About
• Over 10 years of transformative experience with privately held…
Articles by Nick
Activity
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Finally another nutraceutical publication is complete after much perseverance! Thank you Atanas G. Atanasov, International Natural Product Sciences…
Finally another nutraceutical publication is complete after much perseverance! Thank you Atanas G. Atanasov, International Natural Product Sciences…
Shared by Nick Arkells, JD, MBA
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Six years ago this morning I grabbed my briefcase and eight other team members, and left my position as a Managing Director at Morgan Stanley to…
Six years ago this morning I grabbed my briefcase and eight other team members, and left my position as a Managing Director at Morgan Stanley to…
Liked by Nick Arkells, JD, MBA
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We have secured approval for a dispensary that has retail & delivery by right in Monterrey County. Radre Holdings is now reviewing offers from…
We have secured approval for a dispensary that has retail & delivery by right in Monterrey County. Radre Holdings is now reviewing offers from…
Shared by Nick Arkells, JD, MBA
Experience & Education
Licenses & Certifications
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Global Human Capital Trends
Columbia University School of Professional Studies
Credential ID Deloitte LLP -
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Volunteer Experience
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Strategic Policy Advisor
International Natural Product Sciences Taskforce
- Present 7 years
Science and Technology
The International Natural Product Sciences Taskforce (INPST) represents an open innovation platform bringing together scientists and key opinion leaders of the natural product scientific research field, as well as members of multiple scientific excellence centers and pharmaceutical-, biotech-, healthtech-, and natural product-related industries. https://inpst.net/
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Certified in Medical Devices and Pharmaceuticals (Dual)
Regulatory Affairs Professionals Society (RAPS)
Science and Technology
RAPS Champion, RegEx Pro, RegEx Rising Star
RAPS is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. -
Reviewer
International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
Health
ISPOR is the leading global professional society in pharmacoeconomics and outcomes research.
Founded in 1995 as an international multidisciplinary professional membership society, the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) advances the policy, science, and practice of pharmacoeconomics (health economics) and outcomes research (the scientific discipline that evaluates the effect of health care interventions on patient well-being including clinical, economic,…ISPOR is the leading global professional society in pharmacoeconomics and outcomes research.
Founded in 1995 as an international multidisciplinary professional membership society, the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) advances the policy, science, and practice of pharmacoeconomics (health economics) and outcomes research (the scientific discipline that evaluates the effect of health care interventions on patient well-being including clinical, economic, and patient-centered outcomes). -
Eagle Scout
Boy Scouts of America, Connecticut Yankee Council
Social Services
Served my community & fellow scouts for many years; ultimately culminating in my Eagle Scout Leadership Project.
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Credentialed Mediator & Arbiter
Lubbock County
Social Services
Volunteered to offer Alternative Dispute Resolution Services (ADR) for both mediations and arbitrations. The primary focus of my time was spent resolving disputes between local business owners. The other portion of my volunteer time was spent as an arbiter to negotiate rehabilitative options between veterans and the district attorney's office.
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Volunteer
Texas RioGrande Legal Aid
Social Services
Worked on writing memorandums and conducted legal research with nonprofit organizations. Research was directed toward cooperatives and taxation of 521 farmer's cooperatives. Also intellectual property in the area of informational torts.
Publications
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Biosimilar Regulatory Policies Issues and Implications: Where are We Headed?
Arkells N, Chopra A, Chopra I. 23rd Annual International Meeting of International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
See publicationBiosimilars hold promise for patients, reducing both patient and national burden of diseases and promoting further research for better healthcare. This review takes a novel approach in the light of the biosimilar patent infringement cases and the corresponding court rulings to better understand the regulatory framework for biosimilar marketing. There is a need for rigorous policy framework from Congress and Food and Drug Administration that promote biosimilar safety, improve patient access, and…
Biosimilars hold promise for patients, reducing both patient and national burden of diseases and promoting further research for better healthcare. This review takes a novel approach in the light of the biosimilar patent infringement cases and the corresponding court rulings to better understand the regulatory framework for biosimilar marketing. There is a need for rigorous policy framework from Congress and Food and Drug Administration that promote biosimilar safety, improve patient access, and reduce the cost of biosimilars.
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Biosimilars: Barriers and Opportunities to Market Access in the United States
Chopra I, Arkells N, Chopra A. 23rd Annual International Meeting of International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
See publicationEmerging biosimilars in the US are governed by an interplay of a multitude of factors. None of the studies we identified comprehensively explored biosimilar market access in light of clinical, economic, legislative, and regulatory data. Although biosimilars have promising growth potential, winning with biosimilars requires understanding of the intricacies of specified factors.
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Shift in the Status Quo: How Biosimilar Interchangeability can Lead to Significant Cost Savings
Chopra A, Chopra I, Giardina C, Arkells N. 23rd Annual International Meeting of International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
This analysis employs a unique approach to understanding the BI of two or more biosimilars from regulatory and healthcare policy perspective. The model predicted that the introduction of infliximab biosimilars in the US is associated with significant cost savings at the payer-level. Additionally, it is anticipated that a greater number of biosimilars would further drive the costs down, resulting in improved patient access. BI analyses should consider all available biologics and biosimilars to…
This analysis employs a unique approach to understanding the BI of two or more biosimilars from regulatory and healthcare policy perspective. The model predicted that the introduction of infliximab biosimilars in the US is associated with significant cost savings at the payer-level. Additionally, it is anticipated that a greater number of biosimilars would further drive the costs down, resulting in improved patient access. BI analyses should consider all available biologics and biosimilars to accurately and precisely predict cost savings.
Other authorsSee publication -
Why Biosimilar Companies Should Pay More Attention To U.S. State Governments
Arkells N, Life Science Connect: Biosimilar Development, Bioprocess
See publicationA carefully coordinated strategy is needed to engage local political leadership and patients as both stakeholders and voters to put pressure on the local governments to adopt statutes supportive of biosimilars. This must be done by engaging the states as partners rather than exclusively relying on federal lobbying. States should not be thought of as “blocking entities” —instead they should be strategic partners that can improve and expand upon the framework set forth by the BPCIA.
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6 Ways Biosimilar Companies Should Engage State Governments
Arkells N, Life Science Connect: Biosimilar Development, Bioprocess, Life Science Leader
See publicationA better strategy is needed to engage local political leadership and patients as legislative advocates, who in turn can put pressure on the local governments to adopt statutes supportive of biosimilars. This can only be achieved by closing the current information gap. By demonstrating to patients an alignment of goals through open communication, biosimilar companies can empower patients to act as critical allies in the struggle for biosimilar success.
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Debunking Five Common Myths Against Flat Rate Pricing in Health Economics and Outcomes Research
N. Arkells, Manticore Consulting Group
See publicationMyths Debunked:
1. Consulting companies can still make adequate profits using a flat rate pricing system
2. Flat rate pricing does not impact performance or quality of work
3. Uncertainty is not dependent on pricing system and can be accounted for with flat rate pricing
4. Flat rate pricing makes it easier to ascertain the value of a project
5. Flat rate pricing eliminates any concerns of an hourly pricing system
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Health Economics and Outcomes Research Consulting Reforms: Flat Rate Pricing Model
N. Arkells, Manticore Consulting Group
See publicationKey Takeaways:
1. Flat rate pricing is a value-based pricing strategy
2. Successful in public and private sectors in predetermining budgets and timelines
3. Cost saving in short- and long-term contracts
4. Feasible from a contractor’s perspective
5. Critical need for an industry-wide reform to ensure real competition -
Improving Adherence to Coronary Artery Disease Medications Among Patients with Incidence Cancer
I. Chopra, A. Chopra, N. Arkells, Manticore Consulting Group
See publicationOf all the risk reduction strategies, optimal BP and low-density lipoprotein choles-terol (LDL-C) levels are central to achieving the main goals of CAD management. Use and adherence to statins and an-giotensin-converting enzyme inhibitors (ACEIs), angioten-sin II receptor blockers (ARBs), and β-blockers are highly effective in achieving optimal BP and LDL-C levels and have become the cornerstone of CAD management.
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Intricate Relationship Between Coronary Artery Disease and Incident Cancer
I. Chopra, A. Chopra, N. Arkells, Manticore Consulting Group
See publicationThe unique relationship between coronary artery disease (CAD) and cancer:
1. Shared risk factors
2. CAD as a risk factor for cancer
3. Negative effects of some cancer treatments on cardiovascular health
4. Dominant condition as the driver of treatments: CAD or Cancer? -
Understanding Breast Cancer Treatment-Associated Cardiotoxicity
I. Chopra, A. Chopra, N. Arkells, Manticore Consulting Group
See publicationCardiotoxicity may be induced by different breast cancer treatments:
• Radiotherapy
• Anthracycline
• Trastuzumab
• Aromatase inhibitors and Tamoxifen
Courses
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Agility and Automation for New Drug Applications Development
RAPS
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Antitrust Law
6083
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Biosimilars, Utilization, and Post Marketing Surveillance in the United States
ISPOR
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CFDA Registration Requirement for Imported Class II/III Medical Devices
RAPS
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Chemical Biological Radiological Nuclear Operations Course
US Army
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China Regulations on Medical Devices - Adverse Event Monitoring and Re-evaluation
RAPS
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China's Clinical Requirements Under the New Registration System
RAPS
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Concepts of Health Technology Assessment
ISPOR
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Decision Theory & Business Analytics
5330
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Defining Patient Centeredness & Engagement in HEOR
ISPOR
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EU Medical Device and IVD Regulations
RAPS
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Economic Analysis for Business
5310
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Emerging Technologies Law
6319
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Ethics: Essential Tools for Regulatory Professionals
RAPS
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FDA Laws & Regulations
RAPS
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Federal Contractor Ethics & Compliance
Deloitte Federal Services
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Global Regulatory Strategy for Medical Devices
RAPS
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Global Regulatory Strategy for Pharmaceuticals
RAPS
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Independent Research Course: Biologics & Biosimilar Regulatory Affairs
7001
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Intellectual Property
6039
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Interpersonal Communication
DOJ
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Joint Humanitarian Operations Course
USAID
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Law & Science Legal Research
6040
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Leveraging Data Science and Innovative Digital Technologies to Optimize Real World Evidence Generation
ISPOR
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Marketing Concepts and Strategies
5360
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Maximizing Access to PDMs
VA OSDBU
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Medical Devices: Definition & Lifecycle
RAPS
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Moving Beyond Conventional Cost Effectiveness Analysis
ISPOR
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Open Source Cost Effectiveness Models
ISPOR
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Overview of China's Regulatory System & New Medical Device Regulations
RAPS
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Patent Law
6050
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Pharmaceuticals: Advertising and Promotional Labeling in the US
RAPS
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Pharmaceuticals: Definition and Lifecycle
RAPS
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Pharmaceuticals: US Regulations
RAPS
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Pharmacoeconomics
ISPOR
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Pharmacovigilance
RAPS
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Prior Authorization Policies for Managing Specialty Drug Spending in the United States
ISPOR
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Project Management for Regulatory Professionals
RAPS
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Regulation of Biosimilars
RAPS
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Regulation of Dietary Supplements and NHPs
RAPS
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Regulation of US and EU Biologics
RAPS
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Regulatory Affairs in the US and Canada
RAPS
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Role of the Regulatory Professional
RAPS
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Statistical Analysis for Business & Management
5345
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Strategic & Global Management
5391
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The Regulatory Perspective of Patient Experience Data
ISPOR
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Trademarks & Unfair Competition
6034
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Using Big Data to Bring the Patients' Voice to Life
ISPOR
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Warrior Leader Course
US Army, NCO Academy
Honors & Awards
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Best Global Health & Economics Outcomes Research Consultancy 2018
Global Health & Pharma International Life Sciences Awards 2018
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Innovation Award for Pharmaceutical Leadership
Global Health & Pharma International Life Sciences Awards 2018
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Certificate of Appreciation DHS
Assistant Director FOIA-DHS: Catrina Pavlik-Keenan
Consistently a top performing legal analyst on the Department of Homeland Security contract. With deep appreciation of your tireless commitment, dedication and service while eliminating the Freedom of Information Backlog for U.S. Immigration and Customs Enforcement (ICE).
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Army Commendation Medal
COL Ruth II
For exceptionally meritorious service while assigned as the 81st Civil Affairs battalion paralegal. Specialist Arkells professionalism and dedication resulted in the expeditious processing of over 300 legal actions. His dedication to duty, professionalism and integrity are in keeping with the finest traditions of military service and reflect great credit upon himself, the 81st Civil Affairs battalion, the 85th Civil Affairs Brigade and the United States Army.
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Army Achievement Medal
LTC Potter
For exceptionally meritorious achievement as the 81st civil affairs battalion paralegal specialist while being solely responsible for all legal actions within the brigade. Specialist Arkells was also instrumental in ensuring the legal section passed the III Corps ORV inspection. Specialist Arkells tireless efforts, dedication to duty and commitment to excellence greatly contributed to overall mission success. His actions are in keeping with the finest traditions of military service and reflect…
For exceptionally meritorious achievement as the 81st civil affairs battalion paralegal specialist while being solely responsible for all legal actions within the brigade. Specialist Arkells was also instrumental in ensuring the legal section passed the III Corps ORV inspection. Specialist Arkells tireless efforts, dedication to duty and commitment to excellence greatly contributed to overall mission success. His actions are in keeping with the finest traditions of military service and reflect great credit upon himself, 81st Civil Affairs Battalion and the United states Army.
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Good Conduct Medal
CPT Pennington
Exemplary behavior, efficiency and fidelity in active federal military service.
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Army Achievement Medal
LTC Minty Jr
For exceptionally meritorious service while assigned as an Armor Crewmen and Chemical Biological Radiological and Nuclear Supervisor in Demon Company, 2nd Battalion, 9th Infantry regiment. Private First Class Arkells dedication to duty and outstanding performance are in keeping with the finest traditions of military service and reflect great credit upon himself, the Manchu battalion, and the United States Army.
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Certificate of Appreciation KBSC
Jude E. Shea, Director of the Korea Battle Simultation Center
For outstanding support during Exercise Ulchi Freedom Guardian. Your expertise, devotion to duty and superb professional efforts were instrumental in making the exercise a tremendous success. Thanks for a job well done.
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Certificate of Appreciation ADR
Texas Tech University School of Law
Awarded for exemplary participation in the Advanced Alternative Dispute Resolution Clinic.
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Distinguished Honor Graduate
Texas A&M - University Central Texas
Awarded for being in the top 5% of your undergraduate class. Consistently achieved the honor of President's list .
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Eagle Scout
Boy Scouts of America
Eagle Scout is the highest achievement or rank attainable in the Boy Scouts of America (BSA). Only four percent of Boy Scouts are granted this rank after a lengthy review process. Candidates must demonstrate exceptional leadership and ethics, over the course of many years.
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Summa Cum Laude
Texas A&M - University Central Texas
Achieved a perfect institution GPA while working full time.
Languages
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Spanish
Limited working proficiency
Organizations
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National Contract Management Association (NCMA)
Member
The National Contract Management Association (NCMA), founded in 1959, is the world’s leading professional resource for those in the field of contract management. The organization, which has over 20,000 members, is dedicated to the professional growth and educational advancement of procurement and acquisition personnel worldwide. NCMA strives to serve and inform the profession it represents and to offer opportunities for the open exchange of ideas in neutral forums.
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Phi Alpha Delta Law Fraternity, International
Member
The purpose of this Fraternity shall be to form a strong bond uniting students and teachers of the law with members of the Bench and Bar in a fraternal fellowship designed to advance the ideals of liberty and equal justice under law; to stimulate excellence in scholarship; to inspire the virtues of compassion and courage; to foster integrity and professional competence; to promote the welfare of its members; and to encourage their moral, intellectual, and cultural advancement; so that each…
The purpose of this Fraternity shall be to form a strong bond uniting students and teachers of the law with members of the Bench and Bar in a fraternal fellowship designed to advance the ideals of liberty and equal justice under law; to stimulate excellence in scholarship; to inspire the virtues of compassion and courage; to foster integrity and professional competence; to promote the welfare of its members; and to encourage their moral, intellectual, and cultural advancement; so that each member may enjoy a lifetime of honorable professional and public service.
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Scrum.org
Member
Scrum.org is dedicated to providing the resources and training needed to develop application of the agility framework. With over 100,000 certified professionals its one of the largest networks for agility in the world. Scrum specifically is a framework within which people can address complex adaptive problems, while productively and creatively delivering products of the highest possible value. Scrum itself is a simple framework for effective team collaboration on complex products.
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Travis County Law Enforcement Officers' Association
Member
The Travis County Sheriff’s Law Enforcement Association (TCSLEA) Fraternal Order of Police Lodge 912 was founded in September 2001. We represent nearly 700 members throughout the Austin area. Our members, as police and correctional officers, patrol and emergency management personnel, are not only dedicated to each other, but to serve and protect the local community.
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