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Why Attend?

Arena International are delighted to announce Clinical Trials in Oncology & Rare Diseases Europe will be returning to Munich on 1-2 December 2026!

The programme will, through a variety of interactive session formats, offer insight on promoting successful collaboration between the clinical trials community and once again offer attendees practical take-aways that they can apply to their own studies.

Our Munich event will cover different perspectives of operational challenges meaning there truly is something for everyone!

Don’t miss out; join us in Munich on 1-2 December 2026! We can't wait to see you there!

 

WHAT TO EXPECT FOR 2026?

At the Clinical Trials in Oncology & Rare Diseases Europe event, taking place on 1st-2nd December in Munich, we are pleased to bring together the definitive group of executives responsible for clinical operations in oncology & rare diseases and enhancing the partnership with vendors. There will be expert guidance through a first class conference programme and numerous networking opportunities.

150+

ATTENDEES TO MEET EACH YEAR

20+

EXHIBITORS TO MEET EACH YEAR

20+

SPEAKERS
150+

ATTENDEES TO MEET EACH YEAR

20+

EXHIBITORS TO MEET EACH YEAR
20+

SPEAKERS

WHY ATTEND?

NETWORK

This is an exceptional networking opportunity for industry accelerators. Meet industry C-Suite and Director level executives to make valuable connections at this annual thought leadership platform.

LEARN

Join like-minded peers to hear new perspectives and case studies through presentations, panel discussions and interactive round tables

ACTION

The conference discusses the vital connections between process, tools and techniques to manage change. Update your knowledge to create new strategies enabling you to enact change.

See What It's All About

Sponsors Included:

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Company Information

ARENSIA Exploratory Medicine, a German-based company, is a leader in “first-in-patient” Phase IB and II/Proof-of-Concept clinical trials across a wide range of disease areas. With 14 proprietary research clinics and cutting-edge Phase I infrastructure, ARENSIA accelerates the early detection of efficacy signals for new therapies at an unparalleled speed. Its streamlined, highly efficient approach reduces patient recruitment time and costs by over 50% compared to conventional trial sites, which are often overcrowded and understaffed. This exceptional performance has resulted in a 93% repeat business rate and robust growth through collaborations with top pharmaceutical companies, biotechs, and global CROs. Headquartered in Düsseldorf, ARENSIA operates with a team of 600 professionals across 8 countries.

Company Website

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

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Company Information

iOMEDICO is a leading full-service CRO and Real-World Data provider focused on oncology and hematology with a recruitment rate of over 6,000 new patients each year. We conduct phase I-IV trials and the RWD platforms provide deep insight into patient journeys and PRO in the indication, support trial design, biomarker analyses and market access purposes.

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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

Suvoda is a global clinical trial technology company specializing in complex, life-sustaining studies in therapeutic areas like oncology, central nervous system (CNS), and rare disease. Founded in 2013 by experts in eClinical technologies, Suvoda empowers clinical trial professionals to manage the most urgent moments in the most urgent trials through advanced software solutions delivered on a single platform. Headquartered outside Philadelphia, Suvoda also maintains offices in Portland, OR, Barcelona, Spain, Bucharest and Iasi, Romania, and Tokyo, Japan. The company’s Net Promoter Score (NPS) consistently exceeds the technology industry average, contributing to the company being selected by trial sponsors and CROs to support more than 1,000 trials across 80 countries.

Company Website

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

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Company Information

Biorce builds AI infrastructure for clinical trials. Our platform, Aika, accelerates how pharmaceutical companies, biotechs, and CROs design and execute clinical research—reducing protocol development time by at least 50% while eliminating costly amendments that delay patient access to life-saving treatments. Built on a foundation of 1 million clinical trials, Aika delivers evidence-based recommendations with complete regulatory transparency. Every decision auditable and defensible before agencies like the FDA and EMA.

Company Website

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

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Company Information

Scimega is a niche Canadian Oncology CRO with a singular focus on promoting and contributing to the successful conduct of cutting-edge oncology clinical trials in Canada. With a permanent, Lean-coached operations team our proven track record assisting mid-size and smaller US biotech/biopharma sponsors to undertake global oncology studies in Canada is bundled with 25 years of lessons learned!

Company Website

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

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Company Information

QPS is a global contract research organization (CRO) providing discovery, preclinical and clinical drug development services since 1995. Our mission is to accelerate pharmaceutical breakthroughs across the globe by delivering custom-built research services. An award-winning leader focused on bioanalytics and clinical trials, QPS is known for proven quality standards, technical expertise, a flexible approach to research, client satisfaction and turnkey laboratories and facilities. We are passionate about our work, creating value for patients and customers while generating opportunities for employees to thrive.

Company Website

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

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Company Information

HEMEX is a European CRO supporting pharmaceutical, biotech, and MedTech SMEs with clinical development solutions. Headquartered in Basel and operating globally, we manage multinational trials. Our services include clinical operations, regulatory support, quality assurance, BA/BE and PK studies, patient recruitment, and advanced medical imaging

Company Website

To learn more, please visit our website - https://hemex.ch/

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Company Information

IDDI optimizes the clinical development of drugs, biomarkers and IVD using a unique combination of advanced biostatistics and innovative data collection technology.

IDDI covers the full spectrum of trial design, clinical data collection, management, analysis and reporting for Phase I- IV clinical trials.

– IDDI’s services include: Clinical Development Plans, Protocol Development, Randomization (IWRS/IRT) with Drug Supply Management, EDC, Medical Coding, Data Management, Biostatistics, IDMC Support, Biomarker/Diagnostics Validation, Medical Writing.

– IDDI’s therapeutic areas of expertise include oncology, ophthalmology, infectious diseases and cardiology.
– Experience: 27+ years – 980+ trials (630+ in oncology) – 20 FDA/EMA approvals to-date
– HQ in Belgium with offices in the USA ( Raleigh, NC, Boston, MA and San Francisco, CA).

Company Website

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

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Company Information

Biotrial is a leading CRO specializing in Drug Development, offering a wide range of expertise. With hundreds of studies conducted, we provide tailor-made solutions in Non-Clinical Pharmacology, Clinical Development, Bioanalysis, Biometrics, ECG, CNS & Imaging Core Lab.

Company Website

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

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Company Information

World Wide Technology (WWT), a $20B, privately held global technology solutions provider leading the AI and Digital Revolution, has over 30 years of experience helping the largest commercial enterprise, public sector and service provider organizations.

WWT provides consulting services, comprehensive lab capabilities and implementation at scale. Through the Advanced Technology Center, WWT’s clients conceptualize, test, validate and deploy innovative technology solutions with hands-on access to cutting-edge capabilities across infrastructure, data and AI, security, cloud and more.

With over 10,000 employees in 55 locations, WWT has been recognized by Fortune and Great Place to Work® for 13 consecutive years.

Company Website

To learn more, please visit our website - https://www.wwt.com/atc/ai-proving-ground/overview

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Company Information

Innovative Trials is a leading global clinical trial patient recruitment company. With over 10 years’ experience, Innovative Trials deploys “boots-on-the-ground” patient recruitment experts in over 70 countries, addressing individual sites’ unique patient recruitment and retention challenges in local language. Innovative Trials has experience in 25 therapeutic areas and 90+ conditions.

Company Website

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

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Company Website

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

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Company Information

Alira Health is a global healthcare consultancy redefining evidence generation through patient partnership. By uniting strategic consulting, CRO services, and technology, the company supports life sciences organizations in accelerating development, improving access, and delivering measurable outcomes across the product lifecycle.

Company Website

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

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Company Information

Since 1997, Clinigen has offered market-leading clinical trial supplies and biological sample management services to meet the most complex clinical supply challenges. Part of Clinigen Group’s global supply chain facility and depot network, we deliver tailored solutions for clients to ensure their clinical trials are a success, regardless of size or scope, from Phase I to Phase IV projects.

Company Website

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

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Company Information

NeSPaT has been providing patient travel and reimbursement services since 2013 combining deep local expertise with wide regional coverage. With a multinational team and a focus on digital innovation combined with a human approach, NeSPaT streamlines patient logistics, offering tailored services, 24/7 support, and seamless documentation management.

Company Website

To learn more, please visit our website - https://nespat.net/

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Company Information

At Wemedoo AG, we develop advanced clinical data systems. Our unified SaaS platform, oomnia, supports all study types and phases, integrating EDC, RTSM, CTMS, eTMF, ePRO/eCOA, and eSource in one system, ensuring real-time access, streamlined processes, and successful clinical trial outcomes.

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Company Information

Medicover Integrated Clinical Services is a unique clinical research organization with 25 years of experience.

We offer Patient Recruitment services through our own Clinical Research Network in Central and Eastern Europe with comprehensive Global Central Lab Services and access to over 8,000 tests from routine to advanced diagnostics including genetics, biomarkers, PK and PD, and PBMC isolation in more than 120 laboratories in Europe and India.

Company Website

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

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Company Information

PSI is a privately-owned, full-service contract research organization (CRO), operating globally. PSI’s reputation on the market place is that of a no-nonsense CRO, capable of saving pharmaceutical sponsors millions of development dollars by consistently meeting clinical trial timelines. PSI’s global reach supports the operations of clinical trials across multiple countries.

Company Website

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

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    Agenda

    • 1 Dec 2026
    • 2 Dec 2026
    Expand All

    Streams

    Stream one

    CLINICAL TRIALS IN ONCOLOGY

    Stream two

    CLINICAL TRIALS IN RARE DISEASES

    8:45 AM

    Chairperson’s opening remarks

    9 AM

    OPENING KEYNOTE Preparing for the MHRA’s Proposed Rare Disease Therapies Regulatory Framework – What Sponsors Need to Know

    • The proposed framework
    • Impact on rare disease developers
    • Practical implications
    • Questions from sponsors

    Reserved for NIHR

    9:30 AM

    Session reserved for event sponsor

    10 AM

    The Future of Rare Disease Clinical Development — Delivering Innovation for Small Patient Populations

    • The biggest opportunities changing rare disease development
    • How sponsors can accelerate development without increasing operational risk
    • Emerging regulatory and scientific priorities
    • Where collaboration will matter most over the next five years

    10:45 AM

    Morning refreshments and networking break

    11:15 AM

    CASE STUDY Reducing Time to Rare Disease Diagnosis Through AI and Data-Driven Care Pathways

    • Identifying where AI is already improving diagnosis
    • Integrating AI into existing clinical workflows
    • Overcoming implementation and governance challenges
    • Measuring impact on referral pathways and patient outcomes

     

    12 PM

    Session reserved for event sponsor

    12:30 PM

    PANEL DISCUSSION Finding Patients Beyond Borders — Where Should Sponsors Run Rare Disease Trials in 2027?

    • Building partnerships with specialist rare disease centres and referral networks
    • Working with centres of excellence to identify patients earlier
    • Balancing international recruitment with long-term site relationships
    • Strengthening collaboration across investigators, advocacy groups and specialist networks

    Speakers

    Tobias Suiter
    Advisor, Clinical Development, Hemastatx
    Frank Tennigkeit
    Senior Director Pediatric Development Rare Diseases, UCB

    1 PM

    Lunch and networking

    2 PM

    CASE STUDY Designing Rare Disease Trials Around Families, Not Just Patients

    • Designing studies around the realities of patients and caregivers
    • Reducing travel and logistical burden for families
    • Supporting long-term participation throughout the study journey
    • Building family-centred approaches into protocol design from the outset

    Reserved for EUPATI

    2:45 PM

    Session reserved for event sponsor

    3 PM

    Building an Efficient Clinical Development Pathway for Rare Diseases

    • Introducing first-in-human therapies safely in small patient populations
    • Balancing safety, efficacy and speed throughout development
    • Using adaptive clinical trial designs where appropriate to accelerate development without compromising quality
    • Working effectively with orphan drug pathways and regulators
    • Practical lessons from rare disease clinical development programmes that delegates can apply within their own organisations

    Speakers

    Tobias Suiter
    Advisor, Clinical Development, Hemastatx

    3:30 PM

    Afternoon refreshments and networking

    4 PM

    Session reserved for event sponsor

    4:30 PM

    INTERACTIVE SESSION What Do Rare Disease Sites Need Most from Sponsors?

    • Common frustrations with sponsors
    • What good collaboration looks like
    • How sponsors can make studies easier to run
    • Practical challenges that improve site performance

    Speakers

    Evelyn Regar
    Head of the Clinical Study Center, LMU Klinikum

    5 PM

    END OF CONFERENCE

    8:15 AM

    Registration and refreshments

    8:45 AM

    Chairperson’s opening remarks

    Speakers

    Rahul Hole
    Director, Clinical Operations, Formycon

    9 AM

    OPENING KEYNOTE The Growing Role of Biomarkers in Oncology Development and Regulatory Decision-Making

    • Biomarkers defining target populations by measuring pharmacological targets and pathogenic cascades
    • Biomarkers as surrogate endpoints for efficacy
    • Where EMA and the FDA have taken different approaches
    • Emerging trends and future challenges

    Co-author: Karl Broich, President of BfArM

    Speakers

    Harald Enzmann
    Head of European and International Affairs, BfArM, Former CHMP chair

    9:30 AM

    Session reserved for event sponsor

    10 AM

    PANEL DISCUSSION Choosing Where to Run Oncology Trials in 2027 — Balancing Cost, Speed and Patient Access

    • Balancing scientific objectives alongside cost, timelines and recruitment potential
    • Understanding how standards of care and comparator availability influence country selection
    • Exploring opportunities in emerging regions while maintaining study quality
    • Selecting countries that improve both operational delivery and scientific validity

    Speakers

    Harald Enzmann
    Head of European and International Affairs, BfArM, Former CHMP chair

    10:45 AM

    Morning refreshments and networking break

    11:15 AM

    FOCUS SESSION + EXPERT COMMENTARY Keeping Patients on Treatment — Overcoming the Hidden Barriers to Successful Oncology Trials

    • Understanding why patients discontinue treatment or follow-up
    • Educating patients on the value of remaining in clinical trials
    • Balancing long-term study requirements with patients’ treatment opportunities
    • Designing studies that support both retention and patient choice

    12 PM

    Session reserved for event sponsor

    12:30 PM

    Shaping Early Oncology Development – Strategic Decisions That Influence Long-Term Success Potential talking points:

    • Common challenges during early oncology development to prepare for long-term success
    • Choosing the right indications from the outset
    • Building meaningful clinical outcome assessments into protocols
    • How early strategic decisions influence later stages of development
    • Bridging early and late-stage thinking to improve long-term programme success
    • Practical lessons and key takeaways for development teams

    Speakers

    Marco Gross-Langenhoff
    Associate Director Regional HEOR Oncology, Astellas

    1 PM

    Lunch and networking

    2 PM

    PANEL DISCUSSION AI in Oncology Clinical Development — Beyond the Hype to Real-World Implementation

    • Understanding where AI genuinely adds value across clinical development
    • Validating AI recommendations through expert oversight
    • Avoiding over-reliance on plausible but incorrect outputs
    • Maintaining accountability while integrating AI into regulated environments
    • Lessons learned from implementation across sponsor organisations

    2:45 PM

    Session reserved for event sponsor

    3 PM

    Preventing Oncology Protocol Amendments Before They Happen

    • Identifying high-risk protocol elements before finalisation
    • Using site and investigator feedback before study start-up
    • Balancing scientific ambition with operational feasibility
    • Reducing rework through better cross-functional review

    Speakers

    Jordi Canes
    Clinical Project Delivery Lead, SOLTI

    3:30 PM

    Afternoon refreshments and networking

    4 PM

    Session reserved for event sponsor

    4:30 PM

    FIRESIDE CHAT How Regulators Are Redefining Evidence Generation Through Real-World Data

    • How regulators are using real-world evidence
    • What evidence sponsors should start generating now
    • Regulatory expectations over the next 3-5 years
    • Preparing for future submissions

    Speakers

    Steffen Heff
    Health Data Lab, BfArM
    Puja Myles
    Director, Clinical Practice Research Datalink, MHRA

    5 PM

    END OF CONFERENCE

    Streams

    Stream one

    CLINICAL TRIALS IN ONCOLOGY

    Stream two

    CLINICAL TRIALS IN RARE DISEASES

    11 AM

    CASE STUDY Designing Protocols That Rare Disease Sites Can Actually Deliver

    • Working with sites before protocol finalisation
    • Identifying operational bottlenecks early
    • Reducing unnecessary protocol complexity
    • Designing studies that fit real-world clinical practice

    Speakers

    Frank Tennigkeit
    Senior Director Pediatric Development Rare Diseases, UCB

    11:30 AM

    Breaking Down Silos – What Clinical Development and Drug Safety Can Learn from Each Other in Rare Disease Trials

    • The biggest misconceptions Clinical Development and Drug Safety have about one another, particularly in complex rare disease programmes
    • Practical lessons from your six-month role swap and how it changed the way you approached collaboration
    • How a better understanding of each function’s responsibilities can strengthen decision-making when working with small patient populations and limited clinical data
    • Simple ways organisations can encourage closer cross-functional collaboration and improve rare disease study delivery

    Speakers

    Kathrin Schirner
    Clinical Scientist, CSL – TBC

    12 PM

    Scaling Rare Disease Clinical Operations as Programmes Grow

    • Knowing when to internalise capabilities versus outsource
    • Building processes that can scale with the pipeline
    • Maintaining oversight as programmes become more complex
    • Avoiding operational growing pains

    12:30 PM

    Lunch and networking

    1:30 PM

    Tracking Global Rare Disease Trial Trends and Preparing for 2027

    • Where rare disease trial activity is growing/declining and which indications are driving this
    • Geographic shifts in where trials are being conducted and emerging locations to watch
    • Benchmarking trial size, duration, sites/countries and other operational metrics against industry standards
    • How trial designs are evolving, including adaptive/platform approaches and strain-agnostic development
    • What the current pipeline and data suggest for 2027 and beyond

    Speakers

    Fiona Chisholm
    Associate Director Research and Analysis, GlobalData

    2 PM

    Outsourcing Rare Disease Trials — What Should Sponsors Keep In-House and What Should They Outsource?

    • Deciding which activities should remain in-house
    • Selecting specialist CROs and niche vendors
    • Managing oversight without increasing internal headcount
    • Building long-term outsourcing partnerships

    2:30 PM

    Managing Long-Term Follow-Up in Rare Disease and Advanced Therapy Trials

    • Building sustainable long-term follow-up strategies
    • Keeping patients engaged over many years
    • Using registries and real-world data effectively
    • Preparing sites for extended study commitments

    3 PM

    PANEL DISCUSSION Making Hybrid Rare Disease Trials Work Without Increasing Complexity

    • Deciding which visits can safely move outside the site
    • Supporting investigators with hybrid delivery
    • Exploring what can be checked or verified remotely
    • Integrating telemedicine into regulated studies
    • Practical lessons from recent hybrid rare disease trials

    3:30 PM

    Afternoon refreshments and networking

    8:15 AM

    Registration and Refreshments

    8:45 AM

    Chairperson’s opening remarks

    Speakers

    Rahul Hole
    Director, Clinical Operations, Formycon

    9 AM

    Think Tanks

    During the Think Tanks session, the conference hall will be divided into 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 the industry. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

    Think Tank 1: How Can Sponsors Make Rare Disease Trials More Attractive for Sites?

    Think Tank 2: Where Are Oncology Studies Losing Time Between Protocol Finalisation and First Patient In?

    Think Tank 3: What Is the One Rare Disease Trial Requirement You Would Remove or Redesign?
    Hosted by: Frank Tennigkeit, Senior Director Pediatric Development Rare Diseases, UCB

    Think Tank 4: Preparing for Regulatory Submissions Dos & Don’ts
    Hosted by: Harald Enzmann, Head of European and International Affairs, BfArM, Former CHMP chair

     

    Speakers

    Frank Tennigkeit
    Senior Director Pediatric Development Rare Diseases, UCB
    Harald Enzmann
    Head of European and International Affairs, BfArM, Former CHMP chair

    10 AM

    Morning refreshments and networking break

    10:30 AM

    EXECUTIVE PANEL Leading Through Today’s Funding Environment — How Biotech CEOs Are Making Development Decisions Differently

    • How CEOs are prioritising programmes
    • Balancing scientific ambition with financial reality
    • Deciding what to progress and what to stop
    • Securing investment in today’s market – are funding opportunities becoming increasingly regional?
    • Partnering, licensing and fundraising
    • What investors want to hear from leadership teams

    Speakers

    Ashesh Kumar
    Chief Executive Officer, Paras Biopharmaceuticals Finland
    Volker Huppert
    Member, Act for Hope

    11 AM

    Session reserved for event sponsor

    11:30 AM

    ASK THE EXPERTS Recovering Oncology Trials That Go Off Track

    • Recognising early warning signs
    • Recovery strategies
    • Working with sites and CROs
    • Lessons learned

    Speakers

    Jordi Canes
    Clinical Project Delivery Lead, SOLTI

    12 PM

    Session reserved for event sponsor

    12:30 PM

    Lunch and networking

    1:30 PM

    Prioritising Resources Across Competing Oncology Clinical Development Programmes

    • Prioritising programmes when resources are limited
    • Allocating people across competing studies without creating bottlenecks
    • Balancing speed, quality and cost across the portfolio
    • Knowing when additional resource will genuinely improve delivery
    • Practical approaches to portfolio-level resource planning

    2 PM

    Session reserved for event sponsor

    2:30 PM

    Streamlined Biosimilar Development in Cancer

    Speakers

    Jens Heyn
    Senior Global Clinical Development Manager, Sandoz

    3 PM

    Session reserved for event sponsor

    3:30 PM

    Afternoon refreshments and networking

    4 PM

    INDUSTRY HOT TAKES – What Today’s Best Clinical Development Teams Are Doing Differently

    4:30 PM

    END OF CONFERENCE

    Speakers

    Select a speaker to learn more

    Back
    Harald Enzmann
    Head of European and International Affairs, BfArM, Former CHMP chair

    Session Details:

    OPENING KEYNOTE The Growing Role of Biomarkers in Oncology Development and Regulatory Decision-Making

    2026-12-01, 9:00 AM

    Session Details:

    Think Tanks

    2026-12-02, 9:00 AM

    Session Details:

    PANEL DISCUSSION Choosing Where to Run Oncology Trials in 2027 — Balancing Cost, Speed and Patient Access

    2026-12-01, 10:00 AM

    View In Agenda
    Next speaker
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    Rahul Hole
    Director, Clinical Operations, Formycon

    A seasoned Clinical Research leader with 19 years of relevant experience in handling global clinical trials in multiple therapeutic areas- Oncology, Endocrinology, Immunology, Cardiology, Ophthalmology, Gastroenterology, Vaccines and Respiratory. Extensive experience in biosimilar development for more than 12 years

    Session Details:

    Chairperson’s opening remarks

    2026-12-02, 8:45 AM

    Session Details:

    Chairperson’s opening remarks

    2026-12-01, 8:45 AM

    View In Agenda
    Next speaker
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    Evelyn Regar
    Head of the Clinical Study Center, LMU Klinikum

    Session Details:

    INTERACTIVE SESSION What Do Rare Disease Sites Need Most from Sponsors?

    2026-12-01, 4:30 PM

    View In Agenda
    Next speaker
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    Steffen Heff
    Health Data Lab, BfArM

    Session Details:

    FIRESIDE CHAT How Regulators Are Redefining Evidence Generation Through Real-World Data

    2026-12-01, 4:30 PM

    View In Agenda
    Next speaker
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    Puja Myles
    Director, Clinical Practice Research Datalink, MHRA

    Dr Puja Myles is Director of the Medicines and Healthcare products Regulatory Agency’s (MHRA) specialist real world data research service, the Clinical Practice Research Datalink (CPRD). She is a public health specialist and prior to joining CPRD, was a public health academic at the University of Nottingham, UK. She is a fellow of the Faculty of Public Health (UK), a senior fellow of the Higher Education Academy (UK) and has a doctorate in epidemiology. She has been the MHRA’s strategic lead on the development of synthetic data generation approaches and applications since 2017. In addition, she has led on Regulatory Science initiatives including AI explainability, handling concept drift, data quality standards for regulatory purposes, regulatory evidence derived from computer modelling and simulation approaches.

    Session Details:

    FIRESIDE CHAT How Regulators Are Redefining Evidence Generation Through Real-World Data

    2026-12-01, 4:30 PM

    View In Agenda
    Next speaker
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    Ashesh Kumar
    Chief Executive Officer, Paras Biopharmaceuticals Finland

    Session Details:

    EXECUTIVE PANEL Leading Through Today’s Funding Environment — How Biotech CEOs Are Making Development Decisions Differently

    2026-12-02, 10:30 AM

    View In Agenda
    Next speaker
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    Tobias Suiter
    Advisor, Clinical Development, Hemastatx

    Dr. Tobias Suiter, MD is a physician and clinical development professional with more than 30 years of experience in the pharmaceutical and biotechnology industry. Trained as a specialist in Internal Medicine, he has held senior medical and leadership roles at companies including CSL Behring, Baxter/Takeda, Biogen and Pharming, with a particular focus on rare diseases and specialty medicines.

    Throughout his career, Tobias has contributed to clinical development programmes from first-in-human development through later-stage clinical trials and regulatory approval, including programmes in rare diseases where small patient populations and limited clinical evidence require careful assessment of dose, safety and benefit-risk. Several medicines he has worked on have subsequently gained regulatory approval.

    Since 2021, he has worked as an independent consultant, advising biotechnology and pharmaceutical companies on clinical development strategy. His experience includes first-in-human clinical development in rare diseases, trial design, benefit-risk assessment, regulatory strategy and the use of pragmatic and adaptive development approaches where appropriate.

    He currently serves as Advisor, Clinical Development, Haemastatx, supporting the development strategy for a novel therapeutic programme in rare bleeding disorders. His approach combines scientific rigor and development efficiency with a strong focus on patient needs and clinically meaningful outcomes.

    Session Details:

    PANEL DISCUSSION Finding Patients Beyond Borders — Where Should Sponsors Run Rare Disease Trials in 2027?

    2026-12-01, 12:30 PM

    Session Details:

    Building an Efficient Clinical Development Pathway for Rare Diseases

    2026-12-01, 3:00 PM

    View In Agenda
    Next speaker
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    Jordi Canes
    Clinical Project Delivery Lead, SOLTI

    Jordi Canes Ruiz is a Clinical Project Delivery Lead at SOLTI, a leading academic cancer research group. With over a decade of experience in clinical research, he oversees the delivery of international clinical trials and specializes in study start-up, operational strategy, resource planning, and collaboration across sponsors, investigators, CROs, and research institutions.

    Session Details:

    ASK THE EXPERTS Recovering Oncology Trials That Go Off Track

    2026-12-02, 11:30 AM

    Session Details:

    Preventing Oncology Protocol Amendments Before They Happen

    2026-12-01, 3:00 PM

    View In Agenda
    Next speaker
    Back
    Marco Gross-Langenhoff
    Associate Director Regional HEOR Oncology, Astellas

    Marco Groß-Langenhoff is a pharmaceutical industry professional with ~20 years of experience in Medical Affairs, Value Evidence, Oncology Development, New Product Planning, HEOR, Marketing, and in academia. He has significant experience across the lifecycle from pre-PoC to pre-, peri- and post-launch in building and implementing medical strategies at country, regional and global level with a focus on oncology across GU, GI, Thoracic Oncology, and Hematology. His current role is New Product Planning Lead in Global Value Evidence at Astellas Pharma, supporting multiple oncology assets in early-stage development.

    Session Details:

    Shaping Early Oncology Development – Strategic Decisions That Influence Long-Term Success Potential talking points:

    2026-12-01, 12:30 PM

    View In Agenda
    Next speaker
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    Jens Heyn
    Senior Global Clinical Development Manager, Sandoz

    Session Details:

    Streamlined Biosimilar Development in Cancer

    2026-12-02, 2:30 PM

    View In Agenda
    Next speaker
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    Volker Huppert
    Member, Act for Hope

    Session Details:

    EXECUTIVE PANEL Leading Through Today’s Funding Environment — How Biotech CEOs Are Making Development Decisions Differently

    2026-12-02, 10:30 AM

    View In Agenda
    Next speaker
    Back
    Frank Tennigkeit
    Senior Director Pediatric Development Rare Diseases, UCB

    Drug Development Expert with more than 20 years of pharmaceutical industry/biotech experience (UCB, J&J, AC Immune, Merz).
    • Medical background in Pharmacology and Neuroscience. Clinical Development experience: mainly in Neurology (Alzheimer’s Disease, Epilepsy, Parkinson's Disease and PSP) and orphan autoimmune disorders.
    • Pediatric Development expert (pediatric development plans, PIPs, PSPs and indication expansions).
    • Extensive experience in planning, executing, publishing and submitting clinical development programs/medical plans for new chemical entities, biologics, and vaccines.

    NDA and submission experience, 5 successful approvals (US, EU, J, CN).
    • Medical/Clinical Team Lead and manager of cross-functional teams.
    • Business Sustainability support for large non-profit research networks.
    • Publication of more than 40 papers and abstracts in scientific medical journals.

    Session Details:

    CASE STUDY Designing Protocols That Rare Disease Sites Can Actually Deliver

    2026-12-02, 11:00 AM

    Session Details:

    PANEL DISCUSSION Finding Patients Beyond Borders — Where Should Sponsors Run Rare Disease Trials in 2027?

    2026-12-01, 12:30 PM

    Session Details:

    Think Tanks

    2026-12-02, 9:00 AM

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    Fiona Chisholm
    Associate Director Research and Analysis, GlobalData

    Session Details:

    Tracking Global Rare Disease Trial Trends and Preparing for 2027

    2026-12-02, 1:30 PM

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    Advisory Board

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    Cesare Spadoni

    Cesare is co-founder and Chief Operating Officer of Oncoheroes Biosciences Inc., a Boston-based biotech company focused on pediatric oncology drug development. Cesare has more than 20 years of experience in the drug development field, in both scientific and commercial roles. Previously, he held senior positions at AMRI, Aptuit Laurus, ThalesNano and Auxiliis. Cesare started his career as research scientist in a pharmaceutical company (Eisai, London) and in academia (Institute of Enzymology, Budapest).

    Following the death of his first daughter Laura to cancer, Cesare set up aPODD Foundation, a London-based charity focused on accelerating paediatric oncology drug development. As aPODD’s chairman he is actively involved on a pro-bono basis in drug repurposing projects, advocacy efforts and research collaborations.

    Cesare holds an MSc in Applied Molecular Biology and a PhD in Neurosciences from UCL, University of London, as well as an MBA from the Central European University, Budapest.

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    Stefano Ferrara

    Stefano Ferrara is a Clinical Development Expert and Director of Clinical Science at BeiGene, specializing in oncology clinical development with a focus on innovative cancer treatments. With over 20 years of leadership in global oncology clinical trials, he has played key roles at Celgene Corp, Novartis Pharma, and Sanofi-Aventis, specializing in GI, Lung, GU, and Pediatric cancers. Stefano is passionate about increasing accessibility to cancer treatment globally. He holds a strong commitment to humanitarian efforts as a supporter of Save the Children. Stefano brings his expertise in both science and advocacy to his role on the advisory board

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    Fatima Scipione

    Fatima serves as the Vice President of Global Patient Affairs at Blueprint Medicines, a global, fully integrated biopharmaceutical company that invents life-changing medicines. We seek to alleviate human suffering by solving important medical problems in two core focus areas: allergy/inflammation and oncology/hematology.

    In her role, Fatima leads transformative collaborations with external advocacy groups, empowering and educating those affected by systemic mastocytosis. She has led the launch of significant initiatives such as GRTY Health’s SM patient platform, MastoConnect (https://mastoconnect.com), and Colors of SM (https://www.colorsofsm.com/), in partnership with the advocacy community, and actively chairs the Equity, Diversity, and Inclusion (ED&I) patient committee, which looks to address the needs of marginalized and underrepresented communities.

    With over two decades of experience in the biopharma sector, Fatima is a dedicated and passionate advocate for patients. Celebrated by PharmaVoice 100 as one of the most inspiring leaders in patient advocacy, her work focuses on amplifying patient voices and harnessing the collective power of individuals to make a positive impact. Fatima is committed to enhancing patient engagement in the development of transformative medicines, ensuring that the patient perspective is integral to every stage of the process.

    She inspires her colleagues to foster a culture of purpose-driven advocacy, ensuring that patient welfare remains at the forefront of their mission. Beyond her professional role, Fatima is deeply involved in civic activities, continually dedicating herself to enhancing patient welfare and advocacy on a broader scale.

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    Frank Richard
    Vice President Medical, Heidelberg Pharma

    Frank has been working in the past in Immune-Oncology, Immunology& Respiratory, Rare Hematology Diseases and Iron Metabolism across big pharma and biotech.

    Frank holds a MD from Charité Medical University, Berlin, an MBA from University of Applied Sciences, Neu-Ulm, and is a board-certified Clinical Pharmacologist.

    Additionally, he exerts an unique expertise and interest in Bayesian Statistics and machine learning in Pharma and Biotech.

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    SPONSORSHIP ENQUIRIES

     

    Conor Taylor


    +44 (0)20 7936 6870

    SPEAKING OPPORTUNITIES

    Head of Production

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    +44 204540 7766

    MARKETING ENQUIRIES

    Marketing Manager

    Hattie Dean


     

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    Sunny Saikia