Ed Price
Method validation is essential in proving the quality, reliability and consistency of a chemical being developed. Proper validation of a method provides documented evidence of method performance and prescribes ongoing measures to ensure quality monitoring for the life of the method.
Sandra Wassink
Technical transfer to a contract development and manufacturing organization (CDMO) mobilizes the efforts of a technical team, from start through commercialization activities and throughout the life cycle of a product. In the case we will describe, the selection process identified key areas that will need CDMO collaboration.
Emmanuel Gomas
Maintaining the integrity of research and getting reliable, repeatable data depends on the stability of a research model. Given the cost and complexity of managing model breeding, cryopreservation is often viewed as a highly efficient insurance policy for a colony.
Luiz Alberto Barberini, CQE, CPIM , MBA
All my professional life has been about supply chain but over the last six years I’ve been engaged with external manufacturing businesses. My career with pharmaceutical multinational Brazilian-based companies went through different areas of supply chain excellence: demand management, planning, S&OP, procurement, logistics, distribution, exports/imports, warehousing.
Annette Stemhagen
An in-depth understanding of the disease or condition for which a drug
or biologic is being developed is an important component of drug
development. However, in some situations, the detail about the disease
or condition may be collected alongside the studies of the compound
under development. This may be particularly true for rare diseases where
patients and data are limited. The FDA in the 21st Century Cures Act1
has
specifically noted the importance of natural history in understanding
the full spectrum of the disease manifestations including “describing
genotypic and phenotypic manifestations and identifying and defining
distinct subpopulations affected by a rare disease or condition”. In the
overall scheme of product development, gaining this knowledge ahead
of or early in the development program is a small investment that can
pay large dividends.
Gary Barker, Denise Moody, April Pierce, Magda Santos
The current pharmaceutical and clinical research environment is in a constant state of change. Business decisions resulting in mergers, acquisitions and resource depletion, coupled with increasing regulatory and pharmacovigilance (PV) safety requirements, have required business leaders to make pioneering decisions and consider innovative ways to conduct business.
Stephie Lee
Toxicology studies that are carried out in compliance with the principles
of Good Laboratory Practice (GLP) are somewhat unique when compared
with most other preclinical in vivo studies. The need to achieve high
exposures, either by administering large doses of the drug molecule
or by using enabling formulations, can make the identification of a
suitable vehicle challenging. For short investigative toxicology studies,
a relatively wide range of vehicles may be used as excipient toxicity is
mitigated by the limited study duration. However, from the standpoint
of formulation development, toxicology studies conducted in early
clinical development are primarily designed to identify acceptable
vehicles for use in longer duration first-in-human-enabling studies. As a
result, greater consideration must be given to not only the safety profile
of the excipients used in these formulations, but also the complexity of
manufacturing and formulation stability that will be required over the
longer dosing interval.
Emre Göllü
Increasing competition driven by economic globalization has become a natural part of the business environment, especially over the last couple of decades through direct effect. Rapid evolution of dynamics and processes in the emerging markets have been fostering competition, so firms are destined to focus on how to improve their profit margins through productivity increases along their entire supply chains, regardless of their sizes.
Dawie Wessels
In 2016, Alzheimer’s Disease International reported that over 47 million people globally were living with dementia. This number is projected to increase to more than 131 million by 2050, as the population ages. This has a huge economic impact – in 2017 worldwide costs were estimated at US$818 billion, and this was expected to exceed a trillion dollars by 2018.
What are some of the current critical issues
facing the industry regarding oral dosage
manufacturing?
Amitkumar Lad, PhD, Sunny Christian, MS, Harshada Sant, MS, Hemant N. Joshi, PhD, MBA
Over the years, the Prescription Drug User Fee Act (PDUFA) has authorized the USFDA to collect user fees from industry to facilitate the review process for certain human drug applications. The fifth authorization of PDUFA (2012-2017) focused mainly on advancing public safety and upgrading the benefit/risk assessment of new medicines. PDUFA VI was passed for fiscal years 2018 to 2022.