Outsourcing in Clinical Trials West Coast 2022

Debating how COVID-19 will impact the way we outsource and conduct clinical trials in the future; a follow up from our 2021 session, what has changed?

• No going back – what’s the ‘New Normal’ in clinical trial operations?
• How can we develop a clinical trial model that can withstand global disruption?
• Highlighting technologies accelerated during the pandemic – are these a flash in the pan or what technologies should we continue to invest in?
• Tips and tricks for keeping studies flexible and on track
• Future trials – summarizing lessons learned from COVID-19, what we carry forward and how to reduce the burden on patients

Moderator: Bruce Morimoto, VP, Drug Development, Cerecin

Panellists: Donald J. Kellerman, Vice President, Clinical Development and Medical Affairs, Zosano Pharma;

Thomas M Tremblay, Vice President of Clinical Development, Trefoil Therapeutics, Inc;

Ravi Kiron, Head, Biopharma External Innovation, EMD Serono

Chair: Donald J. Kellerman, Vice President, Clinical Development and Medical Affairs, Zosano Pharma

What is causing this failure to recruit communities of color & how can we reach underrepresented populations? 

• Examining implications of not getting a diverse patient population– ethical, scientific, clinical concerns
• Understanding the reasons why ethnic minority participation in clinical trials is still low
• Strategies for engaging and recruiting under-represented patients
• Is the problem us? An honest look at the lack of trust communities have in health care and industry and how to build trust
• How are we reaching other marginalized communities, e.g. LGBTQ+, rural?

• A case study on keeping a trial running throughout the pandemic
• Updating protocol and study design in response to changing world environments
• Adapting and complying with new international regulations in response to the pandemic
• Tips and tricks for keeping your studies flexible in changing environments

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

• 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
• Practical solutions and case study to conclude

• Thinking ahead: Evaluating at which point in the trial process CROs should be involved to have the maximum impact
• Considering your CROs wealth of experience and treating them as an equal partner rather than transactional
• Identifying aspects of protocol development your CRO can advise on, such as which countries to approach first
• Risk sharing: Utilizing CROs who have skin in the game to help set up contracts

In a post-pandemic world, what aspects of clinical trials will go back to the way they were, and what we will take from the pandemic?

• Discussing how remote working impacted your teams; the positives and negatives we can take forward
• Outlining what current monitoring plans look like
• Highlighting the changes at site level and how we can maintain communications and visibility when visits are reduced
• Technology works, let’s not put it back on the shelf: exploring tools available for successful communication and monitoring plans, was this a missed opportunity before?

Chair: Bonnie Bain, Global Head and Executive Vice President, GlobalData

• Identifying how using the right tools for remote training can improve performance management of sites
• Exploring how best to implement virtual training to significantly reduce protocol deviations
• Finding the right virtual training supplier who can use simulated scenarios and using real life situations that allow practice decision making in a safe environment
• Remote Site Performance Management tech – how to find out what’s available and what would work with your study?
• Can remote training allow quicker and cheaper site activation?

• Building the company internal virtual trial eco-system is key to make decentralised trials happen – the panel will give their advice on best practices
• Are hybrid models superior to 100% virtualized?
• Considering the challenges with retaining patients and investigators in these new virtual trial designs
• Patient Bias – decentralized trials require patients to have reliable internet service etc, could this induce a bias for which patients are recruited in fully virtual trials?
• Debating strategies for overcoming challenges with virtual trials, such as missing adverse reactions if done remotely, and wearable device integration

Content to come

• Defining decentralized clinical trials (DCT) versus clinical trials with direct-to-patient (DTP) elements
• Pinpointing the advantages of DTP/DTC for sponsors, sites and patients
• Strategies for aligning all stakeholders involved and determining whether to pursue one or the other
• Developing a patient centric approach by utilizing DTP and getting the most out of it:
  • Increased patient recruitment and retention
  • Solving logistical problems pre and post pandemic

Discussing in-depth the efficiency of remote monitoring, including key takeaways from the pandemic

• How to meet regulatory requirements and sponsor responsibility for monitoring using remote monitoring techniques such as
  • Participant Registration Forms
  • Encounter Forms
  • EDC edit check
  • Data reviews
• Exploring the cost effectiveness of remote monitoring
• Pinpointing how to monitor “monitoring”

Chair: Lisa Lea, Director, Global Patient Engagement and Advocacy, Acceleron Pharma

Our 2 expert speakers will each give a 10minute quick fire presentation on creating patient-centric trials, patient advocates and boosting patient engagement. The session will end with an audience Q&A.

• Working with patient advocacy groups from pre-study start-up to facilitate engagement
• Overcoming the barriers and challenges in patient engagement
• Understanding where patient engagement gives you an edge over your competitors
• Getting patient more involved in the trial design decision-making process
• Seeing patients as passionate advocates for your trial utilizing their voice to engage others

Using practical examples, personal experience and future therapies to pinpoint success in patient recruitment and patient-centric trials, with a rare disease focus

• Determining best practices for tele-visits, particularly in rare disease, giving patients more options
• Sponsors staying pro-active by identifying the patient populations most in need of remote visits
• Pinpointing strategies for how/when to interact with these patients remotely during the trial
• Using real life case study examples to evaluate enrolment strategies with rare disease patients; pros and cons
• Theories of enrolment processes moving forward into 2022 and beyond, considering the impact of COVID-19

• How has patient behaviour and willingness to come on site for a clinical trial changed?
• How can you encourage patients to sign up to trials and come to sites when they are worried for their health?
• Discussing methods for mitigating patient recruitment issues due to COVID-19
• Our panelists will discuss how to combat local lockdown challenges by diversifying sites across a range of locations
• How can we proactively engagement with patients and why is effective communication so important?
• Assessing the impact of digital tools in patient recruitment and how they can best be used- how much of recruitment now relies on social media & is this a good thing?
• How can retention be aided by remote visits and incentives? Using case study examples

Moderator: Lisa Lea, Director, Global Patient Engagement and Advocacy, Acceleron Pharma

Panelists: Christine Von Raesfeld, Independent Patient Advocate;

Estela Mata-Carcamo, President, Healthcare Advocate, Looms for Lupus

Chair:  Donald J. Kellerman, Vice President, Clinical Development and Medical Affairs, Zosano Pharma

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

Demystifying site budget and contracting processes to improve financial transparency between sites, sponsors and vendors

• Best practices for fully briefing your vendor on the parameters of your trial to avoid inflated budgets
• Highlighting the importance of country-specific site processes to avoid unforeseen delays
• Identify the hidden costs that sites and sponsors incur that are not in study budgets
• Methods for speeding negotiations along to achieve a mutually satisfactory result
• Effective budget negotiation requires preparation: know your costs and demonstrate value
• Discussing the benefits of applying centralized technology to enable budget and payment tracking

• Strategies for keeping patients at the heart of your trial design
• Exploring patient preferences and what works best for the patient
• Overcoming challenges to clinical trial distribution systems in a post-COVID world
• Decentralized trials – how can you ensure you keep your patient at the forefront of these models?
• Ensuring information is concise and instructions are easy to follow in a virtual setting

• The quality standpoint: getting ready for inspections and making sure to remain compliant (GMP and GCP)
• How to overcome hurdles with cell therapy to ensure quality of product is maintained
• Timelines and logistics challenges

• Appreciating the role that the right outsourcing strategy can play in your company achieving its development goals in 2022
• Determining how to analyse gaps in your company’s resources and capabilities to develop a strategy to best acquire them
• Defining which roles should be kept in-house and which functions are best outsourced
• Recognising how your vendor selection process has changed pre and post pandemic – what do you look for now?

Chair: Donald J. Kellerman, Vice President, Clinical Development and Medical Affairs, Zosano Pharma

Panellists: Laurin Vincent, Former Head, Supplier Performance Management, Genentech;

Gabriel Luciano, Vice President, Clinical Operations, Corvus Pharmaceuticals

Terns Pharmaceuticals;

Interactive roundtable 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 roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables .

Chair: Bonnie Bain, Global Head and Executive Vice President, GlobalData

AI & Disruptive Technology: Harnessing the future of Artificial Intelligence to transform clinical trials 

Delving into the world of AI and Big Data to identify how it can support decentralized trials; site selection; advanced data analytics; robotics and process automation in clinical trials; blockchain and voice-enabled technologies. Case study examples given for time and cost savings when implementing AI and machine learning tools. 

Our expert speaker will give a 20min presentation followed by 10mins audience Q&A.

We welcome Bonnie Bain from GlobalData to present her research into the state of the Biopharmaceutical Industry in 2021. Including:

• Themes that are shaping the biopharmaceutical industry – both today and into the future
• Key emerging technologies & disrupters
• Industry, regulatory and macro-economic factors affecting pharma in 2021

Don’t miss this talk; it is crucial for the biopharmaceutical industry to recognize the factors shaping the clinical trial landscape in order to maximise their future success.

Since its inception in 2016, the Parker Institute for Cancer Immunotherapy (PICI) has heavily leveraged Cloud-based architecture, but with the onset of COVID and the remote work model, PICI launched a yearlong initiative to be a fully cloud-based organization.  Toby Odenheim, Director of Information Technology Governance will cover the benefits and challenges of migrating to the cloud.  

• Business Drivers
• Cloud Architecture
• SSO & Security
• System Validation & Compliance
• Recommendations & Lessons Learned

This session will give you 5 key takeaways for how and why you should incorporate wearables into your study. 

• Discussing what wearable technologies are available and accepted by regulatory authorities
• Exploring home monitoring technologies to collect patient data in a timelier manner
• Overcoming challenges when shifting to wearables whilst ensuring patient safety
• Considering the infrastructure required for wearables when running a large multi-region trial

How are wearables being more widely used to help with reimbursement?