iSpeak

The concept of the digital twin sounds like science fiction: a complete digital representation of your process or system, along with all the flexibility to play with simulations, creating feedback, and targeting optimizations. However, the foundation for...

Featured in this edition of ISpeak iSpeak Reading Roundup are the top blog posts from June 2019. Explore critical- industry initiatives, membership Membership highlights, and more for what the pharmaceutical industry was reading last month. The...

Bay Area leaders started to break the glass ceiling at Berkeley City Club. On the Annual International Worker's Day, May 1st, the ISPE San Francisco | Bay Area Program Committee had the pleasure of hosting its' first Women in Pharma® (WIP) event. The...

What is coming next in biopharmaceutical manufacturing? That question was addressed in plenary sessions at the 2019 ISPE Biopharmaceutical Manufacturing Conference 18-20 June in Boston on the second and third days of the conference. View more about the...

Bart Van Acker Managing Partner Quality By Design NV You’ve been with ISPE for quite some time now. Can you please give me a little information on some...

With ISPE’s new pharma best practices webinars you can learn from industry experts no matter where you are.

ISPE's professional pharma training allows for industry members to study challenges, develop solutions, and gain a better understanding of best practices and advancements in pharmaceutical science. The interactive discussions are led by subject matter...

What is coming next in biopharmaceutical manufacturing? That question was addressed in plenary sessions at the 2019 ISPE Biopharmaceutical Manufacturing Conference 18-20 June in Boston on the second and third days of the conference. View more about the...

Manufacturing biopharmaceuticals has many challenges requiring a clear understanding of every product’s goals and priorities. These challenges will only increase as more sophisticated products and therapies are developed.1 One of the recent advances in...

Solano Community College Hosts Advisory Panel to Honor First Graduating Class On 22 April 2019, more than 40 professionals and students attended the ISPE- Solano Community Advisory Panel at Solano Community College. This event was held in honor of the...

ISPE’s Accelerated Medicinal Product Working Group has examined case studies of accelerated development programs, many of which have had product approvals, to develop key considerations and themes to assist ISPE members and their companies progressing...

For me, one of the best things Women in Pharma™ (WIP) brings to our industry is the ability to learn from others and share our stories about our technical experiences, how we embrace diversity, and build long-lasting, meaningful relationships. Below are...

We need to stop just talking about risk, and get serious about actually developing effective risk management tools. The pharmaceutical industry and its regulatory agencies view risk through the very narrow lens of ICH Q9 – Quality Risk Management...

Day one of the 2019 ISPE Biopharmaceutical Manufacturing Conference started off with dynamic plenary sessions with presentations on: Advancing Tomorrow's Medicines - Overcoming the Manufacturing Challenges Today by Steve Bagshaw, CEng, FIChemE, Chief...

Conference Essentials Conference Agenda Travel Tips Registration and Information Hours Thursday, 20 June | 0700–1800 Friday, 21 June | 0700–1600 Attendee Toolbox Attendee Roster: View the full list of workshop attendees. Presentations:...

Boston, home to Fenway Park and the ever-famous Boston Red Sox, will host the 2019 ISPE Biopharmaceutical Manufacturing Conference. The city is known for its historic significance, professional sports teams, fine arts and delicious culinary options for...

Conference Essentials Conference Agenda Travel Tips Registration and Information Hours Tuesday, 18 June | 0700–1700 Wednesday, 19 June | 0700–1700 Thursday, 20 June | 0700–1200 Exhibit Hall Hours Tuesday, 18 June | 1015–1800 Wednesday, 19 June |...

Discussion: In the introductory blog, “Direct to Patient: The Basics & Quality Considerations”1 a collaborating team of direct to patient (DtP) sponsors, couriers, CROS, and QPs introduced several direct to patient models for distribution of study...