Respiratory
Respiratory drug development and commercialisation encompass improvements in existing classes of systemic and inhaled treatments as well as novel agents for common and rare respiratory conditions. Finding effective and safe new classes of drugs to treat asthma and COPD remains difficult. tranScrip teams have expertise in all major respiratory indications from asthma, COPD, allergy and COVID-19 to orphan indications such as cystic fibrosis or idiopathic pulmonary fibrosis. We are helping our clients address clinical and regulatory challenges, differentiate their products and realise their drug development and lifecycle goals.
What we do
When there is a problem or gap, we can become your long-term partner and create a way to resolve the issue together.
Why we are different
Our respiratory teams are renowned for integrating seamlessly with our clients. We provide effective support by delivering strategic insights and innovative approaches to all aspects of respiratory drug development, from translational science through to registration and medical affairs.
tranScrip has a track record of achievements that include
Designing and delivering large, complex, cross-functional respiratory programmes.
Creation and implementation of development strategy for a monoclonal antibody for COPD.
Serving as the “one-stop shop” drug development organisation for small biotech companies.
Design, implementation and medical oversight for a Phase III asthma study of a CRTH2 antagonist.
Interpreting ‘difficult’ outcomes in clinical trials and steering discussions with the regulatory authorities.
Achieving additional indication for an inhaled COPD product.
Fielding multi-functional submission teams to author and deliver MAAs and NDAs.
Preparation and regulatory defence of an MAA for an inhaled anticholinergic in COPD.
Commercial evaluation of novel approaches, including TPP and pricing assessments.
Evaluation of food allergy products for US and EU markets. Price point testing and discussions with reimbursement bodies.
Strategic clinical and commercial guidance for respiratory devices.
Expert support for development of inhalation devices for various respiratory indications.