Outsourcing in Clinical Trials West Coast: Medical Device Stream Burlingame, CA February 22 nd 2018

Transcription

1 Outsourcing in Clinical Trials West Coast: Medical Device Stream Burlingame, CA February 22 nd 2018 Speakers Confirmed: Lian Cunningham, Vice President, Clinical Affairs and Regulatory Affairs, BAROnova Rosh Vora, VP, Clinical & Regulatory Affairs, PhysioCue Nagesh Uppuluri, Sr. Director Global Medical Affairs, Medtronic Neurovascular Ya-Chen Tonar, VP, Clinical and Regulatory Affairs, Bruin Biometrics Taraneh Farazi, Vice President, Clinical Affairs, Gynesonics Luis Vargas, VP Medical Affairs/Medical Director, Revision Optics Hal Mann, MBA, CCRP, CQA, Director, Clinical Operations, Trial Support & Strategic Outsourcing, Roche Molecular Systems Judy Skroback, CIP, CRCP, Director of Clinical Research, SynCardia Systems Nirav Dalal, Sr. Director, Real-World Evidence and Digital Health, Abbott Song Liu, Director, Clinical Trial Operations, Natera Marcia Wachna, Director Clinical Research, C2 Therapeutics Kunal Sampat, Senior Manager, Clinical Affairs, Abbott Further Information For programme enquires please contact: Chloe Roberts (0) For sponsorship opportunities please contact: Nicholas McCudden

2 OCT West Coast: Medical Device Program February 22 nd :45 Registration and refreshments 8:20 Chair s opening remarks Lian Cunningham, Vice President, Clinical Affairs, BAROnova Medical Device Stream 8:30 Comparing the updated EU and US clinical trial regulations to ensure compliance and approval across both geographies Agenda Highlight Identifying the best approach to gain approval for your device in the EU with Brexit on the horizon Assessing the new EU ICHE6 regulation to understand fully the effect on medical device trials to optimise cost-effectiveness Addressing the benefits of international trials despite regulatory complexities such as different demographics and patient populations Overcoming hurdles within the EU clinical space now that ICH regulations are matching up to FDA principles to ensure a successful study Rosh Vora, VP, Clinical & Regulatory Affairs, PhysioCue 9:00 Addressing the challenges associated with performing international trials in different cultural and regulatory environments to develop strategies for overcoming barriers Pinpointing the importance of international sites generating greater outreach in order to recruit the right patient population Recognising the benefit of having a remote contact for studies abroad to maximise local knowledge and an understanding of country-specific regulations Exploring exactly how involved the sponsor should be with an international trial to encourage efficiency Appreciating good relationships with international site coordinators to solve issues quickly despite time zone differences Nagesh Uppuluri, Sr. Director. Global Medical Affairs, Medtronic Neurovascular 9:30 Presentation session reserved for event sponsor

3 10:00 INTERVIEW SESSION Discussing best approaches to vendor partnerships to effectively manage medical device trials In this session our chair will conduct an interview with Judy Skroback & Marcia Wachna for 25minutes, followed by a 5minute Q&A with the audience. The interview will include the following topics: Agenda Highlight Pinpointing the importance of building trust with your vendors early on to work as a team throughout Assessing the challenge of vendor function and how sponsors can take back control Encouraging CROs to be more flexible with their outsourcing model to accommodate how the sponsor proposes to run the study Addressing site training methods to familiarize site personnel with relevant research and device functions Judy Skroback, CIP, CRCP, Director of Clinical Research, SynCardia Systems Marcia Wachna, Director Clinical Research, C2 Therapeutics 10:30 Morning refreshment break and networking 11:00 Striking the balance between outsourcing and utilizing in-house resources to improve efficiency in your trial: Which model offers the most value to sponsors? Exploring the pros and cons of hybrid vs full outsourcing models to identify the most suitable approach for your study Assessing your internal resources to decide which processes to outsource making the most of in-house capabilities Identify the best methods for gap analysis to gain a global view of what vendor expertise you require Ensuring you are attracting successful suppliers who will provide clinical and regulatory experts to work with you Evaluating the risk of your outsourcing model to understand who is responsible for each aspect of the trial Taraneh Farazi, Vice President, Clinical Affairs, Gynesonics 11:30 CASE STUDY Effective strategies for finding CRO suppliers with true Diagnostics experience and/or developing those capabilities with a true partner: real life examples for IVD s Deciphering which suppliers have the experience you require to be time-efficient with the selection process

4 Identifying the benefits of involving vendors at the earliest stages to build a strategic partnership with key suppliers Considering different ways to find a true device-specific outsourcing partner in a sea of pharma vendors Case study example of partnering with vendors to find medtechs that have the most relevant experience to combine forces Sourcing smaller niche CROs and developing your RFP process to fully understand their specific experience before coming to a conclusion Hal Mann, MBA, CCRP, CQA, Director, Clinical Operations, Trial Support & Strategic Outsourcing, Roche Molecular Systems 12:00 Effectively managing modifications during the conduction of an IDE study to remain compliant Exploring specifically what is required by the regulation Identifying what to consider when evaluating a modification Pinpointing how to implement a change to ensure you continue to run a smooth and successful study Lian Cunningham, Vice President, Clinical Affairs and Regulatory Affairs, BAROnova 12:30 Lunch break and networking 1:30 Exploring ways to negotiate and manage study budgets to ensure resources are allocated efficiently Assessing best practices for negotiating budgets with new vendors to decide on a reasonable amount and align timelines for the study Pinpointing methods for forecasting protocol design costs to improve efficiency Highlighting the importance of regular communication with stakeholders to determine the resources required for the trial Promoting strategies for monitoring sites and vendors to ensure the study stays within a strict budget Considering alternative methods for appealing to new investors to achieve as much funding as possible for your trial Agenda Highlight Kunal Sampat, Senior Manager, Clinical Affairs, Abbott 2:00 Designing and executing clinical trials for screening tests from the perspective of a small medical device company Comparing the difference between clinical trials for screening tests and clinical trials

5 for traditional medical devices/in-vitro diagnostic tests Understanding the challenges in designing and executing clinical trials for screening tests Running smooth trials for screening tests Managing medical device clinical trials with limited resources to ensure you remain within a budget Song Liu, Director, Clinical Trial Operations, Natera 2:30 Exploring the Medical Affairs approach to developing and implementing medical device studies to ensure a successful clinical trial Priming sites and surgeons for success with Training and Education Strategic alignment of study objectives and endpoints to drive value and fill data gaps Discussing data delivery in terms of collecting, analyzing and packaging data to ensure high quality data throughout your trial Identifying the importance of working closely with other clinical staff to educate site personnel and obtain quality study data Luis Vargas, VP Medical Affairs/Medical Director, Revision Optics 3:00 Afternoon refreshment break and networking 3:30 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. All roundtable session run twice, for 45 minutes, allowing delegates to attend up to 2 roundtables. RT 1 To outsource or not to outsource? Developing a successful game-plan to meet your needs as a start-up company Ya-Chen Tonar, VP, Clinical and Regulatory Affairs, Bruin Biometrics

6 RT 2 Discussing the use of real world data to cut the costs of clinical med device trials Nirav Dalal, Sr. Director, Real-World Evidence and Digital Health, Abbott 5:00 Chair s summation and close of conference