Outsourcing in Clinical Trials Europe 2020 - Virtual Conference

Biography: Denise loves to delegate; So 14 years ago when she was offered the job of Clinical Study Manager at a pharmaceutical company with a 100% clinical trials outsourcing model, she jumped at the opportunity. In doing so, she left behind her role as Clinical Research Manager at the Technical University of Munich, where she coordinated industry-sponsored trials in radiology and nuclear medicine. Today, Denise heads up a Global Clinical Operations department, where she is dedicated to establishing the best model of outsourcing for the delivery of succinct and successful clinical trials, that meets company culture, conditions and cash-flow. Denise’s degree in Occupational Therapy and professional experience in psychiatry, has taught her that the key to success is not knowing all of the answers but rather good foresight, instincts and most importantly listening.

Session Details: Two sides of the same coin: Exploring the key considerations for a rapid study start up looking at the sponsor vs CRO point of view 26-10-2020, 2:00 pm 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: What’s the latest focus for regulatory inspection? 26-10-2020, 12:00 pm View In Agenda

Biography: Lode is trusted as a global reference and passionate leader for patient engagement in medicines development. He currently works as Chief Patient Officer at Servier, a foundation-governed global pharmaceutical company. When Dr Dewulf studied and practiced medicine, he quickly realized that true engagement, with the patients and their family, as well as good education about health and disease are at least as important as good medicines to achieve the best health outcomes. He joined the pharmaceutical industry in 1989 to have a broader impact through medical education and engagement. Ten years later, when the internet became a new way to provide quality medical information, he took a sabbatical leave to co-found PlanetMedica, the first Healthcare internet portal in Europe. Back in pharma, he rose to global executive leadership roles in Medical Affairs before, in 2012 at UCB, piloting industry’s first executive role dedicated to patient affairs. Lode has volunteered at NGO and to support individual patients and has also advised private and public organisations about patient centricity/engagement. Lode believes that patient expertise can and should complement medical and scientific expertise. He advocates good listening as the starting point and sees the digital revolution as an opportunity for all stakeholders in healthcare to better understand and work with each other.

Session Details: OPENING KEYNOTE: ‘Work with patients or die’ 26-10-2020, 9:00 am View In Agenda

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: Representing the patient's voice in clinical trials: What should pharma companies be considering for 2020? 27-10-2020, 12:10 pm View In Agenda

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.

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Biography: Tanja holds a PhD in Neurosciences from the University of Montreal. She then moved to Paris to persue her research on metalloproteases as drug targets in academia before joining Pharmaleads in 2006 as Head of Biochemistry, characterizing metalloprotease and inhibitor activity in vitro and in vivo, through the design of specific assays. Her work was essential in selecting Pharmaleads' drug candidates, Dual development in the treatment of severe pain. In 2014, Tanja was appointed Head of Clinical Operations overseeing all operational aspects of the DENKIs clinical trials and was names Director of Clinical Development in 2017.

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Biography: Alphonse Mordiva holds a degree in Medical Biology from the Free University Amsterdam in the Netherlands and have over 20 years of experience working in the biopharmaceuticals industry and Life Sciences. Currently, Alphonse is leading Global Clinical Operations at PIQUR Therapeutics AG (Basel) , a Swiss clinical-stage pharmaceutical company as Head of Clinical Operations. In his role, Alphonse is responsible for all tactical operational aspects of the clinical development program including planning, conduct, and supervision and reporting. Recently Alphonse has founded his own company, LSM LIfe sciences, having a mission to increase capacity in health care system in sub-Saharan Africa. The objective is to stimulate execution of clinical trials according to ICH-GCP standards in the continent to generate data locally for policy makers. Alphonse´s expertise is global clinical operations, providing program oversight, and managing operational team including CRO, leading govenarnance meeting and buiding strategic relationship with key partners enabling effective program and team management. Before joining PIQUR Therapeutics AG in 2018, Alphonse has worked at Sandoz as a Global Clinical Operation Lead Oncology for 4 years, located in Munich. Alphonse was responsible for the coordination and leadership of Oncology/Hematology programs and biosimilar trials. During this time Alphonse has supervised the team and provided leadership during EMA and FDA regulatory inspections. Alphonse was born in Kinshasa, Democratic Republic Congo, Alphonse is inspired by coaching and working in a cross-functional environnemt and embrace divesity in business.

Session Details: Solutions-focused approach: Overcoming hurdles presented with CRO oversight, governance and turnover 27-10-2020, 11:40 am View In Agenda

Biography: Pharma & biotech professional with 16 years’ experience in clinical trial set-up, monitoring, management and in program leadership. My work experience to date includes a number of indications including oncology, paediatric rare diseases, cardiovascular disease, CNS and rheumatology across all phases in small, medium and large biotechnology and pharmaceutical companies. I am experienced in vendor, budget and matrix project team management and possess a sound understanding of the drug development process gained both professionally and academically.  

Session Details: Evaluating recruitment and engagement strategies to develop a successful rare disease drug development model 26-10-2020, 10:00 am View In Agenda

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: Vendors added-value in Patient Centricity in CT: expectations and challenges 27-10-2020, 9:00 am View In Agenda

Biography: A Director of Clinical Operations with more than 17 years of experience in the industry, working in all phases of studies in multiple therapeutic areas, including Oncology, Rheumatology, CNS, Primary Immune Deficiencies, Neurometabolics, Transplant & Endocrinology. Global experience in Pharma & Biotech companies, with expertise & interest in rare, paediatric gene therapy trial, operational & strategic leadership across multiple programs and a strong focus on building and developing teams.  

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Biography: As part of the Microsoft Worldwide Health & Life Sciences team, I work directly with our largest healthcare providers and life sciences companies, empowering innovation and better health outcomes through new systems of intelligence with data driven ecosystems. I have spent my career in technology and began concentrating on healthcare from 2004. My first health provider project focused on London NHS hospitals to create an oncology multidisciplinary case management and collaboration network across 21 locations, as well as an emergency stroke telehealth network in the Northwest of England, and a British Computer Society award winning paediatric cardiology urgent referral system.

Session Details: TECHNOLOGY KEYNOTE - Harnessing benefits of AI applications to pharma and healthcare 26-10-2020, 11:10 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: Harnessing AI to revolutionise study design and patient compliance: Where will we be in 5 years’ time? 26-10-2020, 2:10 pm View In Agenda

Biography: Experienced Innovation & Learning Specialist with a long history of working in the pharmaceuticals industry (20+ years) representing both pharma and CRO. Consistently rated as high performer, skilled in digital product development, learning & development and drug development.

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Biography: An experienced executive leader with 25+ years in a wide variety of life sciences area’s: CRO, Pharmaceutical, Biotech, Functional Food, Diagnostics and Medical Devices. Key leadership roles as (Interim) CEO, CCO and (Senior) Vice President in account, line, marketing, scientific and operational management for local and global companies. Success is driven by focus, commitment, getting it done and an intrinsic motivation to increase people’s personal performance. Member of several Executive Steering Committees, both for large global pharma as biotech companies in Europe and USA. Has secured over $1.5 billion in investments and opportunities. Managed Phase I-IIa clinics in The Netherlands with successful delivery of appr. 250 phase I & II trials. Leading role in international mergers and acquisitions, including organizational integration. Currently CEO of Biotech and Diagnostic start-ups and adviser to PE/VC.

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Biography: Tiphaine Lamblot spent the last 15 years in the pharmaceutical industry where she played key roles in product development and clinical trials. Her career started in France when she was offered to build the quality system for clinical trials at Bordeaux University Hospital and create the clinical research network. She continued her interest in pharmaceutical development in Paris, at Parexel and chose to pursue her passion at Santen where she was involved in both study and product management. Her efforts and skills for business improvement were recognized by promoting her to Clinical Operations Leader. She now acts as representative for Europe Clinical Operations in global steering committees, and has the pleasure to work with the Japanese and American leaders to develop SOPs for Santen, build the company systems such as eTMF, CTMS and provide guidance on digitalization and other key aspects as finance, global data protection and patient centricity in clinical trials. Tiphaine also serves as expert and speaker for a number of emergent and highly innovative companies in the Life Science arena.

Session Details: Budget Negotiation – When saving your money becomes a game 26-10-2020, 3:10 pm View In Agenda

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Session Details: How regulatory institutions in Europe assess marketing authorization applications 26-10-2020, 4:10 pm View In Agenda

Biography: Binbin Wan currently works as an Innovation manager in Bayers' clinical operation.  She is also an expert in clinical trial disclosure with over 8 years experience. Her recent role is one of project manager, leading patient centric related projects in the area of trial transparency. In 2018, Binbin led the project team which successfully launched Bayers' patient friendly Clinical Trial Finding tool. Subsequently in 2020, she managed a team collaborating with multiple R&D functions, bringing the Plain language summary from concept stage through to fruition.  

Session Details: Achieving clinical trial transparency for patients at Bayer 26-10-2020, 4:00 pm View In Agenda

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Session Details: Panel Discussion: PATIENT ADVOCATE Q&A 26-10-2020, 1:00 pm Panel Discussion: PATIENT ADVOCATE Q&A 26-10-2020, 1:00 pm PATIENT ADVOCACY EXPERT ADVICE Gaining patient and caregiver insights into protocol development to reduce burden and boost enrolment 26-10-2020, 3:00 pm View In Agenda

Biography: Frank is currently the Head of Analytics, Global Clinical Operations, at Boehringer Ingelheim’s headquarter based in Ingelheim, Germany. He and his team develop and deliver metrics and KPIs as well as ad hoc analyses (operational and financial) to support data-driven business steering and decisions related to hundreds of clinical trials with a total budget of approx one billion Euro per year. Frank is a physician by training and got his M.D. from the Technical University of Aachen, Germany. During the first years of his career in the pharmaceutical industry Frank published frequently in peer-reviewed journals, mostly on dementia research. Frank has more than 10 years experience as International Project Leader at Boehringer Ingelheim, successfully advancing projects through all clinical phases, from Phase I to launch.   His current interests focus on

• efficiency in study planning, tracking and budgeting
• understanding cost drivers (in particular, trial complexity) and improving budget accuracy
• statistical methods, e.g. predictive modelling
• research on clinical research (meta-research)
• data visualization (incl. business intelligence tools / dashboards)

Session Details: Towards a better understanding of clinical trial protocol complexity 26-10-2020, 11:00 am View In Agenda

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Session Details: Remote monitoring and telemedicine in virtual clinical trials 27-10-2020, 11:00 am View In Agenda

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Session Details: PATIENT SNIPPET STORY 27-10-2020, 10:10 am View In Agenda

Biography: Mgr Clinical Supply Chain Project Management, Global Clinical Operations, Global R&D, TEVA Hadar has a B.Sc. in Chemical engineering From BGU (Ben-Gurion University of the Negev) & B.Sc. in Polymer engineering from Shankar College of Engineering. Experienced in leading R&D projects in Biopharmaceutical companies. Worked in Perrigo API performing commercial procurement for the API division, then joined Teva in 2011 as Senior procurement manager in R&D performing global procurement. Since joining Clinical Supply Chain group, within TEVA's R&D global clinical operations in 2018, Hadar been leading clinical supply chain projects within a variety of programs and TAs, each one includes multiple clinical trials in different clinical phases, identifying unique challenges and tailoring the project planning accordingly with ongoing risk management in accordance with international guidelines and regulations. She holds various responsibilities including plan efficient drug product demands, coordinating the manufacturing with CMC in all TEVA's manufacturing plants, sourcing of comparators, plan and design the clinical drug packaging and labeling, Design IRT/RTSM system, set-up and oversee maintenance and overall ensure timely delivery within specifications, quality and standards. Hadar initiated and led new approach for P&L at Teva, following by process change.  

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Biography: Heather Haselmann has been with Canfield since 2005.  She started as Project Manager and grew to role of Associate Director of Clinical Services overseeing project teams.  This led her to current role as Director of Business Development in which she is able to speak to the team’s expertise and create solutions for their clients.  Heather is responsible for communicating the breadth and depth of clinical project management services, ensures customer service provided at the highest levels, including proposals and follow through of deliverables.  Heather has extensive knowledge of the industry which covers Dermatology, from hair growth to onychomycosis and skin conditions, Aesthetics, Body Contouring, Oncology and Rare Diseases related to skin.  

Session Details: Building Confidence with Photographic Documentation: from early phase clinical trial to marketing projects 26-10-2020, 2:40 pm View In Agenda

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: Accelerating clinical trials in Asia-Pacific 26-10-2020, 9:30 am View In Agenda

Biography: Igor is a 35+ year veteran executive of global key development and deployment projects. A dedicated technology solutions practice leader,  he is an expert in managing on- and offshore value-based development, B2C, B2B and integration. In 2004 Igor formed CoreValue together with his partners to leverage the technology and business knowledge he had gained during the years in IT. The firm grew from 10 people to a global software and technology services company cooperating with mid-sized enterprises and Fortune 50 through 500 companies. Today, Igor Kruglyak is an advisor, a featured speaker at the international technical conferences, a contributor to Kobb Publications, focused on growth delivery.

Session Details: How NLP can uncover influence and relationships to accelerate clinical research and PI (principal investigators) and subject recruitment 26-10-2020, 3:40 pm View In Agenda

Biography: Michael DePalma is a 20+ year expert in the technology, healthcare and life sciences industries. A scientist by education, Michael has spent his career focused on the intersections of human health and technology. Michael has applied his technical and industry background across many of the facets of the healthcare and life sciences space, including clinical trials, drug launch, supply chain, safety and other areas.  Michael holds 3 US Patents, is a serial entrepreneur, 2-time TEDx speaker, the co-founder of multiple organizations, including The Human API, Pensare, and Pocket Rehab. Michael also co-founded Hu-manity.co, an organization focused on the world of human data provenance, ownership, and value, exploring avenues such as the ethics of data collection and use, AI ethics, the socio-economic impacts of data ownership, effect on the supply chain, and research.

Session Details: How NLP can uncover influence and relationships to accelerate clinical research and PI (principal investigators) and subject recruitment 26-10-2020, 3:40 pm View In Agenda

Biography: Angela Stokes has worked in a regulatory capacity for more than 30 years in both start-up and large pharmaceutical companies and CROs worldwide and has experience in a wide range of different indications and therapeutic areas. Her experience spans US, EU, China, Japan and Australia, but she has worked on small projects in many other countries worldwide.   Angela has extensive experience of ICH, FDA and Committee for Medicinal Products for Human Use (CHMP) guidelines for a wide range of pharmaceutical products, including NCEs, Biosimilars, ATMPs and generics. She is also familiar with the International Organization for Standardization (ISO) standards for medical devices and in vitro diagnostics. She has been involved in writing global regulatory project plans, global clinical trial and clinical investigation applications, IMPDs, pre-meeting briefing packages, orphan drug submissions, responses to regulatory authorities, pediatric investigational plans, post-marketing safety update reports, gap analyses, IBs, BLAs, NDAs and MAAs to obtain favorable outcomes based on knowledge gained from direct experiences.   Angela holds Bachelors’ degrees in chemistry and mathematical sciences backed up with Masters’ degrees in pharmacology and toxicology. She is a Fellow of the Royal Society of Chemistry (FRSC) and a Fellow of the Organisation of Professionals in Regulatory Affairs (FTOPRA). She has Chartered status as both a chemist and a scientist. She has written several chapters for books on drug development and regulatory affairs and writes for several peer-reviewed journals including the Regulatory Rapporteur. Angela is a speaker on a variety of MSc and other courses and presents at global conferences on a regular basis. Angela was honored with a TOPRA award for Regulatory Excellence in 2015, she was the President of TOPRA throughout 2018 and has previously been a member of the TOPRA board for 13 years.

Session Details: Achieving orphan drug designation: A global regulatory perspective 26-10-2020, 12:30 pm View In Agenda

Biography: From my educational background I am biologist. I have completed my PhD at the Helmholtz Research Centre of Munich in cooperation with the Technical University of Munich in the field of toxicology. After that I gained several years of experience in the pharmaceutical industry with a focus on quality management. Since nearly 4 years, I am working within TÜV SÜD in the sector of Medical Health Services. Currently, I am leading a team of experts and auditors for non-active medical devices and I am responsible for the Article 117 business in the regions DACH & Nordics. Besides these roles, I am Auditor and Senior Product Specialist for non-active medical devices.

Session Details: The Notified Body perspective: the future of drug-device combinations with the upcoming Medical Device Regulation (MDR) 27-10-2020, 10:00 am THE BIG QUESTION: How do you create effective partnerships with notified bodies? 27-10-2020, 11:20 am View In Agenda

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: eCOA setup: how to ensure a successful launch by navigating complexities? 27-10-2020, 9:30 am View In Agenda

Biography: Michael is a member of Medidata’s Mobile Health Product team and serves as an advisor to clients, partners, and the Medidata internal teams in his capacity as a subject matter expert in electronic informed consent and virtual trials.  Over the last decade, Michael has worked collaboratively with sponsors, CROs, regulators, ethics committees and researchers around the world to pioneer the use of electronic informed consent and virtual trials.  His 30-year career in medical research includes nearly a decade with the US government both conducting and supporting surgical research as well as two decades working in the commercial sector to provide technology solutions that improve and support preclinical and clinical research.  Michael has been a participant in two clinical trials, bringing a unique perspective to the use of clinical technologies. Michael is a decorated veteran of the United States Navy and resides in the Austin, Texas area where he is also an elected public official, serving his local community of Brushy Creek. 

Session Details: Looking beyond the current trend of virtual trials 27-10-2020, 9:40 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: Moving towards site-less trials: How can we learn from virtual trials already taking place in the US? 26-10-2020, 12:10 pm View In Agenda

Biography: Vincent is a life-long operations and business management professional with a 24-year career across construction, environmental science, technology and pharmaceuticals. Vincent provides leadership at the nexus of building relationships, innovating technology and driving collaborative efforts to design, build and grow systems of all types and complexity in the real and digital in the service of patients and clinical trials.

Session Details: Interfacing – it’s okay to have FITS! (If it is Fearlessly Integrated Trial Systems) 27-10-2020, 11:30 am View In Agenda

Biography: As Chief Product Officer at AiCure, Michelle Marlborough is responsible for the product direction, definition and delivery of the company’s award-winning artificial intelligence platform. With over 24 years of experience in life sciences and software development, Michelle has been at the forefront of transforming clinical trials through innovative technology and analytics and previously held the positions of Vice President of Product Management at Veeva and Vice President of Product Strategy at Medidata Solutions. Before making the shift to the technology sector, Michelle worked in data management roles at GlaxoSmithKline and AstraZeneca. There she experienced firsthand the industry’s struggle with outdated processes and systems. Michelle earned her bachelors of science degree in biology and mathematics from Coventry University.

Session Details: Capturing meaningful data and clinical insights throughout the clinical trial process 26-10-2020, 10:30 am View In Agenda

Biography: Matt is responsible for defining and leading the product strategy for ERT’s digital patient product line, with a focus on direct to patient enablement in both post approval research and patient support. Matt has spent the last 12 years leading teams and innovating products in both the clinical research and commercial healthcare settings to reduce patient burden of participation and to support patients in their healthcare journey.  Most recently, Matt was Global Head of Patient Engagement for ICON’s Commercialization & Outcomes division and, prior to that, Head of Direct to Patient Research (Virtual Trials) at IQVIA.

Session Details: The role of emerging technology in improving the patient experience and generating PROs 26-10-2020, 11:40 am View In Agenda

Biography: Catalina has extensive experience in regional and global investigator payments and clinical project lifecycle across EMEA, LATAM and APAC regions and leads the global payments team of over 50 professionals. Catalina’s key strength is communication and problem solving skills working in a multinational environment with various business units to achieve common goals, and has a passion for building relationships and reducing site burden with prime sites.

Session Details: Navigating complexities in global payment operations: Best practices for sponsors 26-10-2020, 11:30 am View In Agenda

Biography: Anna joined the IQVIA Clinical Trial Payments team (formerly DrugDev) in June 2020 and is responsible for providing financial management throughout the duration of the trials, overseeing payment activities so that sponsor requirements are achieved. She also provides support to clinical trial sites around the world and resolves issues to ensure that payments are made in the shortest possible time. Prior to joining DrugDev, Anna worked for IQVIA (former Quintiles) for 5 years, starting as a Clinical Trials Assistant (CTA) and was promoted to Associate Manager of the CTA group. Anna earned a Master of International Politics and Master of Public Administration from UKSW University in Warsaw.

Session Details: Navigating complexities in global payment operations: Best practices for sponsors 26-10-2020, 11:30 am View In Agenda

Biography: Federico joined DrugDev four years ago as Payment Specialist and was promoted to Study Operations Lead after the IQVIA acquisition. He oversees the accounts payable function for clinical trials projects in Europe and Asia, while ensuring that all processes and standards are followed and the appropriate financial controls are observed and in line with sponsor requirements for managing and mitigating risks. Recently Federico has taken on responsibilities for communication initiatives that keep clients informed about payment processes.  

Session Details: Navigating complexities in global payment operations: Best practices for sponsors 26-10-2020, 11:30 am View In Agenda

Biography: Nick Rich joined Novotech business development in March 2017. With a strong passion for Business Development, and a results orientated approach, he brings over 25 years of experience across the life science space. Nick’s specialty is clinical full service outsourcing of pharmaceutical and biotechnology products across Asia Pacific. In his previous roles, he has managed a team of account directors in Asia Pacific based in India, China, Singapore and Japan. Nick holds a Bachelor of Science with Honours from the University of Warwick.

Session Details: Accelerating clinical trials in Asia-Pacific 26-10-2020, 9:30 am View In Agenda

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Biography: Marcin has been working with DrugDev and IQVIA for the past 9 years in the areas of site feasibility, contracting, and financial operations. In his current role, he oversees study-related financial operations for client portfolios, managing multinational site operation payment groups located in Europe, as well as actively contributing to continuous process improvement and excellence in the financial lifecycle offering. Providing services on a wide variety of client projects has bestowed Marcin and his teams with deep insight into the financial and legal requirements of payment recipients worldwide and a true understanding of the variability in client needs across clinical trial conduct.

Session Details: Navigating complexities in global payment operations: Best practices for sponsors 26-10-2020, 11:30 am View In Agenda

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Session Details: The future of EU Clinical Trial Regulation: opportunities to streamline multinational trial approval 27-10-2020, 9:20 am View In Agenda

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Session Details: Revolutionising trial design: Uncovering next-generation setup and technology of clinical trials 27-10-2020, 12:20 pm View In Agenda

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Session Details: From concept to commercial use in health care: Development strategies for medical devices SME 27-10-2020, 2:50 pm View In Agenda

Biography: Chief Operating Officer at OnDosis AB, a Swedish health-tech company developing a new category of prescription regimens, delivered in a connected hand-held device, integrating medicine with flexible dosing. 15+ years of experience from different roles within research and clinical affairs at global medical device companies. Significant experience from development of Class I-III medical devices and drug-device combination products.

Session Details: Rethinking dose finding studies using a connected Dosage Manager - what are the opportunities and risks? 27-10-2020, 12:50 pm View In Agenda

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: NEW FOR 2020: CRISIS RESPONSE Dealing with the unexpected: risk management versus issue management 27-10-2020, 9:50 am View In Agenda

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Session Details: Running clinical operations in the United States: what are the differences from Nordic operations? 27-10-2020, 10:50 am View In Agenda

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Session Details: CASE STUDY: Evaluation of site reengagement initiatives: getting the maximum out of regional coordinator meetings and sponsor site visits 27-10-2020, 1:20 pm View In Agenda

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Session Details: THE BIG QUESTION: How do you create effective partnerships with notified bodies? 27-10-2020, 11:20 am View In Agenda

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Session Details: Partnership strategy: Bridging the gap between clinical development in academia and turning your medical device into reality 27-10-2020, 3:20 pm View In Agenda

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Session Details: Trial oversight in outsourced clinical trials – Experience from a biotech 27-10-2020, 2:20 pm View In Agenda

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Session Details: Keep it simple: meeting the regulatory requirements for contrast agents and nanomedicine 27-10-2020, 3:50 pm View In Agenda

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Session Details: Navigating data management and CROs in complex multi-country trials 27-10-2020, 11:50 am View In Agenda

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Session Details: The Importance of clinical trial transparency for patient engagement 27-10-2020, 1:50 pm View In Agenda