DAY 1|23rd June 2021
Clinical Operations & Trial Design


FDA response to COVID-19 related challenges – lessons learned during the first year of the pandemic


  • FDA Organizational leadership changes
  • OEIO’s involvement in the supply chain for Covid-19 vaccines, PPE and test kits

Lessons learned from the Covid-19 pandemic from the FDA ORA perspective

Gordon Chu

Director of Investigations Branch Division of West Coast Import (DWCI) Office of Enforcement and Import Operations U.S. Food and Drug Administration


Dan Solis

Division Director, Division of West Coast Imports


10:30 am Session reserved – SyntactX


Innovative approaches to building winning relationships and trust with patients, research sites and CROs in a post COVID-19 world 

  • Engaging with patients to understand their needs and preferences to develop insights that will result in better therapeutic experiences
  • Partnering together with sites to design relevant clinical trial protocols and optimize study execution – lessons learned
  • Handling quality assurance in a complex environment where standards and access to care differ globally – can CROs help in navigating a complex regulatory landscape?
  • Top tips to building a partnership-oriented sponsor-CRO relationship to deliver a robust performance and optimized trial execution

Hal J Mann

Director, Clinical Operations and Biometrics

Priya Janakiraman

Director Clinical Science

Johnson & Johnson Vision

Stephanie Kallay

Director, Patient Advocacy and Outreach

Crinetics Pharmaceuticals

Edward Cox

Board Member of DTRA, EVP EVERSANA, former CEO, Dthera

11:30 am The Comeback: Patient Recruitment & Engagement for Medical Device Trials in our ‘current reality’: How COVID-19 has presented opportunities throughout the industry to relearn patient recruitment, site engagement and execution of studies

The already challenging task of recruiting patients for clinical trials was exacerbated by the global COVID19 pandemic. Yet the “current reality” that is emerging brings with it a new creativity and diligence on trial design that will ultimately benefit the industry. This presentation explores a greater awareness and sensitivity towards the patient journey during both recruitment and site engagement for a trial, a pragmatic approach to global site selection, and the customization of site engagement during the life cycle of trials that embrace a wide range of technologies, alongside a necessary change in stakeholder mind set, to successfully execute and collaborate in order for successful outcomes to be achieved in global locations.

  • Site considerations
  • Patient journey
  • Operational execution


Brandy M. Lee

Manager, Clinical Operations, Medical Device and Diagnostics

Covance by Labcorp

12:00 pm Preparing for an FDA advisory committee review – lessons learned

  • What to expect from an ADCOM panel – understanding the process
  • Determining who needs to be involved and advice for preparing your team in advance
  • The importance of the transparency of communication at all stages of the advisory panel process
  • Issues that we raised during the panel and how they were overcome

Jennifer Bolton

Senior Regulatory Fellow

Boston Scientific

12:30 pm Session reserved – NAMSA

1:00 pm The latest EU Medical Device Regulation – understanding the legislation and its requirements

  • Latest developments in EU legislation with respect to medical devices – a yearlong delay in launch due to the global pandemic
  • An update on how US medical device industry is dealing with the transition to the European Medical Device Regulation
  • Looking at the immediate and long-term implications on different medical device products and how the regulation affects global operations for trial sponsors
  • Highlighting changes to the revised standards, such as ISO14155, the impact of changes, and the greater need for clinical data in general as a result of MDR

Louis Marcoux

Sr. Director, Regulatory Affairs

NeoTract | Teleflex Interventional Urology

1:30 pm Global monitoring strategies in a Post-Covid environment

  • Provide an overview of global monitoring expectations post COVID
  • Discuss inoperative monitoring strategies going forward
  • Practical Tips for Optimizing Monitoring visits

Diran Adelakun

Manager, Global Clinical Monitoring Services


2:00 pm Successful strategies for creating self-sufficient local trial operations globally

  • Navigating the complexity of study designs and assessing the volume and method of data being collected. Deciding which regions are best for US trial sponsors?
  • Discovering the key success factors of a high quality clinical investigational plan – patient populations and local expertise
  • How to incorporate site input into the protocol development process? Facilitating open dialogue between industry sponsors and investigators to decrease number of procedures needed to be done within a study and decrease number of protocol amendments in the future
  • Hear lessons learned from working in US versus international sites and key tips for moving forward

Ritu Verma

Head of Global Clinical Affairs

Natus Medical Incorporated

2:30 pm How to deliver medical device trials virtually; the benefits and challenges

  • Why are virtual delivery models ideal for medical device trials and what does it take to run them?
  • What are the benefits and challenges?
  • Fad or fate? What does the future hold?
  • How to access free support for medical device trials in the UK.

Yan Yiannakou

Clinical Director

NIHR Patient Recruitment Centre (Newcastle)

Theo Christie

Business Development Manager (Commercial)

NIHR Clinical Research Network (CRN)

3:00 pm Mitigating the impacts of COVID-19 on clinical trials – lessons learned and long term implications

  • Analyzing the magnitude of the impact COVID-19 had on clinical development in terms of trial activity, across geographies and therapeutic areas
  • 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
  • Exploring effective ways to address statistical implications from missed patient visits, tests, and increased protocol deviations
  • 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?

Nick Damiano

Co-Founder & CEO


3:30 pm Outsourcing considerations for your clinical trial

  • Understand the foundations/bedrock of a GCP/FDA compliant clinical study
  • Evaluate when to outsource versus keep functions in house
  • Explore the integration of auxiliary expertise for successful study execution (e.g. Reimbursement, Healthcare Economics, Healthcare Compliance)

Iman Ahmad

Senior Director Clinical Affairs


4:00 pm How to maximize opportunities for investment and partnering deals in clinical trials – lessons learned from an early stage medtech company

  • How to overcome the product development funding challenge as investors tend to wait to invest until a device achieves sufficient safety and efficacy evidence, or until regulatory approval and reimbursement have been secured
  • Working collaboratively with industry participants to find new sources of funding – the power of networking
  • Locating sites that possess the capacity and willingness to properly execute medical device trial

Jerrold M. Shapiro


Floelle Inc.

4:30 pm Successful models for collaborating with the FDA

  • Leveraging FDA Guidance documents
  • Understanding FDA Review policies
  • Utilizing the Q-Submission process

Judy Skroback

Director of Clinical Research,

SynCardia Systems, LLC

5:00 pm End of Conference

11:00 am The role of FemTech in revitalizing the medical device industry – promoting equitable enrolment in clinical trials to improve cardiovascular health in women

  • Educating principal investigators and site staff about the importance of including women in trials
  • How do you promote recruitment and retention of women? Understanding the main participation barriers for women
  • Tackling the gender gap in health research and education – key considerations when planning, developing and implementing new processes and protocols
  • Exploring how virtual and remote trial models can benefit women’s health trials and how Covid-19 has accelerated this shift

Tenley Koepnick

Senior Director, Clinical Operations

Edwards Lifesciences

11:30 am Decentralized and Hybrid trials for Medical Devices and Diagnostics

A primer and roadmap to implement emerging technologies for device and diagnostic trials

  • The rise of TeleHealth & Remote Trials
  • How to integrate your device or diagnostic via API
  • Two case studies that highlight DCT methodologies that you can incorporate into your DCT strategy

Derk Arts

Founder & CEO


12:00 pm The data management challenge – barriers and solutions

  • COVID-19 and its impact on the adoption of technologies already available to improve patient outcomes
  • Accelerating the development of new device-specific technologies to optimize patient care
  • Maintaining essential data collection to meet study endpoints, the global clinical trial challenge
  • How effective data management can help to accelerate progress toward the aim of improving the patient experience

Frances Rubenstein

Director, Database Management

Nevro Corporation

12:30 pm Session reserved – Axiom Real-Time Metrics

1:00 pm The digital transformation of clinical trials – the importance of data accuracy

  • Redefining digital clinical trials from the point of view of patients, sites, sponsors and regulators
  • How do you ensure accurate data collection and reporting by patients – best practice
  • 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

1:30 pm Session reserved – IQVIA MedTech

2:00 pm 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?
  • An overview of powerful enrolment strategies
  • Diversifying clinical trials – how to engage women and minorities in clinical trials
  • Patient-driven clinical trials – diminishing the burden of participation by making the participant journey as convenient and pleasant as possible
  • A case of overcoming challenging consent and – using effective enrollment aids

Kathryn Wine

Vice President, Clinical Operations

Alydia Health

2:30 pm Creative approaches for conducting device testing that offer broader reach to a diverse audience set along with efficiencies in cost & timing

  • Completing actual & simulated use studies can be time consuming & expensive
  • Key considerations are given for taking lessons learned from market research for how to best engage with subjects in a compliant manner
  • Explore how access to panelists globally can help improve timeline and increase the diversity of your test participants

Shannon Childs

SVP, Strategic Development

Schlesinger Clinical Research

3:00 pm 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 Lee

Executive Director, Head of Oncology Clinical Operations

Radius Health

3:30 pm Session reserved for Event Sponsor

4:00 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

4:30 pm Discovering innovation in digital health and connected medical devices

  • Diving into the latest technology trends for digitally streamlining medical device trials
  • A hybrid area: exploring how digital health tools can power successful medical device trials and conversely the connected and wearable MedTech products offering solutions for pharmaceutical clinical trials
  • Assessing the future of telehealth and telemedicine in shaping patient monitoring norms
  • Hear updates on the regulatory environment for digital health and the FDA’s stance on this market

Jennifer Liu

Technical Program Manager


5:00 pm End of Conference