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Clinical Trial Rescue: Leadership Approach to Propel Clinical Development

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Clinical Trial Rescue: Leadership Approach to Propel Clinical Development

Situation

A rare disease biotechnology company’s gene therapy clinical trial was put on hold, and the company found itself with a poor performing Clinical Trial Leader. Rudderless, and without a clear clinical operations strategy, they needed an experienced leader to navigate the headwinds and move the trial forward to meet their milestones. Missing their milestones had serious consequences. The company approached Halloran because of its experience in rare diseases, gene therapy, and clinical trial leadership.

Challenge

In the critical juncture of being merely two months away from their inaugural site activation and first-in-patient milestone, the company faced a daunting challenge – their clinical operations strategy was teetering on inefficiency, jeopardizing the realization of their pivotal objectives. The urgency of the situation, coupled with constrained clinical resources, demanded immediate intervention.

Recognizing the gravity of the situation, the company decisively sought out expertise –a catalyst capable of orchestrating a swift and comprehensive turnaround. This seasoned professional was tasked with a multifaceted mission: to promptly assess the existing gaps and challenges within the clinical operations framework and, more crucially, to engineer and implement pragmatic solutions that would propel the trial’s development forward.

Solution

The selected expert at Halloran Consulting Group not only had to navigate the complexities of the existing operational landscape but also seamlessly transition into a pivotal role for the trial’s success. Their strategic acumen and swift decision-making were reactive measures and proactive steps toward safeguarding the company’s overarching goals.

Using a six-step plan demonstrated their capacity to showcase a determination to meet immediate objectives and fortify the foundation for a successful and sustainable clinical trial journey.

Results

The company’s clinical hold was lifted, and they were able to meet their first-in-patient goal. With Halloran’s expertise serving as their interim Clinical Trial Leader, their clinical strategy and operations improved to propel their development forward without any further delay.

The company hired a full-time replacement supported by Halloran’s transition plan. Without Halloran’s part-time support, the company’s gene therapy trial would have been delayed.

About Halloran

Halloran is a life science consulting firm that provides strategic regulatory, quality, clinical, and organizational support to industry leaders and startup visionaries in the pharmaceutical, biotechnology, and medical device sectors. Our consultants are subject matter experts who deliver a tailored approach to each engagement, successfully propelling our clients to their next inflection point. We connect clients with our trusted industry partners to drive operational excellence and innovation throughout their organizations. Our aim is to support our clients, and the patients they serve. Stay in the know and follow us on LinkedIn.

Clinical Trial Leadership and Operations

Halloran’s clinical program experts assume clinical program leadership and clinical project management roles within your organization to help you drive your team’s success from strategic planning to implementation. Halloran’s interim program leadership and project management leaders offer you a competitive advantage because of our insights and learnings from our vast client portfolio.  When it comes to staffing your clinical team, resources need to expand and be as fluid as possible during times of intense financial fluctuations. Hiring full-time employees, with overhead costs, can be an expensive proposition. 

Using Halloran’s deep bench, our experts meet you where you are and provide the necessary clinical guidance and leadership your team may need in the short term. Our experts are backed by the resources of an entire Halloran bench who can provide essential insights.

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Clinical Trial Leadership: Enhancing Efficiencies and Reducing Risk

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Clinical Trial Leadership: Enhancing Efficiencies and Reducing Risk

Situation

A small biotech developing an innovative therapy needed to retain a clinical trial leader as they were launching their trial at multiple sites. The company experienced two cycles of leadership turnover, resulting in lagging strategy and operations. They needed to immediately hire an expert to drive progress forward, while they mindfully sought their full-time replacement.

Challenge

To advance their goals the client needed to stabilize operations, establish processes, align roles and responsibilities, improve culture, foster trust, provide mentorship, and enable employees to focus on their workstreams. They needed to do this all simultaneously to drive efficiency and reduce the real risk of study startup delay.

Solution

Up against a tight timeline, minimal resources, and numerous inefficiencies, the client chose Halloran because of our deep expertise, and ability to jump right into the midst of operations and quickly get up to speed. They needed to slow down and focus on finding the right replacement while knowing an expert could stabilize and enhance their clinical operations and infrastructure.

Halloran’s step-by-step approach:

Results

Within the first month, the client shared that – on several different levels – they had already noticed a positive impact. As the six-month engagement ended, the client’s operations improved, and noted enhanced, streamlined processes, and observed better internal and external relationships with sites and vendors. Halloran enabled them to focus on finding the right replacement while having confidence the ongoing trial would continue to reach critical milestones. As the client brought in their permanent hire, Halloran collaborated to assure a manageable and seamless transition; by the time the engagement ended, all projects were either completed or handed off to the new hire in an achievable fashion.

“We got more done in these new meetings than in the past due to Halloran’s efficient processes and prioritization. It allowed us to ‘take a breath’ as we searched for our permanent replacement – all the while, knowing that things were continuing to drive forward.”

– Client feedback

Clinical Trial Leadership and Operations

Halloran’s clinical program experts assume clinical program leadership and clinical project management roles within your organization to help you drive your team’s success from strategic planning to implementation. Halloran’s interim program leadership and project management leaders offer you a competitive advantage because of our insights and learnings from our vast client portfolio. When it comes to staffing your clinical team, resources need to expand and be as fluid as possible during times of intense financial fluctuations. Hiring full-time employees, with overhead costs, can be an expensive proposition. Using Halloran’s deep bench, our experts meet you where you are and provide the necessary clinical guidance and leadership your team may need in the short term. Our experts are backed by the resources of an entire Halloran bench who can provide essential insights.

Want to learn more? Click here to read “Navigating Clinical Trial Leadership Turnover: Halloran’s Five-Step Process”

About Halloran

Halloran experts offer deep expertise in science and advanced knowledge of the development and commercialization lifecycle, leading clients through their most challenging business goals to achieve their greatest chance of success. Whether it is leading new company formation with a fully integrated development team at the ready, enabling investments with robust diligence or market assessments, or providing accelerated, durable development strategies for enhanced company value creation, Halloran is your development partner. Get the latest insights. Follow us on LinkedIn.

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Turning Drug Development Chaos into Order for an NDA

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Turning Drug Development Chaos into Order for an NDA

Situation

The average approval time often takes 10-15 years from Phase 1 to approval. The cost of drug development for sponsors ranges from $314 million to $2.8 billion. The milestone of submitting a New Drug Application (NDA) for approval by the U.S. Food and Drug Administration (FDA) is typically a high priority.

Considering the time and cost considerations, a small biopharmaceutical company with a targeted oncology pipeline approached Halloran Consulting Group (Halloran) requesting Development Program Management with regulatory expertise to assist with their first NDA filing to the FDA.

Challenge

The company received multiple regulatory designations (orphan, fast track, breakthrough designation, priority review and real-time oncology review) to accelerate their approval pathway. However, they lost their Development Program Manager, recently hired a Senior Vice President of Regulatory Affairs, and their internal development team was not fluent in NDA submissions.

As a result, the company had timelines that were not adequately managed, incorporated new resources that changed internal dynamics, and did not have a catalyst to propel development towards the NDA.

Solution

Halloran engaged the company by addressing their key internal infrastructure gaps relating to communication, governance, process, resources, tactical strategy, and timelines.

Halloran put the following infrastructure in place:

Results

The company evolved from a fragmented organization to an integrated unit propelled by proper planning, communication, collaboration, and high performance. This new framework enabled the team to successfully submit their first NDA to the FDA.

Program Management at Halloran

Halloran’s Program Managers define the strategy within their clients’ cross-functional teams and lead the development program through execution. Halloran’s interim Program Managers offer their clients a competitive advantage through their integrated insights and learnings from the development of similar types of products in the industry.

About Halloran Consulting Group

Halloran experts offer deep expertise in science and advanced knowledge of the development and commercialization lifecycle, leading clients through their most challenging business goals to achieve their greatest chance of success. Whether it is leading new company formation with a fully integrated development team at the ready, enabling investments with robust diligence or market assessments, or providing accelerated, durable development strategies for enhanced company value creation, Halloran is your development partner. Stay up to date on our latest insights. Follow us on LinkedIn.

Cited Sources

[1] PhRMA. ‘Biopharmaceutical Research and Development: The Process Behind New Medicines’.

[2] Terry, M. ‘The Median Drug Development Cost is $985 Million, According to New Study.’ Biospace, 2020.

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A Successful Pre-IND Enabling Next Stage of Development

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Learn more about all of Halloran’s Regulatory services here.

Aligning Your Clinical Operating Model – a Case Study by CSL Behring

CONTENT IN COLLABORATION WITH CSL BEHRING
Valerie Reynaert, Head of Global Clinical Operations, CSL Behring

“What clinical operating model do you use?” This question was the basis of a discussion between Halloran Consulting Group and CSL Behring which led to collaboration during a recent Halloran-hosted Clinical Operations Breakfast virtual event on the topic “Transitioning to a Different Clinical Trial Operating Model: An Insider’s Look.”

CSL Behring’s presentation centered around identifying four different operating models – all in-house, hybrid, integrated Functional Service Provider (FSP), and fully outsourced – and how to right size the right model for different clinical trial settings. Choosing an operating model requires analysis of multiple factors including company size, number of programs, priorities and values, and geographic reach, and each selection is unique.

The choice of model is deeply important, as there is a tradeoff between cost, speed, and quality. But can you have it all? Well, there is no one model that reduces the cost of every operational component, and where speed and quality are never comprised to achieve a trial’s outcome.

But there are certainly successful examples. While FSPs are an important part of the clinical ecosystem, CSL Behring shared how they transitioned from a fully outsourced to a full in-house model for a critical role in the clinical trial management realm, and the steps they took along the way to achieve more control and ensure quality processes during the lifecycle of their trials.

In this article, we will explore the operating models, dive into the benefits of an all-in-house or targeted, yet integrated FSP operating model, and discuss how best to approach the transition.

A Model is a Model

Operating a clinical trial, regardless of the development phase, is reliant upon clinical operations professionals to complete essential tasks throughout the entire lifecycle of the trial. Smaller companies may not have the resources in-house or the pipeline to justify an integrated FSP model, and therefore utilize independent contractors to handle an array of traditional and non-traditional services in concert with their full-service Clinical Research Organization (CRO). Larger companies often have the budget and pipeline to support an all-in-house model and/or a selectively targeted FSP model.

Sponsor companies are compelled to establish an all-in-house or fully outsourced model appropriate for their goals, pipeline, and budget. The default, often by convenience or necessity, tends to be an outsourced model to full-service CROs which may or may not progress to the preferred provider or sole source arrangements. An integrated FSP model is one step removed from an all-in-house model, adding a layer of consistency and continuity, but still requires synchronization between roles and responsibilities for Full Time Employees (FTEs), FSPs, and any additional outsourced components.

Regardless of the operating model, transitioning to a different model takes time, energy, and commitment. If a transition is to be made, those at the company must determine their driving factors, and rationale, and enable those conversations forward because upfront planning is essential to success.

Finding Motivation and Transitioning to an All-In-House Operating Model

When sponsor companies evaluate their operating model, they are acknowledging there are issues in control, performance, timeliness, and/or quality throughout the clinical trial stages.              

In the case of CSL Behring, they needed to establish and maintain strong clinical trial site partnerships – a component of their clinical operations ecosystem they intended to improve. Under their prior model, sites had multiple touchpoints with many different professionals at CSL Behring and with their CRO. CSL Behring reflected upon what was working, identified headwinds, and solicited feedback from their sites to improve the relationships.

The site dynamic and relationship needed to be enhanced. CSL Behring understood the critical value of treating sites as key stakeholders in the clinical research ecosystem and began to plan a different approach. Their solution was to create a Clinical Site Ambassador role, partnering with a vendor to provide these resources through an FSP. Resources fulfilling this role would later assume all interactions with their managed sites as a single point of contact.

CSL Behring sought to achieve:

As a result, CSL Behring was able to observe measurable improvements in quality, dependability, and speed across their studies. Additionally, their relationship with their sites drastically improved over time because of the timely and consistent communication and follow-through.

Operating Model Success

When sponsor companies approach their operating model transition, it is important to ensure that each step is thorough and aligns with a quality mindset. Recommendations include:

About Halloran Consulting Group’s Clinical Services

Leaders at Halloran manage their client’s organizations, provide coaching and insight, and offer tools and resources to further develop their staff. Halloran helps clients build the roles and capabilities within their organizations that are required to stay competitive and efficient. In addition, Halloran drives process improvements and change management processes to optimize and standardize performance across clinical operations teams.

To learn more about Halloran’s full suite of Clinical and Organizational Design and Implementation services, click here.

Contact Halloran today.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. CSL Behring’s portfolio of innovative medicines includes a wide range of recombinant and plasma-derived products for treating bleeding disorders, immune deficiencies, and chronic inflammatory demyelinating polyneuropathy, as well as hereditary angioedema and Alpha 1 Antitrypsin Deficiency.

Learn more about CSL Behring.