Medical Clinical Research

CHRISTINA ARNDT GREELEY

*** ********* *****, **** ******, IL 60045

H: 847-***-**** M: 847-***-****

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

EXECUTIVE OVERVIEW

Accomplished healthcare executive and advocate with 20 years of proven

success and unique experience in the pharmaceutical/clinical research

and rare disease, not-for-profit arenas. Strong executive leadership

skills have been developed through a broad range of experience

including basic research, clinical research coordination,

pharmaceutical trial monitoring and management, and not-for-profit

leadership roles. Areas of expertise include:

Clinical Research - Pharmaceutical trial monitoring and management

(Phases I-III), clinical trial coordination

Academic/Laboratory Research - Protocol writing, assay performance,

data entry/analysis, database management

Patient Advocacy - Pharmaceutical partnerships, national umbrella

advocacy group participation, FDA/NIH relationships, coalition

building, professional and public outreach/education, international

collaboration

Management - Strategic planning, board of directors/medical advisory

committee oversight, project/team leadership

Development - Fundraising, grant writing, strategic alliances

Administration - Budget, accounting, process and procedures, staffing

Event Planning - Medical conference and symposia planning and

execution

Marketing/Communications - Journal publications, meeting abstracts,

newsletters, professional and public educational brochures, social

media, web presence and meeting/symposia presentations

EXPERIENCE

Cystinosis Research Network, Inc., Lake Forest, IL

President and Executive Director (July 2007 - July 2012)

Executive Director (July 2012 - Present)

Executive responsible for leadership, strategic direction and

oversight for an international, rare disease, not-for-profit 501(c)3

organization dedicated to supporting and advocating research,

providing family assistance and educating the public and medical

communities about the genetic, metabolic disorder cystinosis.

Managed contracted staff, Advisory Boards, Board of Directors and

Executive Committee, including chairs of Development, Education and

Awareness, Family Support, Research and Finance.

Oversight of $500,000 annual budget, including production of yearly

budgets, annual reports, tax returns and audits.

Primary contact for key pharmaceutical partnerships with Sigma Tau

Pharmaceuticals, Raptor Pharmaceuticals, and Orphan Europe.

o Worked with corporate level executives at Sigma Tau and Raptor

on strategic patient outreach in anticipation of FDA product

approvals.

o Partnered to disseminate product information to the community,

recommend physician investigators for clinical trials, provide

demographic analyses to recommend placement of clinical trials

and product sales force, and execute patient surveys and

analyses informing product marketing and manufacture.

o Collaborated with Orphan Europe and international treating

physicians to distribute sole cystinosis treatment to patients

worldwide.

Established and funded first-ever Cystinosis Clinical Fellowship at

the National Institutes of Health (NIH) to train new clinical experts

in the disorder under direction of William A. Gahl, M.D., Ph.D.,

Clinical Director, National Human Genome Institute and Director, NIH

Undiagnosed Diseases Program.

Expanded international collaborations.

o Sponsored cystinosis symposia at 2010 International Pediatric

Nephrology Association meeting in New York, NY and the 2011

Association of Latin American Pediatric Nephrology meeting in

Sao Paulo, Brazil.

o Worked with international cystinosis support groups in France,

Ireland and Mexico to co-fund research projects and sponsor and

participate in family and medical meetings.

Chaired two international biennial cystinosis medical and family

conferences (2009 in Atlanta, GA and 2011 in San Francisco, CA).

Responsible for leadership of conference planning committee and

oversight of event.

Facilitated workgroup of medical experts, parents and patients which

produced the Cystinosis Pediatric to Adult Care Transitioning Guide

and Cystinosis Parent Handbook, used as model guides by other rare

disease groups.

Worked with Dr. Gahl and NIH Cystinosis Clinical Fellow to publish

first ever Cystinosis Treatment Guidelines.

Christina Arndt

Greeley, page 2

Built strategic relationships with rare disease community as member of

the Genetic Alliance (GA) and the National Organization of Rare

Disorders (NORD), two preeminent umbrella organizations for the rare

disease community, including presence on NORD board of directors and

participation in national events such as Rare Disease Day 2012.

Directed organization's marketing and communication plan.

o Oversaw all content for CRN website (www.cystinosis.org),

patient email listserv, Constant Contact email communications,

YouTube, Twitter, LinkedIn and Facebook presence.

o Spearheaded rebranding of organization's logo and website,

working with development consultant and marketing agency.

o Instituted Salesforce customer relationship management (CRM)

software for organization.

o Published and oversaw all editorial and content decisions for

CRN newsletter, The Cystinosis Advocate, mailed twice yearly to

over 5,000 patients, families, medical professionals and donors.

Vice President, Research (July 2003 - July 2007)

Executive Committee of the Board of Directors. Responsible for

strategic direction and management of all research activities,

including over $1.5 million in grants focused on basic and clinical

research towards the treatment and cure of cystinosis.

Established first cystinosis advocacy group Scientific Review Board

(SRB); recruited expert members, wrote grant proposal review

guidelines and managed the board's activities.

Organized, recruited and managed activities of Medical and

Professional Advisory Committees made up of various worldwide experts

in the disorder.

Issued yearly Call for Research Proposals. Collected/organized

submitted proposals, facilitated SRB review, collected/analyzed SRB's

assessments, and submitted research funding recommendations to the

Board of Directors for approval.

Chaired three international biennial cystinosis medical and family

conferences (2003 in Orlando, FL; 2005 in Salt Lake City, UT; 2007 in

San Antonio, TX). Responsible for all aspects of conference execution

including leadership of conference planning committee, agenda

production, speaker invitations and travel arrangements, poster

session coordination, negotiation with venues, oversight of family

travel scholarship program, leadership of planning conference calls,

budget and corporate sponsorships.

Presented organization's research activities during Family

Conferences.

Co-sponsored scientific symposium at the NIH in 2004 resulting in the

publication of a Consensus Statement on the diagnosis and treatment of

cystinosis in Pediatric Nephrology.

Assisted with authorship and publication of medical and family

brochures.

C.L. Greeley, Inc., Tualatin, OR

Clinical Research Consultant (August 1998 - February 2000)

Contracted Clinical Research Associate with Parke-Davis Pharmaceutical

Research. Monitored and managed sites for Phase III clinical research

in chronic pain trials including the areas of diabetic neuropathy, low

back pain, post-herpetic neuralgia and osteoarthritis. Worked

independently to ensure compliance with Good Clinical Practices and

all federal regulations for west coast sites of Michigan based

company.

Parke-Davis Pharmaceutical Research, Ann Arbor, MI (acquired by Pfizer

in 2000)

Assistant Clinical Scientist (September 1995 - August 1997)

Managed multicenter Phase I international neuroprotection and Phase

III psychiatric clinical trials. Responsible for all aspects of

protocol management including supervision of clinical research

associates, leadership of cross-functional workgroups and

summarization and reporting of study status and results.

Worked with consultants and colleagues from biostatistics,

pharmacokinetics/drug metabolism, clinical pharmaceutical operations,

data coordination, clinical communications and clinical database and

reporting systems to write Phase I severe head injury and Phase II and

III social phobia protocols, including preparation of programming

specifications, data entry criteria, listing and summary tables and

analysis plan.

Wrote amendments and addenda to protocols.

Directed design of case report forms and wrote monitoring guidelines.

Developed/managed study grants, negotiated individual site budgets

with investigators and made/tracked payments.

Recruited investigators and initiated study sites; supervised

regulatory document collection and filing.

Organized and conducted Investigators' Meetings, including

presentation of protocols.

Christina Arndt

Greeley, page 3

Coordinated efforts between internal staff and organizations

contracted to provide services including site monitoring, data

management, central laboratory and central randomization system.

Developed and implemented patient tracking mechanisms.

Produced investigative site newsletters and internal status reports.

Organized efforts of Safety Data Review Board comprised of consultant

neurosurgeons to monitor head injury trial and provided board with

patient safety and summary pharmacokinetic data.

Participated in interdisciplinary Development Team meetings for

compounds in various phases of pre-clinical and clinical development.

Wrote IND Annual Reports for several compounds.

Attended conferences (American Epilepsy Society and NCDEU Annual

Meetings), seminars and internal courses.

Taught internal training course entitled, "Monitoring a Drug Study" to

colleagues.

Presented interim results of head injury trial during clinical

research department forum.

Participated in departmental reengineering effort; reviewed new

procedures and managed the first clinical protocol to be conducted

using newly reengineered processes.

Clinical Research Associate (January 1993 - September 1995)

(Contracted to Parke-Davis through CRO Statprobe, Inc., Ann Arbor, MI,

January 1993 - November 1994)

Initiated and monitored study sites for Phase III adult and pediatric

epilepsy clinical trials. Acted as liaison between sponsor and

physicians, nurse clinical research coordinators, neuropsychologists

and other clinical study site personnel.

Traveled to clinical study sites across the United States to ensure

protocol adherence, compliance with Good Clinical Practices and

maintenance of study documents in accordance with federal regulations.

Monitored study progress and patient enrollment.

Verified and collected study data through review of source medical

documents.

Evaluated evidence of drug safety and efficacy, including

identification/documentation of Serious Adverse Events.

Implemented and maintained neuropsychological/Quality of Life portion

of adult protocols including testing of neuropsychological personnel

for competency. Wrote Quality of Life monitoring guidelines and

meeting minutes for investigator and consultant meetings.

Reviewed listing and summary tables for safety update and research

report generation.

Assisted study manager with administrative responsibilities such as

budget payment and addendum, amendment, newsletter and guideline

preparation.

. Presented Site Monitoring/Study File

Documents/U.S. Regulatory portion of Neurontin

Pediatric Monotherapy Investigator's Meeting.

. Interviewed and trained newly hired Clinical

Research Associates.

. Addressed physician questions regarding current

Neurontin research and presented poster detailing

ongoing monotherapy research at the American

Academy of Neurology Meeting, May 1995.

University of Michigan Medical Center, Department of Psychiatry, Ann

Arbor, MI

Project Coordinator (August 1991 - January 1993)

Liaison between project director and administrative, laboratory,

statistical, medical and nursing staff in Psychoimmunology Program,

Depression Program, Alcohol Research Center and Clinical Research

Center for multiple clinical research projects examining the effect of

psychiatric illness on cellular immunity.

. Hired, trained and supervised staff of research

assistants.

. Constructed comprehensive procedures manual for

project.

. Oversaw all ordering and payroll activity for

two NIH grants.

. Recruited patients and normal control subjects

into study through advertising, telephone

screening, clinical laboratory testing and

structured psychiatric interviews and

questionnaires.

. Managed clinical and laboratory database

including data collection, editing, entry,

verification and report generation.

. Performed statistical analyses and assisted in

interpretation of results.

. Assisted with preparation of manuscripts,

posters and presentation of findings.

Christina Arndt

Greeley, page 4

EDUCATION/PROFESSIONAL DEVELOPMENT

Master of Public Health, Public Health Policy and Administration,

April 1991

University of Michigan, School of Public Health, Ann Arbor, MI

Bachelor of Science, Psychology, April 1989

University of Michigan, College of Literature, Science and the Arts,

Ann Arbor, MI

Research Assistant Positions

Transplant and Health Policy Center, Ann Arbor, MI, September 1990 -

August 1991

Analyzed and researched regulation, legislation and public policy

relevant to transplantation activity at state, regional and national

levels. Collected public policy committee's findings and assisted

with resulting published analysis of Michigan hospitals' compliance

with required request legislation.

University of Michigan, School of Public Health, Program in Nutrition,

Ann Arbor, MI, September 1989 - May 1990

Managed database of NIH studies including data coding, entry,

verification and report generation. Coordinated blood cholesterol

screening program with University of Michigan Fitness Research Center.

University of Michigan, Department of Pathology, Howard Hughes Medical

Institute, Ann Arbor, MI, September 1988 - September 1989

Responsible for all aspects of laboratory management, including supply

ordering and lab upkeep, assay performance and data entry in lab of

John B. Lowe, M.D.

University of Michigan Medical Center, Department of Internal

Medicine, Division of Rheumatology, Ann Arbor, MI, September 1986 -

September 1988

Responsible for all aspects of laboratory management. Completed

series of experiments entailing protocol writing, assay performance

and data analysis leading to several publications in lab of Marilyn C.

Pike, M.D., Ph.D.

VOLUNTEER EXPERIENCE

Illinois School District 103 Parent Teacher Organization Board Member

(2006 - 2008 and 2011 - present)

Illinois School District 103 Learning Fund Foundation Board Member

(2011 - present)

President and Treasurer Village Club of Lincolnshire, Illinois (2003 -

2006)

Girl Scout Leader (2003 - 2006)

PUBLICATIONS/ABSTRACTS/PRESENTATIONS

C. Greeley. Patient Advocacy Panel. Invited speaker at the Drug

Information Association (DIA)/National Organization for Rare Disorders

(NORD) U.S. Conference on Rare Diseases and Orphan Products: Shaping

the Future Now, Washington, D.C., October 22, 2012.

C. Greeley, J. Morales. Cystinosis Research Network Presentation.

Invited speaker at the Cystinosis Satellite Symposium during the 2011

Latin American Pediatric Nephrology Association 9th ALANEPE Congress,

Sao Paulo, Brazil, October 26, 2011.

C. Greeley. Board/Organizational Development. Invited speaker at the

National Organization for Rare Disorders Regional Membership Meeting,

Chicago, IL, September 16, 2011.

C. Greeley, J. Morales. Cystinosis Research Network. Poster

presented at the 5th International Cystinosis Conference 2008 Ireland,

Dublin, Ireland, June 27, 2008.

E. Garofalo, A. Hayes, C. Greeley, M. Hes, M. Mann, M. Pierce and the

U.S. Gabapentin Study Group 82/83. An Open-Label Extension Study of

Gabapentin (GBP; Neurontin ) Monotherapy in Patients with Medically

Refractory Partial Seizures. Epilepsia, Vol. 36, Supp. 4, 1995: 68.

Presented at the annual meeting of the American Epilepsy Society,

Baltimore, MD, December 1-6, 1995.

Christina Arndt Greeley, page 5

C. Dodrill, J. Arnett, A. Hayes, E. Garofalo, C. Greeley, M. Mann, M.

Hes, M. Greiner, E. Koto, M. Pierce and the U.S. Gabapentin Study

Group 82/83. Evaluation of Quality of Life During a Double-Blind

Multicenter Study of Gabapentin (GBP; Neurontin ) Monotherapy in

Patients with Medically Refractory Seizures. Epilepsia, Vol. 36,

Suppl. 4, 1995: 88. Presented at the annual meeting of the American

Epilepsy Society, Baltimore, MD, December 1-6, 1995.

A. Hayes, E. Garofalo, C. Greeley, M. Mann, M. Hes, M. Greiner, E.

Koto, M. Pierce and the U.S. Gabapentin Study Group 945-82/83. A

Double-Blind Multicenter Study of Gabapentin (GBP; Neurontin )

Monotherapy in Patients with Medically Refractory Partial Seizures.

Epilepsia, Vol. 36, Suppl 4, 1995: 89. Presented at the annual

meeting of the American Epilepsy Society, Baltimore, MD, December 1-6,

1995.

A. Hayes, E. Garofalo, M. Mann, M. Hes, C. Greeley, M. Greiner, M.

Pierce and the U.S. Gabapentin Study Group 945-82/83. Gabapentin

(Neurontin ) Monotherapy: A Double-Blind Study in Patients with

Medically Refractory Partial Seizures. Epilepsia, Vol. 36, Suppl.3,

1995: S119. Presented at the 21st International Epilepsy Congress,

Sydney, Australia, September 3-8, 1995.

A. Hayes, E. Garofalo, M. Mann, M. Hes, C. Greeley, M. Pierce and the

U.S. Gabapentin Study Group 945-82/83. Quality of Life Assessments

During a Double-Blind Study of Gabapentin (Neurontin ) in Patients

with Medically Refractory Partial Seizures. Epilepsia, Vol. 36,

Suppl. 3, 1995: S187. Presented at the 21st International Epilepsy

Congress, Sydney, Australia, September 3-8, 1995.

E. Garofalo, A. Hayes, C. Greeley, M. Hes, M. Mann, M. Greiner, M.

Pierce and the U.S. Gabapentin Study Group 945-82/83. Gabapentin

(Neurontin ) Monotherapy in Patients with Medically Refractory Partial

Seizures: An Open-Label Extension Study. Epilepsia, Vol. 36, Suppl.

3, 1995: S119. Presented at the 21st International Epilepsy Congress,

Sydney, Australia, September 3-8, 1995.

A. Hayes, C. Greeley, M. Hes, M. Mann, E. Garofalo, D. Leiderman, M.

Pierce and the U.S. Gabapentin Study Group 82/83. An Ongoing Open-

Label Multicenter Study Evaluating Gabapentin (Neurontin ) Monotherapy

and Safety in Medically Refractory Patients with Partial Seizures.

Neurology, 45 (Suppl 4) April 1995: A250. Presented at the American

Academy of Neurology 47th Annual Meeting, Seattle, Washington, May 6-

13, 1995.

A. Hayes, M. Mann, C. Greeley, M. Hes, P. Spring, E. Garofalo, D.

Leiderman, M. Pierce and the U.S. Gabapentin Study Group 82/83. An

Ongoing Open-Label Multicenter Study Evaluating Gabapentin

(Neurontin ) Monotherapy and Safety in Patients with Medically

Refractory Partial Seizures. Epilepsia, Vol. 35, Suppl.8, 1994: 164.

Presented at the Annual Meeting of the American Epilepsy Society, New

Orleans, Louisiana, December 2-8, 1994.

A. Hayes, D.B. Leiderman, E. Garofalo, M. Pierce, C. Greeley, M. Hes,

M. Mann, P. Spring and the U. S. Gabapentin Study Group 945-82/83.

The Safety and Efficacy of Gabapentin (Neurontin ) Monotherapy and

Safety in Patients with Medically Refractory Partial Seizures: An

Ongoing Open-Label Multicenter Study. Epilepsia, Vol. 35, Suppl. 7,

1994: 68. Presented at the International Congress of Epileptology,

Oporto, Portugal, September 5-8, 1994.

Z. Kronfol, M. Nair, C. Greeley, K. Goel, D. Sufalko. Circadian HPA

Hormones and Immune Measures in Healthy Volunteers. Presented at the

Annual Meeting of the Society of Biological Psychiatry, 1993.

Transplant and Health Policy Center, Public Policy Committee. Are

Michigan Hospitals Complying with the Required Request Law? Michigan

Hospitals, September, 1991: 21-25.

M.C. Pike, M.E. Bruck, C. Arndt, C.S. Lee. Chemoattractants Stimulate

Phosphatidylinositol-4-Phosphate Kinase in Human Polymorphonuclear

Leukocytes. Journal of Biological Chemistry. 1990 February 5;

265(4): 1866-73.

M.C. Pike, C. Arndt. Characterization of Phosphatidylinositol and

Phosphatidylinositol-4-Phosphate Kinases in Human Neutrophils.

Journal of Immunology. 1988 March 15; 140(6): 1967-73.

M.C. Pike, M.E. Bruck, C. Arndt. Influence of the Cytoskeleton on

Human Polymorphonuclear Leukocyte (PMN) Phosphatidylinositol-4-

Phosphate (PIP) Kinase. American Federation for Clinical Research.

Clinical Research. 36(3): 535A, 1988.

M.C. Pike, C.A. DeMeester, C. Arndt. Characterization of Human

Polymorphonuclear Leukocyte (PMN) Phosphatidylinositol (PI) and

Phosphatidylinositol-4-Phosphate (PIP) Kinases. American Federation

for Clinical Research. Clinical Research. 5:856A, 1987.

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