Despite changing demographics in aging populations, regulatory guidance specific to drug development for geriatrics has been limited, with guidances dating back to the 1990s.
Biopharma executives have warned they need more biologics development and manufacturing capacities, particularly in North America. They haven’t been howling at the moon. Four announcements – within two days of each other – offer a sign of relief. And Amgen has provided Outsourced Pharma with its first public estimate of costs for one of those facilities.
During my visit to Thailand, I was privy, not only to the particularly innovative research goals being pursued, but also to a number of challenges the country has recognized and hopes to address within the next few years to encourage a stronger, more diverse industry.
A few weeks ago, I was invited by the Thailand Board of Investment to attend a media trip to learn about the country’s budding life sciences industry. Entering Thailand, a country in which the government is pushing more investment and education in the sciences, was even more striking and meaningful to me given the current scientific climate in the U.S.
In the spirit of this list-making season, I compiled what I thought were the five most important biosimilar-related triumphs in the past year. Many of these events were widely covered by the media and will play an influential role in how the biosimilar industry unfolds through 2017 and beyond.
Pfizer's Bernie Huyghe and ADC Therapeutics' Michael Mulkerrin get bushwhacked with this question in a public forum. Their open replies will help each one of you to your own personal assessment. Be prepared for some soul searching.
Despite changing demographics in aging populations, regulatory guidance specific to drug development for geriatrics has been limited, with guidances dating back to the 1990s.
This is the second of two articles focusing on the issues that pharma companies face when moving into the digital health space. In the first installment, the development process, agency guidance, and the type of quality oversight needed for software incorporated into medical device and combination products were explored. This part focuses on the importance of cybersecurity and software maintenance, how time scales and methods of execution differ from those in traditional pharma, how agile software development works, and how to avoid potential pitfalls.
Data integrity is of paramount importance to ensure patient health and safety and to improve shareholder value, particularly for virtual companies. Startups finding themselves in the throes of managing complex drug development programs realize they may face great risk if they do not begin with the end in mind and integrate data integrity practices early on.
This article, written by members of the BioPhorum Operations Group (BPOG) Continued Process Verification (CPV) Informatics team, summarizes their collective experience in validating the informatics components of their CPV programs, to shed light on common issues and provide recommendations and best practices.
According to trade groups, approximately 45 million packs of medicines leave the U.K. for Europe every month, and 37 million go in the opposite direction. In a year, that’s almost 1 billion packs of medicines. What those borders would look like after a Brexit deal would significantly impact major industries in the U.K. and EU economies.
Follow the paths of two companies as they learn how a science-led, risk-based development approach yields a more successful outcome in the long run.
The pharmaceutical industry will continue to witness major changes and challenges. Considering global economic uncertainties, increasing healthcare costs and expiring patents, the industry appears to be in a state of turmoil. At the same time, markets are diversifying and new fields of growth are opening up. Rapid development of the emerging markets, progress in drug research, the rise in generics production, the availability of high-potency drugs and innovations in manufacturing processes will sustainably modify the global pharmaceutical landscape.
Options to consider when researching dust containment systems to keep hazardous dust out of the environment.
When selecting a bioreactor, It is important that this core technology is carefully chosen, specified, designed, and supported, both now and in the future.
Materials science is now helping pharmaceutical companies to standardize and control areas such as drug form and manufacture to deliver new products more quickly and with greater quality.
Potent active pharma ingredients require ultra careful handling and containment. ChargePoint highlights the challenges and how they were effectively and safely dealt with for contract developer and manufacturer Fermion at Espoo.
Should a sponsor companies seek the traditional route of utilizing multiple partners across the supply chain or does an integrated CDMO offer a more efficient and faster path to commercialization?
