Outsourcing in Clinical Trials Nordics October 30 th 31 st Copenhagen

Transcription

1 Outsourcing in Clinical Trials Nordics 2018 October 30 th 31 st Copenhagen 2018 Speakers Confirmed: Magnus Björsne, CEO, AstraZeneca BioVentureHub Mikkel Skovborg, Executive Specialist, NovoNordisk Thomas Kongstad Petersen, Senior Vice President Global Clinical Operations, LEO Pharma Mirjam Mol-Arts, Senior Vice President, Global Clinical and Non-Clinical R&D, Ferring Pharmaceuticals A/S Fredrik Ceder, Head Of Clinical Operations, Coloplast Bengt Von Mentzer, CEO, PharmNovo Ashesh Kumar, CEO, Paras Biopharmaceuticals Tonni Bülow-Nielsen, Managing Partner, the Danish Growth Fund (Vækstfonden) Adam Bruce, Executive BoardMember, TikoMed Bjarne Flou, CEO, OBI Medical Klaus Abel, Founding Partner, Care4Life Medico Marie Sundin, Outsourcing Program Director, AstraZeneca Ann Hammarstrand, CFO, AroCell Karsten Lindhardt, CSO, Egalet Ann Christine Korsgaard, VP Regulatory Affairs, Afyx Therapeutics Gunilla Andrew Nielsen, Head of Clinical Trials, Swedish Medical Product Agency Lene Grejs Petersen, Senior Advisor Clinical Trials, Danish Medicines Agency Ninette Florboe, Founder, Neel et al Ivs Nabil Al-Tawil, Consultant Physician & Principal Investigator, Karolinska Trial Alliance John Zibert, Chief Medical Officer, LEO Innovation Lab Alberto Della Scala, Associate Therapeutic Strategy Director, Therapeutic Science and Strategy Unit, IQVIA Barbara Zupancic, Senior Director, Head Global Patient Recruitment and Retention, Worldwide Clinical Trials

2 Outsourcing in Clinical Trials Nordics Day 1 October 30 th :15 Registration and refreshments 8:50 Chair s opening remarks Marie Sundin, Outsourcing Program Director, Global Medicine Development, AstraZeneca Improving Clinical Operations and Outsourcing in the Nordics 9:00 Panel Discussion: Improving collaborative terms between CROs & sponsors to enable a stronger working relationship Establishing an excellent clinical operational relationship between CROs and Sponsors to enable better conflict management Unpacking the challenges between CROs and Sponsors in order find solutions for better partnership Identifying methods to deal with conflict management Defining the operational challenges and suggesting solutions Communicating protocol changes to prevent collaborative issues Ashesh Kumar, CEO, Paras Biopharmaceuticals Marie Sundin, Outsourcing Program Director, Global Medicine Development, AstraZeneca Thomas Kongstad Petersen, Senior Vice President Global Clinical Operations, LEO Pharma 9:45 Presentation: Back to the Future: Rediscovering Optimal Patient Engagement Strategies In Early Phase Oncology Research and Orphan Disease Uncover ways to support top investigators so they can optimize patient recruitment and retention best practices at their sites Explore the importance of key opinion leaders involvement and discover how to utilize their extensive knowledge and expertise as a resource for other investigators, CROs and sponsors, particularly in orphan disease Ensure patient centricity is at the heart of engagement by understanding the patient s journey and that of their caregiver and determining where to offer support. Collaborate with each site to make certain it is employing enrollment best practices and utilizing recruitment and retention tools Explore and develop relationships with patient advocacy groups, both in orphan disease and oncology Address retention needs by ensuring patients are well taken care of during their participation, offering transportation assistance and home nursing options. Barbara Zupancic, Senior Director, Head Global Patient Recruitment and Retention, Worldwide Clinical Trials

3 10:15 Keynote Presentation: Delegating Funds: A new foundation designed by Novo Nordisk for funding early stage projects. Discovering further details of this project to attract greater industry interest Outlining the conditions for the foundation in order to comply with the project Specifying the dates of its launch and where companies apply to Mikkel Skovborg, Executive specialist, Novo Nordisk Foundation 10:45 Morning refreshments and networking Clinical trial innovation and Technology 11:15 Presentation: Contracts: Outlining a rational approach to contract agreements in order to build transparent relationships between sponsor/cro Outlining the legal challenges when writing contracts to ensure efficient contractual agreements Finding the uniformity of contracts between hospitals/cros to prevent trial timeline suspensions. Handling different clinical documentations Considering the financial expectations to prepare for unforeseen costs Discussing strategies for risk based management to create a holistic balance for joint ownership Karsten Lindhardt, CSO,Egalet 11:45 Presentation: Australia's 43.5% R&D Refund and Simplified Regulatory Environment as a Gateway to Asia Presenting how Australia s scientific talent, excellent medical infrastructure and lucrative 43.5% R&D cash refund scheme makes it a preferred destination for early phase clinical trials. Recognizing that patient availability makes Asia a key region to accelerate later phase development, at lower costs. Highlighting the partnership between regional specialists, an alternative to large global CRO to manage complex global trial while keeping the flexibility required for Mid-size Biopharma companies.

4 Steven Roan, Manager Business Development, NovoTech 12:15 Presentation: Constructing a network of clinical expertise to ensure a more resourceful running of a clinical trial (delegates will be placed in groups of 4). Discussing the challenges of locating specific expertise for niche products Communicating better with third-party/cros to certify specific expertise before the trial Creating a network to attain specialist roles precise to unique projects Making the Nordics an international hub for collaboration Bengt von Mentzer, CEO, Pharmanova 13:00 Lunch and networking 14:00 Presentation: Digitalizing Clinical Trials, from recruitment to execution Digital initiatives exists in the field of patient recruitment an overview will be given with successful initiatives patient psychology is important to understand in order to retain them for clinical trial enrollment and successful retention through a trial, this will be discussed Few but very interesting initiatives are approaching trial execution through end-to-end digital solutions. This area will be discussed. John Zibert, CMO, Leo Innovation Lab 14:30 Presentation: Using data & analytics to optimize trials operationalization The complexity and costs of running clinical trials continues to rise. To reverse these trends, we need to reimagine our approach to clinical development Data, Analytics, and Technology can help us optimize efficiency in clinical trials, but need to be embedded successfully in operations to maximize impact Three key areas where data can be leveraged are to improve Protocol Design, Site Identification and Patient Recruitment Alberto Della Scala, Associate Therapeutic Strategy Director, Therapeutic Science and Strategy Unit, IQVIA

5 15:00 Panel Discussion: Discussing the conditions for the approval of a clinical trial Highlighting frequent challenges faced by companies Revealing common mistakes made by previous companies Building stronger communication with medicines agencies to. Lene Grejs Petersen, Senior Adviser, Clinical Trials, Danish Medicines Agency Gunilla Andrew Nielsen, Head of Clinical Trials, Swedish Medical Product Agency John Zibert, Chief Medical Officer, LEO Innovation Lab 15:30 Afternoon refreshments and networking 16:00 Presentation: The triad of clinical trial design, regulatory reality and commercial landscape is a moving target that guides investment decisions when entering clinical development BioVentureHub provides new mechanisms for accessing competence and infrastructure within big pharma. Discussing the BioVentureHub approach to support disruptive innovation by merging Pharma, digital and MedTech Revealing a model that utilizes the concept of the sharing economy applied to life sciences in order to strengthen Biotechs Magnus Björsne, CEO, AstraZeneca BioVentureHub 16:30 Panel Discussion: Funding: Defining the financial expectations for industry Funding to secure market access in emerging economies. Identifying the different strategies when approaching private and Public funding Outlining the terms which need to be met when attaining Funding Maintaining Financial support in order to tackle unforeseen costs long term Tonni Bülow-Nielsen, Managing Partner, The Danish Growth Fund (Vækstfonden) Adam Bruce, Executive BoardMember, TikoMed 17:00 Chair s summary and close of conference

6 Outsourcing in Clinical Trials Nordics Day 2 October 31 st :15 Registration and refreshments 08:50 Chair s opening remarks Presentation: Determining the exact needs for investigators and consultants to assure optimal clinical trials outcomes Drawing the needs for investigators and consultants during clinical trials How does the relationship between sponsor/cro and investigators influence clinical trials outcomes? Are patient/participants retention times low due to insufficient information given by investigators to patients/participants.? Nabil Al-Tawil, Consultant Physician & Principal Investigator, Karolinska Trial Alliance Phase-I Unit, Stockholm 09:30 Keynote Presentation Preparing for the new EU clinical trial regulations What is the Clinical Trial Regulation? Differences between current and future Clinical Trial Application process in EU How can we prepare? Sponsor/CRO interactions Ann Christine, Korsgaard, VP Regulatory Affairs, Afyx Therapeutics

7 10:00 Keynote presentation and Q&A session: Securing and maintaining Economic Funding from a start-ups perspective The expectations start-ups face when approaching funding organisations and venture capitalists. Where does a start-up begin when looking for funds Establishing strategic management to ensure regular funding Capturing the attention and working with Venture Capitalists Evaluating keys area of costs to ensure better company success. Bjarne Flou, CEO, OBI Medical, Denmark Ann Hammarstrand, CFO, Arocell 10:30 Morning refreshments and networking 11:00 Presentation: Discussing the development of Medical Device Applications Hurdles to go through as Tech and Medical Device industries team up Ensuring both Patient Safety and Patient Data regulations ar met Innovate the engagement of the patient population for a more user-friendly and safer app. Qualitative and Quantitative tool box suggestions THE TWIST - ALSO FOR PHARMA: How to test the user-friendliness of app's aimed at being utilised for patient data collection during Clinical Trials Ninette Florboe, Founder, Neel et al Ivs 11:45 Keynote Presentation Assesing the challenges for Post Market Surveillance. Evaluating the distance one goes in their investiagtion within market study The impact MDR has had on performing Post Market Surveillance Defing the boundaries between Clinical investigation and Market Study. Identifying the correct number to perform the study and how to better understand youd product market dynamics Addressing challenges in Patient recruitnemtnt within hospitals. Klaus Abel, Founding Partner,Care4Life Medico 12:30 Lunch and networking

8 13:30 Keynote Presentation: NEXT Partnership a single entry point to clinical trials in Denmark: A national approach to increase performance in clinical trials. Access to established partnerships with hospitals, scientists and patient networks. Building alliances across the public and private sector Creating clinical networks to increase feasibility response rate and execution performance Signe Humle Jørgensen, Center Manager, NEXT Partnership 14:00 Keynote Presentation : Different Geographical Strategies for World Wide Clinical Trial Outsourcing In a world-wide trial there will be different regional needs and capabilities; US, China, EU The company structure and therapeutic focus will determine whether to execute trials inhouse or via CRO s How to deal with a mixed model; outsource part of the execution How to align between companies own systems and benefit from the CRO s workflow. Mirjam Mol-Arts, Senior Vice President, Global Clinical and Non-Clinical R&D, Ferring Pharmaceuticals A/S 14:30 Afternoon refreshments and networking 15:00 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. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Each roundtable session lasts for 45 minutes, and delegates may attend up to 2 roundtables Roundtable 1 Roundtable 2 Roundtable 3 Practical solutions to challenges for startup companies Klaus Abel, Founding Partner,Care4Life Medico Building a connection between CROs and End users to forward clinical trials Bengt von Mentzer, CEO, Pharmanova Discussing the challenges in Collecting Clinical Data to gain CE Mark Fredrik Ceder, Head Of Clinical Operations, Coloplast

9 16:30 Chair s summary and close of conference