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J Pharmacol Ther Res 2017 Volume 1 Issue 2
allied
academies
November 02-03, 2017 Chicago, USA
4
th
International Congress on
International Conference and Exhibition on
Drug Discovery, Designing and Development
Biochemistry, Molecular Biology: R&D
&
T
he discovery and development of new drugs is a very
complex machine. Despite increasing investments and
process improvements in research and development, the
survival rates of drugs in late phases of development has
languished during the past decade. Recent analysis of such
decline in late phase drug development was attributed to non-
drug like compounds synthesized by Medicinal Chemists which
exhibit low aqueous solubility with highly potent ligands which
will bind to a target. With the current challenges facing “big
Pharma”, small biotech start-up (BSU’s) with limited internal
research and development resources in addition to true virtual
pharmaceutical companies (VPC’s) with only an experienced
team of managers without any R&D capabilities are quickly
emerging which adds another layer of complexity in arriving to
a “just right” approach from drug discovery to development. To
recover from such failed approaches, a gate-keeper approach is
now the norm, where preclinical and discovery collaborations
result in a structure and property-based design. This design now
used in lead optimization combines biological activity/potency
focus with optimizing structural features of the candidate to
optimize absorption and pharmacokinetics. This approach is
then effectively progressed to the understanding and defining
of solid state phase and formulation of the drug candidate
when more material is available. Early engagement of the
pharmaceutical development scientists on the identification of
anoptimal phaseand formulationduringdrugdiscovery canadd
significant benefits in drug discovery efforts and downstream
development. These benefits include the demonstration of
dose limiting toxicity to establish acceptable and reproducible
safety margins. Another benefit is the early identification of an
optimal phase that minimize multiple changes in phase that
can contribute to irreproducible plasma levels in various PK
studies as candidate are being considered in toxicity studies.
Furthermore, formulation development in preclinical studies
will also provide some risk mitigation in the development of
clinical trial materials. The current presentation will focus on
the “must do” list to successfully help progress drug discovery
candidates from any pharma organization to development with
low risk that provide a balance of speed and quality.
Speaker Biography
Elizabeth Kwong retired fromMerck after 23 years of service. She currently established
her own company (Kwong Eureka Solutions) as a consultant for small start-up
companies and specialty drug products. Before she retired she was Senior Scientific
Director at Merck & Co. Basic Pharmaceutical Sciences. She was also adjunct professor
in the Dept of Pharmaceutics at the University of Montreal and Dept of Chemistry
at Concordia University. She received her B.S. Pharmacy (1980) and PhD degree
(Pharmaceutical Chemistry -1984) from University of British Columbia, Canada. She
completed a postdoctoral fellowship in Pharmaceutics at the School of Pharmacy,
University of Washington in Seattle (1984-1986).
e:
ec_kwong@videotron.caElizabeth Kwong
Kwong Eureka Solutions, Canada
Just right: Process from drug discovery to development