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It seems every year is a year of great change in the Biopharma industry and for me, I know the conferences are where I find my grounding. I look forward to ISPE conferences both local and international because I get to catch up with dozens of networked...
iSpeak Blog
“The FDA is witnessing a surge of cell and gene therapy products entering early development, evidenced by a large upswing in the number of investigational new drug applications. Based on this activity, we anticipate that the number of product approvals...
iSpeak Blog
The promise and impact of new and rapidly evolving technology and capabilities is modernizing and transforming our global industry. Hence the theme of the 2019 ISPE Annual Meeting & Expo – Modernization, Globalization, and Transform. This theme is truly...
iSpeak Blog
The future landscape of biomanufacturing is changing at the most rapid pace in decades, so the biopharmaceutical professional of today must be prepared for what's new on the horizon in facilities and equipment, production, and process technology in order...
iSpeak Blog
In this evolving world of bioproducts and novel manufacturing approaches, consideration for the upcoming challenges in process validation requires innovation and collaboration among our collective industry leaders and our regulatory agencies. The...
iSpeak Blog
In today's pharmaceutical industry, process validation relies on information and knowledge from product development activities to ensure patient requirements are translated into product attributes. A key to success is establishing a comprehensive...
iSpeak Blog
As many recent pharmaceutical product quality problems have shown, current Good Manufacturing Practices (GMPs) as defined by regulatory guidelines and current best practices may not be “good enough” in the 21st Century. 1, 2, 3  Although, much of the...
iSpeak Blog
Featured in this edition of iSpeak Reading Roundup are the top blog posts from April 2019. See key industry topics, membership experiences, and more for what the pharmaceutical industry was reading last month. 2019 Pharma Best Practices –...
iSpeak Blog
A derivative of a trendy if not overused moniker, used by many other industries to convey a new start, a new future, and substantial change from the past. Is biopharma manufacturing really at such a juncture? The committee members organizing ISPE’s 4th...
iSpeak Blog
In pharma, as with the rest of the industries, the 4.0 concepts are not precisely new, yet the new scenario opens a brand-new perspective: everybody is involved, with new technologies, and new, pervasive information. This means increasing patient demand...
iSpeak Blog
Janette Buechler Sales & Marketing Communications Manager Pharmatech Associates What brought you to ISPE, and what are the various volunteer roles you...
iSpeak Blog
Lessons Over Coffee Mentorship is a key component in career growth that can be found in unexpected ways. Cultivating a range of mentors who offer unique lessons learned and insightful advice that can differentiate your career perspective. A year ago, I...