Scott Kolodny
North Ridgeville
Summary
Senior Director with extensive experience in medical affairs at Sobi Pharmaceuticals, focusing on rare diseases and evidence generation. Demonstrated success in cultivating KOL relationships and developing talent, leading cross-functional teams to improve brand impact and implement innovative clinical strategies. Proficient in clinical trial design and skilled in effective communication.
Overview
23
23
years of professional experience
Work History
Senior Director, Medical Affairs
Sobi Pharmaceuticals
Morrisville
03.2021 - Current
- Accountable for establishing medical strategies and tactics for Immune Thrombocytopenia Purpura (ITP) and Chronic Liver Disease (CLD) indications, supporting Doptelet (avatrombopag) in the United States.
- Established and co-directed a cross-functional Doptelet (avatrombopag) brand team using a matrix-style approach.
- Established and directed Doptelet (avatrombopag) Brand Medical Team using matrix structure
- Orchestrated Matrix-style leadership of Field Medical Science Liaison team to ensure effective execution of medical strategy and tactics for ITP.
- Developed and implemented 2022-2027 Doptelet (avatrombopag) evidence generation strategy aligned with Doptelet (avatrombopag) brand strategic initiatives.
- Formulated and executed comprehensive plans for Doptelet (avatrombopag) pediatric indication medical affairs pre-launch and launch
- Prepared Sobi organization for entry of Promacta biosimilar (Alvaiz) and AB-rated generic.
- Developed ITP KOL archetyping model with targeted discussion topics and relevant data sets.
- Led training sessions for Field Medical Science Liaison team on effective implementation of KOL strategies.
- Executed publication planning and oversight for ITP, including abstract and poster submissions.
- Managed oral presentation preparation and manuscript development for ITP publications.
- Oversaw ISS review processes for ITP projects across the United States.
- Facilitated engagement and development initiatives with thought leaders for ITP in the United States.
- Directed life cycle management strategies for Doptelet (avatrombopag).
- Acted as the U.S. representative on the ITP Global Publication Team and coordinated with the Global Clinical Development team.
- Ensured alignment between US and global teams to enhance project outcomes.
- This position followed the Sobi acquisition of Dova Pharmaceuticals.
EXECUTIVE DIRECTOR, MEDICAL AFFAIRS
Dova Pharmaceuticals
Durham
07.2020 - 03.2021
- Directed medical pre-launch planning for chemotherapy-induced thrombocytopenia indication of Doptelet (avatrombopag) in United States.
Formulated comprehensive launch strategies and tactics targeting CIT indication for Doptelet (avatrombopag). - Developed comprehensive medical strategies for immune thrombocytopenic purpura and chronic liver disease indications to enhance support for Doptelet (avatrombopag) in United States
- Developed integrated strategies to elevate awareness and adoption of Doptelet in relevant indications.
- Crafted and established synopsis/protocol alongside global clinical development for Avatrombopag 307, Phase IIIb study in persistent ITP
- Implemented and disseminated Phase 3 study findings of avatrombopag in chemotherapy-induced thrombocytopenia (CIT).
- Developed two manuscripts stemming from detailed real-world retrospective chart review study evaluating change from other TPO-RA therapies in ITP to avatrombopag.
- Produced, executed, and shared two post-hoc analysis manuscripts originating from original Doptelet (avatrombopag) Phase 3 clinical trial in ITP.
- Led field medical liaison initiatives to enhance strategic partnerships for ITP.
- Executed advisory board planning and implementation for ITP projects.
- Generated evidence through Phase IIIb/IV studies and real-world data for Doptelet.
- Executed pre-launch strategies for pediatric indication of Doptelet.
- Developed and managed publication plans to promote ITP research findings.
- Oversaw ISS review and compliance for ITP in the United States.
- Engaged and cultivated relationships with thought leaders in ITP.
- Directed life cycle management strategies for Doptelet to maximize impact.
- Dova Pharmaceuticals was acquired by Sobi Pharmaceuticals, and my role transitioned to the above position.
EXECUTIVE MEDICAL DIRECTOR (MULTIPLE SCLEROSIS)
Novartis Pharmaceuticals
East Hanover
04.2019 - 07.2020
- Directed management of U.S. Multiple Sclerosis Medical Directors and established comprehensive strategies for Gilenya, Mayzent, and pipeline Multiple Sclerosis products.
- Launched pediatric indication for Gilenya in the United States.
- Successfully launched Mayzent in the United States.
- Executed launch of Kesimpta in the United States.
- Co-led cross-functional US Multiple Sclerosis Strategic Team to align initiatives.
- Led the cross-functional U.S. Multiple Sclerosis Medical Tactical Team to coordinate medical efforts.
- Guided evidence generation and publication planning for multiple sclerosis in the United States.
- Managed thought leader engagement and advisory board planning for multiple sclerosis.
- Transitioned from title of Disease Area Head (Multiple Sclerosis) at Novartis Pharmaceuticals to newly updated role
DISEASE AREA HEAD (MULTIPLE SCLEROSIS)
Novartis Pharmaceuticals
East Hanover
04.2017 - 04.2019
- Directed management of US Multiple Sclerosis Medical Directors while establishing comprehensive US Multiple Sclerosis Medical strategies and tactics for Gilenya (fingolimod), Mayzent (siponimod), and pipeline products [Kesimpta (ofatumumab)] in Multiple Sclerosis (MS)
- Introduced pediatric indication for Gilenya (fingolimod) within United States
- Executed launch of Mayzent (Siponimod) within United States
- Executed launch of Kesimpta (ofatumumab) within United States
- Matrix co-leadership of US Cross-functional Multiple Sclerosis Strategy Team
- Matrix leadership of US Multiple Sclerosis Medical Tactical Team (cross-disciplinary medical team)
- Contributed to North America Medical Affairs Leadership team
- Comprehensive direction for evidence generation (Phase IIIb/IV and Real World Evidence) planning for multiple sclerosis in United States
- Overall oversight for multiple sclerosis publication development and execution in United States
- Leadership of ISS review and oversight for multiple sclerosis in United States
- Leadership of thought leader engagement and development in Multiple Sclerosis across United States
- Led comprehensive planning and execution efforts for multiple sclerosis advisory boards within the United States.
- Serve as North American Medical Affairs liaison for Multiple Sclerosis with Global Medical Affairs and Global Clinical Development
- Pre-launch and launch strategy development for Gilenya (pediatric MS indication), Mayzent (Siponimod), and Kesimpta (ofatumumab)
- Life-cycle management strategy formulation for Gilenya (fingolimod), Mayzent (siponimod), and Kesimpta (ofatumumab)
- Taken on a revised role subsequent to the elimination of the Disease Area Head (Multiple Sclerosis) designation at Novartis Pharmaceuticals.
SENIOR GLOBAL MEDICAL DIRECTOR (MULTIPLE SCLEROSIS
Teva Pharmaceuticals
Philadelphia
03.2015 - 04.2017
- Orchestrated overall global Multiple Sclerosis medical strategies and tactics for Copaxone (glatiramer acetate) and laquinimod (pipeline MS agent)
- Developed Global Medical Strategic Operating Plan (MOP) and Global Medical Affairs Go To Market Access Plan (GTMAP) for Copaxone (glatiramer acetate) and laquinimod (MS pipeline agent)
- Established and co-directed global Copaxone (glatiramer acetate) and laquinimod (pipeline MS agent) brand teams
- Developed and implemented global KOL/Thought Leader Development plan for Copaxone (glatiramer acetate) and laquinimod (MS pipeline agent)
- Contributor to Research and Development (R&D) Leadership group for Multiple Sclerosis (MS).
- Directed strategic guidance, planning, and oversight of global clinical development (Phases 3 and 4/ISS) for Copaxone (glatiramer acetate) and laquinimod (MS pipeline agent).
- Directed project team securing regulatory approval for Copaxone (glatiramer acetate) 40mg TIW with EMA in Europe and Copaxone (glatiramer acetate) 20mg QD with PMDA in Japan
- Facilitated 7 global Multiple Sclerosis (MS) advisory boards to support Copaxone (glatiramer acetate) and laquinimod (MS pipeline agent)
CLINICAL PROJECT PHYSICIAN, MS GLOBAL CLINICAL DEV
Teva Pharmaceuticals
Philadelphia
05.2013 - 03.2015
- Directed clinical project as lead physician for GALA Phase III trial of Copaxone (glatiramer acetate) 40mg TIW
- Developed comprehensive study designs and protocols for both core and open-label segments of the GALA Study.
- Implemented study execution strategies to achieve objectives. Disseminated results of studies to enhance stakeholder understanding.
- Facilitated FDA SNDA submission progress for Copaxone (glatiramer acetate) 40mg TIW.
Coordinated European submission efforts for Copaxone (glatiramer acetate) 40mg TIW.
Managed Japanese PMDS submission process for Copaxone (glatiramer acetate) 20mg QD. - Development of Clinical Strategy for Copaxone (glatiramer acetate) 20mg QD, Copaxone (glatiramer acetate) 40mg TIW, and fractionated Copaxone (glatiramer acetate)
MIGRAINE MEDICAL DIRECTOR (US MEDICAL AFFAIRS)
Teva Pharmaceuticals
Philadelphia
02.2013 - 03.2015
- Directed pre-launch and launch Medical Affairs operations for Zecuity in the United States.
- Established and co-directed the Zecuity cross-functional brand team in the United States.
- Initiated and oversaw Zecuity US cross-functional Medical Affairs launch team
- Spearheaded the annual US Medical Operating Plan (MOP) creation and execution for Zecuity, alongside the US Medical Affairs Annual Operating Plan (AOP) budget development and compliance.
- Formulated migraine US evidence generation and thought leader development strategies
- Orchestrated 6 pre-launch migraine medical advisory boards to enhance Zecuity
- Creation and execution of the ISS migraine initiative, including the development of relevant topics of interest.
US MEDICAL DIRECTOR (MULTIPLE SCLEROSIS)
Teva Pharmaceuticals
Philadelphia
12.2011 - 03.2015
- Formulated comprehensive US Multiple Sclerosis medical strategies and tactics for Copaxone (glatiramer acetate) and laquinimod (pipeline MS agent)
- Developed the US regional Medical Strategic Operating Plan (MOP) and Medical Affairs Go-To-Market Access Plan (GTMAP) for Copaxone (glatiramer acetate) and laquinimod (MS pipeline agent).
- Co-directed US Copaxone (glatiramer acetate) and laquinimod (pipeline MS agent) brand teams in a matrix structure
- Developed and implemented US KOL/Thought Leader Development strategy for Copaxone (glatiramer acetate) and laquinimod (MS pipeline agent)
- Spearheaded design, execution, and publication of Phase 3b GLACIER clinical trial to support global launch of Copaxone (glatiramer acetate) 40mg TIW
- Revised design by adding MRI sub-study, executed and published two manuscripts supporting long-term (30 year) original Copaxone (glatiramer acetate) 20mg trial in Multiple Sclerosis (9004).
- Contributor to Research and Development (R&D) Leadership Team for Multiple Sclerosis (MS).
- Directed strategic guidance, planning, and oversight of global clinical development (Phases 3 and 4/ISS) for Copaxone (glatiramer acetate) and laquinimod (MS pipeline agent)
- Oversaw project team securing regulatory approval of Copaxone (glatiramer acetate) 40mg TIW with EMA in Europe and Copaxone (glatiramer acetate) 20mg QD with PMDA in Japan
- Directed and managed US Multiple Sclerosis ISS program
- Conducted 8 US Multiple Sclerosis (MS) advisory boards enhancing support for Copaxone (glatiramer acetate) and laquinimod (MS pipeline agent)
GLOBAL CLINICAL LEADER (GLOBAL CLINICAL DEV)
Teva Pharmaceuticals
Philadelphia
06.2011 - 11.2012
- Developed synopses and protocols for two prospective laquinimod Phase II clinical trials in Multiple Sclerosis (LAQ-MS-201 and LAQ-MS-304 studies).
MSL (MULTIPLE SCLEROSIS)
Teva Pharmaceuticals
North Ridgeville
12.2007 - 11.2011
- Managed Multiple Sclerosis (MS) and Parkinson's Disease (PD) MSL territory coverage, strategic development, tactical execution, and KOL management across Ohio and Michigan.
Neuroradiologist
University Radiologists
Cleveland
07.2002 - 12.2007
- Extensive knowledge in design and implementation of MRI sequences and segmentation techniques for brain volume assessment, magnetic resonance spectroscopy, susceptibility-weighted imaging, and diffusion tensor imaging in multiple sclerosis and other CNS diseases
Education
Neuroradiology/Interventional Neuroradiology/Neuro-MRI Fellowships -
University Hospitals of Cleveland/CWRU
Cleveland, OH06.2003
Diagnostic Radiology Residency - Diagnostic Radiology
University Hospitals of Cleveland/CWRU
Cleveland, OH06.2001
Transitional Internship -
John Peter Smith Hospital
Ft. Worth, TX06.1997
Medical Doctorate -
University of Texas Medical School
Houston, TX06.1996
Bachelor of Science -
University of Houston
houston, TX12.1993
Skills
- Medical affairs and clinical development
- Neurology and hematology/oncology
- Rare disease expertise
- Neuroimaging and diagnostic imaging
- Evidence generation strategies
- Talent development and mentoring
- Effective communication skills
- Diagnostic radiology and neuroradiology
- Clinical trial design
- Clinical research methodologies
- Real-world evidence and HEOR
- Advocate development and KOL cultivation
- Relationship management
- KOL archetyping techniques
- Medical writing proficiency
- Leadership capabilities
Publications
Available upon request
Awards
- Sobi Culture Award, 2024
- Global Achievement Award (Gilenya Pediatric Indication US Approval), 2018
- President’s Club Medical Affairs Award Winner, 2015
- Professional Affairs Outstanding Teamwork Award, 2010
- Region of the Year (Central Region), 2009
- Competitive Intelligence Award Winner (Marketing Research) 2008, 2010, 2011
Activities
Special expertise in the design and execution of Phase III/IV clinical trials and Real-World Evidence studies., Additional expertise and academic research in the design and creation of MRI sequences and/or segmentation and assessment algorithms for brain volume assessment, magnetic resonance spectroscopy, susceptibility-weighted imaging, and diffusion tensor imaging in demyelinating diseases of the Central Nervous System (CNS)., Broad knowledge in both general immunology and neuroimmunology as well as rheumatological conditions and treatments.
Affiliations
Special expertise:
Special expertise in the design and execution of Phase III/IV clinical trials and Real-World Evidence studies.
Additional Expertise:
Additional expertise and academic research in the design and creation of MRI sequences and/or segmentation and assessment algorithms for brain volume assessment, magnetic resonance spectroscopy, susceptibility-weighted imaging, and diffusion tensor imaging in demyelinating diseases of the Central Nervous System (CNS).
Broad knowledge in both general immunology and neuroimmunology as well as rheumatological conditions and treatments
Accomplishments
· Sobi Culture Award, 2024
· Global Achievement Award (Gilenya Pediatric Indication US Approval), 2018
· President’s Club Medical Affairs Award Winner 2015
· Professional Affairs Outstanding Teamwork Award, 2010
· Region of the Year (Central Region), 2009
· Competitive Intelligence Award Winner (Marketing Research): October 2008, September 2010, July 2011
References
References available upon request.
Timeline
Senior Director, Medical Affairs
Sobi Pharmaceuticals
03.2021 - Current
EXECUTIVE DIRECTOR, MEDICAL AFFAIRS
Dova Pharmaceuticals
07.2020 - 03.2021
EXECUTIVE MEDICAL DIRECTOR (MULTIPLE SCLEROSIS)
Novartis Pharmaceuticals
04.2019 - 07.2020
DISEASE AREA HEAD (MULTIPLE SCLEROSIS)
Novartis Pharmaceuticals
04.2017 - 04.2019
SENIOR GLOBAL MEDICAL DIRECTOR (MULTIPLE SCLEROSIS
Teva Pharmaceuticals
03.2015 - 04.2017
CLINICAL PROJECT PHYSICIAN, MS GLOBAL CLINICAL DEV
Teva Pharmaceuticals
05.2013 - 03.2015
MIGRAINE MEDICAL DIRECTOR (US MEDICAL AFFAIRS)
Teva Pharmaceuticals
02.2013 - 03.2015
US MEDICAL DIRECTOR (MULTIPLE SCLEROSIS)
Teva Pharmaceuticals
12.2011 - 03.2015
GLOBAL CLINICAL LEADER (GLOBAL CLINICAL DEV)
Teva Pharmaceuticals
06.2011 - 11.2012
MSL (MULTIPLE SCLEROSIS)
Teva Pharmaceuticals
12.2007 - 11.2011
Neuroradiologist
University Radiologists
07.2002 - 12.2007
Neuroradiology/Interventional Neuroradiology/Neuro-MRI Fellowships -
University Hospitals of Cleveland/CWRU
Diagnostic Radiology Residency - Diagnostic Radiology
University Hospitals of Cleveland/CWRU
Transitional Internship -
John Peter Smith Hospital
Medical Doctorate -
University of Texas Medical School
Bachelor of Science -
University of Houston
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