Clinical Innovation Partnerships 2019

11 - 12 September, 2019

Hotel Palace, Berlin

44 (0) 20 7368 9836

Conference day two – Thursday 12 September 2019

8:00 am - 8:45 am Registration and welcome coffee

8:00 am - 8:45 am Women in Clinical Innovation Breakfast: How can you better attract, develop and retain female talent to tap into their full potential in driving your business objectives?

Reimagining Partnerships in the Clinical Trials Ecosystem

8:45 am - 8:50 am Opening remarks – Letitia Thomas, Programme Director, WBR

8:50 am - 9:00 am Chair’s opening address and networking activity

Dr. Raphaële Mary, Former Director Capability, Quality & Strategy, Global Clinical Operations at BMS

Dr. Raphaële Mary

Former Director Capability, Quality & Strategy, Global Clinical Operations
BMS

9:00 am - 9:20 am OPENING KEYNOTE - Modernising your clinical trials: How can you change your organisational structure to focus on real world evidence, remove barriers and deliver studies faster?

• How do you need to change your organisational structure to achieve modernisation?
• How can you convince regulators to have seamless evidence generation leading to real world evidence faster?
• How will vendors (central labs specifically) need to modernize to come with pharma on this journey?
• How will a new org structure remove barriers?

Catherine Mela, Head of Clinical Sample Science at AstraZeneca

Catherine Mela

Head of Clinical Sample Science
AstraZeneca

9:20 am - 10:00 am PANEL WITH INTERACTIVE POLLING - How can you partner on big data sharing across the Sponsor- CRO-Investigator- Patient ecosystem to encourage transparency and share learnings?

• What is meaningful industry collaboration?
• How to encourage transparency and sharing between sponsor to sponsor and CRO to CRO
• Improving partnerships with the human element – how to  build the trust and to involve all the parties, the vendors, CRO, sponsor together and to think in an innovative way
• How to combine all parties to be one team and one goal

Jennifer Coppins, Associate Director CTL Global Development Operations at Theravance Biopharma US

Jennifer Coppins

Associate Director CTL Global Development Operations
Theravance Biopharma US

Jeff Pilot, Senior Clinical Project Manager at Norgine

Jeff Pilot

Senior Clinical Project Manager
Norgine

10:00 am - 10:20 am PRESENTATION - How can you implement new digital tech such as sensors, apps and speech based assessments to improve patient recruitment and experience?

• How can sensors, apps and wearables be used to sense more around patients in advance?
• How can speech bases assessments extract different features from traditional pen and paper?
• How can this help predict patient conditions earlier on/before symptoms start to show?
• How can this help engage patients?

Kai Langel, Director of R&D Operations Innovation EMEA at Janssen Pharmaceutical Companies

Kai Langel

Director of R&D Operations Innovation EMEA
Janssen Pharmaceutical Companies

10:20 am - 10:40 am PRESENTATION - Futurising your clinical trials: How to move into the virtual trial space and take full advantage of technology

Lise Sylvest Helledi, Senior Project Manager & Chair Clinical Trial Intelligence at Novo Nordisk

Lise Sylvest Helledi

Senior Project Manager & Chair Clinical Trial Intelligence
Novo Nordisk

Reimagining Partnerships in the Clinical Trials Ecosystem

10:40 am - 11:20 am Networking Break

Reimagining Partnerships in the Clinical Trials Ecosystem

11:20 am - 11:40 am PRESENTATION - How clinical operations and procurement can work together better to leverage innovation from vendors and reduce trial time and cost

• How can long term partnerships and repeat suppliers see cost decrease?
• How can innovation be cost effective and successful?
• How can sponsors and vendors work better together?
• How can innovation make trials more efficient – efficiency in terms of cost and in terms of the time it takes to deliver a clinical trial?
• How to leverage AI and big data innovation to help pharma improve and lower costs on clinical studies

Rosalinda Graci, Clinical Program Manager – HIV at Gilead

Rosalinda Graci

Clinical Program Manager – HIV
Gilead

11:40 am - 12:20 pm CASE STUDY INTERACTIVE - How can Pharma and CROs share learnings and expertise to join forces and maximise value?

• How can a joined up approach share the successes and failures between pharma and CROs?
• How can learning from past trials help design more successful trials of the future?
• How can CROs deliver more innovation for trials of the future?
• How can CROs and sponsors work together to design futuristic, successful trials?

Hans-Juergen Arens, Contract Clinical Services Director EMEA & LatAM at Fresenius

Hans-Juergen Arens

Contract Clinical Services Director EMEA & LatAM
Fresenius

12:20 pm - 1:00 pm DRILL DOWN ROUND TABLES - How can you use clinical trials technologies to reduce trial time and costs, improve quality and provide a better patient experience?


1.       eTMF  Jeff Pilot, Senior Clinical Project Manager, Norgine
2.       Clinical Trials Platforms
3.       Translations
4.       Virtual Clinical Trials Raphaele Mary, Former Director of Capability & Strategy - Central Clinical Services, BMS
5.       Data
6.       AI & Blockchain
7.       ePRO
8.       eCRF
9.       CTMS
10.   IRS Almac (representative to be confirmed)
11.   Innovation Partnerships & Patient Engagement Catherine Mela, Director Clinical Sample & Bioanalytical Sciences, AstraZeneca
12.   Procurement
Jeff Pilot, Senior Clinical Project Manager at Norgine

Jeff Pilot

Senior Clinical Project Manager
Norgine

Dr. Raphaële Mary, Former Director Capability, Quality & Strategy, Global Clinical Operations at BMS

Dr. Raphaële Mary

Former Director Capability, Quality & Strategy, Global Clinical Operations
BMS

Catherine Mela, Head of Clinical Sample Science at AstraZeneca

Catherine Mela

Head of Clinical Sample Science
AstraZeneca

1:00 pm - 2:10 pm Networking Lunch

1:00 pm - 2:10 pm MASTERCLASS/WORKSHOP

Tracks

2:10 pm - 2:15 pm Opening remarks from the chair

2:15 pm - 2:35 pm PRESENTATION How to develop a strategic partnerships with your CRO to improve transparency, expectations and results in niche disease areas

• How can you move away from only looking at the benefits of CRO and pharma relationships?
• How can you encourage whole-industry collaboration?
• How can you encourage whole-ecosystem collaboration?
• How can transparency between competitors and partners encourage results?

Robert Corbé, Global Trial Manager at Isofol Medical

Robert Corbé

Global Trial Manager
Isofol Medical

2:35 pm - 3:15 pm DRILL DOWN ROUND TABLES - PANEL INTERACTIVE How can you ensure early engagement with your partners to ensure effective vendor oversight, create transparency and improve communication?

SMALL PHARMA Gareth Lewis, European Director of Clinical Operations, Ono Pharma
MID-SIZE PHARMA Estrella Garcia, Director Global Clinical Operations, Almirall LARGE PHARMA Hanne Kusk Jacobsen, Global Director of Clinical Operations Study Management Innovation, Lundbeck 
Gareth Lewis, European Director of Clinical Operations at Ono Pharma

Gareth Lewis

European Director of Clinical Operations
Ono Pharma

Estrella Garcia, Global Clinical Operations Director at Almirall

Estrella Garcia

Global Clinical Operations Director
Almirall

Hanne Kusk Jacobsen, Global Director of Clinical Operations Study Management Innovation at Lundbeck

Hanne Kusk Jacobsen

Global Director of Clinical Operations Study Management Innovation
Lundbeck

3:15 pm - 4:00 pm Networking Break

Making the Right Strategic Choices

4:00 pm - 4:40 pm Dragons’ Den Examining the latest and greatest innovations in digital healthcare technology: Which start-ups offer true added-value and should be considered for your future investment plans?

4:40 pm - 5:20 pm OXFORD STYLE DEBATE - Risk-sharing models are the best way to lower trial costs – FOR & AGAINST

FOR – 
•What are the benefits of new risk sharing relationship management models?
•How you can get more out of your CRO within a more flexible, mature and collaborative relationship?
AGAINST –
•How can you maintain regulatory compliance and appropriate oversight within a risk-sharing relationship? 
•What negative financial impact might affect pharma’s ability to research and produce new drugs?

Catherine Mela, Head of Clinical Sample Science at AstraZeneca

Catherine Mela

Head of Clinical Sample Science
AstraZeneca

5:20 pm - 5:35 pm INTERACTIVE POLLING Investigator Perspective: How can you best work with investigators to establish which innovations are most feasible?

• Are investigators ready for digitalisation?
• Can sponsors/CROs do more to involve regulators in the design of the trial?
• What are the challenges?
• What are the benefits?

Dr. Raphaële Mary, Former Director Capability, Quality & Strategy, Global Clinical Operations at BMS

Dr. Raphaële Mary

Former Director Capability, Quality & Strategy, Global Clinical Operations
BMS

5:35 pm - 5:50 pm End of conference

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