Geoff Schmidt
The life sciences industry is undergoing seismic change as it shifts from a product to a patient outcome orientation and embraces all forms of exciting new science -- from digital therapeutics to gene therapy. Data is more available than ever before, and companies are connecting disparate data sets and developing more personalized treatments.
David Elder, Ph.D., Dr. Ronak Savla, Dr. Pingyun Chen,
Drug development is a very risky endeavor with long cycle-times and high attrition rates. Less than 1 in 20 preclinical candidate molecules reach the market to improve the lives of patients. Phase 2 shows the highest failure rate, attributed primarily to lack of efficacy. Nearly one third of these clinical efficacy failures were “dose-limited by compound characteristics,” e.g. poor aqueous solubility.
Tony Cundell, Ph.D.
Pharmaceutical grade water is critical material for equipment cleaning, as well as ingredient water in drug products, so it deserves our attention.
Jeanne Moldenhauer
It has been reported that microorganisms live social lives. They can use coordinated chemical and physical interactions to form complex communities. These communities are very intricate systems which coordinate microbial behavior.
As part of our celebration commemorating our 20th anniversary, American Pharmaceutical Review asked members of our Editorial Advisory Board and other industry and subject matter experts to reflect on the changes they have seen over the last twenty years and to take a peek at what the industry needs to do to grow in the future.
Johannes Kiefer, Ph.D.
Raman spectroscopy is an established analytical method in the pharmaceutical industry. However, compact Raman devices for field deployment are still rare and the potential for further reducing the size of such instruments reaches a limit.
The 21st Century Care Act (CCA) offers the promise of a quicker regulatory review and lower cost for medical devices, drugs, and combination products. Within the medical device and combination product sectors the autoinjector is positioned as a major contender with the potential to expand the target patient audience for many biotech therapies.
Jonathan Gaik
The ideal active pharmaceutical ingredient (API) is one that flows well, is stable, self-lubricates, compacts well, and is not strain-rate sensitive.
Larry Wigman, Ph.D.
When I first heard the phrase “Drugging the Undruggable” my mind raced between platitudes such as: “When the going gets tough the tough get going,” “Work Smarter not Harder” and the Goldilocks-Like metaphor of “not too big and not too small – just right.”
Eric S. Langer, Ronald A. Rader
Single-use or disposable bioprocessing equipment is now used for =85% of pre-commercial scale, i.e., preclinical and clinical, biopharmaceutical manufacturing, and is increasingly being adopted for commercial products manufacturing.
Karan K. Shah
The ability of ADCs to deliver targeted chemotherapeutic drugs makes this relatively new class of biopharmaceutical drugs the subject of intense drug development activity, most notably for cancer treatment.
William Wei Lim Chin, Vijay Taladi, Ronak Savla
The comprehensive nature of drug development, combined with the demands of multiple stakeholders, requires drug developers to manage both resources and risk if they are to efficiently bring new products to market. The sequential, interdependent nature of the drug development process means that each decision can have a major impact on future development.
Anvit Vasavada, M.S., Sunny Christian, MS, Amitkumar Lad, PhD, Hemant N. Joshi, Ph.D., MBA
The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in July-August 2018.
Robert Dream
Whether you have implemented the full end-to-end Integrated Continuous Biomanufacturing (ICB), or a hybrid version of the technology, and or are considering it in one way or another, continuous bioprocessing has become a household word among biopharma companies. Continuous manufacturing has the potential to increase the efficiency, flexibility, agility and robustness of manufacturing by reducing the number of steps and holds, utilizing smaller equipment and facilities, improving product quality and enabling real-time release.
The industry is adopting modern and more innovative formulation technologies to overcome the challenges with delivery of (i) poorly soluble drugs (amorphous dispersion versus emulsions/nanoparticles) (ii) oral delivery of peptides and proteins (iii) controlled release of opioids (iv) abuse deterrent or tamper resistance formulations (v) cytotoxic drugs via liposomes or nanoparticles, (vi) taste-masking of bitter drugs amongst others.
Andrew Anderson currently leads innovation efforts as VP of Business Development at ACD/Labs. Prior to ACD/Labs, Andrew led efforts in Technology Scouting at PepsiCo – with responsibilities in Technology Assessment, Licensing, and Commercialization.
Miniaturized Raman instruments continue to improve in performance and functionality, and there is a growing desire for miniaturized instruments to become sensors that improve process control and efficiency and thus product quality.
Although conventional methods haven’t evolved tremendously over the years, we and others have made continuous improvements to these mainstays whose versatility and robustness is demonstrated by their longevity in the industry.
Over the last 20 years, adoption of Quality by Design principles has expanded, increasing the assurance of safe, effective drug supply to the consumer, and significantly improving manufacturing quality performance.
The technological evolution in manufacturing of pharmaceuticals has not evolved as rapidly as in other industries. Therefore, gains in efficiency and productivity have improved less than in those industries which needed to change.
Testing instruments have been greatly modernized over the past 20 years to keep up with technology and regulatory changes.
Over the past 20 years, the pharmaceutical industry has undoubtedly seen an influx of mergers and acquisitions, coupled with rapid growth.
Every new advancement has challenged equipment and service companies to be more creative and innovative to meet their customers’ demands.
The combination of XRD, NMR and MS with molecular dynamics enabled the pharmaceutical industry to tackle more challenging drug development.
It’s been said that armies are “prepared to fight the last war;” similar is true for the pharmaceutical industry.
Now in the digital age, we have the luxury of accessing very high quality and extremely customized product or application videos, e-literature, quality documentation, support data, or sales histories.
Compared with 20 years ago there are more complex molecules and means to deliver those treatments.