It’s a familiar story: Pharmaceutical Company X spends years developing Product Y only to discover at a crucial point in the process that Product Y will not succeed. The result is often millions of dollars and development years wasted. But could drug development failure be prevented?
Oftentimes, drug development failure can be attributed to misalignment with one or more factors crucial for success in medical, regulatory, science and manufacturing, and market. Devoting more time and resources to these areas doesn’t always equal success; drug development failures happen to pharmaceutical giants as well as to small startups. But does failure have to happen so often?
At Premier Consulting, we think drug development failure can be prevented. We’ve proven our experience by working on and gaining approval for more than 200 drugs. With a more than 95% FDA concurrence rate, our team helps clients like you to develop successful drugs, time and again. Our process for selecting viable drug candidates is called Product Ideation.
What is Product Ideation?
Product Ideation is a partnering process in which Premier Consulting works with a client (Sponsor) to identify an optimal drug or drug-device product(s) for the Sponsor to develop for approval via the 505(b)(2) pathway. Over the last decade, Premier Consulting has conducted numerous Product Ideation projects for large, medium, and small pharmaceutical companies. Each project required unique criteria, which has helped us to hone a customized process. Premier Consulting’s drug development experience positions us as the most qualified team in the rapidly expanding field of Product Ideation.
So what is the process and how does it start?
Premier Consulting performs the Product Ideation process with extensive consultation with the Sponsor. The process begins with Premier Consulting’s proprietary Product Selection Criteria Questionnaire in which the Sponsor shares preferences regarding all relevant product attributes that will be important for a commercially successful final product. In most cases, the Sponsor requests that the drug be selected from a particular therapeutic area or from a preselected list of candidates, or that it be suited to a technology that the Sponsor has developed.
Examples of the new technology may include a novel drug delivery device or a new formulation offering superior drug delivery or pharmacokinetics compared with existing products. Premier Consulting then considers the Sponsor’s requirements and designs a custom Process Plan that outlines the intended filtering and prioritization process.
Partnering to select an optimal product with a Sponsor involves multiple rounds of prioritizing based on Premier Consulting’s regulatory, CMC, nonclinical, clinical, quality, marketing, and commercialization, and general drug development experience (see Figure above). The Sponsor’s input on strategic priorities is an integral part of the process.
At each step, Premier Consulting generates Target Product Profiles (TPPs) for the remaining candidate products. A dynamic TPP proposes drug product attributes while being continually refined during the entire selection process. The TPP is the critical foundation of a successful drug development program because it forms the basis for the labeling that will distinguish the proposed product in the marketplace.
As the candidate priority list becomes progressively shorter after multiple rounds of consideration and advice, drug development feasibility reports are prepared for the highest priority candidates. These reports provide the Sponsor with in-depth strategic, regulatory, and commercialization information that assist in identifying the final candidate/s for development. After a decision is made, the final step in the product ideation process usually involves a Pre-IND meeting with the FDA to gain agreement on the proposed development program.
What are the Benefits of Product Ideation?
In today’s competitive drug development landscape, the benefits of optimizing your next product according to your company’s capabilities and strategic goals are obvious. Product Ideation allows utilization of Premier Consulting’s databases and regulatory expertise, including ways to reduce your nonclinical and clinical programs by using the 505(b)(2) regulatory pathway. Often, Premier Consulting presents novel solutions to a Sponsor that were not previously considered, including formulation enhancements, and/or changes to the approved indication or dosage form.
A comparison of various development strategies for lead candidates, combined with establishing credibility of the chosen strategy by aligning with the FDA expectations early in a development program, can save time and money on the pathway to the market. In all cases, the benefits of having a Product Ideation partner with experience in creating successful drug development programs and in preparing 505(b)(2) submissions can mean significant reduced costs and/or time to market for a product
What Is the Result?
The final number of drug candidates provided depends on the Sponsor’s initial request, as with all of the requirements laid out at the beginning of Product Ideation. Premier Consulting believes in the process and guarantees that the end result will be a viable candidate(s) that fit your specific requirements and are appropriate for development. The extent of Premier Consulting’s involvement and guidance from that point on is up to you.
Angela Drew, PhD
Product Ideation Consultant