Helping you navigate the unpredictable seas of the commercial development of complex generic drugs
If you diversify your formulation to include inhaled products, you may extend your exclusivity and profitability window.
OIDP performance is impacted by many variables
coming from the product’s formulation, delivery to a local site of action within the lung, the performance of the device, and the patient population that uses the medication…
However due to the complexity of the development and commercialization, it’s not an easy course to navigate.
A major international pharmaceutical company decided to invest in a complete portfolio of inhaled products for asthma and COPD.
However, they decided not to develop a novel inhalation device, but instead use the new products in an old and unwieldy system. Their plan was to look for a more modern device after the launch of the products.
The company severely underestimated the complexity of identifying and negotiating access to a new technology, and developing the existing molecules into a totally different device, with different performance from the existing device.
In addition to that, the new device was a totally untested concept, and ultimately had to be withdrawn from the market and completely redesigned.
Sextants were trusted by sailors to navigate in turbulent seas. Put your trust in Sestante who will help you discover where you are and guide you to where you need to be.
Inhaled formulations can help your company to maintain exclusivity for longer, but the development of an inhaled device strategy is fraught with difficulties.
How we can help:
- By navigating the specific requirements and market dynamics you’re facing, we can help to chose the inhalation technology that is right for you;
- Support innovation by managing the complex interactions among the different aspects of the development of your inhaled products;
- Facilitate dealmaking with technology partners;
- Building a dedicated task force with a broad range of expertise on inhaled delivery and formulation that can assist in the development of the TPP (Target Product Profile) or TVP (Target Value Profile), all the way to development, pricing, launch execution and support.
Resulting in a strategy that includes blueprints and a team ready to support the implementation, hands on!
How the process can work:
- Accounting for life cycle management from the beginning, synchronize all aspects to produce an overarching holistic product development strategy that follows through to implementation and execution;
- Facilitate interactions among internal and external stakeholders;
- Interface with technology providers, both for devices and formulations, such as different device vendors, technology providers and manufacturing partners;
- From scientific evaluation, to technology landscaping, to commercial due diligence, we can compliment your internal resources with our specific inhalation and respiratory expertise.
We have the experience, with “skin in the game” where we take ownership from start to finish!