Outsourcing in Clinical Trials West Coast 2020

This session will look more proactively at the protocol design phase, thinking through the various elements and planning ahead to build in that design upfront

• Another level of complexity: Discussing the implementation of biomarkers into a protocol whilst remaining agile
• Identifying key aspects of an agile protocol which is moving towards a patient-centric approach, such as home visits and the patient voice
• Real life example of a modified protocol based on feedback of patients and other assessments to reduce patient burden
• Machine learning, predicting enrollment and smart analytics- Utilizing data and tech sources to design a flexible recruitment strategy

Drawing on years of experience, Sue Naim, Sr. Director of Clinical Operations at Astex Pharmaceuticals, shares the innovations and best practice strategies that:
• Enable quality data review
• Drive team collaboration and effectiveness with targeted training
• Standardize data review across CRO partners and support patient profile listings review

• Pinpointing the technology-based root cause of inefficiency with the current approach to clinical research
• Exploring the 3 waves of digital transformation in clinical research: making full use of advanced tech such as AI
• What industry change is required in order to adopt better to new technologies?
• Microsoft’s role in transforming clinical research including how to further meet patient needs and reduce burden

• Accessing Australia’s ecosystem for early phase trials. A case study
• Accelerating patient recruitment in Asia for large complex trials
• The advantage of running global trials with regional CRO partners

• 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 enrolment 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

This session focuses on how the use of adaptive trial designs can help sponsors address the unique challenges of early oncology drug development and increase likelihood of success:
• Challenges inherent to early phase oncology clinical trials
• Factors to consider in design of early phase oncology studies
• Adaptive designs for assessing early/late-onset toxicity
• Highlight how adaptive trial designs help optimize efficiency while minimizing the number of patients treated at sub-therapeutic doses

• Identifying challenges in aligning timelines between clinical operations, supply and data management departments
• Highlighting the importance of getting input from all stakeholders during the planning phase to ensure timelines are realistic
• Defining a communication framework which enables departments to effectively report on milestones reached or missed, changing trial parameters
• Providing examples of how breaking down silos enables creative problem-solving with unforeseen challenges
• Reviewing tools available to facilitate better internal communication

JOIN ONE OF OUR BRAND NEW NETWORKING TABLES

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 technologies, such as AI and Blockchain, to 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: What does ‘patient centricity’ mean to you?

TABLE 5: Innovative ways of improving CRO engagement and communication

• Evaluating how to best gauge chemistry and compatibility during CRO selection to ensure you are acquiring a long-term partner
• Impressing the importance of a CRO who has done their homework and develops a comprehensive pitch
• Developing strategies to enable your vendor to become an extension of your in-house team
• Thinking longer term to your phase II or III study which may require a CRO with global capabilities- Do they have a presence in Asia or Europe?

• Outsourcing is not a ‘one size’ fits all paradigm and the needs of emerging biotech must be addressed through nimble and creative partnerships
• Exploring the nuanced challenges that emerging biotech developers face along the drug development journey
• Outlining essential partnerships strategies to meet this challenges

• Exploring who negotiates the budget: Sponsor and/or site?
• Pinpointing procedural costs plus Investigator/Coordinator costs as well as overhead
• How do procedural costs compare with insurance company costs?
• How does this process compare with other financial transactions?

This experiential session addresses the importance of aligning due diligence expectations between biopharma companies and investors (i.e., sell and buy side). Dr. Brownell facilitates the workshop to make it as fun as it is informative, current and memorable. 

Attendees will also receive a report via email of the key points plus a due diligence request from actual investors giving a specific 2020 update.

Maximizing the use of wearable technologies for real time data entry: A more patient-centric approach?

• Exploring the benefits of direct patient input with devices and how best to incorporate them into trials
• Examining facets of your protocol design to gain further patient input on technologies during the trial
• Addressing compliance requirements and current FDA standards
• Exploring home monitoring technologies for patient data collection in a more timely manner

• Explore the driving forces behind the industrywide move to streamline information exchange in clinical trials
• Learn about modern technologies that improve how organizations work together across the clinical environment
• Discover new approaches to sharing trial information with study partners
• Learn best practices for driving greater efficiency and collaboration

Improving health outcomes with a world-class transportation platform

• Leverage Uber Health to help with retention and recruitment for clinical trials
• How Uber Health helps our partners to better serve those they care for
• The power of Uber Health for our most underserved populations (the elderly, low-income, at-risk)

JOIN ONE OF OUR BRAND NEW NETWORKING TABLES

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 technologies, such as AI and Blockchain, to 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: What does ‘patient centricity’ mean to you?

TABLE 5: Innovative ways of improving CRO engagement and communication

• Recognising the ability of AI to keep track of the data we don’t collect
• Harnessing the power of AI to identify the most suitable sites using electronic health records
• Smart Analytics- utilizing databases to identifying which sites are enrolling the most suitable patients for your study
• Considering what processes can be automated through technology and AI to minimize human error

• The role of biomarkers in early clinical development
• Benefits of incorporating a biomarker strategy into your clinical trial design
• Case studies demonstrating faster progress from the use of biomarkers

• Automation technology has been specifically applied to clinical trial planning, sourcing and management challenges
• See how standardization and automation drive major efficiency gains for these processes
• The digital transformation of datasets from a sponsor’s bid history yield valuable intelligence relevant to clinical trial budgeting
• Hear how clinical trial planners have used these insights to realize substantial negotiated savings for outsourced services

• When it comes to innovation, healthcare presents a paradox- This field can be described as both a hare and a tortoise
• While life-altering breakthroughs in medical treatments can come at a rapid pace, improvements to the way healthcare is actually delivered happen very slowly
• New technologies have the ability to challenge this paradigm, but unique problems exist that don’t occur in any other industry

This session will address the ongoing challenge of onboarding in clinical trials and how we can improve trial design and innovation by utilizing patient voices

• Patient voices at the concept stage
• Why are we afraid of using patients and how can we start to combat this?
• No one size fits all when it comes to patient advocacy groups
• Innovative methods and technologies to improve trial design

Agree or disagree? With more being spent on tech but only 50% of studies recruiting on time, should we be spending millions on social media/digital recruitment? Or should we go back to basics and focus on human contact?

• Is the grass roots method the best way to increase awareness and hit start up timelines?
• FOR- Nothing beats human contact: Exploring the effectiveness of forming physician relationships for effective referral
• AGAINST- Social Media is the future: Adopting social media to increase interest in a patient pool
• How patient recruitment success can be determined at the site by understanding patient flow
• Public awareness: How meaningful conversations with patients can encourage them to spread the word

• Overview of need-to-know requirements and submission process updates
• Defining a framework of action including preparation timelines, in-house staffing considerations, and the contents of a dossier submission
• Outline of the most common pitfalls, the potential penalties associated with them, and how to avoid delays
• Recommendations for the evaluation and selection of the right outsourcing partner and when best to initiate

• Ensuring objectives are synchronised by sharing protocol insights with patients
• Identifying strategies for translating patient experience into protocol design to enhance engagement
• Collaborating with KOLs in patient populations for study development and setting up advisory boards
• Best approaches for building an advisory board with the specialities required for your indication

JOIN ONE OF OUR BRAND NEW NETWORKING TABLES

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 technologies, such as AI and Blockchain, to 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: What does ‘patient centricity’ mean to you?

TABLE 5: Innovative ways of improving CRO engagement and communication

• Influencing teams to engage early with patients, caregivers and patient advocacy (Alligator vs. Judge brain)
• There are many right ways to involve patients early and within your program
• Review a case study of examples and impact
• How working with patients and advocacy can reduce trial burden and boost patient enrollment
• Importance of Inclusive Research: how to increase under-represented patient populations into your trial

• Real World Data generated through Patient Reported Outcomes play an increasingly important role across the Drug Development Lifecycle
• In a hyper-connected world, learn how patients’ own technologies enable effective ways of capturing ‘new data’ to deliver high quality PROs

• Discussing how an understanding of your patient population enhances participation and recruitment from diverse groups
• Thinking outside the box about what cultural aspects come into play during the protocol design
• Outlining the most relevant population for your study to identify what minorities to include
• Establishing relationships with sites to align objections and discuss strategies to reach minorities

Chair:  Donald Kellerman, VP Clinical Development and Medical Affairs, Zosano Pharma

This session will include 2 x 10min presentations to discuss whether a Strategic Partnership, FSP or Fully Outsourced model is the best option. The presenters will give case study examples including pros and cons for each model. We will end with an audience Q&A.

Presentation 1: A Strategic Partnership with a CRO allows you to find a likeminded partner and establish a strong relationship leading to greater satisfaction and more effective studies.
Jacqueline Mardell, VP Clinical Operations, Ascendis Pharma

Presentation 2: Aligning your outsourcing model to your business needs and objectives is critical – but the secret sauce is in the cultural mindset of the partnership
Laurin Vincent, Head, Supplier Performance Management, Genentech

Stats on trial delays and costs illustrate the urgent need for a better way to get drugs to patients faster. The concept of Master Protocols has reinvigorated the clinical research industry. But basket trials present unique challenges for sponsors, CROs, and sites alike. Selecting the right CRO partner and creating a comprehensive site management plan will enable sponsors to anticipate and resolve these obstacles

• Why building trust with your CRO and sites is the cornerstone of a successful basket trial
• Understand the site perspective and how the obstacles of a basket trial protocol influence site motivation
• Key considerations to selecting and managing sites: cohort management, regulatory and IRB considerations, site training recommendations, and other challenges unique to basket trials

• Justifying the importance of putting together a governance committee and meeting schedule to address upcoming milestones and risk management
• Monitoring CRO engagement using high level metrics on start-up aspects to draw up timelines goals and assess performance
• Focussing 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 in early stages

• Reviewing FDA and EMA regulatory guidance to ensure compliance
• Discussion of study design options to ensure success in Phase I trials
• Highlighting tips and lessons learned on efficient and effective execution

• 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?

• Exploring the rapidly changing standards of care to develop a more flexible study design
• Handling additional operational safety precautions associated with immuno-oncology to ensure patient safety
• Evaluating long term feasibility of immuno-oncology trials and true cost factors associated to assess long term impact for reimbursement issues
• Can working closely with cluster busters help to identify more potential patients?

• That was then this is now: changes in sponsor/CRO relationships
• Defining the box and stepping away from it
• Beyond the obvious stakeholders
• Passion, commitment and highly integrated professional services
• Growth segmentation, fuelled by competency

• Unlocking best practices for negotiating budgets with new vendors and aligning trial timelines
• Getting into the granularity of the budget to properly understand what you’re paying for each visit
• Appreciating the importance of accurately forecasting protocol design costs
• Assessing tools which can help you decide on budgets giving holistic numbers around procedure costs
• Best practices for implementing site and vendor monitoring to ensure the study stays within a strict budget

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.

Roundtable 1
Discussing best practices for leveraging site intelligence in budget & contracts
Stephanie Molteni, Associate Director, Site Budgets & Contract Management, Clinical Operations, UltraGenyx Pharmaceutical

Roundtable 2
Solving the frustration with change orders: Debating how to justify them & when they are appropriate
Mark J. Milberg, Senior Director, Clinical Outsourcing, Ultragenyx Pharmaceutical

Roundtable 3
Innovative ways of improving CRO engagement and communication
Sue Naim, Director, Clinical Operations, Astex Pharma

Roundtable 4
Vendor partnerships: Discussing the best approaches for choosing providers
Larry Vong, Senior Clinical Data Specialist, Nevro Corp

Roundtable 5
Redefining combination devices in the new era
Host: Hayley Lewis, Senior Vice President of Operations, Zosano Pharm

Roundtable 6
Establishing Post-market surveillance and Clinical Follow Up System per the European and FDA guidelines
Ritu Verma, Head of Global Clinical Affairs, Natus Medical Incorporated

Chair: David Larwood, CEO, Valley Fever Solutions

• Considering a substitute to the traditional placebo group with a Synthetic Control Arm that using pre-existing data
• Highlighting the advantages of placebo arms being modelled on information previously collected such as real-world data and historical control data
• Uncovering how this model could enhance patient interest and enrolment as all patients will get the experimental therapy

• Understanding what ML is and is not
• Use cases for Machine Learning in Clinical Content Management
• Case examples of where ML is best designed to benefit your operations
• Conducting Global Studies with Machine Learning
• The future of Machine Learning and Clinical Operations

When do you need it? When to outsource? And what should be or shouldn’t be in an eTMF?

• Exploring the current trends in streamlining clinical trials with eTMF
• Identifying what internal resources you have to manage eTMF and what can be outsourced
• Allocating a team member with internal authority to be the TMF owner to ensure inspection readiness
• Identifying how eTMF can quicken study start-up to improve overall trial efficiency

• Digital Therapeutics overview (specifically in Alzheimer’s/Dementia)
• Digital therapeutics in a global market (i.e. what it means outside the USA)
• What is happening on the science side and the corporate side
• Issues with digital therapeutics in the global market
• How these issues can be solved to allow digital therapeutics to flourish globally

• Patients will be more empowered
• Trials will become decentralized
• Technology will support this decentralization: Discussing wearables and telemedicine

• Providing an overview of the landscape of women’s health in the medical device industry
• Outlining the history of basic research that created the FemTech landscape
• Presenting case studies of the impact of diversity on clinical trials
• Breaking down the key design principles for companies working in FemTech
• FemTech – closing thoughts & predictions for 2030

Chair:  Norm Gitis, Chair of the Board of Directors, Embolx, Inc

• Providing insight based on real-life examples of how the QMS evolved with the clinical development of a combination product
• Explaining why the categorization of each supplier and their respective governing quality systems enabled scale up and automation in a relatively short timeframe
• Looking at the relationship between the FDA’s GMPs, Quality System Regulations, ISO 9001 and best practices for meeting both sets of guidelines
• Ensuring all elements are covered in Quality Agreements and Internal SOPs

• Breaking down the Investigational Device Exemption and different types of IDEs to understand a premarket approval application
• Discovering how the Early Feasibility Studies IDE has been a game changer for the US device industry;
• An in-depth look at how to successfully transition from EFS IDE to Pivotal IDE
• Innovative approaches that medical device companies can take to get EFS IDE approval

• Outlining the implications of the Protected Health Information law on clinical studies
• An in-depth look at how GDPR applies to your device
• Discovering how the Quality by Design approach can reduce data integrity form consent issues and missing data
• Exploring how the FDA’s post-approval registries studies affect your data collection operations
• Considering how device companies can best approach the challenge of CROs fixed processes, and how data sharing is part of the solution to effective communication in partnerships

In this keynote session our host will introduce the topic with a 15min presentation, which will be followed by an interactive panel discussion

• Thinking about which location offers the most suitable trial site for your medical technology
• Looking at the logistical benefits of doing site selection and patient recruitment outside US
• Considering the European Regulations on MDR and IVDR and how it affects the US market
• Highlighting how European privacy law implicates patient data collection and comparing it to US requirements
• Comparing financial costs of domestic versus international trials to be fully informed of which option is best for your study

• Breaking down the various challenges that accompany outsourcing to CROs in Latin America and Asia Pacific
• Hear real-life examples of CROS management from clinical trials in Australia, New Zealand, and Mexico

• Highlighting how to identify the right vendors that works for both parties on the trial sponsor side and the service provider side
• Building deep vendor relationships in competitive business markets that last
• Managing the most challenging vendors to create effective partnerships
• Providing guidance on how to build KPIs that reflect your strategic priorities using real-life templates and worksheets

• Identifying the key barriers to funding application approval for small, medium, and large sized medical device companies
• Comparing the different funding resources available to start-up companies including angel investors and venture capital firms
• Understand how regulatory approval affects reimbursement rate
• Revealing key techniques for medical device and biotechnology companies to approach angel investors

• Exploring registered nursing options for home-based trials
• Real-world example of virtual reality trials and a summary of the pitfalls and successes of this new concept in clinical practice
• Identifying key products and software available to facilitate remote studies
• Showcasing bioengineering as an innovative solution to the long-term use of biosensors in the body
• How lowering the burden on participants can reduce patient-dropout rate

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.

Roundtable 1
Discussing best practices for leveraging site intelligence in budget & contracts
Stephanie Molteni, Associate Director, Site Budgets & Contract Management, Clinical Operations, UltraGenyx Pharmaceutical

Roundtable 2
Solving the frustration with change orders: Debating how to justify them & when they are appropriate
Mark J. Milberg, Senior Director, Clinical Outsourcing, Ultragenyx Pharmaceutical

Roundtable 3
Innovative ways of improving CRO engagement and communication
Sue Naim, Director, Clinical Operations, Astex Pharma

Roundtable 4
Vendor partnerships: Discussing the best approaches for choosing providers
Larry Vong, Senior Clinical Data Specialist, Nevro Corp

Roundtable 5
Redefining combination devices in the new era
Host: Hayley Lewis, Senior Vice President of Operations, Zosano Pharm

Roundtable 6
Establishing Post-market surveillance and Clinical Follow Up System per the European and FDA guidelines
Ritu Verma, Head of Global Clinical Affairs, Natus Medical Incorporated