Day 1

Day 2

8.45 - 9.00:

Opening Speech

 

8.45 - 9.00: Gaby Anthonijs, Early Development and Alliance Suppliers Strategy Lead, Janssen Biologics

The role of communication in relation to vendor oversight – a best practice approach – and where we are moving to?

 

9.00 - 9.30: Sabrina Wijnen, Managing Director, Clinitude

A practical case study in engaging site monitoring and optimization of CRA roles subject to a unique case study from Philippines

To what extent is the role of the CRA open to optimization

2. How would a more dynamic approach to site monitoring could influence trial results

3. Among all the emerging economies as choice of clinical trial sites, why Philippines

and why now?

4. Lessons learned and comment pitfalls to avoid disruption

5. Recommendations and Q&A

 

9.30 - 10.00: Craig Elliott, Global Head Clinical Operations, Clintec

Patient Centric approaches to Clinical Trials: Improving Patient Experience and Overall Study Quality

Competition for patients in Clinical Trials is high. In order to ensure that trials meet recruitment targets and ensure patient retention, protocols need to be designed with the patients in mind. However, clinical trials need to be scientifically robust, with well-defined outcomes and endpoints, ensure data integrity and comply with international regulatory requirements. The challenge for the pharmaceutical industry is can we design trials that:

1. Ensure the patient experience is positive

2. Be indicative of real world experience

3. Make best use of clinical trial technologies

4. Improve quality

5. Be truly risk based

10.00 - 10.45: BREAK

 

Véronique Freund, Quality Head Europe & APAC, Sanofi

Challenges and opportunities when Sponsor and CRO work together in a Risk Based Monitoring model

What is governance and why is it vital?

Defining the impact of governance on trial success aligned to clinical trial service provider and overall agreement Key examples and model engaged at Sanofi Lessons learned and common challenges associated with such a model Example of IRT governance Recommendation

Q & A

 

11.30- 12.15: Marion Wolfs, Associate Director Risk Management Central Monitoring, Janssen Pharmaceutical

A best practice approach to services providers’ governance: a clear case Sanofi

Although RBM high level definitions and processes are quite similar across the pharmaceutical industry, the practical implementation, naming of documents and processes, system capabilities, etc., can differ widely from company to company. This session will explore experience on what the key conditions are, the requirements in the collaboration between CRO and Sponsor to ensure alignment, how overcome system differences and to come to agreement around processes.

 

12.15 - 13.45: LUNCH

 

13.45 - 14.30: Isabelle Naëije, Associate Global Trial Director, Novartis

Innovation in Clinical Trial Designs

There is a stagnation in the development of novel compounds due to the rapidly escalating costs and the increasing complexity to get approvals. The FDA released in 2006 a list of critical path opportunities allowing to improve the accuracy of tests that predict the safety and efficacy of potential medical products. Let’s review together which new scientific discoveries could be applied during development to help bringing new drugs to patients more efficiently. Adaptive Clinical Trials and Precision Medicine will be looked at closely.

 

14.30 - 15.15: BREAK

 

15.15 - 16.15: Jan Mous, Senior consultant, MRM Consulting

Workshop: The CRO Clinic: A dedicated practical session to Clinical Research Organisation (CRO) selection process and management

• How and when to start CRO selection?

• What makes a CRO the correct partner for your clinical trial?

• Identification of CROs: a focused approach to understanding CRO’s capability in relation to your trial needs.

• Clarification and certification – what are my exact needs for the trials, and to what is the proven capabilities and capacities of the CRO for my Trial?

• The Selection Process: considerations of cost, budget (fixed or open?), quality and time frame of delivery

• Contractual agreement and understanding your key performance indicators but also key risk indicators

• Preparation work for contracting, management of the working relationship and and after trial deliverables

 

 

END OF DAY 1

 

 

 

9.15 - 9.30

Conference Opening Speech

 

9.30 - 10.00: Amer Alghabban, GXP Quality Assurance, Karyopharm Therapeutics

CRO/Sponsor cooperation: collaborating for a successful outcome

It is important to establish objectives and define goals in ensuring that clinical trials agreements between CRO and sponsor are clear and inclusive of all tasks. In preparing for success and mitigating surprises, this session will outline: Drawing up a roadmap defining expectations which are agreeable to all parties. Maintaining transparency between both parties throughout the course of the trial to promote clear communication principles. Common challenges which impact and disrupt the trial process and how to overcome these for a favourable outcome for all.

 

10.00 - 10.30: Caroline Beaudoint, Clinical Trial Manager, Boston Scientific

A clear case for Japan: Understanding the cultural differences and the question of oversight

1) Key differences in cultural traits and how to navigate successfully

2) Lessons learned and common challenges associated with oversight in Japan

3) Engaging the question of regulatory requirements and best approach to managing them

4) Overall expectations and reality check

5) Recommendations and QA

 

10.30 - 11.15: BREAK

 

11.15 - 12.00: Henrik Torp Nielsen, Head Medical Affairs Finance, Novartis

Financial aspects of Clinical trials – Sponsor perspective

1) Why do Investigators need Sponsors and vice versa

2) Key principles for successful Clinical trials (from a Finance perspective)

3) Milestone planning and importance of predictability

3) Fair Market Value considerations

4) What are the main opportunities and challenges

 

12.00 - 12.45: Michele Marzola, Chief Executive Officer & Founder, Interceptin

CRO selection at biotech start-ups

CROs represent a significant part of planned spend at any start-up entering clinical trials; this speech will address the different parameters evaluated and their priorities, with indications on the potential successful partnership between CROs and biotech start-ups.

 

12.45 - 14.00: LUNCH

 

14.00 - 15.00: Anne Dirix, Company Manager, DigiDyco

Catherine Hoet, Business Manager, DigiDyco

Digital Boot Camp – Data and Information Capturing in Clinical Trials a practical guide into

1. Clinical study Payments:

  -What are actually the bottle necks for the sponsors/sites?

  -Can e-invoices offer a solution?

2. e-library for the site start-up documents:

  -What are the pros and the cons to post CV, certificates of site personal on a share platform?

  -Which are the minimum restrictions to ensure a save and a limited environment?

2. e-ICF:

  -Which might be the advantages to use e-ICF?:

     a. for the sponsors, b. for the sites, c. for the patient

  -Why would the Life Sciences hesitate to implement e-ICF?

  -Are the Life Sciences ready today to implement e-ICF?

4. Platform shared financial agreements:

  -On condition the limited access is provided, which are the advantages/ disadvantages, related to the financial agreement negotiations?

     a. for the sites,

     b. for the sponsor

  -Your opinion on using a general template for the financial agreement.

 

15.00 - 15.45 BREAK

 

15.45 - 16.15 Anne Dirix, Company Manager, DigiDyco

Catherine Hoet, Business Manager, DigiDyco

Digital Boot Camp – Data and Information Capturing in Clinical Trials a practical guide into

 

(continues...)

 

END OF DAY 2

END OF THE CONFERENCE