|
Project Global Clinical Trials Analysis Client
Top 5 Multinational Pharmaceutical Company Description
VOI was contracted to explore the suitability of 30 countries as locations for clinical trials with five compounds aimed at diseases in the oncology, endocrinology, rheumatology, nephrology and dermatology fields. The majority of countries with meaningful abilities to conduct clinical research were included in the evaluation set. These ranged from major research centers such as the U.S., France, Germany and Australia to countries with emerging clinical trial infrastructures, such as China, India, Brazil, Russia and South Africa.
Extensive primary and secondary research was conducted to determine the characteristics of each market that might affect clinical trial enrollment. First, we evaluated the structural environment for clinical research in each country. Factors considered in this phase included: nature of regulatory system, length of time required to obtain approval for trial initiation, motivations and incentives for physicians and patients to participate, cultural attitudes toward clinical trials and availability of the necessary human and technical resources.
Next, we collected disease-specific information in each country. For example, we examined epidemiological data, including incidence and prevalence statistics and the percentage of patients meeting the enrollment criteria for each trial. We also determined diagnostic pathways, the number of specialists treating the disease, the number of contacts each patient would have with investigators, investigators’ attitudes toward or prior experience with the therapeutic category and the likelihood that patients would enroll in the trials.
Using the findings from this extensive analysis, we constructed patient enrollment models to forecast recruitment schedules in the individual country and overall trial levels. Probability-based (Monte Carlo) forecasting techniques were applied to these models to determine the likelihood of meeting enrollment objectives on schedule in each country.
Results
Our client was able to consolidate the trials in a substantially smaller number of countries than originally planned. By eliminating countries with a low probability of meeting trial enrollment goals on schedule and concentrating trial activity in countries with a high likelihood of successful enrollment, our client was able to reduce the cost of each trial by 10% to 20% — the cumulative savings across all five trials was measured in the tens of millions of dollars. This was done without jeopardizing the overall probability of on-time trial enrollment.
Project Competitive War Games – Scenario Planning Client
Top 5 Pharmaceutical Manufacturer Description
Our client was approximately one year away from launching a product in the oncology field. The category had two existing competitors and two other pipeline agents with near-term approval prospects. In designing their launch program, our client needed to understand how their product would fit in the market and how their competitors would respond to various actions.
VOI studied the competitive companies, their management backgrounds, past successes and failures and their market actions in oncology and in other categories. We closely examined financial resources, marketing programs and product/pipeline portfolios for both the companies and their licensing partners. We relied on a wide variety of sources for this information. Through diligent research of publicly available information, we were able to accurately piece together the terms of one competitor’s licensing agreement, a move that provided a great deal of insight into this competitor’s intentions.
Using the results of this in-depth research, we developed SWOT analyses and determined the importance of the relevant products to the various competitors and their partners. We then elaborated a number of competitive-action scenarios, evaluated their likelihood of occurrence and developed specified “early warning signs” to monitor so that our client would be alert to developments and able to respond appropriately. Results
In a series of “war game” meetings which included a cross-functional group of senior client executives, we presented the results of our competitive intelligence and laid out the scenarios. This team then developed several marketing and regulatory tactics to employ based on competitive response; these tactics were later communicated to other groups within the company. When the product was approved, our client was prepared with a fully stocked armamentarium of tactical options that resulted in a highly successful launch.
Project Structural Analysis of International Pharmaceutical Markets Client
Top 5 Multinational Pharmaceutical Manufacturer Description
Our client needed to understand the chain of influence in 11 international markets and how this affected the commercial prospects of their products. VOI examined the elements of the decision-making chain in these markets and determined the relative influence of each component (e.g. payers, prescribers, distributors, patients) on the product selection process.
Based on the results of our analysis, VOI recommended initiatives aimed at the most important decision-making segments in each country. Results
Our client was able to realign their marketing efforts to focus on the most important elements of the decision-making chain, while cutting or minimizing programs aimed at less vital elements.
Project Quality-of-Life Claims Analysis Client
Top 10 Multinational Pharmaceutical Manufacturer Description
As a point of competitive differentiation, our client sought to include quality-of-life improvements as a component of their marketing program. To do this, it was necessary to provide sufficient evidence for inclusion of these claims on the product prescribing label.
VOI identified FDA and EMEA policies for inclusion of quality-of-life marketing claims, analyzed violation notices and promotional materials to determine triggers of regulatory sanctions and recommended clinical trial design and endpoints to ensure approval of marketing claims.
Results Our client incorporated our recommendations into the design of their late-stage clinical trials and was successful in obtaining regulatory approval for the necessary product labeling.
Project Comparative Claims Analysis Client
Top 10 Multinational Pharmaceutical Manufacturer Description
Similar to the Quality-of-Life Claims analysis but for a different pipeline product, the same client wanted to include superiority claims against an existing product as part of their marketing effort. To do this, it was necessary to provide sufficient evidence for inclusion of these claims on the product prescribing label.
VOI identified FDA and EMEA policies for inclusion of comparative claims, analyzed violation notices and promotional materials to determine triggers of regulatory sanctions and recommended clinical trial design and endpoints to ensure approval of marketing claims.
Results
Our client incorporated our recommendations into the design of their clinical trials. This product is under regulatory review, but we expect that the comparative claims labeling will be granted.
Project Therapeutic Opportunity Analysis Client
R&D-based Biopharmaceutical Firm Description
VOI reviewed the Congestive Heart Failure (CHF) market for a biotech firm that was deciding whether to follow its normal practice of licensing to a major company or to keep the new product in-house as a means of establishing itself as a full-service company with marketing and other capabilities.
We thoroughly evaluated the potential for this product based on its probability of approval and likelihood of commercial success.
Note: Although this project was specific to the CHF market, we have conducted numerous similar studies for virtually all major and minor therapeutic categories.
Results
Based on our work, our client decided that this product faced too many regulatory and commercial risks to justify a major change in company direction and decided to license the product. Our work served as the basis for product valuation in the licensing negotiations.
|
