Michael Barnes, PharmD, RPh

Somerville, MA | (781)733-4125 | mrbarnes725@gmail.com

Education
University of Rhode Island, College of Pharmacy Kingston, RI
Doctor of Pharmacy (PharmD) - Graduated Magna Cum Laude May 2021

Pharmaceutical Industry Experience

Cerevel Therapeutics, LLC. Cambridge, MA
Global Regulatory Sciences Postdoctoral Fellow July 2021 – Present
Supervisor: Yijia Luo, PharmD, RPh, RAC | Director, Regulatory Strategy and Registration
• Perform quality and content reviews on FDA and EMA regulatory submissions, including initial Clinical
Trial Applications, Clinical Study Reports, Regulatory Green Lights / Drug Release, protocol amendments,
annual reports, and routine submissions (i.e., monthly investigator data)
• Review cross-functional documents in development including Clinical Study Reports, Investigator’s
Brochures, Protocols, and FDA Briefing Documents
• Conduct regulatory and competitive intelligence regarding regulatory approval packages and post-marketing
supplemental information, prepare findings to support regulatory strategy and clinical development for each
compound in the development phase of Cerevel’s pipeline
• Support Global Regulatory Leads with preparation for FDA Meetings including Briefing Document
development, practice project team response strategies, and general logistics
• Review FDA, EMA, and ICH guidances and present relevant information to Regulatory Sub-Teams and
Clinical Sub-Teams regarding requirements for pediatrics, abuse liability assessment, and labeling
• Participate in Rapid Response Team meetings to lead creation of team response to queries from Global
Health Authorities and Ethics Committees
• Maintain records of regulatory submissions and correspondence utilizing Veeva RIM
• Develop key labeling documents, including a draft United States Package Insert, for Program Strategy Team
endorsement to support regulatory strategy and clinical development planning
• Attend study team meetings for all ongoing clinical trials and provide regulatory insight to support study
start-up and maintenance
• Lead Global Regulatory Team meetings to provide relevant information from study team meetings and
ongoing deliverables
• Support Global Regulatory Leads through Submission Working Groups for the preparation and execution of
Investigational New Drug Applications

Merck & Co., Inc. Kenilworth, NJ

Global Medical Information Extern October 2020 – November 2020
Supervisor: Karen Thomas, PharmD | Director, Global Medical Information
• Answered drug information questions and performed literature searches on behalf of the Global Medical
Information team regarding Dificid, Clostridium dificile, and Zinplava.
• Reviewed research poster presentations from “ID Week”, summarized data and presented information to
Global Medical Affairs department at Merck on behalf of the Global Scientific Communications team
• Prepared educational materials and review questionnaires on Clostridium dificile, Cytomegalovirus, Dificid,
Zinplava, and Prevymis on behalf of the Global Medical Information team for the purpose of training the
Merck National Service Center
• Developed Medical Information Response Letter templates on behalf of Global Medical Information and
Global Scientific Communications for common, standard queries regarding Dificid, Zinplava, and Prevymis
US Food and Drug Administration, CDER | OPQ | OBP | DBRRII Silver Spring, MD
Pharmacy Student Experiential Program Extern May 2020 – June 2020
Supervisor: Cyrus Agarabi, PharmD, PhD, MBA | Principal Investigator & Review Officer
• Presented a journal club and review of innovative biomanufacturing methods to an interdisciplinary team of
researchers at the Ph.D. level specifically evaluating the potential of continuous end-to-end platforms in
monoclonal antibody manufacturing
• Performed literature searches and synthesized findings to support an initiative for the Center of Drug
Evaluation and Research, Office of Biotechnology Products’ allocation of funding
• Assisted in development of the Office of Biotechnology Product’s virtual pharmacy student experiential
program

Academic and Research Experience

Purdue University, College of Pharmacy West Lafayette, IN
Adjunct Clinical Assistant Professor July 2021 – Present
Supervisor: Brian Shepler, PharmD | Associate Dean for Engagement and Partnerships
• Co-coordinated course PHRM44200: Introduction to Drug Development and the Pharmaceutical Industry,
for Spring and Fall 2022; developed and presented five lectures to 15 PharmD/BSPS students per semester
on a variety of topics within Regulatory Affairs
• Participated in facilitation of a simulated drug information request for eight PharmD students enrolled in
PHRM84000: Professional Program Laboratory III
• Developed and presented lecture on Renal Impairment Considerations in Drug Development to 146 PharmD
students enrolled in PHRM84800: Principles of Drug Information and Literature Evaluation

Prescribers’ Attitudes on Non-narcotic Controlled Substance Prescribing July 2021 – Present

Research Project Supervisors: Jonathon Parker, Brain Shepler, PharmD
• Submitted a research abstract to Purdue University IRB for the purpose of a manuscript following a survey
of physicians regarding their attitude on prescribing non-narcotic controlled substances and how the
controlled substance system impacts patient care
• Developed and distributed a survey to 800 physicians and nurse practitioners across four states (IN, MA,
MI, and RI) to assess prescribers’ attitudes regarding the controlled substance scheduling system.

Pain Management Audit of Eleanor Slater Hospital September 2019 – May 2020
Research Project Supervisor: Anita Jacobson, PharmD
• Evaluated patient charts to assess improvement in acute and chronic pain management, improvement in
functional status, and patient follow up
• Poster presented at 2020 American Society of Health-Systems Pharmacists Midyear Meeting

Professional Memberships
Drug Information Association June 2021 – Present

American Society of Health System Pharmacists December 2020 – Present

Industry Pharmacists Organization (IPhO) September 2016 – Present

Positions held: URI Vice President (2019 – 2020), URI Finances and Fundraising Chair (2018 – 2019)

Kappa Psi Pharmaceutical Fraternity, Inc. September 2015 – Present

Positions held: Northeast Sergeant at Arms (2020 – 2021), Chair of Northeast Legislative Committee
(2020 – 2021), Chair of Northeast Philanthropy Committee (2019 – 2020), URI Graduate Liaison (2019
– 2020), Chair of Northeast Awards Committee (2018 – 2019), URI President (2018 – 2019), URI New
Member Coordinator (2017 – 2018), URI Recruitment Chair (2016 – 2017)
Honors and Awards
Kappa Psi Pharmaceutical Fraternity Inc., Beta Epsilon, Brother of Year May 2021
Kappa Psi Pharmaceutical Fraternity Inc., Northeast Province, Paul Hiller Award April 2021
Southeastern Massachusetts Pharmacist Association Scholarship August 2020
University of Rhode Island Presidential Scholarship August 2020
Kappa Psi Scholarship Honors (x2) May 2019 & May 2020
Thomas M. Ryan Scholarship (x2) August 2018 & August 2019
Norman A. and Mary Campbell Scholarship August 2019
Grossomanides Family, Kappa Psi Foundation Scholarship July 2019
University of Rhode Island Dean’s List (x9) December 2015 – May 2021
University of Rhode Island Centennial Merit Scholarship September 2015

CERTIFICATIONS AND LICENSURES

Seizure Recognition and First Aid Certification November 2021 – Present
Epilepsy Foundation

Pharmacist License No. 240488 October 2021 – Present

Commonwealth of Massachusetts Board of Pharmacy

USPHS Rx for Change Tobacco Cessation Intervention Certification May 2020 – Present
United States Public Health Service | Purdue University, College of Pharmacy

Community First Responder Overdose Resuscitation Certification May 2020 – Present

University of Rhode Island, College of Pharmacy

Human Subjects Research (HSR) Certification February 2018 – Present

CITI Program, A Division of BRANY

Basic Life Support (CPR and AED) Certification November 2017 – Present
American Heart Association

Pharmacy-Based Immunization Delivery Certification October 2017 – Present

American Pharmacists Association

HIPAA Certification October 2017 – Present

Office of Civil Rights, U.S. Department of Health and Human Services