Outsourcing in Clinical Trials DACH 2023

This unmissable conference will discuss the common challenges and trends impacting the region, including steps for defining contractual relationships and getting the maximum from external providers, incentivising good relationships with CROs and constructing defined deadlines.

21 - 22

November

2023
  • Zurich, Switzerland
  • Ticketed
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MIMI CHOON-QUINONES​

Founder And Chairman, Partners For Patients, PfP.NGO

I am passionate about advocating for patients by improving healthcare policies, advancing medical knowledge, driving innovative digital solutions in the quest to increase medical access to treatments for patients. I feel it is one of my responsibilities to support every patient around the world who struggles to get access to medicines.

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JASMIN HELLWIG​

Associate Director Comparator Sourcing,

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DR. MAX HORNECK​

Head Clinical Data Management And EClinical Systems, Medac

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Marija Popovic​

Manager Feasibility Department PSI CRO

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    2023 Sponsors Include:

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    Company Information

    Medidata is leading the digital transformation of life science, with the world’s most used platform for clinical development, commercial, and real-world data. Rave RTSM is the only fully pre-validated randomization and trial supply management solution that can be configured in minutes and enables mid-study changes with minimal downtime and no change orders. RTSM is built on Rave EDC, so there is no double data entry and minimal reconciliation expediting study start-up and study-close out. Rave RTSM streamlines your operations and provides real-time visibility for your study teams. https://www.medidata.com/en/clinical-trial-products/clinical-data-management/rtsm/

    Company Website

    To learn more , please visit our website - https://www.medidata.com/

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    Novotech is internationally recognized as the leading Asia Pacific centred Biotech Contract Research Organization (CRO) with global execution capabilities.

    Novotech is a clinical CRO with labs, phase I facilities, drug development consulting services and FDA regulatory expertise and has experience in over 5,000 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biotech clients conducting clinical trials in Asia Pacific, the US and Europe. Novotech has over 3000 staff globally and 34 office locations.”

    About Novotech- The Asia Pacific Centred Global Biotech CRO | Novotech CRO (novotech-cro.com)

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    To learn more , please visit our website - https://novotech-cro.com/

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    Company Information

    To support the acceleration of drug development, over the last 12 years, ARENSIA Exploratory Medicine GmbH (www.arensia-em.com) has built up its own research clinics, with full Phase I infrastructure, entirely dedicated to the performance of sophisticated FIRST-in-PATIENT Phase IB, IIA and PROOF OF CONCEPT clinical trials with novel compounds. ARENSIA’s outstanding recruitment performance across numerous disease areas substantially reduces the overall number of sites and countries for any early-phase patient trial. ARENSIA’s speed and data quality provide our Partners/Sponsors with a strategic advantage across the entire lifecycle of a project, as they can progress their novel compounds much faster to later phases of research. ARENSIA is trusted by Leading Pharmaceutical and Biotechnology organizations worldwide. ARENSIA is based with its headquarters in Düsseldorf, Germany, and operates with 400+ talented employees in 7 countries

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    To learn more , please visit our website - http://www.arensia-em.com/

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    Company Website

    To learn more , please visit our website - www.huma.com

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    Viedoc designs engaging software for the life science industry. By accelerating clinical trials on all levels, our solutions support major pharmaceutical, biotech, and medical device companies, as well as renowned research institutions worldwide. Headquartered in Uppsala, Sweden, Viedoc also has offi ces in America, France, Japan, Vietnam, and China. Since our inception in 2003, over 1 million patients in more than 75 countries have participated in studies powered by Viedoc. www.viedoc.com

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    To learn more , please visit our website - www.viedoc.com

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    Worldwide is changing how the world experiences CROs – in the best possible way. From early phase, bioanalytical sciences, late phase, post-approval and real-world evidence, Worldwide Clinical Trials provides full-service drug development services for central nervous system, cardiovascular, metabolic, general medicine, oncology and rare disease therapies.

    Company Website

    To learn more , please visit our website - https://www.worldwide.com

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    YPrime’s cloud-based technology streamlines clinical trial data collection and management. Electronic clinical outcome assessments (eCOA) and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials. Our consulting services help clients simplify downstream processes, while moving faster and more efficiently to their next development milestone. 

    We innovate through pragmatic, forward-looking change that considers the needs of stakeholders in each clinical research role. We’re doing more than streamlining your processes. We’re streamlining your research, helping you get to your next milestone faster. 

    Company Website

    To learn more , please visit our website - http://www.yprime.com/

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    Company Information

    eClinical Solutions is a leading global provider of cloud-based enterprise software and software-driven clinical data services. The elluminate® Clinical Data Cloud provides life sciences companies with greater control of their clinical trial data with one platform for all data sources, from aggregation through to standardization, visualization, and preparation for submission. elluminate software and data driven services have been used by more than 100 life sciences companies on over 500 clinical trials to reduce cycle time and improve data quality. For more information, visit www.eclinicalsol.com, or contact us at info@clinicalsol.com.

    Company Website

    To learn more , please visit our website - www.eclinicalsol.com

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    The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.

    Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

    The international company is a privately owned organisation which has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

    The company has a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.

    To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com.

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    To learn more , please visit our website - https://www.almacgroup.com

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    Company Website

    To learn more , please visit our website - www.bsi-lifesciences.com

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    Company Information

    Clinical ink is the global life science company that brings data, technology, and patient science together.

    Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancements, drive the industry standard for data precision and usher in a new generation of clinical trials.

    By harnessing digital data, we power sponsors, CROs, researchers, and patients to recenter decentralized trials and rewrite the clinical development experience.

    Company Website

    To learn more , please visit our website - http://www.clinicalink.com/

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    Company Information

    EMIS Recruit is an integrated solution that connects Research, Life Sciences and healthcare by embedding clinical research recruitment tools directly into the point of care systems.  EMIS recruit gives research organisations clear visibility of clinically relevant patients based on your study protocol. This enables us to provide you with qualified patients that streamline your recruitment process

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    Company Information

    Endpoint Clinical is an interactive response technology (IRT) solutions provider that supports the life sciences industry. Our innovative, high-quality randomization and clinical trial management technologies are backed by over a decade of award-winning experience and expertise. Endpoint is headquartered in Wakefield, MA, with offices across the US, EU, and Asia.

    Company Website

    To learn more , please visit our website - http://www.endpointclinical.com/

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    Company Information

    Complex innovative clinical trial designs require an integrated synergetic approach to assess novel drug compounds for safety and effectiveness which often span esoteric, regulated and safety outcomes in all phases of the drug development life-cycle.

    The companies of Eurofins BioPharma Services provide a seamless solutions-based approach in support of phase I to IV clinical trials with a unique analytical testing portfolio for Central Laboratory Services, Bioanalytical Services and complex Biomarker Assay Development and Testing Services for drug and vaccine development.

    Company Website

    To learn more , please visit our website - https://eurofinsclinicaltrialtesting.com/

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    Company Website

    To learn more , please visit our website - www.evidentiq.com

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    Company Website

    To learn more , please visit our website - http://www.excelya.com

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    Company Information

    FyoniBio (the service spin-off of Glycotope) offers clinical sample analysis under GCLP. Our focus are PK, ADA and biomarker assays, its development and validation with strong expertise in complex cellular assays. Additionally, FyoniBio is the ideal partner for development of complex biotherapeutics with our innovative GlycoExpress® technology.

    Company Website

    To learn more , please visit our website - www.fyonibio.com

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    Company Information

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON employed approximately 41,150 employees in 113 locations in 53 countries as at September 30, 2022.

    Company Website

    To learn more , please visit our website - http://www.iconplc.com/

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    Company Website

    To learn more , please visit our website - mediantechnologies.com

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    Company Information

    Metronomia is a German clinical research organization (CRO) committed to high quality, best service and outstanding flexibility. A service oriented, stable and highly skilled team provides e-clinical services,clinicaldata management and biostatistical services within phase I – IV and non-interventional studies in allmajor therapeutic areas.

    Company Website

    To learn more , please visit our website - http://www.metronomia.net/

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      Why attend?

      After three years of COVID disruption, we are pleased to announce that the Outsourcing Clinical Trials DACH event will be taking place in Zurich on the 21st – 22nd November 2023. This event will focus upon the operational challenges in clinical development found within Germany, Austria and Switzerland. Over 2 days, delegates will discuss the common challenges and trends impacting the region, including steps for defining contractual relationships and getting the maximum from external providers, incentivising good relationships with CROs and constructing defined deadlines.

      Why Join?

      • Focused conference for the DACH pharma market– Unlike other conferences, our event specifically focuses on the local pharma industry in Switzerland, Germany and Austria, highlighting the current challenges and exciting innovations and opportunities within the market
      • Excellent speaker line up – Senior level speakers from leading organisations such as Roche, Janssen and Celgene along with exciting biotechs like Medac and Medigene
      • Great and Diverse Sessions – Our OCT DACH covers a variety of topics ranging from COVID-19 updates to Direct to Patient and Data management innovation to CRO relationship
      • Unbeatable Networking Opportunities – Meet and network with over 150 senior industry decision makers during our dedicated networking breaks, round tables and interactive sessions

      WHAT TO EXPECT FOR 2023

      Join pharma and biotech experts to discuss new trends and opportunities and learn how they optimize their clinical operations enabling you to stay ahead of the game. Find the right solution providers to partner with, allowing you to accelerate your trial timelines.

      200+

      Attendees

      		40+

      Speakers

      		20+

      Exhibitors
      200+

      Attendees

      		40+

      Speakers
      20+

      Exhibitors

      Testimonials

      See What It's All About

      2022 Agenda

      • 30 Nov 2022
      • 1 Dec 2022
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      8 AM

      Registration and refreshments

      8 AM

      Registration and refreshments

      8:50 AM

      Chairperson’s opening remarks

      8:50 AM

      Chairperson’s opening remarks

      9 AM

      Fear reduction as the core of the patient experience strategy in clinical trials

      • Understanding where patient concerns lie when participating in clinical trials and what pharma companies can do to mitigate against these
      • Aiming to reduce the burden of trial participation on patients as much as possible: where are pharma companies falling short?
      • What more needs to be done when it comes to patient accessibility for clinical trials?

      9 AM

      CASE STUDY: Overcoming operational challenges when running a CAR-T trial: learnings and best practice

      Understanding what makes CAR-T trials unique from an operational standpoint Collaborating with CROs and other partners throughout a CAR-T trial: important considerations Measuring trial performance with KPIs and other metrics during a CAR-T clinical trial

      9:30 AM

      The case for deploying eConsent in every trial and in every country

      • Why eConsent is applicable in every trial, not just decentralized trials
      • The importance of quality in the informed consent process
      • How remote eConsent can expand access to more diverse populations
      • How to deploy eConsent globally with regulatory-compliant configurations and workflows

      9:30 AM

      Unifying Data for Improved Study Conduct Decision-Making

      • The challenges associated with protocol requirements that need data collected from multiple siloed sources
      • How unifying data accelerates and improves the quality of study conduct decision-making
      • Additional benefits of unifying data capture and management on a single platform

      10 AM

      PANEL DISCUSSION: Reducing the burden on patients during clinical trials: are we doing enough?

      • Where are the main pain points for patients participating in clinical trials?
      • Is decentralisation automatically preferable for patients participating in clinical trials?
      • What is being overlooked when it comes to reducing the burden on patients?
      • How important is it to work closely with patients and advocacy groups during trial design, and what is the best way to build an effective relationship with patients?
      • Should you consider having a patient advocate on your existing board of advisors, rather than a separate patient advisory board: assessing the pros and cons
      • MODERATOR:
      • Dr John Shillingford, Director of Clinical Research, AFON Technology
      • PANELLISTS:
      • Benoit Marchal, Chief Digital Trust Officer, Partners for Patients
      • Pietro Scalfaro, Chief Medical Officer, Enyo Pharma
      • Roel van der Heijde, Facilitator and Trainer, Roel Rotterdam and Patient Experience Association

      10 AM

      New trends in clinical data management: how patient centricity is driving data management evolution

      • Effectively monitoring and responding to patient and trial needs: the role of data management
      • Discussing societal, ethical, and legislative implications of data collected from decentralized trials
      • Data privacy and the impact on patients participating in clinical trials

      10:30 AM

      Morning refreshments and networking

      10:30 AM

      Morning refreshments and networking

      11 AM

      Considerations when preparing for virtual and hybrid audits: how has the pandemic impacted quality control?

      • In person audits vs remote and hybrid audits: what are the main differences when it comes to how to best prepare yourself?
      • Understanding guidance from regulatory bodies on remote inspections: key takeaways
      • Long term changes beyond COVID-19: what changes in inspection practice are here to stay?

      11 AM

      Building collaborations with universities and research institutions in the DACH region in order to fund and support your clinical trial

      • How initiating and establishing academic partnerships can help get your clinical trial off the ground
      • Understanding advantages and drawbacks of academic collaboration in clinical research

      11 AM

      Tips and tricks for engaging sites with new technology

      • Considering the impact of new technology and processes on site staff both in terms of benefits and challenges
      • Collaborating with and training site staff to be comfortable with new technology
      • Reducing the burden on sites and ensuring processes are easy to follow and adapt to

      11:30 AM

      Applying machine learning and experience to model the best study scenario: new tech tool!

      Do you struggle to find the best study scenario? Being stretched by too many factors such as funds, corporate objectives, time, etc.? Meet PSI’s Visional, our machine learning-powered, data-driven feasibility platform. This innovative platform uses country-specific feasibility data tailored to the study protocol and models and compares hundreds of country/site combinations, their probability of success, and budgets to find the most optimal scenario that meets our sponsors’ corporate objectives.

      11:30 AM

      Decentralised clinical trials and hybrid trials: what you need to understand to run these successfully

      • Key learnings from running DCT/hybrid trials so far
      • Points to consider designing your coming clinical trials using DCT processes and technologies
      • The building blocks in your DCT/hybrid trials

      11:30 AM

      Navigating complexity through the lens of the end user

      Analyze what makes trials complex and it’s downstream impact Understand how the RTSM enables complex trials and improve end user experiences Walk through a series of examples and use cases

      12 PM

      Clinical Data Management in the area of conflict between sponsor oversight and the guardian of corporate knowledge: a mid-sized pharma perspective

      • Knowing what the CRO is doing
      • Can’t the CRO provide everything anyway?
      • Integrating multiple data sources
      • Securing data for all time (25 years)
      • Client requirements (“I have my SAS data here”)
      • Surprising new clients

      12 PM

      Patient centricity: a supply chain perspective

      • Cross functional awareness of patient centricity in clinical trials
      • Impact of clinical changes on patients and considerations to take into account
      • Handling challenges in supply chains to ensure the patient is always at the heart of supply chain design

      12 PM

      Data transparency vs data privacy: why is this key and where are we falling short?

      • How has the anti vax movement impacted trust in clinical trials and how can transparency around data aim to rebuild this trust?
      • Navigating GDPR requirements: what do we actually need, and is this sometimes overdone?
      • The importance of patient consent and asking the patient’s opinion when collecting and sharing data

      12:30 PM

      How site alliances enable efficiencies for clinical trials

      • Tips to ensure collaboration and efficiency
      • Insights learned from effective site alliances
      • How to take steps to create a site alliance and ensure compliance

      12:30 PM

      Making clinical supply more effective

      IRT as a tool to manage your trial supply chain with flexibility, visibility and control Uncover how clinical trials can leverage a flexible IRT to improve supply chain efficiency and help you control unforeseen circumstances.

      • Challenges to optimizing your clinical supply chains
      • Leveraging technology to create real-time visibility and streamline drug supply management
      • How trials are using flexible IRT to gain control over their supply chains

      12:30 PM

      Lunch and networking

      1 PM

      Lunch and networking

      1 PM

      Lunch and networking

      2 PM

      CASE STUDY: Incorporating technology into your patient recruitment strategy

      • The impact of digital devices on recruitment and engagement with patients
      • Assessing common issues and solutions in order to overcome these

      2 PM

      How clinical infrastructure in Western Europe can support healthcare in Africa

      • An overview of Project CARE: Collaborating to Advance Research Excellence for health equality and health equity in Africa and across the world
      • How Western Europe and the DACH region can support clinical trials in underserved communities
      • What can healthcare providers in the DACH region do to support Project CARE’s mission?

      2 PM

      MINI WORKSHOP: Which geography is most attractive to start-up companies for FIH studies: EU, USA, or APAC?

      • Choosing a location for your clinical trial: navigating regulations in different regions
      • Exploring the differences between the regulatory environment in Europe, the UK, the US and beyond
      • A regulatory perspective on running clinical trials: understanding key regional differences
      • Looking towards Asia: what opportunities are there for clinical trials and what risks and challenges should sponsor companies consider?

      2 PM

      Choosing a CRO as a small to mid sized biotech company: factors to consider

      • Balancing the benefits of working with a small CRO vs a large global CRO: which is better equipped to handle the needs of a smaller biotech?
      • How important is it to choose a CRO with experience in your therapeutic area?
      • Working with multiple vendors: is this the

      2:30 PM

      Big Data, Artificial Intelligence/Machine Learning, and our COVID-19 strategy

      • biotx.ai’s COVID-19 strategy is to find patterns linked to the disease in patients’ genomes as well as in the DNA of the virus. Marco will discuss this clinical trial testing process, why it is a priority and what data is available.
      • Discussing best practice for finding and testing drug target candidates for drug repurposing
      • Using UK Biobank data to match critically ill COVID-19 cases with healthy controls
      • Exploring promising drug targets for the selective treatment of critical COVID-19 patients

      2:30 PM

      Afternoon refreshments and networking

      2:30 PM

      Accelerated performance of complex exploratory patient studies: practical insights from investigational site

      • Unique model of dedicated research clinics in Eastern Europe
      • Strategies for fast patient enrollment and retention
      • Operational tips for flawless study conduct
      • Takeaways after operating under unprecedented circumstances and case studies

      3 PM

      Regulatory and quality strategy for drug-device combination products: what do you need to know?

      • Defining the drug-device combination product regulatory pathway
      • Exploring QMS and cGMP requirements
      • Review of applicable standards
      • Review of investigational use and clinical trials
      • Investigating human factors and usability studies
      • Verification and validation testing: electromechanical, biocompatibility

      3 PM

      CASE STUDY: The practical challenges of running cancer trials as an emerging biotechnology organization

      • Selection of indication
      • Regulatory tactics: what to consider from a regulatory perspective and how to navigate this
      • Clinical operational challenges and how to overcome these
      • What not to do: learnings from running a cancer clinical trial

      3:30 PM

      Afternoon refreshments and networking

      3:30 PM

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      • PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS
      • During the roundtable discussion session, the conference hall will be divided into two ‘zones’. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within clinical operations. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.
      • ROUNDTABLE 1: Handling oncology-specific challenges in clinical operations
      • Dr. Sumeet Ambarkhane, Chief Medical Officer, Alligator Bioscience
      • ROUNDTABLE 2: Strategies for small companies to make sure your study start up is on time
      • Roland Mirow, Director, Katairo GmbH
      • ROUNDTABLE 3: Vendor management for decentralized clinical trials: challenges, risks and solutions
      • Heike Schön, Managing Director, Lumis International

      3:50 PM

      Afternoon refreshments and networking

      4 PM

      CASE STUDY: Fostering co-operation between different vendors on one clinical study

      • Ensuring your vendors and partners are aligned under one shared goal
      • Overcoming communications challenges with vendors during COVID and remote working restrictions
      • Tips and learnings when co-ordinating and encouraging co-operation between multiple vendors

      4:30 PM

      PANEL DISCUSSION: An outlook on the clinical trial landscape in the DACH region: where are we in 2022?

      • The impact of the EU clinical trial legislation: how are sponsor companies handling this?
      • Assessing the knock-on effects of the Russia-Ukraine conflict on clinical trials in the DACH region
      • How close are we to running fully decentralised trials in Europe?
      • Emerging technologies in 2022: identifying new opportunities for the clinical trial industry
      • Living with COVID: what are the long-term effects of the pandemic on clinical trials?
      • MODERATOR:
      • Dr John Shillingford, Director of Clinical Research, AFON Technology
      • PANELLISTS:
      • Marco Schmidt, Managing Director and Chief Scientific Officer, biotx.ai
      • Dr. Max Horneck, Head Clinical Data Management and eClinical Systems, Medac
      • Allison Fidler, Deputy Director, Clinical Operations, Debiopharm

      4:30 PM

      Chairperson’s closing remarks

      5 PM

      Chairperson’s closing remarks

      2022 Speakers

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      John Shillingford
      Director Of Clinical Research, Afon Technology Ltd (Formerly Orsus Medical)

      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:

      CASE STUDY: Overcoming operational challenges when running a CAR-T trial: learnings and best practice

      2022-12-01, 11:00 AM

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      DR. SUMEET AMBARKHANE
      T AMBARKHANE
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      Dr. Claudia Hesselmann
      Founder And CEO, ARENSIA Exploratory Medicine GmbH

      Dr. Claudia Hesselmann, a chemist by training, with a PhD in molecular biology. Claudia has twenty years of expertise in the early phases of drug development. Her experience includes co-founding and holding management positions in various CROs. Her extensive background and social acumen, along with her first-hand knowledge of the industry, led Claudia to co-found ARENSIA Exploratory Medicine in Düsseldorf, Germany. Her primary aim is the contribution of innovative approaches to bring about substantial acceleration to the drug development process and enable more agile patient access to novel therapeutics.

      Session Details:

      Registration and refreshments

      2022-11-30, 8:00 AM

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      Milena Konewko
      Global Study Associate Manager, AstraZeneca
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      PROF. DR. MED. GERHARD EHNINGER
      Chief Medical Officer, AvenCell

      Session Details:

      CASE STUDY: Overcoming operational challenges when running a CAR-T trial: learnings and best practice

      2022-12-01, 9:00 AM

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      Marco Schmidt
      Chief Scientific Officer, Biotx.Ai

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

      Marco provides almost a decade of experience in the biotech ecosystem. He is the author of the textbook "Chemical Biology & Drug Discovery".

       

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      DR DOMINIK STEUBL
      Senior Clinical Program Leader, Boehringer Ingelheim
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      MOHAMED ABUKAR
      Senior Analyst, GlobalData

      Session Details:

      Trends and themes for the clinical trial landscape in the DACH region: insights from GlobalData

      2022-12-01, 2:30 PM

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      Pietro Scalfaro
      Chief Medical Officer, Enyo Pharma

      Session Details:

      CASE STUDY: Overcoming operational challenges when running a CAR-T trial: learnings and best practice

      2022-12-01, 11:00 AM

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      TOMASZ KOWALCZYK
      Regional Director, Clinical Sites Liaison Consultant , Agenus Bio

      Session Details:

      Tips and tricks for engaging sites with new technology

      2022-11-30, 4:30 PM

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      ALLISON FIDLER
      Deputy Director, Clinical Operations, Debiopharm
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      JAGODA MALIK
      Deputy Head, Clinical Research Center, National Institute Of Geriatrics, Rheumatology And Rehabilitation, Poland

      Session Details:

      An academic and a research institution as a Center and Sponsor of clinical trials

      2022-12-01, 12:00 PM

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      Sverre Bengtsson
      Co-Founder, Viedoc Technologies

      Sverre Bengtsson started in the clinical trials industry over 30 years ago. He started as a statistician/statistical programmer, later into data management and since over 20 years into business development. He has been working in both CRO’s as well as in clinical trials technology companies, including the global first ePRO company. Sverre is very interested in making clinical trials efficient, in both study design but also in the processes and technologies used.

       

      Sverre co-founded Viedoc Technologies 19 years ago and is responsible for some of the major accounts but also the vision around the company. He’s on the board of both some industry organisations and in clinical technology companies.

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      Roel van der Heijde
      Facilitator & Trainer, Roel Rotterdam & Patient Experience Association

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

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

      He is a driven and experienced trainer and facilitator in:

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

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

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

      Session Details:

      CASE STUDY: Overcoming operational challenges when running a CAR-T trial: learnings and best practice

      2022-12-01, 11:00 AM

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      Danish Mairaj
      Senior Engineer, Software & Electronics, Vectura Group Plc.

      Danish Mairaj is senior engineer at Vectura Group with over 10 years of experience in medical device industry in various roles including regulatory affairs. Vectura is a leading provider of innovative inhaled drug delivery solutions with the device, formulation and development capabilities to deliver a broad range of complex inhaled therapies.

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      MAGDALENA GOLOS
      Head Of Clinical Study Management, Polpharma

      Session Details:

      Reserved for PSI

      2022-11-30, 11:30 AM

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      MIMI CHOON-QUINONES
      Founder And Chairman, Partners For Patients, PfP.NGO

      I am passionate about advocating for patients by improving healthcare policies, advancing medical knowledge, driving innovative digital solutions in the quest to increase medical access to treatments for patients. I feel it is one of my responsibilities to support every patient around the world who struggles to get access to medicines.

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      ULRIKE GRIMM
      Vice President, Head Global Project & Alliance Management, Vifor Pharma

      Ulrike is an expert in ensuring successful operational execution and excellent team performance with a track record of developing drugs from research to market launch. She has extensive experience in the leadership of multi-cultural and cross-functional project teams, within Research & Development in phase I – IV clinical studies, international product launches, portfolio and alliance management and clinical operations. Ulrike is a pharmacist by training with a Ph.D. in pharmacology. At Merck Serono KGaA she held various positions with increasing responsibilities, starting as a project manager, moving on to International Team Leader and Product Director. In 2007 Ulrike joined Fresenius Biotech with responsibility for the Global Program & Portfolio Management department. In Sept. 2010 she joined Vifor Pharma in Zürich and newly implemented the Global Project & Alliance Management Department. Her responsibilities focus on project, portfolio and change management. During 2013-15 she led the Global Clinical Operations department. As of 2019, Ulrike works as an independent consultant focusing on project and alliance management services for pharmaceutical companies to ensure operational excellence and process improvement. Ulrike is an IMPA-certified Project Director and holds a lean six sigma Black Belt

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      BENOÎT MARCHAL
      Chief Digital Trust Officer, Partners For Patients

      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:

      CASE STUDY: Overcoming operational challenges when running a CAR-T trial: learnings and best practice

      2022-12-01, 11:00 AM

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      JASMIN HELLWIG
      Associate Director Comparator Sourcing,

      Session Details:

      Vendor management: the importance of aligning vendors and sponsors under one shared goal to deliver your trial

      2022-11-30, 10:00 AM

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      HEIKE SCHÖN
      Managing Director, Lumis International GmbH

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

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      DR. MAX HORNECK
      Head Clinical Data Management And EClinical Systems, Medac
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      ROLAND MIROW
      Director, Katairo GmbH
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      LEON HOOFTMAN
      Chief Medical Officer, Isa-Pharma
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      JELENA MIHAJLOVIĆ
      Clinical Operations Program Lead, Immunic Therapeutics
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      Seif Eddine Amara Madi
      Senior Manager Clinical Labs Quality, GSK

      Session Details:

      Considerations when preparing for virtual and hybrid audits: how has the pandemic impacted quality control?

      2022-12-01, 11:00 PM

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      Daniela Duffett
      Solutions Consultant, Suvoda

      Daniela Duffett is the European Solutions Consultant at Suvoda, based out of our Barcelona office. She consults with clients and prospects, delivering presentations and demonstrations, while acting as a Subject Matter Expert on Suvoda’s solutions. She started at Suvoda three years ago on the Project Management side of our Services Delivery organisation, so can impart her hands-on delivery experience & knowledge.

       

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      Chris Mogg
      Solutions Specialist, RTSM, Medidata

      Chris is a RTSM Solutions Specialist at Medidata with over 23 years of experience in Clinical Research specialising in Randomisation and Trial Supply Management (RTSM). He began his career at Clinphone working as a programmer and has held various Technical and Project related roles at Technology Vendors and CROs. With his vast experience and knowledge, he has a great understanding of what it takes to efficiently work with Sponsors and to help them select and develop systems. Chris is a graduate of Nottingham Trent University and holds a Bachelors of Science degree in Physics and Computer Science.

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      RAHUL MALHOTRA
      Director, Therapeutic Strategy Lead, Worldwide Clinical Trials

      Rahul Malhotra has 16 years’ experience within the industry with academia and CROS, in the early stages of his career with Imperial College London. Rahul has worked in multiple Therapeutic areas, with many of those years in Oncology, predominantly global operations and building strategic full service partnerships with Large Pharma and Bio Techs. Rahul has managed and taken an oversight role for multiple and simultaneous global projects in over 26 countries; managing large full service teams and actively presenting in a range of meetings and conferences across the globe. He has a passion for Oncology, working collaboratively and transparently with his colleagues and clients by delivering the highest level of competency, by ensuring every objective is met with extreme care and competence.

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      Andrew Mackinnon
      Vice President, General Manager, eConsent Medable
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      Marija Popovic
      Manager Feasibility Department PSI CRO
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      Neta Bendelac
      Senior Director, Strategy 4G Clinical
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      WHAT TO EXPECT FOR 2022

      Join pharma and biotech experts to discuss new trends and opportunities and learn how they optimize their clinical operations enabling you to stay ahead of the game.

       

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