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

• The latest research and trends of clinical trials globally and in Asia-Pacific
• The reasons why clinical research sites in Asia-Pacific have been less affected by the COVID-19 crisis than in other regions
• The advantage of running global trials with regional CRO specialists

Novotech Session Sponsor

• 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?

Parexel Session Sponsor

• 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

Synteract Session Sponsor

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

Eat lunch with a like-minded group of industry colleagues by joining one of our lunchtime discussion groups on the topics below:

Table 1:Discussing the application of new tech, such as AI and Blockchain, in clinical trials

Table 2:Overcoming common small company pain points

Table 3:C-level discussion: How to make your resources stretch further and reduce time-to-market

Table 4:Exploring best practices for patient recruitment in vaccine trials

• Overview of the changes experienced in your clinical trials as a result of the COVID-19 Pandemic
• Discussing the top burdens such as travel, length of visit, diagnostic tests
• Exploring COVID-19 disproportionate impact: Why
• Addressing minority enrollment in COVID-19 studies
• Considering diversity in clinical trial populations

Premier Research Session Sponsor

• Outlining the rare disease target patient population to strategize the design of the study
• Highlighting the profile campaigns associated each initiative
• Reviewing the patient referral performance and costs involved in each campaign to directly compare

• 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

• 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

Utilizing real life case study examples, Brian Dempster will discuss when to consider a rescue study, address the pitfalls and bust common misconceptions. The session will end with an audience Q&A

• Identifying if your vendor has the capabilities for trial completion and when a rescue study is the best option
• Considering the costs involved and the data transfer process with your rescue vendor
• Exploring how to set up a robust system at the start of your trial to ensure it is adaptable and lasts the full length of your trial
• Bust myths about data going missing and regulators not being satisfied with a rescue study
• Looking at it from the patients’ perspective; better access to the data

• 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

Eat lunch with a like-minded group of industry colleagues by joining one of our lunchtime discussion groups on the topics below:

Table 1:Discussing the application of new tech, such as AI and Blockchain, in clinical trials

Table 2:Overcoming common small company pain points

Table 3:C-level discussion: How to make your resources stretch further and reduce time-to-market

Table 4:Exploring best practices for patient recruitment in vaccine trials

• Appreciating that innovation is just as likely to come from outside the walls of a large healthcare company as it is from within.
• Exploring why many innovative ideas fail at the early stage
• Discussing a model for early stage companies to bring their innovations in therapeutics, medical device or consumer health from concept to fruition

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
Tentatively confirmed:Cindy Croissant, Vice President, Clinical Operations, LumiThera 

THINK TANK 4:

Discuss remote monitoring during a crisis – How can we learn from this so we are better prepared?
Host:Ken Wilson, Outsourcing Lead, Pfizer

• 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

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?

• 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

• ENROLLMENT; Using centralized SMOs and Physician Networks, Patient advocacy groups, Recruitment Services, Access to Big Data
• Regulatory Considerations; FDA Programs and Designations, Study Design Considerations

• Establishing 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 to draw up timeline and performance goals
• Focusing in on inspection readiness to ensure correct documentation on CRO oversight and governance plans
• Navigating best practices to handle turnover by collaborating with your CRO and establishing key expectations

• Quality by design: How can RBM lead to the best quality protocol and avoid running into amendments
• Are sponsors leveraging solutions or building their own?
• Identifying the main aim of implementing RBM for better education and improved protocol quality
• Have we seen uptake in quality, Better quality data submitted to regulatory?

Join our interactive discussion groups to round off the day with your peers and put in place an action plan for your clinical trial. Each roundtable will last 30 minutes,and delegates may attend up to 2 roundtables.

Roundtable 1:
Discussing what to consider when finding a partner for your early stage study & the impact COVID-19 has had on early stage clinical development- how should we move forward from here?
Host: David Beno,CSO, Xeno Biosciences

Roundtable 2:
Overcoming hurdles with CRO oversight, governance and turnover

Roundtable 3:
Innovative ways of improving vendor engagement and communication