At Broughton we work with clients in the early development space, New Product Development (NPD), to give them the evidence required to gain further investment from their backers to take the product into full drug development and ultimately product launch. We help our clients move quickly through NPD to ascertain whether is likely to succeed and to minimize investment in a product that is unlikely to be marketable.
The essential purpose of NPD is to establish as quickly as possible whether the claims in the Target Product Profile (TPP) can be delivered.
Our NPD service helps clients accelerate their product from candidate selection or device prototype to value realization either through the establishment of a Proof of Mechanism (POM), Proof of Principle (POP), or Proof of Concept (POC).
Our team of scientists and regulatory professionals with expertise in innovative medicines and medical devices work within an entrepreneurial and agile framework to deliver rapid results to clients across the industry.
Working in collaborative joint project teams with clients, our energized and passionate subject matter experts thrive in generating high-quality data through scientific excellence to accelerate innovative medicinal products on their development pathway.
You will have access to a dedicated project management team with leading scientific consultants across all workstreams, backed by Broughton’s GLP, GCP and GMP operations. New product development is broken down into three simple phases:
Phase I - Target Product Profile Development and Commercial assessment
The Broughton Project teamwork with clients to understand the product’s biology, proposed patient benefits, the client’s ambitions for the product, for example, launch plans, potential competitors both in market and in-development to build a target product profile (TPP) that sets out what claims will be made for the product in safety and efficacy and what the product needs to demonstrate to be commercially successful.
Based on the TPP and launch data, pricing and positioning, marketing strategy, and assumptions on market size and penetration, Broughton will build a business case for the client to show the likely value of the product when it reaches peak sales and the potential sales until patent expiry. This data may be used by the client for investment discussions prior to starting product development. In addition, the commercial analysis will establish progression milestones which when coupled with risk analysis will show the product’s net present value of each stage of development. The strategy required for the next milestone will be agreed upon with the client and depends on the extent of clinical evidence required. If the product is to be developed to the next stage based on nonclinical data only with appropriate biomarker data to demonstrate potential clinical efficacy, this would constitute a demonstration of Proof of Mechanism (POM) or Principle (POP) which would later be confirmed by the conduct of clinical studies in patients to generate a Proof of Concept (POC) and give security to Phase 3 investment.
The Initiation stage focuses on understanding the vision of your product, product attributes and benefits, and regulatory pathway. This is an important stage in determining the development requirements, which is then used as a reference point to ensure the appropriate activities are conducted to realize your vision whilst minimizing risk. The key areas within the product vision stage are:
Phase II - New Product Development Design
Using a collaborative approach, the Broughton team will assess the available client data and assess whether any of the requirements of the product profile can be discharged with the information already available. If there is more evidence necessary, the team will devise a suitable package of work to generate the necessary data with an associated timeline, risk and cost. There may be a number of different scenarios which will also be shared with the client to discuss their preference. A longer approach with higher costs may be required but would give a greater level of evidence and would involve less risk being carried forward into Phase 3 of the program.
A package of activities will be created to either reach POM, POP or POC and will be shared with the client along with a number of opportunities to uplift the activities and de-risk the product.
Phase III - NPD Delivery to POC and Development Feasibility Assessment
Following an agreement with the Client, phase III delivers the necessary activities required to demonstrate either POM, POP or POC for the product. Following the completion of the activities, results will be compiled into a Client report which details whether the product is likely to meet the vision for the product as defined in the TPP and whether it meets the established criteria for project progression.
A full breakdown of the project plan is provided indicating timings, associated costs and risks that are necessary to take the product to reach the designated milestone.
Demonstration of POM, POP or POC for your product coupled with a good understanding of development feasibility and potential risks, will enable you to secure further investment for additional development.
As data emerges from ongoing studies this will be discussed with the client at joint project team meetings and future activities will be planned based on emergent data. If the scope of the project is significantly increased the timeline and costs associated with delivery will similarly increase. Contracts need to be sufficiently adaptable to accommodate any unknowns that occur during development so that any additional costs are facilitated.
All data captured in early product development will form part of subsequent regulatory product dossiers.
Our scientific strategy encompasses all the information collected through the key phases above to support the require regulatory strategy. Our subject matter experts have years of industry experience and are up to date with the latest pharmaceutical and medical device regulatory landscapes.
Our team of experts, with their collective years of experience in the pharmaceutical sector, covering regulatory expertise, toxicology, dedicated development and validation scientists, and our experienced analytical team have the level of understanding required to design your optimal NPD evaluation.
Download our case study to read how we helped our client maintain regulatory compliance and extend product shelf-life through our method development, validation and stability management service.
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