John Komacko
Brownsburg,IN
Overview
32
32
years of professional experience
1
1
Certification
Work History
Senior Director Sr. Director-Global Regulatory Affairs - Product Communications
Eli Lilly and Company
11.2021 - Current
- Deliver high quality regulatory support and leadership for the regulatory product communications team supporting Alzheimer’s assets including the launch of Kisunla.
- Worked cross-functionally preparing and executing launch, including labeling strategy for drug and diagnostic assets, critical guidance across all channels and teams, and providing coaching teammates and onboarding supporting contractors.
- Provided collaborative leadership and solutions oriented Regulatory advice playing a key role in the success of the Lilly Alzheimer’s team
- Coached and mentored other Lilly team members and contractors to ensure consistency and compliance across the diagnostic, disease state and therapeutic communications.
- Provided regulatory leadership for new claim development process for marketed products and investigational products currently in clinical trials. Provide input on draft claims, market testing and internal implementations strategies.
- Provide regulatory input on ethics and compliance questions related to speaker programs and sales rep interactions.
- Review 2253 FDA submissions performing quality review and sign off for promotional communications.
- Optimized project timelines by effectively delegating tasks and prioritizing workload among team members.
- Cultivated a culture of innovation by promoting creative thinking and encouraging employees to take calculated risks in pursuit of solutions.
- Managed risk effectively by identifying potential threats, developing contingency plans, and implementing mitigation strategies in line with overall business objectives.
Regulatory Advisor – Global Regulatory Affairs Biomedicines
Eli Lilly and Company
09.2017 - 10.2021
- Provide Regulatory support for Global, US and Canada for the following products: Baricitinib, Forteo and Cialis. Lead regulatory strategy for ongoing and future development and postmarketing efforts ensuring compliance and quality with appropriate regulations, internal policies, and external drivers.
- Lead scientist for the Phase 3 clinical development of baricitinib for the treatment of Systemic Lupus Erythematosus. Responsibilities include managing quality submissions, strategies for key FDA interactions, regulatory responses, and overall compliance with regulations of drug development. Additional responsibilities include the development of labeling, promotional claims, and assessments for the label dashboard to pull the development strategy through to the execution of commercial efforts.
- Lead FDA interactions as it relates to development and support of marketed products including formal FDA meetings, pediatric development, phase 3 development, and labeling activities.
- Serve as GRA representative on FAST team
- Maintained up-to-date knowledge on industry trends and regulations, ensuring accurate advice was provided to clients at all times.
Regulatory Advisor – Global Regulatory Affairs US AD/PROMO
Eli Lilly and Company
05.2010 - 08.2017
- Provide Regulatory support for the Axiron, Cialis, Effient, Taltz, Olumiant, Reopro, Strattera, Zyprexa, Forteo, and Livalo Brand teams including strategy for ongoing and future promotional efforts ensuring compliance and quality with appropriate regulations, internal policies, and external drivers.
- Lead FDA interactions as it relates to promotional messaging in the HCP and consumer environment.
- Provide Regulatory support for early phase and life cycle planning for early phase compounds in the autoimmune therapeutic area.
- Serve as GRA US Ad/promo SME for Television and direct to consumer initiatives as it relates to policy and implementation in promotional strategies
Associate Regulatory Consultant – Global Regulatory Affairs US AD/PROMO
Eli Lilly and Company
02.2006 - 05.2010
- Provide Regulatory support for the Cialis and Strattera Brand teams
- Provide regulatory strategy for ongoing and future promotional efforts ensuring compliance and quality with appropriate regulations, internal policies, and external drivers.
- Manage FDA interactions as it relates to promotional messaging in the HCP and consumer environment.
- Manage PharmD preceptorship for the USRA LTC team. Provide mentorship opportunities for students to learn about the industry environment. Utilize student resources to accomplish departmental tasks, research, and training.
TEAM LEADER GPS-US Marketed Products
Eli Lilly and Company
03.2005 - 01.2006
- Responsibility for the Zyprexa, Oncology, Infectious disease, Critical care case management
- Consistent delivery of departmental and company goals including compliance and quality.
- Responsible for overseeing the performance and development of staff with multiple responsibilities (19 pharmacists and nurses).
- Recruitment and retention of employees.
- Analyze the momentum of the business and processes to ensure that compliance is maintained as effectively and efficiently as possible.
- Provide senior management with departmental strategy and plan for implementation to achieve the projected goals.
TEAM LEADER Global Product Safety US Affiliate Operations
Eli Lilly and Company
10.2003 - 03.2005
- Responsible for ensuring compliance with FDA regulations and quality expectations surrounding product requirements
- Lead training and quality team responsible for US Affiliate operations
- Responsible for budget and resource needs of the department
- Oversee external training of outside functions including sales force, medical information, call center personnel, vendors and business partners to ensure compliance with reporting regulations
- Oversee inspection readiness procedures and active participation in audits internally and with FDA
- Develop action and implementation plans cross functionally for process gaps
- Perform risk assessment profiles and utilize gap analysis techniques to identify potential risk areas (i.e. system validation, HIPAA, Code federal Regulation)
- Oversee data management operations supporting Indianapolis based GPS functions
TEAM LEADER MARKETED PRODUCTS
Eli Lilly and Company
08.2001 - 09.2003
- Responsibility for the neuroscience, women’s health, pregnancy, and expedited mailing.
- Consistent delivery of departmental and company goals including compliance and quality.
- Responsible for overseeing the performance and development of staff with multiple responsibilities (28 pharmacists and nurses) 19 direct reports.
- Recruitment and retention of employees.
TRIAGE COORDINATOR
Eli Lilly and Company
12.1999 - 08.2001
- Responsible for overseeing the collection and management of all adverse event data entering the Worldwide Pharmacovigilance and Epidemiology Division.
- Perform medical review of all adverse event reports to apply standards of consistency and completeness in documentation.
- Provide leadership, training, coaching, and mentoring for support staff to facilitate satisfying their performance goals as well as meeting the needs of the department with regards to integrity of the documentation system.
- Responsible for the development and implementation of metrics to aid management in control and understanding the process.
- Provide a quality check of all cases that are ready to be filed in order to ensure that documentation guidelines and adherence to policies.
- Involvement in several projects to improve processes.
PRODUCT SAFETY ASSOCIATE
Eli Lilly and Company
03.1999 - 12.1999
- Management of adverse event data in support of marketed products
- Communication with internal Lilly customers as well as external is critical to ensure complete adverse event reporting to regulatory agencies on a global scale
- Responsibilities include: review of data to identify key areas of focus, knowledge of regulations, knowledge and ability to apply departmental policies. Key skills for this position include: strong medical knowledge as well as knowledge in regulatory requirements, good communication skills, computer skills, leadership, and the ability to work as an individual as well as in a team setting
CONTRACT REGULATORY ASSOCIATE
KELLY SCIENTIFIC (Eli Lilly and Company)
05.1998 - 02.1999
- Case management within the Global Safety Department.
- Tasks include managing adverse event reports for several different therapeutic areas, which included marketed products as well as clinical trial data.
- Ensured compliance with reporting requirements to global regulators.
- Responsibilities included medical assessment, entering and compiling information as well as follow-up communications with health care professionals globally.
PHARMACY MANAGER
WALGREENS PHARMACY
08.1993 - 01.1997
- Provided cost effective health care to meet the medical needs of patients
- Provided training, leadership, and decision-making abilities which translated into an increase of 26% in sales and 36% in volume of prescriptions filled
- Participated in promotional campaigns, reader board, doctor detailing, and good customer relations. Involved in establishing the new Las Vegas market, which became a great learning experience in many ways
Education
Bachelor of Science - Pharmacy
Butler University
01.1993
Masters in Business Administration -
Indiana Wesleyan University
01.2000
Skills
- 15 years experience providing regulatory leadership and support in developing accurate, balanced and compliant advertising and promotion, medical, and corporate communications efforts
- Successfully led team of associates in supporting advertising and promotion activities in the US supporting multiple products Including claims development, change control evaluation, deviation management 2253 support, and escalations
- Significant experience in implementing direct to consumer activities employing brand strategy and strategies to improve patient experiences
- Experience leading FDA interactions in support of Phase 3 development with the FDA review division and DDMAC/OPDP and implementing these strategies
- Successfully led team of direct reports in support of Global Product Safety case management and triage roles and responsibilities
- Provide Regulatory leadership for early drug development Phase 2 and 3 support to ensure successful strategies for product lifecycle development
- Successfully supported multiple product launches
- Label and Claims development
Certification
- Regulatory Affairs Certification (RAC) 2001
Timeline
Senior Director Sr. Director-Global Regulatory Affairs - Product Communications
Eli Lilly and Company
11.2021 - Current
Regulatory Advisor – Global Regulatory Affairs Biomedicines
Eli Lilly and Company
09.2017 - 10.2021
Regulatory Advisor – Global Regulatory Affairs US AD/PROMO
Eli Lilly and Company
05.2010 - 08.2017
Associate Regulatory Consultant – Global Regulatory Affairs US AD/PROMO
Eli Lilly and Company
02.2006 - 05.2010
TEAM LEADER GPS-US Marketed Products
Eli Lilly and Company
03.2005 - 01.2006
TEAM LEADER Global Product Safety US Affiliate Operations
Eli Lilly and Company
10.2003 - 03.2005
TEAM LEADER MARKETED PRODUCTS
Eli Lilly and Company
08.2001 - 09.2003
TRIAGE COORDINATOR
Eli Lilly and Company
12.1999 - 08.2001
PRODUCT SAFETY ASSOCIATE
Eli Lilly and Company
03.1999 - 12.1999
CONTRACT REGULATORY ASSOCIATE
KELLY SCIENTIFIC (Eli Lilly and Company)
05.1998 - 02.1999
PHARMACY MANAGER
WALGREENS PHARMACY
08.1993 - 01.1997
Bachelor of Science - Pharmacy
Butler University
Masters in Business Administration -
Indiana Wesleyan University
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