Outsourcing in Clinical Trials Southern California 2022

With clinical trials picking up globally we are in the position now to share our practical experiences and lessons learned with Decentralized & Hybrid Clinical Trials;

• Strategy/Planning: How do you make the decision to run a DCT; what are the considerations?
• If you could re-do your DCT what would you do differently? What were your biggest hurdles?
• Are Hybrid trials the more realistic and practical approach compared to full DCT – Agree or Disagree?
• Addressing considerations for different therapeutic areas, such as Oncology trial requirements
• Diversity considerations- looking at DCT from tech standpoint and examining language barriers, access to Wi-Fi etc
• Considering how the flexibility in the last 3 years has increased enrolment and patient centricity; how can we continue to do this?

Moderator: Lei Zhang, VP of Clinical Development, Frontage Laboratories

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

Joe Shan, Head of Clinical Operations, Mosaic ImmunoEngineering

• Evolution of the application of RWE throughout the product development lifecycle
• What information are you really getting with your outsourcing templates
• Leveraging brains, not process to drive effective proposals

• Strategies for successfully hiring and growing a ClinOps team in this day and age
• Millennials hire differently: Understanding how to hire, and manage, younger people
• Importance of changing expectations in the work place
• WFH vs in an office: Pros and cons of hiring and managing a more remote ClinOps team in the US
• What can small biotech ClinOps teams learn from large Pharma, and vice versa
• Technology works, let’s not put it back on the shelf: exploring tools available for a successful communication framework

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

Panellists: Jennifer Lee, Senior Vice President of Clinical Operation, Biostats, and Data Management, Elevar Therapeutics;

Tony Yu, Vice President of Clinical Trial Operations, Genelux Corporation

• Designing fit for purpose workflow around the patient
• Relieving burden of added technical and administrative tasks for site staff
• How customized support increases engagement, compliance and retention

• Oversight with less presence– designing an oversight plan based on KPIs, fewer monitoring visits and more virtual meetings, how to make this work
• Lessons learned on how to effectively build working relationships remotely
• Strategies to deliver training and upskill your clinical trial team
• Handling hard discussions with the site remotely if can’t get there in person
• Guidance on improving CRO communication channels– how to keep CROs in the loop and draw on their extensive experience
• We are all human, we all fail: Ensuring positivity in initial stages and taking responsibility

• Where is the Research Industry headed and why there is a need for Hybrid/DCT approaches within clinical research?
• When people living with rare diseases decide to participate in a clinical trial, you must keep in mind that…
  • They likely have other significant time commitments
  • They may have had adverse experiences
  • They need clear instructions and guidance to successfully complete testing and processes
  • They may not have received effective treatments for their condition to date and may have high hopes in the trial
• Patient perspectives and preferences are the soul of Medable’s Patient Success team

JOIN ONE OF OUR NETWORKING TABLES

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

• Exploring best practices for selecting central labs
• Pinpointing strategies for vetting 3rd party vendors and labs
• Discussing in-house vs outsource testing: which should you be doing? How to decide?

• Insights about setting up an Australian entity
• IP arrangement
• Maximizing R&D rebates
• Further details on executing clinical trials in Australia

• What does data mean to our patient communities?
• How can we engage and incentivize patients to support decentralized trials?
• How can that data help us to drive solutions in personalized care? While both saving costs and improving quality of life?

• Virtual clinical supply model
• Direct to Patient capabilities
• Medical procedures, services, and product reimbursement
• Global clinical supply offering

• Is it worth tweaking the relationship? How do you know when/how to severe ties? This session will consist of a quick 15min presentation followed by audience Q&A 
  • Utilizing milestone data to identify if the CRO-sponsor partnership is efficient and successful
  • Renegotiate – pros and cons of tweaking the CRO relationship compared to cutting ties, particularly in niche areas
  • Don’t burn bridges – identifying when to bail and how to go about it with grace
  • Exploring exactly why the CRO isn’t hitting those milestones and what can be changed

• Is there too much focus on data and a lack of empathy/compassion in trials?
• Has Covid and the digital age widened the gap between clinical trials and the human touch?
• Panellists give their advice: Building relationships with communities, HCPs, and the patient themselves
• How best to identify and involve touch points in the patient community as well as grass root organizations
• Examining why tech is not always the most effective way to work with patients
• Finding the balance of incorporating tech into trials with the advice of patient groups – getting more from your remote calls/meetings

Moderator: Christopher LeMasters, EVP & COO, XinThera

Panellists: James Wabby, Global Head, Regulatory Affairs – (CoE), Emerging Technologies, Combination Products and Devices, AbbVie;

• Key learnings from running DCT/hybrid trials so far
• Points to consider designing your coming clinical trials using DCT processes and technologies
• The building blocks in your DCT/hybrid trials

All things Combination Products: Strategies for incorporating medical devices into a pharma clinical study

James Wabby will give a 15min intro into the topic, his real-life experiences and best practices; followed by 15min audience interaction and Q&A.

• How can we do a better job of characterising and identifying the product upfront in development process?
• Importance of not assuming is a pharma or drug product, but seeing it as a drug-device system and focussing on safety aspects
• Strategies to partner regulatory affairs and clinical affairs to ensure device delivery system is cleared in all relevant countries

Get data capture right: Developing case report forms to gain data feedback on your device deficiencies during the study

The emergence of DCTs has inspired a new way of thinking about clinical research. As the industry looked to solve the problems created by COVID-19, technologies, protocols, even regulatory standards changed. The needs of patients changed as well.

This panel discussion will highlight:

• Realities of patient-focused training and support in the decentralized trial environment
• Best practices, common errors, and solutions that allow you to consider the support and training of your patients in your trial design
• Considerations for monitoring the success of your training and support to proactively avoid issues resulting from patients misunderstanding proper trial participation

JOIN ONE OF OUR NETWORKING TABLES

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

• Using EDC to automate clinical trials – how can we improve information-sharing, by reducing manual processes, improve visibility and oversight?
• Strategies to improve your source data verification processes
• Is eSource DDC which captures data electronically, directly into the eCRF at the moment of data creation, a better option?

Operational oversight within outsourced models has become increasingly complex for teams who are tasked with managing trials amid a rapidly changing landscape of partners, technologies, and global regulations. The elluminate Clinical Data Cloud provides one source of truth for clinical and operational data to manage trials across sources.

• Operational analytics including enrollment, protocol compliance and safety
• Risk-based analyses and insights with elluminate RBQM
• Operational knowledge for data-driven development with elluminate CTMS
• Centralized issue management across roles in operations, data and medical review
• Sample tracking, data forecasting and financial performance indicators

• Hot area for 2022 – what’s the next step for regenerative medicine?
• The fastest growing pipeline for new therapeutic submissions to the FDA – debating the pros and cons
• With the shift away from expensive, personalized treatments, toward more scalable and standardized “off the shelf” treatments… what does this mean for regenerative medicine?
• Reimbursement models will accommodate innovative regenerative medicine products and emphasize value

Is it worth tweaking the relationship? How do you know when/how to severe ties?

This session will consist of a quick 15min presentation followed by audience Q&A

• Utilizing milestone data to identify if the CRO-sponsor partnership is efficient and successful
• Renegotiate – pros and cons of tweaking the CRO relationship compared to cutting ties, particularly in niche areas
• Don’t burn bridges – identifying when to bail and how to go about it with grace
• Exploring exactly why the CRO isn’t hitting those milestones and what can be changed