Project Manager Management

LILY HSIN-YU HSU

*** ****** ***, * **** P ark, CA 94025 408-***-****; ************@*****.***

* ***** ** ********** ** clinical project management, clinical software development, pharmaceutical marketing, health

SUMM ARY

economics and outcome research, healthcare fund management, and life science business development.

Thorough knowledge and understanding of global regulatory requirements, eClinical, ePRO, and mHealth software

applications, clinical data management, pharmaceutical p roduct development and commercialization, pricing and market

access strategy, and product life cycle management.

Solid strategic p lanning and problem solving skills in managing cross-functional Phase I-IV clinical studies a cross

therapeutic areas (Alzheimer's disease, cardiovascular, inflammation, liver disease, and oncology).

EXPERIENCE

11/12 -present Bracket Global, San Francisco, CA, Project Manager

Responsible for development and management of multiple global IxRS projects for pharmaceutical clients.

Develop protocol-specific system requirements, integration specifications (Medidata RAVE, CTMS, Fisher, Almac), data

transfer and data management plan, data change forms, a nd s it e training materials.

Lead the cross-functional project team of clinical trial managers, CRAs, inventory manager, clinical data managers,

biostatisticians, business system analysts, software developers and testers, and QA specialists to ensure the timely and

quality preparation of project deliverables based on approved scopes.

Manage an internal team of data analysts, project specialists and assistants, tech support specialists, developers and testers to

facilitate project tasks in a timely manner.

Provide on-going advices to project stakeholders to better manage enrollment, inventory resupply, and data reconciliation.

Strengthen customer relationship and maximize business opportunities by encompassing enhancements and new projects.

08/11- 07/12 Zoomedia Inc., San Francisco, CA, Business Development Associate

Expanded client base by analyzing client unmet needs and delivering life science communication solutions.

Responsibilities include: lead generation, account management, capabilities presentation, RFP proposal preparation,

contract negotiation, requirements review, web applications development, and project management.

Developed life science brand key messages, increased product awareness, and enhanced customer engagement with

SEO/SEM and patient-centric social media campaigns. Clients include Gilead, InterMune, Medivation, Medtronic, Pfizer,

Regeneron, and Theravance.

10/08 – 05/12 ClinSolver LLC, Cupertino, CA, Co-founder and Product Manager

Co-founded ClinSolver and developed a software-as-a-service (SaaS) clinical trial management system prototype to

facilitate cost-effective patient recruitment and successful trial completion.

Developed “Critical Flow”, “Trial Power Monitor”, and model-based risk management platform by applying health

economics modeling, statistical optimization analysis, and project management methodologies.

04/09 – 08/11 OrbiMed Advisors, San Francisco, CA, Biotechnology Associate/Executive Assistant

Supported S r . Managing D irector on daily deal work, responsibilities include: conduct due diligence on clinical data,

product pipeline, IP, and business plan; review financial model, term sheet, and cap table; manage deal log and

database; and prepare VC panel and deal presentation slides, investment memo, and quarterly portfolio summary.

02/05-01/08 Roche Pharmaceuticals, Taipei, Taiwan, Phar macoecono mics Manager, Marketing Department

Implemented heath economics and outcome research (HEOR) projects for 10 products in anemia, autoimmune diseases,

oncology, primary care, and virology, to support product pricing & reimbursement and improve market access.

Received “Award of Excellence” in 2006 and 2007.

Led phar macoecono mics taskforce to achieve project milestones in a 3-year company and business transformation

project ”Funding Assured by Scientific Tactics (FAST)”. Ranked as top 10% performer in post-project peer review.

06/04-01/05 PPC CRO, Taipei, Taiwan, Associate Project Manager

Managed Phase I-IV and BA/BE studies by collaborating with sponsors, principal investigators, study coordinators, and lab

technicians. Provided services in clinical trial design, protocol writing, IRB submission, site monitoring, patient recruitment,

data management, interim and final analysis, and study final report preparation.

SKILLS Proficient in Microsoft Word, Excel, PowerPoint, Project, Visio, and AQT.

GCP certified. In-depth knowledge of FDA regulations, clinical trial design, and IxRS, EDC, CTMS, and ePRO systems.

Outcome research and economic modeling: decision analysis, Markov modeling, and Monte-Carlo simulation.

Strong analytical skills with hands-on experience in SAS and R programming.

ADDITIONAL Publications: 13 conference abstracts and 10 health economics reports

Language: fluent in Mandarin Chinese

EDUCATION UC Berkeley Extension, December 2008, Certificate of Project Managem ent

Stanford University, June 2003, Stanford, CA

M.S. in Epidemiology, S chool of Medicine, Health Research and Policy

M.S. in Statistics

National Taiw an University, June 1999, Taipei, Taiwan

B.S. in Public Health

PUBLICATIONS

Conference Abstracts

1. Health Research Economics of Randomized Clinical Trials: Model-Based Risk Management (RCT-RM), HIMSS Conference, Las

Vegas, NV, February 20-24, 2012.

2. Health Research Economics of Patient Recruitment: Probabilistic Modeling of Multi-center Clinical Trial Recruitment for Cost

Forecasting, SoCRA Conference, San Diego, CA, September 23-24, 2011.

3. Discrete-event Simulation for Randomized Clinical Trial Recruitment Modeling and Trial Planning: A Case Study, American Academy

of Physical Medicine and Rehabilitation (AAPM&R) Meeting, Seattle, WA, November 4-7, 2010.

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4. Cost-effectiveness Analysis of Rituximab for Rheumatoid Arthritis, ISPOR 3 Asia-Pacific Conference 2009.

5. Phar macoeconomic Evaluation of Capecitabine for Advanced Gastric Cancer in Taiwan, ASCO Annual Meeting 2008, ISPOR 13th

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Annual International Meeting, and ISPOR 3 Asia-Pacific Conference 2009.

6. Cost-effectiveness Analysis of erlotinib compared with docetaxel and pemetrexed for second-line treatment of advanced NSCLC in

Taiwan. Poster PCN10, ISPOR 10th EU Congress, Dublin, Ireland, October 20-23, 2007.

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7. Cost-effectiveness Analysis of Adjuvant Trastuzumab for HER-2 Positive Early Breast Cancer in Taiwan. Poster PCN16, ISPOR 10

EU Congress, Dublin, Ireland, October 20-23, 2007.

8. Phar macoeconomic Analysis of Erlotinib as Second-line Treatment of Advanced NSCLC in Taiwan. Poster No. 6558, the ECCO 14

Conference, Barcelona, Spain, September 23-27, 2007.

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9. Cost-effectiveness Analysis of Adjuvant Trastuzumab for HER-2 Positive Early Breast Cancer in Taiwan. Oral Presentation, the 6

Biennial Meeting of the Asian Breast Cancer Society, Hong Kong, September 20-22, 2007.

10. Pharmacoeconomic Analysis of Capecitabine in Adjuvant Treatment of Stage III Colon Cancer in Taiwan. Awarded “Top 2 Scientific

Poster”, Roche Oncology Asia Forum, July 2007.

11. Pharmacoeconomic Analysis of Capecitabine in Adjuvant Treatment of Stage III Colon Cancer in Taiwan, Oral Presentation, ISPOR

th

12 Annual International Meeting, Arlington, VA, USA. May 19-23, 2007.

12. Cost-effective Analysis of 48 vs. 24-week Treatment of Peginterferon Alfa-2a plus Ribavirin for Patients with Genotype-1 CHC in

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Taiwan. Poster P-0454, the 17 APASL Conference, Kyoto, Japan, March 27-30, 2007.

13. Cost-effectiveness Analysis of Rituximab for the Treatment of DLBCL in Young Patients in Taiwan, Regional Conference on Cost-

effective Healthcare, Singapore, October 28-31, 2006.

Health Economics Reports

1. Economic Evaluation of Capecitabine/cisplati n (XP) vs. 5-FU/cisplatin (FP) Regimen in Adjuvant Treatment of Advanced Gastric

Cancer in Taiwan, December 2007.

2. Pmacoeconomic Evaluation of Rituximab for Rheumatoid Arthritis in Taiwan, November 2007.

3. Phar macoeconomic Analysis of Ceftriaxone for the Treatment of Intra-abdominal Infection in Taiwan: A Multi-center Chart Review

Study from the Hospital Perspective, September 2007.

4. Phar macoeconomic Evaluation of Adjuvant Trastuzumab for HER2- Positive Early Breast Cancer in Taiwan, June 2007.

5. Phar macoeconomic Evaluation of Erlotinib for the Second Line Treatment for Patients with Locally Advanced or Metastatic Non-Small

Cell Lung Cancer in Taiwan, December 2006.

6. Phar macoeconomic Evaluation of Capecitabine vs. 5-FU/LV as Adjuvant Treatment for Stage III Colon Cancer in Taiwan, November

2006.

7. A Phar macoeconomic Evaluation of Peginterferon Alfa-2a plus Ribavirin (PEG-2a/RBV) for the Treatment of Chronic Hepatitis C in

Taiwan, May 2006.

8. The Economic Burden of Anemia among Patients Receiving Chemotherapy in Taiwan- A Case Study for Four Prevalent Cancers (Lung,

Colorectal, Breast, and Gastric Cancer), May 2006.

9. A Pharmacoeconomic Evaluation of Rituximab for the Treatment of Diffuse Large B-cell Non-Hodgkin’s Lymphoma Patients under 60

Years of Age, January 2006.

10. Analysis of Medical Resource Utilization of the Five Most Prevalent Cancers in Taiwan (Lung, Liver, Colorectal Cancer, Gastric, and

Women Breast Cancer), May 2005.

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