Mohammed R. Khan
In the beginning was the manufacturing—and it reigned supreme. Pharmaceutical companies manufactured what they could and when
they could, all at their own pace, and then passed on the finished products to sales for conversion into cash.
C. Ray Goff, Jr.
What if you owned a beat-up, noisy car that was in need of alignment, had issues with timing, or had leaking motor oil? You would fix it and bring it up to a reliable, smooth-running, well-oiled machine. What if you owned a musical instrument, like a piano, that
had keys that stick, was slow to respond, and had a tone that was off key? You would fix it and bring it to produce rich tones right on pitch. Once fixed, the instrument could reach its normal potential. The fine tuning starts once the normal operation is achieved and moves to the next level.
Dennis Jenke, Ph.D., Vishal J. Barge, Ph.D.
Containers (also known as bags) are used to store final drug products, active pharmaceutical ingredients (APIs), and starting reagents and process intermediates used during the manufacturing of either the drug product itself or ingredients in that drug product.
Laszlo Otvos, Ph.D.
With central research and development funding at an all-time low in the United States [1], early biotech investors tend to target low investment projects with the expectation of a 30× return from their few successful ventures.
Kate Hammeke
Pharmaceutical companies will continue to struggle to sustain profitability as more drugs reach the end of their patent life. In 2013, 120 companies had patents expire on drugs that accounted for approximately $29B in annual sales—a figure that was double the
predicted revenue loss. As a result, many biopharmaceutical companies are implementing strategies to boost revenue and profit margins while
reducing fixed and variable costs. These strategies include increasing merger and acquisition activity as well as greater efforts to in-license therapeutics developed by smaller firms. The tactics of the past decade remain in play in terms of staff reductions and a strong emphasis on outsourcing. The goal of all efforts is to contain the ever-increasing
costs associated with drug development and to sustain profitability by streamlining the cost of clinical trials—in part by looking to emerging market CROs.
Derek Hennecke
As CEO of a Contract Development and Manufacturing Organization (CDMO), I make it my business to know what my clients like and don’t like about CDMOs. So it was with great interest that I
read a 2013 survey by Avoca which said that the most common complaint by sponsors of their
outsourcing partners was that they were under-resourced and the staffs lacked adequate training,
experience and qualifications.
Historically, new active ingredients were targeted to oral tablets or vialed small volume parenterals. Additional delivery routes were typically investigated for life-cycle management. This approach was
well-suited to development of active ingredients selected by rapid animal model screening for efficacy against a range of diseases.
Daniel J. Littlefield
Modality Solutions is an engineering services company that integrates cold chain management systems to ensure regulatory compliance, product
quality, and patient safety.