Outsourcing in Clinical Trials: Medical Devices USA 2022

• How to prepare for an FDA Advisory Panel in 2022?
• FDA response to medical device regulatory challenges
• How to avoid time consuming delays – preparing your team and communicating with transparency
• Exploring the best ways to communicate with all branches of the FDA

Kristin Stallcup, Senior Director, Customer Success, Castor

• How hybrid and decentralized trials have altered traditional clinical pathways
• Top tips to implementing a digitally-enabled research
• Discovering the benefits to patients, such as improved access to research and a more positive trial experience
• Exploring the new ways in which sponsors, sites and patients must navigate as a result of the COVID-19 pandemic

• Exploring the new ways in which sponsors, sites and patients must navigate as a result of the COVID-19 pandemic
• An overview of successful strategies to advance decentralized trials and remote monitoring
• How can you get more out of clinical trial data and obtain more comprehensive, consistent and reliable outcomes from clinical trials?
• Debating the true potential of digitization in reducing the number of participants and lowering the cost of bringing device to market

Session reserved for Viedoc

• Deciding which regions are best for US trial sponsors?
• Understanding the Reasons for Venturing into these regions
• Key success factors of a high quality clinical investigational plan – patient populations and local expertise
• Hear lessons learned from working in US versus international sites and key tips for moving forward

Session reserved for Axiom Real-Time Metrics

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.

R1: Partnerships: discussing the best approaches for choosing providers

Alejandra Maciel, VP Clinical Affairs, Epigenomics

R2: CEO perspective:  strategies for running a medtech start-up

Rodney Brenneman, CEO, PhageTech

R3: Top tips to a successful patient recruitment and engagement strategy

Christine von Raesfeld, CEO and Patient Advocate, People with Empathy

R4: Understanding the true impact of the COVID-19 pandemic on the medical device industry – what does the future hold?

Jennifer Duggan, Senior Director Global Study Management Global Clinical Operations, Abbott

• Proven strategies that can help you to rescue trials that go wrong
• The potential ramifications of not thoroughly testing your product – could additional tests be worth it?
• Should devices be trialed even if the FDA doesn’t require it? And how vigorous should those trials be?
• What latest technology developments can help you in mitigating the risk?

It takes a village to develop a medical device, and the often highly specialized nature of such products creates challenges for clinical trial design, physicians and patients alike. In this presentation, we explore 5 ways clinical trials are optimized through the deliberate employment of a multi-disciplinary CRO team able to work with sponsors, trial sites, regulators, and medics to develop and commercialize new devices and diagnostic equipment.

• Managing disruption and overcoming challenges such as delays in patient enrollment and study initiation or inability of patients or sites to comply with scheduled visits
  
• An overview of successful strategies to advance decentralized trials and remote monitoring
  
• COVID-19 as a catalyst for change – encouraging protocol amendments innovation and flexibility in patient engagement 
  
• What does the future hold for the post-COVID-19 clinical research in medical devices?

• Building trust with your CRO in a virtual landscape
• 3 key factors you need to take into consideration when selecting a CRO in order to ensure they are best able to handle your study needs
• Mapping out everything to consider when partnering with a CRO – how to encourage CROs to meet the changing needs of medical devices industry
• Handling quality assurance in a complex environment where standards and access to care differ globally – can CROs help in navigating a complex regulatory landscape?

MODERATOR:

Dov Gal, VP Regulatory, Clinical and Quality; Compliance Officer, ReShape Lifesciences Inc.

PANELLISTS:

Long Doan, Sr Director Clinical Research, Glaukos

Paulette Niemyski, Senior Clinical Consultant, EBR Systems

• Building a novel diagnostic platform – the view from a small start-up perspective
• Creating a lean start-up clinical structure – learning to scale down whilst overcoming the usual challenges
• Working collaboratively with industry participants – research sites and CROs in a post COVID-19 world
• Discussing the solutions available for novel device companies and the options available that can most successfully bring a device to market – the long term impact of the pandemic on virtual patient monitoring

• Best-in-class approaches for selecting CRO partners
• Top tips to a successful RFP process
• How do you identify all types of risks and how do you mitigate it – lessons learned
• From scorecards to selection committee – discover critical factors for a successful CRO partner selection

• AI as an enabler to drive down the costs of clinical trials whilst ensuring patient safety and improved timeliness
• Applying advanced machine-learning techniques to objectively measure symptoms and quantify the impact of therapies – lessons learned from the pharmaceutical industry
• Exploring the potential of AI in gathering more objective evidence by automatically collecting consistent, unbiased data
• Effective ways to capture new kinds of data from clinical trials subjects using sensors, wearables, smartphone apps, and other devices – an overview of solutions available on the market

• Patient’s view – what information is critical to support the participation decision-making process from the patient’s point of view?
• Overcoming the barriers and challenges in patient engagement -an overview of powerful enrolment strategies
• Diversifying clinical trials – how to engage women and minorities in clinical trials
• Patient-driven clinical trials – understanding patient behavior and mitigating patient recruitment issues due to COVID-19
• Exploring how virtual and remote trial models can benefit all industry participants including patients