Outsourcing in Clinical Trials Southern California 2021

• Developing a clinical trial model that is able to withstand global disruption
• Switching gears: Should we be analysing which parts of our clinical trials can go virtual?
• Lessons learned from developing protocol designs and vendor/site relationships quicker during the pandemic
• Future trials: Assessment of how upcoming clinical studies will be conducted in light of the pandemic and what the long-term effects will be

Novotech Sponsor

• Key drivers of clinical trial growth in the Asia Pacific region
• DCT landscape and potential for change in the future?
• Debunking Decentralized Clinical Trial (DCT) myths and understanding the reality
• Key considerations to maximise the opportunity for DCTs and Hybrid Asia Pacific trials

• Considering the facets of ClinOps tasks that can be done remotely such as monitoring and IRBs- what can we learn from a global trial model?
• Exploring technologies available to clinical teams to allow them to function more remotely
• Harnessing the knowledge of CROs that are strictly remote; would this work for your study?
• Discussing the benefits of holding investigator meetings online to allow cost savings and higher attendance
• Working remotely is more productive; do you agree? Would this work for your team?

• New methods to incorporate Asian data into Western Phase I protocols for maximum speed and efficiency
• Latest regulatory environment for Chinse and Japanese Phase I data requirements
• What data is needed to allow Asian countries to join global trials? When and where can these data be collected?

• Understand the market and patient drivers: Identifying the best form of advisements based on the region
• Considering the patient and their motivators to encourage engagement throughout the study
• Identifying the importance of site & co-ordinator relationships so they have a vested interest and want to work with you to on-board patients
• Exploring the risk benefit ratio of incorporating social media recruitment in your study

• ‘Patient Centricity’: A concept much larger and more important than a current industry trend
• Explore the consequences of paying too little attention to the patient’s journey
• How oncology trials are different
• Learn approaches to ‘bake in’ a patient-centric mindset

A positive to come out of COVID-19? This decision will relieve pressure from notified bodies and manufacturers, but how can we prepare for 2021?

• Providing an overview of what the delay means, the key areas to focus on and the changes we will see when MDR comes into effect
• Pinpointing the benefits of the new MDR, how this can bring harmony with all countries
• Case study examples of an application including deliverables to ensure compliance with MDR
• Discussing how CROs/consultants are prepping for this and developing a task force for clients
• Navigating the guidance to understand what preparation needs to be done to eliminate gaps in your procedures

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
• 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

• Why target specific subsets of patients in early phase trials
• Protocol design considerations to expedite time to approval
• Use of patient selection tools to support a patient-first approach

• A few ideas for sponsor proactivity
• Site selection details that should (but often don’t) appear in requests for proposals (RFPs) to CROs
• Strategies for designing better site selection questionnaires that support faster study start-up

• What to look for and watch out for when evaluating a prospective clinical supply partner
• Making the choice between Integrated or a al carte service – risk and benefits
• Understanding the role of a clinical supply manager in the strategic planning process

• Pinpointing how a CRO- sponsor relationship can aide both clinical and preclinical research
• Exploring the approaches companies are currently taking to select a certain type of CRO
• Best strategies for enrollment and retention when working with a CRO to recruit healthy volunteers
• Examining the challenges that arise from high turnover rates in smaller CROs and how to overcome these
• Highlighting the advantages of niche CROs focussing on a specific indication and therefore having outreach in that patient community

• Utilizing real life examples, identifying what software and quality system is required when there’s a lack of regulatory guidance available
• Connected combination product development process
• Premarket requirements such as Design Control
• Use of software apps used in a clinical trial setting
• Audience Q&A

UBC Session Sponsor

• Overview of RNA based therapeutics
• Comparative analysis across therapeutic modalities
• Unique features of RNA based therapeutics that impact early clinical development strategies

• Impact of COVID on Clinical Trials from March 2020
• Using census data as a means of refining investigator selection based on availability of diverse populations
• Optimizing clinical trial design through dynamic simulation tools

Our panellists will give their no.1 recommendation for budding entrepreneurs and will address the following questions;

• What characteristics should a founder have?
• What are the top three characteristics that funding organizations seek in start-ups?
• What is the most challenging aspect of launching a start-up?
• What do you look for in partner and how do you find investors?
• What are the pluses/minuses to starting a company with a business partner?
• What’s the most important thing you do every day and why?
• How do you stay motivated when things get rough?

Interactive think tank 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 think tank session lasts for 45 minutes, and delegates may attend up to 2 roundtables.

THINK TANK 1:

Discussing best practice for bringing new tech and digital platforms into clinical trials
Host: Rupesh Kanchi Ravi, Head, Pfizer Oncology Clinical Research Lab, Pfizer

THINK TANK 2:

Collaborating with academic institutes as a way to increase product development efficiencies for small-to-mid sized companies?
Host: Sarjan Shah, Chief Operating Officer, Auritec Pharmaceuticals

THINK TANK 3:

Considering a small company’s perspective on eTMF management for effective running of your clinical trial
Host:Cindy Croissant, Vice President, Clinical Operations, LumiThera 

THINK TANK 4: Title tbc

Host: Axiom 

• Evaluating how one function impacts the others and how constant communication results in a quicker resolution
• Identifying current challenges in aligning timelines between departments to address common issues
• COVID-19 lessons learned: Providing examples of how breaking down silos enables creative problem-solving in a crisis
• Defining a communication framework which enables departments to effectively report on milestones reached or missed, changing trial parameters and raise issues

In this session, Paul Richardson, Sr. Director, Consulting at THREAD will share his perspectives and best practices focused on scaled adoption of decentralized clinical trial approaches. Topics include:  

• Global implementation
• How to move beyond pilots
• The convergence of DCT technology and real-world data
• The use of analytics to prove out the value proposition of DCT
• The importance of working closely with research ambassador teams, participants & sites to enable change management

Our host will give a brief overview of their best practices for patient on-boarding and engagement. The audience will then be split into 5 groups and within each group you will be given a task where you will have to come up with a solution together. 

• 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 patient 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 and their families using Google to learn more about clinical trials and the risks they pose, how do you communicate to patients and their extended support group that joining your study is a good option?

• Building effective & meaningful partnerships
• Solve problems creatively and proactively
• Ensure seamless operational execution
• Establish teams with strategic and therapeutic expertise
• Consider funding and co-development/partnership opportunities from the start

• Discovering how the FDA provides support more efficiently during a crisis and how the industry can help
• Discussing the challenges/drawbacks with the EUA process on the industry
• Prioritization: What products were released for the COVID-19 pandemic and how were these selected?
• Considering the impact if your device or drug is selected
• Assessing the impact of EUA causing other FDA regulatory programs to slow down due to shifting resources

• 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

• Discussing novel antibody immunotherapy protocols to understand key considerations during the design phase
• Presenting results from brain cancer patients treated with pritumumab
• Exploring the benefits of an unconventional target for immunotherapy

• Delving into the virtual clinical supply model
• Pinpointing Direct to Patient capabilities
• Global clinical supply offering
• Discussing medical procedures, services, and product reimbursement
• Best practices for improving site feasibility and removing barriers

Topic 1: The ever-growing importance of patient recruitment & engagement- lessons learned from the pandemic

Topic 2: The implications of COVID-19: how has it impacted the way we outsource and conduct clinical trials in the future? How prepared are we for next time?

Moderator: Anca Copaescu, CEO, Strategikon