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Oncology
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Infectious Diseases
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CNS/Pain
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Respiratory Respiratory
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Respiratory
Maximising Opportunities Overcoming Challenges Respiratory drug development and commercialisation encompass improvements in existing classes of inhaled treatments as well as novel agents for more severe disease and rare respiratory conditions. Finding effective and safe new classes of drugs to treat asthma and COPD remains difficult. At TranScrip we are helping our biotech and pharma clients seize opportunities, address challenges and succeed in realising their drug development or lifecycle management goals by continually adapting and adopting new effective ways to work.
Internal Medicine
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Diverse programmes: Effective execution
A snapshot of our recent projects COMPLEMENT INHIBITORS Design of phase I clinical programme in asthma. Selection of study sites. Regulatory strategy to support European development.
SME
TRANSLATIONAL
VARIOUS PRODUCTS
CRTH2 ANTAGONIST
Evaluation and preparation of development plans for new therapies in allergy.
Support of phase III study in asthma. Study feasibility and investigator suitability, preparation of investigator training and contingency plans for patient recruitment and retention.
TOP 50 PHARMA
TOP 50 PHARMA
CLINICAL DEVELOPMENT
INHALED PRODUCT
INHALATION DEVICES
Regulatory support, obtaining orphan drug designation for Pulmonary Arterial Hypertension. Medical oversight of clinical trials and support to drug safety activities.
Expert clinical support for the development of inhalation devices for various respiratory indications.
SME
MEDIUM PHARMA
INHALED ANTICHOLINERGIC Regulatory and medical support for an MAA in COPD.
MEDIUM PHARMA
Regulatory support in the preparation of submission dossier in asthma and responses to regulatory questions.
MEDIUM PHARMA
REGISTRATION
INHALED COMBINATION PRODUCT Provided leadership to an integrated (client and TranScrip) regulatory submission team for a new indication in asthma.
TOP 50 PHARMA
PULMONARY ARTERIAL HYPERTENSION
INHALED LABA
Scientific advice for development projects and product positioning.
TOP 50 PHARMA
POST-LICENSING
SURFACTANT
VARIOUS PRODUCTS
Risk Management Plan update for an orphan drug in Respiratory Distress Syndrome in newborns.
Assessing respiratory portfolio for the Japanese and Asian markets.
MEDIUM PHARMA
SME
Insightful collaborations: Seamless integration INSIGHTS
TIO N
DIFFERENTIATING PRODUCTS IN CROWDED MARKETS
TIO
EXPEDITING APPROVAL THROUGH NEW REGULATORY PATHWAYS
VA
PORTFOLIO MANAGEMENT AND COMMERCIAL STRATEGY
NO
SUPPORTING DEVELOPMENT OF ORPHAN DRUGS
IN
RA
BESPOKE TRAINING PROGRAMMES
N
MAXIMISING VALUE OF INNOVATIVE PRODUCTS
INTEG
Working as long-term partners, our respiratory teams integrate 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, worldwide. Our team’s support development of pharmaceuticals and devices across all major respiratory indications from asthma, COPD, allergy (including food allergy) to orphan indications like cystic fibrosis, idiopathic pulmonary fibrosis and pulmonary arterial hypertension.
TranScrip has a proven track record of achievements that include: Designing and delivering large, complex, cross-functional respiratory programmes
Serving as the drug development organisation for small biotech companies
Interpreting ‘difficult’ outcomes in clinical trials and steering discussions with the regulatory authorities
Fielding multi-functional submission teams to author and deliver MAAs and NDAs
Providing management and oversight for all drug safety needs
Designing and delivering tailored training programmes for product launches
Tim Joslin, Head of Respiratory Contact Tim to find out more about our expertise and how we can work with you. Email: tim.joslin@transcrip-partners.com Tel: +44 (0)118 963 7846
www.transcrip-partners.com
October 2015
CONTACT INFORMATION