Cambridge Healthtech Institute's

Budgeting & Outsourcing

 

April 7-8, 2020

 

The ability to budget for, select, and contract with CROs, vendors, and other partners is key to keeping a trial on time and within budget. Once the trial is underway, it is essential to oversee how these outsourced partners are performing and ensure that established metrics and deliverables are met. Learn more at this lively conference program at CHI's 9th Annual Clinical Trial Innovation Summit.

 

Final Agenda

 

MONDAY, APRIL 6

2:30-5:30 pm Pre-Conference Workshops

Workshop 2: Digital Clinical Development: Tutorial, Case Studies, and Future Readiness

Workshop 3: Inspection Readiness in Changing Global Regulatory Environment

*Workshops are included in your registration. However, please RSVP to reserve your seat.

TUESDAY, APRIL 7

8:15 am Registration and Morning Coffee

Real World Data, Artificial Intelligence and Analytics to Reshape Clinical Development

9:00 Organizer’s Opening Remarks

Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)

9:05 Chairperson’s Remarks (Sponsorship Opportunity Available)

9:10 Digitalization of Clinical Trials: Breakthroughs in Technologies and Data

Peter BergethonPeter Bergethon, MD, Vice President, Head of Digital and Quantitative Medicine, Biogen

Medicine as systems science characterizes the health state by measurable properties. Changes in state over time (dynamics) define trajectories through growth, health and disease. Dynamic transitions define trajectories between health, illness and therapeutic interventions. Capturing time dependence is the power of digital technology. Herein lies the power of digital medicine. We will review specific cases showing how this paradigm is transforming our clinical trial landscape.

9:30 CO-PRESENTATION: The Role of Real-World Data in Creating New Pathways to Biopharma Industry Transformation

Alan LouieAlan Louie, PhD, Research Director, Life Sciences, IDC Health Insights


Charles MakinCharles Makin, Global Head, Real World Evidence Strategy, Biogen


In parallel to other industry best practices, the biopharmaceutical industry is embracing digital transformation as it seeks to better leverage data across the life science ecosystem. In conjunction with these efforts, increasingly available real-world data (RWD) promises to bring new patient-specific data and insights to the industry, data which bring researchers closer to understanding patient-level treatment responses while also opening new channels to engagement. With strong support from regulators, real-world evidence offers significant potential to accelerate new drug discovery and development, improve process efficiencies, and improve patient outcomes over the near term.

9:50 AI in Human Health – Connecting Data Modules from Discovery Biology to Clinical Development

Rangaprasad SarangarajanRangaprasad Sarangarajan, PhD, CSO & Senior Vice President, Clinical and Translational Sciences, Research & Development, BERG

Drug development programs in companies are predicated on biological insights supporting a hypothesis of target and its role in disease etiology. This presentation will focus on the data modules essential for linking discovery biology to early/late stage clinical development and the leveraging of AI in the integration of the various dataflow to make data-driven informed decisions and ensure success. It will outline how to utilize data, AI analytics with RWD-based support for planning drug development to propel products all the way through the clinic.

10:10 Grand Opening Coffee Break in the Exhibit Hall (Sponsorship Opportunity Available)

STUDY BUDGET BEST PRACTICES

11:10 Chairperson’s Remarks (Sponsorship Opportunity Available)

11:20 Peeling Back the Secrets to Successful Clinical Trial Budgeting and Negotiations

Deena BernsteinDeena Bernstein, MHS, President, Amplified Clinical Research Consulting Services, LLC

Hear from three stakeholder perspectives on clinical trial budgeting: sponsor, CRO, and site. How to meet at an agreeable negotiation point where everyone walks away satisfied and needs for cost and price are met.

11:45 Sponsor Perspective on Study Budgets

Debora AraujoDebora Araujo, Founder & CEO, ClinBiz

This talk will address sponsor challenges, needs, and considerations when budgeting with sites and CROs. I will also address other budgeting strategies from a sponsor perspective.

12:10 pm Overall Study Best Practices

Erin O'BoyleErin O’Boyle, Senior Director, Clinical Operations, Rezolute, Inc.

This talk will explore overall study budget best practices. We will discuss questions around considerations for internal costs, outsourcing budgets, and site and patient expenses.

12:35 Transition to Luncheon Presentation

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

1:25 Coffee & Dessert Break in the Exhibit Hall (Sponsorship Opportunity Available)

SELECTING AND CONTRACTING WITH EMERGING TECHNOLOGY AND SERVICE PROVIDERS

2:00 Chairperson’s Remarks (Sponsorship Opportunity Available)

2:10 PANEL DISCUSSION: Budgeting for and Contracting with Emerging Technology and Service Providers

Moderator:

Debora AraujoDebora Araujo, Founder & CEO, ClinBiz


Panelists:


Marina MalikovaMarina Malikova, PhD, Executive Director, Surgical Translational Research: Operations and Compliance, Boston University School of Medicine


Scott SawickiScott Sawicki, R&D Sourcing Consultant, Adare Pharmaceuticals


There are so many new technologies and services being integrated into clinical trials, with many new companies popping up and many traditional service providers pivoting to address these growing needs. How can sponsors determine fair market value for these types of companies, and how does this affect overall forecasting, budgeting, and contracting activities? Panelists will discuss the impact of changing technologies and study design.

3:25 Transition to Keynote

Why Do Trials Succeed and Why do they Fail? Insights from Industry and Academia

3:35 Organizer’s Opening Remarks

Marina Filshtinsky, MD, Executive Director, Conferences, Cambridge Healthtech

Institute

3:40 Chairperson’s Remarks (Sponsorship Opportunity Available)

3:45 BEST CLI Trial: Lessons Learned From Execution Of A Complex Multicenter RCT

Alik FarberAlik Farber, MD, Chief, Division of Vascular and Endovascular Surgery, Associate Chair for Clinical Operations, Department of Surgery, Boston Medical Center; Professor of Surgery and Radiology, Boston University School of Medicine

The BEST-CLI trial is the largest RCT ever undertaken to evaluate strategies for treatment of critical limb ischemia (CLI). This study is an international, multispecialty, prospective, multicenter, randomized comparative effectiveness trial of endovascular versus open surgical revascularization in patients with CLI who are candidates for both procedures. The study has been performed at 134 sites and has enrolled 1843 patients. Its execution had had multiple obstacles and challenges that the trial leadership team has successfully navigated.

4:15 CO-PRESENTATION: What Causes Studies to Fail? Understanding Causal Drivers of Operational Success Using Machine Learning

Marcy KravetMarcy Kravet, BS, MBA, Head, Operational Design Center (ODC), Global Clinical Operations, EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany


Sylvia MareckiSylvia Marecki, PhD, Design Analyst, Operational Design Center (ODC), Global Clinical Operations, EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany


It is currently unknown what drives successful study enrollment despite extensive analysis conducted across the industry, which largely has focused on correlations. The Operational Design Center at EMD Serono has leveraged causal machine learning to analyze hundreds of variables across thousands of clinical trials with the objective of identifying causal drivers of enrollment success, which can be optimized to conduct faster, less expensive trials. Early insights will be shared.

4:45 Welcome Reception in the Exhibit Hall (Sponsorship Opportunity Available)

5:45 End of Day

 

WEDNESDAY, APRIL 8

7:45 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee

MANAGING RISK IN VENDOR SELECTION AND ITS IMPACT ON CONTRACTING

8:25 Chairperson’s Remarks (Sponsorship Opportunity Available)

8:35 PANEL DISCUSSION: Effective Contracting as a Vehicle to Increase Quality and Mitigate Risk

Nguyen_MaiModerator: Mai Nguyen, MPH, Senior Consultant, The Avoca Group


Panelists:

Bella SessomsBella Sessoms, MPH, Director, Portfolio Sourcing Management, Portfolio Sourcing and Relationship Management, Astellas Pharma Global Development


Chuck BradleyChuck Bradley, Vice President, Clinical Development, FibroGen, Inc.

 

 

Andy LawtonAndy Lawton, Director & Consultant, Risk Based Approach Ltd.


Clinical trials rely on vendors and partners to carry out numerous tasks, something that comes with an inherent risk. This panel will discuss the latest trends in vendor oversight and contracting, and how to mitigate risk and build in quality by design with vendors and partners using effective contracting strategies. Panelists will discuss the pros and cons of common oversight and risk mitigation approaches supported by effective contracting including quality agreements, metrics, and incentive/penalty clauses, as well as the impact these have on the contracts process and downstream clinical operations.

9:50 Coffee Break in the Exhibit Hall (Sponsorship Opportunity Available)

STRATEGIES FOR STREAMLINING BUDGETS AND CONTRACTS WITH CROS AND SITES

10:40 Chairperson’s Remarks (Sponsorship Opportunity Available)

10:50 Implementing Agile Methodologies to Improve Contract and Budget Cycle Times

Cameron McClureCameron McClure, PMP, PMI-ACP, CSM, CCRP, Senior Manager, Clinical Business Operations, BeiGene

This will be a collaborative presentation/discussion that will focus on utilizing Agile techniques to increase efficiencies within the contract and budget negotiation lifecycle. I will also focus on how this implementation can increase the productivity of a company overall. There will be a focus on vendor relationships, standard industry practices and why the need for change is imminent.

11:15 Clinical Trial Billing Compliance for Success as a Site or a Sponsor

Kelly WillenbergKelly Willenberg, DBA, BSN, CHRC, CHC, CCRP, Consultant, Kelly Willenberg, LLC

Discuss an overview of billing compliance in clinical trials and the risk areas involved. Review the CMS Clinical Trial Policy (NCD 310.1) and Investigational Device regulations (IDE). Explain how to enhance revenue by implementing a clinical trial billing compliance program.

11:40 Transition to Breakout Discussions

INTERACTIVE ROUNDTABLE BREAKOUT DISCUSSIONS

11:45 Find Your Table and Meet Your Moderator

11:50 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. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. 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.

12:30 pm Community Networking Lunch in the Exhibit Hall (Sponsorship Opportunity Available)

1:40 Transition to Plenary Keynote

Understanding the Patient Journey to Improve Trials

1:45 Organizer’s Opening Remarks

Kaitlin Searfoss Kelleher, Senior Conference Director, Cambridge Healthtech Institute

1:50 Chairperson’s Remarks (Sponsorship Opportunity Available)

1:55 The Journey from Patient to Advocate to Leader: Changing the Clinical Research Game

Rob LongRob Long, Executive Director, Uplifting Athletes

I will talk about my journey from Division I football and top NFL prospect to cancer patient. My experience of undergoing chemo and radiation and fighting through a battle with brain cancer has enabled me to leverage my story to make a difference in the lives of those affected by rare diseases. The attendees will gain insights into what it means to be a volunteer at the front lines of oncology research and clinical trials. New approaches to partnering with advocates, disease communities and young researchers will be shared. In addition, we will discuss the future of rare disease research and outreach and illustrate where industry and the patient community can go together in collaboration. Read an article published about Rob Long's journey,  Ex-Syracuse punter Rob Long takes on cancer, survival and what comes next

NOTE: Uplifting Athletes and Cambridge Healthtech Institute are proud to include some new young researchers in rare disease at this conference. They are our future partners. Advocacy groups interested in nominating young researchers for the Uplifting Athletes Young Investigator Draft can submit to: https://www.upliftingathletes.org/rare-disease-research; Nominations open on November 21, 2020. Click here for additional information on applying for a guest pass directly.

2:10 PATIENT CO-PRESENTATION: The Patient’s Point of View: Clinical Trial Perceptions and Experiences

Annick de BruinAnnick de Bruin, MBA, Director, Research Services, Center for Information & Study on Clinical Research Participation (CISCRP)


Phyllis KaplanPhyllis Kaplan, Trial Volunteer and Patient with T1D


Results from a large-scale global study conducted in 2019 among patients and the public offer robust insights into the latest perceptions of clinical research and enrollment barriers, as well as patient engagement preferences (exploring patient receptivity to virtual trial models and the latest technologies). The 2019 CISCRP Perceptions & Insights study is the largest global study of its kind (over 12,400 responses from around the world, including experiences of 3,600+ prior study participants), offering robust global insights that audience members can directly apply within their own organizations. Learn what information is critical to support the participation decision-making process from the patient’s point of view. Identify key participation elements which matter most to patients and their support network. Determine which convenience-enhancing solutions create the biggest impact on overall experiences.

2:30 CASE STUDY CO-PRESENTATION: Co-Creating with Patients to Create a Better Clinical Trial Experience

Jackie ZimmermanJackie Zimmerman, Patient Advocate


Maura SnyderMaura Snyder, MBA, Global Head, Clinical Trial Engagement, Clinical Insights and Experience, Janssen Pharmaceuticals


Janssen, in partnership with one of our patient advocates, will co-present on an initiative established in 2019 to bring the global patient perspective and input into the Janssen patient engagement plans in immunology. While it’s important to hear about the strides that the industry is making in the areas of patient engagement – it’s more important to hear directly from the patients about their perspective on this. This discussion will provide the audience practical, tangible ways to approach patient engagement. There are a variety of methodologies to approach this patient voice work and we will share one way that we have found to be very beneficial and successful.

2:55 Closing Remarks

Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute

3:00 Close of Conference


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