and collaboration, he has fostered meaningful partnerships with sponsors by delivering timely and efficient IRT solutions for complex clinical trials.

Session Details: View In Agenda

Biography:  

Neta Bendelac, 4G Clinical Senior Director of Strategy, has over 10 years of experience in Clinical Supply Chain Management. She headed the Clinical Supply Chain department at Teva Pharmaceuticals, where she established new and innovative approaches to managing IMPs in clinical trials, designing them with a highly acclaimed and unique patient perspective. Prior to Teva, Neta worked as an international Supply Chain consultant, providing simulations and optimization tools to clients worldwide. Neta holds a BS in Industrial Engineering  and a Master of Business Administration (MBA) from Tel Aviv University, Israel. Neta is always focused on execution, finding joy in creative solutions to help patients around the world.

Session Details: View In Agenda

Biography: Dan Pavitt has worked in Information Technology since 2001 specialising in eClinical Solutions since 2006.  A Software Engineer by training, Dan has helped countless clinical teams implement and realise value from a range of eClinical products including Randomisation and Trial Supply Management (RTSM/IRT/IxRS), Electronic Clinical Outcome Assessment (eCOA) and Clinical Trial Management Systems (CTMS) tools.  Dan has worked for a range of Pharma companies and technology vendors, he joined Medidata in 2019 and is currently responsible for the Rave RTSM Solution in Europe.  

Session Details: View In Agenda

Biography: David Smets is an mHealth Solution Specialist at Medidata, a clinical software platform provider. He works closely with life sciences companies and CROs to execute clinical trials that include eCOA, eConsent, and wearable devices, imaging and biosensors. He is passionate about bringing value to clinical research and ultimately improving outcomes for patients through innovation and technology. David has been working in this area for over 10 years, in various operational and commercial roles, focusing on AI, imaging and mHealth solutions.

Session Details: View In Agenda

Biography:

Session Details: View In Agenda

Biography: Sverre Bengtsson started in the clinical trials industry over 30 years ago. He started as a statistician/statistical programmer, later into data management and since over 20 years into business development. He has been working in both CRO’s as well as in clinical trials technology companies, including the global first ePRO company. Sverre is very interested in making clinical trials efficient, in both study design but also in the processes and technologies used.   Sverre co-founded Viedoc Technologies 19 years ago and is responsible for some of the major accounts but also the vision around the company. He’s on the board of both some industry organisations and in clinical technology companies.

Session Details: View In Agenda

Biography:

Session Details: View In Agenda