The case studies below are examples of work carried by Aedestra. The examples are meant to be representative. The details of the clients, situations and solutions have been anonymised to respect Aedestra’s confidential obligations.
Market analysis, P&L analysis, Strategy roll-out
A European generic manufacturer wanted to expand its activity and market inhaled finished dosage forms in the USA. Aedestra provided its client with a full market review, identifying potential product targets and competitors. A first group of products were selected for full analysis to assess the viability of their development. Project plans and development budgets were drafted to account for different commercial scenarios. These took into account the capability of the client, its manufacturing and RA expertise. A portfolio of generic nebules was selected on the basis of their blow fill seal expertise, the investment they could afford, and the market opportunities and presented to their investment partners. The products will be developed on-time for a first to file opportunity.
Due diligence, in/out licensing
Softmist inhalers are one of the hot topics in inhaled drug delivery. Respimat from Boehringer Ingelheim is the reference product a number of pharmaceutical companies are trying to emulate. Aedestra was commissioned by a top 5 US generic manufacturer to search for a softmist device technology. Aedestra was aware of a number of viable options, and led their due diligence. Full project plans and budgets were drafted to quantify the value of the investment that led to the successful completion of an in-licensing deal.
Innovation, Product optimisation, R&D Audit
A north american drug development company wanted to test their molecules for nasal delivery for brain targeting. Aedestra was asked to accelerate their product development and resolve technical challenges due to the low water solubility of the compound. Aedestra created a series of formulation options to accommodate the characteristics of these molecules, leading to a successful lead compound identification and the validation of the nasal route as a viable drug delivery option with a dry powder nasal delivery innovation.
Clinical studies, bio-equivalence targeting
Generic inhaled companies are currently pursuing a number of EU DPI products. Achieving bio-equivalence (BE) is often fraught, as is the case with fluticasone or tiotropium. Aedestra was commissioned to resolve issues with Cmax and AUC BE irregularities stemming from formulation/device interactions. A Design of Experiment approach was drafted to explore the product design space. This was done in close collaboration with a clinical CRO in order to accelerate the clinical studies. This new approach reduced the clinical studies by 1/3 and enabled an earlier product filing.
A pMDI specialist company wanted to file its European dossier with in vitro data only. Aedestra provided the knowledge and experience to plan accordingly, in particular to improve the performance of the pMDI product, defining the key performance criteria to achieve in vitro bioequivalence. A number of discussions with the regulatory authorities were held to review and discuss the data package to be provided.
Examples of work we have carried out include:
- Strategic planning, P&L analysis to define target portfolio
- Due diligence of technologies or providers to support strategic investment decisions, and in/out licensing opportunities
- Advising on product development process
- Innovation management, new product creation: formulation and device
- Resolution of problems occurring during development or on marketed product: formulation, API selection, device-formulation interactions
- Planning of clinical studies for bio-equivalence success
- Filing of dossier and regulatory authorities discussions
- R&D audit, talent scouting and new facility creation
Aedestra can help you achieve success by providing strategic and technical expertise throughout your product development. We can help you develop the right product in the right way, reducing cost, time and risk.
If you would like to discuss how we can help you, contact us here.
Over the last 15 years, Aedestra Ltd has worked with numerous clients to hone in its expertise in inhaled products development. Our services reflect our focus on providing solutions and support to resolve the technical and strategic challenges our clients face with inhaled products development: brand or generic, nebules, nasal, pMDI, DPI or softmist inhalers, nicotine inhalers and inhaled antibiotics.
Our first-hand experience from within the industry gives us a unique position to help our clients achieve their ambitions to develop and file inhaled dosage forms in a number of geographies. We are particularly specialised in the EU, USA and Asian markets.