Integrated Product Development
Biopharmaceutical product development is a complex, costly and risky undertaking with an overall failure rate of > 96%, and a 90% failure rate during clinical development. Our experts in integrated product development (IPD) know what it takes to deliver new therapies to the patients that need them and bring deep scientific and product development expertise to every development challenge. Through our holistic bench-to-bedside integrated product development approach our IPD leads utilize their extensive global product development experience to guide clients in creating and executing global product development strategies that improve the probability of regulatory approval and successful commercialization.
Our Integrated product development solution (IPD) provides bench-to-bedside support and strategic partnership from early discovery through clinical development for companies bringing new drugs, biologics and medical devices to market with the scientific and strategic consulting support of our IPD experts. Our IPD leads have extensive global development experience and can help create efficient and time-saving global development strategies that include all key functional areas (clinical, regulatory, statistics, quality, CMC, among others). Our leads are also experienced in facilitating multi-disciplinary integration across the various interdependent functions, which increases a product’s chance of commercial success by optimizing program execution thereby reducing costs and white space between stages which ultimately minimizes risk and improves probability of success.
Bringing products to the market is a complex, risky, and costly journey. With a sharp focus on what is needed to bring your product to the market our IPD solution provides a framework for critical decisions that facilitates integration of multi-disciplinary teams and activities as part of the product development process, creating efficient execution of the development strategy. This integrated “Bench to Bedside” approach helps clients “see around corners” identify risks and develop more efficient and time-saving development strategies has the following benefits:
Optimizes decision-making and program execution.
Reduces cost and white space between stages.
Minimizes risk and improves the probability of success.
An Integrated Development Strategy (Product Roadmap)
Product development is a high-risk and expensive endeavor. When examining failed development programs, some themes stand out:
- Not having a destination and a roadmap.
- Spending excess time focusing on basic science before moving on to drug development-focused activities (they are not the same)
- Having a too sharp focusing on the next milestone without consideration of future development activities.
- Failure to interact with Regulatory Agencies early in development.
- Working in siloes and not taking a holistic, bench to bedside and integrated approach.
- Insufficient consideration of the regulators perspective on benefit:risk.
Not considering interrelatedness of different activities and not understanding the critical path.
A robust product development program must include a clear, well-defined destination – captured in the Target Product Profile (TPP) —that describes where your drug fits into clinical practice and the global marketplace and helps to define the development strategy including the various activities and studies as well as their timing. The TPP will:
- Define what unmet needs your treatment addresses and patient populations it will benefit.
- Establish the specific indications your drug will be used to treat.
- Outline the dosage, frequency and route of administration compared to the competition.
- Clarify beneficial safety and efficacy claims for patients and physicians.
- Differentiate your product from the competition – marketed products or those under development.
- Define the critical scientific and clinical questions your global development strategy and studies must address.
Our Integrated Product Development team helps to create or refine your TPP early in the development process to guide the design of an integrated development plan that includes a regulatory/clinical roadmap, strategy and risk mitigation plan.
PharmaLex puts together a team of subject matter experts, fit-for-purpose for the stage of development, led by a senior product development expert. The IPD lead and team work in close collaboration with client experts to forge a strategic partnership. This 1+1 = 3 approach leverages the expertise from both the IPD and client teams to optimize creation and execution of the global product development strategy. The team’s expertise encompasses the strategies and activities of all key functions needed for developing your product concluding with a successful launch and market entry. The team, under the leadership of the senior product development expert, will focus on critical issues such as :
- Understanding the unmet need, patient population and benefit of the product.
- Avoid having a solution looking for a problem.
- Is the innovation “druggable” with a clear path to market approval?
- Can it be developed (endpoints, recruitment issues, COGs)
- What will it take to bring the product to the market?
- Ability to pass regulatory scrutiny.
- Differentiation
- High-level understanding of the market/competitive and reimbursement landscapes
- Evidence of effectiveness in both animals and the clinic.
No matter what your product is, company leadership, potential development partners, licensors, and investors have similar expectations revolving around these critical issues. Mapping, proper planning and execution not only enhances your chances of regulatory success but also increases the chances of success funding cycles.
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