Development Project Management

KRISTINE A. ERICKSON, Ph.D, O.D.

** ***** ****** **** ( Blairstown, New Jersey 07825

978-***-**** ( *********@*****.***

DIRECTOR

Medical Affairs ( Medical Information Tracking ( Clinical Operations

Proven clinical research director with 20 years of combined experience in

project management, strategic drug development/implementation and

pharmaceutical sponsors/partners relationship-building. Adept in vendor

contract and outsourcing negotiations. Expert in grant writing and

submission process strategy development.

. Directed all aspects and phases for clinical development of novel

recombinant peptides.

. Designed and implemented preclinical and clinical programs to develop

oral recombinant peptides from preclinical toxicology studies through

phase III pivotal studies..

AREAS OF EXPERTISE

Clinical Trial Project Management ( Budget & Expense Control ( Pre-

Clinical/Clinical Development Planning

FDA Preparation ( Research Proposal Cultivation & Facilitation (

Preclinical/Clinical Data Analysis

Project Risk Management ( Regulatory Due Diligence & Compliance ( IND

Reporting

PROFESSIONAL HISTORY

Unigene Laboratories, Inc., Boonton, New Jersey ( 2007-Present

Senior Director of Clinical Affairs

Oversee and direct clinical trial executions. Manage timelines, resources

and budgets of clinical development initiatives. Draft and submit

regulatory documents, investigator brochures and IND reports. Develop

regulatory strategies to secure approval for domestic and international

marketing. Ensure compliance with SOPs, FDA regulations and ICH GCP

guidelines. Select and audit investigators, study sites, CROs, SMOs,

central labs and central imaging facilities.

Major Contributions:

. Directed Phase I-III development and implementation of oral calcitonin

in 40 months.

. Negotiated regulatory strategy with FDA for clinical trial timeline.

. Managed $33M+ in research budgets for 2 trials.

. Negotiated FDA approval of abbreviated preclinical toxicology program.

. Co-Developed regulatory strategy for marketing approval for European

Union.

Ophthalmic Research Associates, North Andover, Massachusetts ( 1996-2007

Consulting Pharmacologist/Toxicologist; Consulting Clinical Investigator

Oversaw drafting/submission of preclinical and clinical

pharmacology/toxicology sections of INDs, annual reports, protocols, and

investigator brochures. Prepared clients for FDA meetings to facilitate

approval of requests. Conducted clinical investigator training. Performed

clinical investigations for various clinical trials.

Major Contributions:

. Performed clinical assessment of dry eye via company's proprietary

environmental model.

. Conducted clinical assessment of ocular allergy via company's antigen

challenge model.

KRISTINE A. ERICKSON, Ph.D, O.D. ( Page 2 978-***-**** (

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

TOXIKON CORPORATION, Bedford, Massachusetts ( 2006-2007

Study Director

Directed GLP studies for development of new pharmaceutical and drug

devices. Served as sponsors' point-of-contact for strategic development of

preclinical toxicology programs for IND development. Directed research team

in execution of proof-of-concept, ADME, toxicokinetic, dose finding, acute,

subacute and chronic toxicology, and safety and genotoxicity studies.

ADDITIONAL EXPERIENCE:

Tufts University School of Medicine

Professor in Ophthalmology

. Directed NIH-funded glaucoma research program.

Boston University School of Medicine

Associate Professor in Ophthalmology and Pharmacology

. Directed NIH-funded glaucoma research program.

Harvard Medical School

Associate Professor in Ophthalmology

. Directed NIH-funded glaucoma research program.

EDUCATION & TRAINING

Optometry Residency

Boston University School of Medicine, Department of Ophthalmology, Boston,

Massachusetts

Doctor of Optometry

New England College of Optometry, Boston, Massachusetts

Doctor of Philosophy in Pharmacology

University of Wisconsin, Madison, Wisconsin

ACCREDITATION

American Academy of Optometry Fellow

AWARDS

Alcon Research Institute Award (Research Excellence) ( ASOPRS Award (

Quickert Thesis Award

ARVO Travel Fellowship ( ISER Travel Fellowship

PUBLICATIONS (Selected)

"The Perfused Human Ocular Anterior Segment as a Model for Aqueous Outflow

Physiology"

Journal of Glaucoma 1:44-53, 1992.

"Expression of adenylate cyclase subtypes II and IV in the human outflow

pathway". Invest Ophthalmol Vis Sci, 41(5);998-1005, 2000.

LICENSURE

Optometry, New Jersey, 2007-Present (inactive #27OA006123500)

Optometry, Massachusetts, 1995-2008 (#3396)

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