Jeff Tremain
Lyophilization has become a necessary and effective component of drug product manufacturing across the pharmaceutical industry, driven by safety, quality, and stability. Lyophilization remains a ...
Nice Insight
TECHNOLOGY SPONSOR: Comparator Drug Sourcing Globyz, one of That's Nice's Road to 2021 sponsors, discusses how the company is envisioning the future of the pharma/biopharma industry. Globyz ...
Ratish Krishnan
Gene therapies have come a very long way since the first clinical trials back in the early 2000s. Viral vectors and adeno-associated viruses (AAVs) have been studied for over 50 years, and their ...
Mark Woolf
Understanding Cold-Chain Shipping Challenges and Comparing Solutions for Temperature-Sensitive Product Handling The number of biologic new molecular entities approved by the U.S. Food and Drug ...
Bailey Zwarycz, Ph.D
Both current in vitro and in vivo models used in the development of candidate therapies for the treatment of intestinal diseases have severe limitations. RepliGut®, an in vitro human intestinal ...
Nice Insight
The ex vivo cell and gene therapy medicine field has entered into a new era driven by the registration of the first autologous products, namely Kymriah (Novartis, 2017, U.S.), Yescarta ...
Ratish Krishnan
Gene therapies have come a very long way since the first clinical trials back in the early 2000s. Viral vectors and adeno-associated viruses (AAVs) have been studied for over 50 years, and their ...
Lisa Caralli, Matthew Rota, Jim Spavins
Approximately six out of 100 molecules make it from the discovery stage to phase III clinical trials (Figure 1). The attrition of the other 94 molecules represents a gap in early-stage ...
Ulrich Reichert, M.D.R.A.
Nitrosamines, potentially carcinogenic compounds, were first discovered at unacceptable levels in valsartan-based blood pressure medicines in June 2018. Since then, they have been found in other ...
Vikas Revankar
The timeline, complexity, and cost involved in advancing biologics from lead identification to patient delivery is tremendous. The synergy of process intensification and digital technologies ...
Liz Boazak, Ph.D.
Advanced microphysiological systems can replicate aspects of intestinal complexity, such as epithelium self-renewal by stem cells in in vitro crypts or the interactions of microbes and ...
Jeff Tremain
Lyophilization has become a necessary and effective component of drug product manufacturing across the pharmaceutical industry, driven by safety, quality, and stability. Lyophilization remains a ...
Gerhard Noessner, Ph.D.
The key to successful development of safe, efficient, and cost-effective active pharmaceutical ingredient (API) production-scale processes is the application of smart chemistry and process ...
Daniela Kovats
Contract development and manufacturing organizations (CDMOs) face the challenge of managing new active pharmaceutical ingredients (APIs) in development projects with less toxicity and ...
Mariah Baltezegar, Patrick Bennett, Panteli Theocharou, Tim Rich,
Clinical trials for cell and gene therapies present a unique set of challenges, beginning with patient identification and recruitment and continuing on through implementation and long-term ...
Ron Laethem, Ph.D.
Gastrointestinal (GI) issues are common side effects of many drugs. Anticipating such side effects before clinical trials is limited by a lack of effective models for evaluating preclinical ...
Bailey Zwarycz, Ph.D
Intestinal inflammatory diseases are highly complex, which has thus far prevented development of an effective in vitro disease model. With access to a donor-derived cell biobank and the ability ...
Our fourth quarter edition features leading insights from subject matter experts covering a range of topics, with a focus on innovations driving the future of healthcare, including solutions to the COVID-19 pandemic. In this issue, leaders from all facets of the pharmaceutical industry discuss their approach to developing and distributing COVID-19 vaccines globally, enabling innovation, facilitating decentralized clinical trials, stem cell technology, and ways to communicate and conduct marketing virtually during the pandemic.
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