SPEAKERS

SAMPLE OF KEYNOTE SPEAKERS AND THEIR CASE STUDIES

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
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

Ekkehard BROCKSTEDT

Head Clinical Development & Operations FOT

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 1

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

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
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

Marta GARCIA MANRIQUE

R&D. Chief Patient Officer

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 for the opportunity to join this conference. Very well organised, excellent speakers.

– Global Clinical Safety Therapeutic Area Head, CSL Behring

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