In a captivating webinar led by industry experts, Dr. Swati Jaiswal, Senior PBPK Consultant at Certara, and Dr. Erica Winter, Director of Clinical Pharmacology at EQRx, Model-Informed Formulation Development (MIFD) took center stage. The session provided valuable insights into the strategic utilization of model-informed approaches in drug development projects. A compelling case study on development … Continued
The prevalence of diabetes in the US is incredibly high and affects more than 10% of the population. Patients living with diabetes rely on insulin to manage their blood sugar levels and maintain a healthy life. Over the past 20 years, drug manufacturers have increased insulin prices by more than 300%. In recent months, insulin … Continued
In the world of pharmacokinetic/dynamic (PBPK/PD) modelling, compound PBPK models are incorporated into compound files that serve as a vital component for accurate predictions for virtual clinical trials. Version 22 of the Simcyp PBPK Simulator boasts an extensive library of 130 small molecule and 6 large molecule compound models, encompassing enzyme and transporter substrates, inhibitors, … Continued
You are having a good day as a quality assurance professional at a small pharmaceutical company until you open an email from your company president asking for an explanation. She is forwarding an email to you from the United States Food and Drug Administration (FDA). The second paragraph in the FDA email reads: This warning … Continued
On 16 May 2023, the European Medicines Agency (EMA) held a webinar to announce plans to restart the publication of clinical data contained in regulatory submissions under Policy 0070. The Policy was originally suspended in 2018 as part of EMA’s Business Continuity Plan for its relocation in the wake of Brexit (read about it in … Continued
Access to safe and effective medications is critical for pediatric patients, yet 60-70% of medicines prescribed to children are off-label. In Japan, only 30% of new drugs are approved for pediatric use. Unlike the US and the EU, Japan has no regulation mandating pediatric drug development. Still, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has … Continued
A Global Risk Mitigation Plan (GRMP) is a critical step in drug development as it helps sponsors identify and address potential Market Access, Pricing & HEOR (health economics outcomes research) barriers that could affect the launch and commercial success of their product. The GRMP typically consists of two parts: a Risk Assessment Tool and a … Continued
The regulatory environment for Pharma and Med Tech creates business challenges for digital engagement. Many countries have strict regulations around promoting and advertising medicines and med tech. These regulations can make it difficult for companies to engage with customers and healthcare professionals through digital channels. Additionally, the life sciences industry is heavily focused on research … Continued
Early paediatric investigation plan (PIP) submissions – an unnecessarily bitter medicine? In the European Union (EU) Paediatric Regulation, the first PIP submission is requested early in the clinical development program. The regulation states it should be submitted at the end of phase 1 clinical studies, while the European Medicines Agency (EMA) website gives somewhat more … Continued
In the United States, treatments or medical services that require the patient be admitted into a hospital or other health care facility are typically paid for via diagnosis-related group (DRG) reimbursement, a bundled payment methodology for inpatient care. Under DRGs, the payer reimburses the provider a lump sum for the totality of the patient’s care … Continued
