Navigating Due Diligence in Cell and Gene Therapy: Key Risks and Strategic Insights
The Cell and gene Therapy (CGT) industry is experiencing rapid growth. It offers groundbreaking treatments that have the potential to improve patient outcomes across a range of diseases significantly. Unlike traditional pharmaceuticals, CGT products leverage genetic modification, cell reprogramming, and regenerative medicine to target the root causes of diseases rather than just managing symptoms. As a result, […]
PMWS24: Agile Manufacturing and Patient-Centricity
Since 2021, the Pharma Manufacturing World Summit has gathered SVPs and VPs of Manufacturing, Quality, Supply Chain, Technical Operations Executives, and other industry professionals. These industry leaders are responsible for making pivotal decisions that shape the pharmaceutical industry’s future. This year, speakers placed an emphasis on covering new topics that highlighted agile manufacturing and patient-centricity. […]
Cell and Gene Therapy Evolution: Groundbreaking Innovations
Introduction Cell and gene therapy evolution has undergone remarkable advancements, transforming the landscape of modern medicine. These therapies offer revolutionary approaches to treating diseases by addressing them at their most fundamental levels—whether through the introduction of healthy cells to repair damaged tissue or by correcting faulty genes responsible for disease. My journey in the world […]
Gene Therapy Evolution: Transforming Medicine Innovation
Introduction In 1991, James Watson said, “Many people say they are worried about the changes in our genetic instructions. But these (genetic instructions) are merely a product of evolution, shaped so we can adapt to certain conditions which might no longer exist. We all know how imperfect we are. Why not become a little better […]
Cell Therapy vs Gene Therapy: Key Guide for Quality Leaders
Cell therapy and gene therapy are cutting-edge approaches in modern medicine, aiming to treat or potentially cure diseases at a fundamental level. Cell therapy involves transplanting healthy or modified cells into a patient to repair or replace damaged tissue, and it is commonly used in regenerative medicine and cancer treatments. In contrast, gene therapy alters […]
New FDA Draft Guidance: Rare Disease Drug Development
The FDA has released a draft guidance titled “Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings.” The document offers valuable insights and strategic advice for sponsors involved in rare disease drug development. This guidance is currently being distributed for comment purposes only, and the FDA is seeking feedback from industry stakeholders. Key […]
Meet the Amazing Cell and Gene Team at Compliance Architects
At Compliance Architects®, we take pride in our team of experienced experts. They are dedicated to handling the challenges of Cell and Gene Therapy (CGT). We’re excited to introduce two expert Cell and Gene team members: Diluks De Silva and Teresa Gorecki. With decades of extensive experience and industry insights, Teresa and Diluks are working […]
New Advances in Organ Transplantation
Organ transplantation stands as a sign of hope for those battling organ failure, yet the chance of rejection continues to haunt the success of these life-saving procedures. Daniel Pavicic Meier, an experienced pharmaceutical consultant, recently shared a LinkedIn post highlighting a new therapy that proves effective against kidney transplant failures. Our Practice Lead, Teresa Gorecki, […]
Streamlining Drug Development: FDA’s Advanced Technology
The U.S. Food and Drug Administration (FDA) has introduced industry guidance that outlines the Platform Technology Designation Program, designed to bring efficiencies to drug development, manufacturing, and review processes. This program, established under section 506K of the Federal Food, Drug, and Cosmetic Act (FD&C Act), provides a pathway for sponsors to leverage data from designated […]
Navigating Great Talent Acquisition in the Pharmaceutical Industry 2023
Diluks De Silva was honored to speak with Geoff Mix, Head of Content and Research for the Executive Platforms’ Blueprint podcast series. Usually, it’s Jack Garvey or Teresa Gorecki, whose interviews Geoff often cites when prepping new guests. This time, he wanted to put Diluks in the spotlight to discuss talent acquisition in the pharmaceutical […]
