1. WENDY BLANDA, MSEM, PhD wblanda@yahoo.com
158 N. B Street, Tustin, CA 92780 (949) 374-2855
DIRECTOR / MANAGER – FORMULATIONS and OUTSOURCING
Small Molecule & Polymer Chemistry / Process & Product Development / Pre-formulation / R&D / QbD/ IP
DHF/Total Lifecycle Planning / Outsourcing / Sustained Release / Risk Assessment / Project Management
A multi-disciplinary scientist, I have proven concept-to-market success with biodegradable polymer systems. My
particular expertise is in extruded or injection molded products, in-situ gelling depots, biodegradable implants,
vaginal rings, solutions and suspensions. Building top CMC teams who deliver complex products on time/within
budget, my key assets include:
• Formulating sustained release delivery systems for specialty Fortune 500 pharma firms
• Managing inter-disciplinary project teams who excel under tight timelines
• Making astute decisions despite imperfect information to effectively manage risks
• Assuring scale-up and technology transfer success in GMP environments
A multiple patent holder, I am known as a strong motivator and high energy leader/collaborator. My credentials
include a PhD in Macromolecular Science and Engineering (Physical Chemistry) from the University of Michigan,
a MS in Engineering Management from Cal State, Northridge, and a BS in Chemistry from Cal Poly, SLO.
Selected Achievements
Outsourced pre-formulation and formulation development for five pipeline projects IPM is an international
product development partnership with no in-house R&D capabilities. As the sole polymer formulation expert, RFP’s
for five pipeline projects were developed, and suppliers selected. Oversaw the formulation development of
microbicide and hormone product development, amounting to greater than one million in company funds.
Implemented a QbD Strategy for product development One particular combination product at IPM was having
drug-excipient interaction issues in pre-clinical phase development. Using polymer chemistry knowledge, drug-
drug and drug-polymer pre-formulation studies were designed for all pipeline projects. This prevented the selection
of poorly compatible excipients prior to full-scale manufacturing process development.
Championed new formulation strategy, bringing concept to project status. National Eye Institute asked
Allergan to supply GMP implants for a Phase 1 study. Having had prior experience with this particular compound,
provided data to show new formulation would be more tolerable in-vitro. Persuaded Institute to change direction
with new product, enabling patients to receive a sustained delivery formulation lasting several months vs. 2x/day.
Received patent for providing product process solution. Oculex had problems with hot melt extrusion process
for Ozurdex, a drug-device combination product. Proposed pre-processing the powder blend to gain a denser final
product. Process was adapted prior to Phase 3 testing and is now used successfully in Allergan’s Westport, Ireland
commercial facility.
Integrated technology into acquiring company. Allergan acquired Oculex, but it lacked a lab, organized team,
and sufficient knowledge of sustained release drug delivery. Worked with facilities team to set up a 2,000 sf. lab
space for Oculex technologies. Installed equipment and trained Allergen staff in fabrication/analysis techniques.
What was originally known as “the Oculex technology” at Allergan has been expanded in new, innovative ways.
Outsourced formulation of pre-clinical supplies, providing more time for Phase 1 in-house development.
Allergen project needed supplies quickly, but no open manufacturing time was available in its plant. Hired a
Contract Research Organization (CRO), communicating methodology, transferring materials and conducting on-site
training with CRO formulators. Received supplies early, saving money and enabling on time IND submission.
Career History & Highlights
Associate Director of Formulation Technologies, International Partnership for Microbicides, Silver Spring, Md,
2013-present. Served as manager of pre-formulation and formulation development activities for five pipeline
projects, ranging from pre-clinical through commercialization stage.
• Oversaw the RFP, proposal, selection, and oversight process for outsourcing of formulation
development of vaginal rings for the developing world.
• Author of drug product CMC sections of IND and eCTD

2. • Implemented design history file, design reviews, and risk assessment for drug-device combination
products (ISO14971, ISO 13485, ISO13578)
• Managed the formulation development of microbicide and hormone multipurpose technologies
(MPT’s) for HIV and pregnancy prevention in the developing world.
Senior Scientist, Allergan, Inc., Irvine, CA, 2006-2013. Served as formulator and manager in Drug Delivery
Research group. Developed sustained release product, from pre-clinical through Phase 2. Also, CMC team lead
for controlled release products including small molecule, peptide, and protein therapeutic agents. Managed and
developed junior scientists, including direct reports.
• CMC team leader for two sustained release implant project teams
• Contributor and reviewer for chemistry and manufacturing controls input for IND and NDA
• Advanced products from lab scale proof of concept stage to GLP and GMP manufacturing
• Formulated monoclonal antibodies, peptides, alpha-2 agonists, tyrosine kinase inhibitors, SiRNA’s,
NSAID’s, immunosuppressants, glucocorticoid steroids, and other compounds for intraocular
sustained release drug delivery
• Developed injectable rod, colloid, emulsion, suspension, microsphere, in-situ gelling and organic
solvent based injectables of biocompatible polymers (PLA, PLGA, POE, HA, HEC, polyelectrolytes)
• Evaluated new drug delivery technologies and vendor capabilities
• Extensive experience with viscous gels, slurry suspensions, aseptic manufacturing, terminal
sterilization, particle sizing, silicone molding, emulsion systems, semi-solids, and powder blending.
Scientist, Allergan, Inc., Irvine, CA, 2003-2006.Served as formulator and CMC team member in Formulation
Development group from pre-clinical to product launch.
• Technical expert for hot melt extrusion of injectable implants. Extensive experience with twin screw
extrusion, powder blending, milling, inspection systems, and production line automation
• Responsible for responses to FDA inquiries, SOP’s, technical reports, and manufacturing
procedures
• Represented formulations development on cross-functional teams (CMC) involving analytical
chemistry, biology, toxicology, pharmacokinetics, and pre-formulations specialists.
• Utilized physico-chemical analysis techniques (SEM, DSC, TGA, FTIR, HPLC, GPC, rheometry,
mechanical property testing, etc.) to characterize drug products in development, for trouble
shooting, and for the determination of the relationship between system characteristics and drug
release
Senior Scientist, Formulations Development, Oculex, Inc., Sunnyvale, CA, 2001-2003. Optimized Ozurex™
Phase 2B/Phase 3 process scale-up using design of experiments for startup specialty pharmaceutical firm.
Collaborated in design/build of custom extrusion systems for GMP manufacturing. Led process development and
scale-up team. Transferred formulation and manufacturing processes from Oculex to Allergan post-acquisition.
• Optimized the Posurdex (Ozurdex™) Phase 2B and Phase 3 process scale-up using design of
experiments (DOE)
• Implemented new technologies and automation in the lab and on the pilot line
• Trained pilot line personnel on drug-polymer formulation and processing methods and oversaw
GLP and GMP manufacture of novel drug delivery systems
• Performed bridging studies to demonstrate the equivalency of Phase 2, Phase 2B, and Phase 3
manufacturing processes
Engineer, Fiber Optic Products, JDS Uniphase, San Jose, CA, 2000-2001. Polymer specialist for submarine
components and high reliability research group. Performed failure analysis for fused fiber device based on polymer
performance degradation, reporting results to global customers and implementing solutions in manufacturing.
Graduate Student Instructor, University of Michigan, Ann Arbor, MI, 1995-2000. Taught general, organic, and
physical chemistry classes/lab sections to undergraduates. Tutored students individually and in small groups.
Technical Services Scientist, McWhorter Technologies, Carpentersville, Il., Summer 1995. Acted as
troubleshooter and optimizer for resin and dispersed pigment coatings formulations

3. Summer internship, Deft Inc., Irvine, CA., Summer 1994. Formulated and tested latex, epoxy, acrylic, and
polyurethane coatings for aerospace and wood coating applications.
Professional Affiliations: Association for Women in Science (AWIS), Society for Science and the Public (SSP),
Project Managers International (PMI), Controlled Release Society (CRS), Association for Research in Vision and
Ophthalmology (ARVO), International Society for Professional Engineers (ISPE), Investigative Ophthalmology &
Visual Science (IOVS)
Patents:
• #62/067,122 “Platinum-catalyzed silicone drug delivery devices and methods of use thereof“
• #10/836,904 “Controlled Release Drug Delivery Systems and Methods for Treatment of an Eye
(intraocular implant with controlled porosity/surface roughness”, 4/30/2004
• #11/116,698 “Macromolecule-Containing Sustained Release Intraocular Implants and Related
Methods (antibacterial, anti-angiogenic, anti-inflammatory, proteins, antibodies, nucleic acids)”,
4/27/2005
• #11/117,879, “Memantine Intravitreal Implants (PLGA-memantine intravitreal implant”, 4/29/2005
• #11/119,001 “Biodegradable Intravitreal Tyrosine Kinase Implants (particular TKI implant)”,
4/29/2005
• #11/118, 288 “Steroid Containing Sustained Release Intraocular Implants and Related Methods
(Steroid-containing implants with biphasic or pulsatile release profile)”, 4/29/2005
• #60/721,600, “Anti-Angiogenic Sustained Release Intraocular Implants and Related Methods
(biodegradable bevacizumab or ranibizumab intavitreal implant)”, 9/28/2005
• #11/364,687, “Anti-Angiogenic Sustained Release Intraocular Implants and Related Methods
(Macugen, Lucentis, Avastin & VEGF trap biodegradable implants)”, 2/27/2006
• #11/370,301, “Sustained Release Intraocular Drug Delivery Systems (ImClone FAB antibody
fragment, siRNAs, fibronectin biodegradable implants”, 3/8/2006
• #11/394,765 “Alpha-2 Agonist Polymeric Drug Delivery Systems (intraocular brimonidine implants
made from ester and acid end polymers)”, 3/31/2006
• #11/474,149 “Steroid Containing Sustained Release Intraocular Implants and Related Methods
(triamcinolone implant) (implant comprises auxiliary agent to reduce a steroid side effect)”,
6/23/2006
• #11/565,917, “Intraocular Drug Delivery Systems (2Me-2 microspheres; alpha 2 (brimonidine) PLA
microspheres; brimonidine PLA or polyortho ester implant; for sub-tenon insertion without
hyperemia)”, 12/1/2006
• #11/932,373 “Methods for Reducing Neovascularization or Edema”, 10/31/2007
• #11/954,602 “Dermal Filler”, 12/12/2007
• #1776091 “Ocular Implant made by a Double Extrusion Process (milling and double extrusion
method for making implant. Posurdex.)” 12/19/2007 (Granted)
• #12/026,736 “Stabilization of Mitochondrial Membranes in Ocular Diseases and Conditions
(cyclosporine DDS)” 2/6/2008 (Pending)
• #262422 “Ocular Implant made by a Double Extrusion Process Extruded Posurdex (case)”,
11/24/2008 (Granted)
• #1740186 “Biodegradable Intraocular Implants Containing Prostamides”, 6/11/2008 (Granted)
• #12/105,233 “Memantine Intravitreal Implants (Memantine Implant)”, 8/14/2008 (Pending)
• #12/173,746 “Ocular Implant made by Double Extrusion Process (hydrophobic and hydrophilic end
groups PLGA)”, 11/20/2008 (Pending)
• #11/952,938 “Intraocular Formulation (steroid containing microspheres in hyaluronic acid)
(treatment of articular/joint pathologies)”, 7/12/2007 (Pending)
• #11/859,310 “Pharmaceutical Formulations and Methods for Treating Ocular Conditions (ocular
treatment method by superior quadrant injection of drug in hyaluronic acid)”, 9/21/2007 (Pending)
• #11/954/629 “Botulinum Toxin Formulation (botulinum toxin in hyaluronic acid)”, 12/12/2007
(Pending)
• #11/954,602 “Dermal Filler (botulinum toxin in hyaluronic acid for treating wrinkles or as a dermal
filler)”, 12/12/2007 (Pending)
• #12/176,238 “Method for Treating Atrophic Age Related Macular Degeneration (Avastin in HA for
treating dry AMD)”, 7/18/2008 (Pending)

4. • #12/255,497 “Drug Delivery Systems and Methods for Treating Neovascularization”, 10/21/2008
(Pending)
• #12/369,705 “Valproic acid drug delivery systems and intraocular therapeutic uses thereof”,
2/11/2009 (Pending)
Publications:
• 2016 Journal of Controlled Release, article, “Controlling levonorgestrel binding and release in a
multi-purpose prevention technology vaginal ring device”
• 2016 International Journal of Pharmaceutics, article, “Matrix and core-type multipurpose vaginal
rings for controlled release of dapivirine and levonorgestrel”
• 2016 HIV R4P, poster, “Intravaginal Drug Delivery System With Dual Microbicide Delivery”
• 2016 HIV R4P, poster, “Formulation Development of DS003 in Ethylene Vinyl Acetate Vaginal
Rings”
• 2016 HIV R4P, poster, “Manufacture, Release Testing and Content Assay of Dapivirine and
Dapivirine and Levonorgestrel Vaginal Rings for Testing of Pharmacokinetics in Sheep”
• 2016 HIV R4P, poster, “Impact of Butyrate Prodrug on Extent of LNG Binding in Platinum-
Catalysed Silicone Elastomer Vaginal Rings”
• 2016 HIV R4P, poster, ”Development of Reservoir Vaginal Rings Containing Dapivirine or
Hormonal Contraceptive Steroids”
• 2015 CHAARM consortium, presentation, “The IPM Pipeline Projects”
• 2015 CRS, poster, “Predicting in-vitro cumulative 28-day dapivirine release from a cured disc by
modeling: A novel critical quality attribute”
• 2014 AAPS, poster, “Dapivirine Vaginal Rings: Disc Model Offers Method to Evaluate Formulation
Factors Modulating Drug Release Independent of Molding”
• 2014 HIV R4P, poster, “Selection of a Hormonal Contraceptive Agent for Inclusion with Dapivirine
in a Silicone Elastomer Vaginal Ring”
• 2014 HIV R4P, poster, “Thermal properties and eutectic behaviour of dapivirine in combination with
steroid hormones and other antiretrovirals”
• 2014 HIV R4P, poster, “Evaluation of the Factors Contributing to Levonorgestrel Binding in Addition
Cure Silicone Elastomer Vaginal Rings”
• 2014 HIV R4P, poster, “Formulation development of a combination silicone elastomer ring for
vaginal delivery of dapivirine and levonorgestrel”
• 2014 HIV R4P, presentation, “Development of Reservoir Vaginal Rings Containing Dapivirine or
Hormonal Contraceptive Steroids”
• 2012 AAPS Fall Symposium, poster, “Effect of drugs on gelling temperature and morphology of
thermosensitive triblock co-polymer gels”
• 1999 Materials Research Society symposium, presentation, “The Agreement of Poly[5,5’-(4,4’-
dinonyl-2,2’bithiazole] Spectrum Signatures to Those of Corresponding Oligomers”
• 1998 Materials Research Society symposium, presentation, “The Solid State Spectroscopy of [5,5’-
(4,4’-dinonyl-2,2’bithiazole]; From Oligomers to Polymers”
• 1999 Materials Research Society Symposium Proceedings (Solid State Ionics), publication, “Pi-
Stacking in conjugated Polymers and Oligomers: A Structural and Spectroscopic Study”
• 1998 American Chemical Society symposium, poster, “The Effect of Side Chain Group on the
Spectroscopy of Poly(bithiazole)s”
• 1997 Materials Research Society symposium, poster, “Spectroscopic Studies of the
Piezochromism of Substituted Poly(bithiazole)s”