The Pharmaceutical industry is under unique pressure in today's compliance crazy yet instant gratification world. These conflicting climates make it ever so difficult to satisfy all stakeholders.
People want instant fixes to all ailments in a pill, but increasing government compliance to protect consumers lengthens the process, increases the cost, and heightens the risk to develop and manufacture the very products being demanded by patients.
ProModel has a long history of working with pharmaceutical companies to help them identify where and how to improve their performance in order to more effectively meet the many conflicting objectives placed upon them.
Product Launch and Revenue Recovery Analysis
A large pharmaceutical manufacturing company was dramatically behind on the launch plan for its latest product. For every month they were late to market, they would lose nearly $2 million in projected revenue. They needed to accelerate their execution to get back to plan, with a limited budget, and were not sure how to get back on track. Based on prior success with ProModel, they asked us to analyze the situation with them in order to determine the best solution.
Determine the best course of action to regain projected lost revenue at the lowest cost
Determined the top three cost effective courses of action to recover lost time and revenue.
Implemented management's top choice to accelerate the projected launch date by a full month, resulting in $1.8 million in expected revenue for a total cost of approximately $600k.
Exceeded their IRR and ROI requirements for investing in this type of recovery project.
Learned that had they invested in the particular resource from the start, the product could have launched as much as 8 months earlier, resulting in additional revenue of close to $15 million.
Formulation and Filling Facility: Process Improvement Analysis to Improve Scheduling and Throughput
This biotech company's only final stage bio-manufacturing facility in the world was struggling to meet rapidly increasing customer demand. Repeated unanticipated production delays and starvations at critical parts of the operation were causing not only late and missed deliveries, but the expiration of batches of product at a cost of approximately $1 million per batch.
The production team at the facility had not been able to identify the root cause of the delays, nor find a suitable solution. As a result, they were planning to invest $1.2 billion to add another 500,000 square feet to the existing biotechnology bulk manufacturing facility.
They needed a solution to understand the best course of action to fix the manufacturing problems. The major objectives were to:
Uncover the root cause(s) of the unanticipated delays creating the late and missed deliveries.
Provide the client with a solution that allows them to analyze and identify, in a risk free environment, which potential changes will eliminate the delays.
Determine if and when the additional capacity from the new facility would be required.
The client project team, working together with ProModel accomplished the following:
Determined how the facility could produce two more lots per month, which has reslted in a monthly revenue increase of over $25 million.
Defined the right combination of in-process inventory levels and process changes (going to a pull system) that would virtually eliminate line starvations, which resulted in cost avoidance of over $3 million per year.
Provided a user friendly interface for scheduling and evaluating the schedule of the production operation.
Developed the capability to quickly schedule around the impact of significant unplanned downtimes.
Provided the ability to optimize labor use and eliminated the need for additional staff.
Provided a better way to do long-term expansion planning and predicted when and where more line capacity would be required.
An example output chart which displays the monthly throughput of the current push scheduling strategy compared to two different variations using a pull strategy. The pull strategies clearly improve the monthly throughput. Scenario 2 improves it by two lots per month from 12 to 14. This has resulted in a monthly revenue increase of over $25 million.
Clinical studies account for almost half of the over one billion dollar cost of drug development. More than 80% of all clinical trials experience significant delays, the cost of which can exceed $35,000 a day. Patient recruitment and retention in clinical trials are widely recognized as the leading clog in the new drug development pipeline. The unfortunate result of this problem is that pharmaceutical, biotech, and medical device companies spend millions in additional development costs â€“ and lose hundreds of millions in revenue. ProModel developed Clinical Trials Simulator to help with this situation.
Clinical Trials Simulator's design and easy to use interface gives you the power to:
Experiment with and optimize the number of sites any trial will require
Mitigate risk around recruitment by accurately projecting "True" patient enrollment and retention
Accurately project trial milestone dates such as FSFV, LSLV or close out
Accurately forecast the cost of the optimal trial solution
Clinical Trials Simulator is a user friendly decision support technology that takes into account all the inherent variability in Clinical Trials and generates realistic data on how patient recruitment will perform so you can make better decisions, faster.