Arthur Daemmrich is an assistant professor in the Business, Government and the International Economy Unit and a faculty member of the HBS Healthcare Initiative. His research analyzes managerial and public policy dilemmas that arise for firms and regulators as they seek to control health and environmental risks associated with innovative products and services. Daemmrich has worked on regulation, innovation policy, and international business, with a particular focus on the pharmaceutical, biotechnology, and chemical industries. Daemmrich has published in interdisciplinary scholarly journals and the trade press. His first book, Pharmacopolitics (2004), compares drug regulation in the United States and Germany by analyzing regulatory laws, clinical trial methods, and post-market monitoring in the two countries. His edited volume, Perspectives on Risk and Regulation: The FDA at 100 (2007) includes contributions from FDA officials and industry leaders and identifies key trends in the regulation of pharmaceuticals, medical devices, food, and dietary supplements. Daemmrich is currently writing a book comparing the regulation of the chemical industry in the United States and Europe. Tentatively titled, Bodies at Risk: Chemicals, Testing, and Regulation in the United States and European Union, the book has an explicit focus on testing programs and will advance our understanding of why the U.S. and EU are adopting different approaches to identifying and managing risks associated with commodity chemicals, despite similar test methods, industry structures, and pro-regulatory pressure from non-governmental organizations. The project also is revealing that new chemical testing programs challenge traditional product-by-product regulatory approaches differently in the United States and Europe. Resolving the uncertainty generated by test programs will involve the design of novel institutions at the interface of business and government. Presently, Daemmrich is initiating a new research project into innovation and regulation of biomedical information, focused on electronic medical records and accountable care systems. Healthcare technologies designed with the intention of improving patient care through greater information gathering and analysis will confront profound questions concerning their relationship to privacy, intellectual property, and consumer choice. Broadly, this research seeks to analyze how different national histories and policies concerning privacy and the regulation of corporate and government use of biomedical data will affect health insurance, care delivery, and biopharmaceutical innovation in the future. Before joining the HBS faculty in 2007, Daemmrich was the founding director of the Center for Contemporary History and Policy at the Chemical Heritage Foundation in Philadelphia, where he led a group carrying out theoretical and applied work on innovation, entrepreneurship, and scientific and industrial infrastructure. He holds a Ph.D. in Science and Technology Studies from Cornell University and a B.A. in History and Sociology of Science from the University of Pennsylvania.
Publications
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Book
| 2007
Perspectives on Risk and Regulation: The FDA at 100
Arthur A. Daemmrich and Joanna Radin
Perspectives on Risk and Regulation: The FDA at 100 brings together the viewpoints of Food and Drug Administration officials and industry leaders on the future of regulating food, drugs, medical devices, and dietary supplements. In a period of rapid scientific and market changes the success of regulation in these areas increasingly hinges on communication and collaboration between the FDA and the private sector. By situating forward-looking perspectives of agency leaders and industry representatives within FDA’s regulatory history, this volume presents readers with new tools for evaluating policy recommendations and will better equip the public and experts to assess pressing regulatory issues. http://people.hbs.edu/adaemmrich/FDAfinal.pdf Keywords: Private Sector;
Governing Rules, Regulations, and Reforms;
Policy;
Health Care and Treatment;
Business and Government Relations;
Risk and Uncertainty;
Cooperation;
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Book
| 2006
Reflections from the Frontiers, Explorations for the Future: Gordon Research Conferences, 1931-2006
Arthur A. Daemmrich, Nancy Ryan Gray and Leah Shaper
Keywords: Research;
Conferences;
Cognition and Thinking;
History;
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Book
| 2004
Pharmacopolitics: Drug Regulation in the United States and Germany
Arthur A. Daemmrich
Keywords: Health;
Governing Rules, Regulations, and Reforms;
Government and Politics;
United States;
Germany;
Citation: Daemmrich, Arthur A. Pharmacopolitics: Drug Regulation in the United States and Germany. University of North Carolina Press, 2004. (Winner of Edward Kremers Award of the American Institute of the History of Pharmacy For best book in pharmaco-historical writing published in the previous two years presented by American Institute of the History of Pharmacy.)
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Book
| 2004
R&D Meets M&A: Proceedings of the 2003 Conference on Innovation and Creativity in Chemical R&D
Arthur A. Daemmrich
Keywords: Research and Development;
Mergers and Acquisitions;
Conferences;
Innovation and Invention;
Creativity;
Science;
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Article
| Trade, Law and Development
|
Epistemic Contests and the Legitimacy of the World Trade Organization: The Brazil–USA Cotton Dispute and the Incremental Balancing of Interests
Arthur A. Daemmrich
The World Trade Organization (WTO) features prominently in studies of international institutions, often cast either as a tool of rich-world domination over the poorer South or as a neutral mediator facilitating a tariff-free world of economic prosperity. This article instead analyses how the WTO has sought legitimacy for itself and for the underlying institution of free trade in the midst of questions regarding its organizational mandate and management of international trade negotiations. Historically, legitimacy for GATT and later the WTO was understood to derive from expanding membership and success at major trade round negotiations. In the past decade, and despite a lack of progress in the Doha Round, legitimacy has been built through institutional deepening by means of dispute resolution processes. This shift, I argue, raises epistemic questions of expertise, the relationship of models to real-world outcomes, and methods for bounding disputes over scientific facts. Based on a case study of the Brazil-Upland Cotton dispute and a trend analysis of over 400 total WTO disputes, I find that the WTO dispute settlement process is helping to legitimize the institution of free trade through its public display of rational authority and neutral expertise. At the same time, dispute panels have begun to pass judgment on issues of econometric and scientific uncertainty. As a result, the basis for the broader legitimacy of the WTO is shifting from questions of representation that have long drawn attention to epistemic issues, especially concerning the design of international trade models. The article thus provides insights on the resolution of disputes in global trade while contributing to our understanding of the evolving role of modeling at international organizations.
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Article
| History and Technology
|
Synthesis by Microbes or Chemists? Pharmaceutical Research and Manufacturing in the Antibiotic Era
Arthur A. Daemmrich
This article presents a case study of the rise of Pfizer as a leading pharmaceutical company, with a focus on changing relationships between manufacturing technology and R&D between the mid-1940s and the mid-1960s. Pfizer first moved into pharmaceuticals through participation in the U.S. government's penicillin effort during World War II. Having greatly expanded its biological manufacturing capacity to meet state needs, Pfizer adopted an R&D program to find new microbial antibiotics suited to its manufacturing technology after the war ended. In the 1950s and 1960s, Pfizer transformed itself into a chemistry-orientated pharmaceutical firm by reorienting its R&D toward chemistry. This led to a growing divergence between R&D and manufacturing and the eventual replacement of biological manufacturing with chemical manufacturing. The article explores the changing trajectories of R&D and manufacturing at Pfizer, their shifting positions within the firm, and the consequences of these changes and shifts for the firm's success, strategy, and organization.
Keywords: Research and Development;
Production;
Technology;
Transformation;
Relationships;
Success;
Organizations;
Programs;
Chemicals;
Alignment;
Pharmaceutical Industry;
United States;
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Journal Article
| Environmental History
|
Risk Frameworks and Biomonitoring: Distributed Regulation of Synthetic Chemicals in Humans
Arthur A. Daemmrich
The ability to detect and measure the presence of synthetic chemicals at trace levels in humans coupled to increased environmental NGO mobilization concerning chemical exposure has challenged risk and regulatory frameworks built up over the past quarter-century. This article analyzes changing definitions of risk in U.S. environmental regulation and describes challenges posed by emerging detection techniques, government and NGO surveys of chemicals in citizens, and reduction of information asymmetries through the internet. A new framework for regulation is proposed involving a networked approach among industry, NGOs, and government regulators.
Keywords: Chemicals;
Governing Rules, Regulations, and Reforms;
Risk Management;
Natural Environment;
Pollution and Pollutants;
Non-Governmental Organizations;
United States;
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Journal Article
| Bulletin for the History of Chemistry
|
The Gordon Research Conferences As Scientific Infrastructure
Arthur A. Daemmrich and Leah Shaper
Conferences serve as a crucial part of scientific infrastructure by offering participants the opportunity to announce novel findings, discuss research methods, and take part in a variety of networking activities. Presenting papers and learning about unpublished new work is vital for a scientist to stay current in their discipline. Yet conferences have drawn minimal attention from historians and sociologists of science, whose analysis of scientific infrastructure has instead focused on formal scientific communication through journal articles and on-line forums, the formation of new disciplines and subfields, and shifting funding structures for academic and industrial labs. This article focuses on the Gordon Research Conferences (GRC) as a case study of the significance of conferences to the scientific enterprise. We argue that GRC’s growth is a product of internal and external factors: conferences stimulate intensive discussion and real-time peer review, new topics are chosen through a review process oriented to frontier areas of science, and the GRC format fosters intimacy among participants even as the overall size of the scientific enterprise expands. More generally, we seek to make visible the otherwise hidden role of conferences within scientific infrastructure.
Keywords: Conferences;
Interpersonal Communication;
Infrastructure;
Science-Based Business;
Social and Collaborative Networks;
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Article
| Focus on Law Studies
|
Pharmaceutical Regulation in the United States and Europe
Arthur A. Daemmrich
Keywords: Health;
Governing Rules, Regulations, and Reforms;
Europe;
United States;
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Article
| Pharmacy in History
|
Pharmacovigilance and the Missing Denominator: The Changing Context of Pharmaceutical Risk Mitigation
Arthur A. Daemmrich
In the wake of Vioxx, Avandia, and other recent prominent cases of drugs found to cause side effects after marketing, the safety of pharmaceuticals has come to the forefront of American public policy. Press attention, congressional investigations, and legislative debates are highlighting the complex risk choices faced by patients, physicians, industry, and regulators in the post-market arena. To put current events in context, this article reviews historically the key institutions that have collected and responded to reports of side effects in the United States since the early 19th century. Three major periods emerge from this survey: an era of professional control; an era of regulation by the state; and a still-emerging information era dominated by statistical analysis of consumer populations. In each period, reformers sought to extend methods for uncovering side effects from the clinic to the market, yet a fundamental lack of consensus on how to determine the scope and magnitude of any one side effect plagued risk management efforts. The article concludes that it is critical to make institutions in our current ‘consumer era’ more attentive to individual patients who are put at risk.
Keywords: Brands and Branding;
Policy;
Risk Management;
Government Legislation;
Risk and Uncertainty;
Goals and Objectives;
Customers;
Pharmaceutical Industry;
Health Industry;
United States;
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Article
| Chemical and Engineering News
|
A Rising Drug Industry: Pharmaceuticals since 1870
Arthur A. Daemmrich
Keywords: Health;
Business History;
Pharmaceutical Industry;
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Article
| Chemistry Business
|
Rethinking Mergers and Acquisitions: How to Involve R&D in Company Growth
Arthur A. Daemmrich
Keywords: Mergers and Acquisitions;
Research and Development;
Growth and Development;
Business Ventures;
Citation: Daemmrich, Arthur A. "Rethinking Mergers and Acquisitions: How to Involve R&D in Company Growth." Chemistry Business (September 2004).
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Article
| Pharmacy in History
|
Invisible Monuments and the Costs of Pharmaceutical Regulation: Twenty-Five Years of Drug Lag Debate
Arthur A. Daemmrich
Keywords: Cost;
Health;
Governing Rules, Regulations, and Reforms;
Communication;
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Article
| Chemical Heritage
|
Science and Medicine in Court: Expert Testimony in the German Thalidomide Trial
Arthur A. Daemmrich
Keywords: Science;
Health;
Courts and Trials;
Pharmaceutical Industry;
Germany;
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Article
| Social History of Medicine
|
A Tale of Two Experts: Thalidomide and Political Engagement in the United States and West Germany
Arthur A. Daemmrich
Keywords: Health;
Government and Politics;
Pharmaceutical Industry;
United States;
Germany;
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Article
| Science as Culture
|
Risk versus Risk: Tragic Choices in Drug Regulation in the United States and Germany
Arthur A. Daemmrich
Keywords: Risk and Uncertainty;
Decision Choices and Conditions;
Health;
United States;
Germany;
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Article
| Nature Biotechnology
|
The Tragedy of the Commoners: Biotechnology and its Publics
Arthur A. Daemmrich
Keywords: Biotechnology Industry;
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Article
| Social Studies of Science
|
The Evidence Does Not Speak for Itself: Expert Witnesses and the Organization of DNA Typing Companies
Arthur A. Daemmrich
Keywords: Genetics;
Business Ventures;
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Chapter
| The Fragmentation of U.S. Health Care: Causes and Solutions
| 2010
From Visible Harm to Relative Risk: Centralization and Fragmentation of Pharmacovigilance
Arthur A. Daemmrich
Adverse drug reactions pose distinct but potentially catastrophic risks to patients, physicians, pharmaceutical firms, and regulators. Between the early 1960s and the present, national systems were built to collect, standardize, and respond to individual reports of side effects, with the Food and Drug Administration (FDA) playing the central role in the United States. In recent years, however, this centralized approach to the collection and analysis of adverse events through doctor-initiated case reports has been superseded by innovative, though episodic, pharmacoepidemiological studies of large databases that identify the probability of side effects in a population. This chapter advances a historical comparison of these two methods—individual case reports and population meta-analysis—and draws attention to the fragmentation of the institutional basis for assessing pharmaceutical risk. Our analysis of the evolution of techniques for identifying and responding to adverse drug reactions suggests that only government regulators are in a position to integrate case report and statistical analysis. Despite the appeal of fragmented post-market drug safety studies, centralization may be necessary to achieve faster and better integrated pharmacovigilance in the present era of large-scale pharmaceutical use for chronic conditions.
Keywords: Governing Rules, Regulations, and Reforms;
Health Testing and Trials;
Business and Government Relations;
Risk and Uncertainty;
Safety;
Pharmaceutical Industry;
United States;
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Chapter
| Ways of Regulating: Therapeutic Agents between Plants, Shops, and Consulting Rooms
| 2008
Where is the Pharmacy to the World? Pharmaceutical Industry Location and International Regulatory Variation
Arthur A. Daemmrich
A consumer-oriented model for drug development and use has attracted attention in recent years as an alternative to the much-maligned approach of mass-marketing blockbuster drugs. In a parallel development, patients and disease-based organizations have assumed greater roles in defining disease categories than in the past and now influence clinical trials and participate in regulatory decision-making. Yet these developments are far from universal and are taking very different forms around the world. Building on data showing that pharmaceutical firms headquartered in the United States have performed well since 1980 when compared to firms in Europe or Asia (measured both by sales and by numbers of new product introductions), this essay explores the interplay of regulation, definitions of "patient" and "consumer," and centers of power for the pharmaceutical industry. A comparison of the United States and Germany in particular, and the United States and European Union more generally, suggests that how countries resolve tensions between protecting patients and empowering consumers will impact the international competitive standing of their domestic pharmaceutical industries.
Keywords: Geographic Location;
Governing Rules, Regulations, and Reforms;
Health Testing and Trials;
Demand and Consumers;
Pharmaceutical Industry;
European Union;
Germany;
United States;
Citation: Daemmrich, Arthur A. "Where is the Pharmacy to the World? Pharmaceutical Industry Location and International Regulatory Variation." Chap. 16 in Ways of Regulating: Therapeutic Agents between Plants, Shops, and Consulting Rooms. Vol. 363, edited by Jean Paul Gaudillière, and Volker Hess, 271–290. Berlin, Germany: Max-Planck-Institut für Wissenschaftsgeschichte, 2008.
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Chapter
| Law and Science
| 2008
The Evidence Does Not Speak for Itself: Expert Witnesses and the Organization of DNA-Typing Companies
Arthur A. Daemmrich
During the past 15 years, new biotechnology companies have promoted DNA typing as a sophisticated criminal and paternity identification technique. Private testing laboratories produce results that link individuals with crime scenes and fathers to their children. Special problems of trust have arisen, because the domain of scientific practice termed 'DNA typing' emerged in a commercial context, and its results serve as the basis for expert witness testimony in contentious courtroom settings. Firms accordingly had to develop their own rules for legitimating truth-claims and standardizing and regulating laboratory practices. I argue here that the primary commodity crafted by DNA-typing companies—the courtroom credibility of DNA prints—required an intertwining of scientific authority, corporate practices, and the persona of the expert witness. This paper describes an actor-network coming into being and shows how credible institutions, organizations that manufacture integrity as their main sellable product, adopted a vertically integrated structure in order to control the production of DNA evidence from the laboratory to the courtroom.
Keywords: Governing Rules, Regulations, and Reforms;
Courts and Trials;
Organizational Structure;
Practice;
Genetics;
Science-Based Business;
Trust;
Commercialization;
Vertical Integration;
Citation: Daemmrich, Arthur A. "The Evidence Does Not Speak for Itself: Expert Witnesses and the Organization of DNA-Typing Companies." Chap. 12 in Law and Science. Vol. 1, edited by Susan S. Silbey, 367–398. England: Ashgate Publishing, 2008.
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Chapter
| The Risks of Medical Innovation: Risk Perception and Assessment in Historical Context
| 2006
BioRisk: interleukin-2 from laboratory to market in the United States and Germany
Arthur A. Daemmrich
Keywords: Product Development;
Risk and Uncertainty;
Health Testing and Trials;
Pharmaceutical Industry;
Biotechnology Industry;
United States;
Germany;
Citation: Daemmrich, Arthur A. "BioRisk: interleukin-2 from laboratory to market in the United States and Germany." In The Risks of Medical Innovation: Risk Perception and Assessment in Historical Context, edited by Thomas Schlich, and Ulrich Tröhler, 242–261. Routledge, 2006.
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Chapter
| Storia della scienza
| 2004
L'industria farmaceutica
Arthur A. Daemmrich
Keywords: Pharmaceutical Industry;
Citation: Daemmrich, Arthur A. "L'industria farmaceutica." In Storia della scienza, v. 8, 869–874. Istituto della Enciclopedia Italiana, 2004.
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Chapter
| Regulation of the Pharmaceutical Industry
| 2003
Regulatory Laws and Political Culture in the United States and Germany
Arthur A. Daemmrich
Keywords: Government and Politics;
Governing Rules, Regulations, and Reforms;
United States;
Germany;
Citation: Daemmrich, Arthur A. "Regulatory Laws and Political Culture in the United States and Germany." In Regulation of the Pharmaceutical Industry, edited by John Abraham, and Helen Lawton Smith, 11–41. Palgrave Macmillan, 2003.
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Chapter
| La médicine expérimentale au tribunal
| 2003
La tragédie de la thalidomide: affaires judiciaries et résponses législatives, 1959-1971
Arthur A. Daemmrich
Keywords: History;
Courts and Trials;
Government Legislation;
Health Disorders;
Pharmaceutical Industry;
Citation: Daemmrich, Arthur A. "La tragédie de la thalidomide: affaires judiciaries et résponses législatives, 1959-1971." In La médicine expérimentale au tribunal, edited by Christian Bonah, Etienne Lepicard, and Volker Roelcke, 291–318. Éditions des archives contemporaines, 2003.
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Chapter
| An Assessment of the German Biotechnology Sector in Comparative Perspective
| 1999
Biotechnology, Competitiveness and the Regulatory State
Arthur A. Daemmrich
Keywords: Technological Innovation;
Innovation Strategy;
Competitive Advantage;
Governing Rules, Regulations, and Reforms;
Government and Politics;
Policy;
Business and Government Relations;
Biotechnology Industry;
Citation: Daemmrich, Arthur A. "Biotechnology, Competitiveness and the Regulatory State." In An Assessment of the German Biotechnology Sector in Comparative Perspective, edited by Stephen J. Silvia, 33–48. American Institute for Contemporary German Studies, 1999.
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Chapter
| Global Issues Guidebook
| 1995
Pharmaceutical Companies and Health Care Reform
Arthur A. Daemmrich
Keywords: Health Care and Treatment;
Governing Rules, Regulations, and Reforms;
Government and Politics;
Policy;
Business and Government Relations;
Pharmaceutical Industry;
Citation: Daemmrich, Arthur A. "Pharmaceutical Companies and Health Care Reform." In Global Issues Guidebook, edited by Laura Baraff, and Nicola Short, 403–407. Student Pugwash USA, 1995.
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Teaching Note
| HBS Case Collection
|
2012
Telecommunications Regulation and Coordinated Competition in Romania (TN)
Arthur A. Daemmrich
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Teaching Note
| HBS Case Collection
|
2012
GlaxoSmithKline in Brazil: Public-Private Vaccine Partnerships (TN)
Arthur A. Daemmrich
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Case
| HBS Case Collection
|
2012
(Revised from original 2012 version)
Telecommunications Regulation and Coordinated Competition in Romania
Arthur Daemmrich, Alex Radu and Ana Sarbu
Leaders of the Romanian telecommunications agency must decide about a proposed international merger and how to structure bandwidth auctions critical to the telecoms market. The case is designed to teach about regulatory choices from the perspective of a regulatory agency, but it also describes the competitive standing of domestic and international telecoms providers in Romania and the challenges of operating as a "foreign" multinational, even in the European Union where protection of national champions is supposedly obsolete. Policy tradeoffs are developed among approving, delaying, or denying the proposed merger of domestic Romtelecom with Greek-based Cosmote. Likewise, tradeoffs are described for bandwidth auctions, notably among public transparency, maximizing revenue, preventing collusion, promoting efficient use of spectrum, broadening coverage, and fostering innovation in products and services.
Keywords: regulation;
Auction Policy;
European Union;
government policy;
cell phone industry;
Mergers and Acquisitions;
Telecommunications Industry;
Romania;
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Teaching Note
| HBS Case Collection
|
2012
(Revised from original 2011 version)
Brazil: Leading the BRICs? (TN)
Arthur A. Daemmrich and Aldo Musacchio
Teaching Note for 711024.
Keywords: Brazil;
Citation: Daemmrich, Arthur A., and Aldo Musacchio. " Brazil: Leading the BRICs? (TN)." Harvard Business School Teaching Note 711-025, June 2012. (Revised from original March 2011 version.)
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Case
| HBS Case Collection
|
2012
GlaxoSmithKline in Brazil: Public-Private Vaccine Partnerships
Arthur A. Daemmrich and Ian McKown Cornell
Three years into a major public-private partnership between GlaxoSmithKline and Fiocuz, Brazil's principal health institute, the company assesses technology transfer and joint research under the agreement. GSK was selling its Synflorix vaccine (against pediatric pneumonia) at fixed prices even as it transferred technology and know-how to Brazil for eventual domestic production. At the same time, GSK was co-sponsoring research into a new vaccine for Dengue fever with the Brazilian government. GSK's management must consider whether the PPP provides strategic advantage to its consumer healthcare businesses in Brazil and to accesss other emerging markets as well as the risks posed by the aggressive product obsolescence built into the technology transfer agreement.
Keywords: Public-Private Partnerships;
Business and Government Relations;
Foreign Direct Investment;
Health Care and Treatment;
Globalized Firms and Management;
Biotechnology Industry;
Pharmaceutical Industry;
Brazil;
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Background Note
| HBS Case Collection
|
2012
(Revised from original 2010 version)
Stalemate at the WTO: TRIPS, Agricultural Subsidies, and the Doha Round
Arthur A. Daemmrich
This note analyzes disputes over intellectual property enforcement and agricultural trade barriers at the center of the Doha Round of World Trade Organization (WTO) negotiations. Fundamental principles of intellectual property rights and agricultural subsidies are described, along with the challenges of creating and operating multilateral institutions. The note begins with a brief history of multilateral negotiations under the General Agreement on Tariffs and Trade (GATT), then describes key events of the Doha Round that began in 2001, and the WTO's dispute settlement process. A stalemate has developed between developed and developing countries in WTO talks, leading to the proliferation of bilateral agreements. The note challenges readers to develop an informed position on global trade governance and the economic benefits and political tradeoffs associated with reduced trade barriers and the elimination of domestic subsidies.
Keywords: Agribusiness;
Trade;
Globalization;
Governance;
International Relations;
Intellectual Property;
Agreements and Arrangements;
Agriculture and Agribusiness Industry;
Pharmaceutical Industry;
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Case
| HBS Case Collection
|
2012
(Revised from original 2010 version)
U.S. Healthcare Reform: International Perspectives
Arthur A. Daemmrich and Elia Cameron
The national economic implications of rising healthcare costs were poorly understood, even as the United States, Germany, and the United Kingdom instituted reforms in early 2010. Presenting opportunities for cross-national policy learning, this case describes the political economy of healthcare reform. In late March 2010, a major healthcare reform act was signed into law in the United States, expanding coverage and regulating insurers. However, it was not clear that expanding coverage would resolve a longstanding dilemma of rising costs for insurance and care. As the Department of Health and Human Services implemented the new law, it drew on lessons from Germany, which had implemented changes to regulated but competitive insurance and provider markets, and the United Kingdom, which had introduced market-style initiatives while keeping insurance and delivery under the National Health Service.
Keywords: Macroeconomics;
Insurance;
Governing Rules, Regulations, and Reforms;
Health Care and Treatment;
Laws and Statutes;
Business and Government Relations;
Health Industry;
Public Administration Industry;
Germany;
United Kingdom;
United States;
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Supplement
| HBS Case Collection
|
2012
(Revised from original 2011 version)
U.S. Healthcare Reform: Reaction to the Patient Protection and Affordable Care Act of 2010
Arthur A. Daemmrich
Supplement to "U.S. Healthcare Reform: International Perspectives" updating key events and disputes concerning the reform law, including the 2010 Congressional elections, legislative proposals, legal challenges, and responses by employers.
Keywords: Governing Rules, Regulations, and Reforms;
Government Legislation;
Political Elections;
Health Care and Treatment;
Lawsuits and Litigation;
Business and Government Relations;
Public Opinion;
Health Industry;
Public Administration Industry;
United States;
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Teaching Note
| HBS Case Collection
|
2011
(Revised from original 2011 version)
U.S. Healthcare Reform: International Perspectives (TN)
Arthur A. Daemmrich and Elia Cameron
Teaching Note for #710-040 and 711-103.
Keywords: Health Care and Treatment;
Governing Rules, Regulations, and Reforms;
United States;
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Case
| HBS Case Collection
|
2011
(Revised from original 2009 version)
International Lobbying and The Dow Chemical Company (A)
Arthur A. Daemmrich
This case explores company strategy, business-government relations, and collective action challenges associated with international and domestic lobbying regarding regulation of the chemical industry. In the fall of 2006, a five-year legislative process for a major new law regulating chemicals in the European Union appeared to be nearing its conclusion. REACH—the Registration, Evaluation, Authorization, and Restriction of Chemicals—would create a new European Chemicals Agency, require companies to submit testing data on existing and new compounds, and restrict the manufacture of hazardous substances. Andrew Liveris, CEO of the Dow Chemical Company, has to decide whether the company should engage in direct discussions with the European Parliament and Commission, with the implication that the company can influence the regulations but also would have to support the final outcome. The case summarizes Dow's history, competitive dynamics in the sector, and regulation of the chemical industry before describing the REACH legislative process and various approaches to lobbying used by chemical companies, trade groups, and environmental NGOs.
Keywords: Governing Rules, Regulations, and Reforms;
Government Legislation;
Business and Government Relations;
Power and Influence;
Competitive Advantage;
Corporate Strategy;
Chemical Industry;
Manufacturing Industry;
Europe;
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Supplement
| HBS Case Collection
|
2011
Brazil: Leading the BRICs? (PPT)
Arthur A. Daemmrich
Keywords: Brazil;
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Teaching Note
| HBS Case Collection
|
2011
International Lobbying and the Dow Chemical Company (TN) (A) & (B)
Arthur A. Daemmrich
Teaching Note for 710027 and 710028.
Keywords: Governing Rules, Regulations, and Reforms;
Production;
Non-Governmental Organizations;
Strategy;
Business and Government Relations;
Government Legislation;
Chemical Industry;
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Case
| HBS Case Collection
|
2011
(Revised from original 2008 version)
Arcadia Biosciences: Seeds of Change
Arthur A. Daemmrich, Forest L. Reinhardt and Mary Louise Shelman
Arcadia Biosciences is an entrepreneurial California agricultural biotech company seeking to earn carbon credits by modifying commodity crops for use in China and India. Eric Rey, Arcadia's CEO, faced a strategic inflection point in early September 2008. The company had a plan to share carbon credits allocated by the United Nations Clean Development Mechanism Executive Board to China, for use of Arcadia's rice varieties, since they enabled farmers to reduce nitrogen fertilizer use, in turn lowering greenhouse gas emissions. But the company's proprietary traits for nitrogen use efficiency, salt tolerance, and water use efficiency also had more conventional paths to market based on licensing deals to large seed companies. Alternatively, Arcadia could acquire a seed company and develop and market its seed directly. A different near-term growth area involved commercializing enriched safflower oil, which had undergone several proof-of-concept tests and for which Rey foresaw a clear market in nutritional supplements and functional foods. The case provides context on the company; describes advances in crops genetics focused to climate change and associated resource issues of fertilizer use, water use, and soil salinity; and poses strategic choices for a start-up company operating at the intersection of business, agriculture, and climate change.
Keywords: Business Startups;
Entrepreneurship;
Growth and Development Strategy;
Environmental Sustainability;
Science-Based Business;
Weather and Climate Change;
Agriculture and Agribusiness Industry;
Biotechnology Industry;
China;
India;
California;
Citation: Daemmrich, Arthur A., Forest L. Reinhardt, and Mary Louise Shelman. " Arcadia Biosciences: Seeds of Change." Harvard Business School Case 709-019, January 2011. (Revised from original December 2008 version.)
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Teaching Note
| HBS Case Collection
|
2012
(Revised from original 2010 version)
Arcadia Biosciences: Seeds of Change (TN)
Arthur A. Daemmrich and Forest L. Reinhardt
Teaching Note for 709019.
Keywords: Biotechnology Industry;
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Case
| HBS Case Collection
|
2012
(Revised from original 2011 version)
Arcadia Biosciences: Seeds of Change (Abridged)
Arthur A. Daemmrich
Arcadia Biosciences is seeking to introduce genetically modified rice to China that will lower farmers' costs and generate environmental benefits through reduced greenhouse gas emissions. The case describes challenges facing this small agricultural biotechnology company, notably uneven enforcement of intellectual property in emerging market countries and uncertainty regarding the provision and market value of carbon credits under international climate change agreements. In September 2008, Eric Rey, Arcadia's CEO, faces an inflection point concerning his leading technology, genes for Nitrogen Use Efficiency (NUE) in rice. He can determine a price to charge for NUE seed based on savings to farmers from their reduced use of expensive nitrogen fertilizers. Or he can advance a plan to earn revenue from carbon credits allocated under the Kyoto Protocol to China for use of Arcadia's rice, since reduced nitrogen fertilizer use will lower greenhouse gas emissions. The case provides context on the company; describes advances in seed technologies focused to climate change and the associated resource issue of fertilizer use; and presents the strategic choices facing a start-up company operating at the intersection of business, agriculture, and climate change agreements.
Keywords: Plant-Based Agribusiness;
Intellectual Property;
Genetics;
Environmental Sustainability;
Science-Based Business;
Weather and Climate Change;
Agriculture and Agribusiness Industry;
Biotechnology Industry;
China;
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Supplement
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2010
(Revised from original 2009 version)
International Lobbying and The Dow Chemical Company (B): Regulatory Reform in the USA?
Arthur A. Daemmrich
Keywords: Governing Rules, Regulations, and Reforms;
Government and Politics;
Chemical Industry;
United States;
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Case
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2012
(Revised from original 2009 version)
Denmark: Globalization and the Welfare State
Arthur A. Daemmrich and Benjamin Kramarz
This case describes how Denmark has balanced the impacts of globalization, including outsourcing and movement of labor, with its social welfare offerings. Reforms implemented during the past two decades drove down unemployment, promoted new company formation, and put the country at or near the top of international polls on the ease of doing business. The case describes how Danes forged a consensus that embraced international trade and outsourcing while supporting continuous upgrading of workplace skills. In April 2009, the new Prime Minister, Lars Løkke Rasmussen, is balancing short-term responses to a global recession against longer-term planning for the Danish labor market and macroeconomy. Can Denmark keep its borders open to the free movement of goods, services, and labor while also sustaining the breadth of its welfare offerings?
Keywords: Macroeconomics;
Trade;
Globalized Economies and Regions;
Governing Rules, Regulations, and Reforms;
Job Cuts and Outsourcing;
Employment;
Welfare or Wellbeing;
Denmark;
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Teaching Note
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2012
(Revised from original 2009 version)
Denmark: Globalization and the Welfare State (TN)
Arthur A. Daemmrich
Teaching Note for [709015].
Keywords: Globalization;
Government and Politics;
Poverty;
Denmark;
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Teaching Note
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2009
Targanta Therapeutics: Hitting a Moving Target (TN)
Arthur A. Daemmrich
Teaching Note for [709002].
Keywords: Governing Rules, Regulations, and Reforms;
Product Development;
Business Strategy;
Initial Public Offering;
Mergers and Acquisitions;
Policy;
Selection and Staffing;
Health Testing and Trials;
Resource Allocation;
Biotechnology Industry;
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Background Note
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2009
(Revised from original 2008 version)
A Managerial Perspective on Clinical Trials
Arthur A. Daemmrich
This note describes the history and regulation of clinical trials, managerial challenges related to pharmaceutical product testing, and current debates regarding prescription drug safety. Since clinical testing takes between five and seven years, and consumes up to 70 percent of a drug's total development costs, pharmaceutical and biotechnology leaders need to understand clinical trial management. Likewise, with a growing variety of new product introductions requiring pre-market testing, managers and analysts in many business sectors will benefit from understanding clinical trials.
Keywords: Governing Rules, Regulations, and Reforms;
Health Testing and Trials;
Product Development;
Safety;
Biotechnology Industry;
Pharmaceutical Industry;
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Case
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2009
(Revised from original 2009 version)
Targanta Therapeutics: Hitting a Moving Target
Arthur A. Daemmrich
This case explores regulatory, product testing, and business strategy at Targanta Therapeutics, a biotech company preparing its first new drug application to the FDA. In October 2007, Mark Leuchtenberger, president and CEO of Targanta—which has just held a successful IPO—weighs options for the approximately ten-month review period after the company submits to the Food and Drug Administration. The case reviews Targanta's origins and "de-risking" of oritavancin, an antibiotic therapy for drug-resistant infections that was first invented at Eli Lilly and then spun out to InterMune before Targanta acquired it in late 2005. To highlight the impact of regulatory policy on business strategy, the case then describes a set of choices facing the firm, including staffing a marketing and sales group, carrying out additional clinical testing to expand the approved indications, applying for European market approval, or keeping funds in reserve in the event that the FDA requests further data.
Keywords: Decision Choices and Conditions;
Entrepreneurship;
Governing Rules, Regulations, and Reforms;
Health Testing and Trials;
Product Development;
Business and Government Relations;
Business Strategy;
Biotechnology Industry;
Pharmaceutical Industry;
Research Summary
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Research Summary
Bodies at Risk: Chemicals Testing in the United States and Europe
by
Arthur A. Daemmrich
This book project examines environmental regulation comparatively between the United States and Europe, with a focus on testing programs and controls on the manufacture of commodity and specialty chemicals. Findings thus far indicate that different relations among industry, government, and NGOs in the two contexts are shaping demands for chemicals testing and approaches to regulation, with important implications for both single-market and global firms. The project is built around case studies of the high-production volume testing program, endocrine disruptor testing, children's health testing programs, and an emerging set of tests for synthetic materials in human bodies often termed "body burden" studies. Whereas the US has recently advanced voluntary testing programs with the aim of sharing 'risk-based' information across industry, NGOs, and the EPA, the EU is developing mandates for testing that provide information to industry, that force industry to provide 'precautionary' information to the new European Chemicals Agency.
Awards & Honors
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Arthur A. Daemmrich: Winner of the 2006 Edward Kremers Award from the American Institute of the History of Pharmacy for best book published in the previous two years for Pharmacopolitics: Drug Regulation in the United States and Germany (The University of North Carolina Press, 2004).
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