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Catherine H. Chang, M.S.

, MPH
10519 Old Ellicott Circle
Ellicott City, MD 21042
cchangchem@hotmail.com
(818)269-7266
Qualifications:
* Extensive experience in Life Science Consulting for Big Pharma Companies Glob
al Pharmaceutical Market Access, R&D, and Commercialization Strategies.
* Extensive knowledge and experience in Drug R&D and Marketing/Commercialization
Process: Over 10 years experience in pharmaceutical/biotech industry. Familia
r with pharmaceutical market, financing, R&D(both discovery and CMC), FDA approv
al process, and intellectual property issues.
* Consulting and project management experience. Ability to plan, coordinate and
manage workflow for multi-stream long-term projects.
* Six Sigma Black Belt Certification
* Native fluency in spoken and written Mandarin Chinese and Japanese. Over 10 ye
ars of experience as freelance technical/medical translator.
* Computer: IBM/PC and Mac: Microsoft Word, Excel, PowerPoint, Project, Outlook
, and Visio.
* Data Analysis Software/Risk Management: SIMU8, ATRISK, STATA, SPSS, SAS, Tree
Age, MS Access.
Professional Experience (Pharmaceutical/Healthcare):
07/09-Present
Senior Consultant
Quintiles Baltimore, MD
* Performed market access consulting for high profile pharmaceutical companies t
o develop launch strategies for new pharmaceuticals. Conducted primary and seco
ndary studies to gain deep understanding of pricing and reimbursement issues, ma
naged projects and maintained payer relationships with clients across the globe,
especially with emerging markets.
* Participated in various projects involved in R&D strategy( both discovery and
CMC space) pharmaceutical product Development, Regulatory & Quality, and Market
Intelligence
07/07-11/08
Business Consultant
Accenture Chicago, IL
* Performed financial valuation of various ambulatory service centers and formul
ated strategic solutions for healthcare providers for executing mergers and acqu
isitions. Considered various factors in marketing competition and Healthcare Po
licy projecting into the future.
* Helped one of nations largest health insurers to modernize their claim process
ing system by implementing a Service Oriented Architecture to enable their key b
usiness offerings to member subscribers and expand market share. Participated i
n the strategic planning, preparation, and the implementation of the Complementa
ry (Medicare Supplemental Claims) System Shutdown.
* Performed functional designs and requirements gathering for a pharmacovigilanc
e business application with multi-national end-users. Engaged in writing design
documents, update MEDRA, WHO dictionaries with full consideration of build and
test environments. Ensured all compliance to the FDA and EMEA.
* General Project management - Conduct project status meetings, risks/issues, bu
ilt complex project management tools for tracking project progress in multi-phas
e project settings.
* Helped clients to build a batch scanning documentum system to archive regulato
ry and commercial records electronically. Conducted QA work to ensure its compl
iance to CFR 21 Part 11 FDA Regulation.
06/06-08/06
Summer Associate Sg2 Consulting
Skokie, IL
* Performed a market research (primary and secondary) and analysis on Quality an
d Cost of oncology based on the projected market and regulatory dynamics, and te
chnological innovations in hospitals. Evaluated Payment Models for Pay-For Perfo
rmance Initiatives.
* Compiled hospital specific data (Familiar with DRG, CPT codes) on In-patient a
nd Outpatient oncology and performed quantitative assessment on predicted Medica
re funding and reimbursements. Made strategic recommendations based on hospital
infrastructure and regulations.
* Forecasted cancer care market and suggested changes in facility, operation, le
adership, and workforce alignment that can bring most efficient practice and hig
hest quality for clients.
08/0308/05 Amgen Inc.
Thousand Oaks, CA
Associate Scientist (Drug Discovery-Medicinal Chemistry)
* Designed and performed synthesis of small molecules in search of new drugs for
treatment of diseases in various therapeutic areas. Performed multi-step synth
esis and interpreted results from bioassays relating to toxicology and drug meta
bolism, generated two patented clinical candidates.
7/01-2/03 Roche Palo Alto
Palo Alto, CA
Research Associate (Process Development)
* Designed and managed projects involving large scale synthesis of various pharm
aceutical drugs for clinical trial. Heterocyclic, carbohydrate, and prostaglandi
n chemistry.
* Made improvement in quality and economical efficiency of synthesis methods for
scaling up reactions up to 50kg in pilot plants. Made purchases, evaluated out
sourcing options, budgets. Familiar with cGMP/GLP requirements for pilot plant
procedures and proper handling of API(Active Pharmaceutical Ingredients) under S
OP. Optimized and delivered 50Kg of anti-viral drug intermediate for Phase 1 c
linical trial.
6/998/99 and 6/98-8/98 Procter & Gamble Healthcare and Pharmaceuticals
Cincinnati, OH
Summer Intern
* (Summer, 1999): Worked with the osteoporosis drug design group. Delivered 20g
of osteoporosis drug candidate (Prostaglandin analog) for in vivo studies using
a large-scale multi-step synthesis.
* (Summer, 1998): Worked for P&Gs Oral Technology Center. Developed an efficien
t experimental model and assays for screening potential enzymatic reagents for s
oftening dental calculus (tartar) for developing a teeth whitening strip to be m
arketed in Asia. Participated in new product development consumer-interest re
search.
Related Experience:
10/05-2/06 University of Michigan-School of Public Health A
nn Arbor, MI
Research Assistant
* Reviewed Promotional material (pamphlets, videos) for UMHS Nursing Recruitment
and Retention relating to nursing professional development for the Michigan Dif
ference campaign. Designed survey and interviews for focus group in finding cur
rent impediments and recommended alternative promotional tools and strategies to
increase retention and reduce cost.
* Performed extensive evaluation for the Michigan Office of Surgeon General for
its role and function, conducted interviews and surveys with key stakeholders an
d community partners. Outlined the goals of initial implementation and funding,
evaluated operation of OSG and its resources and provided evidence-based recomme
ndations. The report was submitted to the Governors office and the legislators.

Education:
April 2007 University of Michigan Ann A
rbor, MI
Master of Public Heath- Health Management and
Policy
December 2000 University of Colorado Bou
lder, CO
M.S., Organic Chemistry
Biotechnology Entrepreneurship Certification
December 1997 University of Arizona T
ucson, AZ
B.S. Cum Laude: Chemistry
Interests and Affiliations:
- Member of the ISPOR
- Member/volunteer of the Los Angles World Affairs Council
- Member of Biomedical Engineering Society at CU Boulder.
- Member of the Wind Symphony at University of Colorado, University of Arizona,
U.C. Berkeley, and Stanford University.
- Classical Music, Piano and clarinet performance,
- Music Composition, Analysis, Conducting, Orchestration.
Publications/Patents
Alexander Saipa, Mikhail A. Osipov, Kenneth W. Lanham, Catherine H. Chang, David
M. Walba, Frank Giesselmann*. The intrinsic photoferroelectric effect in the
smectic C* phase of a chiral azobenzene. J. of Mater. Chem. 2006, 26, 4170.
USPTO: 20060069110 Class: 514275000: Substituted heterocyclic compounds and m
ethods of use

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