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
  • Ticketed
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Why attend?

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

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 Get ready to actively participate and share your insights in this engaging, hands-on session

United for progress: AI and emerging technologies shaping the future

  • 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

  • Selection of DHTs for clinical trials
  • Impact of DHTs in clinical trials
  • Use cases and future development

 

Speakers

Jade Sternberg
Digital Health Lead, digitalswitzerland

12:45 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

From chaos to clarity: using GenAI to structure unstructured data in RWE Studies

  • The challenge: unstructured data in RWE studies
  • GenAI in action: structuring unstructured data and deriving insights
  • Implementing GenAI: best practices and strategic considerations

Speakers

Dragan Mileski
CTO and Co-Founder of Climedo

3 PM

Establishing a culture of quality in clinical trials: 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 enough?
  • What are the strategies to embed quality deep in the clinical research culture?
  • How the culture of quality would drive innovation in clinical research?

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

8:50 AM

Chairperson’s opening remarks

Speakers

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

9 AM

Navigating ICH GCP E6 (R3): updates and best practices

  • Understanding the changes in ICH GCP E6 (R3) vs ICH GCP E6 (R2) 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

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
Enrico Perfler
Founder, 1Med

11:30 AM

Building the bridge from pre-clinical to clinical studies: an overview of the regulatory landscape

  • Gaining a comprehensive overview of the regulatory landscape when transitioning from pre-clinical to clinical studies, focusing on the investigational medicinal product (IMP) nature and its implications for regulatory submissions
  • Key operational considerations, including navigating complex regulatory frameworks and meeting the requirements of the EU Clinical Trials Regulations, will be discussed
  • Exploring how advanced therapies, such as gene, cell, and tissue therapies, are reshaping regulatory strategies and driving innovation in the clinical trial process

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

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

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

  • Optimizing a protocol requires going beyond benchmarking historical clinical trials for any disease
  • It must involve pressure testing the protocol synopsis with key stakeholders, including investigators, site coordinators, and patients.
  • This stakeholder engagement process best ensures that your protocol will be as site and patient-friendly as possible
  • The Protocol Nexus and Protocol Optimizer offerings from Syneos Health Consulting help solve these problems by providing expert guidance and tailored solutions

Speakers

Jacopo Sgualdino
Senior Engagement Manager, Commercial Advisory Group, Syneos Health Consulting

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
Local Contact Person for Pharmacovigilance
Zulfiya Garyaeva
Senior Director Business Development, 1MED

9:45 AM

VIRTUAL SESSION Exploring WHO’s new framework for strengthening of trial systems

  • Strengthening regulatory and ethical frameworks and ensuring trials follow global standards and Good Clinical Practice
  • Building capacity and infrastructure, training researchers and enhancing facilities for high-quality trial execution
  • Promoting data transparency and global collaboration, registering trials and sharing data to improve research outcomes
  • Streamlining approval processes, speeding up trial initiation for urgent health needs while maintaining safety and compliance

Speakers

Vasee Moorthy
Senior Advisor, R&D, World Health Organization

10:15 AM

FIRESIDE CHAT Oversight management: Fostering a collaborative partnership between Sponsor and CRO

•Assessing overall project risk and appropriate surveillance tactics
•Ensuring that KPIs are informative and meaningful
•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

11:30 AM

Drug safety, regulations, clinical trials, and DACH region

  • 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
Local Contact Person for Pharmacovigilance

12 PM

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

12:30 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

1 PM

Lunch and networking with Prize Draw at 14:15

2:30 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

3 PM

Taming the beast: effective financial management of clinical trials

  • Building a cost-effective study framework
  • Navigating financial aspects of the vendor selection process
  • Effective strategies for forecasting and managing the clinical trial budget

Speakers

Clare Price
Clinical Operations Leader, CDR-Li

3:30 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

4:30 PM

Chairperson’s closing remarks

Speakers

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

END OF CONFERENCE

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

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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

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Nadiia Wyttenbach
Managing Director, Growth Equity, Redalpine

Nadiia Wyttenbach is a healthcare investor with a dual profile in Life Sciences and Investing with over 15 years of combined experience.

In 2009, she started her career in the fast-growing bioprocessing industry. She worked on advanced issues of viral filtration at Sartorius, one of global leader in bioprocessing.

After obtaining a PhD in Molecular Health from ETH in Zürich, she worked in Investment Banking, Private and Listed Equity.

Her investment experience ranges from large, publicly traded firms like IQVIA to small, specialized suppliers, medical technologies and tools companies. Subsector-wise, she has invested across the healthcare continuum, from Pharma and its supply chain to HealthTech and Digital.

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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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, 3:30 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, 12:00 PM

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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, 3:30 PM

Session Details:

Chairperson’s opening remarks

2024-10-29, 8:50 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:

Establishing a culture of quality in clinical trials: 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 Oversight management: Fostering a collaborative partnership between Sponsor and CRO

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:

Taming the beast: effective financial management of clinical trials

2024-10-30, 3:00 PM

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Jade Sternberg
Digital Health Lead, digitalswitzerland

Jade Sternberg is a Senior Manager and Digital Health Lead at digitalswitzerland. Passionate about healthcare, technologies and digitalisation, she bridges the gaps between different stakeholder groups in the ecosystem to increase collaboration and innovation. She holds a Bachelor and Master in Bioengineering from EPFL.

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

Josué holds MD from the University of Yaoundé 1, Cameroon and worked (1997-2000) as general practitioner in the University Hospital of Yaoundé. He then completed a MSc in molecular biology at the Free University of Brussels (Vrije Universiteit Brussel), followed by a diabetes cell therapy-focused PhD training and Postdoctoral fellowship at the same university. In 2015, Josué joined the Phase 1 field as Clinical Research Physician in a CRO and started a postgraduate training in Pharmaceutical Medicine, before moving two years later to Pfizer Clinical Research Unit in the role of Principal Investigator. In his current role of Clinical Operations Director, Josué supervises the teams of Investigators, Projects Managers and Regulatory Staff. He is responsible for several innovative projects aiming at improving clinical trial participant’s experience and PCRU deliveries while maintaining full compliance to GCP, national and international regulations. This includes being Subject Matter Expert for electronic consent and for Decentralized Clinical Trial modalities.

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 E6 (R3): 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, 2:30 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, 3:30 PM

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Joan D’souza
Local Contact Person for Pharmacovigilance

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:

Drug safety, regulations, clinical trials, and DACH region

2024-10-30, 11:30 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 Get ready to actively participate and share your insights in this engaging, hands-on session

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 Oversight management: Fostering a collaborative partnership between Sponsor and CRO

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, 12:00 PM

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Chairperson’s closing remarks

2024-10-30, 4:30 PM

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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

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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:

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

2024-10-29, 11:00 AM

Session Details:

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

2024-10-29, 10:00 AM

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Dragan Mileski
CTO and Co-Founder of Climedo

Dragan is an IT specialist with a strong entrepreneurial drive. In 2017 he dedicated himself to a mission to help patients get the best possible medical treatment through intelligent software solutions. As a result he co-founded Climedo Health where he took the role of Chief Technology Officer (CTO). At Climedo, Dragan leads dedicated product and tech teams focused on developing top-notch software solutions. These solutions aim to transform post-market #RWE studies by providing better real-time transparency of outcomes and enhancing engagement with healthcare professionals throughout the process.

Session Details:

From chaos to clarity: using GenAI to structure unstructured data in RWE Studies

2024-10-29, 2:30 PM

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Jacopo Sgualdino
Senior Engagement Manager, Commercial Advisory Group, Syneos Health Consulting

Jacopo Sgualdino is a Senior Engagement Manager with 9 years of consulting experience in the Commercial and Market Access fields. The focus of Jacopo’s consulting activities is partnering with big pharma and clinical stage biotechs to help them develop and commercialize products across all therapeutic areas and geographies.

Session Details:

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

2024-10-29, 2:30 PM

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Vasee Moorthy
Senior Advisor, R&D, World Health Organization

Dr. Vasee Moorthy is Senior Advisor, Research for Health Department, WHO Science Division, Geneva, Switzerland. Since 2008, he has held progressively senior roles at WHO in malaria vaccine policy development, Ebola vaccine phase 1-2 trials, global norms in sharing research data and results during public health emergencies, WHO R&D Blueprint for action to prevent epidemics, global consensus on clinical trials policy norms, WHO COVID-19 Research & Innovation Roadmap and the WHO Solidarity Trial of therapeutics supporting clinical trials networks in over 40 Member States in all WHO regions, and most recently, the adoption of resolution (WHA75.8) on clinical trials. Prior to joining WHO, Dr. Moorthy worked as a medical researcher at the University of Oxford, UK (2005-2008); with an NGO, PATH, in USA (2003-2005); running a clinical trials programme at MRC Laboratories in The Gambia (1999-2003), and as a government medical officer in Kwazulu/Natal, South Africa (1996-1997). He received a B.A. and M.A. from the University of Cambridge in Natural Sciences, a B.M.B.Ch medical degree and a Ph.D in malaria immunology and clinical trials both from the University of Oxford.

Session Details:

VIRTUAL SESSION Exploring WHO’s new framework for strengthening of trial systems

2024-10-30, 9:45 AM

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Georgios Sarantis
Senior Clinical Trial Manager, Granite Bio

George is an experienced Senior Clinical Research Professional with a demonstrated history of working in the pharmaceutical industry from big pharma (Novartis, Pfizer) and medium sized biotech (Arena Pharmaceuticals) to Biotech startup (Granite Bio) and non-profit organizations (AO Foundation).
He is involved in all Clinical Operation activities and Sponsor-CRO relationships for more than 10 years and he gained a holistic experience in Vendor Oversight/Management activities for various vendors and Patient Recruitment initiatives.

Earlier in his career, George was acting as Research Scientist in Analytical Chemistry.

Graduated with a B.Sc. in Chemistry from the Aristotle University of Thessaloniki, acquired a M.Sc. in Pharmaceutical Engineering from KTH, The Royal Institute of Technology in Stockholm and holds an M.B.A. from the University of Sheffield, where he focused on healthcare and marketing.

Session Details:

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

2024-10-30, 12:30 PM

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OCT Advisory Board

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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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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.

 

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