Medical Device Manufacturing Manager and Regulatory Affairs Lead

Sandra Forrer ******.******@*****.*** Page *

Sandra Forrer

408-***-**** ******.******@*****.*** linkedin.com/in/sandraforrer SUMMARY

Medical Device Manufacturing and Regulatory Affairs with extensive experience in biochemistry and assay design and implementation in both low and high throughput platforms for IVD. Experimental design included statistical analysis of development and implementation phases of the assay. Goal and deadline focused, adept at process management and streamlining data processing and reporting. Completed Medical Device regulation certification with UCSC extension, additionally pursuing a certification in Regulatory Affairs with a concentration in Medical Device Regulations.

-GLP/GMP

-510K submission -

SOP & regulatory

documentation writing

-Validation/Verification

- Data Analysis/Reporting

- Process Management

- Protein expression

PROFESSIONAL EXPERIENCE

-Tissue Culture

-Biochemistry/Enzymology

- Multiplex assays (Luminex, MSD,

Panomics)

NeVap, Inc. San Jose, CA 2014 – current

Consultant – Device design and Regulatory Compliance Setting up the initial quality systems for regulatory compliance with 21CFR part 820 and ISO 13485. Writing basic RA documentation: Quality Manual, Design Controls, Documentation Controls, Design History File and Verification

/Validation Protocols for the development of a novel endotracheal tube and eventual 510K submission. Medimmune, Inc. Mountain View, CA 2014 – 2015 Consultant – Biomarker Validation and Clinical Trial Screening

Develop immunochemical and cell-based assays for measurement of potential pharmacodynamics markers in biological matrices such as whole blood, serum and plasma. Conduct bio-analytical sample analysis in support of Non-GLP and GLP pharmacology and toxicology in vivo studies. Prepared Standard Operating Procedure, validation protocols and reports.

Quidel Corporation Santa Clara, CA 2012-2013

Manager of Manufacturing – Specialty Products Group Organized, planned, implemented, and maintained all ELISA and rtPCR manufacturing methods and processes for new and existing products at SPG. Managed, motivated and guided 10 direct reports in achieving and exceeding departmental and corporate goals and deadlines. Production was never on back order in part due to energetic teamwork and interdepartmental planning. Insured regulatory compliance with 21CFR820 and ISO 13485 and participated in FDA inspection. Updated and wrote SOPs, test methods, user guidelines and work instructions.

- Provided the necessary support and leadership to Specialty Products Reagent Chemistry and Rare Reagent departments resulting in a highly motivated, cross-trained team capable of efficiently supporting the highly changeable and adaptable nature of an entrepreneurial production unit.

- Created and monitored production planning to insure accurate, on time product delivery of high quality product per the Master Schedule with minimal overage or scrap at or below cost targets. Worked with other operations personnel to develop a dependable MPS/MRP and supported indirect expenses supporting validation and improvement work.

- Performed testing and formulation of reagents and reviewed batch records in compliance with Quality System Regulations. Worked with Quality Assurance to modify documents to reflect process improvements. Oversaw completion of training records and participated in CAPA performance and review. Sandra Forrer ******.******@*****.*** Page 2

- Supported continuous product and process improvements by working with the management team in defining improvement objectives and allocating the necessary resources.

- Ensured the efficient use of resources, material, equipment and personnel in producing cost effective, high quality products.

Gilead Sciences (CV Therapeutics), Fremont, CA 2007 – 2012 Associate Scientist 1 – Biology

Oversaw the daily lab management of a biomarker discovery and assay support group for several research targets including cardiovascular disease, metabolic disease and novel chemistry for inflammation. Routinely performed multi-assay analysis on samples from large clinical and preclinical studies eliminating the need for external analysis costs. Developed whole cell assays and novel ELISAs to address unmet research needs in the areas of gene expression (rtPCR) and metabolic disease. Developed and screened proprietary antibodies to meet research needs. Performed preliminary toxicological assays/liver toxicology for potential drug candidates.

- Constantly expanded the biomarker assay portfolio to meet expanding therapeutic areas. Evaluated and optimized commercially available kits and developed novel in-house immunoassays to meet diagnostic needs.

- Prioritized, validated and performed 40 assays on 5 different platforms for plasma, serum, urine, tissue lysates and cell culture media in 5 species.

- Routinely received, organized and catalogued large numbers of samples from in-house and external researchers. Implemented standardized test requests, test sample requirements and data reporting formats resulting in fewer errors and faster turnaround time.

- Using a combination radioactivity/HPLC assay to run Qualitative Structure Activity relationship assays for proprietary small molecule assay for metabolic disease. Scios Inc, (Johnson & Johnson), Fremont, CA 1999 – 2006 Associate Scientist, High Throughput Screening (HTS) 2003- 2006 Developed and executed multiple target screening assays for lead structure drug discovery projects. Maintained database for raw and processed data as part of the compound lead discovery process in a cytokine inhibition project.

- Developed robotic methodologies for screening 96 and 384 well small molecule libraries against selected inflammation and oncology targets. Over 300,000 compounds were screened using two screening platforms, radioactivity and fluorescence. Biochemical follow-up on putative hits led to the development of new chemistry scaffolds for synthesis.

- Supervised intern in the development of new screening methods aimed at eliminating the use of radioactive materials, reducing radiation exposure levels and radioactive waste costs. New projects were developed using non-radioactive assays.

- Analyzed data through the use of Activity Base, Spotfire, AIM and Pipeline Pilot programs. Data was made available to the Computational Chemists to perform Qualitative Structure Activity Relationship Analysis, which ultimately directed the project chemistry synthesis program. Staff/Senior Research Associate, Alzheimer’s Research/Protein Expression 1999-2003 Independent and team research in the areas of protein expression and purification. Main focus was in the areas of Alzheimer’s, inflammation biology and assay development for HTS. OTHER PROFESSIONAL EXPERIENCE

Novartis (Sandoz) Crop Protection, Palo Alto, CA Scientist I-III, Plant Biochemistry Group, AWARDS

Novartis Presidential Award for novel mode of action studies. EDUCATION/TRAINING

Sandra Forrer ******.******@*****.*** Page 3

Bachelor of Science, Biology Medical Device Regulation Lessons in Leadership SJSU

Simon Fraser University, Canada UCSC Extension extension Fluorescent Assay Design Regulatory Affairs

Statistics & Probability DeAnza

Soc. for Biomolecular Screening UCSC Extension College JOURNAL PUBLICATIONS (as S.A. Brunn and S.A. Forrer) 1. Ericson, M.C. and S.A. Brunn. “Cysteine Residues at the Active Site of Glutamine Synthetase from Spinach Leaves. Biochem. Biophys. Res. Comm. 133(2), 1985, 527-531. 2. Brunn, S.A., Muday, G.K. & P. Haworth. “Auxin Transport and the Interaction of Phytotropins.” Plant Physiol. 98, 1992, 101-107.

3. Muday, G.K., Brunn, S.A., Haworth, P. & M.V. Subramanian. “Evidence for a Single Naphthylphthalamic Acid Binding Site on the Zucchini Plasma Membrane.” Plant Physiol. 103, 1993, 449-456. 4. Subramanian, M.V., Brunn, S.A., Bernasconi, P., Patel, B.C. and J.D. Reagan. “Revisiting Auxin Transport Inhibition as a Mode of Action for Herbicides.” Weed Science, 45(5), 1997, 621-627. 5. Koltun D.O., Parkhill E.Q., Vasilevich N.I., Glushkov, A.I., Zilbershtein T.M., Ivanov A.V., Cole A.G., Henderson I., Zautke N.A., Brunn S.A., Mollova N., Leung K., Chisholm J.W., Zablocki J., “Novel potent, selective, and metabolically stable stearoyl-CoA destaturase (SCD) inhibitors. Bioorganic & Medicinal Chemistry Letters (2009). Doi: 10.1016/j.bmcl. 2009.02.019 6. Koltun D.O., Vasilevich N.I., Parkhill E.Q., Glushkov, A.I., Zilbershtein T.M., Mayboroda E.L., Boze M.A., Cole A.G., Henderson I., Zautke N.A., Brunn S.A.,Chu N. Hao, Mollova N., Leung K., Chisholm J.W., Zablocki J., Orally bioavailable, liver-selective steroyl-CoA desaturase (SCD) inhibitors. Bioorganic & Medicinal Chemistry Letters; 19:3050-3053, 2009.

7. Koltun, DO, Zilbershtein TM, Migulin VA, Vasilevich NI, Parkhill EQ, Glushkov AI, McGregor MJ, Brunn, SA, Chu, N, Hao, J, Mollova, N, Leung, K, Chisholm, JW, Zablocki, J. Potent orally bioavailable, liver-selective stearoyl-CoA desaturase (SCD) inhibitors. Bioorg Med Chem Lett. 2009 Aug 1:19(15):4070-4. Epub 2009 Jun 13.

BOOK CHAPTERS/REVIEW ARTICLES

1. Brunn, S.A. & P. Haworth. “ The Chemiosmotic Transport of Auxin at the Plasmalemma.” In Plant Membrane Transport: The Current Position, Elsevier, Amsterdam. pp 425-426, Eds. J. Dainty, M.I. DeMichelis, E. Marie

& F. Rasi Caldogno (1989).

2. Brunn, S.A., Subramanian, M.V., Walters, E., Patel, B. & J.D. Reagan. “Biochemical Characterization of Auxin Transport Protein Using Phytotropins.” In Bioregulators for Crop Protection and Pest Control, American Chemical Society, Chapter 16, pp 202-211, Ed P.A . Hedin, (1994). ABSTRACTS and POSTERS (referenced)

1. Ericson, M.C. & S.A. Brunn. “Specific Amino Acid Residues at the Active Site of Glutamine Synthetase from Spinach Leaves.” Plant Physiology Supplement, 80(4), #43, 1986. 2. Jacobson, J.A., Muday, G.K., Brunn, S.A. and P. Haworth. “Characterization of a New Class of Auxin Transport Inhibitors.” J. Cell Biochem, S15A, #A523, 1991. 3. Muday, G.K., Jacobson, J.A., Brunn, S.A. & P. Haworth. “Determination of the Role of NPA-Binding Protein in the Transport of Indole Acetic Acid.” J. Cell. Biochem. S15A, #A535. 1991. Sandra Forrer ******.******@*****.*** Page 4

4. Rosen, B., Patel, B.C., Subramanian, M.V., Reagan, J.D., Brunn, S.A, and P. Bernasconi. “Search for Natural Ligands that Regulate Auxin Transport in Zucchini.” Plant Physiology Supplement, 111(2), #463,1996. 5. Chakravarty, S. et al. “TGF-β RI Kinase (ALK5) Inhibitors: In-vitro and In-vivo Characterization of a Novel Orally Active Pteridine SD-208.” IPK2005, Warsaw, Poland. 6. Chisholm J.W., Schwartz K, Forrer S.A., Van Petten M., Belardinelli L., Dhalla A.K.,: The A1 adenosine receptor partial agonist GS-9667 inhibits adipocyte lipolysis through inhibitory effect on HSL and ATGL. ADA 2011 Poster Presentation June 26, 2011.

7. Liles J. T., Oliver J., Forrer S.A., Chisholm J.W., Belardinelli L., Dhalla A.K., Beneficial Effects of Ranolazine in a Model of Pulmonary Hypertension and Right-sided Heart Failure. American Thoracic Society’s 2011 International Conference. C61 Pulmonary Hypertension Experimental Models II/ Thematic Poster Session/Tuesday, May 2011, Colorado Convention Center. 8. Liles JT, Oliver J, Forrer SA, Chisholm JW. Ranolazine treatment delays the development of diabetes in ZDF rats through β-cell preservation, American Diabetes Association, 71st Scientific Sessions, June 24-28, 2011 San Diego CA.

PRESENTATIONS

1. “Biochemical Characterization of Auxin Transport Protein Using Phytotropins.” American Chemical Society, Symposium Series 557, at the 205th National Meeting of the American Chemical Society, Denver, CO, March 28- April 2, 1993.

2. “The Mode of Action of SAN835H: Inhibition of auxin transport.” Weed Science Society of America, Orlando FL., February 3-6, 1997.

PATENTS

1. Guyer, C.D., Johnson, M.A., Volrath, S.L., Brunn, S.A. and E. R. Ward. “Riboflavin Biosynthesis Genes from Plants and Uses Thereof. Jan 1998, US Patent File Application No. 09/016,581

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