Columbia University Herbert Irving Comprehensive Cancer Center

Experimental Therapeutics / Phase I Program

Introduction

The Columbia University Herbert Irving Comprehensive Cancer Center (HICCC) Experimental Therapeutics/Phase I program aims to lead the development of new treatments for cancer. The Experimental Therapeutics/Phase I team comprises a group of doctors, researchers, nurses, and coordinators dedicated to enrolling and caring for a diverse population of patients in early-phase clinical trials.

This semester, a multidisciplinary team of students from across the Columbia University campus worked with the HICCC to aid them in their mission, specifically by pursuing two initiatives. First, the team worked to develop a comprehensive strategic positioning statement for the Phase I program. Second, the team focused on identifying and prioritizing high-level strategic recommendations to support the strengthening of the positioning statement.

The Business Problem

HICCC’s Phase I Program sits at an interesting moment in its history. The program is known for its clinical and research expertise, diverse patient population, and quick trial activation, but it struggles with patient accrual. It is also currently in the process of recruiting a new Director.

Historically, the program has found it “easy to open trials, but hard to close them.” This remains a weakness, considering how clinical trial partners look for sites that can quickly activate trials and successfully enroll patients. Additionally, HICCC is looking to leverage its location and patient population to better compete with strong regional contemporaries, using the unique qualities of HICCC to expand patient access to Phase I trials to people who otherwise wouldn’t have access to them.

Project Objectives

Given the business problem, the HICCC Phase I program sought to enhance its strategic positioning within the experimental therapeutics space. The team had two objectives:

1. Strategic Positioning Statement: Develop a strategic positioning statement for HICCC’s Phase I program
2. Strategic Recommendations: Identify high-level strategic recommendations that will support their strategic position

Type of Analysis

Data Collection

The team conducted key interviews with internal (leadership, physicians, staff) and external (biotech companies) stakeholders. Questions for the internal team included: 1) What are the strengths and weaknesses of the program? 2) How would you define the success of the program? 3) What do you look for in biotech partners? Meanwhile, core questions for external stakeholders included: 1) What do you look for in Phase I Clinical Trial sites? 2) If you’ve had experience working with them, how would you evaluate HICCC as a clinical trial site? We also conducted a site visit and reviewed HICCC’s internal documents to supplement our understanding of our interview findings. Lastly, desk research on best practices in clinical trial recruitment (e.g., peer-reviewed articles and case studies) was also completed.

Analysis

The team developed the 5P framework (Fig. 1) to ensure that the strategic positioning statement and recommendations encompass all areas of focus for the HICCC Phase I. A SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis highlighted strategic areas that the HICCC Phase I Program should focus on sustaining and improving, which became the basis for the strategic positioning statement. A prioritization matrix analysis emphasized strategic options that are high priority. This addresses both project objectives, respectively.

Final Recommendations

Strategic Positioning Statement

The SWOT analysis showed that HICCC’s Phase I Program should leverage its strengths and establish internal alignment, thereby improving patient enrollment. Therefore, the team arrived at the following strategic positioning statement for the Phase I program.

The HICCC Phase I Program should aim to:

1. Sustain High-Quality Trials
2. Improve Patient and Provider Awareness of Ongoing Trials
3. Establish Internal Alignment on Highlighting Capabilities
4. Establish Internal Alignment on Strategic Direction

Strategic Recommendations

The team consolidated ten options that the HICCC Phase I program can explore. After completing a prioritization matrix analysis (Fig 2.), the team recommends high-impact, low-effort initiatives for the HICCC Phase I Program, namely:

1. Empower physicians to more easily refer patients to clinical trials through a culture that better recognizes referrals and better technological tools
2. Build an internal culture of increased mentorship and professional development opportunities
3. Capitalize on technology platforms throughout the Phase I process, from identifying the eligibility of patients for particular trials to performing enrollment via telemedicine platforms

Contributors: Joseph Alukal (Irving Medical Center), Janelle Panganiban (Mailman School of Public Health), Peter Richards (Columbia Business School), Hirohime Shu (Columbia Business School), Jonathan Wu (Columbia Business School)

Figures

Figure 1. The 5P Framework for HICCC Phase I Program

Figure 2. Prioritization Matrix

Figure 3. Team Visit to HICCC Phase I Program