Outsourcing in Clinical Trials Texas 2022

• Highlighting the key challenges associated with rare disease trials especially considering the lack of available therapies
• Outlining your CRO selection process including how to evaluate their level of experience
• Pinpointing best practices for rare disease patient recruitment and engagement in order to prevent study start-up delays
• Recognising the need for effective site and investigator engagement

• Sponsors need CROs that can offer more than simply CRO staff.
• Pharm-Olam is proactively and purposely building site networks and relationships with appropriate vendors and local partners to support their three Centers of Excellence
• Learn how this approach is adding value to study start-up and study execution thus providing more value to Sponsors

Recognizing the intrinsic value of patient advocacy groups (PAGs) to help boost patient engagement in all phases of the drug development process. This session will be followed by 10mins Q&A.

• Exploring the role and importance of PAGs in healthcare
• Pinpointing the struggle of patient engagement when there is not a disease-specific patient advocacy group
• Establishing inclusive stakeholder relationships and best practices for expanding partnerships
• Stakeholder educational opportunities
• 10mins audience Q&A

Take the chance to visit vendors in the exhibitor hall and discover new solutions that will speed up your clinical trials

This session will explore the process once the initial IND is submitted to the FDA. Understanding the rational for imposing the clinical trial hold is critical for the sponsor to avoid or mitigate this risk.

• Overview of the basic steps to the process for the initial 30 days after an initial IND is submitted to the FDA
• Understanding the types of clinical hold
• Rational for imposing a clinical Trail hold for phase I by the FDA
• Identification and options for resolution of the clinical hold
• Analyzing the options for the sponsor’s response to clinical hold
• Discussing best practices for the dialogue between the Sponsor and the FDA during the initial submission phase

Patient-centricity gets a lot of buzz, but what are the benefits of involving patients in the planning of a clinical trial? This presentation looks at:

• Where in the process to get patient input—from protocol reviews to endpoint selection to assessments
• How patient input can benefit enrollment, compliance, and outcomes
• What tactics can be used to elicit meaningful input

• Specifying the individuals you agreed to work with during the contract stage to avoid losing valued team members
• Harnessing methods for maximizing CRO engagement once you have the right team
• Implementing best practices for establishing good communication between internal teams and vendors
• Promoting frequent face-to-face meetings and reporting metrics to promote open communication

After lunch visit vendors in the exhibitor hall and discover new solutions that will speed up your clinical trials

• Overview of clinical trials in MD Anderson
• Introducing values a quality site would bring to sponsored trials
• Discussing what sponsors could consider to facilitate clinical research and patient care

• Australia’s scientific talent, excellent medical infrastructure and lucrative R&D cash refund scheme makes it a preferred destination for early phase clinical trials.
• Patient availability makes Asia a key region to accelerate later phase development, at lower costs.
• The partnership between regional specialists, an alternative to large global CRO to manage complex global trial

• Identifying how RWE is used to locate patients for faster recruitment
• Delving into electronic medical health records to identify patient numbers before you set out study parameters
• Navigating RWE to gain metrics on how many patients sites bring in to improve site selection processes
• Exploring competitive intelligence and landscape assessments to identify investigators with the capacity for your study
• Highlighting the use of RWE for protocol modelling and regulatory submission
• Building regulatory, clinical and healthcare economics strategies- involving cross functional teams

• Addressing the pros, cons and planning stages associated with implementing a clinical study in Australia
• Exploring the importance of trust with your vendor to ensure you can rely on them to successfully run your trial abroad
• Pinpointing practical methods involved with planning and executing clinical trials in Australia
• Discussing what small companies should consider when contemplating running a study in Australia

Take the chance to visit vendors in the exhibitor hall and discover new solutions that will speed up your clinical trials

‘The globe is getting smaller so more needs to be done internationally’

• Pinpointing the importance of international sites generating greater outreach in order to recruit suitable patients
• Recognising the benefit of having a local contact for abroad sites to maximise local knowledge and regulations
• Appreciating good relationships with international site coordinators to solve issues quickly despite time zone differences
• Exploring the motivation to conduct more device trials in China to take advantage of the largest population in the world

• Developing the in-house infrastructure to conduct scientifically valid research and avoid the pitfalls of attempting to outsource pioneering work, especially related to cannabis
• Understanding the unique challenges qualified participating families face and structuring/conducting your trial in an empathetic manner that helps ensure completion
• Recognizing the value of both analytical & observational data for teeing-up future studies and establishing the protocols to gather all, including ‘blind’ 3rd parties
• Creating a trial template that can be both replicated and evolved to help establish the foundation for future cannabis clinical studies

• Outlining the role of patient screening in medical device trials to ensure the most suitable patients are selected
• Screening patients appropriately so that qualified and quality patients are enrolled
• Identifying challenges with informed consent in medical device trials to ensure compliance with the protocol
• Identifying the logistical challenges of doing trials to reduce the burden on both the patients and the site

• Developing an internal strategy for vendor management during start-up to meet deliverables and ensure correct specification
• Promoting strong vendor communication plans with weekly calls and regular face-to-face meetings
• Considering the advantage of having an experienced clinician review your protocol pre-start-up to ensure it will be well-received by sites
• Outlining the main reasons for start-up delay to put structured agreements in place so this can be avoided

• Determining how best to evaluate your internal capabilities to decide what to keep in-house to make the most of your resources
• Highlighting the challenges of hybrid vs fully outsourcing models to identify the most suitable method for achieving your development goals
• Evaluating the risk of either outsourcing model to determine who is ultimately responsible for the various aspects of the trial
• Defining big vs small company perspectives to understand the key factors that should be considered in the final decision

• Appreciating that innovation is just as likely to come from outside the walls of a large healthcare company as it is from within
• Exploring why many innovative ideas fail at the early stage
• Discussing a model for early stage companies to bring their innovations in therapeutics, medical device or consumer health from concept to fruition

Take the chance to visit vendors in the exhibitor hall and discover new solutions that will speed up your clinical trials

• To discuss the different programs embedded within TMC Innovation: TMC Biodesign, TMCx, TMCx+, TMC Corporate Partners
• TMCx’s individualized approach for startups attempting to navigate major healthcare systems
• How to measure success? A startup perspective

Cancer therapies are utilizing complex biologics but clinical sites remain uneasy with the preparation, administration, or handling of these products and the patients receiving them. This session will explore how designing and outsourcing education to clinical sites as a strategic plan between the Sponsor and the CRO can help to increase patient enrolment and site interest.

• Identifying stakeholders
• Designing a comprehensive education plan
• When and what activities can

After lunch visit vendors in the exhibitor hall and discover new solutions that will speed up your clinical trials

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 runs for 30 minutes and delegates have an opportunity to take part on 2 roundtables.

RT 1- MDR Debate- Discussing the best strategies for developing a post-market plan & clinical follow up for you device to ensure acceptance

Jane Hart, Vice President, Global Clinical Affairs, Acelity

RT 2- Establishing strategies for vendor management and oversight to strengthen collaboration

Sofia Achaval Wied, Executive Director of Development , Tvardi Therapeutics

RT 3- CPRIT Roundtable- Discussing how to meet the challenges of company funding

Cindy WalkerPeach, Chief Product Development Officer, Cancer Prevention & Research Institute of Texas

RT 4- What is medical affairs? How to incorporate or outsource medical affairs activities early in Clinical Development in order to maximize the value proposition of your product at Launch

Dr Ike Ogbaa, US Medical Affairs Lead, Sanofi