Your organization is under high outside scrutiny – and your entire industry is often distrusted by the public. How is your company culture balancing the priorities of therapeutic success for at-risk patients and delivering higher financial returns?
- Demonstrate the positive outcomes that can occur when the focus is on the patient
- Create processes to combat inequities within trials and studies
- Explain the benefits, both fiscal and moral, of dedication to patient success
In a small company, there may be only one person representing IITs. What is the best way they can continue to support their patient populations?
- Detail the successes of small- or micro-sized teams
- Discuss the advantage of partnering with smaller firms to eliminate excessive oversight and potential timeline delays
- Showcase how influential smaller biotech firms are becoming in the IIT space
The numerous terms at work in IITs can cause confusion, especially when academic institutions use different definitions than pharma. This session will minimize confusion and lead to a better understanding for all involved parties
- Identify and consistently define key terms
- Explore areas of inconsistency to avoid future confusion
- Interact with fellow attendees to gain a better insight into areas of uncertainty
Both Budgets and Contracts are considerable pain points in initializing studies and trials, with major impacts on timelines. Having a clear, concise, and understandable contract and a flexible but consistent budget template can help with start-up speed and help alleviate some of the common pressures that come with these negotiations
- Discuss the proper and concise formats of contracts and budgets
- Establish potential protocols to help collaborators have meaningful discussions surrounding contracts and trial budgets
- Debate solutions to consistent contract and budget concerns with members of sites/institutions, pharma, and independent investigators
Both Collaborative Studies and Traditional IITs/IIRs are part of your research toolkit. Though both have the same basis for collecting patient data, there are distinct pros and cons to each.
- Convey the similarities and differences between the types of studies
- Discuss the regulatory concerns raised by both types of studies
- Highlight the main risk areas of each
Dedication to Diversity, Equity, and Inclusion is critical to creating equitable spaces for underserved populations. And it is increasingly necessary to ensure all R&D avenues are explored. In this session, we will:
- Discuss new avenues of engaging marginalized communities
- Discuss the advantage of partnering with smaller firms to eliminate excessive oversight and potential timeline delays
- Examine processes that put ideas into actionable programs
With many qualified staff like nurses, MSLs, and Clinical Specialists pulled in the direction of COVID, the IIT world was hampered by this unavoidable staffing crisis. Now with things returning to normal, but staff still an issue, how do you know you’re hiring not just the appropriate number of staff, but the right staff?
- Present the space positively for prospective candidates
- Capitalize on the strengths of current staffers to improve data outcomes
- Understand the importance of a caring and understanding staff presence from all aspects of a study and trial
- Elli Gourna Paleoudis, MS, PhDDirector, Investigator Initiated Research ProgramHackensack Meridian Health
- Kaitlin MorrisonDirector of UNC Lineberger Sponsored Clinical ResearchUNC LINEBERGER COMPREHENSIVE CANCER CENTER
- Sheila WatersSr. Director, Field Medical AffairsSECURA BIO
- Colleen LemoineMedical Science LiaisonSECURA BIO
With both the FDA and other regulatory bodies updating their compliance processes and guidelines, it can be hard to stay ahead of the curve. This consistent adjustment presents its own set of unique challenges and needs dedicated staff attention.
- Explain latest FDA updates
- Highlight upcoming changes to protocols and best practices
- Provide guidance on fringe and other “grey area” topics that provide complex problems to trial and study leaders
An IIT/IIR benefits tremendously from a well-traveled and experienced MSL, who may take on many roles within the trial. Better grasping MSL performance can lead to overall better study planning and outcomes. In this session, we will:
- Discuss the importance of proper engagement and oversight MSLs provide
- Rely on MSLs to unite teams and functions
- Ensure MSLs are prepared for timeline management
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.