Outsourcing in Clinical Trials DACH 2023

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

  • Zurich, Switzerland
  • Ticketed
close

Why attend?

WHAT TO EXPECT FOR 2023

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

250+

Attendees

30+

Speakers

20+

Exhibitors

75%

Attendees at Director+ level

250+

Attendees

30+

Speakers

20+

Exhibitors

75%

Attendees at Director+ level

See What It's All About

2022 Agenda

  • 30 Nov 2022
  • 1 Dec 2022
Expand All

8 AM

Registration and refreshments

8 AM

Registration and refreshments

8:50 AM

Chairperson’s opening remarks

8:50 AM

Chairperson’s opening remarks

9 AM

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

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

9 AM

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

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

9:30 AM

Unifying Data for Improved Study Conduct Decision-Making

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

9:30 AM

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

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

10 AM

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

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

10 AM

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

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

10:30 AM

Morning refreshments and networking

10:30 AM

Morning refreshments and networking

11 AM

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

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

11 AM

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

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

11 AM

Tips and tricks for engaging sites with new technology

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

11:30 AM

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

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

11:30 AM

Navigating complexity through the lens of the end user

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

11:30 AM

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

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

12 PM

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

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

12 PM

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

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

12 PM

Patient centricity: a supply chain perspective

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

12:30 PM

Lunch and networking

12:30 PM

Making clinical supply more effective

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

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

12:30 PM

How site alliances enable efficiencies for clinical trials

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

1 PM

Lunch and networking

1 PM

Lunch and networking

2 PM

How clinical infrastructure in Western Europe can support healthcare in Africa

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

2 PM

CASE STUDY: Incorporating technology into your patient recruitment strategy

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

2 PM

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

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

2 PM

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

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

2:30 PM

Afternoon refreshments and networking

2:30 PM

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

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

2:30 PM

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

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

3 PM

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

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

3 PM

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

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

3:30 PM

Afternoon refreshments and networking

3:30 PM

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

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

3:50 PM

Afternoon refreshments and networking

4 PM

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

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

4:30 PM

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

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

4:30 PM

Chairperson’s closing remarks

5 PM

Chairperson’s closing remarks

2022 Speakers

Select a speaker to learn more

Back
LEON HOOFTMAN
Chief Medical Officer, Isa-Pharma
Next speaker
Back
PROF. DR. MED. GERHARD EHNINGER
Chief Medical Officer, AvenCell
Next speaker
Back
Andrew Mackinnon
Vice President, General Manager, eConsent Medable
Next speaker
Back
ALLISON FIDLER
Deputy Director, Clinical Operations, Debiopharm
Next speaker
Back
MOHAMED ABUKAR
Senior Analyst, GlobalData
Next speaker
Back
JAGODA MALIK
Deputy Head, Clinical Research Center, National Institute Of Geriatrics, Rheumatology And Rehabilitation, Poland
Next speaker
Back
Neta Bendelac
Senior Director, Strategy 4G Clinical
Next speaker
Back
DR. CLAUDIA HESSELMANN
Founder And CEO, ARENSIA Exploratory Medicine GmbH

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

Next speaker
Back
MAGDALENA GOLOS
Head Of Clinical Study Management, Polpharma
Next speaker
Back
SVERRE BENGTSSON
Co-Founder, Viedoc Technologies

Sverre Bengtsson started in the clinical trials industry over 30 years ago. He started as a statistician/statistical programmer, later into data management and since over 20 years into business development. He has been working in both CRO’s as well as in clinical trials technology companies, including the global first ePRO company. Sverre is very interested in making clinical trials efficient, in both study design but also in the processes and technologies used. Sverre co-founded Viedoc Technologies 19 years ago and is responsible for some of the major accounts but also the vision around the company. He’s on the board of both some industry organisations and in clinical technology companies.

Next speaker
Back
CHRISTOPHER MOGG
Solutions Specialist, RTSM, Medidata
Next speaker
Back
RAHUL MALHOTRA
Director, Therapeutic Strategy Lead, Worldwide Clinical Trials

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

Next speaker
Back
BENOÎT MARCHAL
Chief Digital Trust Officer, Partners For Patients

After 25+ years’ experience in the digitalization of clinical trials, the active participation of Benoît in the public-private consortium EHR4CR (Electronic Health Record for Clinical Research) has made him realize that there is a lot of value in all the data collected in the routine clinical setting and we should really maximize such usage in the best interest of medical research and thus the patients. Nevertheless, that is only achievable if we involve the patients in the most trustable, transparent and privacy respectful way. Through his participation to Partners for Patients, Benoît ambitions to promote the various approaches going in such a direction.

Next speaker
Back
DANIELA DUFFETT
European Solutions Consultant, Suvoda

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

Next speaker
Back
SEIF EDDINE AMARA MADI
Senior Manager Clinical Labs Quality, GSK
Next speaker
Back
Pietro Scalfaro
Chief Medical Officer, Enyo Pharma
Next speaker
Back
DR. SUMEET AMBARKHANE
T AMBARKHANE
Next speaker
Back
JOHN SHILLINGFORD
Director Of Clinical Research, Afon Technology Ltd (Formerly Orsus Medical)

John Shillingford, PhD is an experienced clinical researcher whose career in the Pharmaceutical, Medical Device and CRO industries has stretched over 40 years. John has both lived and worked in a number of European Countries as well as the USA. He is now lives in Germany. His wide experience of Drug and Medical Device Development in Europe and the USA has been acquired during the management of both Clinical and Data Operations for major Global Programmes. John has held senior positions in Management, Clinical Operations and Project Management for, Aptiv Solutions, Averion International (a Medical Device Research Company), PRA International and Imform GmbH. Currently John is Clinical Operations Director and a member of the Board of Afon Technology Ltd, a UK based Medical Device Company, Consultant to International Research Companies and additionally continues to run a number of training courses in Vendor and Project Management.

Next speaker
Back
JELENA MIHAJLOVIĆ
Clinical Operations Program Lead, Immunic Therapeutics
Next speaker
Back
MARCO SCHMIDT
Chief Scientific Officer, Biotx.Ai

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

Next speaker
Back
Milena Konewko
Global Study Associate Manager, AstraZeneca
Next speaker
Back
ROLAND MIROW
Director, Katairo GmbH
Next speaker
Back
HEIKE SCHÖN
Managing Director, Lumis International GmbH

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

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

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

Next speaker
Back
TOMASZ KOWALCZYK
Regional Director, Clinical Sites Liaison Consultant , Agenus Bio
Next speaker
Back
DR DOMINIK STEUBL
Senior Clinical Program Leader, Boehringer Ingelheim
Next speaker
Back
MIMI CHOON-QUINONES
Founder And Chairman, Partners For Patients, PfP.NGO

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

Next speaker
Back
JASMIN HELLWIG
Associate Director Comparator Sourcing,
Next speaker
Back
ROEL VAN DER HEIJDE
Facilitator & Trainer, Roel Rotterdam & Patient Experience Association

Roels inspiration: “Be the change you wish to see in the world” - Ghandi Roel van der Heijde lives in Rotterdam, The Netherlands. He has a MA in International Business, is an international acknowledged NLP trainer, executive team coach and a certified death and grief counsellor. He is a driven and experienced trainer and facilitator in: - Patient Fear Reduction (for all caregivers); - Team Collaboration; - Vulnerability & Leadership; - Discrimination & Inclusion. Roels motivation: “Acknowledgement and recognition of the fears and emotions of our patients are the basis for excellent patient experience and patient safety”. “Working with Groups I experience as thoroughly fascinating and inspiring. In interaction with groups I am every time amazed by the enormous potential of practical knowledge and direct experience that lies hidden in groups and that is so easily overlooked. Herein lies the basis for excellent vulnerable leadership.

Next speaker
Back
Marija Popovic
Manager Feasibility Department PSI CRO
Next speaker
Back
DANISH MAIRAJ
Senior Engineer, Software & Electronics, Vectura Group Plc.

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

Next speaker
Back
DR. MAX HORNECK
Head Clinical Data Management And EClinical Systems, Medac
Next speaker

Plan Your Visit

2022 Sponsors

Select a sponsor to learn more

FEATURED SPONSORS

SESSION SPONSORS

ASSOCIATE SPONSORS

ROUNDTABLE SPONSOR

EXHIBITORS

CO-SPONSORS

Media Centre

MEDIA PARTNERS

Become A Media Partner

WHAT TO EXPECT FOR 2022

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

 

Find the right solution providers to partner with, allowing you to accelerate your trial timelines.

See What It's All About

Enquiry

Contact Us

SPONSORSHIP ENQUIRIES

Nick McCudden

Head of OCT Events

+61 280 978 126

SPEAKER ENQUIRIES

Louisa Manning

Senior Producer

+44 (0) 207 936 6822

MARKETING ENQUIRIES

Moona Popal

Marketing Manager

SPONSORSHIP ENQUIRIES

To enquire about sponsorship opportunities for the conference, please contact:

Nick McCudden

Head of OCT Events


+61 280 978 126

SPEAKER ENQUIRIES

To enquire about speaking opportunities for the conference, please contact:

Louisa Manning

Senior Producer


+44 (0) 207 936 6822