Outsourcing in Clinical Trials New England 2021

• Rethinking trial design – has the barriers and disruption of the past 18 months shown us that different and innovative trial designs are possible?
• Importance of finding new ways to push forward in patient engagement and retention
• Exploring how to keep pushing the clinical trials industry forward and predictions for the future of trial innovation

• 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

The patient experience is essential to the success of any trial, whether it’s a decentralized trial, traditional, or hybrid. As patients demand greater flexibility in how and where they participate in clinical trials, eCOA plays a vital role in supporting an interactive, patient-centric experience. Creating a unified experience for investigators, patients, caregivers, and sponsors requires a modern approach involving several factors that range from regulatory and technological considerations to patient access and usability, to name a few.

Join Medidata’s Matt Noble as he discusses key considerations for implementing eCOA as part of a broader decentralized trials strategy. Topics include:

1.       What are the demographics of your patient population? How much training will be needed?

2.       Considerations from both the patient and regulator perspective for incorporating “Bring Your Own Device” (BYOD) capabilities into your studies.

3.       How robust is your eCOA Library? What countries will your study be running in?

4.       Working proactively with instrument owners to accelerate study timelines.

The plan for commercialization and regulatory approval is often something that is not considered until the trial is well underway – but should we be beginning this process sooner? 

• Discussing how deciding on the commercialization plan in the early phase can save time and money further down the line
• Tips for analyzing and identifying the commercial landscape so that your trial can be planned accordingly
• How planning the patient journey early on can lead to easier patient engagement and investor satisfaction

• Initiating and fostering relationships with advocacy groups, patient registries, and KOLs
• Maximizing patient services to support rare clinical trial recruitment and retention
• Selecting and partnering with appropriate vendors to meet population, indication, and country/site mix goals
• Leveraging social media technology in rare clinical trials

Minorities are overwhelmingly under-represented in clinical trials so what is causing this failure to recruit a diverse patient group onto trials? And what impact is it having on the health of all Americans?

• Exploring reasons why minority participation in clinical trials is still low
• Engagement tactics that can be used to actively recruit under-represented groups onto your study
• Examining the implications of not getting a diverse patient group on your study – could this negatively impact the safety of your drug/device?
• Is the problem us? An honest and reflective look at the lack of trust certain communities might have in the biotech industry. What can we do to fix this?

Patient Centricity, Patient Engagement, Patients as Partners – these are not just “buzz words”. This talk provides you a comprehensive overview of the rapidly developing landscape in Patient-Centered Clinical Research. You will learn about a myriad of initiatives from regulators, industry, and advocacy groups aimed at improving and accelerating clinical research through collaboration with patients, their communities, and other key stakeholders.

• Defining and clarifying what we mean when use the terms: Patient Centered Research, Patient Engagement and Patients as Partners.
• Reviewing the major regulatory developments in support of Patient Centered Research.
• Gain insights from the largest bi-annual global survey on patient and public perspectives of clinical research, including insights on participant experiences.
• Explore the critically important work being done to measure and evaluate the value proposition of Patient Centered Research activities, sometimes referred to as “Return on Engagement” or “ROE”.
• Analyze concrete examples of Patient Centered Research programs and projects, including sharing research results, collecting and acting-on the patient community’s input and feedback, and developing user-friendly registry websites that educate and empower patients and the public.

• 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

• Exploring how to select the best vendor partner for your gene therapy trial
• Debating what aspects should be outsourced, what can be kept in ho house and how to make the decision
• What key factors do we need to look at when making decision on outsourcing – and how to select the best partner to suit these needs

Nearly 2 years into the COVID-19 pandemic, there have been more than 235 million cases reported globally, with nearly 5 million deaths. Vaccines have been successfully developed and deployed in record time; however, antiviral therapy directed against SARS-CoV-2 is limited to viral spike-directed monoclonal antibodies that require parenteral administration and have limited utility. There is an urgent need for oral direct-acting antiviral agents. We report an unprecedented collaboration that enabled accelerated generation of phase I data, including administration of the first-in-human (FIH) dose of a potent, direct acting anti-SARS-CoV-2 agent within 5 days of receiving regulatory approval in the United Kingdom (UK). Single and multiple ascending dose (SAD and MAD, respectively) cohorts were enrolled in double-blind, placebo-controlled fashion, with a 6:2 active-to-placebo ratio in each cohort. A food-effect (FE) cohort included 10 subjects who were randomized to receive drug in the fasted or fed state followed by the fed or fasted state to complete a fed and fasted sequence for each subject. Dose escalation decisions were accelerated and MAD cohorts were initiated prior to completion of all SAD cohorts with the provision that the total daily dose in a MAD cohort would not exceed a dose proven to be safe and well-tolerated in a SAD cohort. Dosing in healthy volunteers was completed for eight single ascending dose (SAD) cohorts, seven multiple ascending dose (MAD) cohorts, and one food-effect (FE) cohort within approximately 16 weeks of initial protocol submission to the Research Ethics Committee (REC) and Medicines and Healthcare products Regulatory Agency (MHRA). Working to standard industry timelines, the FIH study would have taken approximately 46 weeks to complete and 33 weeks to enable phase 2 dosing. Data from this study supported submission of a phase 2/3 clinical trial protocol to the US Food and Drug Administration (FDA) within 8 weeks of initial protocol submission, with FDA comments permitting phase 2 study initiation within two additional weeks. In the setting of a global pandemic, this model of collaboration allows for accelerated generation of clinical data 31 compared to standard processes, without compromising safety.

• Discuss the role of technology ecosystems in supporting DCT innovation
• Appraise advances in digital health technologies (i.e., wearable devices) and trends in DCT implementation
• Learn about the increasing digitalization of DCTs and the evolving use of digital endpoints
• Examine DCTs as a care option (CRAACO) to unify the health journeys of participants
• Analyze equity, inclusion, and diversity (EDI) plans in DCTs from multiple perspectives: regulator, sponsor, sites, and participants
• Explore the medical, logistical, regulatory, legal, and ethical considerations learned when deploying DCTs across multiple geographies

• Exploring how eDiaries can provide new options for sponsors by being more intuitive and less invasive than paper
• Delving into the specific devices that can be used to capture eDiary data- pros and cons
• Can better adherence to the study protocol and improvements in patient centricity be seen when implementing eDiaries?
• How can eDiaries help with patient questionnaires and alerts by scheduling tools and reducing human error?

ClinTwin360: Leveraging Cloud Sourced EDC to Reinvent Clinical Trial Recruitment and Execution

• Identifying a way for sponsors to quickly find potential participants for clinical trials
• Strategizing an approach for asking questions for virtual trials
• Assessing a tool for leveraging Apple Health data for clinical insights

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?

In this session, John Reites, CEO 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. 

Join Myonex as we discuss the Challenges and Opportunities around Drug Distribution for Clinical Trial with Perspectives from a Clinical Pharmacist at a Clinical Site

• Exploring how to move from R&D to a successful Phase 1 trial
• Working across departments to ensure all goals are met
• Discussing the fundamentals of preparing for an early phase trial, timelines needed and other decisions needing to be made in the R&D phase
• Utilizing historical data and operational trends to analyze potential risks

Join the team from Viedoc as they host this interactive, live demo of their platform and capabilities.

Getting the start of your trial right is more important now than ever – join this talk to discuss how pandemic shaped protocols can advise future trial design

• The COVID-19 pandemic forced the industry to re-examine protocols and design strategies. What lessons can be learnt from this for future start up studies?
• Examining changing patient attitudes since the pandemic and how this needs to be reflected in early stage trial protocols
• Discussing the need for flexibility in all early phase trials in order to be resilient in a disrupted and changing world

Is outsourcing always the right answer for your clinical trial? It can often be difficult to determine whether clinical operations are best done in house or handled externally by a partner company. Our panel will discuss:

• Keeping operations in house can have the benefit of saving money but are we also running the risk of not correctly handling some key aspects of the trial
• Debating what aspects should be outsourced, what can be kept in house and how to make the decision
• What key factors do we need to look at when making decision on outsourcing – should time and money be our only considerations?
• At what stage in your company’s development / expansion should you outsource?

As a follow-up to our previous session on the practical applications of machine learning, this year’s session will revisit the topic with case studies of ML in practice in the eTMF. We will review the state of machine learning, what it can and cannot do, where and why it is best applied, and then demonstrate the high level of accuracy and efficiency accomplished when this technology is leveraged for right-fit use cases (like document classification, metadata extraction, and auto-coding). Attendees will leave with a pragmatic understanding of machine learning for clinical documentation and ways to employ machine learning to improve speed, quality, and completeness in the eTMF.

Join Calyx’s Michael Mendoza and learn how EDC needed to adjust capabilities from traditional CDM to CDS to better service patient visit flexibility and increase access to clinical data to make decisions quickly in a Risk Based environment.

• A quick introduction to the importance of QA and how this can be applied to clinical operations
• Discussing how COVID has changed the global regulatory paradigms – what you need to know
• Exploring gaps in the regulatory and QA systems that are not being covered as a result of COVID – and how the QA and operations teams can work together to fill these gaps
• Assessing how to proactively include Quality assurance into your trial design to ensure the correct procedures are in place at all trail stages

• Exploring technologies accelerated during the pandemic such as decentralized trials – are these a flash in the pan or what technologies should we continue to invest in?
• Working in “the new normal” – discussing how remote working impacted your teams; the positives and negatives we can take forward
• How our panel kept their studies on track – tips and tricks for keeping studies flexible and resilient
• A discussion of the future: how our panel plan on taking their businesses forward into the future

Speaker tbc from Care Access – check back soon for updates!

Great things happen when you combine the power of synchronous (live) virtual meetings with asynchronous (24/7) web platforms. Done correctly, Synch/aSynch strategies can boost productivity and engagement among Sponsors, Investigators, Patients, CRAs and others. Effectively meshing live and 24/7 digital technologies can also yield tremendous value in data capture, quality, cost savings and carbon footprint. This presentation will review use cases and approaches that leverage Synch/aSynch methodologies.

• How has the pandemic effected drug pipeline activity and global clinical trial starts?
• Are we seeing evidence that productivity and performance are waning?
• Based on actual experience, can we expect consolidation and retrenchment in practices implemented during the pandemic?

This interactive session offers 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. In small groups, we invite you to share your experience and advice for working in the “new normal” while maintaining high quality clinical trials.

Talking points will include: how have your teams managed over lockdown periods? Will your teams continue to work from home? What advice can you offer in ensuring strong happy teams? What new technologies are you interested in that can help improve staff efficiency and satisfaction?

An exciting, interactive way to build your personal network and learn from the experience and expertise of others.

The discussion session lasts for 30 minutes, and there will be a round-up afterwards.

• NLP & ML use case scenarios
• Machine training methodology
• Examples of production implementations
• Benefits & Key to success

Repurposing off-patent drugs has long been proposed as a strategy which reduces risk, reduces cost, and reduces time to market for new treatments.  However, its potential in drug development has not been realized. In this panel discussion, we will explore some of the barriers to adopting a repurposing strategy and gain insights from an investor, a drug developer, a lawyer, and a program officer at NCATS on ways to address any obstacles to achieving success.

Moderator: John Seman, CEO, REVITALE Pharma

Panelists:

Bruce Bloom, Chief Collaboration Officer, Healx;

Matthew Fedowitz, Shareholder, Buchanan Ingersoll & Rooney PC;

Michael King, Managing Director, HC Wainwright & Co

Tentative: Bobbie Ann Mount, Program Officer, National Center for Advancing Translational Sciences

• Explore challenges in clinical trial execution in rare diseases
• Discuss strategies to overcome these challenges
• Share lessons learned from initiating and completing clinical trials in Rett Syndrome

• Immuno-oncology is making a major impact on oncology therapy
• Pyroptosis, a form of programmed cell death, has been implicated as a key step in immune activation
• AAV gene vectors carrying pyroptosis enabler as a means to induce pyroptosis as an anti-cancer technology will be discuses
• Exploring the impact of novel therapeutic technology on the clinical trial
• Pinpointing some of the clinical operations aspects of novel therapeutics

We welcome Oliver to discuss the unique challenges that must be correctly dealt with when developing a combination drug delivery and medical device product. We will take a deep dive into: 

• The different regulatory pathways that a combination product must go down
• Clinical trial models to ensure both aspects of the product are thoroughly tested for safety and efficacy
• Potential pitfalls and how to ensure they are avoided
• Exploring how to ensure these combination products are approved by insurance companies, hospitals and medical staff

Join this informal discussion session, where our speaker will share their top tips on the challenges unique to medical device trials. We welcome questions and input from the audience.

 Topics to be covered include:

• Top tips on vendor negotiation and management – how to ensure you are working with a partner who can cater to specialized medical device needs
• Staying on budget and sticking to timelines: advice on how this can be done
• Setting up governance and risk control meetings to ensure you remain in control of all aspects of your trial

• Debating the importance of Women’s Health Equity and how it impacts us all
• What the clinical trials industry can be doing to promote Women’s Health
• A brief look into future of FemTech