Summary
Overview
Work History
Education
Skills
Certification
AWARDS
Publications and Meeting Abstracts
Timeline
Generic

Manoj C. Rodrigo

Belmont,CA

Summary

Experienced Cardiovascular and Neurovascular Researcher with proven success at managing and executing high impact projects for medical device & pharmaceutical clients.

• 15+ years of industry experience, including expertise in providing safety surveillance for global heart failure and stroke clinical trials

• Provider of impactful recommendations for successful clinical trial design and optimization leveraging expertise in both preclinical and translational methods

• Author of successful manuscripts, fundable grants, reports, and clinical-led regulatory responses

• Strong presentation, communication and team collaborative skills

• Accomplished project leader/manager with a strong balance of technical and business acumen essential for delivering innovative solutions to research programs

Overview

31
31
years of professional experience
1
1
Certification

Work History

Independent Scientific Consultant

Self Employed
09.2024 - Current
  • Provide subject matter expertise, scientific data analysis, and medical writing services to advance translational and clinical programs for medical device and pharmaceutical clients.


Associate Director Medical Safety

Cytokinetics
06.2023 - 08.2024
  • Performed pharmacovigilance signal detection activities to ensure signal identification and evaluation for all products
  • Performed individual and aggregate data analyses, interpreted safety signals/trends, documented, and communicated safety findings
  • Conducted medical review of individual case safety reports
  • Contributed to drafting and reviewing relevant sections of clinical and regulatory submissions (protocols, ICF, study reports, DSURs, marketing applications etc.)
  • Contributed to the creation and maintenance of Reference Safety Information and Investigator Brochures for assigned products
  • Reviewed and summarize scientific literature relevant to pharmacovigilance on assigned projects
  • Contributed to audit inspection readiness activities by ensuring alignment with FDA and EMA pharmacovigilance requirements and guidelines

Principal Medical Safety Specialist

Stryker Neurovascular, Medical Affairs
05.2016 - 06.2023
  • Conducted GCP and ICH compliant clinical research and safety surveillance for stroke trials (US Class III and II devices)
  • MedDRA coded all AEs and medical history in EDC, and ensured timely reporting of appropriate SAEs to local and foreign regulatory authorities
  • Drafted/reviewed sections of 2 successful FDA PMA submissions and post market approval supplements
  • Safety SME for EUMDR submissions and triage lead for FDA panel activities
  • Performed medical risk assessments for non-conformances and Heath Hazard Assessments for field actions
  • Contributed to new product development efforts by providing safety expertise during early product design phases
  • Authored safety-related sections in CERs, Annual reports, patient narratives, IFUs, FMEAs, and Risk Tables for assigned products
  • Managed safety committees (DSMB/CEC/MAC) and supervised CRO safety activities
  • Prepared/reviewed materials for cross-disciplinary teams and external KOLs (abstracts, podium presentations, manuscripts, and marketing materials etc.)

Associate Scientist (Contractor)

Genentech Inc.
07.2014 - 05.2016
  • Provided physiology & pharmacology expertise to develop a large-scale predictive Quantitative Systems Pharmacology (QSP) model of chronic asthma to evaluate efficacy of novel biologics in clinical development to treat severe asthma.
  • Mined and curated data from scientific literature and analyzed proprietary preclinical/clinical trial data to formulate QSP model calibration/validation constrains
  • Developed an internal clinical data repository to be used across departments at Genentech
  • Prepared/presented project related presentations to cross-disciplinary teams

Associate Director/ Scientist

Entelos Holding Corp.
11.2006 - 06.2014
  • Served as SME to develop large-scale in silico predictive models of metabolism, cholesterol, atherogenesis, hypertension, heart failure, and CKD to evaluate efficacy and safety of novel drug targets
  • Prepared/presented research presentations, formulated recommendations, and drafted/finalized project reports for customer milestone deliverables
  • Served as project leader and managed a global team of engineers and biologists (10FTE) to successfully develop a predictive model of metabolism and CVD
  • Provided QA oversight prior to releasing of predictive models to customers
  • Contributed to business development by brining in 3 revenue generating consulting projects and prepared digital marketing materials for company website

Postdoctoral Research Scientist

UCSF Cardiovascular Research Institute
01.2002 - 10.2006
  • Characterized the role of alpha adrenergic receptor subtypes in adaptive and maladaptive hypertrophy of the heart.
  • Screened gene expression patterns in pathological and physiological hypertrophy in preclinical models
  • Drafted manuscripts and published research results in peer-reviewed journals and presented findings at department seminars and at major conferences.
  • Provided guidance to junior researchers on experimental design, troubleshooting issues, and interpretation of results.

Research Associate

Sanford School of Medicine, USD
09.1993 - 08.1996
  • Studied the role of venous tone in the development of hypertension and evaluated the role and effects of hypothalamic nuclei (PVN) on blood pressure regulation.
  • Surgically implanted catheters for drug administration and measured blood pressure in rodents
  • Performed stereotaxic surgeries to implant intratheacal cannula to micro inject study drugs directly into the PVN to evaluate central control of blood pressure regulation
  • Collected, analyzed, and prepared figures consisting of research data for abstracts and poster presentations

Education

Postdoctoral Research Fellowship - Heart Failure Research

University of California, San Francisco, CVRI
San Francisco, CA
10-2006

Ph.D. - Physiology & Pharmacology

Sanford School of Medicine
Vermillion, SD
05-2002

Bachelor of Science - Biology

Sanford School of Medicine, USD
Vermillion, SD
05-1994

Skills

  • Clinical trials
  • Pre-clinical research techniques
  • Scientific collaboration
  • Technical Writing
  • Data Interpretation
  • Time management
  • Complex Problem-Solving
  • Training and mentoring
  • Literature review and meta-analysis
  • Protocol design
  • Quantitative skills
  • Critical Thinking

Certification

  • Barnett International Monitoring for Medical Devices Training (15hrs), Fremont CA 2019
  • Jacobs Institute Clinical Immersion Program (20hrs), Buffalo NY 2018
  • Stryker Neurovascular Intermediate Brain Training (20hrs), Fremont CA 2018

AWARDS

  • Stryker RAQA Convergence Award for Clinical Approval of Surpass Streamline in China 2021
  • Stryker Customer Excellence Q2 Leadership Team Award 2021
  • Stryker Customer Excellence Q3 Edge Award for Collaboration 2018

Publications and Meeting Abstracts

Peer Reviewed Articles

1. Sandroni PB, Schroder MA, Hawkins HT, Bailon JD, Huang W, Hagen JT, Montgomery M, Hong SJ, Chin AL, Zhang J, Rodrigo MC, Kim B, Simpson PC, Schisler JC, Ellis JM, Fisher-Wellman KH, Jensen BC. The alpha-1A adrenergic receptor regulates mitochondrial oxidative metabolism in the mouse heart. J. Molec. Cel. Cardiol. 2024 Feb;187:101-107.

2. Gadkar K, Feigelman J, Sukumaran S, Rodrigo MC, Staton T, Cai F, Bauer R, Choy D, Stokes C, Scheerens H, Ramanujan S. Integrated systems modeling of therapeutic intervention in severe asthma: Exploration of IL-33/ST2 antagonism. CPT Pharmacometrics Syst Pharmacol. 2022 Sep;11(9):1268-1277.

3. Hallow KM, Lo A, Beh J, Rodrigo M, Ermakov S, Friedman S, de Leon H, Sarkar A, Xiong Y, Sarangapani R, Schmidt H, Webb R, Georgieva-Kondic A. A model-based approach to investigating the pathophysiological mechanisms of hypertension and response to antihypertensive therapies: Extending the Guyton model. Am J Physiol Regul Integr Comp Physiol. 2014 May;306(9):R647-62.

4. López JE, Myagmar BE, Swigart PM, Montgomery MD, Haynam S, Bigos M, Rodrigo MC, Simpson PC. Beta-myosin heavy chain is induced by pressure overload in a minor subpopulation of smaller mouse cardiac myocytes. Circ Res. 2011 Jul 21 [Epub ahead of print].

5. Muramatsu I, Morishima S, Suzuki F, Yoshiki H, Anisuzzaman AS, Tanaka T, Rodrigo MC, Myagmar BE, Simpson PC. Identification of alpha 1L-adrenoceptor in mice and its abolition by alpha 1A-adrenoceptor gene knockout. Br J Pharmacol. 2008 Dec;155(8):1224-34. Epub 2008 Sep 22.

6. O'Connell TD, Rodrigo MC, Simpson PC. Isolation and culture of adult mouse cardiac myocytes. Methods Mol Biol. 2007;357:271-96.

7. O'Connell TD, Swigart PM, Rodrigo MC, Ishizaka S, Joho S, Turnbull L, Tecott LH, Baker AJ, Foster E, Grossman W, Simpson PC. Alpha1-adrenergic receptors prevent a maladaptive cardiac response to pressure overload. J Clin Invest. 2006 Apr;116(4):1005-15.

8. Wang GY, Bergman MR, Nguyen AP, Turcato S, Swigart PM, Rodrigo MC, Simpson PC, Karliner JS, Lovett DH, Baker AJ. Cardiac transgenic matrix metalloproteinase-2 expression directly induces impaired contractility. Cardiovasc Res. 2006 Feb 15;69(3):688-96. Epub 2005 Sep 23.

9. Ishizaka S, Sievers RE, Zhu BQ, Rodrigo MC, Joho S, Foster E, Simpson PC, Grossman W. New technique for measurement of left ventricular pressure in conscious mice. Am J Physiol Heart Circ Physiol. 2004 Mar;286(3):H1208-15. Epub 2003 Oct 16.

10. Rodrigo MC, Martin DS, Eyster KM. Vascular ECE-1 mRNA expression decreases in response to estrogens. Life Sci. 2003 Oct 24;73(23):2973-83.

11. Rodrigo MC, Martin DS, Eyster KM. Estrogen decreases biglycan mRNA expression in resistance blood vessels. Am J Physiol Regul Integr Comp Physiol. 2003 Oct;285(4):R754-61.

12. O'Connell TD, Ishizaka S, Nakamura A, Swigart PM, Rodrigo MC, Simpson GL, Cotecchia S, Rokosh DG, Grossman W, Foster E, Simpson PC. The alpha(1A/C)- and alpha(1B)-adrenergic receptors are required for physiological cardiac hypertrophy in the double-knockout mouse. J Clin Invest. 2003 Jun;111(11):1783-91.

13. Rodrigo MC, Martin DS, Redetzke RA, Eyster KM. A method for the extraction of high-quality RNA and protein from single small samples of arteries and veins preserved in RNAlater. J Pharmacol Toxicol Methods. 2002 Mar-Apr;47(2):87-92.

14. Olson DM, Sheth MV, Rodrigo MC, Burghardt JS, Eyster KM. Effect of developmental age and hyperoxia exposure on kinase and phosphatase activities in newborn rat lungs. Exp Lung Res. 1998 May Jun;24(3):339-53.

15. Eyster KM, Berger TL, Rodrigo MC, Sheth MV. Protein phosphatase activity in the rat ovary throughout pregnancy and pseudopregnancy. Biol Reprod. 1998 Feb;58(2):338-45.

16. Martin DS, Rodrigo MC, Appelt CW. Venous tone in the developmental stages of spontaneous hypertension. Hypertension. 1998 Jan;31(1):139-44.

17. Martin DS, Rodrigo MC, Egland MC, Barnes LU. Disinhibition of the hypothalamic paraventricular nucleus increases mean circulatory filling pressure in conscious rats. Brain Res. 1997 May 9;756(1-2):106-13.

18. Martin DS, Appelt C, Rodrigo MC, Egland MC. Acute stress increases venomotor tone in conscious rats. Am J Physiol. 1996 Oct;271(4 Pt 2):H1375-83.


Book Chapters

1. Lo A, Beh J, De Leon H, Hallow MK, Ramakrishna R, Rodrigo M, Sarkar A, Sarangapani R, Georgieva A: Using a systems biology approach to explore hypotheses underlying clinical diversity of the renin angiotensin system and the response to antihypertensive therapies. In: Kimko HHC and Peck CC, eds. Clinical Trial Simulations: Applications and Trends. 2 nd ed. 2010.


Selected Meeting Abstracts

1. Gadkar K, Sukumaran S, Rodrigo M, Stokes C, Scheerens H, Ramanujan S. A clinical-data driven mechanistic systems model of asthma disease and treatment. American Society for Clinical Pharmacology and Therapeutics (ASCPT), March 2015, New Orleans, LA,USA.

2. Hallow MH, Sarkar A, Georgieva A, Ermakov S, Lo A, Beh J, Rodrigo MC. The Cardiovascular-Renal Simulator (CVR-sim): a large-scale mechanistic model for evaluating the effects of antihypertensive agents on chronic heart failure. American Conference on Pharmacometrics (ACoP), April 2011, San Diego, CA, USA

3. Sarkar A, Hallow MH, Soubret A, Helmlinger G, Sarangapani S, Georgieva A, Ermakov S, Lo A, Rodrigo MC, Beh J, De Leon H. Multiscale disease model of heart failure and renal disease with therapeutic application in drug R&D. Biomedical Engineering Society (BMES), October 2010. Austin, TX, USA.

4. Rodrigo MC, Swigart PM, Myagmar B, Cha J, Zhu B, Yeh C, Mann M, Karliner JS, Simpson PC (2006). Beta blockers switch mitogen activated protein kinase signaling from maladaptive beta- to adaptive alpha-1 adrenergic. AHA Annual Meeting 2006, Chicago, IL.

5. Rodrigo MC, Joho S, Swigart PM, Foster E, Grossman W, Simpson PC (2005). The Alpha1-B adrenergic receptor subtype is required for physiological cardiac hypertrophy in normal development. AHA National Meeting 2005, Dallas, TX.

6. Rodrigo MC, Collier M, Uezato H, Deng D, Bristow J, Simpson PC (2002). Transcriptional profiles in physiological and pathological cardiac hypertrophy. Circulation 106:II-34. AHA Annual Meeting 2002, Chicago, IL.

Timeline

Independent Scientific Consultant

Self Employed
09.2024 - Current

Associate Director Medical Safety

Cytokinetics
06.2023 - 08.2024

Principal Medical Safety Specialist

Stryker Neurovascular, Medical Affairs
05.2016 - 06.2023

Associate Scientist (Contractor)

Genentech Inc.
07.2014 - 05.2016

Associate Director/ Scientist

Entelos Holding Corp.
11.2006 - 06.2014

Postdoctoral Research Scientist

UCSF Cardiovascular Research Institute
01.2002 - 10.2006

Research Associate

Sanford School of Medicine, USD
09.1993 - 08.1996

Postdoctoral Research Fellowship - Heart Failure Research

University of California, San Francisco, CVRI

Ph.D. - Physiology & Pharmacology

Sanford School of Medicine

Bachelor of Science - Biology

Sanford School of Medicine, USD
Manoj C. Rodrigo