User:JRobble/sandbox/Kevin Outterson

Kevin Outterson is the N. Neal Pike Scholar in Health and Disability Law at Boston University School of Law and the Executive Director of the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X). Outterson's work focuses primarily on law and economics of antibiotic resistance, health law, intellectual property, and global access to medicine.

Biography
In 2014, Outterson was named a Centre for Global Health Security Associate Fellow at the Chatham House's Royal Institute for International Affairs and the N. Neal Pike Scholar in Health and Disability Law at Boston University School of Law, where Outterson also serves as a Co-Director of the Health Law Program and a Faculty Co-Advisor and Editor on the American Journal of Law & Medicine. Since 2016, Outterson has served as the Executive Director of CARB-X, a $540 million international public-private partnership that works with Biomedical Advanced Research and Development Authority (BARDA), Wellcome Trust, National Institute of Allergy and Infectious Diseases (NIAID), German Federal Ministry of Education and Research (BMBF), the UK Global AMR Innovation Fund (GAMRIF), and the Bill & Melinda Gates Foundation to promote antibacterial innovation internationally. As part of his work on antimicrobial resistance, Outterson has testified before Congress, the World Health Organization (WHO), and various state legislatures. Outterson was also awarded the 2015 Leadership Award by the Alliance for the Prudent Use of Antibiotics and has served on the advisory panel for the Longitude Prize.

Prior to serving on CARB-X and becoming a Professor of Law at Boston University School of Law, Outterson attended the University of Reading as a Rotary Scholar. Outterson also holds a B.S. from Northwestern University, a J.D. from Northwestern University Pritzker School of Law, and an L.L.M. from the University of Cambridge. Outterson has also previously served as a partner at two major United States law firms -- McDermott, Will & Emery (Chicago, IL) and Baker Donelson (Nashville, TN) -- and has taught as a Professor of Law at West Virginia University College of Law.  Until 2016, Outterson also served as the Editor-in-Chief of the ''The Journal of Law, Medicine & Ethics. ''

CARB-X
CARB-X was formed in 2016, after receiving a grant through the 2016 U.S. National Strategy for Combating Antibiotic-Resistant Bacteria initiative, which sought to launch a biopharmaceutical accelerator. In addition to the U.S. Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA), CARB-X is funded by Wellcome Trust, National Institute of Allergy and Infectious Diseases (NIAID), German Federal Ministry of Education and Research (BMBF), the UK Global AMR Innovation Fund (GAMRIF), and the Bill & Melinda Gates Foundation. CARB-X funds a variety of therapeutics and preventative measures -- including antibiotics, vaccines, microbiome approaches -- through Phase 1 clinical trials, in order to address the large gaps in funding at this stage of innovation. CARB-X also supports the development of rapid diagnostics projects through Verification and Validation phases of development. While the product scope that CARB-X is interested in is broad, CARB-X primarily funds antimicrobial products targeting pathogens that qualify as “Urgent/Serious” in the CDC Threat Assessments or “Critical/High” in the WHO Global Priority Pathogen List.

As of August 2020, CARB-X has provided over $240 million in non-dilutive funding to support projects with 67 companies and other product developers. The goal is to support early development antibacterial innovation at a time when private industry investment is lacking and government policies serve as disincentives to antibacterial innovation. Hence, "the CARB-X portfolio is one of the world’s largest early development pipelines of new antibiotics, microbiome, vaccines, rapid diagnostics, and other nontraditional products to prevent, diagnose, and treat life-threatening bacterial infections." As one of the largest providers of early-stage drug development funding, CARB-X aims to provide up to $480 million in grants and other financial support by 2022, in order to promote innovative diagnostic and therapeutic developments in the field, including the production of new classes of antibiotics.

Despite the substantial contributions that CARB-X has made in the field of antimicrobial resistance, CARB-X and similar organizations are unable to fill the funding gaps in areas of antimicrobial resistance innovation on their own, especially as smaller pharmaceutical companies require significant support beyond the stages of development that CARB-X provides'''. ''' Hence, apart from his work with CARB-X, Outterson devotes much of his scholarship to addressing issues relating to finding sustainable sources of funding innovation in the pharmaceutical industry.

Scholarship
The majority of Outterson's recent scholarship has revolved around the pharmaceutical industry. Outterson has written extensively about how intellectual property law affects pharmaceutical and, more specifically, antibiotic development. The necessity for promoting innovation is a common theme with Outterson's scholarship and with his work for CARB-X, a biopharmaceutical accelerator that aims to award up to $480 million in grants by 2021. Outterson's work demonstrates that grants are innovative tools that can support research by providing clear incentives and financial support that will reduce pharmaceutical and antibiotic development costs.

Outterson has advocated reforming the current pharmaceutical business model for antibiotics, as it disincentivizes investments in new effective antibiotics, by finding alternative methods of funding pharmaceutical development. Outterson also proposes charging higher prices for antibiotics in the insured market, while offering lower prices for pharmaceutical products in other public, private, and non-profit sectors. Furthermore, despite the consensus regarding the harms of pharmaceutical arbitrage, the process in which products are bought at below market prices and exported to higher priced markets, or parallel trading, Outterson believes that pharmaceutical arbitrage does not significantly threaten innovation from a social-welfare perspective and could, in fact, make drugs more affordable. There appears to be an overstatement of how prevalent issues relating to pharmaceutical arbitrage are, as there does not appear to be any empirical evidence of a widespread problem.

Outterson also believes concerns regarding counterfeit drugs are overstated, as production of non-functional generic copies of patented drugs are largely produced domestically and can be disincentivized by (1) decreasing drug prices and (2) increasing the availability of low-cost generic drugs. Outterson has argued in favor of Generic Open (GO) licensing, which would reduce drug prices and the resources necessary to develop novel pharmaceuticals by encouraging generic competition and a market-based approach, while permitting the originating biopharmaceutical companies to profit through royalty payments. As biopharmaceutical companies often find the return on investment to be low for antibiotic development, GO licensing could be a promising solution to issues plaguing sufficient antibiotic production.

Outterson has noted that legal scholarship often does not adequately distinguish antibiotics from other drugs, despite the increased complexity of the legal ecology associated with antibiotics. Outterson argues that legal and market structures accelerate antibiotic resistance infections, as the discrepancy between private and social values lead to supply and demand issues. As the patent process promotes the production of new drugs, the system does not incentivize antibiotic manufacturers to dedicate resources to urgent cases that require antibiotics as they approach the end of the patent term. Rather, the patent process promotes marketing of products for a variety of minor clinical conditions, despite the fact that antibiotic effectiveness is greatly reduced if antibiotic use is not conserved. Furthermore, antibiotic developers have no incentive to ensure the long-term usefulness of their product once their patent has expired and generic competition proliferates. Efforts to reform the patent system to address this issue, through the introduction of the 2011 Generating Antibiotics Incentives Now (GAIN) Act, which offers "qualified infectious disease products" an additional period of market exclusivity, have been criticized by Outterson as insufficient. Outterson has warned that "qualifying infectious disease product designations should not be interpreted as evidence of accelerated antibiotic development," especially when only four antibiotics took advantage of the special designation from 2011-2014. Instead, Outterson has argued that the need to promote antibiotic development, while restricting unnecessary antibiotic uses can be addressed by separating antibiotic profits from sales volume.

Outside of his extensive scholarship on the inequalities in healthcare perpetuated by intellectual property law and pharmaceutical companies, Outterson has also written about other public health challenges that have resulted in disparities related to access to quality healthcare. For example, Outterson has written about poverty tourism, a trend where individuals from developed nations visit impoverished communities as poverty tourists. Outterson calls attention to the concerning trend of commodifying poverty in this way, and cites specific examples of Rio de Janero hotels advertising 'slum' tours directly alongside traditional tourist activities, like hang gliding or national park tours.

Casebooks
Nicole Hubberfield, Elizabeth Weeks Leonard, and Kevin Outterson, The Law of American Healthcare (2017).

Journal Articles
Evelina Tacconelli, Elena Carrara, Alessia Savoldi, Stephan Harbarth, Marc Mendelson, Dominique L. Monnet, Celine Pulcini, Gunnar Kahlmeter, Jan Kluytmans, Yehuda Carmeli, Marc Ouellette, Kevin Outterson, Jean Patel, Marco Cavaleri, Edward M. Cox, Chris R. Houchens, M L. Grayson, Paul Hansen, Nalini Singh, Ursula Theuretzbacher, & Nicola Magrini, Discovery, Research, and Development of New Antibiotics: The WHO Priority List of Antibiotic-Resistant Bacteria and Tuberculosis, 18 The Lancet: Infectious Diseases 318 (2018).

Kevin Outterson, Pharmaceutical Arbitrage: Balancing Access and Innovation in International Prescription Drug Markets, 5 Yale Journal of Health Policy, Law & Ethics193 (2005).

Kevin Outterson, Christine Ardal, Steven Hoffman, Abdul Ghafur, Mike Sharland, Nisha Ranganathan, Richard Smith, Anna Zorzet, Jennifer Cohn, Didier Pittet, Nils Daulaire, Chantal Morel, Zain Rizvi, Manica Balasegaram, Osman Dar, David Heymann, Alison Holmes, Luke Moore, Ramanan Laxminarayan, Marc Mendelson & John-Arne Røttingen, International Cooperation to Improve Access to and Sustain Effectiveness of Antimicrobials, 387 The Lancet 296 (2016).

Kevin Outterson, Nicole Huberfeld & Elizabeth W. Leonard, Plunging into Endless Difficulties: Medicaid and Coercion in National Federation of Independent Business v. Sebelius, 93 Boston University Law Review 1 (2013).

Kevin Outterson, The Ethics of Poverty Tourism, 7 Environmental Philosophy 93 (2010).

Kevin Outterson, Steven J. Hoffman, John-Arne Rottingen, Otto Cars, Charles Clift, Fiona Rotberg, Göran Tomson, Anna Zorzet & Zain Rizvi, An International Legal Framework to Address Antimicrobial Resistance, 93 Bulletin of the World Health Organization 66 (2016).

Anthony So, Neha Gupta, Samir Brachmachari, Ian Chopra, Bernard Munos, Carl Nathan, Kevin Outterson, Jean Pierre Paccaud, David Payne, Rosanna Peeling, Melvin Spigelman, Johan Weigelt, [https://www.sciencedirect.com/science/article/pii/S1368764611000161?casa_token=tqDQ7C0KFjcAAAAA:R71mjuLfn26zhUHhOHOl7OwkZURMAq-R6C8UO2HPF6faofEZKAwGqgOkbGAlM2zoV6nFcyoY_MA#! Towards New Business Models for R&D for Novel Antibiotics], 14 Drug Resistant Updates 2 (2011).

Kevin Outterson, Julie Balch Samora, Karen Keller-Cuda, Will longer antimicrobial patents improve global public health?, 70 Journal of Antimicrobial Chemotherapy 6 (2007).

Kevin Outterson, John Powers, Gregory Daniel, Mark McClellan, Repairing the Broken Market for Antibiotic Innovation, 34 Health Affairs 2 (2015).

Kevin Outterson, The Vanishing Public Domain: Antibiotic Resistance, Pharmaceutical Innovation and Global Public Health, 67 University of Pittsburgh Law Review 67 (2005).