8:20 am Registration & Opening Remarks

Donald J Kellerman
Vice President, Clinical Development and Medical Affairs
Zosano Pharma
8:30 am KEYNOTE Establishing best practices to get investment during a crisis
With investors holding onto their money due to an uncertain environment, how has COVID forced people to find new ways of doing business?
- Contracting and budgeting during COVID-19 – lessons learns and best practices for crisis management
- Strategic approach: Exploring results from model testing in order to release more funds
- Debating when to look at alternative funding such as funding via a strategic partner: How to maintain a level of control over your trial
- Discussing options of offshoring your trial to reduce costs

Ravi Kiron
Head, BioPharma External Innovation, EMD Serono
9:00 am Asia Pacific: the solution for accelerating your clinical trial program in the current climate
- A word on Novotech
- Current trends for clinical R&D
- Ensuring Clinical Trial Continuity during COVID-19
- Leveraging regional advantages to accelerate development

Rod Bugawan
Business Development Manager, Novotech
9:30 am Session reserved for Saama
10:00 am Session content TBC

Kelly McKee
Senior Director, Patient Registries & Recruitment
Medidata
10:30 am Solutions-focused approach: Overcoming hurdles presented with CRO oversight, governance and turnover
- The importance of a governance committee and meeting schedule to address milestones and risk management
- Monitoring CRO engagement using high level metrics on start-up aspects to draw up timelines
- Focusing in on inspection readiness to ensure correct documentation on CRO oversight
- Navigating best practices to handle turnover by collaborating with your CRO and establishing key expectations

Thomas M. Tremblay
Vice President of Clinical Development
Trefoil Therapeutics, Inc
11:00 am Operationalizing patient recruitment and retention in rare disease trials
- Choosing the right vendors based on the population, indication, and country/site mix
- Establishing and nurturing relationships with patient advocacy groups, key opinion leaders, and registries
- Harnessing the power of social media and the rare disease space
- A look at the impact of COVID-19 on rare disease trial recruitment
- Utilizing patient services to support recruitment and retention including the use of translators/interpreters, travel concierges, home health, etc

Jess Conicelli
Executive Director, Strategic Development, Rare, Orphan, & Pediatric Diseases, Synteract
11:30 am Debating how COVID-19 will impact the way we outsource and conduct clinical trials in the future: How long will we feel the ripples of this pandemic?
- Developing a clinical trial model that can withstand global disruption
- Switching gears: Analysing which parts of our trial can go virtual
- Lessons learned from developing protocol designs and vendor/site relationships quicker during the pandemic
- What contingency plan and tech can we use if patients can’t get to clinic- remote assessments?
- Future trials: What are the long-term effects of the pandemic on clinical trials?

Donald J Kellerman
Vice President, Clinical Development and Medical Affairs
Zosano Pharma
12:00 pm Session reserved for CATO SMS

Shannon Macquarrie
Vice President, Clinical Trial Operations, CATO SMS
12:30 pm Networking Lunch
1:00 pm Human factors engineering – the trends in usability engineering and moving towards the best designed human factors evaluation validation study
With the need to further minimize use-related hazards and risks, how much information do we need for a comprehensive safety evaluation?
- Considering the pitfalls with formative human factors studies vs market research
- Fit for purpose: Assessing human factors studies including flexibility, cost efficiency and more carefully managed resources
- Establishing a human factors validation study that tests intended uses, under the projected use conditions
- Incorporating Agency feedback and impact to IFU revisions
- Strategic planning: Considerations for pediatric indications requiring human factors studies

Jasmine Begin
Director of Regulatory Affairs and Quality Assurance
Zosano Pharma
1:30 pm Decentralised & hybrid trials – the way forward for more patient centric trials

EB McLindon
Senior Vice President, Site & Patient Solutions
ICON plc.
2:00 pm Moving past the traditional RFP process to allow effective vendor comparison: Breaking down RFI & RFP processes
- What’s the benefit of doing an RFI for a select few vendors prior to RFP?
- How can you be proactive when constructing RFI?
- Aspects to consider: what matters most; what attributes are you looking for; how to do your due diligence for an unknown vendor; how to clearly differentiate between vendors?
- Constructing an RFI/RFP with a niche vendor vs. large CRO
- Debating the optimal amount of protocol info to give vendors to ensure a full understanding

Michael Cox
Associate Director,Procurement, contract and vendor management
Fibrogen
2:30 pm Proactively planning for complexity in early clinical development
As early clinical studies have grown in complexity, the presenter will share insights on:
- Ensuring your strategies align with your desired endpoints
- Informing key decision points in early clinical trials
- Working with adaptive study designs or hybrid designs
- Planning ahead for unknown issues or changes
- Incorporating a risk management strategy

Brandi Lute
BS, MBA Director, Global Project Management, Covance by Labcorp
3:00 pm Handling organizational growth: Best practices in change management and process improvement to build a highly engaged and productive team
As a company transitions from a start-up to a larger business, what are the steps to manage this process?
- When is the best time to expand and what resources do you need to have for a smooth expansion?
- Does expanding your operations mean you need to outsource more?
- Examining how to make decisions on which operations to outsource at each stage of a company’s growth
- Identifying investment areas and how to go about acquiring the funding
- Why is it imperative to implement change management and process improvement during organizational growth?

Christina Hawley
Director of Clinical Affairs
ReCor Medical
3:30 pm Factors to Consider in the CRO Selection Process
- “Career limiting” Decision?
- So many choices/ So little time!
- CRO Location?
- Previous Experience with my company?
- Therapeutic Category experience?
- Size of the CRO vs My Needs?
- Costs?

Terry Tormey
Chief Executive Officer
Xenon VR
4:00 pm Close of Event
10:30 am TECHNOLOGY KEYNOTE - Creating a unified clinical technology environment
This session will focus on the key drivers for consideration for planning a unified Clinical Technology environment, including
- Using a requirements driven approach for Vendor & System Selection
- Assessing different platforms to enhance productivity, cost efficiency and expedite decision points
- Pros and Cons of using a Primary Vendor versus Best-of-Breed
- Cross System Integration and Efficiencies
- Change Management & Validation consideration

Toby Odenheim
Director, Technology and Governance
Parker Institute for Cancer Immunotherapy (PICI)
11:00 am Best practices to scale your global hybrid decentralized studies
As the industry continues to shift to decentralized clinical trial (DCT) approaches, sponsors and CROs must now focus on how to make this change globally. Attendees will learn to:
- Establish a global DCT platform and library-focused approach
- Evaluate country-specific regulatory requirements and feature specific limitations
- Develop a unique, efficient approach to global device provisioning
- Assess DCT vendors for optimal capabilities related to integrations, technical helpdesk and multi-lingual support availability

John Reites
President, THREAD
11:30 am Exploring the move towards virtualization in clinical trials as the new industry focus
With the industry forced into a remote setting, how can we be smarter about this
- Mitigating COVID-19 risks with virtualization methods
- Debating the idea of having a hybrid model by mixing traditional and remote methods
- Exploring how the rise in digital technology has enabled the move towards virtual trials: What tools are out there?
- Considerations in trial design to enable remote data capture

Danie Ramirez
VP Technology Search & Partnering
LEO Pharma
12:00 pm Best practices for patient recruitment, site engagement & scalable decentralized trials
This session will share best practices learned during the COVID-19 pandemic to successfully scale decentralized across all trial sizes and therapeutic areas.
- Why decentralized and hybrid are an imperative for any size trial or therapeutic area
- Lessons in scaling decentralized and hybrid trials to meet the needs of any size study
- Utilizing AI-enabled technology to drive patient recruitment, site engagement, and risk-based monitoring

Nagaraja “Sri” Srivatsan
SVP & Chief Digital Officer, IQVIA R&DS Technology Solutions
12:30 pm Networking Lunch
1:30 pm Session reserved for ERT
2:00 pm PANEL DISCUSSION - Considering a small company’s perspective on eTMF management for effective running of your clinical trial
When do you need it? When to outsource? And what should be in an eTMF?
- Exploring the current trends in streamlining clinical trials with eTMF
- Identifying what internal resources you have to manage eTMF and what can be outsourced
- Allocating a team member with internal authority to be the TMF owner to ensure inspection readiness
- Identifying how eTMF can quicken study start-up to improve overall trial efficiency

David Larwood
CEO
Valley Fever Solutions

Sharon Stothard
Director, Clinical Operations – Process, Systems & Quality
Assembly Biosciences

Alexander Markiel
Director, Clinical Documents
Nektar Therapeutics
2:30 pm Session reserved for Axiom Real-Time Metrics
3:00 pm What is required for a drug to be approved under the LPAD pathway?
The FDA LPAD pathway to approval can be helpful, if you work with a limited population with a life-threatening disease (Limited Population Pathway for Antibacterial and Antifungal Drugs)
- Outlining criteria for LPAD trials: working with small patient pool with a life-threatening disease and unmet needs?
- What drugs have been approved under the LPAD pathway?
- Pinpointing the challenges of these trials such as enrollment and understanding patient motivations
- Discussing the FDA guidance and parameters on LPAD approvals
- Real life case study examples

David Larwood
CEO
Valley Fever Solutions
3:30 pm Assessing the benefits and challenges of integrating technology in oncology trials: What does the future hold for your trials?
- Anticipating the realistic shift towards incorporating new technology, accelerating oncology drug development by investing in training and services
- Investigating methods to make cutting edge digital tools more financially accessible to allow for its wider use and benefit by smaller organizations
- Appreciating the incorporation of mobile technology in clinical trials which enables easy accessibility for patients
- Considering the risks regarding the reliability of data and technology
- Connecting with the right technology vendors in a growing and competitive industry to ensure that you receive the best quality service

Jennifer Lee
Senior Director, Head of Oncology Clinical Operations
Radius Health
4:00 pm Close of Event
10:30 am How to get creative with recruitment in or out of a crisis?
- In a post-COVID-19 landscape how can we create a more virtual patient recruitment process?
- Inclusion/Exclusion criteria- you’ve designed the perfect protocol, carefully thought out criteria but this perfect population doesn’t exist and your site can’t achieve it, what should you do?
- You have a clinical trial where the disease is not officially a rare condition but it is also not common, you still need to enroll a large volume of patients, what would be your strategy?
- How can you encourage patients to sign up to trials and come to the trial site/hospital when they are worried for their health?
- The Google Effect: with more patients/families using Google to learn about trials and the risks, how do you communicate to patients and their extended support group that they should join your study?

DIANA CHUNG
Senior Vice President
Clinical Development & Operations at Terns Pharmaceuticals
11:00 am Session reserved for PCM Trials
11:30 am Keeping the patient at the heart of your clinical trial design
- Ensuring objectives are synchronised by sharing protocol insights with patients
- Identifying strategies for translating patient experience into protocol design to enhance engagement
- Collaborating with KOLs in patient populations for study development and setting up advisory boards

Trisha Devlin
Sr. Director, Patient Value, Dermira
12:00 pm Decentralization strategies in rare disease studies
- Reducing patient (and caregiver) burden
- Building flexibility and patient choice into protocol design
- Future-proofing rare disease trials
- Case Study: Special considerations for rare pediatric populations

Haley Arellano
Associate Director, Operational Strategy & Feasibility, Precision for Medicine
12:30 pm Networking Lunch
1:00 pm INFLUENCERS PANEL DISCUSSION - Join the new influencers: Engaging patient opinion leaders, patient advocacy groups (PAGs), influencers, social networks
- Converting the emotional perspective to a data driven patient voice to all stakeholders in the trial
- Working with PAGs to develop the lay language for your trial ensuring patients clearly understand the study
- Discussing how to get patients involved in the trial design and to further promote the study
- Developing a strategy for social media and participation in online communities
- Putting patients at the steering wheel by inviting them to join advisory boards and examine recruitment strategies for a patient-focussed approach

DIANA CHUNG
Senior Vice President
Clinical Development & Operations at Terns Pharmaceuticals

Yu Ping Yen
Clinical Development and Operations Consultant
Polyphor Pharmaceuticals

Alicia Staley
Senior Director, Patient Engagement
Medidata

Michael Obedoza
Project Manager Clinical, Novotech
1:30 pm Session reserved for Anju Software
Outsourcing & Clinical Operations
Clinical Innovation & Technology
Medical Device
8:30 am ‘Working with niche CROs allows our study to be a priority because it’s a bigger piece of their pie…’ is it this simple?
- Exploring different approaches to finding niche CROs to ensure your partner can meet your specific needs
- Looking into unique ways niche vendors approach standard procedures such as enrollment and retention
- Identifying the issues that arise from high turnover rates in smaller CROs and putting a contingency plan in place to manage that risk
- Highlighting the advantages of niche CROs focussing on a specific indication and therefore having outreach in that patient community

Meraf Eyassu
Senior Director, Clinical Operations
FibroGen, Inc.
9:00 am Session reserved for UBC
9:30 am Mastering your outsourcing strategy: What are the key things to consider?
- Building relationships between stakeholders to become the sponsor of choice for CROs/sites
- Determining your outsourcing needs by identifying in-house capabilities
- Exploring different types of collaboration between sponsors, CROs and niche providers: what outsourcing models work for you?
- Utilizing the procurement team for cost savings, improved budgeting, technology, and stronger partnerships
- Identifying pros and cons of using niche providers to meet your needs

Mark J. Milberg
Senior Director, Clinical Outsourcing
Ultragenyx Pharmaceutical
10:00 am Session reserved for Avantor
10:30 am Creating an effective vendor audit process with a risk-based approach: Is the future remote?
- Advantages of remote vendor audits; can this be done for small/niche vendors?
- Importance of having preliminary conversations regarding logistics and how docs will be shared remotely
- Front-end planning: Working with your auditing team to scope out the most effective process for a remote vendor audit
- Exploring regulatory agencies view on remote audits and when going onsite is mission critical
- Will this continue post COVID as we see cost savings and better adaptation to technologies?

Gale McCandlish
Associate Director, R&D Quality and Compliance
Gilead Sciences
11:00 am Exploring what we need to know when choosing the right CRO for your trial
- Questions to ask your provider so that you can ensure they have understood your needs
- Identifying exactly what you need from a CRO and what aspects can be better managed in house
- How best to negotiate the best teams and what to look for when reviewing the CVs of potential project managers
- How do you know when you have hit on the right partner? Our panel share their thoughts on what makes them know they have found the right vendor

Karrie A Hilsinger
Clinical Program Study Director
Immunomedics
11:30 am Networking Break
12:00 pm GLOBAL DATA KEYNOTE - Clinical trials disruption due to COVID-19
- Understanding how COVID-19 affected clinical trials and most impacted therapy areas
- Clinical trial disruption in countries most affected with COVID-19
- Disruption of pivotal trials and potential impact regulatory approval of drugs
- Learning from disruption and future path for clinical trials outsourcing

Revati Tatake
PhD, Global Director of Databases and Analytics
GlobalData
12:30 pm Exploring lessons learned from previous early phase/preclin studies to develop best practices moving forward
- Investigating what is needed to properly resource an early phase study to ensure you have set aside sufficient time and budget
- Assessing various study designs for early phase trials to decipher which is best for balancing patient safety with quick progression to Phase II

Michael Lauw
Senior Director, Clinical Operations, Surrozen
2:00 pm Close of Conference
8:30 am PANEL DISCUSSION Creating a clinical trial landscape where small companies have better access to tech and innovation
- With biotech companies increasing in numbers and influence on the market, what tech is available for them?
- Overcoming the barrier of cost as well as acceptance and adoption of new technologies- Can we convince small biotechs to change the way they work?
- Discussing the possibility of vendors having a subset of tools that are affordable and can be easily adopted by smaller companies

Vineeta Gulati
Director, Clinical Operations
Clinical Operations, Global Solutions for Infectious Diseases

Bai Xu
CEO
Nanomed

Danie Ramirez
VP Technology Search & Partnering
LEO Pharma
9:00 am COVID-19 Transforming Suppliers to Partners: Will It Last?
- How COVID-19 Trials have rebalanced speed vs. risk
- How the Pandemic accelerated the demand for advances in technology
- How the world has moved to rapidly adopt decentralized trials and DTP
- After the Pandemic, what will remain and what will fade away?

Catherine Hall
VP of Clinical Innovation and Quality, endpoint Clinical
9:30 am This is Not a Trend: Exploring why patient-centred clinical research will continue to change the research paradigms of the past and the impact it can have
This talk provides you a comprehensive overview of the rapidly developing landscape in Patient-Centered Clinical Research.
- Defining what we mean when use the terms: Patient Centered Research, Patient Engagement and Patients as Partners
- Reviewing the major regulatory developments in support of Patient Centered Research
- Gain insights from the largest bi-annual global survey on patient and public perspectives of clinical research
- Explore the work being done to measure and evaluate the value proposition of Patient Centered Research activities
- Examples of Patient Centered Research programs, including sharing research results and acting-on the patient community’s input, and developing user-friendly websites

Behtash Bahador
Associate Director Relationship Management and Development
CISCRP
10:00 am Tips for over-coming today’s drug supply challenges though through scalable, adaptable technology
- Optimize buffer stock management and forecasting
- Automate IRT supply strategy updates to reduce cost, risk and effort
- Manage and oversee supply chain with flexible self-service tools and actionable insights
- Support traditional, decentralized or hybrid trials with flexible IRT strategies
- IRT design best practices for complex and evolving trial designs

Mark Berry
Senior Project Manager, Drug Supply Center of Excellence, Cenduit

Tom Nelson
Project Management Consultant, Cenduit
10:30 am Unlocking how to properly utilize Real World Evidence to improve site selection, design and execution
- 80% of trials don’t hit enrolment timelines- Identifying how RWE can be used to locate specific patient populations
- Delving into electronic medical health records to identify patient numbers before setting out study parameters
- Navigating RWE to gain metrics on how many patients sites bring in to improve site selection
- Highlighting the benefits of utilizing RWE for protocol modelling and regulatory submission

Bai Xu
CEO
Nanomed
11:00 am How to build your DTx and CRAACO Strategy - enabled by emerging Digital Health Technologies

Louisa Roberts
VP, Commercial and Strategic Healthcare & Tech Partnerships, PRA Health Sciences
11:30 am Networking Break
12:00 pm Remote audits & inspection preparations: What’s the latest focus for regulatory inspection?
- Strategies to alter sponsor processes ensuring more robust monitoring whilst keeping an open relationship with vendors
- Deciding on the level of governance depending on critical data and level of risk
- Utilising internal SOPs to guide you on vendor oversight specific to each individual provider
- Focussing in on inspection readiness to ensure correct documentation on CRO oversight and governance plans

Sandy Mohan
Vice President, Quality
Iovance Biotherapeutics
2:00 pm Close of Conference
8:00 am Registration and networking
8:30 am Patient-centric, Remote, Covid-Responsive: Next-Gen medical device models for the new abnormal
- Evaluate how to meet changing pandemic-influenced patient and practitioner demands using innovative medical device designs
- Hear a case study on how needle-free, vascular access innovation aims to reduce patient pain, anxiety, and practitioner risk while improving quality outcomes, system efficiency, and serving as an asset for socially distanced healthcare
- Explore the innovation and technology needed for remote operations and staff training during the pandemic
- Consider how to do pilot testing, introduce new products, and support hospitals during the Covid-19 crisis, and how this will shape future business models

Eric M.Stone
Co-Founder & CEO
Velano Vascular
9:00 am Exploring Extractables & Leachables – the journey for medical Device and pharma
- Defining the terms and answering common regulatory questions
- Designing the Extractables Study; breaking down guidance documents and everything you need to know:
- Time, Temperature, Solvents, Endpoints
- Analytical Evaluation Threshold (AET)
- Instrumental Analyses
- Total Non-Volatile Residues
- Offering insight on how to using the Extractables Data to prepare for Leachables Study
- Designing the Leachables Study – is it possible?
- Device Use, Combination Devices, Implantables
- Compounds not yet Identified
- Method Qualification

Roger Pearson
President Analytical Services
Aspen Research Corporation
9:30 am Mapping the road ahead under the EU Medical Device Regulation
- 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
- After the application deadline was postponed from May 2020 until May 2021 due to the global pandemic, are medical device companies on track to meet their new requirements?
- 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
Senior Director
Regulatory Affairs, Teleflex, Inc.
10:00 am Achieving flexibility in post-approval device study models to reduce the burden
- Reviewing the FDA guidance for post-approval surveillance requirements for medical device trials
- Breaking down the guidelines on balancing pre-market and post-market data collection
- Discover the large variety of types of post-market studies that are acceptable to FDA
- Laying out the model for collaborating with the FDA to apply the guidance in a mutually beneficial way

Judy Skroback
Director of Clinical Research,
SynCardia Systems, LLC
10:30 am TECHNOLOGY FOCUS 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
Abbott
11:00 am Selecting the right vendor for your trial and creating lasting partnerships
- Mapping out everything to consider when partnering with a service provider, such as a CROs’ regional expertise, monitoring capacity, site relations and network
- Looking at your company’s needs and finding a medical device partner who will be the perfect match for your trial
- Sharing experience on how to deal with your vendor going through a mergers and acquisition and smoothen the transition
- Hear advice on how to set up and retain an effective relationship from the beginning, with case study examples from device trials and lessons learned

Nick Damiano
Co-Founder & CEO
Zenflow
11:30 am Networking break – go to exhibition hall
12:00 pm PANEL DISCUSSION Exchanging best practices for having a strong global presence in medical device trials
In this keynote session our guests will introduce the topic with a 30min debate, which will be followed by an interactive panel discussion with both panellists and the audience
- Sharing first-hand experiences of coping with the impact of Covid-19 disruption on global clinical operations
- Exploring strategies for medical device companies to create self-sufficient local trial operations
- Debating which regions are best for US trial sponsors from a regulatory, financial, and operational point of view
- Looking at factors to consider such as patient populations and local expertise needed for your trial
- Hear lessons learned from working in US versus international sites and key tips for moving forward
- Offering different experiences of working in different regions and lessons learned

Nick Damiano
Co-Founder & CEO
Zenflow

Jennifer Liu
Technical Program Manager
Abbott

Ritu Verma
Head of Global Clinical Affairs
Natus Medical Incorporated

Hal J Mann
Director, Clinical Operations and Biometrics
Roche Molecular Solutions
12:30 pm Become a pro in Women’s Health medical devices and FemTech clinical trials
- Diving into the advancing space for medical device trial space for women’s health indications
- Discover the rise of FemTech and women’s health medical device innovation
- Highlighting key considerations for protocol development of trial design to ensure day-today operations meet patients’ needs
- Exploring how virtual and remote trial models can benefit women’s health trials, such as for gynaecological products and how Covid-19 has accelerated this shift

Tracy MacNeal
CEO
Materna Medical
1:00 pm Pinpointing strategies for patient recruitment in medical device trials
- Hear a case study of overcoming the clinical operations hurdles for a challenging women’s health study
- Providing key tips on how to establish relationship and trust with all stakeholders, from female patients to sites
- Sharing experience of partnering with and training large site teams and motivating sites to meet recruitment targets
- Discover strategies for successful patient recruitment amid the disruption of a global pandemic in an already complex trial environment

Kathryn Wine
Vice President, Clinical Operations
Alydia Health
1:30 pm CEO perspective: running virtual operations as a small medical device start-up
- Hear first-hand experience of running a virtual medical device company developing ophthalmic treatments
- Sharing experience dealing with the supplier delays during the Covid-19 and overcoming these issues
- Providing expert guidance on how to choose the right collaborator and create effective partnerships
- Thinking strategically about how to create sustainable growth from pre-commercial all the way to global commercial market access

Barry J. Linder
MD, MS, President & CEO,
Eyedetec Medical, Inc
2:00 pm Close of Conference
SPONSORSHIP ENQUIRIES
To enquire about sponsorship opportunities for the conference, please contact:
Nick McCudden
T: +61 280 978 126
E: NicholasMcCudden@arena-international.com
CONFERENCE ENQUIRIES
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