- William W. van Osdol has over 15 years of experience leading teams in controlled drug delivery, including developing injectable depots, transdermal patches, and oral formulations. - He has expertise in mathematical modeling of drug transport and computational simulation to optimize formulations. - His background includes positions at DURECT Corporation, ALZA Corporation, Hybritech, Inc., and the National Cancer Institute.

1. William W. van Osdol
Mountain View, CA 94040, (650) 207-8752
bill.vanosdol@gmail.com
SUMMARY
 Scientist / engineer with 15+ years of experience in controlled release drug delivery
 Team leader adept in the design, evaluation and optimization of injectable, transdermal and oral
controlled release formulations, and in their ADME-PK analysis and computational simulation
 Extensive background in mathematical modeling and computational simulation of physiological
mass transport, and in exploratory data analysis
 Background in biological applications of calorimetry, and in the design and implementation of
novel calorimetric techniques
 Trained as a biophysicist and applied mathematician
PROFESSIONAL EXPERIENCE
DURECT Corporation, Cupertino, CA 2006 – March, 2016
Principal Scientist
Led a small team developing injectable depots for the controlled delivery of small molecules, peptides,
proteins and oligonucleotides over durations of days to months: Developed a new platform (CLOUDTM
),
based on novel proprietary excipients, specifically for compounds with good aqueous solubility; achieved
target nonclinical delivery and efficacy for GLP-1 analogues, a protein hormone, and a hypo-methylating
anti-leukemic
Supported development of SABERTM
depot risperidone (ReldayTM
): Contributed to formulation
optimization through analysis and interpretation of PK/PD data from nonclinical and clinical studies. This
program has completed Phase 1 clinical testing
Supported development of an abuse-deterrent, oral controlled release formulation of methylphenidate:
Helped to define target human plasma profiles, and guided formulation optimization by defining in vitro
release profiles from target plasma profiles via in vitro - in vivo correlation. This program is in Phase 3
clinical trials in Taiwan
Contributed to depot technology business development: Helped to attract a dozen client-funded feasibility
programs by giving technical presentations and serving as a technical liaison; led several client-funded
technical feasibility projects; identified compounds for internal development as controlled release injectable
depots
Developed mathematical models of drug delivery from injectable depot, implantable and transdermal
dosage forms, and applied them to guide formulation optimization
ALZA Corporation, Mountain View, CA 1994 - 2006
Research Scientist
Identified candidates for controlled release oral delivery: Developed prospective ADME/PK computational
models for new chemical entities, to predict and compare the performance of immediate release and
controlled release oral formulations

2. William W. van Osdol Page Two
ALZA Corporation (cont)
Collaborated with Transform Pharmaceuticals to develop a high throughput screen of transdermal
formulations; the platform greatly expanded ALZA’s capacity to explore and optimize transdermal dosage
forms, and supported development of a transdermal patch for treatment of Alzheimer’s disease
Contributed to the development of an adhesive matrix transdermal fentanyl patch, and a gel-reservoir, rate-
controlled fentanyl patch for pediatric use
Assessed the feasibility of transdermal delivery of new chemical entities. Designed formulations and
experiments; analyzed / interpreted experimental results; wrote technical reports; liaised with clients. These
activities generated several patent applications
Facilitated product design by developing computational models of percutaneous transport (in collaboration
with Prof. Peter Pinsky, Department of Mechanical Engineering, Stanford University)
Developed fracture mechanics test methods for the adhesion of transdermal patches in vivo. Identified
important functional differences between classes of adhesives (in collaboration with Prof. Reiner
Dauskardt, Department of Materials Science and Engineering, Stanford University)
Conducted experimental studies of chemical enhancement of transdermal permeability, and from the data,
developed statistical models to predict the potency of candidate permeation enhancers. This work resulted
in proposals for a couple of new permeation enhancers
Hybritech, Inc., San Diego, CA 1993 - 1994
Staff Scientist
Developed and applied computational tools to predict the PK/PD performance of novel, antibody-based
strategies to target radionuclides to solid tumors for diagnosis and therapy
National Cancer Institute, Bethesda, MD 1990 - 1993
Senior Staff Fellow
Developed statistical analyses of in vitro screening data to elucidate the mechanisms of action of novel
cancer chemotherapeutic agents: Part of a broad program to understand the role of tumor genetics in cancer
chemotherapy, this work is presented in several publications
Developed and applied reaction-diffusion-convection models to evaluate and compare antibody-based
strategies for diagnostic and therapeutic targeting of radionuclides and toxins to solid tumors; this work has
contributed to the development of clinical protocols
EDUCATION
Ph.D., Biophysics, University of Virginia
Master of Science, Applied Mathematics, University of Virginia
Bachelor of Science, Mathematics, Yale University

3. William W. van Osdol Page Three
CONTINUING EDUCATION
Systems Biology, Coursera 2014
Polymer Short Course, Golden Gate Polymer Forum 2012
Rheology Short Course, Golden Gate Polymer Forum 2011
Advanced GastroPlusTM
Simulation and Modeling Workshop, Simulations Plus, Inc 2010
Pharmacokinetics for Pharmaceutical Scientists, School of Pharmacy, UC San Francisco 2005
C Language Programming I & II, UC Santa Cruz Extension 2003
PERL Programming, UC Santa Cruz Extension 2003
Certificate in Bioinformatics, UC Santa Cruz Extension 2002
Digital Signal Processing I & II, UC Berkeley Extension 1998
PROFESSIONAL AFFILIATIONS
The Biophysical Society
American Association of Pharmaceutical Scientists
PATENTS
PCT application 2014/069156: Sekar, M., Yum, S-I., Theeuwes, F., van Osdol, W.W., Branham, K., Moro,
W., Tipton, J., Matriano, J., and Gibson, J. (December 8, 2014). Complex Comprising Active Agent and
Functionalized Polymer.
US patent application 61/563,469: Sekar, M., Yum, S-I., Theeuwes, F., and van Osdol, W.W. (November
24, 2012). Radiation Sterilized Drug Delivery Composition.
US patent application 13/304,174: van Osdol, W.W, Theeuwes, F., Sekar, M. and Yum, S-I (November 24,
2011). Biodegradable Drug Delivery Composition.
US patent application 20100260844: Scicinski, J.J., van Osdol, W.W., Su, H-C., Arenberg, M.H. and Shah,
J (October 14, 2010). Oral pharmaceutical dosage forms.
US patent 6699497: van Osdol, W.W., Crisologo, N.M. and Yum, S-I (March 3, 2004). Formulations for
the transdermal administration of fenoldopam.
US patent application 20030198662: van Osdol, W.W., Gale, R.M., Brandwein, D.H., Padmanabhan, R.
and Sunram, J. (October 23, 2003). Transdermal administration of N-(2,5-disubstituted phenyl)-N'-(3-
substituted phenyl)-N'-methyl guanidines.
US patent application 20030026829: Venkatraman, S.S., Li, S., Gale, R.M., Stepic, J. and van Osdol, W.W.
(February 6, 2003). Transdermal administration of fentanyl and analogs thereof.
US patent application 20010051181: van Osdol, W.W. and Watanabe, T. (December 13, 2001). Novel
formulations for the transdermal administration of asimadoline.

4. William W. van Osdol Page Four
PUBLICATIONS
Articles
Rim, J.E., Pinsky, P.M. and van Osdol, W.W. (2009). Multiscale modeling framework of transdermal drug
delivery. Annals of Biomed. Eng. 37(6), 1217-29.
Rim, J.E., Pinsky, P.M. and van Osdol, W.W. (2008). Using the method of homogenization to calculate the
effective diffusivity of the stratum corneum with permeable corneocytes. J Biomech. 41, 788-96.
Rim, J.E., Pinsky, P.M. and van Osdol, W.W. (2007). Using the method of homogenization to calculate the
effective diffusivity of the stratum corneum. J Membrane Sci 293, 174-182.
Eichenbaum, G., Pollock-Dove, C., Nguyen, J., Li, S., Evans, J., Borghys, H., Kennis, L., Dong, L.,
van Osdol, W., Dai, W., Scicinski, J., Chen, J., Xu, Y., Ashton, D., Mackie, C. and Megens, A. (2006).
Preclinical feasibility assessment of the controlled release oral delivery of compounds in a lead series of
atypical antipsychotics. J. Pharm. Sci. 95, 883-895.
Wu, K.S., van Osdol, W.W. and Dauskardt, R.H. (2006) Mechanical properties of human stratum corneum:
effects of temperature, hydration and chemical treatment. Biomaterials 27, 785-795.
Rim, J.E., Pinsky, P.M. and van Osdol, W.W. (2005). Finite element modeling of coupled diffusion with
partitioning in transdermal drug delivery. Annals of Biomed. Eng. 33, 1422-1438.
Banerjee, R.K., Sung, C., Bungay, P.M., Dedrick, R.L. and van Osdol, W.W. (2002). Antibody penetration
into a spherical prevascular tumor embedded in normal tissue. Annals of Biomed. Eng. 30, 828-839.
Praxmarer, M., Sung, C., Bungay, P.M. and van Osdol, W.W. (2001). Computational models of tumor
imaging and treatment protocols. Annals of Biomed. Eng. 29, 340-358.
Weinstein, J.N., Myers, T.G., Kohn, K.W., ..., van Osdol, W.W., ..., and Paull, K.D. (1997). An
information-intensive approach to the molecular pharmacology of cancer. Science 275, 343-349.
Sung, C. and van Osdol, W.W. (1995). Pharmacokinetic comparison of one- and two-step, antibody-based
tumor-targeting protocols. Journal of Nuclear Medicine 36, 867-876.
van Osdol, W.W., Myers, T.G., Paull, K.D., Kohn, K.W. and Weinstein, J.N. (1994). Use of the kohonen
self-organizing map to study the mechanisms of action of chemotherapeutic agents. Jour. Natl. Canc. Inst.
86, 1853-1859.
Sung, C., van Osdol, W.W., Saga, T., Neumann, R.D., Dedrick, R.L. and Weinstein, J.N. (1994).
Streptavidin distribution in metastatic tumors pretargeted with a biotinylated monoclonal antibody:
theoretical and experimental pharmacokinetics. Cancer Research 54, 2166-2175.
van Osdol, W.W., Sung, C., Dedrick, R.L. and Weinstein, J.N. (1993). A distributed pharmacokinetic
model of two-step imaging and treatment protocols using streptavidin-conjugated monoclonal antibodies
and radiolabeled biotin. Journal of Nuclear Medicine 34, 1552-1564.
van Osdol, W.W., Ye, Q., Johnson, M.L. and Biltonen, R.L. (1992). Effects of the anesthetic dibucaine on
the kinetics of the gel-liquid crystalline transition of dipalmitoyl phosphorylcholine multilamellar vesicles.
Biophysical Journal 63, 1011-1017.

5. William W. van Osdol Page Five
Articles (cont)
Juweid, M., Neuman, R., Paik, C., Perez-Bacete, M.J., Sato, J., van Osdol, W.W. and Weinstein, J.N.
(1992). Microdistribution of monoclonal antibodies in solid tumors: effect of the binding sites barrier.
Cancer Research 52, 5144-5153.
Weinstein, J.N. and van Osdol, W.W. (1992). The macroscopic and microscopic pharmacology of
monoclonal antibodies. Intl. Jour. of Immunopharm. 14, 457-463.
Ye, Q., van Osdol, W.W. and Biltonen, R.L. (1991). The gel-liquid crystalline transition of some
multilamellar lipid bilayers follows classical kinetics with a fractional dimensionality of approximately
two. Biophysical Journal 60, 1001-1006.
van Osdol, W.W., Fujimori, K. and Weinstein, J.N. (1991). An analysis of monoclonal antibody
distribution in microscopic tumor nodules: consequences of a "binding site barrier". Cancer Research 51,
4776-4784.
van Osdol, W.W., Johnson, M.L., Ye, Q. and Biltonen, R.L. (1991). Relaxation dynamics of the gel-liquid
crystalline transition of phosphorylcholine bilayers. Biophysical Journal 59, 775-785.
van Osdol, W.W., Mayorga, O.L. and Freire, E. (1991). Multifrequency calorimetry of the folding-
unfolding transition of cytochrome c. Biophysical Journal 59, 48-54.
van Osdol, W.W., Biltonen, R.L. and Johnson, M.L. (1989). Measurement of membrane phase transition
kinetics. Bioch. and Biophys. Res. Meth. 20, 1-46.
Mayorga, O.L., van Osdol, W.W., Lacomba, J.L. and Freire, E. (1988). Frequency spectrum of enthalpy
fluctuations associated with macromolecular transitions. Proc. Natl. Acad. Sci. USA. 85, 9514-9518.
Book Chapters
Wright, J.C., Sekar, M., van Osdol, W.W., Su, H-C. and Miksztal, A.R. (2012). In situ forming systems
(depots). In Long Acting Injections and Implants, (J.C. Wright and D.J. Burgess, Eds.) Springer, Inc., New
York, NY, 153-166.
Phipps, J.B., Cormier, M., Gale, R.M., van Osdol, W.W., Padmanabhan, R. and Dadonna, P. (2004).
Transdermal drug delivery. In Encyclopedia of Biomaterials and Biomedical Engineering, Marcel Dekker,
Inc., New York, NY, 1677-1689.
Padmanabhan, R., Gale, R.M., Phipps, J.B., van Osdol, W.W., and Young, W. (2002). D-TRANS
technology. In Modified Drug Delivery Technology (M.J. Rathbone, J. Hadgraft and M.S. Roberts, Eds.)
Marcel Dekker, Inc., New York, NY, 481-497.
van Osdol, W.W., Myers, T.G. and Weinstein, J.N. (2000). Neural network techniques for the informatics
of cancer chemotherapeutics. In Methods in Enzymology, Vol. 321, (M.L Johnson and L. Brandt, Eds.)
Academic Press, San Diego, CA, 369-395.
Freire, E., van Osdol, W.W., Mayorga, O.L. and Sanchez-Ruiz, J.M. (1990). Calorimetrically determined
dynamics of complex unfolding transitions in proteins. In Annual Reviews of Biophysics & Biophysical
Chemistry, Vol. 19, (D.M. Engelman, C.R. Cantor and T.D. Pollard, Eds) Annual Reviews, Inc., Palo Alto,
CA, 159-188.

6. William W. van Osdol Page Six
Book Chapters (cont.)
Johnson, M.L., van Osdol, W.W. and Biltonen, R.L. (1986). Measurement of the kinetics of lipid phase
transitions: a volume perturbation kinetic calorimeter. In Methods in Enzymology, Vol. 130, (C.H.W. Hirs
and S.N. Timasheff, Eds.) Academic Press, Orlando, 534-551.
Proceedings
Wu, K.S., van Osdol, W.W. and Dauskardt, R.H. (2002). Mechanical and microstructural properties of
stratum corneum. In Biological and Biomimetic Materials - Properties to Function, (J. McKittrick, J.
Aizenberg, C. Orme, and P. Vekilov, eds.). Materials Res. Soc. Proc., 724, N.2.7.1-N.2.7.7.
Banerjee, R.K., van Osdol, W.W., Bungay, P., Dedrick, R.L. and Sung, C. (2001). Finite element model of
antibody penetration in a pre-vascular tumor nodule embedded in normal tissue. Jour. Contr. Release,
74(1-3), 193-202.
van Osdol, W.W., Myers, T.G., Paull, K.D., Kohn, K.W. and Weinstein, J.N. (1995). The kohonen self-
organizing map applied to in vitro screening data for chemotherapeutic agents. Proceedings of the World
Congress on Neural Networks, vol. 2, INNS Press, 762-766.
Weinstein, J.N. and van Osdol, W.W (1992). Early intervention in cancer using biological ligands:
micropharmacology and the "binding site barrier". Cancer Research 52, 2747s-2751s.
Selected Abstracts
Sekar, M., van Osdol W.W., Yum, S.I., Theeuwes, F., Branham, K., Moro, W.B. and Gibson, J. (2015).
Controlled delivery depots of liraglutide, a GLP-1 analogue, via subcutaneous injection. IBC 17th
Annual
TIDES Conference, San Diego, CA, May 3-6.
Sekar, M., van Osdol W.W., Yum, S.I., Theeuwes, F., Branham, K., Moro, W.B. and Gibson, J. (2015).
Drug delivery of biologics: a controlled release strategy. IBC 17th
Annual TIDES Conference, San Diego,
CA, May 3-6.
Sekar, M., van Osdol W.W., Yum, S.I. and Theeuwes, F. (2012). Continuous delivery of interferon 2a via
subcutaneous depots. American Association of Pharmaceutical Scientists (AAPS) Annual Meeting,
Chicago, IL, October 14-18.
Sekar, M., Okumu, F., van Osdol, W., Tamraz, W., Tung, D. and Sverdrup, F. (2009). SABERTM
formulations for intra-articular delivery of rhGH. AAPS National Biotech Conference, Seattle, WA, June
21-25.
Eichenbaum, G.M., Nguyen, V.A. and van Osdol, W.W. (2005). Computational evaluation of controlled
release oral delivery for some atypical antipsychotics. 32nd
Annual Meeting and Exposition of the
Controlled Release Society, Miami Beach, FL, June 18-23.
Rim, J.E., Pinsky, P.M. and van Osdol, W.W. (2005). A molecular dynamics study of the diffusion of
fentanyl in dppc bilayers. Annual Meeting of the Biophysical Society, Long Beach, CA, February 12-16.

7. William W. van Osdol Page Seven
Selected Abstracts (cont.)
Rim, J.E., van Osdol, W.W. and Pinsky, P.M. (2003). Computational models of transdermal drug delivery.
30th
Annual Meeting and Exposition of the Controlled Release Society, Glasgow, Scotland, July 20-24.
Wu, K.S., van Osdol, W.W. and Dauskardt, R.H. (2003). Mechanical and delamination behavior of soft
tissues: stratum corneum and other soft tissues. Materials Res. Soc. Spring Meeting, San Francisco, CA,
April 21-25.
Sung C., van Osdol, W.W., Banerjee, R.K., Bungay, P.M. and Dedrick, R.L. (2001). Models for antibody-
based detection and treatment of avascular tumor nodules. AAPS Annual Meeting, Denver, CO, October 21-
25.
Jagota, A., Masso, M. and van Osdol, W.W (2000). Characterizing gene expression by condition.
Conference on the Critical Assessment of Techniques for Microarray Data Mining, Duke University,
Raleigh, NC, December 18-19.
van Osdol, W.W. and Fieldson, G.T. (2000). Neural network prediction of chemical enhancement of
transdermal drug flux in vitro. 27th
International Symposium on the Controlled Release of Bioactive
Materials, Paris, France, July 7-13.
van Osdol, W.W. and Fieldson, G.T. (1999). Neural network models of transdermal permeation
enhancement. Gordon Res. Conf. on the Barrier Function of Mammalian Skin, Barga, Italy, April 18-23.
Banerjee, R.K., Dilber, I., Praxmarer, M., Bungay, P., van Osdol, W.W. and Sung C. (1998). Numerical
simulation of antibody penetration in a solid tumor nodule using finite element methods. International
Mechanical Engineering Congress, Anaheim, CA, November 15-20.
Sung, C. and van Osdol, W.W. (1996). Transport of tumor-targeted ribonucleases. Annual Meeting of the
Biomedical Engineering Society, State College, PA, October 14-17.
Sung, C. and van Osdol, W.W. (1995). Effects of molecular weight and intracellular processing on tumor
penetration of immunotoxins. Fourth International Symposium on Immunotoxins, Myrtle Beach, SC, June
8-11.
Sung, C., van Osdol, W.W., Dedrick, R.L. and Weinstein, J.N. (1994). Application of the streptavidin-
biotin system in two-step antibody-based tumor targeting protocols. Annual Meeting of the American Inst.
of Chem. Eng., San Francisco, CA, November 13-18.
Sung, C., van Osdol, W.W., Dedrick, R.L. and Weinstein, J.N. (1993). Two-step targeting of antibodies to
tumors: theoretical and experimental studies. Annual Meeting of the Biomedical Engineering Society,
Memphis, TN, October 23-26.
van Osdol, W.W., Ye, Q., Johnson, M.L. and Biltonen, R.L. (1993). Effects of the anesthetic dibucaine on
the kinetics of the gel-liquid crystalline transition of DPPC multilamellar vesicles. Biophysical Journal
64,2, 70A.
Weinstein, J.N., Juweid, M., van Osdol, W.W., Sato, J., Saga, T., Heya, T. and Neumann, R. (1992).
Monoclonal antibody distribution in tumors: theoretical and experimental validation of the "binding site
barrier" hypothesis. Meeting of the American Assoc. for Canc. Res., San Diego, May 20-23.