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 Brian Sall, Senior Vice President Global Operations, Bavarian Nordic 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, Dermtreat Gunilla Andrew Nielsen, Head of Clinical Trials, Swedish Medical Product Agency Lene Grejs Petersen, Senior Advisor Clinical Trials, Danish Medicines Agency Maurizio Salvi, Senior Policy Advisor, European Commission Ninette N Florboe, Director of Regulatory Affairs, Hedia diabetes assistant Esther Gerteis, VP Clinical Affairs, CorFlow Therapeutics AG Nabil Al-Tawil, Consultant Physician & Principal Investigator, Karolinska Trial Alliance John Zibert, Chief Medical Officer, LEO Innovation Lab

2 Outsourcing in Clinical Trials Nordics Day 1 October 30 th :15 Registration and refreshments 8:50 Chair s opening remarks 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 reserved for Worldwide Clinical Trials 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

3 11:15 Panel Discussion: 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. Steven Roan, Manager Business Development, NovoTech 12:15 Workshop 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

4 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 Session Reserved for IQVIA 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.

5 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 Outsourcing in Clinical Trials Nordics Day 2 October 31 st :15 Registration and refreshments 08:50 Chair s opening remarks Biopharmaceutical Stream Medical Device Stream Live Debate: Determining the exact needs for investigators and consultants during clinical trials Drawing the needs for investigators and consultants during clinical trials How does the relationship between sponsor/cro and investigators influence clinical outcomes Are patient retention times low due to communication between investigators and patients? Nabil Al-Tawil, Consultant Physician & Principal Investigator, Karolinska Trial Alliance Presentation: Preparing for the new MDR regulations coming in 2020 Outlining significant changes to help prioritize duties Deciphering prospective challenges that companies should be aware off Exploring methods in approaching the new risk classification system for in vitro diagnostic medical devices Untangling the details of the Implant Card and its impact on patient data protection Allocating and Managing budgets and resources in preparation for the new MDR regulatory changes.

6 09:45 Keynote presentation and Q&A session: Securing and maintaining Economic Funding from a start-ups perspective 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. Ann Hammarstrand, CFO, Arocell 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 10:30 Morning refreshments and networking 11:00 Workshop: Patients as Partners: Explore novel ways of involving patients from the initial stages in drug development until end of clinical trials Creating patient-centric processes in a pharma company Building patient friendly protocols and uncovering challenges faced by patients and professionals in order to ensure better patient recruitment and retention. Center the drug development process around patients Conducting qualitative research to support clinical trials Panel Discussion: Categorizing the conditions for the approval of a clinical trial Outlining specific limitations on testing devices on patients Establishing when and how the ethics committee involved in the trials Building Clinical Evidence for Legacy Products to ensure regulations are met Promoting open communication with ethics communities and notified bodies to ensure punctual budget trials. Identifying steps to align new MDR regulations for niche products Esther Gerteis, VP Clinical Affairs, CorFlow Therapeutics AG

7 11:30 12:00 Keynote Presentation Preparing for the new EU clinical trial regulations Ann Christine, Korsgaard, VP Regulatory Affairs, Dermtreat Quick Fire Round: Moving compounds forward during first clinical trial phases Creating an effective approach to safety and reliability conditions Discussing the need to employ CROs to conduct the whole trial or aspects of the trial Deciphering which aspects of the trial will be cost deficient 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 Quick Fire Round Considering the challenges in Collecting Clinical Data to gain CE Mark in order to comply with the new MDR regulations Discussing the tighter regulations on high risk devices and how companies should address this Suggesting solutions for the challenge with product equivalence. Safety issues? Fredrik Ceder, Head Of Clinical Operations, Coloplast Ninette N Florboe, Director of Regulatory Affairs, Hedia diabetes assistant 12:30 Lunch and networking 13:30 Keynote Presentation: Signe Humle Jørgensen, NEXT Partnership

8 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 16:30 Chair s summary and close of conference