Conference Schedule
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Strategies To Facilitate Successful IITs

IIT programs are beneficial to the scientific and clinical communities, and to patient care. A study must be designed to be objective, transparent, and scientifically sound.

  • Demonstrate the value of the IIT program to the organization
  • Establish a cross functional team to determine the scope, strategy and oversee the IIT
  • Understand guidelines for setting up the submission process
  • Examine safety reporting practices
  • Discuss the approval and communications of study results and the close-out process

It is important that there is a clear understanding of the company’s and investigator’s role throughout the study to facilitate execution, alleviate confusion and unnecessary bottlenecks.

  • Define and set expectations for each party early in the process
  • Recognize differences in the role of investigators in both IITs and company-sponsored studies
  • Understand the level of involvement from the pharma organization
  • Maintain frequent communication to anticipate issues and address them proactively

An Investigator-Initiated study plays a vital role in the discovery of new drug indications and can ultimately lead to improved evidence-based medicine and outcomes for patients. However, it is crucial that study proposals align with the organization's research portfolio and business strategy.

  • Evaluate the foundation of your organization’s IIT program
  • Hear regulatory and ethical requirements for program compliance
  • Review strategies for “Directing” the focus of proposals

While conducting IITs, there are many key factors that must be considered among regulatory and compliance issues.

  • Understand how to meet FDA and ICH compliance requirements in protocol development, consenting, data collection and beyond
  • Hear how to implement efficient procedures to support IITs
  • Understand the increasing FDA scrutiny of clinical trials and discuss ClinicalTrial.gov compliance
  • Identify the risks involved with supporting investigator-initiated research

RWE is increasingly considered vital for the development of treatment strategies. It is being used to support clinical trial designs and observational studies to generate new treatment approaches.

  • Use IIT strategy to drive market differentiation and value
  • Determine how IIT strategies fit into the context of overall business and product strategy
  • Incorporate regulatory, clinical/ medical affairs, and commercial strategy for pipeline and in-line products
  • Define clear priorities for IIT research based on market requirements
  • Build strategic relationships with key partners to obtain RWE data
  • Understand the challenges and opportunities of incorporating RWE into IIT strategies

Overcome Publication and Contract Negotiations Challenges

The most desired outcome in a study is adding scientific data to the body of knowledge around a product. While Investigators are responsible for publishing the data of their research, study sponsors have a responsibility to ensure that the study is reported. Publication teams must recognize the differences in working with investigator authors in order to manage projects effectively, compliantly, and within contractual specifications.

  • Discuss strategies to maximize the value of IIT publication
  • Examine the challenges and limitations in publishing investigator initiated research
  • Understand the differences between company-sponsored publications and IITs publications
  • Incorporate the publication clause in the initial IIT agreement
  • Review the external perception of IIT publications vs. internally developed publications

Prior to study initiation, your contracts must consider external guidelines, and all stakeholders need to understand how contracting sets the foundation and background for study conduct. A well-developed contract helps ensure sustainability, if you give it the attention and priority it requires. This session will provide insights to negotiate IIT and Collaborative Research contract across all therapeutic areas globally.

  • Overview of key expectations from concept submission to decision
  • Understand the differences between IISR and Collaborative Research contract negotiations
  • Review appropriate budgets and payment schedule
  • Highlight best practices for global contracting
  • Steps to avoid common contracting delays
  • Provide strategies to assess metrics and trial performance

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.

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Planning Successful Partnerships and Collaboration

Collaborative research is evolving and, while it brings a new avenue for industry and non-industry partners to work together effectively to develop safe treatments for patients, it also brings its own challenges and risks. The process can be very complex and requires new governance frameworks in order to be successful.

  • Understand how employing a more collaborative approach to research studies can lead to more effective and safe treatments
  • Define what qualifies as a Collaborative Research
  • Outline the differences between a Collaborative Research and an IIT
  • Implement a communication strategy and a risk control framework
  • Examine the critical facets of Collaborative Research that are essential to avoid delays and disputes
  • Ensure appropriate processes and contractual arrangements are established

In order to maximize your returns from supporting IIS, you should choose your investigators wisely. Selecting the right investigator and building the relationship is the key to the success of a study.

  • Learn key criteria for evaluating investigators and proposed IITs to make the best selection
  • Recognize the importance of advocating for the PI and building positive productive relationship
  • Identify red flags that could impact the timelines of the study
  • Explain pharma’s role in providing support for IIT studies to ensure compliance
  • Examine the hardships PIs face during a study lifecycle

The Medical or Clinical Science Liaison is often the organization’s main connection with a scientific expert, taking a key role in bringing investigator ideas to the company and helping to initiate an IIT program.

  • Examine appropriate boundaries for the medical or clinical science liaison in an IIT program
  • Understand the unique challenges liaisons face in interactions with investigators
  • Discuss how to balance the MSL role with operations to ensure alignment in the process
  • Review compliance considerations when MSLs work with IITs

Strategies for Protocol Development and Multi-Site Management

The protocol is the roadmap in defining the steps required to conduct a successful study.

  • Discuss the fundamental guidelines for development of a clinical research protocol
  • Review the structure of a protocol including considerations related to research methodology, plans for analysis, budget preparation, and study timelines.
  • Examine best practices on what to do and not to do during protocol development
  • Share insightful tips gathered from trials and investigators
  • Analyze the areas that PIs and their administrative teams should focus on when writing an IIT protocol

Successfully operating multisite IITs will test your management skills to the limits. You will need flawless understanding of investigator and sponsor responsibilities and the ability to handle multiple challenges at once. Outline the fundamentals of multisite IIT management

  • Evaluate the sponsor’s responsibilities and external site quality control
  • Discuss best practices for providing investigational drugs and managing the regulatory file
  • Step to ensure proper oversight to manage multi-site trials

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.