IRPN: Innovation & Food & Drug Law & Policy (Sub-Topic)最新文献

Current Perspectives and Challenges in the Pharmaceutical, Life Science and Health Care Sectors 制药、生命科学和卫生保健领域的当前前景和挑战

IRPN: Innovation & Food & Drug Law & Policy (Sub-Topic) Pub Date : 2019-07-26 DOI: 10.2139/ssrn.3427037

Natalia Haraszkiewicz-Birkemeier

引用次数: 1

A Road Untaken: What Makes Entrepreneurs Promote Breakthrough Innovation? 未走的路:企业家推动突破性创新的原因?

IRPN: Innovation & Food & Drug Law & Policy (Sub-Topic) Pub Date : 2018-04-12 DOI: 10.2139/ssrn.3161869

Yujin Kim

{"title":"A Road Untaken: What Makes Entrepreneurs Promote Breakthrough Innovation?","authors":"Yujin Kim","doi":"10.2139/ssrn.3161869","DOIUrl":"https://doi.org/10.2139/ssrn.3161869","url":null,"abstract":"This paper examines the strategic conditions that drive entrepreneurial innovators to pursue novel innovation rather than innovation that is closer to existing technologies. To an increasing extent, startups commercialize innovation in a cooperative setup. Because radical breakthrough innovation is more difficult to communicate than its incremental counterpart, entrepreneurial innovators may avoid breakthrough innovation for which the cost of developing credible information is exceedingly high. In the context of the Orphan Drug Act (ODA), this study uses a difference-in-difference approach to measure whether entrepreneurs are more likely to bring novel innovations to the market when the policy change unexpectedly lowers the cost of obtaining information that will convince investors through a small market test. Using a new measure of the novelty of innovation and a detailed panel dataset of therapeutic molecules, this empirical study finds that biotech startups bring more breakthrough drugs to markets affected by ODA. This research also finds that in ODA-affected areas, entrepreneurs are more likely to make partnerships with pharmaceutical partners, but the timing of the partnership is delayed to the advanced development stage for startups to create credible evidence of novel drugs. Taken together, the results of this study suggest that the cost of convincing investors prevents entrepreneurs from marketing novel innovation and that a public policy can moderate inefficiency in the “market for ideas” by decreasing the information friction.","PeriodicalId":191980,"journal":{"name":"IRPN: Innovation & Food & Drug Law & Policy (Sub-Topic)","volume":"35 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2018-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116801116","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

Antitrust Scrutiny of Excessive Prices in the Pharmaceutical Sector: A Comparative Study of the Italian and UK Experiences 制药行业价格过高的反垄断审查:意大利和英国经验的比较研究

IRPN: Innovation & Food & Drug Law & Policy (Sub-Topic) Pub Date : 2018-04-08 DOI: 10.54648/woco2018012

M. Colangelo, C. Desogus

引用次数: 3

Developing Novel Drugs 开发新药

IRPN: Innovation & Food & Drug Law & Policy (Sub-Topic) Pub Date : 2017-12-29 DOI: 10.2139/SSRN.3095246

Joshua L. Krieger, Danielle Li, D. Papanikolaou

引用次数: 31

Why Cooperation is a Better Strategy to Achieve Competitive Advantage in Immuno-Oncology for Pharma Rivals Pfizer and Merck KGaA - Analyzing the Companies' Benefits 为什么合作是辉瑞和默克制药竞争对手在免疫肿瘤领域获得竞争优势的更好策略——分析两家公司的利益

IRPN: Innovation & Food & Drug Law & Policy (Sub-Topic) Pub Date : 2017-10-06 DOI: 10.2139/ssrn.3061160

Evgeniia Popova

引用次数: 0

Food Security, FTA and Trade Protectionism in Asian Countries 亚洲国家的粮食安全、自由贸易协定与贸易保护主义

IRPN: Innovation & Food & Drug Law & Policy (Sub-Topic) Pub Date : 2016-05-04 DOI: 10.2139/ssrn.2864395

Aruna Kumar Nishanka

引用次数: 0

Food Safety and Sustainable Development 食品安全和可持续发展

IRPN: Innovation & Food & Drug Law & Policy (Sub-Topic) Pub Date : 2014-06-11 DOI: 10.6027/9789289337267-4-en

P. Krajewski

引用次数: 4

The Impact of Global and Local Cohesion on Innovation in the Pharmaceutical Industry 全球和地方凝聚力对制药行业创新的影响

IRPN: Innovation & Food & Drug Law & Policy (Sub-Topic) Pub Date : 2012-05-01 DOI: 10.1002/SMJ.957

Isin Guler, Atul Nerkar

引用次数: 131

As You Sow, so Shall You Reap: Evidence of Innovation and Drug Portfolio Diversification from the Stock Market 一分耕耘，一分收获:来自股市的创新和药物投资组合多样化的证据

IRPN: Innovation & Food & Drug Law & Policy (Sub-Topic) Pub Date : 2010-04-01 DOI: 10.2139/ssrn.1605127

Anushri Bansal

{"title":"As You Sow, so Shall You Reap: Evidence of Innovation and Drug Portfolio Diversification from the Stock Market","authors":"Anushri Bansal","doi":"10.2139/ssrn.1605127","DOIUrl":"https://doi.org/10.2139/ssrn.1605127","url":null,"abstract":"Drug discovery and development is a risky and time-consuming process. Typically, a new product costs around $1.3 billion and takes 15–20 years to reach the shelves, while an overwhelming majority of innovations fail along the way. The probability of attaining a US Food and Drug Administration (FDA) approval for a compound that has attained a patent grant is a mere 0.02 per cent. However, the pharmaceutical industry’s sustainability and profitability is dependant on product discovery and innovation. Against such a background, this article looks at returns to innovation for 66 companies in the biopharmaceutical industry. Based on Original New Drug Approvals (NDA) by the FDA from 1997–2007 and patent grants from 1984–2005, this study assesses market rewards for bringing new drugs to the market and undertaking risks by diversifying product portfolios. Using an event-study analysis, this article makes two conclusions. First, FDA drug approval receives a positive and longlasting response from the stock market. Second, FDA policies alongside factors such as R&D expenditure, drug type and reputation of the company based on previous drug approvals, play an instrumental role in encouraging pharmaceutical companies to innovate, by reducing the interval between a patent grant and FDA approval. Finally, the market offers sizable rewards for undertaking the risk of product diversification and also rewards frequent participants.","PeriodicalId":191980,"journal":{"name":"IRPN: Innovation & Food & Drug Law & Policy (Sub-Topic)","volume":"170 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2010-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114923213","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

Regulatory Beneficiaries and Informal Agency Policy Making 监管受益人和非正式机构政策制定

IRPN: Innovation & Food & Drug Law & Policy (Sub-Topic) Pub Date : 2006-02-01 DOI: 10.2139/SSRN.881137

Nina A. Mendelson

{"title":"Regulatory Beneficiaries and Informal Agency Policy Making","authors":"Nina A. Mendelson","doi":"10.2139/SSRN.881137","DOIUrl":"https://doi.org/10.2139/SSRN.881137","url":null,"abstract":"Administrative agencies frequently use guidance documents to set policy broadly and prospectively in areas ranging from Department of Education Title IX enforcement to Food and Drug Administration regulation of direct-to- consumer pharmaceutical advertising. In form, these guidances often closely resemble the policies agencies issue in ordinary notice-and-comment rulemaking. However, guidances are generally developed with little public participation and are often immune from judicial review. Nonetheless, guidances can prompt significant changes in behavior from those the agencies regulate. A number of commentators have guardedly defended the current state of affairs. Though guidances lack some important procedural safeguards, they can help agencies supervise low-level employees and supply valuable information to regulated entities regarding how an agency will implement a program. Thus far, however, the debate has largely ignored the distinct and substantial interests of regulatory beneficiaries--those who expect to benefit from government regulation of others. Regulatory beneficiaries include, among others, pharmaceutical consumers, environmental users, and workers seeking safe workplaces. When agencies make policy informally, regulatory beneficiaries suffer distinctive losses to their ability to participate in the agency's decision and to invoke judicial review. This Article argues that considering the interests of regulatory beneficiaries strengthens the case for procedural reform. The Article then assesses some possible solutions.","PeriodicalId":191980,"journal":{"name":"IRPN: Innovation & Food & Drug Law & Policy (Sub-Topic)","volume":"43 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2006-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129946934","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 28