We are there! Novartis was the first biotech company to successfully make it through the approval process of a CAR T-cell based gene therapy. With the approval of Kymriah, pediatric and young adult patients with a form of acute lymphoblastic leukemia will have hope of being cured.
The 2017 Biopharmaceutical Manufacturing Conference brings together key international thought leaders to discuss the latest developments in the biopharmaceutical sector. Spencer Fisk, Vice President & Global Head Cell & Gene Technical Development & Manufacturing at Novartis will be featured sharing his lessons learned on Unique Aspects in Commercializing CAR T-cell Therapy. I know I am energized to see this presentation and hear about his forward-thinking approach as an early adopter in moving the needle.
The new frontier of personalized medicines is not only here, it is going to force traditional manufacturing to change their models to have a local presence for direct access to their patient population. Tim Tyson, CEO of Avara, will be speaking about how he is optimizing his CDMO organization to support the upcoming needs of our rapidly changing pharmaceutical industry.
As an industry, it is our responsibility to change with the innovation of technology and train our teams to work in a new type of manufacturing. Fifty percent of quality incidents and related problems within the pharmaceutical industry are related to human performance1. Rich Tree, Vice President at CAI will be speaking on Engineering Human Competency – A Key Factor in Operational Agility.
At the 2017 Biopharmaceutical Manufacturing Conference this December, we will have speakers talking about:
Is your company taking the risk to be a part of the strategic discussion for the future of manufacturing or are they sitting around waiting for the next guy to show him how they plan to achieve success in our new world of personalized medicines?
If you want to act now, please join me in San Francisco 4–6 December to hear leading industry speakers discuss their strategies to help create Operational Agility for Today’s Challenges.
Join ISPE and your colleagues from around the world in scenic San Francisco, California, 4 – 6 December for the 2017 Biopharmaceutical Manufacturing Conference! This year's event will expand the conversation beyond manufacturing capacity needs to address innovative operational and process development strategies to prepare you for launch readiness.
Your three-day conference experience includes:
Through the ISPE Foundation Professional Development Grant program, Silas Tamufor attended the 2023 ISPE Annual Meeting & Expo in October 2023. Tamufor is a PhD student and ISPE Boston Chapter member who began serving as the ISPE Boston Educational Programs Committee Chair in December 2023. He, along with 87 other students and recent graduates, attended the conference thanks to the...
To meet the biopharmaceutical industry’s duty to manufacture safe and effective therapies for patients, a robust quality system is fundamental to success. A quality system should link to quality culture and prioritize focusing on quality, led by management, that fosters sustainable compliance and consistent production of high-quality drugs. Strong quality culture attributes include a proactive...
Stability sampling and testing are key to ensuring that products maintain safety, identity, strength, purity, and quality throughout their claimed shelf life. It is also a regulatory requirement per ICH Q5. However, storing product samples in different environmental conditions, testing those samples for three to five years (or more) after initial manufacture, and properly analyzing and...