About the Outsourcing in Clinical Trials Series Speaking Faculty

Transcription

1 About the Outsourcing in Clinical Trials Series The Outsourcing in Clinical Trials Conference series launched over a decade ago and now runs in more than 14 locations worldwide. The acclaimed series is a platform for medical device professionals to collaborate with service providers and other industry stakeholders to find innovative solutions to the most pressing challenges in conducting clinical trials. Thousands of clinical professionals attend our conferences year after year. The Outsourcing in Clinical Trials USA conference has been developed specifically to meet the needs of the vibrant medical device hub in Midwest. The agenda has been developed through direct collaboration with and support from the local industry to ensure the conference is content-driven and addresses the practical needs of our attendees Speaking Faculty Lars Oddsson, CTO&Co-Founder, RxFunction Brent Shelton, Vice President, Cardialen Mahtab Fatemi, VP of QA/RA, Nuvaira Eric Simso, CEO, Zift Medical Terry Noel, Sr Clinical Research Specialist, Medtronic Jennifer Bolton, Regulatory Fellow, Boston Scientific Laurie Lynch, Director RA/QA/Clinical, Pursuit Vascular Diana Peremislov, Clinical Trial Manager, Medpace Karen Krygier, Director Clinical Research, Global Kinetics Corporation Susan Wuollett, President & COO, Protege Biomedical Michael Wuollett, Co-Founder & CEO, Protégé Biomedical Chris Pulling, CEO, MicroOptx Frank Jaskulke, VP, MEMBER SERVICES, Medical Alley Association Rupa Dash, Sr. Clinical Research Associate, Medtronic Luke Dery, Co-Founder & VP Operations, Pelvital USA Anna Calleja, Cardiologist, Clinical Reviewer, TÜV SÜD America Tim O'Malley, CEO, Innova Medical Design Beata Blachuta, Medical Analyst Manager, Global Data Adam Steadman, VP, Clinical Development, Syneos Health Nissa Mollema, Clinical Operations Manager, Monteris Medical Beth Larson-DeBruzzi, Clinical Data Manager, Monteris Medical

2 Outsourcing in Clinical Trials : Medical Devices USA th July Programme Day One 07:45 Registration and refreshments 08:20 Chair s opening remarks Tim O'Malley, CEO, Innova Medical Design Examining the state of Medical Alley - The Times, they are a changing? 08:30 Exploring changes in healthcare delivery and payment to be prepared in every facet of product commercialization including clinical research Assessing the impact of new regulations in product registry time, cost and outsourcing market Investigating how Minnesota is doing given these changes and what adaptations companies are making to win in the emerging healthcare environment Frank Jaskulke, VP of Member Service, Medical Alley Association Mapping the new European Regulation Adjusting studies for MDR compliance 09:00 Analysing documentation, process and governance needs to adjust for future requirements Understanding the direction of regulatory changes within EU and the drive towards worldwide uniformity Deconstructing compliance with data acquisition to avoid changes to your clinical study Creating closer connections between Post Market Surveillance and your clinical study team to maximise your study outcomes Anna Calleja, Cardiologist, Clinical Reviewer, TÜV SÜD America Key to Trial Success: Don t Underestimate the Role of the Clinical Trial Manager The Clinical Trial Manager (CTM) plays a critical role in advancing your clinical research. We ll review five areas of execution that can impact clinical trial success: 09:30 Recruitment and Retention - faster enrollment with fewer dropouts Vendor Management - ensure outside vendors are up to par Functional Area Plans - integrate all areas of the trial Risk Management - understand where risk could be and prepare Communication - keep lines open for efficiency Diana Peremislov, Clinical Trial Manager, Medpace 10:00 Morning refreshments and networking

3 Optimizing CRO Interactions and Establishing Productive Partnerships 10:30 Define communication channels and go-to personnel for both client and CRO in advance For international studies, verify corporate and field language capabilities and materials are present Conduct post study survey from both client and CRO perspectives assessing effectiveness of communication process noting successes and breakdowns Rupa Dash, Sr. Clinical Research Associate, Medtronic Resolving Product Field Crisis, Poorly Performing Center or Client-CRO Tensions What can happen and how to prepare in advance 11:00 How to address a product issue or patient injury - lines of responsibility and communication protocol Managing a non-responding center or one with submitting partially completed reports does Client or CRO address the situation and how and when Resolving clinical differences of opinion or continuous issues between client and CRO Interpreting trial performance by encouraging regular face-to-face discussions with your service provider Working with vendors for precise budget management and for early warning if extra resources need to be found Terry Noel, Sr Clinical Research Specialist, Medtronic Clincial Trial Strategies on a Limited Budget: Keys to a Cost-Effective & Successful Trial 11:30 Completing entire product cycle analysis early to avoid the need for additional trials and clinical data gathering Exploring new software systems to speed up data management Considering investing in high-tech CROs who can multi-task from data management to medical writing The benefits of working with Boutique CROs who can tailor their services to your needs compared with cheaper suppliers Eric Simso, CEO, Zift Medical 12:00 Session reserved for Syneos Health Adam Steadman, VP, Clinical Development, Syneos Health 12:30 Lunch and networking Challenges in the Planning and Execution of Early Feasibility Studies 13:30 Evaluating the FDA s EFS program and the essential factors necessary for establishing protocols Underlining the considerations that need to be taken into account when deciding to conduct EFS studies outside of US to avoid delays during the study Investigating challenges for EFS studies done in multiple locations Including regulatory consultancy and data monitoring to ensure the

4 trial stays on track Brent Shelton, Vice President, Cardialen [Case Study] How did we prepare pre-clin trials from funding to regulatory compliance 14:30 Brief company history: Husband and wife team started in our kitchen and had $0 budget Bootstrapping feasibility: Getting through feasibility as inexpensively as possible to get us to the point where we could raise funds Pre-clinical trials: How we determined which test we needed (and which we didn t) Rent-an-Exec Model: How we used Regulatory consultants and CROs to help us on a project-by-project basis Funding milestones: Using regulatory trials as funding milestones Collaboration with FDA: Using the FDA (Q-Sub specifically) to determine which trials were necessary (or not) Patience and Resilience: How we dealt with setbacks, FDA reg changes, and delayed clearances Michael Wuollett, CEO, Protégé Biomedical Susan Wuollett, President&COO, Protégé Biomedical [Panel] Early stage product development: Large and small company Best Practices 15:00 Funding clinical trials large company versus start-up process and demands for funding clinical trials Scientific vs medical vs marketing vs reimbursement clinical trial goals VC approaches to clinical studies and importance in funding for start-ups How to present clinical trial plans to venture capitalists The role of angel investors in sponsoring early product trials Brent Shelton, Vice President, Cardialen Eric Simso, CEO, Zift Medical Michael Wuollett, CEO, Protégé Biomedical 15:45 Afternoon refreshments and networking Speaker Hosted s 16:15 Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practices and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts, the 2018 roundtable sessions will be focused on the overarching theme of Utilising Data and New Tech in Medical Device Trials. Each roundtable will focus on a specific aspect of exploring new technologies in clinical trials and enable you to discover best practices and overcome key challenges in clinical data management. Each roundtable session lasts for 45 minutes, and delegates may attend 1 roundtable. A list of best

5 practices compiled by each roundtable will be distributed after the conference 1 Defining a global regulatory strategy to prepare for strengthened data privacy as a result of the GDPR regulation 2 Exploring clinical data management systems to ensure accuracy and reliability of data Nissa Mollema, Clinical Operations Manager, Monteris Medical Beth Larson-DeBruzzi, Clinical Data Manager, Monteris Medical 3 Investigating EDC systems for your study to simplify your workflow 4 Developing best practices for communicating with international sites through communication technologies to ensure engagement 5 Exploring the use of real world clinical evidence to support expanding claims for the FDA Laurie Lynch, Director RA/QA/Clinical, Pursuit Vascular 6 Expecting artificial intelligences influence in trial execution and discussing how to prepare for it 17:00 Chair s summary and close of conference Tim O'Malley, CEO, Innova Medical Design Outsourcing in Clinical Trials : Medical Devices USA th July Programme Day Two 08:15 Registration and refreshments 08:50 Chair s opening remarks Regulatory approval requirement overview FDA vs CE Marking Overview and comparison of the regulatory approval process and trial requirements for FDA new guidance vs. CE Marking Supporting US and EU clearance in a single trial: Harmonization of requirements to ensure trials efficiency US or Europe first? Considering cost and time to approval Beyond regulatory approval overviews of the US and European medical device markets

6 Beata Blachuta, Medical Analyst Manager, Global Data Healthcare Cyber Security: The CRO s role in protecting Clinical trials data in an increasingly hostile environment 09:30 The IRB s view of patient data security: Focusing on HIPAA compliance to ensure approval Regulations pertaining to patient data protection including GDPR to avoid data privacy violations in European trials On-site vs. Cloud-based models: Balancing cost, convenience and security The role of Data Centre and internal regulatory professionals in the validate of standards and processes for data management and security. Developing CRO sourcing strategies depending on your study to avoid trial inefficiency 10:00 Clearly defining the needs of your study and determining the resources that vendors can offer to yield the most cost-effective solution for a particular type of study Assessing your vendor selection criteria and how to readjust for every study to ensure the right resources and processes for your study Investigating your potential partners track record and capabilities their longevity in the market, employees and experience in your therapeutic area Working with your vendor throughout the stages of a clinical study to execute the most cost effective, efficient, and quality-driven study Karen Krygier, Director Clinical Research, Global Kinetics Corporation 10:30 Morning refreshments and networking Deconstructing Patient Preference Trials a step ahead of FDA guidance 11:00 Benefits of a Patient Preference Trial: Analysis of released FDA guidance Deconstructing the detail of this draft guidance and direction to patient friendly market PPT from the view-point of the regulatory executive Mahtab Fatemi, VP of QA/RA, Nuvaira [Case Study] How we prepared for FDA advisory panel review 11:30 Pinpointing the critical factors and best practices for FDA advisory committee preparation Recruiting external experts to review scientific data and set ADCOM preparation strategies Profiling FDA Advisory Committee members to ensure successful product registry Collaborating with industry representative on advisory committee Creating messages and scripting the ADCOM presentation and Q&A to defend your product well in advance

7 Jennifer Bolton, Regulatory Fellow, Boston Scientific Investigating development and execution of an efficient clinical trial strategy to bring a class Ⅱ device to market 12:00 TBC Luke Dery, Co-Founder & VP Operations, Pelvital USA Incorporating reimbursement strategy into clinical study design to avoid extra trials 12:30 Establishing critical data collection needs early in study design in support of reimbursement requirement. How the early development of clear reimbursement pathways can accelerate the reimbursement process Healthcare Economics: How will you demonstrate value to payers? Lars Oddsson, CTO, RxFunction 13:00 Lunch and networking Speaker Hosted s 14:00 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 30 minutes, and delegates may attend up to 2 roundtables 1 Evaluating which factors to consider when choosing markets for product launches Beata Blachuta, Medical Analyst Manager, Global Data 2 Can EFS strategy shorten time to market? Chris Pulling, CEO, MicroOptx 15:00 Chair s summary and close of conference