Sponsors and Agencies (SA)

Covers: the nature of “sponsorship”; defining roles and responsibilities between sponsors, grantors, awardees; private sector sponsors: technology, foundations; state sponsorship issues; federal agency updates; new initiatives in research; international agency relations;  working with program officer leadership; and sponsoring agency rules.

Monday, May 16, 2016

M106: Pitfalls and Solutions: Federal Contract Flow-downs to Universities/Non-profits
Monday, May 16, 2016 - 9:30am to 10:45am

Content level: Intermediate

Congratulations! You have received a Subagreement from a Federal Agency through a Sponsor. Ideally, negotiations are quick and painless as both Parties fully understand the other Party's positions and allowabilities in regards to flowing down Federal Regulations. Unfortunately, that's not always the case. In this session, we'll discuss how the FAR and its prescriptions are applied to various entities and how to explain applicabilities to your Sponsors. The speakers will also present a case study negotiating a Subagreement that was already negotiated and awarded, then transferred with a new PI to you from another organization.

Learning objectives:

1. How to interpret and read a FAR prescription, identify the appropriate flow down based on the entity type, and identify issues that may result from inappropriate flow down provisions.

2. Various negotiation strategies that may be utilized when the Sponsoring party doesn’t understand how to apply the appropriate flow down provision.

Prerequisites: None

Speaker(s):

Anna Thomas, Contract Officer and Danell Thompson, Contract Officer, University of Colorado Boulder

M206: National Institutes of Health (NIH) Update (Webinar)
Monday, May 16, 2016 - 11:00am to 12:15pm

Content level: Basic

This session is a comprehensive review of what is new and being developed within the National Institute of Health's (NIH) programs, policies, and budgets. Participants will learn about the newest updates to NIH's budget and compliance initiatives and how their respective institutions will be affected. Upon completion of the presentation, participants will have the opportunity to ask questions about the new and existing policies and procedures.

Learning objectives:

  1. Learn basic information concerning the NIH, including new, emerging initiatives as well as recurring policy reminders.
  2. Learn basic information concerning NIH eRA activities, including eRA Commons and electronic submission of NIH grant applications, progress reports and other post-award electronic processes.

Prerequisites: None

Speaker(s):

Stefanie Harris, Grants Policy Analyst, National Institutes of Health (NIH)

M306: National Science Foundation (NSF) Update
Monday, May 16, 2016 - 2:15pm to 3:30pm

Content level: Basic

This session will cover new developments at the National Science Foundation (NSF) - programs, policies, people and budgets. Senior NSF staff will provide a comprehensive review of what is new and developing at NSF.

Learning objectives:

  1. Learn about the NSF Fiscal Year (FY) 2016 and 2017 budgets and administration priorities for NSF programs.
  2. Understand how NSF has implemented recent changes to proposal and award policies and procedures.

Prerequisites: None

Speaker(s):

Beth Strausser, MPA, Senior Policy Specialist, National Science Foundation (NSF)

M307: Making Grants Happen at the Bill & Melinda Gates Foundation
Monday, May 16, 2016 - 2:15pm to 3:30pm

Content level: Basic

Overview of Bill & Melinda Gates foundation with emphasis on operational perspective with a focus on two grant examples (Capacity Building and Research & Development).

Learning objectives:

  • Overview of Bill & Melinda Gates foundation with emphasis on operational perspective
  • Grant Making Investment Workflow: End to End

Prerequisites: None

Speaker(s):

Megan Isenhower, JD, M.I.M., Senior Officer and Lee KlejnotSenior Officer, Grants & Contracts Management, Bill & Melinda Gates Foundation

 

Tuesday, May 17, 2016

T106: Budget Negotiation Challenges: It's Your Cost of Doing Business
Tuesday, May 17, 2016 - 9:00am to 10:15am

Content level: Intermediate

Clinical trial budgets are always negotiable. Still, many investigators and clinical teams accept original budgets proposed by industry sponsors. The process of budgetary negotiation may seem intimidating, overwhelming or ungrateful. In reality, negotiation allows both the sponsor and the site to arrive at a consensus which will benefit both sides. With an acceptable budget, the site is more likely to fully commit to subject enrollment and site compliance by allocating proper resources and effort, which will result in producing higher quality data. Trial success can be easily compromised when budgets are negotiated poorly or accepted with no negotiation at all. Who is the right negotiator at the site level? How to muster sufficient negotiation power? When to push back and what to forgo? These and other questions will be addressed in the course of the session. The participants will discuss practical negotiation tips and techniques. Actual budget negotiation examples will be used to reveal most common stumbling blocks between sites and sponsors and the ways to circumvent them.

Learning objectives:

  1. Define the role of budget negotiation in trial success.
  2. Utilize various budget negotiation tips and techniques.

Prerequisites: None

Speaker(s):

Pavel Kruchek, MBA, Director, Business & Financial Operations and Vanessa Bryant, Senior Budget Analyst, University of Utah, Clinical Trails Office

T206: What to Expect in a US Food and Drug Association Inspection
Tuesday, May 17, 2016 - 10:30am to 11:45am

Content level: Basic

This presentation will describe the US Food and Drug Association (FDA)'s clinical investigator inspection program. It covers the common forms, terminology, and what to expect during an FDA inspection - the who, what, where, when and a little bit of the why and the how.

Learning objectives:

  1. Understand FDA's Clinical Investigator inspection process.
  2. Understand the site's role in an FDA inspection.

Prerequisites: None

Speaker(s):

Alexander M. Kay, Supervisory Investigator (SCSO), US Food and Drug Administration (Seattle District), Puget Sound Resident Post

T306: Using Philanthropy to Support Research
Tuesday, May 17, 2016 - 1:45pm to 3:00pm

Content level: Intermediate

Learn the benefits and important differences in securing and using philanthropic gifts to support research. Hear from an experienced fundraiser and current research administrator how to secure millions in gifts to support important research. The speaker will review simple steps to foster an environment of gift-supported research at your institution, large or small. Learn what needs to happen to cultivate new and existing donors and how to partner philanthropic funding opportunities with research priorities. The speaker will discuss engaging your faculty, physicians and other staff in philanthropy. Guidelines for distinguishing between gifts and grants will also be shared. Unless your research program is blessed with a fully-funded endowment producing perpetual income sufficient to sustain and grow your research, or you’re 100% confident you will be fully funded by the government, then you need to attend this session. This practical session will provide tips to use right away and in the long-term.

Learning objectives:

  1. Understand how to link and support research needs with philanthropic opportunities.
  2. Understand the distinction between a sponsored program grant and a philanthropic gift.

Prerequisites: None

Speaker(s):

Kevin Titus, MBA, Business Director, Cincinnati Children's Hospital Medical Center

Wednesday, May 18, 2016

W106: Spotlight on Clinical Trial Sponsorship
Wednesday, May 18, 2016 - 9:00am to 10:15am

Content level: Intermediate

There is a natural concern with the responsibility implied by assuming the role of “sponsor” in a clinical trial agreement. In a commercially sponsored clinical trial, for example, the site can reasonably require that a drug company assume most liability for subject injury, unless an injury is caused by the site’s gross negligence. Pharmaceutical companies are not the sponsor, however, for Investigator Sponsored Trials (ISTs, sometimes called Investigator Initiated Trials or IITs). Between these extremes are the complex cases where a mix of delegated roles and responsibilities are assigned and where the “duty of care” relation between a physician and their patient may take precedence in any case. This session discusses sponsorship in terms of the Food and Drug Administration (FDA) regulations and reviews several cases where judicial interpretation of a sponsor’s duties had an impact on liability.

Learning objectives:

  1. Define the different roles and responsibilities for sponsors and investigational in Investigate New Drug (IND) clinical trials.
  2. Understand how roles can be delegated and how liability involves duty of care and fiduciary duties.

Prerequisites: None

Speaker(s):

Doug Mounce, MS, Grants & Contracts Manager, Cancer Research & Biostatistics, Tammy Buist, BA, MBA, Chief Business Development Officer, Cancer Research and Biostatistics, and Frank X. Curci, Partner, Ater Wynne, LLP.