Kristine Erickson
Brooklyn,CT
Summary
Award-winning clinical and basic research professional with extensive experience at the Vice President and Senior Director levels. Key opinion leader in glaucoma research, forging strong relationships with NIH and FDA. Published author with a leadership role in developing global clinical and regulatory strategies for novel biologics and small molecules.
Overview
40
40
years of professional experience
1
1
Certification
Work History
Vice President and Therapeutic Area Head, Ophthalmology Medical Science
Tourmaline Bio
01.2023 - Current
- Provides medical leadership for the Thyroid Eye Disease (TED) program and other development efforts in ophthalmology indication.
- Medically leads the clinical trial strategy for the TED program and other eye disease programs, aligning with the company's overall vision and strategy.
- Provides medical expertise and leadership in developing protocols, statistical analysis plans, investigator's brochures, clinical study reports, and other clinical trial-related documents.
- Provides medical expertise and leadership in developing medical content for regulatory submission packages.
- Medically oversees and liaises with external partners, CROs, and investigators to ensure the effective and efficient conduct of clinical trials.
- Provides medical direction for operational aspects of the clinical trials.
- Reviews, analyzes, and interprets clinical trial data.
- Serves as the medical expert for internal stakeholders, providing guidance and support on medical and scientific matters related to drug development in TED and other eye disorders.
- Represents the company at scientific conferences and symposia, including presenting clinical and scientific data.
- Serves as the medical lead for regulatory interactions and submissions, providing medical input and ensuring compliance with regulatory requirements.
- Fosters a culture of innovation, collaboration, and scientific excellence within the program teams and the organization.
- Organizes Advisory Committees and data safety monitoring boards.
- Serves as a contributing author of published manuscripts.
- Oversees the scientific content of data presentations at major scientific meetings.
- Served as a critical contributor to the successful IND filing of the pacibecitub product.
- Developed the strategy for the clinical development of pacibecitub for thyroid eye disease.
Principal
Roemega, LLC
01.2018 - 01.2023
- Company Overview: A consulting company offering guidance on clinical development and regulatory strategy.
- Founder and key contributor.
Adjunct Professor
MCPHS University, Department of Optometry
01.2018 - 01.2019
- Instructor of record: Systemic Pharmacology and Ocular Pharmacology.
- Developed and implemented course syllabi, lesson plans, and assessments.
- Facilitated active learning through class discussions, group activities, and individual projects.
- Provided constructive feedback on student assignments to promote student success.
Vice President Clinical Research
Aerie Pharmaceuticals
01.2017 - 01.2018
- Provided overall scientific guidance and strategic direction in developing clinical programs
- Supervised operational components of clinical studies, ensuring on-time deliverables and compliance with ICH and regulatory authority standards
- Acted as the primary developer of clinical/scientific content for communications with regulatory agencies and IRBs
- Directly developed scientific and medical portions of clinical study reports and safety reports.
- Achieved successful NDA filing of Rhopressa, a novel Rho-kinase inhibitor.
- A key contributor to a successful FDA advisory committee meeting regarding Rhopressa.
- Organized Advisory Committee meetings.
- Oversight of the scientific content of numerous presentations of data at major scientific meetings
- Co-chairman of the cross-functional Rhopressa launch committee.
Senior Director Clinical Sciences – Ophthalmology
Regeneron Pharmaceuticals, Inc
01.2011 - 01.2017
- Provided overall scientific guidance and strategic direction in developing clinical programs
- Supervised operational components of clinical studies, ensuring on-time deliverables and compliance with ICH and regulatory authority standards
- Supervised production of medical and scientific portions of clinical research protocols, derived from clinical study concepts.
- Acted as the primary developer of clinical/scientific content for communications with regulatory agencies and IRBs/ethics boards
- Directly developed scientific/medical portions of clinical study reports, safety reports, and IND and BLA filings
- Key contributor to the successful BLA filing of EYLEA and subsequent FDA correspondence
- Drove the successful IND filing of the nesvacumab/Eylea combination product
- Developed the strategy for the nesvacumab/Eylea combination product for macular degeneration
- Organized Advisory Committees and data safety monitoring boards
- Contributing author of published manuscripts
- Oversight of the scientific content of numerous presentations of data at major scientific meetings
Senior Director Clinical Affairs
Unigene Laboratories, Inc.
01.2007 - 01.2011
- Provided effective leadership of internal and external resources for all clinical development efforts
- Developed strategy and implemented drug development goals
- Was the principal clinician responsible for the implementation of clinical trials
- Developed effective clinical research plans, including the writing/review of protocols, Investigator Brochures, and the clinical and toxicology sections of Investigational New Drug applications (INDs), New Drug Applications (NDAs), and Clinical Trial Applications (to global regulatory authorities)
- Oversaw IRB and ethics committee submissions and liaised with those committees.
- Functioned as an expert liaison between Unigene and leading academic specialists
- Coordinated project risk management
- Successful design and implementation of a clinical/regulatory strategy for developing oral calcitonin from Phase I through Phase III, meeting tight timelines (18 months).
- Design and implementation of an oral PTH program
- Assumed a vital role in the successful negotiation of a 505(b)(2) regulatory strategy for oral calcitonin with the FDA
- Successfully designed a pivotal protocol that received FDA approval through Special Protocol Assessment.
- Assumed a vital role in the global regulatory and ethics committee approvals of the Phase III oral calcitonin pivotal study
- Identified, performed due diligence, and negotiated contracts with multiple CROs, central laboratory facilities, and the US and International study sites
- Contributing author of published manuscripts
Investigator
Ophthalmic Research Associates
01.1997 - 01.2007
- Clinical investigator, oversight, and training of study investigators; supervision of study site staff.
- Sub-investigator on clinical trials in the development of multiple currently marketed ophthalmic allergy and dry eye drops.
- Trained and supervised investigators at study sites on the clinical assessment of dry eye using the controlled adverse environment model.
- Trained and supervised investigators at study sites on the clinical assessment of ocular allergy using the conjunctival antigen challenge model.
Consulting Toxicologist/Pharmacologist
Consulting Toxicologist/Pharmacologist
01.1991 - 01.2007
- Strategic input into the cost/time-effective development of clinical research programs from preclinical toxicology through Phase III
- Coordinated the writing and authored multiple INDs, Investigator Brochures, and Annual Reports.
- Prepared clients for FDA meetings
- Attended FDA meetings on behalf of clients
Associate Professor
New England College of Optometry
01.1995 - 01.2004
- Professor of record: Ocular Pharmacology
- Professor, Optometry Continuing Education Series
- Clinical Preceptor: Optometry interns and residents
- Preceptor VOSH (Volunteer Optometric Services to Humanity)
- Founding Director, Joseph Smith Community Health Center Eye Service
Professor in Ophthalmology
Tufts University Medical School
01.2001 - 01.2003
- Director of the basic glaucoma research program.
- Collaborative investigator on the center core grant
- Lecturer in Ophthalmology, Resident grand rounds series.
- Preceptor of graduate and postdoctoral students.
- Played a vital role in successful departmental fundraising
- Organized ocular pharmacology lecture series for ophthalmology residents.
- Authored peer-reviewed research papers
- Served on the Editorial Board of Investigative Ophthalmology and Visual Sciences
Associate Professor in Ophthalmology/ Associate Professor in Pharmacology
Boston University School of Medicine
01.1996 - 01.2001
- Director of the basic glaucoma research program
- Lecturer in Ophthalmology, Resident grand rounds series.
- Preceptor of graduate and postdoctoral students.
- Played a vital role in successful departmental fundraising
- Served on NIH study section
- Served on two private foundation study sections
- Authored peer-reviewed research papers and book chapters
- Served on the Editorial Board of Investigative Ophthalmology and Visual Sciences
Instructor, Assistant, and Associate Professor in Ophthalmology
Harvard Medical School/Massachusetts Eye and Ear Infirmary
01.1985 - 01.1996
- Investigator in basic glaucoma research
- Lecturer in Ophthalmology, Resident grand rounds series.
- Lecturer in the Lancaster Course
- Preceptor of graduate and postdoctoral students.
- Chairman of the Institutional Animal Care Committee.
- Played a vital role in successful departmental fundraising
- Organized the Anterior Segment portion of the International Congress of Eye Research (1994)
- Awarded an NIH R01 grant and established a long-standing glaucoma research program.
- Recipient, Alcon Award for Excellence in Ophthalmic Research
- Authored peer-reviewed research papers and book chapters
Education
Ph.D. - Pharmacology
University of Wisconsin
OD -
New England College of Optometry
Skills
- Effective Organizational Communication
- Task Management Proficiency
- Effective Team Leadership
- Contract Negotiation
- Fundraising Expertise
- Proposal Writing
- Operations Management
- Client Relationship Building
- Data Analysis
- Relationship Building
- Presentations
- Training and mentoring
- Complex Problem-Solving
- Strategic Planning
- Critical Thinking
- Cross-functional team leadership
Certification
TPA Optometry License, Massachusetts, #3996
Degrees
- OD
- PhD
Timeline
Vice President and Therapeutic Area Head, Ophthalmology Medical Science
Tourmaline Bio
01.2023 - Current
Principal
Roemega, LLC
01.2018 - 01.2023
Adjunct Professor
MCPHS University, Department of Optometry
01.2018 - 01.2019
Vice President Clinical Research
Aerie Pharmaceuticals
01.2017 - 01.2018
Senior Director Clinical Sciences – Ophthalmology
Regeneron Pharmaceuticals, Inc
01.2011 - 01.2017
Senior Director Clinical Affairs
Unigene Laboratories, Inc.
01.2007 - 01.2011
Professor in Ophthalmology
Tufts University Medical School
01.2001 - 01.2003
Investigator
Ophthalmic Research Associates
01.1997 - 01.2007
Associate Professor in Ophthalmology/ Associate Professor in Pharmacology
Boston University School of Medicine
01.1996 - 01.2001
Associate Professor
New England College of Optometry
01.1995 - 01.2004
Consulting Toxicologist/Pharmacologist
Consulting Toxicologist/Pharmacologist
01.1991 - 01.2007
Instructor, Assistant, and Associate Professor in Ophthalmology
Harvard Medical School/Massachusetts Eye and Ear Infirmary
01.1985 - 01.1996
Ph.D. - Pharmacology
University of Wisconsin
OD -
New England College of Optometry
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