Ed Price
The 400 percent increase in the cost of the life-saving allergy treatment EpiPen has gotten its manufacturer, Mylan, into some deep scrutiny – and rightly so. Maybe it’s a combination of greed, market dominance, regulatory requirements and clearly more and more entities taking a share of the profits. Yet this debacle should shed light on the real issue – the need for greater competition to prevent any one company from having a monopoly. It also should shed light on the regulatory environment which supports that monopoly. Although it makes for great political theater, with the media focusing on stuttering company executives trying to justify four-figure price increases or unhinged congressional representatives trying to convince their constituents that they are fighting for John Q. Public, everyone is ignoring the real issue: ever-increasing FDA regulations are preventing new approvals and thus stifling competition.
Dr. Elham Blouet
Parenteral preparations are defined as solutions,
suspensions, emulsions for injection or
infusion, powders for injection or infusion,
gels for injection and implants.1
They are sterile
preparations intended to be administrated
directly into the systemic circulation in humans
or animals
Mark Sawicki, Ph.D.
Prior to the adoption of newer, more advanced systems we use in clinical
trials today, bias was a common theme. As noted in the article: “FDA and
Clinical Drug Trials: A Short History” by Suzanne White Junod, Ph.D.,
this was often observed when physicians would treat sicker patients
with known controls, while seemingly stronger patients received
experimental products. Furthermore, when not blinded, knowledge of
a patient’s treatment regimen tended to affect the level of care a health
care worker would provide and also influenced their observations.
Bikash Chatterjee
As we bid farewell to 2016 to face the opportunities and challenges of
2017, the global life sciences industry can be best described as being
on the cusp of great change. For the last ten years, U.S. market growth
has been transitory, with M&A activity defining the primary defensive
strategy to stifle global competition and pricing pressures.
Dr. Elham Blouet
Can you tell us about Sekisui XenoTech and the
products and services the company offers to the
pharmaceutical industry?
John Michnick, PhD
Growth in demand for new anti-cancer drugs has seen more and more
pharmaceutical companies researching highly potent molecules, but
these companies may not have the specialist resources and infrastructure
needed to take these developments beyond the R&D scale. Meanwhile,
for projects that involve DEA Schedule II-III controlled substances, there
is also a need for knowledgeable, experienced, and licensed partners
to work with these compounds safely and within legislative constraints.
John Michnick, Ph.D., Director, Sales & Business Development at
Cambrex, discusses how and why specialist contract manufacturers are
in a good position to take on these challenges.
John Michnick, PhD
In general, how has the lyophilization market changed over the last five years? How have these changes allowed LSNE to better assist your clients?
Mark Sawicki, Ph.D.
Around 2003 was a peak crunch-time or
period of concern that severe bioprocessing
capacity shortages would develop, with
utilization rates peaking then at 76% for
mammalian systems and many potential
blockbusters in the pipeline. The subsequent
expansion of capacity, with many new
facilities coming online, brought utilization
rates down, so that by 2006 a rather stable
and healthier capacity utilization rate in the
60% - 67% range was attained.
Mark Sawicki, Ph.D.
Clinical trials are at the heart of the process for bringing new medicines
to patients. One of the most critical aspects to the conduct of any
clinical trial is identifying the right group of people to include in the
study. Unfortunately, many of the clinical trials conducted in the
United States suffer from a lack of diversity, with minority populations
being consistently underrepresented. In addition, there is often a lack
of consideration of cultural and genetic factors which are particular
to Asian, African-American, Hispanic, and other minorities that may
influence results. This ethnic diversity gap can lead to less than ideal
development of new medicines and can further exacerbate minority
health issues.
Mark Sawicki, Ph.D.
Shipping and storing clinical trial therapeutics and biospecimens
involve more than moving materials from Point A to Point B. In the
biopharmaceutical industry, material transport and storage are especially
complex operations because the materials cannot be exposed to
temperatures outside the range(s) prescribed for storage and/or transport
- a phenomenon known as a “temperature excursion.” While frozen
materials are shipped and received every day, the logistics surrounding
their storage create new challenges for even the largest and most experienced
clinical trial networks and supply chain managers.
Nigel Walker
As pharmaceutical manufacturing becomes increasingly globalized, with
companies engaging both contract development and manufacturing
organizations (CDMOs), as well as contract research organizations
(CROs) in multiple countries, contamination precautions are increasingly
important. Biopharmaceuticals have also continued to grow in number
and significance, further highlighting contamination concerns. This
is especially due to the heightened need for aseptic conditions while
processing these drugs. In response, the industry is looking for effective
ways to decrease contamination. In fact, according to the 2016 Nice Insight
Pharmaceutical Equipment Buying Trends Survey, 69% of respondents
expressed interest in purchasing cleanroom equipment and systems.1
However, the sterility of processes and equipment is only part of the
equation as the environment at large also contributes to contamination.
Sunny Christian, MS, Harshada Sant, MS, Amitkumar Lad, PhD, Hemant N. Joshi, Ph.D., MBA
This column summarizes New Drug Applications (NDAs) approved
in the second quarter 2016 (May-June 2016). In this quarter, FDA
approved 23 NDAs.