Cambridge Healthtech Institute recently interviewed Dr. Satoshi Ohtake of Pfizer about challenges in manufacturing and processing technologies Novel Drying Technologies and where the industry is headed in coming years.  Dr. Ohtake is the keynote speaker at the 12th Annual Lyophilization and Emerging Drying Technologies which is taking place on January 15-16, 2019 in San Diego, CA where he will be delivering his talk on “Overcoming Implementation Challenges of Novel Drying Technologies and Continuous Manufacture”. This conference is being organized as part of the 18^th Annual PepTalk which runs from January 14-18, 2019 in San Diego, CA.

KEYNOTE PRESENTATION

Overcoming Implementation Challenges of Novel Drying Technologies and Continuous Manufacture

Satoshi Ohtake, PhD, Senior Director, Pharmaceutical Research and Development, Biotherapeutic Pharmaceutical Sciences, Pfizer, Inc.

While the pharmaceutical industry continues to demonstrate its creativity associated with novel compounds in development, the processing technologies utilized for their manufacture have not kept their pace. This is not a reflection of the paucity of innovation associated with processing technology. The barrier can broadly be classified as economic, logistical, technical and psychological, and all elements need to be overcome for successful implementation of a new technology.

SPEAKER BIO
Satoshi Ohtake is the Senior Director of Pharmaceutical Research and Development at Pfizer, where he oversees all biotherapeutic drug product development activities. Prior to joining Pfizer, he’s held positions of increasing responsibility at Nektar Therapeutics and Aridis Pharmaceuticals specializing in the development of novel processing technologies and formulation of various modalities ranging from small molecules to live attenuated vaccines. He also serves as an executive board member of a non-profit organization, adjunct faculty member at University of Kansas, and Editorial Advisory Board member of peer-reviewed journals. He received his B.S. from Caltech and Ph.D. from University of Wisconsin Madison, both in Chemical Engineering.

Can you tell us about yourself and about your role at Pfizer?
I am the Senior Director for Pharmaceutical Research and Development at Pfizer. My group is responsible for formulation and process development of all biotherapeutic compounds in Pfizer’s diverse portfolio, including mAbs, vaccines, and gene therapy, to name a few, as well as regulatory filings and post-licensure support. Prior to joining Pfizer, I worked at a start-up biotechnology company, Aridis Pharmaceuticals, that specialized in the development of live-attenuated vaccines utilizing novel formulation and drying technologies and I started my industrial career at Nektar Therapeutics that focused on the development of inhalable pharmaceuticals. I am a Chemical Engineer by training, so I’ve enjoyed learning about the various processing technologies and utilizing the fundamentals I learned at Caltech and University of Wisconsin to better optimize the process.

What are major obstacles in your field of research?
Time, cost, and balance between short- and long-term objectives. As we are constantly faced with the challenge of delivering high quality, safe products to patients, time is always a challenge. Do we rely on our experience and leverage past learnings and existing technology to deliver as quickly as possible, or do we implement new technology? What are the benefits and costs of new technology implementation? Those need to be carefully weighted within and outside of the company.

What are the most effective ways to deal with the manufacturing and scale up issues for novel drying technologies?
Collaboration. There is a need for discussion with key stakeholders within the company, for example the commercial manufacturing group, as new technology developed in isolation will go nowhere and there is necessity to ensure that the technology will be fully GMP compliant at scale. Even if a promising technology is identified, there is a need to assess and communicate the business rationale for making the switch from the existing technology. I’ve encountered effective collaboration not only with the technology providers but also with “rival” companies, as the industry as a whole will benefit from collaborating to tackle common challenges that will be encountered by all interested parties in implementing novel technologies. Finally, engagement with regulatory agencies will gain greater importance and there certainly is interest, as evidenced by the formation of the Emerging Technology Team at the FDA.

Where is the field headed in coming years and what will revolutionize this field of research?
Continuous, flexible manufacture with enhanced analytical capabilities (i.e., sensors) supplemented by digital strategy. With advancement in medical research, we are faced with novel stabilization and manufacturing challenges. However, the push for quality, safety, and speed to market does not, and should not disappear. Development and implementation of novel processing technologies will help address these challenges, however, they need to be supplemented with appropriate analytical technologies and better utilization of data. The pharmaceutical industry generates a large quantity of data, but are they utilized to the best of our capabilities? Can we design an effective feedback loop utilizing data being generated real-time to make appropriate modifications without human intervention or off-line analyses? Progress is evident in all of these fields and now is the time to bring them all together.

Why have you chosen to speak at 12th Annual Lyophilization and Emerging Drying Technologies conference at PepTalk and what are you looking forward to at 2019 gathering?
What can audience expect from your talk?
I’ve been attending the PepTalk for many years and have had the privilege of meeting many scientists and entrepreneurs to make life-long connections. I’m looking forward to meeting old acquaintances as well as new ones so that I can leave the conference with new ideas and collaborations.

Do you have any closing remarks?
If you’re interested in contributing to the implementation of novel technologies, please come say hello as I have many ideas and would like the opportunity to network and seek opportunities to collaborate.