Mike Chace-Ortiz, CEng, Odile Le Roy des Barres, Celine Rodier
Look at any country or region with a strong
generic pharmaceutical and active ingredient
manufacturing sector, and you are sure to
see a diverse industry with business models
that range across a spectrum. That spectrum
is typically comprised of fine chemical and
API producers, generic drug manufacturers
and marketers, CRAMS (Contract Research &
Manufacturing Services) providers, specialty
pharmaceutical companies promoting smaller
niche brand portfolios, young companies
developing NCEs or applying new technologies
to old molecules, all the way to billion-dollar
fully integrated enterprises with global
businesses that range from API production
to research and development of novel small
molecules, biologics and biosimilars.
Daniel Joelsson
It’s not news to anyone in the pharma or biotech industries that clinical
trials have become increasingly complex over the last decade. With
the shift towards precision medicine, greater emphasis on exploratory
endpoints, and trials with multiple arms or dosing regimens, this trend
is sure to continue. Studies now incorporate more procedures and more
specimens are collected than ever before. Hard measures on the increase
of the number of samples collected from patients are difficult to come
by, but the general sentiment of staff involved with the management of
the samples is that the amount has grown significantly.
Eric S. Langer
Contract manufacturing organizations (CMOs) are typically on the
leading edge of new biopharmaceutical manufacturing technology
adoption, as evidenced by many CMOs hiring for positions like
‘technology scout’ and ‘director of innovation’. CMOs tend to be at the
forefront of newer device adoption due to their business models, which
see them handling multiple products that require a high degree of
flexibility. If they can successfully adopt acceptable technologies more
rapidly, they can establish themselves with a competitive advantage.
Their rapid adoption of single-use and disposable equipment over the
past 10 years is an example of this trend.
Sonal Pathak, MS, Harshada Sant, MS, Hemant N. Joshi, Ph.D., MBA
This column summarizes New Drug Applications (NDAs) approved in the
fourth quarter 2015 (November-December 2015). In these two months,
FDA approved 30 NDAs.
JoAnn P. Pfeiffer, Marilyn Windschiegl, JD
Study budgets and contracts are complex business
processes. Both are generally created by the sponsor and
provided to the site; however, the authors regularly advise
study sites that neither document is set in stone and
should be approached as a work-in-progress. Negotiating
a budget to compensate the site for all research costs
and obtaining an acceptable contract requires careful
review of multiple study documents to identify all costs,
deliverables, and sponsor expectations. This article
reviews keys to successfully manage the budget and
contract process at the study site.
Ed Price
Judging by a resurgence of IPO activities since the new year and increasing
product commercialization news in the pharma and biopharma industries,
the future of these industries is clearly on the rise. And as the market for
generics continues to heat up, so too does the role of CMOs as strategic
outsourced development partners.
Guy Tiene, MA
Demand for outsourcing services in the
pharmaceutical and biopharmaceutical sectors
continues to grow 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.