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PhD

Location:
Highlands Ranch, CO
Posted:
March 30, 2016

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Resume:

Rahul Bohra, PhD

***** ***** *** ****** • Highlands Ranch, CO 80130 • act5wm@r.postjobfree.com • 303-***-**** OBJECTIVE

As a Medical Science Liaison, leverage the education, skills and persona groomed specifically for pharmaceutical / clinical implement, to deliver high impact education and disease state training. THERAPEUTIC AREAS / CLINICAL EXPERIENCE

Medical Science Liaison at Veloxis Pharmaceuticals covering transplant centers and KOLs in the great- plains and mid-west regions (WI, MN, ND, SD, MT, WY, CO, NE, KS, NM and TX). Helped launch the 505

(b) (2) branded immunosuppressant product. Supported medical affairs, market access and sales departments by presenting and discussing the science, PK, CT and on/off label data with surgeons, nephrologists, specialty pharmacy and payers. Attended and represented the company at several global medical conferences. With medical affairs, developed hypothesis and design for a novel phase IV study.

Manager of Clinical Trials and R&D at Esoterix, Inc. (LabCorp/Covance) for hemophilia/coagulation drugs and clinical diagnostics; providing comprehensive global solutions for clinical trial assay validation and testing of study specimens for ~80% of upcoming hemophilia/ coagulation drugs (phases II-IV) from major multinational pharma sponsors. Became adept in regulatory compliance (FDA, CLIA, CLSI, EMA).

Doctoral research in in vivo and in vitro immunosuppression using clinically prevalent T-cell suppression drugs (Tacrolimus/FK-506, Cyclosporin A, Sirolimus and Everolimus). Identifying renal, neural and systemic toxicity pathways and exploring the mechanisms in resulting inflammation and cell death. KEY ACHIEVEMENTS

To provide consultation and assist study sponsors, a company sponsorship was presented to attain the RAPS (Regulatory Affairs Professional Society) certificate in global and local regulatory affairs of medical devices and pharmaceuticals. Courses were successfully completed and certificate received in Jan 2015.

Received the NIH NCRR Pre-Doctoral Translational Research Training Award for Metabolomics study of immunosuppressant nephrotoxicity mechanisms and presented my translational research nationally.

As my doctoral studies employed wide variety of techniques not native to my laboratory, I forged extensive collaborations across campuses, laboratories, core facilities and maintained relationships / resources with colleagues and professors who helped me complete my projects successfully.

While in India, I cleared the prestigious CSIR National Eligibility Test (NET) for Junior Research Fellowship & Lectureship in Life Sciences which was followed by receiving the CSIR golden jubilee research internship award. (CSIR: Council for Scientific and Industrial Research, Government of India) EDUCATION

UNIVERSITY OF COLORADO DENVER, ANSCHUTZ MEDICAL CAMPUS • AURORA, CO PhD – Structural Biology and Biochemistry, Department of Anesthesiology • Awarded May 2012

• Metabolomics study of Immunosuppressant nephrotoxicity mechanisms in rat and human cell model, performed using four clinically prevalent immunosuppressant drugs (Tacrolimus/FK-506, Cyclosporin A, Sirolimus and Everolimus) with various doses and combination. The results were remarkably favorable for Everolimus (US approval was pending at the time) and project secured industry funding for further molecular and biochemical investigations.

• Biochemical investigations were performed in human kidney proximal tubule cell line to assess mechanisms that underlie drug induced nephrotoxicity. The project received NIH NCRR CCTSI pre- doctoral training award and provided a platform to present my research findings at the national level.

• The techniques and diagnostic strategies I utilized in my research have been used towards several R01 grants (funded). Data from my doctoral studies was used towards FDA approval of Everolimus for the prevention of organ rejection after renal transplant indication (Zortress®). I participated in proposing an Investigator Initiated Phase IV Trial (NCT02062892) sponsored by Novartis but was later withdrawn due to patient enrollment issues. The trial switched stable renal transplant patients from tacrolimus / sirolimus combination to tacrolimus/everolimus combination and monitored molecular biomarkers. Rahul Bohra • PhD • Page 2 • act5wm@r.postjobfree.com • 303-***-**** EDUCATION (continued)

SIKKIM MANIPAL UNIVERSITY • MANIPAL, INDIA

Master of Science – Bioinformatics • Awarded Dec 2005

• Thesis: Human Protein Reference Database annotation at the Institute of Bioinformatics, Bangalore UNIVERSITY OF RAJASTHAN • JAIPUR, INDIA

Bachelor of Science – Biotechnology • Awarded Jul 2002

• Thesis: Study of various PCR techniques at the Birla Institute for Scientific Research, Jaipur CERTIFICATE

REGULATORY AFFAIRS PROFESSIONAL SOCIETY

• For professional development and to gain better understanding of regulations for drug/ device development in the US and around the globe, I completed the dual certificate course in regulatory affairs of the medical device and pharmaceuticals in January of 2015. PROFESSIONAL EXPERIENCE

MEDICAL SCIENCE LIAISON, GREAT-PLAINS / MID-WEST (WI, MN, ND, SD, MT, WY, CO, NE, KS, NM AND TX) Veloxis Pharmaceuticals Inc., Edison, NJ, Nov 2015 – Mar 2016 Veloxis is an international company with headquarters in Hørsholm, Denmark. Veloxis owns a unique, patented delivery technology to enhance the absorption and bioavailability of tacrolimus (immunosuppressant).

• Deliver high value scientific training, disease state insights and clinical information to HCPs and payers.

• Proactively identify specific information needs and supply with researched in-depth information.

• Perform in a compliant manner with sales and market access colleagues to establish and maintain strong relationships with KOLs and medical professionals.

• Investigator initiated trials (IITs): Facilitate, ensure scientific rigor and submit to medical affairs review

• Provide clinical trial data and disease state presentations in one-on-one, group and remote settings. MANAGER, CLINICAL TRIALS AND R&D

Esoterix, Inc. (A LabCorp Company), Englewood, CO, Nov 2012 – Oct 2015 A world-renowned reference laboratory for specialty coagulation testing, attracts leading hemophilia/ hemostasis drug companies for global clinical drug development and clinical trial testing.

• Perform the scientific, technical and regulatory duties for bioanalytical and CLIA/GCP assay validations for Phase II-IV clinical trials, routine testing of coagulation parameters and hemostasis drug monitoring.

• Supervise technical, quality control, and support staff to ensure compliance with study protocols, in- house processes and applicable regulations. Assist in development of procedures to comply with federal regulations and industry standards while reporting directly to the Technical Director and VP of LabCorp.

• Write bioanalytical and GCP method validation plans, sample analysis protocols, and final study reports.

• Collaborate with scientific/project personnel on validation study, clinical testing and regulatory aspects. RESEARCH CONTRACTOR / REGULATORY ASSOCIATE

CBR international Corp • Boulder, CO • June – August 2012 Clinical: Performed literature meta-analysis for multiple phase III clinical trial study designs. Regulatory: Composed agency (FDA/EMA) communications and submission document templates with recommendations for clients according to industry guidelines. CMC: Performed extensive gap analysis for process development history: researched executed batch records, summary reports and other source documentation. INTERN

Institute for Genomics and Integrative Biology • New Delhi, India

• Internship at the business development unit and tool development for peptide mass fingerprinting. INSTRUCTOR AND COORDINATOR FOR BIOTECHNOLOGY CURRICULUM Rai University • Rajasthan, India

Rahul Bohra • PhD • Page 3 • act5wm@r.postjobfree.com • 303-***-**** ABSTRACTS

Bohra R, Schöning W, Schmitz V, Lawrence R, Schniedewind B, Klawitter J, Klawitter J, Christians U, Differences in nephrotoxicity: combination of cyclosporine with sirolimus vs. everolimus. 2011 National Predoctoral Clinical Research Training Program, May 2011. Abstract and Presentation Schöning W, Bohra R, Brunner N, Schmitz V, Shokati T, Lawrence R, Schniedewind B, Klawitter J, Klawitter J, Christians U Everolimus And Sirolimus Have Different Effects On The Rat Kidney When Combined With Cyclosporine. American Transplant Congress, 2010, abstract and poster “Distinguished poster award” Bohra R, Schöning W, Schmitz V, Brunner N, Shokati T, Lawrence R, Schniedewind B, Klawitter J, Klawitter J, Christians U, Sirolimus and everolimus have different effects in rat kidney when combined tacrolimus. 2010 National Predoctoral Clinical Research Training Program, June 2010. Abstract and Poster Christians U, Bohra R, Schöning W, Shokati T, Brunner N, Schmitz V, Lawrence R, Schniedewind B, Klawitter J, Klawitter J: Sirolimus, but not Everolimus, Enhances Tacrolimus Nephrotoxicity in the Rat. American Society of Transplantation meeting, 2009, Abstract and Poster PUBLICATIONS

Bohra, Rahul, Jacek Klepacki, Jelena Klawitter, Jost Klawitter, Joshua Thurman, and Uwe Christians.

"Proteomics and metabolomics in renal transplantation quo vadis?" Transplant International (2012) Bohra, Rahul, Wenzel Schöning, Jelena Klawitter, Nina Brunner, Volker Schmitz, Touraj Shokati, Ryan Lawrence et al. "Everolimus and Sirolimus in Combination with Cyclosporine Have Different Effects on Renal Metabolism in the Rat." PloS one 7, no. 10 (2012): e48063. KEY STRENGTHS

Proven communicator providing efficient delivery combined with social intelligence. Adept at explaining complex information in practical terms in one-on-one engagement or group presentations.

Respect and tolerance for different ideologies, beliefs, behaviors and opinions.

Strong work ethic, with a sense of personal accountability.

Desire for continual growth of knowledge, scientific expertise and business acumen.

Excellent data/information gathering abilities supported by superior technical skills and meticulous research. Highly efficient at quickly finding relevant information and references. Able to visualize scenarios and scope out details that would help or harm a given project.

Friendly, collaborative team player, welcome in social settings and key contributor in planning sessions. Always willing to lend a helping hand no matter the type of task. Drive to see and help the projects through various personnel/departments. Self-critical, curious and outspoken. RELEVANT SKILL SET

Extensive technical writing experience in writing/composing validation protocols and reports, clinical trial final PK/PD study reports and data summaries according to applicable regulations.

Assessment, summarization and reporting of large data sets utilizing a wide range of laboratory, research, statistical systems and applications such as MS Excel, IBM SPSS, EP Evaluator etc.

Expert understanding of clinical data generation, its analysis and interpretation. For example: data generated from enzymatic coagulation assays (optical, mechanical and kinetic), data from quantitative measurement and profiling of bio-fluids using LC-LC/MSn and NMR, and data from routine clinical tests.

Expert knowledge of IT, productivity software and scientific instrumentation. Quick to master novel technologies and software on regular and mobile platforms.

Fluent in English and Hindi languages.



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