DEVELOPING PRACTICAL STRATEGIES FOR IMPROVING YOUR CLINICAL TRIAL PARTNERSHIPS TO EXPEDITE DRUG DEVELOPMENT Event Outlook Speaking Faculty

Transcription

1 DEVELOPING PRACTICAL STRATEGIES FOR IMPROVING YOUR CLINICAL TRIAL PARTNERSHIPS TO EXPEDITE DRUG DEVELOPMENT Event Outlook BRAND NEW TOPICS FOR A DACH AUDIENCE THE LEADING OUTSOURCING SERIES IN EUROPE NETWORKING OPPORTUNITIES WITH INNOVATIVE VENDORS 2018 Speaking Faculty Gisele Tavares, Procurement - Global Head Alliance Management & Internal Business Partner, Roche François Curtin, COO, GeNeuro SA Jessica Cordes, Director Clinical Operations, Medigene AG Olivier Goarnisson, Director, Medical Affairs Operations, Celgene Guido Koch, Chief Operating Officer, Topadur Pharma AG Pamela Bacon, Head of Medical Affairs Communication and Operations, Worldwide Market, Celgene Melanie Eymann, Clinical Outsourcing and Risk Manager, Santhera Pharmaceuticals Ltd Dirk Weber, Chief Medical Officer, Cellestia Biotech AG Michele Ollier, Partner, Medicxi Geofrey De Visscher, CTO, Elanix Biotechnologies Kathleen Schmidt, Clinical Project Manager, Adrenomed AG Max Horneck, Head of Clinical Data Management and eclinical Systems, Medac GmbH Marie Laurencin, Senior Global Trial Lead, Novartis Ruth Proebe, Associate Director Clinical Affairs, CR Bard Ruggero Fariello, Co-Founder, PharmaFox Therapeutics Ulrike Grimm, Head Global Project & Alliance Management, Vifor Pharma Paul Smallman, Director, Technical Services, PCI Clinical Services Dr Piet Swart, Dip PharMed, Pharmacologist, Executive Vice President, Nuvisan Patrick McManus, Chief Development Officer, Exom Group SRL Further Information For sponsorship enquiries please contact: Alexander O Leary Alexanderoleary@arena-international.com Tel:

2 Conference Name: Outsourcing in Clinical Trials DACH 2018 Conference Date: 9 th 10 th October 2018 Programme Day One 08:15 Registration and refreshments 08:50 Chair s opening remarks 09:00 Building collaborations with external providers to guarantee the best delivery through innovation - Using these relationships for the benefit of both Pharma and external providers and ultimately patients - Defining relationships contractually to get the maximum solutions from external providers - Fostering strategic relationships between sponsors and external providers for a successful long term collaboration HIGHLIGHT KEYNOTE SPEAKER Gisele Tavares Procurement - Global Head Alliance Management & Internal Business Partner Roche 09:30 SPONSORED SESSION: New Tech or Old Process? - Do we need new technology to support standard clinical packaging process? A discussion on what we could be using versus what we consider standard practice. - How much better is new technology versus what we have been doing? Highlight the differences through examples of what new technology looks like and what our current state is. - Who is going to pay for this? A discussion on the costs of advancing technology and who is stuck with the bill. Paul Smallman, Director, Technical Services, PCI Clinical Services 10:00 Considerations in observational research the importance of long term partnerships - Differences between observational research and interventional studies - Choosing the right sites - How to ensure recruitment but not introduce bias - Retaining patient and sites (especially in long duration studies) Pamela Bacon, Head of Medical Affairs Communication and Operations, Worldwide Markets, Celgene 10:30 SPOTLIGHT SPONSOR: GERMANY How to accommodate customer s needs and streamline clinical study conduct from a CRO s perspective Inamed GmbH 10:45 Morning refreshments and networking

3 11:15 ONSTAGE INTERVIEW: Working to foster a reputation in clinical development to partner with large solution providers for trusted timelines and high quality deliverables During this session, Dirk Weber will be interviewed to understand what he feels are the best methods to build a new relationship with large solution providers and what the best angles are for small pharmaceuticals. ONSTAGE INTERVIEW - Choosing the right large solution provider who creates investment and understands your goal - Key factors to select the most suitable large solution provider from a start-up biotech company perspective compared to the view from large pharma companies - Working with providers to create a solid partnership with well-established CROs and vendors - Building reputation to create a long term collaboration with large solution providers for smoother clinical processes MASTERCLASS 11:45 Dirk Weber, Chief Medical Officer, Cellestia Biotech AG/Aurealis Pharma AG Constructing strategic models on sharing the risk between providers and biopharmaceuticals - Defining back up plans for a smoother timeline - Ensuring incentives for solution providers to persuade external providers to conduct clinical trials to defined deadlines - Characterising relationships between vendors and biopharmaceuticals to engage solution providers to work best for sponsors Olivier Goarnisson, MD, Director, Medical Affairs Operations, Celgene 12:15 SPONSORED SESSION: The digital revolution for a faster and cost-efficient trial conduct - How to shorten start-up times by utilizing digital tools - Higher patient s engagement with the eicf, and at home patient visits through telemonitoring - applications - Novel monitoring approach by esource data; leading to a reduction in on-site monitoring visits Patrick McManus, Chief Development Officer, Exom Group SRL 12:45 Lunch and networking Understanding the Best Methods for Complying with the General Data Protection Regulation Act - Preparing, centralising and automating critical processes needed for effective compliance and processes to implement during and after trials - Determining how biopharmaceuticals and solution providers have adapted data management in line with GDPR without interrupting trial timelines 13:45 - Steps for training trial staff on GDPR and the management of sensitive data during trials - Understanding what is contractually, legally and operationally needed in order to confirm GDPRcompliance SESSION RESERVED: Ulrike Grimm, Head Global Project & Alliance Management, Vifor Pharma

4 SPONSORED SESSION: Finding the right partner to work with from preclinical into phase I 14:15 Dr Piet Swart, Dip PharMed, Pharmacologist, Executive Vice President, Nuvisan SESSION HIGHLIGHT 14:45 Maintaining oversight and monitoring of solution providers involved in establishing your clinical trials for a secure timeline and better risk management - Understanding the best methods of being kept up-to-date about deviations in your clinical trials to efficiently and effectively overcome potential risks - Investing in speaking with solution providers to cultivate relationships and eventual effective micromanagement for compliance - Focusing on robust processes, consistent reporting and how solution providers can ask the right questions throughout the collaborations to overcome the root cause of potential risk Jessica Cordes, Director Clinical Operations, Medigene AG 15:15 SPOTLIGHT SPONSOR: AUSTRIA QPS Austria GmbH 15:30 Afternoon refreshments and networking 16:00 Characterising end points of the trials jointly to analyse key milestones in a long term project - Exploring the best methods of investment to make sure timelines are taken back and worked properly for efficiency - Detailing the process for a smoother run and to determine the financial anchors needed in clinical trials - Determining the best methods to operationally define end points of clinical trials to ensure completion of major and minor steps - Adjusting study planning to link operational and data management to help acquire information earlier for the trials François Curtin, COO, GeNeuro SA 16:30 Exploring Advances in Technology to Improve Patient Recruitment and Retention - Analysing innovations and new methods to enhance recruitment what works and when does back to basics trump new technology? - Simplifying clinical processes to reduce the burden of the trials for patients during their everyday lives, such as interviewing technology and patients portals - Changing the face of clinical trials the benefits of apps and wearables for instant patient data - Accessing a greater number of patients with technology such as patient portals, for a more diverse patient population

5 SESSION RESERVED: Ruggero Fariello, Co-Founder, PharmaFox Therapeutics 17:00 Chair s summary and close of conference

6 Conference Name: Outsourcing in Clinical Trials DACH 2018 Conference Date: 9 th 10 th October 2018 Programme Day Two 08:15 Registration and refreshments 08:50 Chair s opening remarks WORKSHOP: Defining Key Performance Indicators (KPIs) for clarification of trial success WORKSHOP During this session, delegates will split into smaller groups to identify the best methods of measurement to understand successful relationships with CROs during clinical trials. HIGHLIGHT - Discussing whether qualitative or quantitative indicators are the best measure of the success of a clinical trial - Executing project plans with KPIs to understand where resources are best allocated to strengthen the performance during clinical development - Measuring strengths and weaknesses of different key areas of the trials for process improvement Melanie Eymann, Clinical Outsourcing and Risk Manager, Santhera Pharmaceuticals Ltd PANEL DISCUSSION: Functional or Full-Service Outsourcing; Discussing which model offers the perfect combination of high quality results, cost-effectiveness and time saving? 09:30 - Working with a variety of different solution providers for better expertise on each outsourced section of the trial - Managing the varying timelines of each specialised supplier to ensure overall trial milestones are achieved - Conducting shorter timelines with a large number of solution providers to ensure more accountability towards the project - Understanding the benefits of functional outsourcing vs full service outsourcing, including the financial and operational aspects of these services Marie Laurencin, Senior Global Trial Lead, Novartis Ruth Proebe, Associate Director Clinical Affairs, CR Bard 10:00 Session Available for Sponsorship

7 FIRESIDE CHAT: Is it time to scrap Request for Proposals? Debating whether RFPs prevent CROs from showcasing innovative problem-solving abilities to consider alternative methods of vendor selection 10:30 - Identifying the elements a RFP must have to attract the best in business suppliers - Verifying vendor qualifications effectively to prevent loss of timeline and cost during vendor selection - Best practice for due diligence to support vendor selection for the clinical process - Planning the GDPR effect upon RPF documentation for assurance of alignment to GCP Marie Laurencin, Senior Global Trial Lead, Novartis 11:00 Morning refreshments and networking 11:30 MASTERCLASS MASTERCLASS WITH MAX: Integrating Clinical Data Management Systems (CDMS) to Support Data Integrity and Management Interactive discussion with a specialist regarding current CDMS models of small and what the models of the future will look like - Designing an effective CDMS model for flexible and reliable management of data - Understanding how sponsors communicate with CROs to standardise processes and improve data accuracy - Outlining responsibility for clean, accurate data and determining how data should be shared between trial partners - Acquiring data accurately for compliance towards Good Clinical Practice (GCP) Max Horneck, Head of Clinical Data Management and eclinical Systems, Medac GmbH 12:00 Session Available for Sponsorship 12:30 PANEL DISCUSSION: Discussing how to overcome common operational challenges for small pharmaceutical companies to expedite trial timelines PANEL DISCUSSION - Detailing the top considerations for selecting CROs when you are a small company to ensure compatibility - Exchanging anecdotes of how trial partners can be a help or a hindrance to determine how you can work better together - Considering how you can leverage clinical trial technologies on a budget to expedite trial timelines Panel Chair: Dr. François Curtin, COO, GeNeuro SA Michele Ollier, Partner, Medixci Jessica Cordes, Director Clinical Operations, Medigene AG

8 13:15 Lunch and networking Speaker Hosted Roundtables Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Once all roundtables are 14:15 concluded, you will be able to take away these ideas and use them for you own challenges! RT 1 RT 2 RT 3 RT 4 RT 5 Each roundtable session lasts for 45 minutes, and delegates may attend up to 2 roundtables Asking the right questions to narrow down your selection of service providers during the bid defence to ensure you choose the right partner for your trial needs Dr Guido Koch, Chief Operating Officer, Topadur Pharma AG Defining the best practices in building partnerships with Local Authorities to maximise your understanding of and access to the required patient population for your clinical trials ROUNDTABLE AVAILABLE FOR SPONSORSHIP! Interrogating the use of technology, such as wearables, during clinical trials and how this strengthens recruitment of patients ROUNDTABLE AVAILABLE FOR SPONSORSHIP! Debating how to strike a balance between micromanagement and a hands-off approach during oversight of external providers Kathleen Schmidt, Clinical Project Manager, Adrenomed AG Calculating potential key performance indicators: best ways to measure the performance of solution providers to measure progress Geofrey De Visscher, CTO, Elanix Biotechnologies 15:45 Chair s summary and close of conference