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Case Study Overview

The following case studies have been derived from key projects that our teams have undertaken. Case studies summarized below highlight select types of initiatives, including:

  • Clinical study patient recruitment

  • Strategic alliance

  • Pre-launch assessment

  • Generics

  • Pipeline and commercial analysis

Case Study: Patient Recruitment

 

Situation:

Our client was developing a therapy for an indication in a small patient population. Recruitment was challenging and the client's clinical study was more than 6 months behind schedule. Our client was offering $1,000 per patient enrolled in the study.

 

Intelligence Developed:

In addition to addressing many other issues, we determined that sponsors competing for the same patients at the same sites were offering $2,000 per patient enrolled in the study.

 

Financial Impact:

Our client modified their recruiting strategy and accelerated enrollment. Drug development was completed, and an NDA was submitted and approved without continued, excessive recruitment delays. Additionally, market impact and creation of a revenue stream were accelerated.

 

 
Case Study: Strategic Alliance

 

Situation:

Our client was strongly considering investing and aligning with a privately-held drug delivery technology firm. The route of administration could enhance patient compliance and grow the market. Very small clinical studies appeared encouraging, however data presented at scientific congresses was merged.

 

Intelligence Developed:

We identified:

  • The clinical research organization (CRO) that conducted the clinical studies

  • In a highly controlled environment, the bioavailability attained was far below accepted therapeutic thresholds

  • The sponsor was attempting to suppress the results of the studies

 

Financial Impact:

Our client decided not to pursue the strategic alliance and several hundred million dollars were saved, and applied to other fruitful opportunities.

 
Case Study: Pre-Launch Assessment

 

Situation:

Our client was in late-phase development and preparing for market entry with their product, which would be the third product launched in the category. This program required broad-based due diligence on two competitive targets.

 

Intelligence Developed:

We developed details and transitioned findings into strategic understanding and recommendations on each investigative target, including:

  • Managed care programs (commercial, Medicare Part D), uptake, and decision making on their positioning

  • Marketing plan components, messaging, positioning, financial support and professional/patient/managed care efforts

  • Sales organization, size and structure/allocation

 

Financial Impact:

Our client invested accordingly. Resulting from the program, our client focused on a rapid uptake in managed care with transitional programs to support professionals and consumers.

 
Case Study: Generic Entry Timelines and Life Cycle Extension

 

Situation:

Our client with the rights to an innovator drug wanted to determine the timetable to continue its promotional investment in light of generics coming. Our client forecasted generic competition based on public information and guidance from internal legal and regulatory staff. The investigative issue was to identify generic development activity, plans and timetables and regulatory strategy.

 

Intelligence Developed:

We identified:

  • Multiple signals indicating generic development activity was well advanced, ahead of client's timeline

  • A regulatory pathway being pursued by one developer could lead to accelerated market entry. Additionally, generic peers established channels to influence the FDA outside the normal Advisory Committee venue

 

Financial Impact:

As a result of the program, our client curtailed brand support ahead of schedule and accelerated investment/development of follow-on branded products to extend revenue in the therapeutic franchise. The financial impact of this program was in the hundreds of millions of dollars.

 
Case Study: Pipeline and Commercial Analysis

 

Situation:

Our client, a current sector leader, initiated a new assignment in a focused therapeutic sector (e.g., oncology). Our client requested a comprehensive pipeline sweep and commercial strategy assessment for selected therapeutics. The program was designed to provide continuous competitive surveillance over a 12-month period, and a timing of a major medical congress coincided with the program.

 

Intelligence Developed:

We recommended attendance at the medical congress as all competitive targets would be present, along with an opportunity to speak with and establish relationships with individuals attending to discuss the issues of the program. Prior to the congress, upfront planning was performed to define the companies, products and key information topics/questions to be analyzed. This enabled our team to identify opportunistic locations to gain insights. Going into the congress, 75 key information questions were established with 55 of the questions being answered during the congress (~73% of questions). Follow up interviews were set up to address any remaining questions. The content obtained from the congress provided a strong benchmark and allowed for the introduction of "drill down" issues during the remainder of the program.

 

Financial Impact:

Comprehensive knowledge was obtained short term, which was then implemented into our client's strategic planning process. Targeted tactical issues became the focus during the balance of the program. Strategic knowledge obtained from program allowed our client to effectively react to competitor activities. Ultimately, while the financial benefit to the business is unknown, the business analysis and strategic consulting provided to our client with maximum value.