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Nanotechnology offers many exciting possibilities in
target-oriented delivery of precision medicines. Life science companies are
leveraging nanotechnology to advance delivery for improved efficacy in new
therapeutics as well as optimize existing medicines. Learn about how industry
leaders are adopting this technology into their process and the benefits they
are able to achieve by doing so.
Producing Nanotechnology Based Drugs: From Lab to Production Nanotechnology promises the development of
novel diagnostics and therapeutics with enhanced and targeting abilities and
high bioavailability. Therapeutic areas include cancer drugs, nucleic acid
therapeutics, ocular drugs, vaccines, contrast agents for MRI, only to mention
a few. Although numerous formulations have been successfully tested in the lab
and several found their way to market, challenges still exist with respect to
product quality, scale up and cost-effective production.
Presented here are is an integrated
approach to nanomaterials development and production, based on the main factors
that influence the desired properties, quality characteristics and cost: (a)
chemistry/formulation, (b) hardware (processors), and (c) processes
(operational maps). Also presented, are examples from the implementation of
Nanoliposomes: The What, Why, and How Liposomes are the first drug delivery
system using nanotechnology to be commercialized for drug delivery. Discovered
in 1965, liposomes were first used as a model for biological membranes, later
as ingredients in cosmetics, and finally as a drug delivery system. The first liposomal drug product, liposomal
doxorubicin, was approved by the FDA in 1995 and only fourteen more
pharmaceutical products using liposomal technology have been approved since.
Although there has been significant research on nanoliposomes over the past
several decades, their use for delivery of bioactives is still considered to be
nascent. The broad applicability and potential advantages the technology offers
including reduced toxicity, increased stability, biocompatibility, and ability
to target delivery sites make nanoliposomes an attractive nanoformulation
strategy. Despite the benefits of nanoliposomes, many challenges in the
formulation, testing, and manufacturing remain.
This presentation is for scientists and
engineers interested in learning about the advantages and challenges of using
nanoliposomes as a drug delivery system.
Location: IPSEN, 650 E Kendall St, Cambridge MA, 02142
Mimi Panagiotou, President/CEO, Delphi
Scientific, LLC Dr. Panagiotou the President and CEO of Delphi Scientific,
LLC, a company that develops pharmaceutical nano-formulations. Additionally,
she currently serves as an expert witness in patent challenges in the Pharmaceutical
Nanotechnology space. Prior, she was the CTO of the Materials Processing Group,
IDEX Corporation. In that position, Dr. Panagiotou was responsible for the
overall direction of the technology, new product development and collaborations
with the Industry and Academia. Dr. Panagiotou holds a MS and Ph.D. in
Mechanical Engineering from Northeastern University. She co-authored over 60
papers for journals and conference proceedings, and is a co-inventor in several
patents. Further, she led the development and commercialization effort of an
award winning microreaction technology (NANO 50TM International award).
Jeff Atkinson, Head of Process Sciences, Ipsen Biosciences Dr. Jeff Atkinson started his career at Southern Research
Institute (SR) in 1996 as a researcher in controlled release of
pharmaceuticals. While at SR he gained
experience in microparticle formulation and process development, clinical
manufacturing, and project management.
In 2005 SRI spun out the controlled release group to form Brookwood
Pharmaceuticals where he continued to develop expertise in the field of
controlled release working on multiple delivery platforms such as
microparticles, liposomes, and solid lipid nanoparticles. Over the years Jeff worked in various roles
including researcher, lead scientist, production supervisor, and project
manager. About a year after Brookwood
Pharmaceuticals was formed, he left full-time employment to work on a doctorate
in chemistry. While in graduate school
he consulted for Brookwood Pharmaceuticals, SurModics Pharmaceuticals, and
Evonik – Birmingham Labs providing expertise in process development,
validation, and clinical manufacturing.
After completing his doctorate, Jeff joined Evonik in 2012 as the
Director of Parenteral Formulation Development at Evonik – Birmingham
Laboratories. In September 2017 Jeff
joined Ipsen as the Head of Process Science at the Cambridge, US site. He holds
a B.S. in Biochemistry from Brigham Young University and a Ph.D. in Chemistry
from the University of Alabama at Birmingham.
Early Bird (Ends 12/5/2019) Member: $50 Non-Member: $95 ISPE Young Professionals Member: $20 ISPE Student Members: FREE