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The development of biotech drugs poses challenges that cross several disciplines.
The development of biotech drugs poses challenges that cross several disciplines. Deepa Deshpande, PhD, the new vice-chair of the Biotec section of the American Association of Pharmaceutical Scientists (AAPS, Arlington, VA, www.aapspharmaceutica.com) says her section is in a unique position to provide an interdisciplinary forum for scientists to exchange information related to the research, development, and commercialization of biotechnology-based products.
“The members of the AAPS Biotec Section come from diverse backgrounds in industry and academia, but share common interests in the evolving field of biotechnology,” says Deshpande, who is associate director of regulatory affairs at Acologix Inc. (Hayward, CA, www.acologix.com). “As technologies get more complex, and products get more complex, I think this intermeshing of the various disciplines-such as preclinical development, formulation development, manufacturing, regulatory sciences-is an area where the Biotec section can have a very strong contribution.”
One of the significant challenges facing the biotechnology industry, she says, is integrating new, complex technologies into the drug development process, and managing the risks involved. “With gene therapy products, for example, the challenge is getting enough drug to the cellular targets while maintaining an acceptable safety profile,” she says. “That’s why you see a lot of focus on advanced drug delivery systems.”
However, such new technologies developed to face a drug delivery challenge can lead to challenges on the manufacturing side, Deshpande notes.
“You may get very good efficacy with your formulation in clinical trials, but then are you going to be able to manufacture it at the scale you need in a commercial setting?”
Deshpande says the Biotec Section plans to support industry in addressing these challenges by continuing the organization’s core activities-scientific programming, education, providing networking and professional development opportunities, and student outreach.
“As an organization, our goal is to make sure we effectively support these programming activities, not only for the annual meeting programming but also for the National Biotechnology Conference, and other programs, such as workshops and open forums.”
Another key goal is to continue to support the existing focus groups, and also to attract and develop new focus groups to the section. The Biotec section has three focus groups: the Nucleic Acid Based Therapeutics Focus Group (www.aapspharmaceutica.com/inside/focus_groups/NucleicAcid/index.asp), the Ligand Binding Assay Bioanalytical Focus Group, (www.aapspharmaceutica.com/inside/focus_groups/Ligand/index.asp), and the Pharmacogenetics & Pharmacodynamics Focus Group (www.aapspharmaceutica.com/inside/focus_groups/PGX/index.asp). Additional new groups have been proposed on topics such as vaccines, alternate delivery, and biomarkers.
Deshpande will begin her three-year term in November of this year, as will new members of Executive Council of AAPS and leaders of the other seven sections.