Austin, Texas Metropolitan Area
19K followers 500+ connections

Join to view profile

About

Experience & Skills:
• Over 10 years of transformative experience with privately held…

Articles by Nick

Activity

Experience & Education

  • Confidential

View Nick’s full experience

See their title, tenure and more.

or

By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.

Licenses & Certifications

Volunteer Experience

  • International Natural Product Sciences Taskforce Graphic

    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/

  • Regulatory Affairs Professionals Society (RAPS) Graphic

    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).

  • Boy Scouts of America, Connecticut Yankee Council Graphic

    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.

  • Lubbock County Graphic

    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.

  • Texas RioGrande Legal Aid Graphic

    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

  • 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)

    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…

    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.

    See publication
  • 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)

    Emerging 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.

    See publication
  • 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 authors
    See publication
  • Why Biosimilar Companies Should Pay More Attention To U.S. State Governments

    Arkells N, Life Science Connect: Biosimilar Development, Bioprocess

    A 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.

    See publication
  • 6 Ways Biosimilar Companies Should Engage State Governments

    Arkells N, Life Science Connect: Biosimilar Development, Bioprocess, Life Science Leader

    A 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.

    See publication
  • Debunking Five Common Myths Against Flat Rate Pricing in Health Economics and Outcomes Research

    N. Arkells, Manticore Consulting Group

    Myths 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

    See publication
  • Health Economics and Outcomes Research Consulting Reforms: Flat Rate Pricing Model

    N. Arkells, Manticore Consulting Group

    Key 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

    See publication
  • Improving Adherence to Coronary Artery Disease Medications Among Patients with Incidence Cancer

    I. Chopra, A. Chopra, N. Arkells, Manticore Consulting Group

    Of 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.

    See publication
  • Intricate Relationship Between Coronary Artery Disease and Incident Cancer

    I. Chopra, A. Chopra, N. Arkells, Manticore Consulting Group

    The 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?

    See publication
  • Understanding Breast Cancer Treatment-Associated Cardiotoxicity

    I. Chopra, A. Chopra, N. Arkells, Manticore Consulting Group

    Cardiotoxicity may be induced by different breast cancer treatments:
    • Radiotherapy
    • Anthracycline
    • Trastuzumab
    • Aromatase inhibitors and Tamoxifen

    See publication
Join now to see all publications

Courses

  • Agility and Automation for New Drug Applications Development

    RAPS

  • Antitrust Law

    6083

  • Biosimilars, Utilization, and Post Marketing Surveillance in the United States

    ISPOR

  • CFDA Registration Requirement for Imported Class II/III Medical Devices

    RAPS

  • Chemical Biological Radiological Nuclear Operations Course

    US Army

  • China Regulations on Medical Devices - Adverse Event Monitoring and Re-evaluation

    RAPS

  • China's Clinical Requirements Under the New Registration System

    RAPS

  • Concepts of Health Technology Assessment

    ISPOR

  • Decision Theory & Business Analytics

    5330

  • Defining Patient Centeredness & Engagement in HEOR

    ISPOR

  • EU Medical Device and IVD Regulations

    RAPS

  • Economic Analysis for Business

    5310

  • Emerging Technologies Law

    6319

  • Ethics: Essential Tools for Regulatory Professionals

    RAPS

  • FDA Laws & Regulations

    RAPS

  • Federal Contractor Ethics & Compliance

    Deloitte Federal Services

  • Global Regulatory Strategy for Medical Devices

    RAPS

  • Global Regulatory Strategy for Pharmaceuticals

    RAPS

  • Independent Research Course: Biologics & Biosimilar Regulatory Affairs

    7001

  • Intellectual Property

    6039

  • Interpersonal Communication

    DOJ

  • Joint Humanitarian Operations Course

    USAID

  • Law & Science Legal Research

    6040

  • Leveraging Data Science and Innovative Digital Technologies to Optimize Real World Evidence Generation

    ISPOR

  • Marketing Concepts and Strategies

    5360

  • Maximizing Access to PDMs

    VA OSDBU

  • Medical Devices: Definition & Lifecycle

    RAPS

  • Moving Beyond Conventional Cost Effectiveness Analysis

    ISPOR

  • Open Source Cost Effectiveness Models

    ISPOR

  • Overview of China's Regulatory System & New Medical Device Regulations

    RAPS

  • Patent Law

    6050

  • Pharmaceuticals: Advertising and Promotional Labeling in the US

    RAPS

  • Pharmaceuticals: Definition and Lifecycle

    RAPS

  • Pharmaceuticals: US Regulations

    RAPS

  • Pharmacoeconomics

    ISPOR

  • Pharmacovigilance

    RAPS

  • Prior Authorization Policies for Managing Specialty Drug Spending in the United States

    ISPOR

  • Project Management for Regulatory Professionals

    RAPS

  • Regulation of Biosimilars

    RAPS

  • Regulation of Dietary Supplements and NHPs

    RAPS

  • Regulation of US and EU Biologics

    RAPS

  • Regulatory Affairs in the US and Canada

    RAPS

  • Role of the Regulatory Professional

    RAPS

  • Statistical Analysis for Business & Management

    5345

  • Strategic & Global Management

    5391

  • The Regulatory Perspective of Patient Experience Data

    ISPOR

  • Trademarks & Unfair Competition

    6034

  • Using Big Data to Bring the Patients' Voice to Life

    ISPOR

  • Warrior Leader Course

    US Army, NCO Academy

Honors & Awards

  • Best Global Health & Economics Outcomes Research Consultancy 2018

    Global Health & Pharma International Life Sciences Awards 2018

  • Innovation Award for Pharmaceutical Leadership

    Global Health & Pharma International Life Sciences Awards 2018

  • 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).

  • 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.

  • 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.

  • Good Conduct Medal

    CPT Pennington

    Exemplary behavior, efficiency and fidelity in active federal military service.

  • 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.

  • 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.

  • Certificate of Appreciation ADR

    Texas Tech University School of Law

    Awarded for exemplary participation in the Advanced Alternative Dispute Resolution Clinic.

  • 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 .

  • 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.

  • Summa Cum Laude

    Texas A&M - University Central Texas

    Achieved a perfect institution GPA while working full time.

Languages

  • Spanish

    Limited working proficiency

Organizations

  • 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.

  • 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.

  • 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.

  • 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.

Recommendations received

View Nick’s full profile

  • See who you know in common
  • Get introduced
  • Contact Nick directly
Join to view full profile

Other similar profiles

Explore top content on LinkedIn

Find curated posts and insights for relevant topics all in one place.

View top content

Add new skills with these courses