A new product takes a long and winding road from a laboratory to the patients it is designed to help. Many factors and organizations affect just how many months and dollars it will take to shepherd a new product from preclinical studies to market. Carefully documented, regulatory-compliant clinical trials are key to marketing approval. Clinical trials involve a choreographed network of regulatory agencies, sponsor companies, and clinical investigators. Myriad specialists in that network include those who produce and deliver an…
Regulatory Affairs
Management Engagement Is Key to Successful Quality Systems
Many models are available for establishing a quality system in regulated industry, whether for pharmaceuticals, medical devices, or biologics. Each company establishes a set of standard operating procedures (SOPs) that enables it to manage operations and then implements a quality system around its product and process. But why do some quality systems work well, whereas others falter or fail miserably? Does the fault lie in procedures, implementation, or maybe training? Perhaps the answer can be found by examining the involvement…
Throwing a Flag at Biosimilars
PHOTO COURTESY OF ROGER LUNDBLAD (PICTURED). When I officiated at high school (US) football, I learned a lot from the experience. Contrary to popular opinion, there are rule books referees study. However, although the rule book is modest in size, the case book for interpretations is large. This brings me to the topic of generic or follow-on biologicals and biosimilar products for which there will be rules, and the interpretations will be many. Continuing with the US football analogy, the…
Shared Risk
Risk is inversely proportional to one’s distance from a problem. For regulators, it seems straightforward to control biopharmaceutical and medical device risk. For pharmaceutical, biotechnology, and medical device executives, however, risk is hardly so clearly defined; it extends, grows, twists, and compounds through a chain of suppliers, consultants, and business partners. So when regulatory officials claim that compliance accountability cannot be delegated, biopharmaceutical and medical device companies are left holding the bag. Years ago, as a C-level executive for a…
The Biopharmaceutical Industry’s New Operating Paradigm
Currently the biopharmaceutical industry is transitioning to a new business model of production efficiency through implementing operational excellence (Op Ex). Borrowing from such principles as “lean manufacturing” and “Six Sigma” (6σ), and incorporating quality by design (QbD) (1), Op Ex is being applied through the implementation of such advanced enabling concepts and technologies as quality risk management (QRM) (2), process analytical technology (PAT) (3), and systems biology (SB) (4). Some people see a conflict here: This paradigm shift is occurring…
Is the FDA Trailing on the Biopharmaceutical Drive?
In the heady days of the biotech boom of the early 1990s, the ground shook as salvo after salvo of innovative regulatory guidance documents emerged from the US Food and Drug Administration (FDA). Even their titles were innovative: “Points to Consider in the Production…” rather than the stodgy “Code of Federal Regulations, Volume X, Part XX.” The FDA was supporting the development of the emerging biopharmaceutical industry through rapid uptake of technological and clinical developments and speedy conversion into guidance…