Outsourcing in Clinical Trials Europe 2021
Virtual Event: 8:30 AM CEST
5th-6th May, 2021
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Outsourcing in Clinical Trials Europe 2021
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We are thrilled to announce return of the leading clinical outsourcing and operations conference in Europe! The 11th OCT Europe edition will be hosted on 5th & 6th May 2021 on our brand new virtual platform.
Following its success, we are pleased to forecast the 2021 edition will attract even more, with a great speaker line up and up to date content.
Attendees will hear talks from Mads Dalsgaard, Head of Experimental Medicine & Clinical Development at Lundbeck - who will discuss ‘The Virtual Clinical Trial Eco-system’, as well as a keynote from Bodo Lutz, Associate Director Data & Digital GDQ at Novartis, on whether the Pharma industry is too conservative with wearable tech.
How to get recruitment in a crisis and best practices for strong CRO communications will be discussed during the interactive sessions, giving participants the opportunity to debate how to include patient voices in clinical trials and their view on recruitment. Experts from Insmed, Sanofi, Norgine and Almirall will be leading the discussions on these topics.
Day 2 of this executive summit will open with a session on leveraging CRO partnerships and expertise to maximise trial success. Blockchain strategies, decentralized trials, RWE and refining the bidding process will be discussed during the second day. We will also hear from the CEO of LEO Innovation Lab.
Do not miss this opportunity to network with your peers and learn best practices from the European industry leaders.
Register today!
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💻 Watch live and recorded thought leadership presentations
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📊 Take part in our interactive polls
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Testimonials
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‘That was a superb day, it feels like we’ve been at a real, in person, conference!’ Worldwide Clinical Trials
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‘A great event, I met more people than I do at an in-person event and I’ve got loads of follow ups’ Conversis
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‘The whole setting is actually very well accomplished! Thanks again for the invitation!’ Apogenix AG

Martin O’Kane
Head of Clinical Trials Unit at Medicines and Healthcare products Regulatory Agency,MHRA
Biography: Dr Martin O'Kane MRPharmS is Unit Manager of the Clinical Trials Unit in the Licensing Division of the Medicines and Healthcare products Regulatory Agency (MHRA). He studied pharmacy at University of Aston and after completing a PhD in pharmacology and post-doctorate neuroscience research project at the University of Glasgow, moved to Japan to work within the pharmaceutical industry. He joined the MHRA in 2005 as a Pharmacopoeial Scientist within the British Pharmacopoeia and moved to the MHRA Clinical Trials Unit as a Pharmaceutical Assessor in 2007. He became Unit Manager of the Clinical Trials Unit in November 2015 and has been actively involved in development of new clinical trials policy, systems and procedures and well as the UKs exit from the EU. Most recently he has been involved in supporting expedited approval of, and guidance for, clinical trials for COVID-19 vaccines and therapeutics and supporting the recovery and resilience of non-COVID trials.
Session Details: LIVE PANEL DISCUSSION How to get creative with recruitment in or out of a crisis? 05-05-2021, 12:30 pm View In Agenda

Dr Bodo Lutz
Risk Management, Data Integrity, Quality Management Systems, Quality Assurance,Novartis
Biography: Bodo Lutz is working for Novartis since 2011 as an expert within Global Drug Development Quality for clinical data integrity, risk management and company’s decentralized trial projects. In this position he is an alliance manager for multiple partners ranging from clinical operation functions to external parties advancing the acceptance and implementation of digital technologies enabling patient centric trials. He has more than 15 years of industry experience from CROs, Medical Device and Pharmaceutical companies, in roles focusing on quality and compliance. He regularly provides university lectures on quality topics for MSc Clinical Research programs. Bodo Lutz, a German 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: LIVE PANEL DISCUSSION Is the pharma industry still too conservative with wearable tech? 05-05-2021, 10:30 am View In Agenda

Sonja Weiser
Senior Director Clinical Operations,Insmed
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 DISCUSSION Establishing best practices for a strong communications channel with your CRO whilst building, but not immediately expecting, trust- What 5 key things do our panellists think we should focus on right now? 05-05-2021, 8:30 am View In Agenda

Morten Pedersen
VP, Head of Clinical Operations,Lundbeck
Biography: Morten completed his Master’s degree in Biotechnology at National University of Ireland, Galway, in 1997, specializing in Pharmacology. He joined Lundbeck in August 2020 as VP, Head of Clinical Operations. Career to date Morten started at a CRO in 1997 as a CRA on an Epilepsy study. In the subsequent years he worked in CRO’s, consultancy and big Pharma taking on roles within Project Management, Program Oversight, Innovation and Strategic Partnerships. He joined Pfizer in 2003 and has a wide range of project management experience delivering projects across multiple therapeutic areas. From 2007 to 2011 he held a leadership role in Pfizer’s Clinical Study Management group providing Operational Oversight in various outsourcing models. As Group Lead of Emerging Markets and Established Products Business Units he managed a team of Program Directors in a variety of Therapy Areas from Phase II to Late Phase and Non-Interventional trials. From late 2011 Morten joined an Innovation technology CRO in the role of Senior Director and Head of Strategic Partnerships with the aim of improving Clinical Trial efficiencies and supporting Trial Sites. In August 2016 he joined InVentiv Health as VP, Head of Program Delivery in Neuroscience, before the group merged with INC to become Syneos Health.
Session Details: OPENING PANEL DISCUSSION Establishing best practices for a strong communications channel with your CRO whilst building, but not immediately expecting, trust- What 5 key things do our panellists think we should focus on right now? 05-05-2021, 8:30 am View In Agenda

Veerle Aertsen
Co-Founder, EUPATI,
Biography: Eupati fellow, YOPD research advocate and DBS expert, advisor to various stakeholders, co-founder Eupati Belgium and Belgian Neuropatients Alliance. Representing the patient's voice in several projects. Keen on talking about the unmet needs of People living with neurodegenerative conditions. Regular participant and speaker in conferences, workshops, meet-ups with industry, Roadmap Initiative to Good Lay Summaries. As YOPD is a rare condition especially in women I am proud of my BBMRI-ERIC Stakeholder Forum membership; always bringing the needs of patients to the table, as an equal partner, not as windowdressing or because it gets in necessary funding. There is a before (diagnosis: 15/11/09) and after; I am now more focussed, driven, passionate about what I still can do, despite many challenges. I have ticked the box of raising awareness, fundraising and influencing policy makers. Now all I want to do is to eradicate shame, prove neuropatients are still valuable partners and fight stigma.
Session Details: View In Agenda

Mads Dalsgaard
Senior VP, Head of Experimental Medicine & Clinical Development,Lundbeck
Biography: Mads Dalsgaard is Senior Vice President and Global Head of Experimental Medicine and Clinical Development in Lundbeck. An MD by training with experience from neurology and holds a DMSc in neuroscience as well as an MBA from IMD in Switzerland. Within Lundbeck, Mads Dalsgaard is responsible for global Clinical Development from first-in-man to registration and beyond to phase IV. He is a strong advocate of leveraging innovative and technological tools to support and facilitate clinical development, both on scientific and operational aspects such as around digitalization, data science, biomarkers and bioinformatics, to both secure translational planning and optimal development planning and for the benefit of all stakeholders including patients and caregivers. He is furthermore passionate around precompetitive collaboration across institutions and companies to drive R&D productivity among others through data sharing.
Session Details: PLENARY KEYNOTE: The Virtual Clinical Trial Eco-system 05-05-2021, 9:30 am View In Agenda

Helén Johansen Blanco
Senior Clinical Director, Clinical Development,Cantargia
Biography: Helén Johansen Blanco has 20+ years of clinical development experience, managing Phase I to III clinical trials leading to the successful launch of several oncology products. She has experience in project management of large global clinical trials conducted in all continents of the world, mainly within oncology, but also therapeutic areas as cardiovascular and gastrointestinal. Mrs. Blanco has previously worked for large international pharma companies such as Astra Zeneca and Mylan, as well as small, medium to large sized biotechnology companies as Nordic Nanovector and Celgene, in addition to smaller and larger CROs such as Smerud and Covance. Currently she holds a position as Head of Clinical Operations at Oncoinvent, a small medium sized biotech company located in Norway. She holds a MSc in Biophysics and medical technology from Norwegian Technology and Science University and is currently writing her thesis for a Master in Business Administration.
Session Details: OPENING KEYNOTE Allowing your CRO a seat at the table: Leveraging CRO partnerships and expertise early on to maximize trial success 06-05-2021, 9:00 am View In Agenda

Fabio Miceli
Associate Director Country and Clinical Quality,Norgine
Biography: Fabio graduated from the University of Amsterdam with a Master’s degree in Medical Biology. Following his study he pursued a career in the pharmaceutical industry, initially in the management of clinical research & development for Clinical Research Organizations, Pharma and Biotech companies. The last 15 years of Fabio’s career were spent in the Quality Assurance arena covering various Quality roles – firstly at Genzyme and currently at Norgine. Fabio has gained significant expertise in the areas of GCP, GVP, Commercial (Codes of Practice) and Affiliate Quality, and is a Subject Matter Expert in auditing, global audit program management, fraud and misconduct assessments, due diligence activities, (QA) vendor management, process improvement, change management, risk management and Competent Authority Inspection management. Alongside his Quality remit at Norgine, Fabio has recently taken up an operational role within Norgine’s Pharmacovigilance department as deputy EU QPPV.
Session Details: OPENING PANEL DISCUSSION Establishing best practices for a strong communications channel with your CRO whilst building, but not immediately expecting, trust- What 5 key things do our panellists think we should focus on right now? 05-05-2021, 8:30 am View In Agenda

Diego Herrera Egea
Head of Clinical Data n Information Management,Almirall
Biography: BSc. Life Science graduated in the University of Barcelona, specialized in Hematology and Biochemistry and Teaching Laboratory Practices during 3 years. With almost 30 years working in Pharma Industry, I have been evolving into different positions in the area of clinical research and technologies and leading innovation projects. The current position is Head Clinical Data and Information Management. Nowadays, working on strategies partnerships to improve the digitalization of clinical trials and data visualization.
Session Details: OPENING PANEL DISCUSSION Establishing best practices for a strong communications channel with your CRO whilst building, but not immediately expecting, trust- What 5 key things do our panellists think we should focus on right now? 05-05-2021, 8:30 am View In Agenda

Benoît Marchal
Chief Digital Trust Officer,Partners for Patients
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: Doing a RWD study in a similar way to a clinical trial, all thanks to patient empowerment 05-05-2021, 11:30 am View In Agenda

John Zibert
John Zibert, Prev. CMO, LEO Innovation Lab, and CEO Studies&Me,
Biography:
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: Moving towards decentralized site-less trials: Learnings from an EU perspective? 06-05-2021, 10:00 am View In Agenda

John Shillingford
Director of Clinical Research,Afon Technology Ltd (Formerly Orsus Medical)
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: Strategies to engage with proactive CROs and how to challenge your CRO counterparts when you aren’t satisfied with the results 05-05-2021, 12:30 pm View In Agenda

Bernard Hamelin
VP Head of Evidence Generation,Sanofi
Biography: Dr. Bernard Hamelin M.D. has more than 25 years of experience in France and abroad in the fields of clinical development and medical affairs at AstraZeneca and Sanofi pharmaceutical companies. In recent years, his work has focused on real-life health related data and digital platforms to accelerate research and clinical development and to improve the generation of evidence supporting the access and marketing of innovative molecules. The convergence between recent discoveries in molecular and cellular biology and the digital transformation resulting from access to large amounts of health-related data has led pharmaceutical companies to revisit the planning and conduct of clinical studies. The use of these data has also made it possible to better communicate to health authorities and health care professionals the risks and benefits observed by patient sub-groups. Finally, the integration of data from various sources, such as the patient’s behaviors and preferences and the management of care systems has made it possible to develop more robust predictive models. Thanks to his experience and the links he has been able to create with institutional and private data providers and digital companies, Bernard is today considered as an expert by the industry of real-world data. A member of the French National Society of Liver and Digestive diseases, Bernard Hamelin has acquired medical expertise in several other therapeutic areas such as immunology, oncology, rare diseases, respiratory and cardio-vascular diseases.
Session Details: AI and Real-World Evidence (RWE) to support drug development 05-05-2021, 2:00 pm View In Agenda

Max Horneck
Head of Clinical Data Management and eClinical Systems,Medac GmbH
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: Innovation in sponsor oversight: Planning, managing, documentation, and data. A real live experience report 06-05-2021, 12:00 pm View In Agenda

Stefania Alvino
Digital & Multichannel Marketing Manager ,Daiichi Sankyo
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: LIVE PANEL DISCUSSION How to get creative with recruitment in or out of a crisis? 05-05-2021, 12:30 pm REMOTE ASSISTANCE: Telemedicine and patient management in chronic disease, and how COVID-19 has changed the paradigm 05-05-2021, 3:00 pm View In Agenda

Disa Lee Choun
Head, Integrated Clinical and Operations Analytics,Janssen Pharmaceuticals
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: LIVE PANEL DISCUSSION Is the pharma industry still too conservative with wearable tech? 05-05-2021, 10:30 am OPENING TECH KEYNOTE Blockchain for improving clinical trials 06-05-2021, 9:00 am View In Agenda

Martine Zimmermann
SVP, Head of Global Regulatory Affairs,Alexion Pharma International
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.
Session Details: How mechanism of action-driven development can address the COVID-19 challenge 05-05-2021, 3:00 pm View In Agenda

Peter Rutherford
Global Medical Lead - Orphan Renal Diseases,Vifor Pharma
Biography: Experienced medical affairs and market access leader - specific expertise in implementing patient centric care and service improvement initiatives. Member of EMEA Executive Leadership Committee of Medical Affairs Professional Society (www.medicalaffairs.org) Strategic health planning in developed and developing markets
Session Details: LIVE PANEL DISCUSSION How to get creative with recruitment in or out of a crisis? 05-05-2021, 12:30 pm Why are machine learning and AI techniques gaining traction in the life science industry? 06-05-2021, 10:00 am View In Agenda

Mats Sundgren
Director Health Informatics,AstraZeneca
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: View In Agenda

Jose Manuel Ordoñez
Spain-CCO Therapeutic Area Leader Oncology/Hematology,Roche
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: The expanding role of Artificial Intelligence within drug development and clinical trials 05-05-2021, 2:00 pm View In Agenda

Robert S. Greene
President,Hunger and Thirst Foundation
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: LIVE PANEL DISCUSSION How to get creative with recruitment in or out of a crisis? 05-05-2021, 12:30 pm View In Agenda

Marta Garcia
Patient Officer-Clinical Development, Patient In R&D,Servier
Biography: Originally graduated as a Pharmacist in Madrid, and later completed my academic education with an MBA and a Master in Public Health from Liverpool University. Over 25 years of international experience within the pharmaceutical industry in Regulatory Affairs, Medical Affairs, Marketing, Scientific Communications and Clinical Operations in global and local positions in areas from cardiovascular to oncological diseases. In the last 2 years my main professional interest has shifted towards Patient centricity within clinical development, recently taking on new responsibilities as R& D Chief Patient Officer. My current responsibility is the incorporation of patients´ voice across the research and development process of new medicines. This covers the development and coordination of project and study patient centric plans, identification of best-practises and development of KPIs in a cross-traversal manner with patients partners and internal stakeholders.
Session Details: Gaining patient input to improve your protocols and clinical development plans (Why, How, Impact) and enrolling under-represented patient populations 05-05-2021, 11:30 am View In Agenda

Silvana Giro
Senior Manager, Responsible Global Outsourcing and Contract Management Europe, Global Medical & Regulatory Affairs,Bracco Imaging
Biography: From 1984 to 1988 employed by Ciba-Geigy, in the Sales Marketing of chemical products, within the Customer Services. Since 1988 employed by Bracco S.p.A. and then by Bracco Imaging S.p.A., developing different skills: Clinical Project Planning, Budget Control Since 2000 responsible for Contract Management in Europe, including contractual negotiation for all global functions within Global Medical & Regulatory Affairs. Since June 2002 also responsible for Global Outsourcing within Global Medical & Regulatory Affairs. Since 2001 Silvana Giro has been invited as speaker and moderator to several conferences and seminars.
Session Details: Managing a standardized outsourcing process allows a bidding process transparent and duly motivated 05-05-2021, 3:00 pm View In Agenda

Pavlina Walter
Head of Clinical Operations,Tesla Medical
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: For sponsors it is more profitable to involve study coordinators in the study: Do you agree or disagree? 05-05-2021, 10:30 am View In Agenda

Annelies Legters
Senior Director Clinical Operations,AM-Pharma
Biography: Starting in the Clinical Research area 30 years ago as a study coordinator I have worked my way to being senior director of clinical operations of AM-Pharma through roles in clinical Pharmacology, different CNS areas in midsize Pharma. CNS, Leukemia and now Acute Kidney Injury in Biotech companies. The Biotech has really stolen my heart and sole because of the creativity you have to use in these small companies and the close cooperation with every department. Regulatory Inspections are not a threat but I actually have to say I like them. Partially because I like to be challenged but also because I believe you can constantly work towards a good outcome. There are always findings but they are also a recipe for improvement.
Session Details: ‘Keep Calm It’s Only An Inspection’ 06-05-2021, 12:00 pm View In Agenda

Gabriëlle Haring
Senior QA Manager Site Qualification EU,Kite Pharma
Biography: I am a professional who is quality focused without losing the fun and creativity in the process. Although I like to see high quality I will not get lost in the details and will maintain a high level overview. I am interested in working with different people and cultures; a global thinker with understanding of cultural differences. A team player who loves to share her knowledge with other people and usually volunteers for teaching and coaching tasks. I am eager to keep on learning new things to get the best out of my performance.
Session Details: ‘Keep Calm It’s Only An Inspection’ 06-05-2021, 12:00 pm View In Agenda

Mike Hutton
Head of Strategic Relationship Management, EU,Almac
Biography: Mike Hutton graduated from University of East Anglia with a PhD in Biochemistry and spent 10 years in Scientific and Medical Research in Birmingham, Cambridge and Norwich. In 1999, Mike joined a leading central laboratory provider in London in a Project Management capacity before moving to Almac Clinical Technologies in 2002 as a Project Manager. Mike has now been with Almac over 17 years, working in various roles of increasing responsibility, from Project Management to Operational Management, and now, in a tactical commercial role. Mike is currently Head of Strategic Relationship Management, EU and oversees several key clients along with developing new and exciting business in EU and beyond with Almac’s leading Interactive Response Technology.
Session Details: Catching up during COVID: Proven technology for meeting the accelerated timelines 2021 hybrid clinical trials demand 05-05-2021, 2:30 pm View In Agenda

Steven Roan
Senior Business Development Manager,Novotech
Biography: With over 15 years healthcare industry sales experience, I am strongly passionate about biotechnology, and clinical trials. I currently work for Novotech, the Asia Pacific CRO. Contact me to learn more about my experiences serving clients, and conducting clinical trials in the Asia Pacific region.
Session Details: Asia Pacific: The solution for accelerating your clinical trial program 05-05-2021, 9:00 am View In Agenda

Alan Runacus
Business Development Manager,World Courier
Biography: Alan is an industry expert in specialty transport and logistics; currently serving as a Business Development Manager, for World Courier based in the UK. With over 25 years' experience in the express and specialist transport industry, assisting in the development of robust solutions that add value in the supply chain, Alan is an established senior sales and logistics professional.
Session Details: How to upgrade your clinical trial logistics through a strategic partnership 06-05-2021, 9:30 am View In Agenda

EB McLindon
Senior Vice President Site, Patient and Decentralized Solutions,ICON
Biography: E.B. McLindon is an accomplished senior executive with proven ability to build, develop and manage businesses. Utilising a background in finance and technology, he helped create Accelovance, a CRO that owns and operates clinical research sites. E.B. is passionate about engaging patients – either directly through outreach or through site development, and simplify the research journey for both patients and sites.
Session Details: Decentralised & hybrid trials – the way forward for more patient centric trials 05-05-2021, 3:30 pm View In Agenda

Ben Manderman
Executive Medical Director, Oncology Lead Europe,Pharm-Olam
Biography:
Session Details: Go East! Advantages of research sites in Central and Eastern Europe 05-05-2021, 2:30 pm View In Agenda

Deepu Joseph
Vice President, Global Head of Clinical Data Management,Quanticate
Biography: Deepu Joseph is currently serving as the vice president and global head of clinical data management with Quanticate and has over fifteen years experiencing in managing and driving clinical data management operations delivery across major CROs.
Session Details: Why a pre-planned data strategy is important for decentralised trials 06-05-2021, 10:30 am View In Agenda

Amanda Cross
Executive Director, Service Strategies ,CROS NT
Biography: Amanda specialises in developing efficient and effective processes for clinical trial oversight and increasing customer satisfaction. A dynamic professional, Amanda has almost 25 years of operational and commercial experience in the clinical trial industry at both pharmaceutical companies and CROs. She began her career as statistician, moving with time to project management and customer relationship roles. During her career, Amanda has built and implemented numerous cost-effective solutions for pharmaceutical companies to help them to increase data quality, shorten timelines and reduce costs. Amanda holds a bachelor’s degree in Statistics from Virginia Polytechnic Institute and State University.
Session Details: Defining a Data Strategy: How to effectively manage your key asset 05-05-2021, 3:30 pm View In Agenda

Bonnie Bain, PhD
Global Head and Executive Vice President of Healthcare Operations and Strategy,GlobalData Healthcare
Biography: Bonnie Bain, PhD, is the Global Head and EVP of Healthcare Operations and Strategy. Bonnie has over 20 years’ experience in the healthcare sector and a proven track record of developing innovative solutions on both the client and agency sides of the business. Bonnie was GlobalData Healthcare’s first Western analyst, and under her leadership, the company launched a number of premium syndicated reports, analytical tools, and databases in the pharmaceuticals and medical devices space. Prior to GlobalData, Bonnie was Vice President and Global Research & Analysis Director for Informa’s Pharma Division, which includes Datamonitor Healthcare, Scrip Group, and Business Insight. Bonnie also worked for several years at Decision Resources as an Analyst and Project Manager. On the client side of the industry, Bonnie worked for several years as a Senior Manager in Marketing Strategy and Analytics at Boston Scientific, where her work contributed to the successful commercialization of the first ever Access and Visualization Platform at the company. Bonnie has a PhD in Biochemistry and Molecular Biology from Purdue University and completed a Post-Doctoral Fellowship in Molecular Pharmacology at the University Of Miami School Of Medicine. She also has a graduate certificate in Applied Management Principles from Purdue University Krannert School of Management.
Session Details: Opening Remarks 05-05-2021, 8:15 am The state of the biopharmaceutical industry 2021 by GlobalData’s Bonnie Bain 05-05-2021, 11:30 am Clinical trials disruption due to COVID-19 05-05-2021, 2:00 pm Opening Remarks 06-05-2021, View In Agenda

Estelle Haenel
Medical Director,Kayentis
Biography: Estelle has joined Kayentis, a global eCOA solutions provider, in 2019, to consolidate the scientific expertise of the company and drive patient and site centric developments. Estelle has more than 20 years’ experience in the pharmaceutical industry, in both pre-clinical and clinical research. She joined Pfizer in early 2012 after having worked for both other big pharmas’ and biotech companies. She led projects from phase 1 through 4 in multiple therapeutic areas and has also solid expertise in the Non-Interventional space as well as in Clinical Pharmacology.
Session Details: Let’s challenge our beliefs: Do we really know what clinical trial patients need? Do we have the right understanding of how they perceive digital clinical trials? 05-05-2021, 1:30 pm View In Agenda

Revati Tatake
PhD, Global Director of Databases and Analytics,GlobalData
Biography: Revati Tatake currently serves as a Global Director of Databases and Analytics at GlobalData, where her primary responsibilities are to lead the development and continuous enhancement of integrated databases and analytical tools for providing competitive and business intelligence for pharmaceutical and biotechnology sectors Revati has more than 20 years’ experience, both in academic research and the healthcare industry, during which time she focused on basic and clinical research, drug discovery and competitive intelligence projects across many therapeutic areas. After academic career at Tata Cancer Research Institute and the University of Connecticut Health Center, she began her healthcare industry career at Boehringer Ingelheim Pharmaceuticals, where she led drug discovery projects involving small molecules, gene therapy and cell therapy for cardiovascular diseases, Rheumatoid arthritis and Diabetes. In addition to leading drug discovery projects, Revati co-chaired novel target identification group, scouted novel technologies for enhancing drug discovery efforts, established collaborations with experts in academic institutions to complement internal projects and evaluated in-licensing opportunities for their scientific and technical merit. She is a co-inventor on several issued US patents and applications related to the projects on cell and gene therapies. Before joining GlobalData, Revati worked at Citeline, where she was involved in competitive intelligence and analytics of clinical trials and pharmaceutical products. Revati holds a PhD in Tumor Immunology from Tata Cancer Research Institute. She was a post-doctoral fellow at the University of Connecticut Health Center.
Session Details: Clinical trials disruption due to COVID-19 05-05-2021, 2:00 pm View In Agenda

Peter V. Henstock
AI & Machine Learning Lead,Pfizer
Biography: Peter Henstock is the Machine Learning & AI Lead in the Quantitative Data Science group at Pfizer. His work has focused at the intersection of AI, visualization, statistics and software engineering applied mostly to drug discovery but more recently to clinical trials. Peter holds a PhD in Artificial Intelligence from Purdue University along with 6 Master’s degrees. He was recognized as being among the top 12 leaders in AI and Pharma globally by the Deep Knowledge Analytics group. He also currently teaches graduate AI, Software Engineering, and Computer Vision courses at Harvard.
Session Details: RECRUITMENT CASE STUDY: An innovative open-source iPhone app designed for patient recruitment 05-05-2021, 12:30 pm View In Agenda

Radha Krishnan
Global Head Biorepository Operations & Strategy, Avantor,
Biography: Radha is a cross-functional biopharmaceutical executive with expertise in leading business transformation projects driving process excellence, cost synergies and technological innovation in the management of Clinical trials/Biobanking. Her in-depth understanding of Central lab operations coupled with experience in financial planning and strategic pricing enabled the successful implementation of various technologies supporting the central lab process delivery and optimization.
Session Details: The critical role of biorepositories and archiving in successful clinical research 05-05-2021, 11:00 am View In Agenda

Nozomu Miyawaki
Senior Manager, Global Clinical Development,SOUSEIKAI Global Clinical Research Center
Biography: Mr. Miyawaki had made a successful career transition from the language education to the life science business at a leading Phase 1 Site in Japan 8 years ago. Within less than a decade, he made himself to a senior manager level rapidly and became one of the most influent people in the company, proving his enthusiasm and the talent to develop values to our global sponsors/partners. By learning and utilizing the skills and knowledge through collaboration, communication, and aligning global industry partners, he now plays a crucial role to create and maintain the top-notch clinical solutions for the worldwide market.
Session Details: This Is How It’s Done! – Unlocking the secrets to successful drug development in Japan 05-05-2021, 11:00 am View In Agenda

Laura Acosta
Vice President of Product Management,Anju Software
Biography: Laura Acosta is Vice President of Product Management and is responsible for the product direction of the eClinical suite at Anju Software. Laura has 23+ years of experience providing software products to the Life Sciences industry. Laura has played many roles in that time including Development Management and Product Management. In her product management role, she has worked with many large Pharmaceutical and BioTech companies, and CROs. She has a B.S. in Computer Science from Tufts University and a M.S. in Computer Science from Boston University.
Session Details: Utilizing adaptive systems to get the most from decentralized trials 05-05-2021, 3:30 pm View In Agenda

Kim Rejndrup
Senior Vice President of Product Development, Anju Software,
Biography: Kim joined Anju Software with the acquisition of OmniComm Systems, which he had been at since 2017, managing the eClinical Suite's product development. His expertise in clinical operations software is driving Anju’s products to new levels of innovation. Prior to Anju, Kim gained about 20 years of experience at Oracle Corporation as Vice President of Development for many clinical research applications, including systems for electronic data capture (EDC), clinical trials management, data management, medical coding, and data warehousing. Kim holds a Bachelor's degree in Informatics from the Aarhus Business College in Denmark.
Session Details: Utilizing adaptive systems to get the most from decentralized trials 05-05-2021, 3:30 pm View In Agenda

Krista Bradley
Executive Vice President of Clinical Research, PCM Trials
Biography: Krista Bradley joined PCM TRIALS as the Executive Vice President in January 2020. She brings over 20 years of healthcare and clinical research expertise from The Cleveland Clinic, University of Colorado Cancer Center, and most recently as the National Vice President of Research for Common Spirit Health (Catholic Health Initiatives). Ms. Bradley’s career has been focused on team building, improving operational efficiency, and organizational leadership. She is passionate about the value of research, its potential impact on the lives of patients, and its role in shaping the future of medicine. Ms. Bradley is currently completing her MBA in Healthcare Management at Western Governor’s University. She retains an active license as a Registered Nurse in the state of Colorado and received her certification as a clinical research professional in 2010.
Session Details: View In Agenda

Julie Church-Thomas
Director of Site Relations,PCM Trials
Biography: Julie has been with PCM TRIALS since its inception in 2008, working in all facets of the business including project management, human resources, quality, marketing, business development and is now spearheading the site relations efforts to provide support to the sponsors and CROs in outreach and education of sites.
Session Details: View In Agenda

Jess Conicelli
Executive Director, Strategic Development, Rare, Orphan, & Pediatric Diseases, Synteract,
Biography: Jess has 15 years of clinical research experience, with much of that time uniquely focused on rare and orphan diseases. Most recently, Jess oversaw clinical operations at the University of Pennsylvania’s Orphan Disease Center and Gene Therapy Program, both housed within the Perelman School of Medicine. While at Penn, Jess worked closely with biotech companies to implement strategic clinical development initiatives and with thought-leaders to foster collaboration within the rare disease community. She oversaw vendor partnerships to create patient registries and natural history studies, and, most impactfully, she worked hand-in-hand with patient advocacy groups, providing rare disease patients and their families with data-driven guidance while accelerating the clinical research process. Prior to Penn, Jess spent eleven years in the CRO industry with Syneos Health, formerly INC Research, where she held director level positions growing their therapeutic business units, with a specific focus in global rare disease and pediatric trials. Jess earned bachelor’s degrees in both Molecular Biology and Psychology from Meredith College in Raleigh, NC.
Session Details: How Advanced Technology is Shaping Rare Disease Clinical Research 05-05-2021, 10:00 am View In Agenda

Sheila Rocchio
Chief Marketing Officer, eClinical Solutions
Biography:
Session Details: Digital Strategies to Power #NoGoingBack 05-05-2021, 2:30 pm View In Agenda

Ben Thoren
Director, Services Delivery,Suvoda
Biography: As Director of Services Delivery, Ben oversees services delivery out of Suvoda’s Bucharest office. Ben has over 11 years of experience in the software industry, holding a variety of positions in professional services, global operations and business development. He has consulted with Fortune 2000 clients across a variety of industries on how to best leverage technology to solve mission-critical business challenges
Session Details: Optimizing Supply Chain with Enhanced Dynamic IRT 05-05-2021, 12:00 pm View In Agenda

Julia Forjanic Klapproth
Owner & Senior Partner, Trilogy ,
Biography: After receiving her PhD in developmental neurobiology, Julia started her career as a medical writer in the regulatory group at Hoechst Marion Roussel (later Sanofi) in 1997. Since then she has been president of the European Medical Writers Association (EMWA) twice (2001-2002, 2007-2009). In 2002, Julia co-founded Trilogy Writing & Consulting, a company specialized in providing regulatory medical writing. In addition to managing the company as President/Senior Partner, she writes a wide array of clinical documents including study protocols, study reports, and is specialized in the clinical parts of CTD submission dossiers.
Session Details: The Value Proposition of Good Medical Writing for Clinical Study Protocols 05-05-2021, 1:30 pm View In Agenda

Behtash Bahador MS
Director, Health Literacy,CISCRP
Biography: Behtash Bahador is an Associate Director at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.
Session Details: This is Not a Trend: Exploring why patient-centred research will change the research paradigms of the past 05-05-2021, 10:30 am View In Agenda

Patricia Cornet
Group Director and Lead Community Partnerships,Bristol Myers Squibb, Women of Color in Pharma Co-Founder
Biography: Progressive change agent with deep expertise in leading high performing teams, delivering innovative business strategy, and creating advocacy models transforming the way patients gain access to treatments. Proven innovator and trusted business partner who solves complex business, patient, and physician problems. Global pharmaceutical leadership experience spanning clinical operations, medical affairs, and research. Highly reputable advisor in the following therapeutic areas: Cardiovascular, Oncology, Immunoscicence, and Virology. Notable for designing and implementing global, disruptive integrated recruitment engagement strategies. Diversity thought leader and community advocate with a focus on advancing the careers of women.
Session Details: EXPERT PANEL: Patient engagement and diversity in clinical research; discussing collaboration strategies to move the needle forward 05-05-2021, 4:00 pm View In Agenda

Lorena Kuri
WOCIP Director, Global Leadership; Head, Diversity Strategy, Bristol Myers Squibb ,
Biography: I am a people oriented, active and sensitive change agent leading the R&D efforts to help serve more Patients around the world. My international experience and transferable skills helped me change careers after more than 14 years in Commercial roles, finding a match in Clinical Operations, expanding the opportunity to help medically underserved populations. My business acumen and customer focus have been key to demonstrate results in different roles, but more importantly to engage with key stakeholders. I hold a Masters in Human Capital, and am fluent in Spanish, English and Portuguese. I believe in the value of connecting others and am proud of building this connections and helping whenever is needed. I am an inclusion advocate.
Session Details: EXPERT PANEL: Patient engagement and diversity in clinical research; discussing collaboration strategies to move the needle forward 05-05-2021, 4:00 pm View In Agenda

Annie Harris
WOCIP Founding Member & Director of IT; Director, Technology Enablement, Covance,
Biography: Experienced Director Of Technology with a demonstrated history of working in the clinical development technology area. Strong professional in IT Strategy and System Business Process.
Session Details: EXPERT PANEL: Patient engagement and diversity in clinical research; discussing collaboration strategies to move the needle forward 05-05-2021, 4:00 pm View In Agenda

Vickie Laurent
WOCIP Board Member; Global Regulatory Affairs Lead, LEO Pharma,
Biography: Experienced leader within the pharmaceutical industry in the US and EU with demonstrated experience producing results in new drug development and drug approvals across global markets. Skilled driver of strategic Global Regulatory Affairs, Drug Development across multiple indications including Oncology, Hematology, Cardiovascular, medical Dermatology, across R&D and Commercial. Global and commercial minded with strong clinical/medical, business, P&L understanding and interpretation as well as ability to seamlessly transition between therapeutic areas, transversing comfortably between R&D, commercial, and cross regionally
Session Details: EXPERT PANEL: Patient engagement and diversity in clinical research; discussing collaboration strategies to move the needle forward 05-05-2021, 4:00 pm View In Agenda

Kemi Olugemo
WOCIP Director of Communications; Executive Medical Director, Head Neurology Clinical Development, Akcea Therapeutics,
Biography: Physician-Executive with clinical experience and expertise in all phases of CNS drug development, global medical strategy, business development, and innovations in lifecycle planning.
Session Details: EXPERT PANEL: Patient engagement and diversity in clinical research; discussing collaboration strategies to move the needle forward 05-05-2021, 4:00 pm View In Agenda

Ravi Kiron
Head, BioPharma External Innovation, EMD Serono,
Biography: Dr. Ravi Kiron based in California, USA is an experienced pharma/biotech executive with decades of experience in discovery R&D through late-stage clinical development, intellectual property and regulatory, technology & business development, M&A, strategy and product commercialization, negotiating and executing partnerships by leveraging his extensive global business development networks in CVMD, Oncology, CNS, Wound Healing, Microbiome and Diagnostics. He was a tenure-track faculty member at Cornell University Medical College and adjunct faculty at University of Rhode Island. Dr. Kiron served in various operational & management roles at Pfizer Inc., and J&J/ALZA, in Cardiovascular R&D, Oncology clinical development (Tarceva), strategic business development and M&A (acquisition of WLA, PHA & other biotech). Dr. Kiron has consulted for several dozen global biotech & pharma companies, founded and led multiple companies/new ventures, served as an Entrepreneur In Residence (EIR) at SRI Ventures, ShangPharma Innovation and advises company and non-profit boards. Currently, Dr. Kiron is Head, BioPharma External Innovation at the Merck KGaA/EMD Serono’s Silicon Valley Innovation Hub in Menlo Park, California and is exploring cutting edge game changing technologies (Artificial Intelligence & Machine Learning, Microbiome, Electroceuticals etc.) to have an impact on pharma/biotech research, product development and launches.
Session Details: Establishing best practices to get investment during a crisis 05-05-2021, 4:00 pm View In Agenda

Dani Peters
MAITP President,Magnet Strategy Group

Joanna Schulman
CEO,AIDIA COLLECTIVE

Ben Schlatka
VP, Digital Biomarker Solutions ,Medidata
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: From Sensors to Insights: Transforming clinical research with connected device data 05-05-2021, 11:00 am View In Agenda

Thomas Ellmann
Vice President, CSI Life Sciences & Healthcare, Head of Clinical Trials Logistics,DHL
Biography: Thomas has been an instrumental figure in the DHL Life Sciences & Healthcare sector for over 14 years. As a Global Sector Team member, Thomas is now leading the cross-divisional development of clinical trials logistics offering. He recently co-authored the white paper “Pandemic Resilience” and is central to business development efforts in DHL’s Global Task Force to support distribution readiness for global vaccine manufacturers, governments, and NGOs. Thomas is also leading the company’s COVID-19 vaccine distribution strategy. Previously, Thomas was Sales Leader for EMEA, including Emerging Markets in the Middle East and Africa, where he had responsibility for an extensive portfolio of pharmaceutical and medical devices companies. Before joining the DPDHL Group, Thomas spent several years in FMCG and specialty chemicals industries, where he held roles in supply chain and customer services. Thomas holds a Master’s degree in Physics from the WWU Münster, Germany
Session Details: Shifting gears: Accelerating clinical trial logistics in 2021 & beyond 06-05-2021, 11:30 am View In Agenda

Heather DiFruscia
VP, Randomization & Trial Supply Management,Axiom Real-Time Metrics
Biography:
Session Details: Unified Platforms: Benefits and considerations when running global studies 06-05-2021, 9:30 am View In Agenda

Brian Dempster
Senior Director, Global Clinical Management,Axiom Real-Time Metrics
Biography: Brian Dempster has over 25 years of clinical development experience, gained across a variety of therapeutic areas and geographical regions. He began his career as a CRA before being accepted to Amgen’s Leadership and Management Program. During a decade at Amgen, Brian held program leadership positions in Oncology, Endocrinology and Bone Health in Europe, Canada and the US. In 2014 Brian joined Vital Therapies (VTL) where he was instrumental in the creation and execution of clinical development strategy, overseeing the entire Phase II and Phase III programs of VTLs combined device and biotherapeutic system for the treatment of liver failure. Utilizing Fusion eClinical Suite in partnership with Axiom: Before joining Axiom, Brian led the clinical development group at Endologix, which oversaw the global team involved in the pre-approval and post-market clinical development of Endologix’s products, serving patients with a need for abdominal aortic aneurysm sealing and repair. Brian has a thorough understanding of the clinical development process and has used this to successfully bring products to market. This includes leading teams through several regulatory inspections in relation to submissions, to FDA, MHRA and PMDA. Brian has a particular interest and passion for trial documentation standards, having forged the path for introduction and transition of several eTMF programs.
Session Details: Unified Platforms: Benefits and considerations when running global studies 06-05-2021, 9:30 am View In Agenda

Dr Vivienne van de Walle
Founder and Director of PreCare Trial & Recruitment,PTR
Biography: Viviënne van de Walle studied medicine both at the University of Maastricht and at the University of Oxford. In addition to her MD degree she holds a medical research degree in Genetics, Pediatrics and Genetics. In 2004 she successfully defended her thesis for her PhD in Auxology and in 2011 she passed the CPI exam. She has always combined clinical research with patient care and has been a full time principal investigator at independent clinical research sites. She co-founded and owns the independent research site PT&R (www.ptr.nu) since 2006. Her entrepreneurship is reflected by her skills as thought leader and in consulting, educating and managing at CROs, pharma, nutritional companies and in executive and advisory board functions at eCOA vendors and trade organizations i.e. ACRP, SCRS, TransCelerate, CISCRIP and the NVFG. With her PT&R-team she was also the proud winner of the inaugural SPRIA EU award of the SCRS . In 2019 she was nominated for the Clinical Trial Europe - Christine Pierre Life Time Achievement Award and in 2020 she was nominated at the 5th World Congress on Advanced Clinical Trials and Clinical Research for Women in Science Awards / Women Scientist. She started her research career as a participant in a clinical trial and is now participating in a preventive COVID trial for HCP. As a result, Viviënne has a unique perspective of the various sides of the table in clinical research and is eager to share her many years of experience. As she states: “I love it when you pick my brain”.
Session Details: Pandemic: Upcoming site challenges and the impact on clinical supply planning 06-05-2021, 10:30 am View In Agenda

Ray Collia
VP Sales,S-Clinica
Biography: Ryoma (Ray) Collia is Vice President Sales at S-Clinica. With a solid background in sales for over thirty-three years, with a particular focus on business development and strategic growth, Ryoma brings over ten years of experience in Life Sciences, seven of which has been within Clinical Trials. Ryoma made a move into the Life Sciences sector to 'give back' to the industry after his wife's life was dramatically saved by doctors and nurses in 2007 and her subsequent recovery 18 months later. Since then, Ryoma has worked closely with Pharma, CROs, Sites and Patient Advocacy groups to achieve that goal. He is a passionate advocate for patients and clinical sites, and is also very proud to volunteer for and support the Pharmaceutical Contract Management Group as a Steering Committee Member.
Session Details: View In Agenda

Carol Tester
Vice President, eCOA Partnerships,YPrime
Biography: Carol Tester, Vice President, eCOA Partnerships, focuses on development of global customer relationships to identify ways that YPrime can serve its biopharmaceutical clients. A recognized subject matter expert in eCOA technology, she brings 20 years of industry experience with more than 15 years of operational and strategic business experience. Carol began her career as a member of the Royal Navy before moving into the Life Science industry after 5 years of service. Her industry tenure started in Data Management at Novo Nordisk, Pfizer and Novartis before accepting a Consultant role for Actelion in Switzerland. Her eCOA experience stems from positions as Relationship Manager, Director of Client Relations as well as Program Director with various eCOA vendors. Carol has overseen global study programs, supervised project management teams and managed key account relationships.
Session Details: Is BYOD right for your eCOA Clinical Trial? 05-05-2021, 12:00 pm View In Agenda

Celeste A. Elash
Vice President, eCOA Science,YPrime
Biography: Celeste A. Elash, MS, is the Vice President of eCOA Science for YPrime. Throughout her 25-year industry career, Celeste has served as a clinical research scientist, with a variety of contributions to the advancement of patient-focused drug development and eCOA adoption. Celeste has conducted research for Purdue University, Western Psychiatric Institute and Clinic. She also contributed to some of the earliest electronic patient-reported outcomes studies at the University of Pittsburgh. Prior to joining YPrime, Celeste served as an independent consultant to biopharmaceutical companies and both in operations and as clinical science advisor for two eCOA providers. She currently represents YPrime on the Critical Path Institute’s ePRO Consortium.
Session Details: Is BYOD right for your eCOA Clinical Trial? 05-05-2021, 12:00 pm View In Agenda

Mike Mendoza
Senior Director, Product Management,Calyx
Biography: A highly experienced Senior Director of Clinical Data Systems with considerable global experience within the CRO and technology environments. Key experiences are within the US, Indian and all European markets across all phases and multiple therapeutic areas. Well versed in GDPR, validation, and regulatory requirements across US and EU markets.
Session Details: Exploring technology fatigue for sites in clinical trials 06-05-2021, 11:30 am View In Agenda

Patricia Cornet
Group Director and Lead Community Partnerships,Bristol Myers Squibb, Women of Color in Pharma Co-Founder
Biography: Progressive change agent with deep expertise in leading high performing teams, delivering innovative business strategy, and creating advocacy models transforming the way patients gain access to treatments. Proven innovator and trusted business partner who solves complex business, patient, and physician problems. Global pharmaceutical leadership experience spanning clinical operations, medical affairs, and research. Highly reputable advisor in the following therapeutic areas: Cardiovascular, Oncology, Immunoscicence, and Virology. Notable for designing and implementing global, disruptive integrated recruitment engagement strategies. Diversity thought leader and community advocate with a focus on advancing the careers of women.
Session Details: EXPERT PANEL: Patient engagement and diversity in clinical research; discussing collaboration strategies to move the needle forward 05-05-2021, 4:00 pm View In Agenda

Lorena Kuri
WOCIP Director, Global Leadership; Head, Diversity Strategy, Bristol Myers Squibb ,
Biography: I am a people oriented, active and sensitive change agent leading the R&D efforts to help serve more Patients around the world. My international experience and transferable skills helped me change careers after more than 14 years in Commercial roles, finding a match in Clinical Operations, expanding the opportunity to help medically underserved populations. My business acumen and customer focus have been key to demonstrate results in different roles, but more importantly to engage with key stakeholders. I hold a Masters in Human Capital, and am fluent in Spanish, English and Portuguese. I believe in the value of connecting others and am proud of building this connections and helping whenever is needed. I am an inclusion advocate.
Session Details: EXPERT PANEL: Patient engagement and diversity in clinical research; discussing collaboration strategies to move the needle forward 05-05-2021, 4:00 pm View In Agenda

Annie Harris
WOCIP Founding Member & Director of IT; Director, Technology Enablement, Covance,
Biography: Experienced Director Of Technology with a demonstrated history of working in the clinical development technology area. Strong professional in IT Strategy and System Business Process.
Session Details: EXPERT PANEL: Patient engagement and diversity in clinical research; discussing collaboration strategies to move the needle forward 05-05-2021, 4:00 pm View In Agenda

Vickie Laurent
WOCIP Board Member; Global Regulatory Affairs Lead, LEO Pharma,
Biography: Experienced leader within the pharmaceutical industry in the US and EU with demonstrated experience producing results in new drug development and drug approvals across global markets. Skilled driver of strategic Global Regulatory Affairs, Drug Development across multiple indications including Oncology, Hematology, Cardiovascular, medical Dermatology, across R&D and Commercial. Global and commercial minded with strong clinical/medical, business, P&L understanding and interpretation as well as ability to seamlessly transition between therapeutic areas, transversing comfortably between R&D, commercial, and cross regionally
Session Details: EXPERT PANEL: Patient engagement and diversity in clinical research; discussing collaboration strategies to move the needle forward 05-05-2021, 4:00 pm View In Agenda

Kemi Olugemo
WOCIP Director of Communications; Executive Medical Director, Head Neurology Clinical Development, Akcea Therapeutics,
Biography: Physician-Executive with clinical experience and expertise in all phases of CNS drug development, global medical strategy, business development, and innovations in lifecycle planning.
Session Details: EXPERT PANEL: Patient engagement and diversity in clinical research; discussing collaboration strategies to move the needle forward 05-05-2021, 4:00 pm View In Agenda

John Reites
CEO, THREAD,
Biography: Executive intrapreneur turned digital health entrepreneur, my career includes nearly 20 years leading global drug development, clinical research, and decentralized clinical trials (DCTs) for life science organizations. As CEO of THREAD, I lead our global organization in achieving our 1/5/30 mission to modernize clinical research by offering biopharma and CRO customers one (1) comprehensive platform that is five (5) times more inclusive and makes research 30% more efficient. After co-founding and growing THREAD, we were acquired in 2019 by JLL Partners and Water Street with strategic investment for continued growth and focus on accelerating drug development for our customers. Named one of the Top 100 Influencers in Digital Health, I also provide expertise and execution experience in digital health, clinical research innovation, and DCTs. Learn more about John at www.linkedin.com/in/johnreites
Session Details: Best Practices to Scale Your Global Hybrid Decentralized Studies 06-05-2021, 12:30 pm View In Agenda

Amanda Woodrooffe
Senior Vice President, General Manager UK Labs,Precision for Medicine
Biography:
Session Details: Combining lab data & logistics with clinical to empower decision making in today's environment 06-05-2021, 1:00 pm View In Agenda

Megan Morrison
Vice President, Asia Pacific Strategy Lead,Worldwide Clinical Trials
Biography: Megan is based out of Australia and is an industry leader in Asia-Pacific with 20 years’ experience working clinical trials in the region. She has held roles at big pharma, large global CROs, local CROs, and is currently vice president, commercial strategy lead, Asia-Pacific at Worldwide Clinical Trials. Megan has worked with countless sponsors to help them operationalize their studies and navigate the nuances of the Asia-Pacific region.
Session Details: Unlocking Australia as part of your multi-region clinical trials 05-05-2021, 1:30 pm View In Agenda

Bert Hartog
Senior Director Janssen Clinical Innovation, Janssen-Pharmaceutica NV,
Biography:
Session Details: LIVE PANEL DISCUSSION Is the pharma industry still too conservative with wearable tech? 05-05-2021, 10:30 am View In Agenda
Clinical Services International (CSI) is a global leader of sourcing and management of commercially available medicines (comparators, concomitant medication) for clinical trials.
Headquartered in London and with operations in UK, Germany, Denmark, Japan and USA, we provide efficient solutions and serve worldwide trials. Our longstanding experience and relationships with manufacturers, enables us to provide custom made solutions to address the most complex requirements.
We accelerate drug development and reduce timelines by providing a fully integrated service.
Address Regulatory, Quality, Operational, Clinical requirements
Manage the entire supply chain and offer tailor-made solutions
Comprehensive expertise in Oncology and Biosimilar products.
Advanced Technology and Innovative approach
Trusted partner of leading Biopharmaceuticals, CROs and CMOs.





















World Courier handles approximately 80% of the clinical trials market worldwide requiring a premium courier service. Specialists in packaging and airfreight qualification, compliance and dangerous goods, operating Best Practice in temperature sensitive pharmaceuticals 24x7x365 service; all shipments leave on next-flight-out; all packing materials to UN specifications; real-time web tracking and email alerts; ISO 9001 certification worldwide.
www.worldcourier.com







Advanced Clinical is a global clinical research services organization, providing CRO, FSP, Strategic Resourcing and Consulting Services for biopharmaceutical and medical device organizations. Our company is committed to improving all lives touched by clinical research and we address the hopes of patients and healthcare professionals with industry-leading services and technology in life sciences. Visit our website to learn more about how we deliver a Better Clinical Experience.








CROMSOURCE is an international contract research organization providing a comprehensive services to the pharmaceutical and biotechnology companies. Specializing in clinical development and staffing solutions, we offer a flexible approach to ensure our clients’ unique needs are supported. CROMSOURCE is unparalleled in offering an end-to-end guarantee covering trial timelines, enrollment, and price. CROMSOURCE operates offices across Europe and North America.




Linical is a global speciality CRO headquartered in Osaka, Japan, listed in the prime segment of the Tokyo Stock exchange, and dedicated to serve its clients as a true partner in development. With more than 900 employees Linical directly covers more than 20 countries and all key markets in Asia-Pacific, Japan, Europe and N. America via its own offices.










Clinerion’s real-world data solutions radically increase effectiveness in clinical research & accelerate drug development for a faster availability of medicines. We are committed to the early detection, prevention and cure for all chronic and acute diseases, and the use of our patented technology for the good of patients and society.


We are the quantitative imaging experts working across the entire drug development spectrum to better diagnose, characterize, treat and cure disease. Invicro is leading innovation to elucidate biological processes for our pharmaceutical and biotechnology partners around the world. www.invicro.com





WorldCare Clinical
SPONSORSHIP ENQUIRIES
OCT Europe offers a leading platform for solution providers to raise awareness of their solutions to the pharmaceutical and medical device industry. Opportunities include thought leadership, exhibition space, private drinks and dinner networking events and much more. To enquire about sponsorship opportunities for the conference, please contact our commercial team at:
Alexander O’Leary
Head of Sales – OCT Europe
T: +44 0207 9366 690
E: AlexanderOLeary@arena-international.com
SPEAKER OPPORTUNITIES
The programme for OCT Europe will be devised in collaboration with the life sciences sector. If you’re interested in contributing to the event please get in touch with our production team at:
Chloe Roberts
Portfolio Manager, Clinical Events
T: +44 0207 936 6822
E: Chloe.Roberts@arena-international.com