This is the second of three blog posts discussing best practices for developing oligonucleotide therapeutics. The first blog in the series explained how these therapies work. Characterizing the pharmacokinetics (PK) of an investigational oligonucleotide drug is an important part of...
Meet Rachel Bombara, Sr. Regulatory Operations Specialist at Certara. In this brief video Rachel shares how she manages tight deadlines and how she leverages technology to support her daily submission work.
Certara offers Plain Language Documents to meet EMA/UK regulations with customizable templates, infographics, and accessible designs for clinical trial communication.
Antibody drug conjugates (ADC) are a unique way to obliterate tumor cells and represent an underutilized immunotherapeutics option in oncology, whether as monotherapy or in combinations. The first FDA approval of an ADC was in 2011, with the introduction of...
In November 2019, the US FDA granted accelerated approval for Oxbryta™ (voxelotor) tablets for the treatment of sickle cell disease (SCD) in adults and children 12 years of age and older. Voxelotor is an oral therapy taken once daily, it...
Many cystic fibrosis (CF) patients take several medications at one time to manage symptoms and the disease. In 2012, FDA approved Ivacaftor (Kalydeco®) for treatment of the underlying cause of CF in a small subset of the patient population. In...
The paper “Opening a Debate on Open-Source Modelling Tools: Pouring Fuel on Fire vs. Extinguishing the Flame of a Healthy Debate” published in ASCPT’s CPT Pharmacometrics & Systems Pharmacology exposes the different perspectives around origin, use and ongoing advancement of...
A Tier 3 Sponsor called upon Certara to support its rolling BLA submission, the second submission we supported for this Sponsor in the overall partnership. The agile nature of the submission meant the Certara team would need to be strategic,...
Developing interactive and easy-to-use stakeholder engagement content market access, medical affairs, and sales field teams is a time-consuming, expensive, and often decentralized process. BaseCase is “no-code” platform that enables you to visualize large complex datasets and economic models, which demonstrates...
In Raj’s Corner, we’ve assembled a series of expert blog posts that will explain drug development best practices that support the most streamlined and informative clinical development program, to maximize the returns of investment of your program.
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