Clinical Research Medical

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BIBHUDATTA MISHRA, Ph.D.

Lutherville, MD-***** 734-***-**** ************@*****.*** www.linkedin.com/in/bibhudattamishra/ EXECUTIVE SUMMARY

• Skilled Clinical Research Coordinator in a sponsor setting backed by evidence to identify and engage with Key Opinion Leaders, clinical trial professionals, and other stakeholders resulting in the smooth coordination of two phase-2, and two phase-1 clinical trials across 48 research sites.

• A strategic and agile neuroscience expert with a strong background in cellular neurobiology with +12 years of research experience leading to long-lasting research projects, 16 peer-reviewed scientific publications, one patent, and external funding exceeding $2 million.

• Excellent team player and active builder of prolific collaborations with internal and external stakeholders, excellent interpersonal, oral and scientific writing and editing skills with the ability to interpret and communicate complex scientific information and data.

Therapeutic Area Specialties: Ophthalmology (Glaucoma, Retinitis Pigmentosa, Diabetic Retinopathy), Neurology (axon degeneration/death, and synapse degeneration in all neurodegenerative disorders). CLINICAL RESEARCH EXPERIENCE

CLINICAL TRIAL COORDINATOR JANUARY 2019-SEPTEMBER 2019 LANDOS BIOPHARMACEUTICALS INC.

• Served as a central point of contact with Contract Research Organizations for ongoing clinical trial milestones such as patient recruitments, source documentations, pre-site selections, third-party vendor selections, clinical supply operation, scientific review committee, Trial Master Files, and related coordination resulting in smooth dosing of the first patient in two phase-2 studies, and priming two phase-1 studies.

• Prepared, reviewed, and submitted research ethics committee/regulatory documents by assuring regulatory compliance of investigational sites with company Standard Operating Procedures, European Medical Agency

/U.S.Food and Drug Administration, and International Council of Harmonization guidelines resulting in developing and maintaining good working relationships with investigators and study staff.

• Assisted in the project-specific meetings and coordinated with departmental meetings resulting in the smooth progress of two phase-2, and two phase-1 studies.

MEDICAL COMMUNICATION EXPERIENCE

MEDICAL WRITING ADVISOR JULY 2014-JULY 2019

RESEAPRO SCIENTIFIC SERVICES

• Authored clinical study reports, and summarized documents for several key therapeutic areas including neuroscience, cardiovascular, and oncology, resulting in 50+ collaborative publications within five years.

• Coordinated publication management support for Reseapro scientific business unit with Key Opinion Leader to build awareness of new indications for recently Food and Drug Administration approved drugs resulting in the generation of product-specific medical information resources.

• Provided leadership/guidance on cross-functional project teams on a wide range of issues related to documentation resulting in the preparation and the presentation of findings from clinical study trials. 2

BASIC SCIENCE RESEARCH EXPERIENCE

RESEARCH FELLOW APRIL 2016-DECEMBER 2018

JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE

• Strategically designed and delivered nanoparticle-mediated gene therapy project to understand retinal degeneration in the etiology of Glaucoma resulting in one publication, one patent (pending filing) and two new collaborations.

• Led a multi-investigator initiated collaborative project with a cross-functional team of Subject Experts across the USA and developed high-throughput drug discovery platform to optimize stem cell transplantation resulting in the finding of twenty potential drug-like candidates.

• Completed a certification course on clinical trial design. Developed excellent interpersonal, oral, and written communication resulting in a presentation at three international meetings. RESEARCH FELLOW APRIL 2014-MARCH 2016

NATIONAL EYE INSTITUTE

• Expertly led, managed, designed, and executed two major research projects to study differential gene expression during early Diabetic Retinopathy. Presented research highlights in three international meetings, resulting in two publications.

• Pioneered and developed the concept of photoreceptor degeneration process in early diabetes resulting in one review article and establishing a foundation for two new projects.

• Liaised with Subject Experts to maximize data outcome in retinal degeneration disease state, served as a reviewer to Scientific Reports and PLoS ONE, co-supervised two junior scientists and provided technical support. RESEARCH FELLOW OCTOBER 2010-MARCH 2014

UNIVERSITY OF MICHIGAN

• Developed effective leadership by managing and training two new undergraduate researchers resulting in 4 collaborative publications within three years.

• Identified and characterized the neuronal response to injury in neurodegenerative disease model systems resulting in one “cover page” research publication in the Journal of Neuroscience and a best undergraduate thesis award to one of the undergraduate mentees.

• Demonstrated effective communication and presentation skills and conveyed critical scientific findings in 3 international and three national meetings.

EDUCATIONAL BACKGROUND

Ph.D., Molecular Neuroscience, 2010 University of Hamburg, Hamburg, Germany M.Sc. Biotechnology, 2005 Madurai Kamaraj University, Tamilnadu, India SKILLS

• Clinical Research: Efficient in communicating with different vendors and filing and preparing trial documents under clinical and regulatory operations. Experience writing clinical reports.

• Science Communication and Review: Experienced medical writer/science communicator with five years of medical writing and 12+ years of scientific literature content development and review experience.

• Data Presentation: Excellent oral and written data presentation record in national and international conferences.

• Publication: Strong publication record in high-impact factor peer-reviewed journals. Proficient in MS Office.

• Prioritization and Organization: Efficient in managing multiple projects with strict deadlines. 3

SELECTED RESEARCH PUBLICATIONS

https://www.ncbi.nlm.nih.gov/pubmed/?term=Bibhudatta+Mishra ACHIEVEMENTS

• 2018: National Eye Institute Travel Grant to attend the annual ARVO conference at Honolulu, Hawaii.

• 2015: Assistant Professor, University Grant Commission-India (offer declined).

• 2011: Roll of Honor-Class of 2011 Drosophila Neurobiology: Genes, Circuits, and Behavior, CSHL.

• 2004: Summer Program Scholarship Recipient, Hindustan Lever Limited, India.

• 2003: Master Program Scholarship Recipient, Department of Biotechnology, Government of India.

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