Dr. Ronak Savla, Jeff Browne, Vincent Plassat
According to the popularly cited study from Tufts Center for the Study
of Drug Development, it costs $2.6 billion to receive a drug approval.1
Despite the increased investments and revolutionary therapies
brought to market, return on investment from drug launches is near
historical lows.2 Luckily, issues such as challenging physicochemical
properties and unfavorable absorption characteristics can be addressed
early in the development process. Screening formulation
options in the pre-clinical setting has the potential to reduce both
costs and risk of attrition.3
Johannes Kiefer, Ph.D.
Many pharmaceutically active molecules are chiral and their
physiological effects are determined by enantioselective interactions
with proteins in a biological organism. These effects can be very
different for the enantiomers of a chiral substance. Hence, it is of
utmost importance to produce enantiopure substances in the
pharmaceutical industry.
Steve Kuehn
Whether seeking market leverage or financial advantage, drug owners
across Pharma’s primary sectors are increasingly seeing contract
service providers as strategic partners, allies with the development
tools, technologies and operational expertise to help them remain
cost competitive and speed their products to market. These and
other dynamics are spurring increased capital equipment spending
by contract manufacturers pursuing new business across the space.
It’s also spurring new investment in operations that support major
strategic initiatives like a move to large-molecule processing or the
launch of a “branded” prefilled sterile injectable into the generics space.
Many factors play into the success of an excipient. Besides the
chemistry fulfilling pharmacological pre-requisites, presence in
most frequently used dosage forms, considerable sales volumes,
and existing in multiple grades within broad applications, a
“successful excipient” is responsible for safe and efficacious drug
delivery, regardless of route of administration.
Our approach is not to be just another vendor. Really, the goal is
to partner with customers to find the best solution to meet their
needs. Our in-depth product application and regulatory knowledge
allows us to act as consultants. In this way, we work directly with
our customers to learn about their needs before recommending
a product to make sure it will solve their problem and it’ll be
something they’ll use for many years.
Rodolfo J. Romañach, PhD
Two recently published FDA and EMA documents describe expectations
for the submission of spectroscopic methods to the regulatory
agencies and are important advancements for the implementation
of modern non-destructive analytical methods in the pharmaceutical
industry.1,2 Both documents are focused on the description of near
infrared spectroscopic methods. However, the FDA Draft Guidance
indicates that the same fundamental concepts of validation may be
applied to Raman, X-ray, and other Process Analytical Technology
(PAT) analytical techniques. These expectations must become part of
the plans or procedures for the development of PAT spectroscopic
methods.
Among the promising
new oral controlled release technologies are bioavailability enhancing
technologies coupled with extended release technologies. An example
of these are gastro resident systems which enable the extended delivery
of drugs with limited colonic absorption. While older hydrophilic matrix
based technologies such as Accuform™ have been in the market for several
years, newer technologies are in development that bind to the mucosal
membranes and have ability to also repel gastric contents, thus allowing for
extended gastric residence.
Daniel Seeliger, Timothy D. Fenn, Anne R. Karow-Zwick
Biologics, in particular monoclonal antibodies,
have revolutionized medicine in the
last two decades and nowadays represent
the standard of care for a variety of diseases,
most notably in oncology and autoimmune
disorders. This fact is reflected by the market
share biologics have obtained in 2015, in
which seven of the top ten selling drugs
belong to this class.
Guy Tiene, MA
Due to the continued global economic recovery and rising consumption
of advanced medicines around the world, drug manufacturers
of all sizes have increased their investments in innovation, leading to
burgeoning pipelines and near-record-level approval rates by FDA.
That has led to a significant need for research support. Indeed, the
latest estimates from TechNavio (January 2015) have the bio/pharma
contract research services market growing at a compound annual
growth rate (CAGR) of 9.83%. According to the 2016 Nice Insight CRO
Outsourcing Survey of bio/pharma professionals (n=586), 56% of
respondents indicate that they spent more than $50 million annually
on services provided by contract research organizations (CROs) in
2015, up from 23 to 24% for the period 2012-2014. There are, however,
numerous differences in the preferences, needs and expectations for
emerging, small, mid-sized and large bio/pharma companies.
Patti Seymour, Dawn M. Ecker
As the number of commercial products and pipeline candidates grows, a crucial issue facing the industry is the current and future state of biomanufacturing capacity.
Yan Wang, Wen Qu, Stephanie H. Choi
Polylactide (PLA)/Poly(lactide-co-glycolide) (PLGA) is widely used in
many FDA-approved drug products. There are currently 15 FDA-approved
PLA/PLGA-based drug products available on the US market
(Table 1). PLA/PLGA-based drug products are designed to reduce
dosing frequency and potential drug toxicity. They are also useful for
improving patient compliance with a better therapeutic option to treat
patients who adhere poorly to frequent oral or injectable medication.
However, as these products are generally expensive, the availability
of generic PLA/PLGA-based counterparts would make them more
affordable, more widely available, and thus benefitting more patients.
Tong (Jenny) Liu, Ph.D., Catherine Sheehan, Steven Wolfgang, Ph.D.
As the third part and final part of this series,
this article focuses on future directions and
challenges faced by the USP excipient Upto-Date
initiative with regard to excipients.
The article will provide the key findings of the
USP Excipients Workshop held in November
2015 that focused on several topics, including
challenges involved with introducing new
or missing NF excipient monographs and
opportunities to update USP excipient
standards used in injectable and biologic
dosage forms. Excipients are often complex
substances that, within their definition and
specification in a USP monograph, can exhibit
relatively wide variation in composition.