Job seekers take advantage of opportunities provided by
AAPS Career Center at the Annual Meeting and Exposition.
Over 90 companies provided more than 300 job postings for Graduate students and postdoctoral fellows participate in the AAPS
attendees at the conference. Annual Meeting and Exposition Graduate Lunch sponsored by Lilly.
difficult to pin down due to the inherently large degree of heterogeneity phenomenon – prozone effects – to undermine the integrity of
for most biomarkers – not just between subjects, but often within immuoassay data.
subjects as well. Speakers and participants shared perspectives on best On Tuesday afternoon, the AAPS Graduate Student Symposium in
practices to overcome these and other difficulties in order to obtain Biotechnology (Sponsored by Pfizer Global Biologics) honored the
clinically meaningful data. achievements of outstanding graduate students. Awards were given to
On Sunday, biotechnology scientists attended a short course, GLP- four individuals whose graduate research programs in Biotechnology-
Compliant Validation of Ligand Binding Assays: A Practical and Rational related disciplines have contributed substantially to Biopharmaceutics.
Approach. Individuals who perform assays in support of PK, PD and/or The first of these four students was Ashutosh Kulkarni (University of
toxicokinetic studies received basic training in Bioanalytical Methods Southern California), who described structure-function studies of an
Validation for macromolecules, the main focus of the course being intestinal peptide transporter using cysteine scanning mutagenesis and
immunoassay techniques (ELISA, RIA, etc). thiol-specific reagents. This work is of interest to AAPS scientists
On Sunday evening, the AAPS Research Achievement Award in because it advances efforts to capitalize on dipeptide transporters as a
Biotechnology (Sponsored by Hoffman-La Roche) was presented to platform for improving the oral bioavailability of an assortment of
Victor C. Yang, Ph.D. of The University of Michegan. In addition to drugs. The second award recipient, Zaki Megeed (University of
being recognized on Sunday evening, Dr. Yang was honored on Tuesday Maryland) described hydrogels made of polypeptides similar to silk or
afternoon at the Biotechnology (Biotec) Research Achievement Award elastin. Using intra-tumoral injection, this hydrogel system enables
Winner Roundtable. At the roundtable session Dr. Yang gave a plasma DNA or plasmids in an adenovirus carrier to undergo sustained
presentation describing his laboratory’s work on a novel prodrug delivery for up to 21 days. The third student to be recognized, Ronald
technology, “ATTEMPTS” (antibody targeted, triggered, electrically- Shikiya (University of Nebraska), discussed research on the energetics
modified prodrug-type strategy). The ATTEMPTS strategy involves a of bulges and mismatches in DNA hairpins, work that has implications
therapeutic enzyme which is modified with small cationic species in in the design of primers and antisense oligonucleotides for
order to promote binding to a negatively charged heparin-linked biotechnology applications. The fourth award recipient, Carol Stotz
antibody. The antibody blocks the activity of the enzyme drug until the (University of Kansas) described work related to deamidation, one of
target site is encountered, at which point the substrate competitively the major chemical reactions leading to degradation and inactivation of
displaces the antibody. This technology platform, which selectively peptide and protein drugs. Her presentation showed that more than
triggers the release of active enzyme drugs at their target sites, is of keen primary and secondary structural information is needed to make an
interest to biopharmaceutical scientists because it holds promise in accurate prediction of deamidation rates.
administering potent enzyme drugs without associated toxic side- On Wednesday morning, a sunrise pharmacy school session,
effects. Functional Bioassays (Potency Assays) Used as Quality Control Tests for
Monday afternoon a roundtable session, Bioequivalence of Biotechnology Products described assays used for product
Biotechnology Products provided a review of pharmaceutical characterization, formulation, product release, comparability studies
equivalence, comparability testing, and assessments of therapeutic and lot-to-lot consistency. Attendees learned about engineered cell
equivalence for biological products. Tuesday morning, a sunrise lines that model disease specific signaling pathways and the potentially
pharmacy school entitled The Pros and Cons of Different Immunoassay high mileage that can be gained from such cell lines in drug discovery,
Formats described the potential for a little known analytical target validation, and manufacturing. The participants were further
January 2004 AAPS NEWSMAGAZINE 21