I didn t quite buy into the DCAT announcement regarding its departure from the Waldorf Astoria, the long-time central location for DCAT Week in New York City each spring. Call me cynical a degree in public relations can do that but I just couldn t believe checking out of the Waldorf would be as easy as it sounded. I took this cynicism directly to Margaret Timony, Executive Director of the Drug, Chemical Associated Technologies Association.
At the turn of the 21st century, a rare, Houston-based biotech, busy pursuing the development of its own drugs and IP, discovers it has a sought-after talent for viral vector manufacturing. It decides to pursue contract manufacturing. This begins a tale of how devoted leadership in the midst of significant difficulties can provide a saving grace and strengthen careers.
From the oil patches of Wyoming to biomanufacturing in southern California, this is a tale of living your career, and the essence of leadership. There s a recurring theme of including people, taking calculated risks, learning about yourself, and being damn stubborn, says David Enloe, President and CEO at Ajinomoto Althea, Inc. Maybe not quite in that order.
A few weeks away from Outsourced Pharma San Diego. we re already into provocative discussion on outsourcing of drug development and manufacturing. Everything from the role of finance managers in CMOs; pharmacists in biopharma; Car-T and personalized medicine in development; the FDA in foreign lands; and project managers in situ. Frank Sorgi, Ph.D. President and CEO of FLAG Therapeutics, Inc. leads the charge.
We re entering our era of technology. It s transferring preeminence from science to tech innovation. New players will enter; traditional biopharma will retool. Tech implementation of all hues will coalesce in the outsourcing model. Gr nenthal of Aachen, Germany, is a leader in this new paradigm. Alexander Kraus, VP Product Development, Technical and Government Affairs, Gr nenthal USA, Inc. explains how and why.
This is the first in a series of articles on Six Sigma that will introduce you to this methodical, rigorous approach to process excellence, and share the author s experiences using the technique in the pharmaceutical industry.
These are exciting times for us, the continuous manufacturing enthusiasts.
This review of recent regulatory actions related to data integrity first explores data integrity deficiencies cited in FDA warning letters issued between FY2013 and FY2015. Then, it moves to a review of the recently published FDA draft guidance on data integrity. Finally, it addresses the finalized version of the WHO guidance on the topic.
Life science companies are obsessed with collecting dumb data. We assemble it, retain it, and hoard it to support regulatory and legal requirements.
PHARMA OUTSOURCING WHITE PAPERS
Using a risk-based approach for planning the timeline and strategy for your drug s development and scale-up can help you avoid very costly delays. Yet, in the race to bring a drug to market, assessing risk can often be overlooked. Each case is going to be different; however, by creating a comprehensive plan for risk management (applying ICH Q9 as a basis), you can lower the overall level of risk from beginning to end. This not only puts you in the best possible position to avoid questions from the FDA at the time of submission but it also results in a more efficient development process and a higher-quality product.
The Consumer Packaged Goods (CPG) Industry relies on continuous product innovation to introduce successful new products and drive business growth.
PHARMA OUTSOURCING APP NOTES CASE STUDIES
Welcome to OutsourcedPharma.com, the website dedicated to pharmaceutical drug development services.
Outsourced Pharma provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and health care markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their Bio and Pharma sponsors. Outsourced Pharma is part of the Life Science Connect media group, and also a sponsor of Outsourced Pharma West conferences.
With regular sections on pharmaceutical drug development, contract manufacturing, contract research services, contract packaging services, formulation development services, contract analytical testing, API (Active Pharmaceutical Ingredients) manufacturing, stability testing services and other areas in pharmaceutical contract development and manufacturing, we bring complete coverage of outsourcing trends and issues to the pharmaceutical contract development and manufacturing marketplace.
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The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.
- Upcoming Webinar: The Implications Of Inaccurate Forecasting In Biologic Drug Substance Manufacturing And Strategies To Mitigate Risks: A Live Discussion
- CDMO Set For Live Biological Filling Boost
- PBOA Statement On Reauthorization Of The Generic Drug User Fee Amendments
- LI-COR Now Offers Contract Manufacturing For Early-Phase cGMP Materials
More Industry News
Novel therapeutics such as gene and cell therapies, nanoparticles, and combination products requiring targeted delivery, novel treatments for wound healing, cardiovascular disease, and bone regeneration, and new medical device technologies call for innovative surgical procedures in preclinical trials to determine safety and efficacy.
The technology transfer of a process, whether it is from R D to commercial manufacturing or from one manufacturing site to another, is a critical step in the life cycle of any drug product.
The paper-based lab versus the digital lab. The largest barrier to innovation for any lab is performing tasks manually and recording experiment data in paper lab notebooks. Easy-to-use digital applications can increase productivity while reducing wasted time and inefficiencies associated with searching for relevant experiment data.
The global countdown to serialization compliance is well underway. Early adopters, such as Turkey and Argentina, required serialization as early as 2010, and were followed by others such as India, China and Korea. Over the next three years, many other major markets will require adherence to their own serialization requirements, including the United States and the European Union. Expect that by 2018, serialization mandates will govern most of world s drug supply. Biopharmaceutical companies that don t comply will find it impossible to market their drugs in countries that have instituted serialization regulations.
As the principal means of assuring chemical identity and purity, instrumental analysis is the lifeblood of pharmaceutical development and manufacturing. In addition to standard instrumental methods, molecules may undergo enzymatic or cell-based assays to demonstrate some critical quality. Products often become married to analytical methods, and transferring this panel of tests during a technology transfer requires care.