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

• Key drivers of growth in Asia Pacific specifically China
• Regulatory reform and how this has impacted clinical development
• Case Study:  what can the accelerated pathway look like

Join leaders in the industry to explore the past, present, and future of Decentralized Clinical Trials. Learn what it takes to optimize the patient experience by utilizing connected capabilities from patient to sponsor. How has this shift in technology affected patients, and how can these innovations be better executed to yield better results? Through the partnership between Medidata and Circuit Clinical, explore the future of clinical research with a turn key DCT solution accompanied with unmatched expertise.

The differences between the three regulatory bodies, and how speed and cost can both be improved by selecting the right location or mix of locations for your clinical trial, without the need to sacrifice quality.

• Selecting the appropriate location to meet cost, timeline, and quality requirements.
• Leveraging multiple locations in appropriate situations to maximize benefits and create efficiencies, also considering the speed to first-in-human milestone, to be eligible for the next round of investment.
• Selecting partners that understand the advantages and requirements of each regulatory body.
• Helping clients to understand the regulatory path and associated costs for conducting first in human studies in either USA, Australia, or the UK.

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?

• Spectrum of Biotech/CRO models
• Pros and Cons of each
• More detailed description of newer and more integrated models
• Discussion of some of the newer and pioneering approaches
• Preservation of Biotech ownership of assets in all models

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?

This stream will resume at 2:30pm

• How a decentralized approach is making the clinical trial possible
• The benefits of using mobile research nurses when conducting a trial involving patients with limited mobility
• How remote, in-home research is expediting patient enrollment
• The success of the TOPAZ trial in rapidly enrolling patients with Parkinson’s who are at risk of debilitating or life-threatening bone fractures caused by falls

21^st century outsourcing relies on a continued focus on Data Integrity to ensure vendor’s services, computerized systems and new technologies undergo a risk-based evaluation from pre-selection, identification, selection, oversight all the way to vendor decommissioning. We will walk you through the following:

• Understanding “intended use”: From needs assessment / specifications gathering to Request for Information (RfI).
• Pre-selection: Strategies for analysing vendor capabilities and potential risks to data integrity.
• Vendor Qualification, oversight and continuous process improvements.
• Are we the problem? The Unattainable triangle of speed, cost, quality.
• Tips and tricks for keeping staying flexible yet in adherence to regulatory requirements.
• Overcoming challenges together and considerations for equal partnership.
• Vendor decommissioning, GxP data retention capabilities, media and timeframes.

Moderator: Mark J. Milberg, Senior Director, Clinical Outsourcing, Ultragenyx Pharmaceutical

Panellists: Ndidi Rickert, Tara Safakish, Amy Finnigan, Jeff Lewis, Ultragenyx Pharmaceutical

• Decentralized Clinical Trials are becoming the new norm – but let’s consider the impact on every step of the Clinical Workflow.
• Digitization and decentralization go hand in hand – but does this approach lead to the “consumerization” of clinical trials and redefine how patients engage with providers?
• The characteristics of Decentralized Clinical Trials present multiple Supply Chain challenges – is collaboration the solution to these challenges and importantly, are they worth rising to?

• 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

Chair: Anca Copaescu, CEO, Strategikon

The intersection of the health and technology has gotten stronger over the last number of years, but are they ready to take their relationship to the next level? Mike DeCastro will discuss how strategic partnerships, enhanced logistics, and mobility solutions are blossoming within the health ecosystem, pledging to create real change for vulnerable communities

• Expanding on the ways in which brokers, TPs, and technology companies can work together to improve care logistics.
• Detailing how Uber Health’s HIPAA-supported platform has been able to improve operations for population health managers and their patients.
• Highlighting how Uber Health’s platform has been optimized to fill gaps in care for vulnerable communities.

What are the components that are driving the DCT transformative innovation?

1. 1. • Technology as an enabler
      • The complex technology ecosystem required to support DCTs
      • Challenges of global deployment and support
      • Concierges services following patient-centric approaches
      • Lessons learned to date

• 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

• 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

• Detailing current industry DCT offerings and providers and understanding specific areas of strength
• Aligning Sponsor trial goals with DCT options to facilitate operational success
• Discussing what data can be collected vs. how data should be collected
• Predicting emerging trends and events in decentralized trials over the next 24 months

• Which technologies gained importance due to COVID-19?
• How has the industry adapted to trial disruption and supply chain delays?
• What does the future of work in pharma look like?
• What is the industry growth outlook over the next 12 months?

• Learn about how virtual sites work through a real world example
• Watch how telemedicine tools being employed for dermatology assessments
• See how various mobile and telemedicine visits are scheduled and coordinated as part of virtual sites

• 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

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

Listen in as speakers take a deep-dive into what it takes to implement a decentralized or hybrid strategy. Using real-world experiences to highlight key operational, technical and regional considerations, join in this lively discussion answering questions such as:

• What does a hybrid or decentralized clinical trial (DCT)  look like in action?
• What should you consider when getting started with a hybrid or DCT?
• What business changes need to occur for successful implementation?

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

• Getting creative: finding ways to pair patients with trials
• Ensuring that patients have every possible access to information from consent through result publication
• How to support patients through the trial
• Ensuring that patient needs are understood and balanced with the need for controlled data

• Leveraging strategic site partnerships with local community hospitals
• Expanding the advanced clinical trial offering and awareness
• Community outreach via press release and patient story
• Easing the financial burden of local clinical trials vs travel to large hospitals for additional options
• Recent case study and patient story

• 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

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

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

In this session, Dr. Skip Sands shares his experiences evaluating and selecting CRO partners, and provides advice to help you avoid the misalignments and misunderstandings that can cause these relationships to run off track. During his 20 years serving as the chief medical officer at emerging and small biotech firms, he experienced first-hand how selecting the right development partner was one of the most important decisions they would make.

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

• Virtual Clinical Supply Model
• Direct to Patient Capabilities
• Global Clinical Supply Offering (NEW)
• Medical Procedures, services, and product reimbursement (NEW)
• Improve Site Feasibility and Remove Barriers (NEW)

• The regulatory standpoint: developing robust regulatory submissions
• Enabling Inspection readiness: ensuring regulatory compliance, patient safety and product quality
• Expecting the unexpected: 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?

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: Anca Copaescu, CEO, Strategikon

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.

• Identifying how using the right tools for remote training can improve performance management of sites
• Exploring how best to implement virtual training to reduce protocol deviations
• Finding the right virtual training supplier who can simulate critical protocol challenges by using lifelike, online scenarios 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?

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”

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 will cover the benefits and challenges of migrating to the cloud. 

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

• 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

Engaging with participants to influence clinical research design is the standard for industry innovators. Our ability to gain participant feedback in design, throughout the life of the study and at close-out is a way our industry can “be,” not just “say,” we are patient-centric.  

This approach is available to our industry and being utilized today to enhance traditionally designed and decentralized research studies. The benefits are obvious, but the solutions have historically been challenging to collect, listen to and incorporate. That is now changing via the intersection of participant engagement science, decentralization, and digital technologies.  

Objective:  Promoting equitable enrolment in clinical trials to improve cardiovascular health in women.  The lessons from this session can be applied more broadly to expand diversity of race and socioeconomics in device clinical trials

• Why is there a need to promote enrolment of women?
• What is being done to promote enrolment of women?
• How can a Sponsor promote enrolment of women?

• Sourcing and getting the right quotes for your study
• Mapping out a plan to ensure all targets are met
• Outlining typical challenges and best ways to overcome them

• Developing your clinical program strategy
• Factors to consider when building out your clinical team at various development stages
• Evaluating whether activities should be outsourced or resourced from within
• Identifying areas for clinical infrastructure investment and growth

• From your experience, what are the most important aspects needed in developing a robust clinical trial?
• What are the typical bottlenecks you encounter when mapping out your clinical programme and how do you overcome these obstacles
• What advice would you give those who are looking to conduct a trial for the first time?

• Providing insight based on real-life examples of good and bad clinical trial design from the FDA perspective that will help you adjust your operational strategy
• Explaining why prioritizing patient-centricity and safety is a crucial component of receiving FDA approval
• Looking at the relationship between the FDA’s Quality System Regulations and ISO 13485 and best practices for meeting both sets of guidelines

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.