TODD D. CAVALCANTO, ESQ.

**** ******** *** **. #**** ? Miami, FL 33131 ? 484-***-**** ?

aca5qu@r.postjobfree.com

EXECUTIVE SUMMARY

Talented published attorney with significant education and experience in

clinical research, regulatory affairs, safety monitoring and quality

control/assurance for 505(b)(1), 505(b)(2) and 505(j) applications as well

as the bio-similar regulatory pathway. Currently serve as the regulatory

expert, legal counsel and safety monitor for a full-service, Contract

Research Organization.

CORE COMPETENCIES

Regulatory Affairs in the Drafting, negotiating and ICH-GCP and Quality

clinical research sector approving contracts for Control/Assurance

regulatory agencies, private

vendors and pharmaceutical

companies

Statutory and policy Safety Monitoring a pivotal Clinical Research

analysis of FDA 505(b)(2) Phase III Study Associate

regulations,

EDUCATION AND PROFESSIONAL DEVELOPMENT

Licensed to practice law in Florida

Juris Doctor (2010)

University of Miami School of Law, Coral Gables, FL

Master of Science, Biology (2007)

Bachelor of Science, Biology (2007)

Villanova University, Villanova, PA

. Written Thesis titled Hormone-regulated Inflammation of the Immature

Rat Uterus in Response to Leukocyte Infiltration and MMP Activation.

PROFESSIONAL ORGANIZATIONS

National LGBT Bar Association

. Member - 2008 to Present

American Bar Association

. Member- 2010 to Present

RELEVANT EMPLOYMENT EXPERIENCE

biorasi, llc, Aventura, FL

August 2012 to Present

Associate, Regulatory Affairs

. Manage all legal affairs for a full-service, Contract Research

Organization

. Oversee the regulatory submissions and filings for bioRASI both with

the FDA and EMA

. Draft, negotiate and approve all contracts bioRASI enters into with

clients, clinical sites and vendors

. Manage the regulatory submissions in a Phase III Clinical Trial for a

505(b)(2) investigational medicinal product aimed at helping Multiple

Sclerosis patients

. Oversee all safety monitoring for over 40 clinical sites across three

countries while ensuring all AE and SAE data are reported accurately,

timely and as per the protocol.

. Manage 10 clinical sites as a Clinical Research Associate for a Phase

III Clinical Trial through in-depth oversight on all phases of the

sites' clinical involvement in the study from site selection through

initiation, screening and enrollment, EDC and Source Monitoring and

site close-out

. Manage the IRB and FDA regulatory submission for a Phase III

BioSimilar Clinical Trial under the FDA's latest draft guidelines for

BioSimilars. Perform Quality Control on all IRB activities of over

100 clinical sites along with updating and approving company-wide

Standard Operating Procedures for this unique project

. Manage all unblinded study activity for over 100 sites in a Phase III

BioSimilar Clinical Trial through private access to all EDC systems

with the goal of ensuring proper protocol execution and payment

administration

. Work cooperatively with the Chief Compliance Officer torReview, modify

and approve all SOPs with the goal to ensure they are up-to-date and

reflect accurate and complete procedures at bioRASI.

OFFICE OF THE CITY ATTORNEY OF SUNNY ISLES BEACH, Sunny Isles Beach, FL

August 2011 to July 2012

Assistant City Attorney

. Managed the collection of over $400,000 in Code Enforcement violation

fines as well as the imposition and ultimate release of liens on

delinquent properties through in-court and out-of-court negotiations

with homeowners

. Analysed public policy in the area of public health, finance and

taxation, real property and Eminent Domain

. Drafted contracts, easements and other agreements on behalf of the

City

. Performed statutory, case-law and policy analysis on the above-

mentioned pressing issues affecting the city and advised the City

Attorney on possible solutions to these issues through written and

spoken legal memoranda

. Drafted and responded to motions, complaints, answers, requests for

productions, interrogatories and other pleadings in the areas of land

use, zoning, foreclosure and code enforcement

. Responded to foreclosure complaints received by the City dealing with

properties within Sunny Isles Beach

UNIVERSITY OF MIAMI SCHOOL OF LAW, Coral Gables, FL

August 2010 to July 2011

Student Services Fellow

. Served as a liaison throughout the law student body, as well as the

South Florida legal community to provide the University with new

programs and solutions.

. Identified the need for additional career networking opportunities for

students, and helped establish a year long program to network local

attorneys and Judges with students.

MIAMI-DADE COUNTY STATE ATTORNEY'S OFFICE, Miami, FL

June 2009 - November 2009

January

2010 - April

2010

Certified Legal Intern, County Court Division (2010)

Legal Intern, Felony Domestic Violence (2009)

. Advocated for the State of Florida through written communication in

the form of legal motions and memoranda and oral communication in a

court of law before a county court judge

. Assisted in managing three successful bench trials, which included all

hearings, motion calendar appearances and court litigation. Trials

resulted two convictions and one dismissal for mental instability

. Assisted the Division Chief of the Felony Domestic Violence Division

with a first-degree murder trial by providing case-law and statutory

analysis on premeditation standards and plea calculations

. Wrote several memoranda of law in the area of criminal prosecution,

the use of scientific evidence in the courtroom and assisted in

writing a direct examination of a medical expert

. Interpreted scientific testimony given by a medical examiner on cause

of death analysis

PUBLICATIONS

"Regulated expression of matrix metalloproteinases, inflammatory mediators

and endometrial matrix remodeling by 17?-Estradiol in the immature rat

uterus." Reproductive Biology and Endocrinology, Volume 7; Issue 124,

2009.

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