SEPTEMBER 20-21, 2021 | VIRTUAL EVENT

AGENDA – ALL TIMES ARE IN EASTERN TIME

Visit our virtual lobby and connect with fellow attendees. You can chat, video, and even make a list of the people you want to meet and knowledge you’re looking to gain through our bespoke 1:1 match-making services.
  • What it is and what it is not
  • Need for IITs
  • Process, from concept pre-approval to submitting the final budget and protocol
Dr. Viraj Suvarna
Former Senior Vice President
LUPIN PHARMACEUTICALS
  • The COVID-19 Pandemic affirmed the significant health care inequities in the US and across the globe.
  • IIS/IIT Programs provide a unique opportunity for a company to address these issues in multiple ways.
  • The presentation will highlight methodology to understand the level of diversity in an IIS/IIT program and some recommendations to address the gaps.
Sloan Stribling, PMP
Director – Early Development, Collaborations, and Translational Oncology IIS Team Lead
MERCK
Panelists:
Kathleen Maley,
SLRM, Associate Director
MERCK

Sloan Stribling, PMP
Director – Early Development, Collaborations, and Translational Oncology IIS Team Lead
MERCK

Kathryn Josephs
Director, ISR/NRDG, Medical Affairs
MIRATI THERAPEUTICS
A safe space to talk candidly through your challenges, new tools/tactics. Dedicated VIDEO Q&A time to ask our presenters questions directly, share your thoughts with, and engage with your industry peers face-to-face. This is not a live chat or faceless group—a unique opportunity to replicate those hallway conversations and coffee breaks from live events.

Speakers:
Sloan Stribling, PMP
Director – Early Development, Collaborations, and Translational Oncology IIS Team Lead
MERCK

Kathleen Maley,
SLRM, Associate Director
MERCK

Dr. Viraj Suvarna
Former Senior Vice President
LUPIN PHARMACEUTICALS
  • Best practices for budget negotiations between industry collaborator and sites
  • Develop a protocol-based budget review process, using Medicare Coverage Analysis to ensure correct application of research and routine care assessments
  • Use third-party benchmarking software to ensure standardized application of Fair Market Value (FMV) analyses of IIT budgets
  • Develop a clear process for budget negotiation which includes pathway for escalations and exceptions
  • Develop standard payment terms and negotiate with budget.
Jennifer Kellen
Director, Investigator Grants
EXELIXIS

Michael Worden
Senior Investigator Grants Manager
EXELIXIS
  • Meeting FDA compliance requirements within IITs
Alan Minsk
Partner and Leader, Food and Drug Practice Team
ARNALL GOLDEN GREGORY LLP
  • Engaging with the Medical Science Liaisons (MSLs) to support scientific discussions and thought leader engagement
  • Capitalizing on the therapeutic expertise of Medical Directors
  • Overcoming limited resources by utilizing a rotation program (e.g. clinical operations)
Kat Long
Director Medical Affairs
ALKERMES

Stephanie Daub (Ebner)
Director, Field Medical Excellence
ALKERMES
Sloan Stribling, PMP
Director – Early Development, Collaborations, and Translational Oncology IIS Team Lead
MERCK

Joel Nunez
Director Content and Experience
MOMENTUM EVENTS
A safe space to talk candidly through your challenges, new tools/tactics. Dedicated VIDEO Q&A time to ask our presenters questions directly, share your thoughts with, and engage with your industry peers face-to-face. This is not a live chat or faceless group—a unique opportunity to replicate those hallway conversations and coffee breaks from live events.
Visit our virtual lobby and connect with fellow attendees. You can chat, video, and even make a list of the people you want to meet and knowledge you’re looking to gain through our bespoke 1:1 match-making services.
  • Assessing the feasibility for the MSL to identify data gaps (i.e. understand what kind of data KOLs would like to see and also what data would be of strategic value to the company)
  • Facilitating submission and approval of the study to work with the internal team (which includes other members of the medical team, and may include members of the marketing, regulatory affairs, clinical teams) to get study approved
  • Developing a data dissemination plan - when the study is complete, what conferences will the data be presented at? What journal will it be submitted to? What other KOLs can you share the data with once it is published?
Jeremy Keeton
ONC IIT Advisor
ELI LILLY
A safe space to talk candidly through your challenges, new tools/tactics. Dedicated VIDEO Q&A time to ask our presenters questions directly, share your thoughts with, and engage with your industry peers face-to-face. This is not a live chat or faceless group—a unique opportunity to replicate those hallway conversations and coffee breaks from live events.

Jeremy Keeton
ONC IIT Advisor
ELI LILLY

Amy Place
Global Medical Affairs
SCHOLAR ROCK
  • Differentiate investigator’s role in IIS/IITs from that in company sponsored studies
  • Explain pharma’s role in providing support for ISS/IIT studies to ensure compliance
  • Understand the required documentation from the Investigator/ Sponsor’s perspective before, during and after the study
Moderator:
Christina (Cwalinski) Zukowski
Medical Investigator Sponsored Studies Operations Manager
IPSEN BIOPHARMACEUTICALS

Scott McConnell
Vice President Medical Affairs
CHIASMA

Lillian Phan
Associate Director, ISR & CU Program Operations, Global Medical Affairs
BEIGENE

Laura Seravalli
SLRM, Associate Director
MERCK
  • Determining clinical site support needs to make these trials faster, more efficient, and more supportive of company objectives.
  • Best practices to manage demand for multiple study drugs.
  • Maintain Record of IIT Shipments to Inform Sunshine Reporting
Tammy Moll
SLRM Lead, Associate Director
MERCK
Dr. Oscar Segurado
Chief Medical Officer
ASC THERAPEUTICS
A safe space to talk candidly through your challenges, new tools/tactics. Dedicated VIDEO Q&A time to ask our presenters questions directly, share your thoughts with, and engage with your industry peers face-to-face. This is not a live chat or faceless group—a unique opportunity to replicate those hallway conversations and coffee breaks from live events.