Conference Schedule
IITs can be an effective tool for both large and small biopharmaceutical companies. With the increased interest in IITs, it is important to have a clear understanding of what an IIT is, the process of managing the entire project, and how it fits into the clinical research landscape.
  • Provide an overview of what an IIT is and is not
  • Address the common challenges (inadequate funding, support, design, regulatory burdens)
  • Address the need for transparency across internal and external stakeholders through to completion and publication
  • Discuss the process, from concept pre-approval to submitting the final budget and protocol
Racial and ethnic minorities have historically been underrepresented in clinical research. The pandemic has highlighted the health disparities globally and the importance of advancing diversity and inclusion in clinical trials. IIT programs are an opportunity to improve diversity in patient recruitment.
  • Evaluate IIts to ensure diversity in patient recruitment
  • Discuss best practices to include D&I in sponsored studies
  • Recognize the impact IITs can have on increasing patient recruitment and enrollment in trials
  • Examine the opportunities for MSLs and Medical Affairs to improve clinical trial diversity
With life science organizations receiving an increasing number of IIT requests, medical affairs teams need to effectively evaluate whether an IIT proposal aligns with a company’s strategic priorities and overall medical strategy while gaining cross-functional buy-in. MSLs play a key role in understanding what kind of data KOLs would like to see and what data would be of strategic value to the company.
  • Share key tactics for MSLs to collaborate and effectively manage an IIT
  • Highlight how to optimize the review process, provide proper oversight after approval
  • Discuss how to ensure the timely and successful execution of an IIT
  • Delve into managing goals and expectations
  • Ensure cross-functional alignment on priorities and tactics
  • Tips to guarantee a compliant investigation throughout the entire lifecycle process
Initiating, sustaining, and taking an IIT to fruition is not an easy task. A clear understanding of what the process entails from conception to completion is critical to the success of a trial.
  • Discuss how to coordinate your internal resources for success
  • Address key strategies for successfully initiating a program
  • Understand optimal methods to review a proposal
  • Demonstrate the value of the IIT program to the organization
  • Consider where compliance should be involved in the life cycle
Join us for a Networking Lunch break to grow your industry network and continue discussing today’s hot topics
A well-designed IIT can ultimately lead to improved evidence-based medicine and outcomes for patients. From conception to completion, it is imperative that the project is managed well to ensure a successful outcome.
  • Discuss the IIT process across industry
  • Learn how to create an IIR Strategy
  • Define how to optimize submission and review process
There are many steps that must be taken to assess risk and integrate quality when developing, initiating and conducting an IIT. If properly combined, these tactics are sure to achieve the desired results.
  • Develop an IIT quality oversight process
  • Monitor IIT quality using performance indicators and investigator communication
  • Ensure high-quality final results from IITs
  • Describe how to apply quality principles to IITs
  • Discuss how to best work with pharma
Join your peers to continue the discussion while networking over refreshments
A well-planned budget ensures the trial can be completed in accordance with the trial protocol and any relevant funding agreements. There are numerous options, risk, and error sources that you must consider when designing budgets.
  • Share insights to better understand the budget development process
  • Identify the expenses that are essential for your study to succeed
  • Develop a clear process for budget negotiation which includes pathway for escalations and exceptions

Our facilitated, Interactive Discussion Groups (IDGs) optimize peer-to-peer learning by crowdsourcing solutions to common challenges surrounding developing and managing IIT programs. The connections you make through the IDGs will become your most valuable takeaways. You will have the opportunity to sit in on two 30-minute sessions with groups capped at 25 to ensure helpful conversations. Choose from TWO of the below:

  • Discuss the site selection impact on a successful study
  • Examine reasons for timeline delays and poor-quality data
  • Review Standard Operating Procedure (SOP)
  • Share strategies for onboarding and activation of the site
  • Discuss the administrative team needed to support development and maintain the protocol
  • Analyze the three areas that PIs and their administrative teams should focus on when writing an IIT protocol
  • Techniques to encourage investigators to publish study
  • Discuss how to manage the publication process including contract language
  • Explore the challenges with getting the study published
  • Evaluate the financial risks
  • Discuss communication challenges
  • Recognize the implications of drug supply shortages
  • Ensure expertise and experience of investigators
IITs expand product knowledge and often identify new ways of using existing treatments, thus improving the health of patients. But as more life science companies consider supporting IITs, there are many factors that should be considered, including regulatory issues, before proceeding. This session will review some of the FDA and non-FDA issues to help organizations make a more educated decision before supporting an IIT.
Engaging with investigators in a positive way and understanding their pain points is key to developing, building and maintaining a meaningful relationship. Establishing solid connections in this manner can raise the likelihood of successful study completion.
  • Share insights on being the advocate for the Investigator
  • Discuss how to capitalize on the strategic alignment of the company and the research experience of the investigator
  • Identify best strategies to establish and maintain meaningful relationships with Investigators
  • Examine successful strategies to work with difficult investigators
  • Recognize the importance of setting expectations that can impact the success of a study
  • Understand the importance of properly training a PI in IIT overseeing operations
Unlike an IIT, Collaborative Research methods provide a relatively new opportunity for industry and non-industry partners to work together effectively to develop safe treatments for patients. Collaborative Research may be conducted before, during or after a regulatory approval of a drug or medical device, and may be interventional, observational or preclinical.
  • Outline the differences between an industry-sponsored study and Collaborative Research
  • Define the framework for Collaborative Studies
  • Determine when to implement Collaborative Studies vs. IIT
  • Review compliance considerations
  • Highlight the most important challenges
IITs have the added benefit of cementing relationships with investigators who can potentially contribute to the future success of the organization. However, the relationship can be damaged when expectations outlined in the research agreement are not met and the study has to be canceled.
  • Insights on key strategies to terminate the project and preserve relationship
  • Discuss how to protect the relationship between the MSL and the Investigator
  • Explore common challenges that results in a termination
  • Highlight the importance of outlining clear expectation in the research agreement

Join us for a Networking Lunch break to grow your industry network and continue discussing today’s hot topics

To improve communication and relationships with your sites and Investigators, it is imperative that you listen to their concerns and challenges. In this session, hear insight from sites on their experiences working with sponsors.
  • Hear suggestions on how trial sponsors can better meet their needs to execute higher quality trials
  • Learn what the top challenges encountered working sponsors
  • Rework communication based on lesson learned
  • Examine the value of developing IITs in collaboration with the key stakeholders through carefully planned meetings
Designing and building databases for an IIT can be a daunting process. A well-designed system is essential to manage and analyze your data, track trial progress, monitor site compliance, query data, create reports of various trial parameters.
  • Understand the principles and formats of database design
  • Insights on using a design that is easy to learn and navigate
  • Highlight common data management tips and tricks
  • Discuss lessons learned and landmines to avoid
  • Explore the advantages of levering technology to simplify portfolio management
  • Share experiences and advise on how set up your trial submissions to enable a roll up (milestones, budgets, enrollment)
  • Tools such as Power BI or Tableau to surface information for consumption
  • Specify which key reports are needed for decision making
  • Map out approaches to drive decisions with leadership