iSpeak Blog

What's Next for Biopharma Manufacturing?

Robert Dream, PE, CPIP, PhD

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:

  • Hear from Global Experts
    Learn from a diverse group of leaders from Alnylam, AstraZeneca, Biogen, FDA, Genentech, Germfree Laboratories, Immunogen, Kite, M+W Group, Pharmatech Associates, and more!
  • Get Actionable Education
    Leave this event with actionable strategies from engaging education sessions. NEW this year is a 3-hour interactive workshop on lab to GMP production for cell and gene therapy.

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