$2,085 – $6,275

2nd Clinical Trial Financial Management Summit (EXL)

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Sonesta Philadelphia Downtown Rittenhouse Square

1800 Market Street

Philadelphia, PA 19103

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2nd Clinical Trial Financial Management Summit

Developing procedures for budgeting and financial accruals is a challenge the industry has yet to master. Each organization has a budget that is unique and difficult to predict and manage. Protocol amendments, the number of participating sites, monitoring strategies, and misalliances all drive costs up. It is critical to find reliable partners and tools to effectively plan for future challenges.

Establishing the difference between a realistic forecast and approved spending can be difficult. Fluctuations in trial forecasts from quarter to quarter make funding requests challenging but well-formed teams, systems, tools and processes can help. This summit will bring together sponsors, CROs, and sites to collectively work toward accurately and efficiently forecasting and managing trial budgets.

Top Five Reasons to Attend

  1. Gain insight into innovative solutions that deliver on-budget clinical trials using real-world data
  2. Establish and employ accurate resource and financial forecasts in clinical trials
  3. Learn to manage contracts and negotiations with outsources partners and vendors
  4. Balancing savings, quality, and speed in the selection of CROs and vendors
  5. Pinpoint best practices for funding of a clinical trial through grants and government

Who Should Attend

Pharmaceutical and Medical Device professionals with responsibilities in the following areas:

  • Clinical Finance
  • Clinical Strategic Planning
  • Budget Management
  • Contracting
  • Outsourcing
  • Trial Management
  • Clinical Program Management
  • Clinical Operations
  • Clinical Research
  • Protocol Management
  • Study Management
  • Clinical Project Management

Agenda

Day One
Wednesday, April 4
8:30AM – 9:30AM Registration and Continental Breakfast
9:30AM – 9:45AM Chairperson’s Opening Remarks
Importance of an Accurate Timeline
9:45AM – 10:30AM Review the Importance of an Accurate Timeline to Minimize Costly Delays
Richard Brand, CFO, BEYONDSPRING INC.
Budgeting/Contracting Strategies
10:30AM – 11:15AM Keys to Developing an Accurate Prediction Model
Jonathan Cohen, Executive Director, Business Operations, REGENERON PHARMACEUTICALS
11:15AM – 11:45AM Networking Break
11:45AM – 12:30PM Explore Why Oncology Studies Finish Late and Over Budget — Sponsor and Site Perspective
12:30PM – 1:30PM Luncheon
1:30PM – 2:15PM Develop Advanced Budgeting Strategies to Manage Clinical Trials
Débora S. Araujo, Associate Director, Site Budget and Payments, Site Enablement — Clinical Operations, BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.
2:15PM – 3:00PM Grant Forecasting: New Approaches to Predicting Clinical Trial Costs
James Sacchetta, Manager, Technical Operations, PREMIER RESEARCH
3:00PM – 3:30PM Networking Break
3:30PM – 4:15PM Ensure Trial Designs Include the Collection of the Data Required for U.S. Sunshine Act Reporting As Well As European (EFPIA) Reporting
Kim Zahan, Director Finance, GLAXOSMITHKLINE
4:15PM – Day One Concludes

Day Two
Thursday, April 5
8:00AM – 9:00AM Continental Breakfast
9:00AM – 9:15AM Chairperson’s Recap of Day One
Working With Sites and CROs
9:15AM – 10:00AM Industry Overview of Critical Necessities and Potential Improvement Methods
Jinyong Oh, Sr. Director, Head of Finance, Global Pharm R&D Operations, JOHNSON & JOHNSON
10:00AM – 11:00AM Develop a Novel Process to Improve Clinical Trial Sourcing
Crystal Wilmesherr, Senior Category Manager, Science and Technology Services, Specialty Generics, MALLINCKRODT PHARMACEUTICALS
11:00AM – 11:30AM Networking Break
11:30AM – 12:15PM Escalation and Expansion of a Multiparty Study
Victor Lucariello, Business Analytics, CELGENE CORPORATION
12:15PM – 1:15PM Luncheon
1:15PM – 2:15PM Integrate Capabilities to Provide a Centralized Approach and User Experience for Investigators Budget and Payment Process
Tara Dubois, Head of Clinical Trial Cost Management, PFIZER
Phil Paone, Director of Site Budgets and Contracts, PFIZER
2:15PM – 3:15PM Panel Discussion: Financial Management From the Perspectives of Sponsors, CROs and Sites
Moderator:
Jim Kremidas, Executive Director, ASSOCIATION OF CLINICAL RESEARCH PROFESSIONALS

Panelists:
Victor Lucariello, Business Analytics, CELGENE CORPORATION
Jeff Kingsley, CEO, IACT HEALTH
Utilizing the Best Tools Internally and Externally
3:15PM – 4:00PM Understand How to Budget for Digital and Remote Clinical Trials
If you are interested in participating in this session, please contact Megan Heburn at mheburn@exlevents.com.
4:00PM – Conference Concludes

Faculty


Débora S. Araujo
Associate Director, Site Budget and Payments, Site Enablement — Clinical Operations, BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.

Richard Brand
CFO, BEYONDSPRING INC.

Jonathan Cohen
Executive Director, Business Operations, REGENERON PHARMACEUTICALS

Jon Cohen has been Executive Director of Business Operations at Regeneron since May 2016. In his current role, Jon is responsible for Vendor Management, Cost Management, Resource Planning, and Clinical Metrics and Analytics and has been leading efforts to drive more efficiency in executing clinical trials. Prior to joining Regeneron, Jon was Executive Director Business Operations at Pfizer, where he directed a contracting organization engaged in writing and negotiating more than 3,000 contracts annually valued at $1.9 billion in annual spend while also leading an analytics and reporting group that developed and delivered a wide range of clinical portfolio, operations and vendor performance metrics. Prior to this role, Jon was in finance roles of increasing responsibility at Pfizer supporting a variety of areas in R&D, where he and his team made contributions to budgeting, forecasting, variance analysis, scenario planning, financial valuations, economic modeling and decision analysis. Jon received an MBA in finance and strategic management and a master’s degree in international affairs from Columbia University. He holds a Bachelor of Arts degree with a double major in history and political science from Tufts University.

Tara Dubois
Head of Clinical Trial Cost Management, PFIZER


Jeff Kingsley
CEO, IACT HEALTH

Dr. Kingsley has been faculty with the Columbus Regional Health Family Medicine Residency as well as Director of Family Medicine and Urgent Care. He currently holds faculty appointments with the Mercer School of Medicine, Philadelphia College of Osteopathic Medicine Georgia, and Georgia Regents University.

Dr. Kingsley is founder and CEO of IACT Health, a research management organization, and nine wholly owned and integrated clinical research offices throughout Georgia. The family of companies conducts phase I through IV research in nearly every medical specialty; inpatient and outpatient; pharmaceutical, biotechnology, and medical device. He has dedicated his career to clinical research since 2006.

Dr. Kingsley currently serves as Chair of the Board of Trustees for the Association for Clinical Research Professionals, which represents more than 13,000 clinical research professionals internationally. He is the former Treasurer for ACRP and APCR, Past President of ABSAME, sits on three additional Boards, and participates on numerous other local, national, and international committees.

Jim Kremidas
Executive Director, ASSOCIATION OF CLINICAL RESEARCH PROFESSIONALS

Jim Kremidas is currently the Executive Director for ACRP, a nonprofit association the represents the clinical research enterprise. Prior to that he conducted consulting services for a variety of clients, including support for investigator sites, academic institutions, sponsors and suppliers. He was the SVP of Patient Recruitment at two large CROs for more than six years, where he and his team were responsible for developing and implementing patient enrollment strategies for global clinical trials. Prior to that, he spent 24 years with Eli Lilly and Company. From 1999 to 2008 he led their clinical trial patient recruitment and retention efforts. In this role, he focused on predicting and accelerating the enrollment rates for all corporate studies. While in Strategic Sourcing he was responsible for the outsourcing of clinical development projects to strategic suppliers, including CROs, scientific staffing firms and patient recruitment suppliers. Before his assignment in clinical development strategic sourcing, Mr. Kremidas led Lilly’s efforts to select and establish relationships with direct to consumer and professional advertising agencies, as well as to implement standardized processes for the development and implementation of marketing materials.

He is on the advisory board of CISCRP (a nonprofit organization focused on enhancing patient participation in clinical trials) and is also a volunteer for the Clinical Trial Transformation Initiative (CTTI) with Duke and the NIH. He is a frequent presenter at industry conferences and his articles/papers have been published in a wide variety of trade journals.

Victor Lucariello
Business Analytics, CELGENE CORPORATION

After college internships, Victor has worked in the pharmaceutical industry for over 15 years, initially working in the labs and progressively moving to a combination of science with finance & business. While at Celgene, during 2010–11 he was responsible for developing and implementing new procedures for site budget development to reflect current business and study needs. As process owner, he created a new site budget appendix format with a separate payment terms document, which has been in use since Jan 2012. These templates have evolved over time to improve negotiation efficiency and even to incorporate industry trends. Victor continues to lead and participate in many initiatives for process improvement within CR&D, coordinating with clinical functions as well as finance and project management.

In his current role, his main responsibilities are budget forecasting for clinical trials and development of investigator grants; from providing high-level estimates for a study concept, preparing detailed estimates for governance presentations, and to the creation and approval of global site budget templates based upon a finalized protocol. Since first working on investigator budgets in 2006, Victor has experience with investigator- and sponsor-initiated budgets for clinical pharmacology through post-marketing studies, primarily in oncology but other therapeutic areas as well. Victor graduated Rutgers University in the pre-medical track with a B.S. focusing on human biology.


Jinyong Oh
Sr. Director, Head of Finance, Global Pharm R&D Operations, JOHNSON & JOHNSON

Phil Paone
Director of Site Budgets and Contracts, PFIZER

James Sacchetta
Manager, Technical Operations, PREMIER RESEARCH

Crystal Wilmesherr
Senior Category Manager, Science and Technology Services, Specialty Generics, MALLINCKRODT PHARMACEUTICALS

Kim Zahan
Director Finance, GLAXOSMITHKLINE

Please contact the event manager Marilyn (marilyn.b.turner(at)nyeventslist.com ) below for:
- Multiple participant discounts
- Price quotations or visa invitation letters
- Payment by alternate channels (PayPal, check, Western Union, wire transfers etc)
- Event sponsorship

NO REFUNDS ALLOWED ON REGISTRATIONS
Prices may go up any time. Service fees included in pricing.
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Date and Time

Location

Sonesta Philadelphia Downtown Rittenhouse Square

1800 Market Street

Philadelphia, PA 19103

View Map

Refund Policy

No Refunds

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