Outsourcing in Clinical Trials Europe 2022

Biography: Since 2000, Kai has been a pioneer in patient-facing solutions for clinical trials working with young innovative technology companies. In 2012, Kai co-founded eClinicalHealth, the developers of the Clinpal remote clinical trial platform. Through his involvement in technical, operational and scientific roles, he has gained deep and holistic understanding of the clinical trial process and the key mechanisms of our ecosystem. Kai brings his entrepreneurial spirit and creative mindset to support Janssen’s global regulatory policy work across a range of topics. Kai has a passion for broad pre-competitive collaboration and is motivated to modernize the ways our broader ecosystem works together to advance the adoption of novel tools and methods to support efficient and patient-centric pharmaceutical R&D.  

Session Details: INTERACTION TECH SESSION Missing digital measurement standards: why are they important and what does it mean for the ecosystem? 04-05-2022, 1:45 pm View In Agenda

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Session Details: RWE enabling us to make better choices, better plans, reducing costs and timelines 04-05-2022, 4:15 pm View In Agenda

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Session Details: A site engagement strategy for 2022 & beyond 04-05-2022, 9:30 am View In Agenda

Biography: Hans-Juergen Arens PhD is currently Vice President of International Clinical Research Services at Frenova Clinical Research. He has nearly three decades of experience in the pharma and medtech industries and worked previously in global clinical research and development at Takeda, Merck KGaA, and Abbott/AbbVie. At Fresenius Medical Care he headed the Department of Medical Affairs from 2010 to 2016 for the company’s renal pharmaceuticals international business. Hans-Juergen uses his expertise to involve himself and his team in directing international clinical trial and data services, supporting clients with medical and operational leadership, as well as consulting services. As Head of Frenova International he has developed a service portfolio dedicated to supporting external sponsor companies in the planning, preparation and execution of clinical trials at centres throughout Europe, Middle East, Africa, Latin America and Asia/Pacific. He received his PhD in Pharmacology/Toxicology from Johannes Gutenberg University Mainz, Germany.

Session Details: CASE STUDY: Exploring the world of running clinical trials within dialysis clinics 04-05-2022, 5:15 pm View In Agenda

Biography: A Clinical Research Professional (Pharmacist) and PhD (Medical School - Pharmacology/Toxicology) and PMP with more than 20 years of experience in Health Care Industry / Drug Development / Clinical Research. Expertise ranging from Clinical Research experience in Pharma, Biotech and CRO with focus on Oncology, Immunology, Infectious Disease, Respiratory indications and Rare/Orphan diseases. Focused on goal achievement, constant striving for improving processes on an international / global level, strong project management background (PMP), dedication to people management as the main success factor in clinical research – foster open & trustful communication on an international management level. Strong beliver in "Manage by example".

Session Details: OPENING PANEL Establishing strong CRO/sponsor/site relationships and building trust in a more virtual landscape- What 5 things do our panellists say we should focus on right now? 05-05-2022, 8:50 am View In Agenda

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Dr. John Zibert is Chief Medical Officer at LEO Innovation Lab, LEO Pharma’s independent innovation unit, where he leads a decentralized clinical trials unit, Studies&Me, working to personalize treatment development. Dr. Zibert has a history of more than seven year with LEO Pharma where he has held a number of positions as medical director for Region Europe, Medical advisor, Project leader and scientist. Dr. Zibert has senior experience with pharmaceutical drug development for various skin diseases, for which he contributed to the launch of two new products. He holds a B.Sc. in microbiology, M.Sc. in Human biology and a Ph.D. in medicine. 

John Zibert has been carrying out International clinical research on skin diseases and cancers for over a decade, with several publications in high-tier peer-reviewed journals. 

Prior to his scientific work, Dr. Zibert spent seven years in the Danish armed forces’ health and sports sector, and as a paramedic.

Session Details: OPENING KEYOTE Decentralized/Hybrid Trials: Exploring the framework of the regulatory landscape and how to implement these trials in Europe 04-05-2022, 8:30 am PANEL DISCUSSION: Trials & tribulations of conducting a clinical trial in Europe throughout the pandemic, tips & tricks for the future 04-05-2022, 11:30 am 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.

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Biography: Robert Greene, Founder and President HungerNdThirst Foundation, Board Member European Cancer Patient Coalition, Patient Advisory Committee Members European Cancer Organisation and Patient Advisory Board Member Data Saves Lives. An Advocate for a more patient centred and patient-centric approach in care and clinical trials.

Session Details: Chair’s opening remarks 04-05-2022, 8:20 am KEYNOTE: The Diversity Conversation 04-05-2022, 10:30 am View In Agenda

Biography: Marco is a biochemist with a strong expertise in Chemical Biology & Drug Development. In his PhD thesis he developed novel methods for fragment-based drug discovery. It was honored by the German Chemical Society with the Klaus Grohe Prize of Medicinal Chemistry. Afterwards he joined the University Chemical Laboratory Cambridge UK, working for the Bill & Melinda Gates Foundation on novel anti-tuberculosis drugs. During his stay at the University of Cambridge Marco was awarded with a prestigious Marie Curie Fellowship of the European Commission for the development of a novel drug class targeting RNA interference. After returning to Germany he co-founded biotx.ai, a company that develops novel statistical tools for efficacy prediction of drug candidates from population data. biotx.ai has received multiple awards for its machine learning technology specifically designed for the analysis of biomedical data. Marco provides almost a decade of experience in the biotech ecosystem. He is the author of the textbook "Chemical Biology & Drug Discovery".  

Session Details: TECH KEYNOTE Big Data, AI/ML and our COVID-19 strategy 05-05-2022, 8:50 am View In Agenda

Biography: Martine Zimmermann is Senior Vice President and Head of Regulatory Affairs, R&D & Commercial Quality at Alexion, AstraZeneca Rare Disease. Dr Zimmermann has over 25 years of combined R&D and global regulatory strategy experience. She joined Alexion in 2009 and has since then been dedicated to the registration of several orphan medicinal products across the globe, as well as to the shaping of the regulatory environment for medicines under development for rare diseases. Prior to Alexion, Dr Zimmermann held numerous R&D and regulatory roles in companies such as Aventis (now Sanofi), Servier and H. Lundbeck A/S. Dr Zimmermann also serves currently as a Director in the Board Inventiva Pharma. From 2019 to 2021 she served as a Director in the Board for CAELUM Bioscience. She received her PharmD from the University Louis Pasteur in Strasbourg, France, and is based in Zurich, Switzerland. Martine has been a champion of diversity, equality, inclusion and belonging, having been recognized by the Healthcare Businesswoman’s Association as a Luminary in 2020, and efforts by serving as an executive sponsor for Alexion’s flagship Women In Leadership (WIL) employee resource group.

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Biography: Dr Christine Natasha Ryan holds a PhD in Neuroscience from the University of Cambridge, Cambridge, UK and an MBA from Stockholm School of Economics. Following a post-doc at the Brain Research Institute, St. Hans Hospital, Roskilde, Denmark, CNR remained in Scandinavia moving to Sweden to work at Astra, which then became AstraZeneca, holding line management and competitive intelligence roles. CNR has engaged in preclinical research at blue chip companies such as AstraZeneca, smaller pharmaceutical companies, CROs and biotechs, working at Karo Bio AB, and Cerca Insights among others. CNR joined Gabather AB as Principal Scientist in 2017, becoming VP Operations in 2018.

Session Details: PANEL DISCUSSION: Trials & tribulations of conducting a clinical trial in Europe throughout the pandemic, tips & tricks for the future 04-05-2022, 11:30 am CASE STUDY: Small Pharma does what Big Pharma does 04-05-2022, 2:45 pm View In Agenda

Biography: CEO of WPD Pharmaceuticals Inc and WPD Pharmaceuticals Sp. z o.o. Experienced expert in medicinal products, medical devices, supplements and plant protection products R&D at every stage - from planning and scientific advice through supervision to the closure and finalization of the project. A founder of several start-ups in the e-health industry and a member of the board and supervisory board of several R&D companies. Author of the publication „Change of the product development model as an opportunity for the Polish pharmaceutical industry” (in Polish). Member of the editorial committee of the book „Clinical Trials” (in Polish). Lecturer in postgraduate study programs.

Session Details: Patients from Ukraine in the clinical trials- How can we help? Poland Case Study 05-05-2022, 11:30 am View In Agenda

Biography: CEO Dr Michael-Robin Witt holds a Ph.D. in Neuropharmacology from the Royal School of Pharmacy, Copenhagen, Denmark. He has published more than 50 publications in peer-reviewed scientific journals. Following 12 years in academic research, at the Brain Research Institute, St. Hans Hospital, Roskilde, Denmark. MRW has held senior line and project management positions in Scandinavian Biotech companies including Neurosearch AB (1999-2000), AstraZeneca R&D (2000-2003), KaroBio AB (2003-2007). In 2007, MRW co-founded Axcentua Pharmaceuticals AB, acting as CSO for 5 years before joining Lead Discovery Malaysia in 2012 where he currently holds the positions of CEO & CSO. MRW joined Gabather AB in September 2014 and was appointed Principal Scientist in October 2015. He is currently CEO.

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Biography: A leader with nearly 20 years of experience in Research and Development in the pharmaceutical industry: Alexion’s (AstraZeneca Rare Disease) Vice President, Global Head of Country Operations Management, Patryk is accountable for driving transformative improvement in the delivery of Alexion Sponsored clinical trial programs and leading the country operations team providing oversight of clinical studies conducted at sites across the Alexion portfolio worldwide.   Patryk was with AstraZeneca for 17 years where he started in 2003, holding various operational and strategic positions: Vice President of the Management Board in 2018-2020, Regional Director Europe for Research and Development in 2016-2020 – both at AstraZeneca Pharma Poland sp. z o.o. Earlier, he had developed his competences in the foreign branches of AstraZeneca in Sweden and Germany and managed and co-founded a Clinical Research Department in Ukraine. Patryk Mikucki is a graduate of the Faculty of Veterinary Medicine in Lublin with the title of Doctor of Veterinary Sciences and PhD in Epizootiology. He is an author of several scientific publications in this field. Moreover, he is a graduate of the Warsaw-Illinois Executive MBA.

Session Details: PANEL DISCUSSION: Trials & tribulations of conducting a clinical trial in Europe throughout the pandemic, tips & tricks for the future 04-05-2022, 11:30 am View In Agenda

Biography: Michael is responsible for a team of 11 people and the overall delivery of the conducted studies. The group runs several studies in different indications with a clear focus on rare diseases. In 2016 AOP Orphan received approval for one new product (RAPIBLOC®). In 2019 AOP received the marketing authorization for their first biological (BESREMi®), after completing a series of clinical studies and successfully passing a series of EMA inspections under Michael’s responsibility. Before joining AOP Orphan Michael has been operations manager for Haemophilia at Baxter. Michael has many years of experience as a project manager and learned the job in clinical research from scratch starting as CRA at Amgen. Michael received his Ph. D in biochemistry from the University of Vienna.

Session Details: PANEL DISCUSSION 04-05-2022, 11:30 am View In Agenda

Biography: With a broad background as cancer rehabilitation specialist through exercise referral, Natacha is an EUPATI fellow with significant experience in patient advocacy and patient education in the field of cancer. Before joining Lymphoma Coalition in 2017, she had successfully held Patient and Public affairs roles in cancer charities in Spain since 2011. Natacha was appointed Board Member of ECPC from 2016 to 2017 and is currently Chair of EBMT Patient Advocacy Committee, and member of EHA´s European Affairs Committee, ESMO Patient Advocacy Working Group, GoCART Coalition and contributes to other projects at European level, as Harmony Alliance, T2EVOLVE, and RESILIENCE. Natacha is a true believer in the power of cooperation. She has worked at a national and European level with multi-stakeholders’ partnerships, educational groups, and she is deeply interested remove barriers to access to care for patients with lymphoma and to improving the quality of life for patients. Natacha has contributed to Health Technology Appraisal processes and is frequently invited to provide the patient perspective in different scenarios. In addition to the role at EU level, she is currently member of the Institutional Working Group on the Plan to Access Advanced Therapies in the National Health System in Spain.

Session Details: Delving into an initiative to reduce bureaucracy in clinical trials 05-05-2022, 3:30 pm View In Agenda

Biography: Mats has more than 35 years of experience in the pharmaceutical industry (Discovery, Development, IT, Marketing, Patents and Clinical Science). He is integration lead for implementing EHR driven services in AstraZeneca. On behalf of AstraZeneca, he was the Coordinator of the European IMI EHR4CR project during 2011-15 (35 partners, incl. 10 pharma companies) aiming to R&D the concept of scalable federated EHR services. Mats provide health analytics support strategic support on Pragmatic Clinical Trials RWD enabled services. Mats previous lead for AZ engagement in the EIT Health sponsored project EHR2EDC with European HCOs together with Janssens and Sanofi. He is on the board of Directors of the European Institute for Innovation through Health Data , i-HD and a member of TriNetX Advisory Board, and is author of +50 publications and books in science and economics (innovation management, clinical science, medical informatics, eHealth and business modelling).

Session Details: THE EVOLUTION OF THOUGHT IN CLIN TECH Looking at social media & real-world data strategies for patient recruitment using a real-life case example 04-05-2022, 10:30 am View In Agenda

Biography: I am a passionate drug development executive with over 20 years of extensive global clinical operations and clinical sciences experience in oncology, neurology, gastro-intestinal and metabolic orphan diseases at mid-size and start-up biotechnology companies; I have actively contributed to the registration of 3 medicinal products and led multiple investigational products from idea to phase II/III, overseeing all the clinical and regulatory operational activities. I have an in-depth knowledge of FDA/EMA regulations for GCP’s, GLP’s and GMP’s and experienced in establishing and developing clinical operations, regulatory affairs and quality assurance systems. I have strong management and leadership abilities and have led development operational teams up to 40 FTE, external consultants and global Clinical Research, Lab and Manufacturing Organizations in over 30 international phase I to IV clinical studies. Special interests: operations excellence, innovation in clinical development operations

Session Details: PANEL DISCUSSION 04-05-2022, 11:30 am View In Agenda

Biography: A Clinical Research Professional with over 10 years’ experience across various settings such as Site, CRO, Small Biotech and Pharma. Expertise in various therapeutic areas  from Oncology and Rare/Orphan Disease. Experience from early phase first in human to late phase and Nov Intervention RWE generation and Registries. Focused on Clinical Operations excellence and process improvements for the benefit of the patients we serve. Currently AD, CPL at Alexion, AZ Rare Disease leading a Cross Functional clinical team in the execution of multiple clinical studies and PASS studies.  

Session Details: Seeing your site as a partner and identifying best practices to ensure you don’t over-burden them 04-05-2022, 4:15 pm OPENING PANEL Establishing strong CRO/sponsor/site relationships and building trust in a more virtual landscape- What 5 things do our panellists say we should focus on right now? 05-05-2022, 8:50 am 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: Ask the expert… A DIGITAL HEALTH & TELEMEDICINE UPDATE 05-05-2022, 10:00 am View In Agenda

Biography: Disa has 15+ years of experience working in technology and innovation especially in the pharmaceutical industry. She is the Head of Integrated Clinical and Operational Analytics at Janssen Pharmaceutical Companies part of Johnson & Johnson. She was previously at UCB as the Head of Innovation and held other leadership roles. Prior to joining the pharma, she was a co-founder of an IT company. She has an EMBA and B.S. in Pharmaceutical Chemistry. In 2017, Disa started a consortium, a cross-industry collaboration on blockchain via PhUSE. Recently, she was awarded Top 100 Women in Technology, Financial Times top 100 most influential BAME Leader, and featured on the cover of CIO Look celebrating Women in Tech 2019. Her passion is on closing the gap for patients with unmet needs and exploring the right digital technologies to accelerate the implementation of end-to-end patient solution.

Session Details: AI & Disruptive Technology: Harnessing the future of Artificial Intelligence to transform clinical trials 04-05-2022, 5:15 pm View In Agenda

Biography: Central City Clinical Hospital of Ivano-Frankivsk City Council CEO of a clinical trials unit that was founded from scratch in 2017 at a state hospital in Ivano-Frankivsk, Ukraine and now developed into an organization with 15-20 multi-specialty trials running simultaneously with a potential to grow. One of the founders and current Board member of the Ukrainian Association for Clinical Research. Adept ENT doctor and principal investigator in otolaryngology with ability to work in a multidisciplinary team, experience in delivering patient care in both public and private settings with the use of the latest industry equipment and technology, as well as establishing own private practice. Proactive and dedicated to seeking opportunities for cooperation with international specialists. Strong knowledge of Ukrainian medical policy landscape through working with the Ministry of Health of Ukraine on reforming healthcare services. Proven track record of planning and executing projects in medical sphere. Best wishes,

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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: Delving into the world of sponsor oversight, technology and data readiness: Are CROs delivering on their promises? 05-05-2022, 11:30 am View In Agenda

Biography: I studied Medicine in Universidad de Navarra (Spain) and did my especialization in oncologist in the same site between 1997 and 2001. I have work as medical oncologist during several years in Pamplona and Madrid, and I joined Roche in 2007 as Country Study Manager. My current position is Therapeutic Area Leader in Clinical Operations for Onco-Hematology studies from 2015. I have a master in coaching and talent development and another in pharmaeconomics and health economy.

Session Details: Diversity and inclusion in clinical trials: The Big Pharma standpoint 05-05-2022, 12:30 pm View In Agenda

Biography: Andreia Cruz e Silva is passionate about working with patient data and looking for innovative ways to improve the field of Data Management in Clinical Research. Has gained experience on Sponsor-CRO interaction as a Clinical Data Manager and Data Analyst at the German midsize pharmaceutical company medac GmbH. With a strong background in scientific research and medical sciences, Andreia completed a Masters in neuroscience (University of Lisbon) and a PhD in biochemistry (Free University of Berlin).

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Roels inspiration: “Be the change you wish to see in the world” - Ghandi

Roel van der Heijde lives in Rotterdam, The Netherlands. He has a MA in International Business, is an international acknowledged NLP trainer, executive team coach and a certified death and grief counsellor.

He is a driven and experienced trainer and facilitator in:

• - Patient Fear Reduction (for all caregivers);
• - Team Collaboration;
• - Vulnerability & Leadership;
• - Discrimination & Inclusion.

Roels motivation: “Acknowledgement and recognition of the fears and emotions of our patients are the basis for excellent patient experience and patient safety”.

“Working with Groups I experience as thoroughly fascinating and inspiring. In interaction with groups I am every time amazed by the enormous potential of practical knowledge and direct experience that lies hidden in groups and that is so easily overlooked. Herein lies the basis for excellent vulnerable leadership.

Session Details: KEYNOTE: The Diversity Conversation 04-05-2022, 10:30 am View In Agenda

Biography: Estrella began her ‘scientific odyssey’ at the University of Navarra, Spain, where she gained a PhD in Genetic Toxicology.  Following this, Estrella held at post-doctoral position at ICI (now Astra Zeneca) in Macclesfield, UK. At ICI Estrella’s focus was on novel anti-tumor drugs in the pre-clinical phase. Subsequently Estrella returned to Spain where she joined Almirall as a Clinical Research Scientist. Since then, Estrella has amassed a 29 year career with the company- taking on roles of increasing demand and responsibility, including Head of Allergy Therapeutic Area and Head of Clinical Development Operations- to the role she holds today. Estrella leads her group and is responsible for clinical trials worldwide. Since Almirall do not have affiliates fully involved in clinical development, the company externalizes all clinical trials, with a strategic focus on keeping only core competencies- particularly for pivotal studies- in-house. In this capacity Estrella has worked with dozens of CROs and service providers managing Phase I to Phase IV clinical trials of all sizes, from small single centre studies to global programs involving hundreds of sites and thousands of patients. Her responsibility is covering the selecting, negotiation, contracting, managing and final evaluation of the CROs responsible for the worldwide clinical development, in order to deliver on the agreed timelines, quality and cost. She has been responsible for ensuring Clinical Development for Aclidinium bromide in COPD was performed worldwide from the operational point of view on time, budget and quality, among other development from Almirall. Now fully focus on Dermatology development, managing trials worldwide mainly in Psoriasis, Acné, Atopic Dermatitis, Actinic Keratosis, among other indications.

Session Details: A patient centric approach that has improved patient retention and patient adherence to the protocol 04-05-2022, 4:45 pm View In Agenda

Biography: Cesare is co-founder and Chief Operating Officer of Oncoheroes Biosciences Inc., a Boston-based biotech company focused on pediatric oncology drug development. Cesare has more than 20 years of experience in the drug development field, in both scientific and commercial roles. Previously, he held senior positions at AMRI, Aptuit Laurus, ThalesNano and Auxiliis. 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 he is actively involved on a pro-bono basis in drug repurposing projects, advocacy efforts and research collaborations. 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: ASK THE EXPERT- The Patient Perspective 04-05-2022, 1:45 pm View In Agenda

Biography: Alvaro Arjona is Editor-in-Chief at GlobalData Media, with extensive  experience in leading editorial teams covering Pharma & Healthcare. Former Editorial Director of Thomson Reuters Drug News, Alvaro started his career making significant contributions to the field of Immunology at Yale School of Medicine. He has also led scientific communications at UCB Pharma and developed data-driven clinical intelligence products at Informa Pharma Intelligence.

Session Details: OPENING PANEL Establishing strong CRO/sponsor/site relationships and building trust in a more virtual landscape- What 5 things do our panellists say we should focus on right now? 05-05-2022, 8:50 am Deconstructing Clinical Trial Decentralization: who is doing what? 05-05-2022, 2:30 pm View In Agenda

Biography: Dr. Bhargava Reddy has over 16 years of experience working in the pharmaceutical industry. He is currently Head of Advanced Insights at Janssen Pharmaceutical supporting clinical operations by providing data science solutions. Prior to this role, he was Associate Director of Advanced Analytics at UCB. In this role, he was responsible for the development and application of machine learning methodologies supporting clinical decision making within Immunology and. He was also leading the analytics work supporting Risk Based Monitoring. Prior to this role, he managed a statistical programming group and was also overseeing a large statistical programming group offshore. Dr. Reddy has published several methodology papers in peer reviewed academic journals in the areas of machine learning and deep learning. He is actively involved as an associate editor for the Frontiers in AI journal and also as a reviewer on several journals. He has a Ph.D. from Oklahoma State University and MS from Northwestern University.

Session Details: AI & Disruptive Technology: Harnessing the future of Artificial Intelligence to transform clinical trials 04-05-2022, 5:15 pm 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: FDA GUIDANCE UPDATE New FDA draft guidance on 'Digital Health Technologies for Remote Data Acquisition in Clinical Investigations’ 04-05-2022, 2:45 pm View In Agenda

Biography: Accomplished and growth-focused professional with 17+ years’ experience managing operations in healthcare sector across multiple locations, including Europe, US and Canada. Proven track record of success in optimising current processes to deliver quality services, establishing and growing businesses through effective change management strategies, and increasing staff performance via exercising strong leadership role. Skilled in collaborating with top businesses / clients across all pharma segments, managing large budgets, as well as directing multidisciplinary global teams to exceed company KPIs. Instrumental in managing projects in all clinical phases, while monitoring operations in line with industry regulations. Possess high degree of commercial awareness and understanding of business drivers within life science industry, including pharma industry, Labs/Analytics, manufacturing, and medical corporations. Exceptional organizational, interpersonal, and communication skills with ability to maintain long-term professional relationships at all levels.

Session Details: A playbook for how to handle an undesirable CRO-sponsor partnership & how to turn it around 05-05-2022, 2:30 pm View In Agenda

Biography: Alina Pszczółkowska is  holding a position of the Head of Study Management Late-Phase Development in Respiratory&Infection and CVRM (Cardivascular Renal Metabolic) areas, supporting AstraZeneca clinical operations worldwide. Being a physician, she has been involved in managing and leading clinical research projects for more than 20 years. Her international experience includes the leadership of AstraZeneca  Site Management and Monitoring organization  in 40 countries across the globe as well as 2 years spent in AZ core science site in Gothenburg, where she led program level operational management of cardiovascular portfolio. She has also had a pleasure to play one of key roles in shaping and transforming AstraZeneca’s global Clinical Trials Centre in Warsaw  to become the largest and truly unique centre of this kind among all innovative pharmaceutical companies  in the country, currently employing more than 1000 people in R&D function. For over 20 years Alina has been supporting and initiating activities in the area of CSR as well as inclusiveness and diversity , which is her true passion.

Session Details: Leveraging operational expertise to improve study design and patient centricity in clinical trials 05-05-2022, 10:00 am View In Agenda

Biography: Anastassia is holding master's degree in Biology and spent 5 years in cancer research laboratory to specialize thereafter in regulatory affairs, policy and patient engagement in the scope of clinical research. She was part of several IMI and EU funded projects, has been closely following the development and implementation of EU directives and regulations relevant to clinical research, including GDPR, but also others such as clinical trials regulation, in vitro medical device regulation, etc. After almost 20 years of work at headquarters of one of the largest European non-for-profit clinical research sponsor (EORTC), Anastassia joined MyData-Trust to bring her expertise at the service of a large circle of organizations active in life science.

Session Details: Data Protection within the scope of clinical research: how to build a meaningful roadmap that increases the value of your business 04-05-2022, 3:15 pm View In Agenda

Biography: Senior Business Development from Novotech with over 16 years of experience in the service provider industry. He is passionate about driving collaborative efforts to improve patient accessibility and diversity in clinical trials. He believes this can be achieved by the convergence of science and technology.

Session Details: The diversity of Asia: What makes this region, particularly China a preferred destination for clinical trials 04-05-2022, 12:15 pm View In Agenda

Biography: Dawn has over 20 years of experience in the pharmaceutical industry. She have worked within every level of clinical data management, from Data Coordinator to Senior Director where she participated in or had oversight for more than 250 clinical trials. During her time in the industry, she has provided consultation to organizations on clinical trial conduct, best practices in Data Management and data capture as well as developed standardized libraries and templates to support the adoption of CDISC standards. She is an active member of SCDM as a GCDMP SME, course designer and webinar presenter as well as Co-Chair of the annual conference (2018-2021) and serves on the SCDM Board of Trustees. Dawn is involved as a member of the CDISC-CDASH core team, Diabetes sub-team, CDASH CFAST Expanded Leadership Team and former Co-Chair of the CRF Library project. Dawn currently holds the position of Vice President, BD Operations, where she supports business development as a Clinical Subject Matter Expert for both software and data services as well as overseeing the Proposals and Solution Consulting departments.

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Biography:

• More than 25 years of successful early phase drug development experience delivering pivotal registration studies​
• Holds a Neuro & Molecular Pharmacology Master’s degree​
• Scientific expertise includes design and delivery of cell therapies, targeted small molecules, immune-oncology clinical development plans across rare indications, solid tumor, and hematological malignancies​
• Experience leading global teams and all phases of oncology clinical development programs for both large and mid-size pharmaceutical and biotechnology clients​

Session Details: A patient centric approach that has improved patient retention and patient adherence to the protocol 04-05-2022, 4:45 pm View In Agenda

Biography:

Session Details: A gateway to efficiency: Oncology Adaptive Design 05-05-2022, 9:30 am View In Agenda

Biography: Ellen Van Strijdonck is the Operational Manager Clinical Operations at SGS Belgium Health & Nutrition, with extensive experience in the field and project management skills. Quickly after her start as Clinical Research Coordinator at the SGS CPU, she continued her career as a Project Manager in Early Phase trials and Human Challenge trials. Ellen successfully implemented eSource at SGS CPU and grew further as Head of the Clinical Project Managers. Ellen has M.Sc. BioMedical Sciences from the University of Antwerp.  

Session Details: Project management with integrity 05-05-2022, 12:00 pm View In Agenda

Biography: Ben Schlatka joined Medidata in 2020 through Medidata's acquisition of MC10's Digital Biomarker Business. After beginning his career as a corporate “intraprenuer” at IBM, Ben grew a series of successful startups including including Volunteer Solutions.org (Sold to the United Way) and Nantero (Sold to Lockheed Martin).  Most recently, Ben Schlatka was co-founder & CEO of MC10, a pioneer in sensors and new end point development in clinical research. Ben is passionate about using digital technologies to transform the lives of patients, in both clinical research and clinical practice. He holds an MBA from the Harvard Business School and frequently lectures on the formation of disruptive science based businesses.

Session Details: Developing a more complete picture of the patient experience through an integrated approach to eCOA and sensors 04-05-2022, 9:00 am View In Agenda

Biography: Paul O’Donohoe is Scientific Lead, eCOA and Mobile Health at Medidata Solutions, a clinical software platform provider. He is responsible for developing the company’s scientific expertise for electronic clinical outcome assessments and mobile health, and is responsible for ensuring internal teams, partners and Sponsors are following industry, regulatory and scientific best practices when it comes to integrating technology into clinical trials. He is passionate about developing the field of eCOA and mobile health through research and active involvement in industry consortia, and is currently the Industry Vice-Director of the C-Path ePRO Consortium. Previously, Paul worked as a research psychologist at a child and adolescent mental health clinic based in Dublin, Ireland. He moved into the health consulting field with United BioSource Corporation where he worked across the health outcomes, health economics and health data capture groups. Prior to Medidata, Paul was Director of Health Outcomes at CRF Health, an eCOA provider, where he led their health outcomes team. He has a MSc in Cognitive and Clinical Neuroscience.

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Biography: Heike is the Shareholder and Co-Founder of Lumis International, Lumis Life Science Consulting and the newly founded UK branch Lumis International Limited. She has more than 25 years of experience in leadership positions in international clinical research and drug development. She has profound knowledge of the clinical drug development processes and regulatory requirements from first in human to market access. She is experienced in developing strategies and concepts for biopharmaceutical and medical device companies covering clinical operations, clinical research, outsourcing, vendor management and oversight management.

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Biography: Elvira Suniega-Tolentino is the Clinical Project Manager Team Leader for Singapore at the Nestlé Clinical Research Unit, responsible for end-to-end clinical project management and operational activities of Nestlé corporate clinical trials serving all Business Units. At the Clinical Research Unit, she is also leading the Vendor/Out-sourcing activities where she drives strategic partnerships with CROs, Universities, Laboratories, etc. Prior to joining Nestlé, Elvira was the Area Clinical Operations Manager for Abbott Nutrition R&D, Asia Pacific Center in Singapore for 11 years. Over the years, she has sharpened her expertise in the industry, bringing in thoughtful and strong competency into Nestlé’s clinical projects.  The combination of her expertise, leadership and passion for innovation strongly supports the continuous improvement and excellence of Nestlé’s clinical research activities to further unlock the power of food to enhance the quality of life for every consumers, today and for generations to come.

Session Details: BRAND NEW: NESTLE CASE STUDY: Outsourcing services required for food/nutritional clinical trials 05-05-2022, 12:30 pm View In Agenda

Biography: Dr. Eriksson is a strategy, operations and board advisor working with some of the most innovative companies in Life Sciences.  He is the former CEO and current Strategic Advisor at Trialbee, a leader in the digitization of clinical research whose clinical trial patient recruitment & enrollment platform is used across the industry in global clinical trials to help biopharmaceutical and medical device companies meet enrollment timelines. An executive with extensive experience in clinical drug development at the clinic, sponsor and CRO levels including Merck & Co. Inc., PAREXEL and ICON. Dr. Eriksson is trained and skilled in clinical pharmacology, clinical research, clinical research operations with emphasis on health care alliances, site operations, feasibility, study start-up & implementation and patient recruitment.  He is a strong business development and leadership professional with an innovative and creative mind to address clinical development challenges and realize new opportunities. Dr. Eriksson is an Associate Professor in Clinical Pharmacology at Lund University, Sweden and at Rutgers University School of Health-Related Professionals in New Jersey, USA.

Session Details: THE EVOLUTION OF THOUGHT IN CLIN TECH Looking at social media & real-world data strategies for patient recruitment using a real-life case example 04-05-2022, 10:30 am View In Agenda

Biography: Mike Keens leads operational performance and growth strategies for Anju Software. Mike brings more than two decades of experience in drug development clinical and commercial operations at organizations that include ADial Pharmaceuticals, Syneos, Firma Clinical Research, and Icon PLC. His expertise includes driving the rapid growth of Clinical Trial and DCT business units supporting studies in more than 60 countries. Keens holds an M.S. in Public Health Sciences and a B.S. in Biology & Psychology and has been recognized by PharmaVOICE magazine as one of the Top 100 Inspiring People in Pharma. He also holds memberships in the American Society of Clinical Oncology (ASCO) and the Association of Clinical Research Professionals (ACRP).

Session Details: TECH SPOTLIGHT- Streamlining clinically relevant data mining for optimal clinical trial planning and investigator identification 04-05-2022, 12:15 pm View In Agenda

Biography: Dr. Mahillo has 28+ years of experience in the clinical research arena, 25 of them in oncology global trials. Her areas of expertise are inmuno-oncology, including cancer vaccines, advanced therapies, genetically modified organisms and other immuno therapies. She has an in-depth knowledge on oncology networks and advocacy groups, with which she cooperates since 1999. Dr. Mahillo is a professor/magister in several Master programs administered at different Universities (Universidad Alcalá de Henares, Universidad CEU San Pablo, CESIF). She has authored of 3 books, 20 scientific articles, and 24 contributions to scientific congresses. Dr. Mahillo was awarded the first prize of the Spanish Society of Medical Oncology (SEOM) in 2015 for her project “Y Seguiré” (will keep on moving), for the promotion of clinical research. Dr. Mahillo obtained her PhD with a research on the role of multicatalytic proteinase (proteasome) as an oncology intracellular target, research line that ended up with the development of bortezomib, a proteasome inhibitor approved for the treatment of multiple myeloma patients.

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Biography: Johanna Morand is the Associate Director, Site Contracts, at Premier Research, responsible for EMEA, LATAM, and APAC, along with the Benelux Country Lead. She has 12 years of experience negotiating contracts for clinical trials (previously with Genzyme, a Sanofi Company, Parexel, and Cmed). Ms. Morand leads an international team of Contract Leads and Contract Specialists. Her aim remains to balance timely execution while managing legal, financial, and operational risks. Ms. Morand holds an LLM in European Law from Leiden University and an LLM in Law and Economics from Utrecht University where she wrote a thesis on European Orphan Medicinal Product Regulations.

Session Details: Europe’s New Clinical Trial Regulation: Benefits and Challenges 05-05-2022, 10:30 am View In Agenda

Biography: Libbi Rickenbacher, Director of Strategy, has over 15 years of experience in the field of life sciences, and is an e-clinical RTSM solutions subject matter expert. Her experience lies at building and managing accounts, clients, and strategic initiatives. Has a proven record of success in conceptualizing and delivering client focused solutions, standards, and providing oversight and guidance to both internal and external teams. Holds BA in both Neuroscience and Psychology and a Doctorate (PhD) in Neuroscience

Session Details: Modern Track and Trace strategies - Decreasing burden and improving supply chain oversight 05-05-2022, 10:30 am View In Agenda

Biography: Sinead is a Digital Healthcare and Clinical Research Executive with a career spanning clinical care, academic research and digital health across multiple therapeutic areas including oncology, internal medicine and vaccines development. She joins THREAD with over 18 years’ experience in clinical service delivery, sponsor research governance, CRO and eHealth. Sinead oversees the Delivery team in the EMEA as the executive sponsor for customer portfolios within THREAD. Sinead is a clinically trained radiotherapist with a bachelor’s degree from the School of Medicine, Trinity College Dublin and a Master of Science clinical research from the University of London.

Session Details: Best practices for global DCT adoption 05-05-2022, 2:00 pm View In Agenda

Biography: Farooq Hussain is the Regional Director Europe for Avantor Clinical Services.  Working with customers across the region to improve their clinical trial effectiveness and efficiencies, through providing scalable, end-to-end service capabilities, including biorepository and sample management, custom kitting, and clinical trial equipment & ancillary solutions.  Farooq has over two decades of experience in the pharmaceutical sector, both for pharma companies in a variety of commercial roles as well as working for service providers to the industry. He earned his BSc in Biological Sciences from Nottingham Trent University.

Session Details: How will the Supply Chain need to adapt to support the growth of Decentralised Clinical Trials? 05-05-2022, 2:00 pm View In Agenda

Biography: Phil Lake is a respiratory specialist who supports clients all around the world and has held various roles in drug development for more than 22 years, predominantly focused on respiratory trials. Previously, he held positions at SmithKline Beecham and GlaxoSmithKline within respiratory drug development, working on respiratory drug development in a range of drug mechanisms and trial designs including landmark studies such as exacerbations, mortality, and mechanistic studies focusing on biopsy and sputum biomarkers. Phil has concentrated extensively on understanding drivers for variability to reduce the risk of study failure that included traditional respiratory indications as well as generic bioequivalence studies and the use of lung function as a biomarker within many rare diseases. He has focused on understanding potential safety signals within drugs which could have negative impacts on lung health. Phil has been pivotal in early centralized over read studies and is committed to driving improvements in lung function testing within decentralized trials.

Session Details: Ensuring rich evidence in DCTs in a world that demands Trial Anywhere™ 05-05-2022, 12:00 pm View In Agenda

Biography: In his role as VP, eCOA Science & Consulting, Bryan brings extensive experience and expertise to achieve smarter drug development, clinical trial design and execution (including decentralized and remote trials) to vastly expand the reach and access of trials to more patients, provide improved patient experience and data quality to deliver accelerated drug & device development programs. Bryan is a thought leader and recognized strategist & visionary and continues to influence, drive and deliver on the pharma wide industry necessity for smarter drug & device development and life cycle management.

Session Details: Ensuring rich evidence in DCTs in a world that demands Trial Anywhere™ 05-05-2022, 12:00 pm 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: Decentralized Clinical Trials/Hybrid Trials: What you need to understand to run them successfully 04-05-2022, 2:15 pm View In Agenda

Biography: Kevin has over 24+ years of experience in the IRT/ RTSM industry, having worked across many technical and project management leadership roles.  Experienced with developing and leading global teams delivering managed services spanning Operations, Project Management, Client Partnerships and Business Transformation.  Kevin is passionate about improving healthcare and utilizing technology that makes a real difference to patients’ lives. Kevin holds a Bachelors’ Degree in Computer Science from Hertfordshire University in the UK.

Session Details: Discover how IQVIA’s Integrated IRT eCOA solution improves data quality and usability while simplifying and accelerating study design and conduct 05-05-2022, 3:00 pm View In Agenda

Biography: Owen Corbin is an attorney admitted to the NC Bar (1996), CIPM, with more than 15 years of industry experience helping customers navigate a complex global regulatory landscape.  He joined IQVIA in 2012 and is currently Sr. Director, DCT Regulatory and Privacy for IQVIA Decentralized Clinical Trials.

Session Details: DCT Technology Due Diligence: Sponsor obligations for DCT Technologies and how to meet them 04-05-2022, 3:15 pm View In Agenda

Biography: As a Director, Operational Strategy with over 17 years’ experience from the Pharma, Biotech and CRO side of clinical trial planning, execution and leadership, Alexis uses her expertise to support Precision for Medicine (PFM) clients. This includes the development of study and portfolio level strategies. Alexis has managed global studies from Phase I FIH to logistically complex Phase III studies and has a passion for operational excellence, process management and study finance. Alexis holds a degree in Neuroscience and a Masters in Biotechnology Law and Ethics. With a focus in Oncology and Rare Disease, PFM is now also supporting clients within Neurology, CVS and Pediatric indications.  

Session Details: Clinical Research in the Era of Personalized Medicine 04-05-2022, 2:15 pm View In Agenda

Biography: Floris is the global commercial lead for Medical Devices at Castor, a global eClinical solutions provider that supports drug and device manufacturers with data collection across the product lifecycle. Over the last 3.5 years, Floris has connected with over 300 medical device companies to help build solutions for their research and development needs. Floris' deep understanding and experience in medical device product development and clinical research helps him discuss these challenges and find solutions.

Session Details: Creating the right technology ecosystem for your clinical trial 04-05-2022, 4:45 pm View In Agenda

Biography: Alastair has 30+ years of experience in the biopharmaceutical development of pre- and post-approval drugs, joining Syneos Health on 2017.  Prior to  joining Syneos Health, Alastair had a Global Delivery Head role at AstraZeneca with responsibility for the delivery of both pre and post approval programmes supporting key brands

Session Details: The growing constellation of asset development partnerships 04-05-2022, 11:00 am View In Agenda

Biography: Guillem is the Founder and CEO of MediQuo as well as the Founder of MeetingDoctors. Investor and board member of more than 30 startups including: Singularu, Cuidum, Landbot, Demium, Homyspace, Hannun, Taiga Agile, Swipcar, Catevering, Dental Residency, Brickbro, Twenix, The Wild Curl, Shimoku, Spathios, Trialing, Pulpo, Rebag, Impossible Bakers, Incapto and Buscoresi among others. He is a physician and mathematician with an MBA from IESE Business School and has deep knowledge in the eHealth market, MedTech and early seed startups. Guillem’s technical knowledge includes the areas of data-mining, signal processing, artificial intelligence and product development.

Session Details: Ensuring rich evidence in DCTs in a world that demands Trial Anywhere™ 05-05-2022, 12:00 pm View In Agenda

Biography: Nina Levin is a senior communications professional with extensive client-facing experience and a thorough understanding of corporate communications and internal and compliance processes. In her role as vice president of client success at Within3, she directs and identifies activities to meet KPIs by developing tailored strategic plans and drawing on experience across medical communications, advertising, and PR to set clients up for success. Nina’s proven track record and industry expertise allows her to deliver and oversee client support activities and apply her experience in process development, improvement, and implementation to ensure optimal results while meeting timelines and providing cost-effective deliverables.

Session Details: Virtual-Hybrid engagement for clinical teams 05-05-2022, 9:30 am View In Agenda

Biography: Achilleas has 12+ years of experience in software industry involving software demonstrations, managing a team of 15+ developers, hands-on coding in Microsoft .Net platform and Business Intelligence Suites like QlikSense. He has enjoyed a progressive career in diverse roles including responsibilities of a Sales Engineer, Team Manager, Software Engineer and Business Intelligence Analyst in various industries like Banking, Retail and now the Pharmaceutical industry with eClinical Solutions.

Session Details: Data-driven operations and oversight with elluminate 04-05-2022, 11:00 am View In Agenda