Industry Insights
-
AI And Psychology In Device Development: Current Roles + What’s Next
7/30/2018
Given the level of regulation in the sector and the significant responsibility of assisting in patient care, it’s important that innovators, providers, and other parties involved have a high-level understanding of both the benefits and the limitations of AI technology.
-
Coming To America? 8 Steps For Successful U.S. Medtech Market Entry
9/14/2020
Despite viable technologies and products, many medtech companies seeking to enter the U.S. market are often unprepared or find themselves awash in decisions that they did not imagine confronting. After seeing dozens of these situations, I have compiled a list of risk mitigation factors that help contribute to market entry success.
-
Meet The Scientist — Dr. Peng Zhang
While pursuing a career as a medical doctor, Peng Zhang realized there were limited treatments for patients suffering from a variety of diseases. She made the decision to fill that void by focusing on discovering and developing therapeutics.
-
5 Major Challenges In CRO Outsourcing — And How To Overcome Them
9/27/2018
This is part 3 of a three-part article series on how best to procure, manage, and implement best practices in the complicated CRO market.
-
Samsung Bioepis CEO: A COVID-19 Call To Action
5/14/2020
There is a lot of speculation around exactly just how this pandemic will impact our own FDA timelines. But whether a drug will get approved several months later than expected is not the core issue on which we should be focused — it’s the consequences these delays or changes in our day-to-day work might have for people with severe and chronic illnesses.
-
Selecting The Right CDMO Partner – Three Keys To Success
10/25/2019
With various competing CDMOs available, selecting the right partner for your business can be difficult. Here are the three key areas to consider when selecting your drug product manufacturing partner.
-
Is Continuous Manufacturing A Good Fit For Generic Drug Products?
7/25/2019
Continuous manufacturing (CM), though well recognized by regulators and technology providers as a means to improve product quality, has seen a slow pace of adoption within the generic manufacturing sector. This article discusses the challenges and mitigation strategies for adoption of CM by generic drug product manufacturers.
-
Development And Manufacturing: Success With HPAPI
Dr. Michiya Hayakawa shares strategies for manufacturing HPAPI (highly potent active pharmaceutical ingredient) drugs and key points for promoting projects that utilize special formulation technologies.
-
Analysis Of The Non-alcoholic Steatohepatitis (NASH) Drug Pipeline & Market: The Second-Wave Candidates
12/7/2020
In Part 1 of this three-part series, we discussed NASH, the market for treatments, the first wave of NASH drugs (at Phase 3) poised to change the management paradigm, and the currently ambiguous pricing/reimbursement landscape. Here in Part 2, we look to the most promising second wave of NASH drugs.
-
Implementing Single-Use At Bioprocessing’s Core
5/20/2016
Expansions and renovations to existing biological facilities, and construction of new facilities, provide a unique opportunity to rethink basic design strategies and use new technologies to build a better facility that will improve compliance. One of the biggest drivers in the current evolution of biological facility design is the implementation of single-use systems (SUS).