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Clinical Trials Innovation

Countdown to Partnerships in Clinical Trials Digital Week

PCT Digital Week

With seven hours of exclusive webinar presentations and live Q&As with leading clinical experts, Partnerships in Clinical Trials Digital Week starts on Monday (9th October).

Here we've gathered together all the highlights on the agenda.

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PCT Digital Week Agenda

Monday 2pm BST - This house believes Pharma and Biotech should resource clinical development in-house rather than waste precious budget on CROs

Carl Emerson – Managing Director, Inside Outside Solutions

- Changes in levels of experience over the years
- Market forces and differentiation for suppliers
- Best practice evolution
- The problem of control
- Alternative agendas and their corrupting influence


Monday 3pm BST – Case Study: Partnering with Clinical Research Networks

Mark Turner – Chair, Enpr-EMA


Tuesday 2pm BST – Assessing and quantifying the use and impact of patient-centric initiatives on drug development practices: Working with biopharmaceutical companies, patient advocacy groups and patients

Stella Stergiopoulos - Research Fellow and Senior Research Project Manager, Tufts Center for the Study of Drug Development

Regulatory agencies, biopharmaceutical companies, patient advocacy groups and patients are all collaborating to create more patient-friendly and centric research.  However, there has been very little data collected on the prevalence of specific patient-centric initiatives as well as their impact.  The Tufts Center for the Study of Drug Development, in collaboration with the Drug Information Association and many biopharmaceutical partners, has conducted a comprehensive study that discusses the current prevalence of use of patient-centric initiatives as well as planned initiatives as well as assessing the initial impact these initiatives have had on study performance.  The results of this study and their implications will be discussed.


Tuesday 3pm BST – Use of the social networks to develop clinical research projects

Begonya Nafria Escalera - Project Manager, Hospital Sant Joan de Déu

- Social media and modern technology - what is the cost/benefits ratio?
- How to involve social media in healthcare and clinical trials
- Application for smart phones; involvement of this?
- The ethics of using social media for patient recruitment
- Increased emphasis on the impact of social media and how it can be used for recruiting patients
- Hear some real examples of where social media has been used successfully


Wednesday 2pm BST – Pediatrics: How to recruit for clinical trials for Phase 1 and study design

Dr Paul Passier - Scientific Director, Astellas Pharma Europe B.V.

- What are the challenges? Recruitment, placebo control trials in paediatrics, informed consent
- When is the best time to start a paediatric trial?
- What is needed to for getting compound approved for paediatric use?
- How to determine the optimal dose selection and how to extrapolate adult information to paediatrics?


Wednesday 3pm BST – Case Study: Early development clinical trials in depressive disorder patients – Operational Aspects

Peter van der Ark - Clinical Research Manager, Experimental Medicine Neuroscience, Janssen

- Early phase clinical studies are complex, short lasting and may need long in-house treatment. Moreover, there is no clinical benefit for the patients. We need their help for signal finding.

-Patients are different from HV’s

- Patients can never be such a “clean” population as healthy volunteers. So we have to think about the in- and exclusion criteria of the protocol to prevent us from looking for a needle in a haystack.

- Additionally, in contrast to healthy volunteers, patients need care and should be given the opportunity to continue most of their normal habits.

- How to recruit MDD patients for early development?

- Recruitment of these patients is much more complex. Most of them have no current treatment relation with a hospital. Strategies for patient recruitment will be discussed.

- How to keep the patient in study?

- MDD patients are different from healthy volunteers. They cannot accept or do not tolerate all we want to investigate. This needs to be considered when setting up the study. By simulating a complex study at Janssen, we learned how to work with the patient and how to involve the patient in the study process.

- A second issue is the housing of the patient. Most phase I units have rooms for 12 subjects to sleep. This is not suitable for patients. The trail center has to organize space for patients, allow visitors and may allow patients to smoke or even drink when feasible and allowed.


Thursday 2pm BST – Virgil’s Story on patient centricity and managing the matrix of expectations

Virgil Simons - Founder and President, The Prostate Net and Prostate NetEuropa

- Are patients more than a revenue stream?
- Engaging patient advocates as part of your marketing strategy
- Patient advocates <=> advocates for pharma
- Patients as your new KOLs
- Creating a new matrix of patient engagement


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