9:00 am CHAIRMAN’S OPENING REMARKS

Dominic Tong, MA
Senior Analyst, Medical Devices
GlobalData
9:15 am KEYNOTE ADDRESS: Getting FDA approval for your device – top tips
- 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

Jennifer Bolton
Senior Regulatory Fellow
Boston Scientific
9:45 am Session reserved for Castor
Kristin Stallcup, Senior Director, Customer Success, Castor
10:15 am Transitioning to a hybrid or decentralized trial strategy
- 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

Jennifer Duggan
Senior Director Global Study Management Global Clinical Operations
Abbott
10:45 am Morning refreshments & networking
11:15 am CASE STUDY: Best practice in remote patient monitoring to improve real-time data collection, minimize study participant loss and reduce costs
- 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

John Hsu
CEO and Co-Founder
iPill Smart Dispenser
12:00 pm Session reserved for Viedoc
Session reserved for Viedoc
12:30 pm Networking lunch
1:45 pm Successful strategies for conducting global clinical trials
- 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

Long Doan
Director, Clinical Affairs
Glaukos
2:30 pm Session reserved for Axiom Real-Time Metrics
Session reserved for Axiom Real-Time Metrics
3:00 pm AFTERNOON REFRESHMENTS & NETWORKING
3:30 pm 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.
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
4:30 pm CHAIRMAN’S WRAP UP

Dominic Tong, MA
Senior Analyst, Medical Devices
GlobalData
4:45 pm CONFERENCE DAY 1 ENDS
9:00 am CHAIRMAN’S OPENING REMARKS

Dominic Tong, MA
Senior Analyst, Medical Devices
GlobalData
9:15 am KEYNOTE ADDRESS: Clinical trials: what can go wrong and what you can do about it
- 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?

Robert Berman
CEO
enVVeno Medical
9:45 am How device and diagnostic developers can benefit from an integrated, multidisciplinary team
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.

Cori Ragan
Regulatory & Quality Systems Principal Advisor
Labcorp’s Medical Devices and Diagnostic Development Division
10:15 am Mitigating the impacts of COVID-19 on clinical trials – lessons learned and long term implications
- 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?

Paulette Niemyski
Senior Clinical Consultant
EBR Systems
10:45 am Morning refreshments & networking
11:15 am PANEL DEBATE: Building successful sponsor-CRO relationships to deliver a robust performance and optimized trial execution
- 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

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

Long Doan
Director, Clinical Affairs
Glaukos

Paulette Niemyski
Senior Clinical Consultant
EBR Systems
12:15 pm How to build a lean start up clinical operation - lessons learned from an early stage medtech company
- 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

Rodney Brenneman
Chief Executive Officer
PhageTech
12:45 pm Networking lunch
1:45 pm CASE STUDY Leveraging the RFP process to identify a great CRO partner
- 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

Alejandra Maciel
Vice President Clinical Affairs
Epigenomics
2:15 pm Transforming clinical trials with the power of AI
- 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

Srihari Yamanoor
Senior Manufacturing Engineer
THINK Surgical
2:45 pm WORKSHOP: Successful patient recruitment and retention strategies
- 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

Christine Von Raesfeld
Independent Patient Advocate
3:45 pm CHAIRMAN’S WRAP UP

Dominic Tong, MA
Senior Analyst, Medical Devices
GlobalData
4:00 pm CONFERENCE DAY 2 ENDS
SPONSORSHIP OPPORTUNITIES
Our sponsorship packages help companies educate their target market on key industry issues and spread brand awareness throughout the industry. If you want to discuss how we can help you generate leads and add-value to your corporate and brand image please contact:
Paul Adams
pauladams@arena-international.com
+44 (0)20 7936 6948
SPEAKING OPPORTUNITIES
We identify and invite individuals we believe to be the best speakers in the market, if you think you can make a difference to the quality of our events please contact the programme director of the event:
Chloe Roberts
T: +44 (0) 207 936 6822
E: chloe.roberts@arena-international.com