7th Annual Outsourcing in Clinical Trials DACH 2024

Providing a specific platform for the clinical trials community in the DACH region to develop innovative clinical operations and outsourcing strategies.

29 - 30

October

2024
  • Hyatt Regency Zurich Airport The Circle, Zurich, Switzerland
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  • Agenda
  • OCT Advisory Board
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Featured Speakers

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Effie Pournara​

Senior Global Medical Director, Novartis

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Christoph Gasteyger​

Executive Director, Global Program Team Lead Hematology/Nephrology, Alexion

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Josue Mfopou Kunjom​

Director Clinical Operations, Pfizer

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Nicolas Le Bec​

Director, Therapeutic Area Quality Lead, Global R&D Quality, Bristol Myers Squibb

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Jasmin Hellwig​

Associate Director Vendor Relationship Management, MSD

Jasmin Hellwig graduated from the Applied Institute of Science in Muttenz, Switzerland, 2005 in Chemistry and joined Inovalab AG the same year as Study Director. In her various roles, including Business Development, Deputy of the General Management and Deputy of Test Facility Management, she enjoyed facilitating success by supporting processes, which meet high quality and business need. Since 2010 Jasmin is part of the Global Clinical Supplies department of MSD, former Schering Plough. She started as Project Lead coordinating packaging of clinical supplies and supporting integration projects. In September 2014, Jasmin joined the Comparator Sourcing and Planning group, supporting Clinical Trials by purchasing comparators on time from various sources. Since 2020, she fosters the Relationship Management group.

Besides various hobbies she cultivates, particularly horses and singing, she graduated as MSc in Management from the Lorange Business School, Zurich, Switzerland, in 2015.

 

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Nadiia Wyttenbach​

Managing Director, Growth Equity, Redalpine

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    Sponsors Include:

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    Company Information

    Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating 25 years of ground-breaking technological innovation across more than 34,000 trials and 10 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and the largest patient-level historical clinical trial data set in the world. More than 1 million registered users across approximately 2,200 customers trust Medidata’s seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster. A Dassault Systèmes brand (Euronext Paris: FR0014003TT8, DSY.PA), Medidata is headquartered in New York City and has been recognized as a Leader by Everest Group and IDC. Discover more at www.medidata.com and follow us @Medidata.

    Company Website

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

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    Company Information

    1MED, is the leading European MedTech specialized solutions provider,
    offering end-to-end development expertise within the medical device, novel technology and combination products fields.

    Founded in 2014, with headquarter in Agno, Switzerland, and employing 100+ professionals across the Europe, 1MED’s mission is to support all the MedTech organizations in facing the complexity associated with the development of innovative medical devices in compliance with MDR.

    Such support may include providing preclinical support, regulatory advice, clinical study management, post marketing support, digital solutions and quality management systems across the clinical research continuum with a cross-functional approach which led to win the certification and certification maintenance of more than 500 different medical devices within the last 5 years.

    Company Website

    To learn more, please visit our website - https://www.1med.ch/

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    Company Information

    We’re more than a supplier: we’re a partner that can deliver consistent quality and superior service, a partner that fuel innovation for foster real and sustainable results. A deep understanding of healthcare industry and our customers’ needs is critical to ensure our range of packaging products and services deliver value through the entire product lifecycle. These insights and the experience of the WestRock Adherence team enable us to work in tune with regulations and clients to provide a service solution underpinned by an innovative and unparalleled range of packaging products including Clinical Trial Packaging, specialty labels, literature & booklets, Adherence packaging, multiple component kits and SMART Digital Adherence Technology.

    Company Website

    To learn more, please visit our website - www.westrock.com/markets/healthcare

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    Company Information

    Scout empowers the life sciences industry with people-first solutions: Scout Meetings, Scout Clinical, and Scout Academy. We specialize in face-to-face, virtual, and hybrid clinical meeting planning, patient payment, travel, and logistics support, and virtual collaboration and education. Since 1995, we have been a trusted partner excelling in customer service, regulatory compliance, and project delivery for leading pharmaceutical and biotechnology companies. Our deep understanding of international regulations and adaptable network of resources is built on operational experience in 109 countries. With white-glove attention to detail and a customizable, comprehensive range of services, Scout makes the complex easier. Learn more at scoutclinical.com.

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    Company Information

    Syneos Health (Nasdaq:SYNH*) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together more than 21,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together, we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to lifeTM visit SyneosHealth.com. 

    Company Website

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

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    Company Information

    Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. We’re a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, our individualized partnership approach provides experience-driven insights and expertise to assist clients in successfully navigating the complexities of delivering novel treatments to patients.

    Company Website

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

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    Company Information

    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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    Company Information

    BSI Life Sciences offers smart eClinical software for CTMS, eTMF and more. BSI makes life science software for people – and has done so for over 25 years. BSI’s software solution is made in Switzerland, Germany, USA and anywhere else clients need to be, and focused on being innovative and user-friendly. They focus on staying ahead of the industry trends and delivering a functional, compliant, and leading edge eClinical solution. This way, BSI helps its customers continuously optimize and accelerate the clinical development process. And that’s what they love! www.bsi-lifesciences.com

    Company Website

    To learn more, please visit our website - www.bsi-lifesciences.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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    TFS HealthScience is a global Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Bringing together nearly 700 professionals, we deliver tailored clinical research services in more than 40 countries. TFS supports customers with comprehensive solutions including full clinical development services, strategic and flexible resourcing. In partnership, we build solution-driven teams of experienced professionals working together for a healthier future. Our mission is to bring treatments to patients faster. For more information, please visit www.tfscro.com.

    Company Website

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

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    Company Information

    SGS is a leading life sciences CRO providing clinical research and bioanalytical testing with a specific focus on early stage development and biometrics. Delivering solutions in Europe and in Americas, SGS offers clinical trial (Phase I to IV) services encompassing full early phase drug development consultancy, clinical project management and monitoring, biometrics, PK/PD modeling & simulation and regulatory & medical affairs services. SGS has its own clinical unit in Belgium including a viral challenge testing facility and two phase I patients units based in Belgium and Hungary.

    SGS has a wealth of expertise in FIH studies, viral challenge testing, biosimilars and complex PK/PD studies with a high therapeutic focus in Infectious Diseases, Vaccines, and Respiratory.

    Company Website

    To learn more, please visit our website - http://www.sgs.com/en/life-sciences/clinical-research-services

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    Founded in 1997, Ergomed is a full service, global Phase I-IV clinical development and trial management service partner with leading expertise in developing oncology and rare disease drugs.  Our portfolio includes experience working with novel therapies, early phase development, immunotherapy, and adaptive trial designs. Ergomed embodies a patient-centric approach to recruitment and retention with access to global patients in vital geographical areas.  Ergomed’s proven delivery record, expertise, and true partnership means our sponsors can trust us to deliver their oncology trials whatever the challenge. We also offer an industry-leading suite of specialist pharmacovigilance (PV) solutions under the PrimeVigilance brand.

    Ergomed has supported and managed clinical development, trial management, pharmacovigilance, and medical information services for over 300 clients in more than 100 countries.

    We deliver a complete solution for oncology trials of all sizes and complexity. For more information about Ergomed, please visit: www.ergomedcro.com

    Company Website

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

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    Company Information

    Climedo offers a digital platform for hybrid clinical trials and observational studies. Its modular and secure solutions include electronic data capture (EDC), eCOA/ePRO and Telemedicine. This enables pharma and medtech companies to validate their medical innovations more efficiently in the post-market phase and to capture data in decentralized, real-world settings.

    Company Website

    To learn more, please visit our website - www.climedo.de

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    Company Information

    Paitient recruitment services for Sponsors, CROs and Sites.
    We find participants for your clinical trial
    Are you looking for healthy volunteers or patients suffering from diseases such as asthma, diabetes, psoriasis or other indications?
    We have the experience to quickly find suitable local patients and subjects for your study.

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    Company Information

    Euromed Pharma deliver strategic services tailored to support companies in their quest to better healthcare. We support each industry player from drug development through the post-marketing phases. We offer solutions in CTS services, Clinical GMP Packaging, Labeling and Distribution, IMP management, Early Access and Named Patient Programs, Pharma Order to cash solutions, and Supply Chain & Logistics. We are present around the world with offices in Italy, Spain, Ireland, Germany, Singapore and the USA. Being one of the Petrone Group companies, Euromed Pharma is positioned at the forefront of innovation in pharmaceutical distribution.

    Company Website

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

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    Company Information

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    Company Website

    To learn more, please visit our website - http://www.biomapas.eu

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      Why attend?

      ‘Providing a specific platform for the clinical trials community in the DACH region to develop innovative clinical operations and outsourcing strategies’

       

      After a hugely successful 2023 conference, we are pleased to announce that the Outsourcing Clinical Trials DACH event will be returning to zurich. This event will focus upon the operational challenges in clinical development found within Germany, Austria and Switzerland. Over two 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, AstraZeneca and Novartis along with exciting biotechs like Medac and Medigene
      • Great and Diverse Sessions – Our OCT DACH covers a variety of topics ranging from updated EMA Guidance 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 2024?

      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

      Agenda

      • 29 Oct 2024
      • 30 Oct 2024
      Expand All

      Streams

      Stream one

      Clinical Operations

      Stream two

      Innovation & Technology

      10:30 AM

      Morning refreshments and networking

      11 AM

      INTERACTIVE SESSION United for progress: AI and emerging technologies shaping the future

      Get ready to actively participate and share your insights in this engaging, hands-on session
      • Upskilling and collaboration journey - how to stay on top of all emerging technologies
      • Use cases - where to begin and what is being done to integrate new technologies into clinical trials
      • Forward looking- what are the most promising ground-breaking technological advancements and innovations such as in silicon clinical trials?

      Speakers

      Eric Hajjar
      Former Associate Director, Global Medical Research Operations, Biogen

      11:30 AM

      Breaking down barriers: the key role of localization in enhancing diversity in clinical trials

      • Urgency vs. Diversity: the pressure for rapid trial results often leads to the exclusion of some diverse populations, in part due to the extensive localization efforts required
      • Impact of localization: avoiding translation work can sideline certain participant groups, highlighting the need for improved translation strategies from sponsors, eCOA providers and translation vendors to enhance trial inclusivity
      • Proactive solutions: adopting automation, integrating localization into technology development, and streamlining workflows for translation are essential for making clinical trials more inclusive and diverse

      Speakers

      Jonathan Norman
      Director, Localization Services, YPrime

      12 PM

      Integrating digital health technologies in clinical trials

      • Improving recruitment and adherence with digital tools
      • Streamlining and securing data analysis with digital platforms
      • Ensuring compliance with digital documentation and reporting

       

      Speakers

      Jade Sternberg
      Digital Health Lead, digitalswitzerland

      12:30 PM

      Digital Display Labels (DDL’s) – Relabelling the Clinical Trial Landscape

      • Digital Display Labels – Introducing DDLs for primary and secondary Clinical Trial packaging
      • Transformational & Innovative technology providing real-time supply chain advantages - benefits in integrated operations,  packaging optimisation, quality, regulatory, and clinical operations efficiencies
      • Secure digital connectivity -  enabling enhanced  supply chain capabilities and efficiencies with new clinical supply packaging opportunities and reducing risk of clinical supply on critical registration path

      Speakers

      Brian Sheridan
      Vice President Global Adherence & Clinicals, Smurfit Westrock
      Martina Marauli
      Director Clinical Supply Innovation, MSD International Business GmbH, Lucerne

      12:45 PM

      15-minute Tech Spotlight

      Session reserved for event sponsor

      1 PM

      Lunch and networking

      2 PM

      Innovative thinking for increasing patient diversity and inclusion in clinical trials

      • Increasing diversity in clinical trial patient recruitment
      • Understanding why diversity in clinical trials is important for trial outcomes
      • Exploring how to advance medicine through increased diversity

      Speakers

      Josue Mfopou Kunjom
      Director Clinical Operations, Pfizer

      2:30 PM

      Session reserved for Climedo

      3 PM

      Fostering a culture of quality in clinical research: a catalyst for innovation

      • Is there any area where quality is more paramount than in clinical research?
      • Are the traditional quality management tools and metrics the right approach?
      • Exploring what embeds quality deep in the clinical research culture

      Speakers

      Effie Pournara
      Senior Global Medical Director, Novartis

      3:30 PM

      Afternoon refreshments and networking

      4 PM

      FIRESIDE CHAT Exploring the benefit of integrative IT applications in clinical trials for small biopharma companies

      • Discuss the importance of the concept of a "single source of truth"
      • How can we improve Data integrity and Accuracy?
      • What can we do to strengthen Regulatory Compliance and Auditability in a scientific driven environment?

      Speakers

      Anke Müller
      Associate Director / Team Lead Clinical Operations, AiCuris Anti-infective Cures AG
      Effie Pournara
      Senior Global Medical Director, Novartis

      4:30 PM

      PANEL DISCUSSION Exploring the transition of innovation & technological advancements in clinical trials

      • Are we making the most of technology & innovation in the clinical trial space?
      • How are these tools being utilized efficiently?
      • The importance of exploring ethical considerations
      • Examining the relationship between innovation, creativity, and regulations
      • What’s next?

       

      Speakers

      Effie Pournara
      Senior Global Medical Director, Novartis
      Eva Herrmann-Keiner
      Senior Clinical Operations Manager, Neurimmune
      Francine Metelo
      Lead Workstream Ethnicity and Culture DEICE Europe, Pfizer
      Paul O’Donohoe
      Senior Director, ECOA Product And Science, Medidata Solutions

      8 AM

      Registration and refreshments

      8:40 AM

      Chairperson’s opening remarks

      Speakers

      Dr. Nicolas Schneider
      Director Clinical Operations and Alliance Management, ITM Isotopen Technologien München

      9 AM

      Navigating ICH GCP V3 regulatory requirements: updates and best practices

      • Understanding the latest changes in ICH GCP V3 regulatory requirements in a user-friendly manner
      • Implementing effective compliance measures to ensure alignment with evolving regulatory expectations
      • Identifying key challenges and ways to overcome them

       

       

      Speakers

      Nicolas Le Bec
      Director, Therapeutic Area Quality Lead, Global R&D Quality, Bristol Myers Squibb

      9:30 AM

      Turning patient-centricity into reality: lessons from developing a patient-engagement platform for clinical trials

      • The high cost of overlooking patient involvement in the clinical trial technology development process
      • Strategies for integrating patient engagement into the technology development process from the outset
      • Key insights from patients on designing clinical trial tools that are truly user-friendly and supportive of their study participation
      • Moving beyond technology for technology's sake to deliver meaningful patient experiences that enhance engagement and retention

      Speakers

      Paul O’Donohoe
      Senior Director, ECOA Product And Science, Medidata Solutions

      10 AM

      Transforming clinical trials: the role of blockchain in revolutionizing clinical data management

      • Ensuring data integrity: how blockchain guarantees tamper-proof clinical records
      • Enhancing transparency and security in clinical trials through decentralized systems
      • Streamlining payment processes and contract management in clinical research with smart contracts
      • Real-world applications: leveraging blockchain for retrospective analyses and observational studies
      • The future of clinical data collection: operational efficiency and financial sustainability with blockchain

      Speakers

      Enrico Perfler
      Founder, 1Med

      10:30 AM

      Morning refreshments and networking sponsored by Aixial

      11 AM

      PANEL DISCUSSION Revitalizing clinical trials in the DACH region: overcoming challenges and enhancing attractiveness

      • Identify the key challenges that make DACH region less attractive for clinical trials
      • Strategies to make the region more appealing for global trials, focusing on speeding up processes, reducing costs, and leveraging technology for efficiency and inclusivity
      • Discuss the consequences of low participation in clinical trial
      • Present strategies to streamline administrative processes and reduce bureaucracy
      • Explore methods to enhance patient recruitment and retention

       

      Speakers

      Cornelia Baumgartner
      Head of Clinical Operations, T-CURX
      Ina Meyer
      Study & Site Operations (SSO) Country Manager Switzerland, Novartis
      Andrea Sauerland
      Senior Vice President Clinical Operations, Endotronix
      Dr. Nicolas Schneider
      Director Clinical Operations and Alliance Management, ITM Isotopen Technologien München

      11:30 AM

      Building the bridge from pre-clinical to clinical studies

      Speakers

      Rocio Mugica Nava
      Director, Regulatory Affairs, Worldwide Clinical Trials

      12 PM

      Aspects to contemplate when selecting a CRO for rare disease trials

      • Does possessing therapeutic expertise remain imperative in choosing a CRO for a rare disease inquiry?
      • Evaluating the advantages of niche specialized CROs versus expansive multinational CROs
      • Extra hurdles in the CRO selection procedure arise when addressing ultra-rare diseases, where CROs may lack familiarity with the condition
      • Discussing the merits and drawbacks of engaging a comprehensive service CRO for your rare disease examination versus collaborating with various vendors across the study

      Speakers

      Christoph Gasteyger
      Executive Director, Global Program Team Lead Hematology/Nephrology, Alexion

      12:30 PM

      Session reserved for event sponsor

      1 PM

      Lunch and networking

      2 PM

      Q&A session What do venture capitalists look for in startups? Unveiling the main criteria for investment

      Speakers

      Nadiia Wyttenbach
      Managing Director, Growth Equity, Redalpine
      Dr. Nicolas Schneider
      Director Clinical Operations and Alliance Management, ITM Isotopen Technologien München

      2:30 PM

      Is your protocol leading to success? The importance of early engagement

      Reserved for Syneos Health

      3 PM

      Developing the first treatment for my own ultra-rare disease – lessons learned

      • Meaningful involvement of patients in the study design phase to reflect their needs and improve trial execution
      • Ethical aspects of trial designs in ultra-rare diseases
      • Partnering with patient advocacy groups to foster meaningful relationships
      • Experiences and lessons learned from being a patient representative in regulatory approval and HTA proceedings

      Speakers

      Dr. Jasmin Barman-Aksözen
      Research Investigator, Lecturer and Rare Disease Patient Advocate, University of Zurich

      3:30 PM

      Afternoon refreshments and networking

      4 PM

      Key considerations and strategic steps to ensure successful and timely execution when planning your first clinical trial as a start-up company

      • Understanding the timeline from the initial idea to the first patient enrolment
      • Assembling a powerful team within your company
      • Creating a realistic project plan and budget
      • Gaining a thorough understanding of the regulatory and competitive landscape
      • Carefully considering the design of your trial, patient availability, the number of patients needed, and the number of sites/countries involved
      • Choosing the right partners, including CROs, vendors, and sites

      Speakers

      Cornelia Baumgartner
      Head of Clinical Operations, T-CURX

      4:30 PM

      PANEL DISCUSSION Enhancing communication between CROs, sponsors and clinical trial sites for an efficient work process

      • Emphasizing the importance of defining clear communication channels, expectations, and escalation procedures among CROs, sponsors, and sites to ensure transparency and accountability throughout the trial
      • Highlighting the benefits of leveraging communication technologies such as centralized platforms and project management tools to facilitate real-time information sharing and collaboration among stakeholders
      • Providing training and resources to enhance communication skills and promote effective teamwork across all levels

      Speakers

      Christoph Gasteyger
      Executive Director, Global Program Team Lead Hematology/Nephrology, Alexion
      Monika Gawlowicz
      MD Investigator, Pratia
      Judit Magos
      Clinical Operations Manager, Viatris
      Dr. Nicolas Schneider
      Director Clinical Operations and Alliance Management, ITM Isotopen Technologien München

      5:15 PM

      Chairperson’s closing remarks

      Speakers

      Dr. Nicolas Schneider
      Director Clinical Operations and Alliance Management, ITM Isotopen Technologien München

      DRINKS RECEPTION

      8 AM

      Registration and refreshments

      8:50 AM

      Chairperson’s opening remarks

      Speakers

      Eric Hajjar
      Former Associate Director, Global Medical Research Operations, Biogen

      9 AM

      PANEL DISCUSSION The clinical trial landscape for small to mid-sized biopharma in the DACH region

      • New regulations and guidance around clinical trials in the DACH region: how will this impact you?
      • Staff turnover and layoffs: handling changes in the industry in order to ensure success
      • Navigating the constantly evolving vendor and CRO landscape as a small to mid sized sponsor company
      • An overview of technology and innovation in the clinical trial industry: what’s working and what isn’t?

      Speakers

      Clare Price
      Clinical Operations Leader, CDR-Li
      Eric Hajjar
      Former Associate Director, Global Medical Research Operations, Biogen
      Joan D’souza
      Contact Person for Pharmacovigilance for Swissmedic and BfArM

      9:45 AM

      Session reserved for event sponsor

      10:15 AM

      FIRESIDE CHAT Ensuring adequate sponsor oversight of clinical trials when outsourced to clinical contract research organisations

      • Ensuring that KPIs are informative and meaningful.
      • Assessing overall project risk and appropriate surveillance tactics
      • Consolidating your overall management strategy that can be coordinated with CRO SOPs
      • Documentation of Sponsor oversight activities throughout the study

      Speakers

      Judit Magos
      Clinical Operations Manager, Viatris
      Eric Hajjar
      Former Associate Director, Global Medical Research Operations, Biogen

      10:45 AM

      Morning refreshments and networking

      11:15 AM

      Understanding pharmacovigilance in clinical trials DACH

      • Mechanism of pharmacovigilance of medicinal products and drug devices in clinical trials in the DACH region
      • Assessment of regulations and responsibilities of key stakeholders
      • Interplay between the health authorities and vendors and challenges related to pharmacovigilance

      Speakers

      Joan D’souza
      Contact Person for Pharmacovigilance for Swissmedic and BfArM

      11:45 AM

      FIRESIDE CHAT Enhancing site accessibility and collaboration in clinical trials to reduce burden on sites

      • Understanding the resource constraints faced by trial sites and the impact on their accessibility and participation in clinical studies
      • Promoting flexibility in data management by accommodating both paper and electronic platforms based on site preferences, ensuring smoother integration and reduced burden on site staff
      • Encouraging open communication with sites to understand their specific needs and preferences

      Speakers

      Ina Meyer
      Study & Site Operations (SSO) Country Manager Switzerland, Novartis
      Eric Hajjar
      Former Associate Director, Global Medical Research Operations, Biogen

      12:15 PM

      Setting up Clinical Operations in a Startup/Biotech Environment: An agile approach to turn a corner

      • Introducing Clinical Operations and GCP in a new Start-up / Biotech environment
      • Focusing on the key components to successfully, and within budget, run a study from scratch
      • Overcome the challenges of a small team inhouse and efficiently perform the oversight

      Speakers

      Georgios Sarantis
      Senior Clinical Trial Manager, Granite Bio

      12:45 PM

      Lunch and networking

      1:45 PM

      Artificial Intelligence in Pharma

      • Generative AI roadmap and latest developments
      • Business impact and use cases
      • Risks, limitations, and other considerations
      • Recommendations

       

      Speakers

      Beyza Karakoy
      Analyst,​ Strategic Intelligence​, GlobalData

      2:15 PM

      Session Reserved for Vasee Moorthy, Senior Advisor, R&D, World Health Organization

      2:45 PM

      Financial oversight of clinical studies and development to optimize cost savings

      • Creating a cost optimized study set-up to work more effectively
      • Reviewing selection processes and negotiations with your vendor
      • Management and closure of study budget

      Speakers

      Clare Price
      Clinical Operations Leader, CDR-Li

      3:15 PM

      Afternoon refreshments and networking

      4 PM

      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 in oncology trials. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

      ROUNDTABLE 1
      Exploring ways to involve patients in clinical trials to advance patient recruitment and retention with regulatory considerations
      Dr. Jasmin Barman-Aksözen, Research Investigator, Lecturer and Rare Disease Patient Advocate, University of Zurich

      ROUNDTABLE 2
      How can we be more efficient in clinical operations with less resources?
      Nicolas Schneider, Director Clinical Operations and Alliance Management, ITM Isotopen Technologien München

      ROUNDTBALE 3
      Aligning clinical teams with supply teams earlier to improve processes and output
      Jasmin Hellwig, Associate Director Vendor Relationship Management, MSD

      Speakers

      Jasmin Hellwig
      Associate Director Vendor Relationship Management, MSD
      Dr. Nicolas Schneider
      Director Clinical Operations and Alliance Management, ITM Isotopen Technologien München
      Dr. Jasmin Barman-Aksözen
      Research Investigator, Lecturer and Rare Disease Patient Advocate, University of Zurich

      END OF CONFERENCE

      5 PM

      Chairperson’s closing remarks

      Speakers

      Select a speaker to learn more

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      Cornelia Baumgartner
      Head of Clinical Operations, T-CURX

      Session Details:

      PANEL DISCUSSION Revitalizing clinical trials in the DACH region: overcoming challenges and enhancing attractiveness

      2024-10-29, 11:00 AM

      Session Details:

      Key considerations and strategic steps to ensure successful and timely execution when planning your first clinical trial as a start-up company

      2024-10-29, 4:00 PM

      View In Agenda
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      Christoph Gasteyger
      Executive Director, Global Program Team Lead Hematology/Nephrology, Alexion

      Session Details:

      PANEL DISCUSSION Enhancing communication between CROs, sponsors and clinical trial sites for an efficient work process

      2024-10-29, 4:30 PM

      Session Details:

      Aspects to contemplate when selecting a CRO for rare disease trials

      2024-10-29, 12:00 PM

      View In Agenda
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      Nadiia Wyttenbach
      Managing Director, Growth Equity, Redalpine

      Session Details:

      Q&A session What do venture capitalists look for in startups? Unveiling the main criteria for investment

      2024-10-29, 2:00 PM

      View In Agenda
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      Monika Gawlowicz
      MD Investigator, Pratia

      Session Details:

      PANEL DISCUSSION Enhancing communication between CROs, sponsors and clinical trial sites for an efficient work process

      2024-10-29, 4:30 PM

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      Dr. Jasmin Barman-Aksözen
      Research Investigator, Lecturer and Rare Disease Patient Advocate, University of Zurich

      Session Details:

      Developing the first treatment for my own ultra-rare disease – lessons learned

      2024-10-29, 3:00 PM

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2024-10-30, 4:00 PM

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      Ina Meyer
      Study & Site Operations (SSO) Country Manager Switzerland, Novartis

      Session Details:

      PANEL DISCUSSION Revitalizing clinical trials in the DACH region: overcoming challenges and enhancing attractiveness

      2024-10-29, 11:00 AM

      Session Details:

      FIRESIDE CHAT Enhancing site accessibility and collaboration in clinical trials to reduce burden on sites

      2024-10-30, 11:45 AM

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      Andrea Sauerland
      Senior Vice President Clinical Operations, Endotronix

      Session Details:

      PANEL DISCUSSION Revitalizing clinical trials in the DACH region: overcoming challenges and enhancing attractiveness

      2024-10-29, 11:00 AM

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      Dr. Nicolas Schneider
      Director Clinical Operations and Alliance Management, ITM Isotopen Technologien München

      Session Details:

      PANEL DISCUSSION Revitalizing clinical trials in the DACH region: overcoming challenges and enhancing attractiveness

      2024-10-29, 11:00 AM

      Session Details:

      PANEL DISCUSSION Enhancing communication between CROs, sponsors and clinical trial sites for an efficient work process

      2024-10-29, 4:30 PM

      Session Details:

      Chairperson’s closing remarks

      2024-10-29, 5:15 PM

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2024-10-30, 4:00 PM

      Session Details:

      Chairperson’s opening remarks

      2024-10-29, 8:40 AM

      Session Details:

      Q&A session What do venture capitalists look for in startups? Unveiling the main criteria for investment

      2024-10-29, 2:00 PM

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      Effie Pournara
      Senior Global Medical Director, Novartis

      Session Details:

      Fostering a culture of quality in clinical research: a catalyst for innovation

      2024-10-29, 3:00 PM

      Session Details:

      FIRESIDE CHAT Exploring the benefit of integrative IT applications in clinical trials for small biopharma companies

      2024-10-29, 4:00 PM

      Session Details:

      PANEL DISCUSSION Exploring the transition of innovation & technological advancements in clinical trials

      2024-10-29, 4:30 PM

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      Judit Magos
      Clinical Operations Manager, Viatris

      Clinical trial expert with 12 years of international experience in both CRO and Sponsor roles, spanning from feasibility to trial reporting across Phase I-IV studies. Highly adept at supervising cross-functional teams in dynamic and fast-paced environments. Recognized as a decisive and trusted team member with an analytical and proactive approach, specializing in various therapeutic areas, including oncology and rare diseases.

      Session Details:

      PANEL DISCUSSION Enhancing communication between CROs, sponsors and clinical trial sites for an efficient work process

      2024-10-29, 4:30 PM

      Session Details:

      FIRESIDE CHAT Ensuring adequate sponsor oversight of clinical trials when outsourced to clinical contract research organisations

      2024-10-30, 10:15 AM

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      Clare Price
      Clinical Operations Leader, CDR-Li

      Session Details:

      PANEL DISCUSSION The clinical trial landscape for small to mid-sized biopharma in the DACH region

      2024-10-30, 9:00 AM

      Session Details:

      Financial oversight of clinical studies and development to optimize cost savings

      2024-10-30, 2:45 PM

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      Jade Sternberg
      Digital Health Lead, digitalswitzerland

      Session Details:

      Integrating digital health technologies in clinical trials

      2024-10-29, 12:00 PM

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      Martina Marauli
      Director Clinical Supply Innovation, MSD International Business GmbH, Lucerne

      Martina holds a Master's in Pharmaceutical Science from Karl-Franzens-University Graz, Austria. Her certifications include Lean Six Sigma Green Belt, St. Gallen Management Institute Business Strategy, and the London Business School programs re. Accelerated Development as well as the Innovation Through Design Thinking.

      Over her 25-year career, she's taken on multifaceted roles at Fresenius Kabi, Roche, and MSD, spanning divisions across Research, Manufacturing, Commercial and Global Support Functions. She developed drug products to market and pioneered a novel single-use auto-injection device platform for sterile dosage forms. Beyond product development, Martina has been leading business process streamlining, strategic development, and organizational integration. Her achievements include establishing the global MSD Innovation and Development Hub in Zurich, founding the global MSD Center of Excellence for Comparator Blinding, innovating an early phase biologics supply chain, amplifying Enterprise Strategy Office projects as a Design Thinking Facilitator and enhancing the Global Market Access forecasting methodology. Currently she is creating innovative solutions for clinical supply operations, clinical sites, and leading digitalization as well as people innovation endeavors; she is leading the MSD Digital Display Labeling (DDL) project as well as co-leading the cross-industry DDL Community of Practice.

      Session Details:

      Digital Display Labels (DDL’s) – Relabelling the Clinical Trial Landscape

      2024-10-29, 12:30 PM

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      Brian Sheridan
      Vice President Global Adherence & Clinicals, Smurfit Westrock

      Brian joined, the then WestRock, in 2018 as Vice President Global Adherence & Clinicals - the business unit focused on providing Adherence focused, patient centric and Child Resistant Senior Friendly (CR-SF) packaging & service solutions to the Pharmaceutical, Biotech & Clinical Trial industries.

      Having majored in marketing, business studies and finance Brians key expertise has been developing packaging solutions supplied to these key markets. Holding a wide range of increasingly elevated positions within companies such as Cardinal Health, Catalent and across several other packaging entities, Brian has gained invaluable insights and a thorough understanding of the demanding requirements, operating systems and ethos of the various market sectors that Smurfit Westrock support today.

      Within the last number of years Brian's focus, together with his globally based team, has been to strategically develop a bespoke, best in class global supply infrastructure within the Smurfit Westrock specialized field of Adherence, Clinical Trial and SMART digital & electronic platforms. These cutting-edge solutions encompass electronically enhanced SMART measure and monitor packaging solutions, such as Cere®Pak, together with developing the vision and capabilities of Cere®Screen Digital Display Labels within the Clinical Trial Supplies arena..

      Session Details:

      Digital Display Labels (DDL’s) – Relabelling the Clinical Trial Landscape

      2024-10-29, 12:30 PM

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      Josue Mfopou Kunjom
      Director Clinical Operations, Pfizer

      Session Details:

      Innovative thinking for increasing patient diversity and inclusion in clinical trials

      2024-10-29, 2:00 PM

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      Francine Metelo
      Lead Workstream Ethnicity and Culture DEICE Europe, Pfizer

      Session Details:

      PANEL DISCUSSION Exploring the transition of innovation & technological advancements in clinical trials

      2024-10-29, 4:30 PM

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      Nicolas Le Bec
      Director, Therapeutic Area Quality Lead, Global R&D Quality, Bristol Myers Squibb

      Session Details:

      Navigating ICH GCP V3 regulatory requirements: updates and best practices

      2024-10-29, 9:00 AM

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      Beyza Karakoy
      Analyst,​ Strategic Intelligence​, GlobalData

      Beyza Karakoy is an Analyst in GlobalData’s Strategic Intelligence team, having joined in September 2021. She authors and manages a portfolio of reports, contributing to the analysis of technologies across various sectors, notably financial services and sport. Her areas of expertise include tech regulation, data privacy, legal tech, and AI. Prior to joining GlobalData, Beyza completed her LLM Master of Laws at the London School of Economics and Political Science.

      Session Details:

      Artificial Intelligence in Pharma

      2024-10-30, 1:45 PM

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      Jasmin Hellwig
      Associate Director Vendor Relationship Management, MSD

      Jasmin Hellwig graduated from the Applied Institute of Science in Muttenz, Switzerland, 2005 in Chemistry and joined Inovalab AG the same year as Study Director. In her various roles, including Business Development, Deputy of the General Management and Deputy of Test Facility Management, she enjoyed facilitating success by supporting processes, which meet high quality and business need. Since 2010 Jasmin is part of the Global Clinical Supplies department of MSD, former Schering Plough. She started as Project Lead coordinating packaging of clinical supplies and supporting integration projects. In September 2014, Jasmin joined the Comparator Sourcing and Planning group, supporting Clinical Trials by purchasing comparators on time from various sources. Since 2020, she fosters the Relationship Management group.

      Besides various hobbies she cultivates, particularly horses and singing, she graduated as MSc in Management from the Lorange Business School, Zurich, Switzerland, in 2015.

       

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2024-10-30, 4:00 PM

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      Joan D’souza
      Contact Person for Pharmacovigilance for Swissmedic and BfArM

      Joan D’souza's treatment experience includes oncology, dermatology, pain management, infectious disorders, vaccines, drug-device combinations, neurology, cardiovascular gastroenterology, respiratory, orphan diseases, rare diseases, and diabetes.

      Joan currently is active in several ISoP special interest groups, including Risk communication (secretary), Medical devices, Geriatric pharmacovigilance, Vaccination, Medication error, and Ecopharmacovigilance. Joan has actively participated in the Pharmacovigilance and Medical devices special interest groups of the European Medical Writers Association. She has frequently written for the ISoP Drug Safety Journal and the European Medical Writers Association Journal. She is also a member of PIPA, UK and RQA, UK. She was also the past-president of ISOP Switzerland and Austria Chapter. She is currently pursuing a Masters in Pharmacovigilance and Pharmacoepidemiology at Eu2P and preparing for her PhD in drug- device combination regulations at the University of Strasbourg.

      Joan is a lawyer (JD licensed to practice law in Minnesota, US) and a physician. She earned a Dean's List designation for academic performance after completing a post-baccalaureate clinical research program at the University of Cincinnati in the US. Joan also obtained an advanced diploma in pharmacovigilance with software training. She also runs a non-profit women’s association called VinspireU, that helps women to settle overseas. Joan resides in Switzerland and has a supportive husband and two beautiful girls. During her free time, she likes singing, playing piano, or hiking with her family.

      Session Details:

      PANEL DISCUSSION The clinical trial landscape for small to mid-sized biopharma in the DACH region

      2024-10-30, 9:00 AM

      Session Details:

      Understanding pharmacovigilance in clinical trials DACH

      2024-10-30, 11:15 AM

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      Jonathan Norman
      Director, Localization Services, YPrime

      With 7 years of experience in localising paper and electronic COAs, Jonathan today leads translation and questionnaire licensing strategies for YPrime. He develops innovative approaches to ensure quality and accuracy in translated clinical trial materials, focusing on reducing translation burdens and increasing trial diversity. Throughout his career, Jonathan has progressed from Project Manager to Director roles in linguistic validation and quality assurance. He's a trusted SME in localisation best practices, maintaining strong relationships with eCOA providers, pharma sponsors, and copyright holders across the clinical research industry

      Session Details:

      Breaking down barriers: the key role of localization in enhancing diversity in clinical trials

      2024-10-29, 11:30 AM

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      Eric Hajjar
      Former Associate Director, Global Medical Research Operations, Biogen

      Session Details:

      INTERACTIVE SESSION United for progress: AI and emerging technologies shaping the future

      2024-10-29, 11:00 AM

      Session Details:

      Chairperson’s opening remarks

      2024-10-30, 8:50 AM

      Session Details:

      PANEL DISCUSSION The clinical trial landscape for small to mid-sized biopharma in the DACH region

      2024-10-30, 9:00 AM

      Session Details:

      FIRESIDE CHAT Ensuring adequate sponsor oversight of clinical trials when outsourced to clinical contract research organisations

      2024-10-30, 10:15 AM

      Session Details:

      FIRESIDE CHAT Enhancing site accessibility and collaboration in clinical trials to reduce burden on sites

      2024-10-30, 11:45 AM

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      Anke Müller
      Associate Director / Team Lead Clinical Operations, AiCuris Anti-infective Cures AG

      Over the last 25 years, my career has evolved in various roles and I have held senior positions in the pharma/biotech industry and with international CROs. Comprehensive knowledge and experience in Clinical Operations, experience from First in Human up until late stage. Global experience, understanding the nuances of operating in a diverse environment. Strong leadership skills, with experience in a managerial role. Medical background and advanced IT skills in Trial Management Systems, EDC and e-TMF

      My aim is to make the people who report to me feel that they are a valued member of a successful team, doing meaningful work in an environment of trust.

      Session Details:

      FIRESIDE CHAT Exploring the benefit of integrative IT applications in clinical trials for small biopharma companies

      2024-10-29, 4:00 PM

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      Eva Herrmann-Keiner
      Senior Clinical Operations Manager, Neurimmune

      Session Details:

      PANEL DISCUSSION Exploring the transition of innovation & technological advancements in clinical trials

      2024-10-29, 4:30 PM

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      Paul O’Donohoe
      Senior Director, ECOA Product And Science, Medidata Solutions

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

      Session Details:

      Turning patient-centricity into reality: lessons from developing a patient-engagement platform for clinical trials

      2024-10-29, 9:30 AM

      Session Details:

      PANEL DISCUSSION Exploring the transition of innovation & technological advancements in clinical trials

      2024-10-29, 4:30 PM

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      Enrico Perfler
      Founder, 1Med

      With a Master of Science in Biomedical Engineering, Enrico Perfler boasts 20 years of professional experience specializing in medical device technology. His profound knowledge and innovative approach have significantly shaped the landscape of this field.

      In 2014, Enrico founded 1MED SA, an innovative international company that provides regulatory support, digital solutions, and comprehensive CRO services to the medical device and pharmaceutical industry, with a particular emphasis on IVD and medical products. Under his leadership, 1MED SA has successfully overseen the development and regulatory approval of over 500 medical devices in Europe, solidifying his status as a prominent figure in the MedTech sector.

      Beyond his remarkable entrepreneurial achievements, Enrico serves as a contract professor of "Regulatory Affairs" at the Faculty of Engineering, University of Pavia. His expertise is further highlighted by his participation in the ISO/TC 194 technical committee for the biological evaluation of medical devices, and in national esteemed standardization groups, including UNI and ABHI. This involvement not only showcases his commitment to advancing industry standards but also underlines his influential role in shaping the future of medical device regulation and safety.

      Session Details:

      Transforming clinical trials: the role of blockchain in revolutionizing clinical data management

      2024-10-29, 10:00 AM

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      OCT Advisory Board

      Select a member to learn more

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      Rosalie Filling
      Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

      In her over 25 years of experience, Rosalie “Rosie” Filling has transformed R&D operations in every company she has worked for, developing clear-cut strategies to help advance clinical trials with high-quality operational execution and scientific excellence.

       

      Rosie is the Vice President, Senior Global Head R&D Operations Endo International plc. She is part of the global R&D leadership team and is charged with the coordination and implementation of clinical development strategies for the company’s research and development. She provides strategic direction and oversight of the R&D Operations team, which includes clinical operations, data management, biostatistics, medical writing, clinical supplies, trial master file/inspection readiness and business operations. This integrated team handles the execution of all aspects related to Endo’s clinical trials. Endo has active research and development programs in men’s health, orthopedics, and endocrinology. Beyond these therapeutic areas, the company also has focused development in the areas of sterile injectables and complex generic products.

       

      Rosie’s main focus at all times is on the end users—the patients. Bringing new and, at times, life-saving medications to patients drives Rosie’s sense of purpose.

       

      Rosie joined Endo from Lupin Pharmaceuticals in Blue Bell, PA where she was Senior Director, Head of Clinical Operations, and built the clinical operations organization to support the US and Global R&D Organization. Prior to Lupin, Rosie spent nearly five years at Teva in Frazer, PA where she was the US site head of Clinical Operations and was responsible for the successful delivery of Inhalation, Women’s Health, and Cardiovascular clinical trials. Earlier in her career, Rosie held various roles at Eisai, MGI Pharma and PPD.

       

      Rosie earned her B.S. in Biology with a minor in Chemistry from the University of Pittsburgh.

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      Kathleen Cohen
      Vice President, Clinical Development, Marinus Pharmaceuticals

      Kathleen Frenia Cohen is Vice President and Head of Clinical Development Operations at Marinus Pharmaceuticals.  Prior to joining Marinus, she spent 20+ years at PRA Health Sciences in a variety of project management and operational oversite roles. Kathleen graduated from the University of the Science in Philadelphia with a PharmD and completed a post-doctoral fellowship in Pharmacoeconomics and Outcomes Research from Rutgers College of Pharmacy. Kathleen resides in Media, PA.

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      THOMAS M TREMBLAY
      Vice President Of Clinical Development, Trefoil Therapeutics, Inc

      Thomas is a registered nurse with both clinical and over 30 years pharmaceutical development experience. His pharmaceutical development experience includes clinical operations, clinical science, clinical development, drug safety and quality. He is currently Vice President of Clinical Development at Trefoil Therapeutics and adjunct faculty at San Francisco State University.

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      Behtash Bahador
      Director, Health Literacy, CISCRP

      Behtash Bahador is the Director of Health Literacy 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.

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