2022 is shaping up to be the “year of the guidance” as the FDA has just released a new guidance on using circulating tumor DNA in early clinical drug development. In this blog, I will reflect on why this agency guidance is so important for new oncology therapeutics. Despite many important advances in oncology drug … Continued
If a new drug or medical device receives a positive evaluation from a national payer, that doesn’t automatically mean that the product will be used locally. The product must be registered on a formulary or selected by a purchasing center first. Successful payer engagement at the local level requires effective value communication. Recent innovations in … Continued
In May 2022, the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) launched its Accelerating Rare disease Cures (ARC) Program1 with the vision of speeding and increasing the development of effective and safe treatment options addressing the unmet needs of patients with rare diseases. This is a very … Continued
The ICH E11A draft Guideline on Paediatric Extrapolation was released on 4 April 2022 entering a public consultation phase. This guideline has several objectives. While aiming to harmonize methodologies and approaches for pediatric extrapolation in drug development, it balances access to pediatric indications and reduction of children’s exposure to experimental medications where warranted. The ICH E11A webpage outlines these … Continued
Have you ever considered if your drug development program would benefit from partnering with experts in scientific and medical communications and publications? Maybe, we should first address what exactly scientific and medical communications and publishing entails. As medical writers with decades of experience, we can say that every day holds unique, intellectually rigorous challenges. We … Continued
Model-informed drug development (MIDD) is a network of closely integrated ecosystems that can seamlessly position a new drug candidate while minimizing uncertainty in technical and regulatory success. Indeed, MIDD affords rational scientific hypothesis testing while enabling the clinical development program using strategic pillars. These strategic pillars form a core component of an innovation ecosystem (Figure … Continued
For just a few seconds, I want you to close your eyes and take a deep breath. Exhale. Now picture yourself at work in the regulatory operations and safety department of a biopharmaceutical company. It is 5:20 PM, and you and another colleague are headed out of the door for the day. You both wanted … Continued
While using physiologically-based pharmacokinetic modeling (PBPK) in determining virtual bioequivalence (VBE) has significantly increased over the past few years, this type of mechanistic biosimulation still offers enormous potential to supplant expensive and time-consuming clinical studies. The paper referenced below addresses our increased knowledge of oral drug absorption and the applicability of the Simcyp Simulator to … Continued
The new Clinical Pharmacology Considerations for Antibody-Drug Conjugates (ADC), Guidance for Industry, was issued by the US Food and Drug Administration (FDA) in February 2022. ADCs are targeted therapies that are designed to deliver cytotoxic payloads to cancer cells. The cytotoxic payload is attached to a monoclonal antibody (that is designed for binding to the … Continued
Over seven years ago, the Management Board of the European Medicines Agency (EMA) adopted Policy 0070, a requirement to publish anonymized versions of clinical study reports (CSRs) and other regulatory submission documents. In December 2018, EMA enacted their business continuity plan, which meant publication of clinical data was put on hold. A limited return of … Continued
