Cambridge Healthtech Institute's 8th Annual

Clinical Trial Forecasting, Budgeting and Contracting:
( 臨床試験についての予測と予算編成、契約 )
 

Innovative Budgeting and Contracting for Cost-Efficient Trials
コスト効率に優れた治験を実現するための革新的な戦略

2018年2月13-14日 | Hyatt Regency Orlando | フロリダ州オーランド

 

臨床試験についての予測と予算編成、契約をテーマにしたこのカンファレンスプログラムでは、効果的な予算編成と明瞭な契約に関するケーススタディやベストプラクティスに加え、成果を明確にするための評価基準や重要業績評価指標なども紹介されます。

 

Monday, February 12

9:00 am - 7:30 pm Registration Open

5:00 - 6:15 pm Pre-Conference Plenary Keynote Panel

6:30 - 8:30 pm SCOPE's Kick-Off Networking Happy Hour on the Garden Terrace Hosted by CHI, DrugDev, & Praxis

8:30 Close of Day

Tuesday, February 13

7:15 am Registration Open and Morning Coffee

8:20 Opening Plenary Keynotes

9:45 Grand Opening Coffee Break in the Exhibit Hall

STRATEGIES FOR FINANCIAL FORECASTING AND BUDGETING

10:45 Chairperson's Remarks

Chris Chan, Executive Director, R&D Finance, Finance, FibroGen, Inc.

10:50 Budget Forecasting and Tracking: Teamwork and Transparency

Kenneith_OlovichKenneth Olovich, Chief Financial and Procurement Officer, Chorus

This talk will discuss how the application of budgetary and invoicing models can lead to increased trust. What do sponsors really need to help them manage CRO and trial related expenses? Some budgetary models require more effort to set up than others; when is it worth the investment? The timing of spend and the accurate projection of the same is just as important as the total spend -- this talk will discuss finding the balance.

11:15 Cost, Time, and Quality Trade-Off in Clinical Trials

Ozgur_OzkanOzgur Ozkan, Decision Science Director, Biometrics and Information Sciences, AstraZeneca Pharmaceuticals

This presentation will report on a novel approach to estimate trial costs at the country level and how it is used within a simulation tool to visualize cost, time and quality trade-offs between alternative recruitment scenarios. We will give an overview of the analysis on the operational/financial data and demo the tool to show how it informs decision making in Clinical Operations.

11:40 Clinical Trial Budgeting/Forecasting SMACK-DOWN: Finance vs. Clinical

Chris_ChanChris Chan, Executive Director, R&D Finance, Finance, FibroGen, Inc.

Although theoretically players on the same team, when Finance and Clinical folks get together to generate clinical budgets and forecasts, conflicts often arise in the form of miscommunications or even animosity that would make the Hatfields and McCoys blush. This session will explore some common conflicts as well as possible resolutions.

12:05 pm Presentation to be Announced



12:30 Session Break

12:40 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:20 Coffee and Dessert Break in the Exhibit Hall

WORKING WITH SITES: BUDGETING AND PAYMENTS

2:00 Chairperson's Remarks

Marina Malikova, Ph.D., MA, Executive Director, Surgical Translational Research Operations and Compliance, Boston University

2:05 Building a Per Patient Cost and, Ultimately, the Entire Investigator Grant Budget

Ken_WilsonKenneth Wilson, Director, Business Operations; Clinical Outsourcing Lead, Pfizer

In this session, we will look at a practical approach for establish a preliminary site budget template, and how this rolls into establishing the entire investigator grant budget. Standard of Care plays an important role in the US, and some countries; this needs to be factored into the budget templates. When all is complete for the site level template, we will evaluate how this can be utilized to build a forecast for total investigator grants and what is factored into these calculations. We will also look at how this feeds into a typical full clinical trial budget and forecast.

2:30 CO-PRESENTATION: Merck's Site Ready Team: Integrating Capabilities to Provide a Centralized Approach and User Experience for Investigators Budget and Payment Process

Cathy_CarfagnoCathy Carfagno, Associate Director, MRL IT, Merck & Co., Inc.


Rochelle_ReddingRochelle Redding, Associate Program Manager, MRL, Merck & Co., Inc.

This talk will present an overview of the strategy that Merck would like to take in changing its global budget and payment process and our thoughts on enabling a more integrated collaboration and interaction with our investigative sites. In order to maintain strong and effective investigator relations and to enhance our site performance, while ensuring meeting FDA compliance rules, we have started to map out a simplified process for creating and negotiating our budgets as well as improving our payment controls, all while operating in a very budget-conscious environment.

2:55 PANEL DISCUSSION: Budgeting with Sites: Bottlenecks, Challenges, and Opportunities

Moderator:
Ken_WilsonKenneth Wilson, Director, Business Operations; Clinical Outsourcing Lead, Pfizer


Panelists:
Marina_MalikovaMarina Malikova, Ph.D., MA, Executive Director, Surgical Translational Research Operations and Compliance, Boston University


Kenneith_OlovichKenneth Olovich, Chief Financial and Procurement Officer, Chorus


Cathy_CarfagnoCathy Carfagno, Associate Director, MRL IT, Merck & Co., Inc.

During site budget negotiations, don't you often want to just ask the other party "Are you crazy or just being stubborn?" We all have different end games during negotiations, and it's important to understand the dynamics of the Sponsor, Site and CRO triad. As this triad continues to be dominant in our industry, it's important that we learn to predict each other's reactions in order to avoid "show-down" meetings where all are frustrated and ready to walk away. We all think we are right, but ultimately, it's about the final negotiated budget, how we get there, and creating a win-win-win scenario for all.

Bioclinica_new3:20 Presentation to be Announced



BREAKOUT DISCUSSION GROUPS

3:50 Find Your Table and Meet Your Moderator

4:00 Interactive Breakout Discussion Groups

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day's sessions. Delegates will join a table of interest and become an active part of the discussion at hand. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.

5:00 Welcome Reception in the Exhibit Hall

6:30 Close of Day

Wednesday, February 14

7:15 am Registration Open

7:45 Breakfast Presentation: A New Way to Pay: SaaS Technology and Outsourcing How You Need It

Stuart Thiede, President, Payments, DrugDev


8:15 Session Break

STRATEGIES FOR EFFICIENT NEGOTIATION AND CONTRACTING

8:25 Chairperson's Remarks

Anca Copaescu, CEO, Strategikon Pharma

8:30 Contracts and Budgeting for Studies Involving Special Populations and Adaptive Designs: Evolving Challenges with Precision Medicine Trials

Marina_MalikovaMarina Malikova, Ph.D., MA, Executive Director, Surgical Translational Research Operations and Compliance, Boston University

In-human (FIH) studies now routinely contain several parts with multiple cohorts with increased dose flexibility and accelerated dose escalation paradigms, each of which might have been previously a separate clinical trial. Sponsors, CROs and investigators struggle to minimize risks and avoid serious consequences, and yet, there remains real risk in an FIH study. Understating challenges associated with the use of special populations is critical to ensure that the study design will allow for the timely and successful completion of the project, while minimizing individual exposure to the risks of participating subjects, planning and implementing budgets, forecasting, managing costs, and assessing safety profile.

8:50 Common Misconceptions about Clinical Trial Agreements

Danielle_BoramDanielle Boram, Esq., MPA, Clinical Contracts Attorney, Associate Director of Contract Management, Clinical Development, ImmunoGen, Inc.

Site contract negotiation is often correctly identified as a rate limiter on the critical path to site activation. What is it about this agreement that gives rise to protracted negotiation cycles? In this talk, I will identify common misconceptions about key clinical trial agreement provisions that often create unnecessary delays in the negotiation process.

9:10 Streamlining CTA Negotiations beyond the Legal Language

Debora_AraujoDebora Araujo, Associate Director, Clinical Contracting Services, Boehringer Ingelheim Pharmaceuticals, Inc.

It is widely known that legal language is one of the main pain points threatening the timely execution of CTAs. The issue has prompted much-needed industry focus and related initiatives in recent years in an effort to standardize legal language and thus streamline CTA negotiations. However, to effectively address the overall delays in CTA execution, some other aspects of the negotiation process must be dealt with as well. In this presentation, we will explore the top aspects of the negotiation process threatening an expeditious CTA execution and some practical ways to counter each of them.

9:30 Strategies to Reduce Time to Contract Approval: A Site Perspective

JoAnn_PfeifferJoAnn Pfeiffer, DrSC., Director, Clinical Research Management, Arizona State University

How can sites accelerate the CTA review process for quicker approval of a fair and balanced contract? This session covers strategies and practical tips to speed up the CTA review and approval process. Topics include preparation, contract pitfalls, language, contract editing, common contract challenges between the site and sponsor, and leveraging site data and metrics.

9:45 Sponsored Presentation (Opportunity Available)

10:10 Coffee Break in the Exhibit Hall

CONTRACTING AND RESOURCE ALLOCATION

11:10 Chairperson's Remarks

11:15 PANEL DISCUSSION: Resource Allocation and Its Effect on Contracting between CROs and Sponsors

Greg_SkalickyGreg Skalicky, Chief Enterprise Business Officer, inVentiv Health


Ratan_RatneshRatan Ratnesh, Director & Head, Clinical Outsourcing, Otsuka


David Freschi, Senior Director, R&D Procurement and Clinical Outsourcing, Regeneron

Tara Dubois, MBA, Head, Clinical Trial Cost Management, Business Operations, Pfizer

Procurement, contracting, and clinical operations teams need transparency with their CRO partners in order to properly understand a CRO's allocation of resources and costs, especially when contracting key deliverables. This panel will address, from the Sponsor's and CRO's perspective, resource allocation considerations during the contracting process: potential challenges, what CROs wish pharma knew, and pitfalls to avoid.

12:05 pm Session Break

12:10 Bridging Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

12:50 Coffee and Dessert Break in the Exhibit Hall

1:30 Close of Conference

Melissa DolenGroup Discounts Are Available! Special rates are available for multiple attendees from the same organization. For more information on group discounts, contact us.


 

2018 SCOPE Conference at a Glance


* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。

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In Memory of Gerald "Jerry" Matczak
Matczak Jerry

Gerald "Jerry" Matczak, lead consultant in clinical innovation at Eli Lilly & Co., was a rare breed in the pharmaceutical world, someone who not only embraced social media, but also listened to activist patients. He has been a part of the SCOPE conference since its inception and won the Patient Engagement Award on Wednesday, the day before his passing. Matczak died suddenly on Feb. 2 at age 54. We will all miss him.

- Cambridge Healthtech Institute (CHI)



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