16th Annual Optimising Clinical Trials Summit:
Site Selection, Feasibility and Patient Recruitment

5 – 6 October 2022 | Berlin

The constant development brings constant challenges. Pharma is familiar with that fact like no other industry. Especially, when it comes to people’s lives in clinical trials. Pharma professionals are fighting not just with the disease, but the time itself. So, how to transform your CT activities effectively and prepare yourself for the future in Clinical Operations?
When producing the 16th Annual Optimising Clinical Trials Summit, our goal was to bring together the C-level experts with valuable insights to one place. Learn more about the innovative methods for site selection, feasibility and patient recruitment, pitfalls and optimization of CT design, as well as protocols overload and comprehensive AI usage.
It’s time to join the conference where you have a chance to be heard, share your ideas. Get a seat for yourself among the leaders Clinical Trials area, find answers to your questions, and enjoy live networking.

Hottest topics that will be discussed this annual

  • Identification of the new ways of qualified and efficient drug/product development process
  • How to make appropriate protocols that will manage the framework of investigators’ activities, their interactions, etc.
  • Why should clinical trials be randomized?
  • How can the integration of AI-based solutions improve the recruitment processes in clinical trials?
  • How to develop a detailed guideline, so the site selection can be done systematically?
  • Usage of creative recruitment methods to increase enrolment: personalized letters, websites, ads, local clinics’ involvement
  • What will affect the study feasibility processes in 2023? How to prepare ourselves for these novelties?
  • How to integrate the RWD & RWE in the CT and generate better results?

SUMMIT WILL HOST SPEAKERS FROM THE WORLD’S LEADING COMPANIES

Jose Manuel CERVERA GRAU

Executive Director, Clinical Development

CASE STUDY DAY 1

How Can the Integration of AI-Based Solutions Improve the Recruitment Processes in Clinical Trials?

New AI and blockchain-based solutions for clinical trials in healthcare are the new challenges for clinical trial (CT) designers and drug developers. It is necessary to know how these technologies will change CTs and what kind of tools will be implemented in traditional CTs. The high requirement for large numbers of patients to demonstrate sufficient efficacy to regulatory agencies is currently not a good optimisation. The limited number of patients due to advances in precision medicine will lead to the implementation of these technologies.

• Artificial Intelligence applied to CTs
• Blockchain applied to CTs
• NFTs applied to CTs
• Smart Contracts applied to CTs

Ekkehard BROCKSTEDT

Head Clinical Development & Operations FOT

CASE STUDY DAY 1

Igniting Excellence in Innovation through Outsourced Trials

• Looking at outsourced trials: Why are we doing this?
• Working with partnerships and optimize performance
• Highlighting key factors in making partnerships successful

Domenico MERANTE

Global Clinical Development Therapeutic Area Clinical Lead Nephrology & Orphan/Rare Diseases

CASE STUDY DAY 2

Challenges and Opportunities in Pediatric Clinical Studies Compared to Adult Clinical Studies

I take this occasion to talk about pediatric clinical studies and to assess the main challenges and also the opportunities when these are compared with adult studies. I will look into this landscape and as an example I will use a case report for a currently ongoing clinical study to be conducted on children and adolescents with secondary hyperthyroidism and vitamin D deficiency.

• Ethics in clinical trials
• Definition of vulnerable groups
• Pediatric studies, including regulations
• Pediatric and Adult studies: main differences, challenges and opportunities
• Conclusions and Take-home messages

Marta GARCIA MANRIQUE

R&D. Chief Patient Officer

CASE STUDY DAY 2

Insights on the Patient Centricity

• Keeping the patient at the centre of your actions. How to ensure that CT outcome matters to patients?
• Patient communication enhancement at all the levels of the CT. Will it enable a conscious, well-in-formed decision about the study participation?
• Can a virtual trial become a solution for patients to join a trial?
• How to facilitate the acknowledgment of the patients' effort in a CT and create a positive experience

Jost LEEMHUIS

Head of Safety Science Germany

CASE STUDY DAY 2

Understanding Patients´ Needs During Drug Development: The Patient Safety Perspective

When prescribing an innovative medication, physicians together with their patients make a benefit-risk evaluation based on the drug´s potential benefits and also outweigh the potential risks experienced by study patients. This patient’s experienced value of the new health technology is a requirement and precondition for regulatory and payer approval. So, how and when to engage patients?
The drug developer should recognize the value of patient’s involvement from the very beginning, even before the product enters clinical development and should continue across the entire life cycle and work to adapt present perceptions and practices throughout their organizations. Supposed individual patient’s needs and perspectives are put at the heart of all efforts from clinical development to regulatory approval and HTA. In that case, these insights should be shared with patients and prescribers to better inform and guide treatment decisions, thus enhance patient-centred care and personalized medicine.

• Pharmaceutical development has to demonstrate the value of the new health technology relative to the outcomes experienced by patients
• Patient engagement works, when the involvement starts already during the early stages of development

Thank you! I have learned a lot and took away a lot of insights I can share with my colleagues. I have to say the variety of sessions and the presenters exceeded my expectations.

– Associate Director, Clinical Project Manager, Teva Pharmaceutical Industries

We offer to world’s leading companies at our summit

Case Studies

Experience leaders will provide you with lessons learned.

Networking

The chance for market-leading business knowledge networking.

Discussions

All attendees will have a great opportunity to discuss a selection of topics in small groups with their peers.

New Ideas

We are partnering with experienced professionals to provide creative ideas, inspiration, and guidance.

Allan Lloyds Summit mission is to exceed expectations

We are committed to achieving new standards of excellence by providing conference formats that encourages interaction, networking and high class knowledge sharing. With experts, well-supported staff, motivated to deliver quality, Allan Lloyds vision is to be recognized as the global leader in providing high quality business conferences.

What we offer to world’s leading companies

  • Experience-based case studies
  • Round table discussions
  • Impeccable networking opportunities
  • Limited number of seats in the audience ensuring friendly atmosphere
  • No media or press presence

Sponsors

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Event programme

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  • What keynote speakers will be taking part in the exclusive speaking panel
  • What Case Studies will be discussed by our senior corporate speakers
  • The minute by minute breakdown of the conference