Supply Chain High School

CDH

Carma Delores Hodge

**** ***** ***** **. ~ St. Louis, MO. 63146 ~ 314-***-**** ~

**********@*****.***

A Pharmaceutical Research and Development Scientist for a top tier

pharmaceutical company, with 5 plus years of distinguished expertise in

Clinical Product Dosage and Administration Instructions for projects in

Phase I-III clinical trials, experience in the therapeutic areas of:

oncology, pain and inflammation, cardiovascular, metabolism, and

endocrinology.

Summary of Qualifications

. Pharmaceutical Scientist with key role to provide technical expertise to

ensure awareness and appropriate use of parenteral formulations to

pharmacists, clinicians, and Clinical Operations colleagues worldwide,

responsible for conducting clinical trials from Phase I - III, in the

therapeutics areas of: oncology, pain, cardiovascular, metabolism, and

endocrinology.

. Recognized as the department Subject Matter Expert (SME) in the area of

Dosage and Administration Instructions (DAI) Verification Protocol

designs; reviewing DAIs for clinical submissions; DAI and DAI SOP related

training; and for DAI technical expertise to support various clinical

site questions.

. Trainer and mentor to Clinical Study Managers/Monitors; internal and

external clinicians/pharmacists worldwide; and many other Biotherapeutic

colleagues on the appropriate use of the Dosage and Administration

Instructions with clinical/commercial drug products.

. Prepare and present DAI presentations to audiences of: Pharmacy

Operations, Clinical Operations, Supply Chain, Pharmaceutical and

Analytical Science colleagues, external clinicians, and at investigator

meetings regarding Phase I - III clinical trials.

. Designing, writing, and implementing DAI verification protocols to

determine the compatibility of parenteral formulations with globally

worldwide dosing components, to support the commercial label for

marketing of various drug products.

Clinical Product Dosage and Administration Instruction Experience

Pharmaceutical Scientist - Pfizer, Inc., St. Louis, MO.

Jul 2004 - Present

Key Accomplishments

. Facilitating the start of ~50 new global clinical site patient dosing

protocols, by evaluating dosing materials and making informed decisions

regarding compatibility with designated drug products.

. Serve as a liaison for ~15 clinical study managers/monitors between 100+

global clinical sites, to provide feedback regarding the appropriateness

of various dosing components for use with drug products.

. Routinely interface across functional lines with Development Operations,

Pharmacy Operations, Clinical Operations, Supply Chain, and external

clinicians to resolve DAI concerns/questions regarding study designs.

. Establishing positive working rapport with nationwide and global vendors

to obtain pertinent component information used in determining

compatibility with drug products.

. Providing feedback to Clinical Operations, and Pharmaceutical Sciences to

facilitate issues of clinical significance when they arise with clinical

trials.

. Providing feedback on DAIs to be submitted for clinical use; as well as

DAI verification study designs.

. Maintaining the DAI Access database with key component material

composition information, and increasing the breadth of information by

more than 200 dosing components used globally around the world.

. Clinical site visits to determine how to add value to DAIs to facilitate

processes for investigators in dosing of investigational study drugs.

Carma D. Hodge ~ 314-***-**** ~ **********@*****.*** Page 2

Formulation Development Experience

Pharmaceutical Scientist - Pfizer, Inc., St. Louis, MO.

Jul 2004 - Present

Key Accomplishments

. Development of liquid and lyophilized biotherapeutic formulations, of

monoclonal antibodies and other protein formulations for the therapeutic

areas: oncology, pain, cardiovascular, metabolism, and endocrinology.

. Enabling the development of Phase I, II, and III projects to reach

formulation nomination milestones.

. Placebo development for Phase IIB project targeted for blinded clinical

investigations.

. Analyzing data and drafting study reports pivotal to regulatory

submissions and filings.

. Designing, writing, and implementing a variety of stability protocols to

determine drug substance and drug product stability profiles and quality

attributes.

. Preparing and presenting scientific presentations for project,

department, and extended team meetings.

. Document Review Committee member charged with reviewing submissions for

IND/NDA, FDA, and BLA.

. Accomplished skills in the area of solid state analysis of lyophilized

formulations to include: Freeze-Dry Microscopy (FDM), Differential

Scanning Calorimetry (DSC), and Powder X-ray Diffraction (PXRD).

. Accomplished skills in the areas of Dynamic Light Scattering (DLS) and

Zeta Potential, to determine particle size, and charge analysis of

protein formulations.

. Lean Six Sigma Yellow Belt certified (2008).

Teaching Experience

Secondary Science Teacher - Hazelwood East High School, St. Louis, MO.

Aug 2003 - Jun 2004

Key Accomplishments

. Taught Chemical Systems and Biology I & II courses to freshman and

sophomore students.

. Developed classroom science curriculum based on Bloom's Taxonomy of

higher ordered thinking.

. Established positive classroom environments as reflected by walk through

observations.

. Engaged student learning by designing alternative assessments tailored to

strengthen analytical thinking skills.

Chemistry Instructor - St. Louis Comm. College at Forest Park, St. Louis,

MO. Jun 2003 - Jul 2003

Key Accomplishments

. Taught introductory chemistry course to high school students

designed to help improve critical thinking skills.

. Developed a curriculum based on Bloom's Taxonomy to challenge

analytical & critical thinking skills.

Educational Assistant II - St. Louis Comm. College at Florissant Valley,

St. Louis, MO. Jan 2003 - May 2003

Key Accomplishments

. Improved student achievement of Biology grades, as indicated by higher

exam, quiz, and homework scores, by tailoring supplemental instruction

lessons to meet their different learning styles.

. Enabled students to become more independent, self-directed learners,

while helping to build their interpersonal skills, by taking on role of

facilitator during daily sessions.

Carma D. Hodge ~ 314-***-**** ~ **********@*****.*** Page 3

Research Experience

Research Technician IV - Barnes-Jewish Hospital, St. Louis, MO.

Feb 2001 - Nov 2002

Key Accomplishments

. Examined patient DNA to determine genetic mutations of rare and often

fatal bone diseases that affect the skeletal and muscular systems of the

body.

. Mentored a STARS and ISEF participant, while supervising her daily lab

duties.

. Mutational analysis of DNA using PCR & DNA sequencing; and DNA alignments

using Align-X 4.5 software.

. Isolated and purified patient DNA using SDS-Page methodology.

Manufacturing/Production Experience

Process Technician II - Genetics Institute (Wyeth Pharmaceuticals), St.

Louis, MO. Apr 1999 - Feb 2001

Key Accomplishments

. Collaborative team efforts to produce biopharmaceuticals used to

treat the blood disorder hemophilia.

. Developed tissue culture expertise from T-flask to 100 & 500L

bioreactors.

. Acquired skills of protein purification using Pharmacia skid and

Unicorn 3.0 software.

. Drafted SOPs, and ensured proper colleague training on SOPs, lab

equipment, and production procedures.

. Maintained production database using MS Access with relevant

data extracted from production batch records.

. Demonstrated proficiency in cGMP.

Education

Graduate Student, PhD program in Biomedical Sciences - Meharry Medical

College, Nashville, TN (1994-1997)

B.A. Chemistry, Basic Specialization - Southern Illinois University

Edwardsville, Edwardsville, IL (1994)

Poster Presentations

. Testing Compatibility of RN624 with the Drug Product Manufacturing

Process: Assessing Impact of Material Construction on Product Quality

Attributes (2008)

. Zeta Potential Analysis as a Potentials Characterization Tool for mAbs

(2007)

. ET-000216: Drug Product Solid State Analysis (2006)

. Qualification Studies for ETC-216 DP Administration Components (2005)

Computer Skills

Proficiency in use of MS Office 2007 to include: Word, Excel, PowerPoint,

Access, and Outlook

Working knowledge of: Documentum, Sharepoint, and Empower Pro

(chromatography) applications

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