When the human genome was fully mapped in 2003, a futuristic concept of personalized medicine materialized. Medicine based on a person’s unique genetic make-up was not just a holy grail, now it was a REAL possibility. Over the past 15 years, personalized medicine based on genetic make-up has had an imperfect track record with medications that failed to get regulatory approval, were too exorbitant in price, and/or failed to be profitable in the marketplace.
There are some shining lights of success stories though that have created a fundamentally new value proposition for the healthcare industry. Now more than ever, patients have a far more proactive role in their own healthcare and medical decisions – their own cells are becoming the basis for treatment in this new paradigm. When physicians and patients draw upon a wealth of genetic and biological data, personalized therapy will become the norm, not the relatively rare and expensive occurrence it is today.
The recent successes of safe and effective personalized medicine represent a game-changing trend for healthcare providers (hospitals and individual physicians), payors (Medicare and private insurance), and patients. It also creates exciting opportunities and new challenges for manufacturers and the regulators of these new therapies that are working together to insure their safety and efficacy.
Join us at the 2018 ISPE Biopharmaceutical Manufacturing Conference in Huntington Beach, CA, 10-12 December 2018 to participate in discussions on these disruptive technologies, new modalities changing the landscape of disease treatment, and improvement and progress in the ever expanding and life-changing arena of biologics manufacturing.
Additional conference highlights include:
The following blog post was provided by Peyton Myers, an undergraduate student at Appalachian State University. Myers attended the 2023 ISPE Annual Meeting & Expo in Las Vegas as an ISPE Foundation Professional Development Grant recipient.
The integration of data science in biopharmaceutical manufacturing, emphasizing data quality, tech transfer efficiency, and process optimization, is the heart of this track. Led by industry experts, discussions explore leveraging digital twins, predictive analytics, and continuous improvement initiatives. Additionally, interactive roundtable discussions provide attendees with a dynamic forum...
The pharmaceutical sector stands at a crossroads of immense possibilities. We are witnessing an unprecedented surge in innovation, fueled by a remarkable partnership between industry and regulatory authorities. For example, there are initiatives fostered by the US Food and Drug Administration (US FDA) to promote innovation with programs such as CATT (CBER Advanced Technologies Team) and ETP...