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Research Studies & Reports

Numerous studies offer a framework for issues that the Center for the Integration of Science and Industry seeks to address. Recent publications are outlined below.


 

January 06, 2021

Article:

Comparing long-term value creation after biotech and non-biotech IPOs, 1997-2016

" "ABSTRACT:

We compared the financial performance of 319 BIOTECH companies focused on developing therapeutics with IPOs from 1997–2016, to that of paired, non-biotech CONTROL companies with concurrent IPO dates. BIOTECH companies had a distinctly different financial structure with high R&D expense, little revenue, and negative profits (losses), but a similar duration of listing on public markets and frequency of acquisitions. Through 2016, BIOTECH and CONTROL companies had equivalent growth in market cap and shareholder value (>$100 billion), but BIOTECH companies had lower net value creation ($93 billion vs $411 billion). Both cohorts exhibited a high-risk/high reward pattern of return, with the majority losing value, but many achieving growth multiples. While investments in biotechnology are often considered to be distinctively risky, we conclude that value creation by biotech companies after IPO resembles that of non-biotech companies at a similar stage and does not present a disproportionate investment risk.

Cleary, Ekaterina Galkina, et al. (2021) "Comparing long-term value creation after biotech and non-biotech IPOs, 1997-2016." PLoS ONE 16(1): e0243813. https://doi.org/10.1371/journal.pone.0243813.


 

December 27, 2020

Article:

Late-Stage Product Development and Approvals by Biotechnology Companies After Initial Public Offering, 1997-2016

" "ABSTRACT:

This work describes the late-stage product portfolios of the biotechnology companies that completed initial public offerings (IPOs) from 1997 to 2016. We asked whether these emerging companies continue to develop innovative, biologic products and produce the innovation promised by the early biotechnology industry. We identified therapeutic products that reached Phase III development from 1997 to 2016, the characteristics of the products, the dates of the initiation of Phase III and product approval, proxy indicators of the innovativeness of each product, and the contribution of each biotechnology company. Companies were characterized by IPO window and clinical status of the most advanced product at IPO. Time from IPO to Phase III or approval, and the estimated probability of a company having a product advance to these milestones, were examined using KaplaneMeier analysis. A total of 319 biotechnology companies completed IPOs from 1997 to 2016. These companies contributed to the development of 367 products that progressed to Phase III, and of 144 new drug approvals, through 2016. The estimated probability of a company having a product reach Phase III was 78%, and the estimated probability of a company receiving at least 1 product approval was 52%, with most approvals occurring >5 years after IPO. Small-molecule drugs represented 74% of products reaching Phase III and 78% of approvals. Reformulations represented 36% of Phase III products and 46% of approvals. The estimated probability of product approval was significantly higher for reformulations than new molecular entities (NMEs) and slightly higher for small molecules than biologics. The estimated probability of a company receiving product approval varied significantly by IPO window and was greater for companies with Phase III products at IPO (74%). These companies contributed to the development of 78 NMEs, 44% of which were classified as first in class, initiating development of 69% and contributing to the clinical development of 96%. These products represented 16% of all NMEs and 28% of biologics approved between 1997 and 2016. Seven products achieved per-annum sales of >$1 billion during the study period. The majority of emerging publicly owned biotechnology companies contribute to products that advance to Phase III development and approval, although these companies are no longer distinctively focused on biologic products.

McNamee, Laura M., et al. "Late-Stage Product Development and Approvals by Biotechnology Companies After Initial Public Offering, 1997–2016," Clinical Therapeutics, 2020, ISSN 0149-2918, https://doi.org/10.1016/j.clinthera.2020.11.012.


 

September, 2020

Article:

Government as the First Investor in Biopharmaceutical Innovation; Evidence From New Drug Approvals 2010-2019

" "ABSTRACT:

The discovery and development of new medicines classically involves a linear process of basic biomedical research to uncover potential targets for drug action, followed by applied, or translational, research to identify candidate products and establish their effectiveness and safety. This Working Paper describes the public sector contribution to that process by tracing funding from the National Institutes of Health (NIH) related to published research on each of the 356 new drugs approved by the U.S. Food and Drug Administration from 2010-2019 as well as research on their 219 biological targets. Specifically, we describe the timelines of clinical development for these products and proxy measures of their importance, including designations as first-in-class or expedited approvals. We model the maturation of basic research on the biological targets for drugs to determine the initiation and established points of this research, and demonstrate that none of the 232 products modelled were approved before this enabling research passed the established point. This body of essential research comprised 2 million publications, of which 424 thousand were supported by 515 thousand Funding Years of NIH Project support totaling $195 billion. Research on the 356 drugs comprised 244 thousand publications, of which 39 thousand were supported by 64 thousand Funding Years of NIH Project support totaling $36 billion. Overall, NIH funding contributed to research associated with every new drug approved from 2010-2019, totaling $230 billion. This funding supported investigator-initiated Research Projects, Cooperative Agreements for government-led research on topics of particular importance, as well as Research Program Projects and Centers and training to support the research infrastructure. This NIH funding also produced 22 thousand patents, which provided marketing exclusivity for 27 (8.6%) of the drugs approved 2010-2019. These data demonstrate the essential role of public sector-funded basic research in drug discovery and development, as well as the scale and character of this funding. It also demonstrates the limited mechanisms available for recognizing the value created by these early investments and ensuring appropriate public returns. This analysis demonstrates the importance of sustained public investment in basic biomedical science as well as the need for policy innovations that fully realize the value of public sector investments in pharmaceutical innovation that ensure that these investments yield meaningful improvements in health.


 

July 06, 2020

Article:

Foundational research and NIH funding enabling Emergency Use Authorization of remdesivir for COVID-19

" "ABSTRACT:

Emergency Use Authorization for remdesivir months after discovery of COVID19 is unprecedented. Typically, decades of research and public sector funding are required to establish the mature body of foundational research requisite for efficient, targeted drug discovery and development. This work quantifies the body of research related to the biological target of remdesivir, RNA-dependent RNA polymerase (RdRp), or parent chemical structure, nucleoside analogs (NcAn), through 2019, as well as NIH funding for this research from 2000 to 2019. There were 6,567 RdRp related publications in PubMed, including 1,263 with NIH support, and 11,073 NcAn-related publications, including 2,319 with NIH support. NIH support for RdRp research comprised 2,203 Project Years with Costs of $1,875 million. NIH support for NcAn research comprised 4,607 Project Years with Costs of $4,612 million. Research Project grants accounted for 63% and 48% of Project Years for RdRp and NcAn respectively, but only 19% and 12% of Project Costs. Analytical modeling of research maturation estimates that RdRp and NcAn research passed an established maturity threshold in 2008 and 1994 respectively. Of 97 investigational compounds targeting RdRp since 1989, the three authorized for use entered clinical trials after both thresholds. This work demonstrates the scale of foundational research on the biological target and parent chemical structure of remdesivir that supported its discovery and development for COVID19. This work identifies $6.5 billion in NIH funding for research leading to remdesivir, underscoring the role of public sector investments in basic research and research infrastructure that underlie new drugs and the response to emergent disease.


 

2020

Article:

The role of NIH funding in vaccine readiness; foundational research and NIH funding underlying candidate SARS-CoV-2 vaccines

" "ABSTRACT:

The COVID-19 pandemic has spurred a diverse array of vaccine development initiatives. Using quantitative, bibliometric methods, we examined the progression of published research on ten fundamental technologies incorporated in candidate vaccines, in light of the challenges and high failure rate of vaccine development, and the role of technological maturity in the efficiency of development. The maturity of vaccine technologies varies widely. Whole virus preparations and non-specific adjuvants used in many successful products continue to exhibit slow advance. Products employing recombinant proteins, novel adjuvants, and viral vectors exhibit a logistic growth pattern characteristic of technologies that have passed the analytically-defined established point. Other technologies, including mRNA and virus-like or nanoparticles have not passed FDA registration and show exponential growth characteristic of technologies short of their established points. Foundational research for COVID-19 vaccines was supported by >16,000 project years of NIH funding totaling over $17 billion since 2000, the majority through cooperative agreements and intramural programs. NIH vaccine funding for emerging threats like other coronaviruses, Zika, Ebola, and dengue has been inconsistent and reactive to recurring disease outbreaks. The broad foundation of emerging and established technologies for COVID-19 amplifies the probability and widens the windows of opportunity for success. This work characterizes the NIH funding that created the repertoire of technologies currently available, as well as the lack of sustained progress or funding for vaccines against recognized, epidemic threats. Sustained funding for enabling technologies and vaccine development is essential to ensure a rapid response to COVID and future pandemic threats.


 

June 20, 2020

Article:

NIH funding for research underlying new cancer therapies

Lacent Oncology FigureABSTRACT:

This work examines National Institutes of Health (NIH) funding for research underlying the 59 new cancer drugs approved from 2010-2016 or their biological targets. The NIH contributed 116,703 fiscal years of project funding for this research, totaling $63.9 billion. This included $54 billion (84%) for basic research related to the drug targets, but not the drugs themselves, and $9.9 billion (16%) related to the drugs. This amount approaches, or exceeds, the annual budget allocation for the National Cancer Institute (NCI) and estimates of cancer research spending by the Research, Condition, and Disease Categorization (RCDC) since 2008. The NCI contributed $20.1 billion (31%) to the total, with some contributed by institutes focused on core capabilities. The majority, however, came from institutes with distinct, disease-specific missions. Spillovers of basic research in other therapeutic areas, particularly endocrinology and immunology, contribute substantially to the body of research leading to new cancer drugs.
 
Cleary, Ekaterina Galkina and Ledley, Fred D. (2020) NIH funding for research underlying new cancer therapies.  Lancet Oncology 21(6):755-757. doi.org/10.1016/S1470-2045(20)30235-7. www.thelancet.com/journals/lanonc/article/PIIS1470-2045(20)30235-7/fulltext


 

April 30, 2020

Article:

We Don't Have to Lose STEM Students to Business

" "ABSTRACT:

Most undergraduate students who leave STEM majors before graduation choose careers in business. This article argues that better integrating business opportunities and context into the STEM curriculum could advance STEM learning, motivate students to remain in STEM as majors, and cultivate a constructive relationship between business, science, and society.
 
Wernick, Naomi LB, and Fred D. Ledley. "We Don't Have to Lose STEM Students to Business." Journal of Microbiology & Biology Education 21.1 (2020). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7198222/


 

March 3, 2020

Article:
Profitability of Large Pharmaceutical Companies Compared With Other Large Public Companies

JAMA paper figure 1ABSTRACT:

Question How do the profits of large pharmaceutical companies compare with those of other companies from the S&P 500 Index?

Findings In this cross-sectional study that compared the profits of 35 large pharmaceutical companies with those of 357 large, nonpharmaceutical companies from 2000 to 2018, the median net income (earnings) expressed as a fraction of revenue was significantly greater for pharmaceutical companies compared with nonpharmaceutical companies (13.8% vs 7.7%).

Meaning Large pharmaceutical companies were more profitable than other large companies, although the difference was smaller when controlling for differences in company size, research and development expense, and time trends.

Ledley, Fred D., et al. "Profitability of large pharmaceutical companies compared with other large public companies." JAMA 323.9 (2020): 834-843.


December 1, 2018

Article:
Representation of Industry in Introductory Biology Textbooks: A Missed Opportunity to Advance STEM Learning

ABSTRACT:

The majority of students who enroll in undergraduate biology courses will eventually be employed in non-STEM (science, technology, engineering, and mathematics) business occupations. This work explores how representations of industry in undergraduate biology textbooks could impact STEM learning for these students and their ability to apply this learning in their chosen work. We used text analysis to identify passages with references to industry in 29 textbooks. Each passage was categorized for relevance to health or environment, for implied positive or negative connotations, and for descriptions of synergy or conflict between science and industry. We found few passages describing applications of STEM learning in non-STEM business occupations and a paucity of content to support context-based learning for students aiming at business careers. A significant number of passages embodied negative connotations regarding industry. Notable passages highlighted irregular or fraudulent business practices or included simplistic caricatures of business practice. We discuss how the representation of industry in these textbooks may impact student engagement, context-based learning, the ability of students to critically apply STEM learning in industry or business occupations, and heuristics that guide intuitive perceptions about the intersection between science and industry.

Simon, Sharotka M., et al. "Representation of industry in introductory biology textbooks: A missed opportunity to advance stem learning." CBE—Life Sciences Education 17.4 (2018): ar61.


February 12, 2018

Article:
Contribution of NIH funding to new drug approvals 2010–2016

ABSTRACT:

This work examines the contribution of NIH funding to published research associated with 210 new molecular entities (NMEs) approved by the Food and Drug Administration from 2010–2016. We identified >2 million publications in PubMed related to the 210 NMEs (n = 131,092) or their 151 known biological targets (n = 1,966,281). Of these, >600,000 (29%) were associated with NIH-funded projects in RePORTER. This funding included >200,000 fiscal years of NIH project support (1985–2016) and project costs >$100 billion (2000–2016), representing ∼20% of the NIH budget over this period. NIH funding contributed to every one of the NMEs approved from 2010–2016 and was focused primarily on the drug targets rather than on the NMEs themselves. There were 84 first-in-class products approved in this interval, associated with >$64 billion of NIH-funded projects. The percentage of fiscal years of project funding identified through target searches, but not drug searches, was greater for NMEs discovered through targeted screening than through phenotypic methods (95% versus 82%). For targeted NMEs, funding related to targets preceded funding related to the NMEs, consistent with the expectation that basic research provides validated targets for targeted screening. This analysis, which captures basic research on biological targets as well as applied research on NMEs, suggests that the NIH contribution to research associated with new drug approvals is greater than previously appreciated and highlights the risk of reducing federal funding for basic biomedical research.

Cleary, Ekaterina Galkina, et al. "Contribution of NIH funding to new drug approvals 2010–2016." Proceedings of the National Academy of Sciences 115.10 (2018): 2329-2334.

December 15, 2017

Article:
As Technologies for Nucleotide Therapeutics Mature, Products Emerge

ABSTRACT:

The long path from initial research on oligonucleotide therapies to approval of antisense products is not unfamiliar. This lag resembles those encountered with monoclonal antibodies, gene therapies, and many biological targets and is consistent with studies of innovation showing that technology maturation is a critical determinant of product success. We previously described an analytical model for the maturation of biomedical research, demonstrating that the efficiency of targeted and biological development is connected to metrics of technology growth. The present work applies this model to characterize the advance of oligonucleotide therapeutics. We show that recent oligonucleotide product approvals incorporate technologies and targets that are past the established point of technology growth, as do most of the oligonucleotide products currently in phase 3. Less mature oligonucleotide technologies, such as miRNAs and some novel gene targets, have not passed the established point and have not yielded products. This analysis shows that oligonucleotide product development has followed largely predictable patterns of innovation. While technology maturation alone does not ensure success, these data show that many oligonucleotide technologies are sufficiently mature to be considered part of the arsenal for therapeutic development. These results demonstrate the importance of technology assessment in strategic management of biomedical technologies.

Beierlein, Jennifer M., Laura M. McNamee, and Fred D. Ledley. “As technologies for nucleotide therapeutics mature, products emerge." Molecular Therapy-Nucleic Acids 9 (2017): 379-386.


June 26, 2017

Article:
Landscape of Innovation for Cardiovascular Pharmaceuticals: From Basic Science to New Molecular Entities

ABSTRACT:

Purpose: This study examines the complete timelines of translational science for new cardiovascular therapeutics from the initiation of basic research leading to identification of new drug targets through clinical development and US Food and Drug Administration (FDA) approval of new molecular entities (NMEs) based on this research. Methods: This work extends previous studies by examining the association between the growth of research on drug targets and approval of NMEs associated with these targets. Drawing on research on innovation in other technology sectors, where technological maturity is an important determinant in the success or failure of new product development, an analytical model was used to characterize the growth of research related to the known targets for all 168 approved cardiovascular therapeutics. Findings: Categorizing and mapping the technological maturity of cardiovascular therapeutics reveal that (1) there has been a distinct transition from phenotypic to targeted methods for drug discovery, (2) the durations of clinical and regulatory processes were significantly influenced by changes in FDA practice, and (3) the longest phase of the translational process was the time required for technology to advance from initiation of research to a statistically defined established point of technology maturation (mean, 30.8 years). Implications: This work reveals a normative association between metrics of research maturation and approval of new cardiovascular therapeutics and suggests strategies for advancing translational science by accelerating basic and applied research and improving the synchrony between the maturation of this research and drug development initiatives.

Beierlein, Jennifer M., et al. "Landscape of Innovation for Cardiovascular Pharmaceuticals: From Basic Science to New Molecular Entities." Clinical Therapeutics 39.7 (2017): 1409-1425 e20.


May 8, 2017

Article:
Timelines of translational science: from technology initiation to FDA approval

ABSTRACT:

While timelines for clinical development have been extensively studied, there is little data on the broader path from initiation of research on novel drug targets, to approval of drugs based on this research. We examined timelines of translational science for 138 drugs and biologicals approved by the FDA from 2010-2014 using an analytical model of technology maturation. Research on targets for 102 products exhibited a characteristic (S-curve) maturation pattern with exponential growth between statistically defined technology initiation and established points. The median initiation was 1974, with a median of 25 years to the established point, 28 years to first clinical trials, and 36 years to FDA approval. No products were approved before the established point, and development timelines were significantly longer when the clinical trials began before this point (11.5 vs 8.5 years, p<0.0005). Technological maturation represents the longest stage of translation, and significantly impacts the efficiency of drug development.

McNamee, Laura M., Michael Jay Walsh, and Fred D. Ledley. "Timelines of translational science: From technology initiation to FDA approval." PloS one 12.5 (2017): e0177371.


March 27, 2017

Article:
Modeling timelines for translational science in cancer; the impact of technological maturation

ABSTRACT:

This work examines translational science in cancer based on theories of innovation that posit a relationship between the maturation of technologies and their capacity to generate successful products. We examined the growth of technologies associated with 138 anticancer drugs using an analytical model that identifies the point of initiation of exponential growth and the point at which growth slows as the technology becomes established. Approval of targeted and biological products corresponded with technological maturation, with first approval averaging 14 years after the established point and 44 years after initiation of associated technologies. The lag in cancer drug approvals after the increases in cancer funding and dramatic scientific advances of the 1970s thus reflects predictable timelines of technology maturation. Analytical models of technological maturation may be used for technological forecasting to guide more efficient translation of scientific discoveries into cures.

McNamee Laura M., and Fred Ledley. “Modeling timelines for translational science in cancer; the impact of technological maturation.” PLOS ONE 12.3 (2017): e0174538.


December 2016

Article:
Marine Microalgae: Climate, Energy, and Food Security from the Sea

ABSTRACT:

Climate, energy, and food security are three of the greatest challenges society faces this century. Solutions for mitigating the effects of climate change often conflict with solutions for ensuring society’s future energy and food requirements. For example, BioEnergy with Carbon Capture and Storage (BECCS) has been proposed as an important method for achieving negative CO2 emissions later this century while simultaneously producing renewable energy on a global scale. However, BECCS has many negative environmental consequences for land, nutrient, and water use as well as biodiversity and food production. In contrast, large-scale industrial cultivation of marine microalgae can provide society with a more environmentally favorable approach for meeting the climate goals agreed to at the 2015 Paris Climate Conference, producing the liquid hydrocarbon fuels required by the global transportation sector, and supplying much of the protein necessary to feed a global population approaching 10 billion people.

Greene, C.H., M.E. Huntley, I. Archibald, L.N. Gerber, D.L. Sills, J. Granados, J.W. Tester, C.M. Beal, M.J. Walsh, R.R. Bidigare, S.L. Brown, W.P. Cochlan, Z.I. Johnson, X.G. Lei, S.C. Machesky, D.G. Redalje, R.E. Richardson, V. Kiron, and V. Corless. 2016. Marine microalgae: Climate, energy, and food security from the sea. Oceanography 29(4), https://doi.org/10.5670/oceanog.2016.91.


October 28, 2016

Article:
Algal food and fuel coproduction can mitigate greenhouse gas emissions while improving land and water-use efficiency

ABSTRACT:

The goals of ensuring energy, water, food, and climate security can often conflict. Microalgae (algae) are being pursued as a feedstock for both food and fuels—primarily due to algae's high areal yield and ability to grow on non-arable land, thus avoiding common bioenergy-food tradeoffs. However, algal cultivation requires significant energy inputs that may limit potential emission reductions. We examine the tradeoffs associated with producing fuel and food from algae at the energy–food–water–climate nexus. We use the GCAM integrated assessment model to demonstrate that algal food production can promote reductions in land-use change emissions through the offset of conventional agriculture. However, fuel production, either via co-production of algal food and fuel or complete biomass conversion to fuel, is necessary to ensure long-term emission reductions, due to the high energy costs of cultivation. Cultivation of salt–water algae for food products may lead to substantial freshwater savings; but, nutrients for algae cultivation will need to be sourced from waste streams to ensure sustainability. By reducing the land demand of food production, while simultaneously enhancing food and energy security, algae can further enable the development of terrestrial bioenergy technologies including those utilizing carbon capture and storage. Our results demonstrate that large-scale algae research and commercialization efforts should focus on developing both food and energy products to achieve environmental goals.

Walsh, Michael J., et al. "Algal food and fuel coproduction can mitigate greenhouse gas emissions while improving land and water-use efficiency." Environmental Research Letters 11.11 (2016): 114006.


August 7, 2015

Article:
What does the current biotech stock market value?

ABSTRACT:

This article examined the valuations, clinical development pipelines, and core technologies of 120 biotechnology companies that completed IPOs between 2012-2014, and compared these metrics with those observed in our previous study of the biotechnology “class of 2000.”  Given the unprecedented number of newly public companies, their very early stage clinical pipelines, their relatively limited capitalization, and the likelihood that the current bull market will experience a correction over the next several years, we express concern about the availability of sufficient capital to drive development of these important products.  

McNamee, Laura, and Fred Ledley. "What does the current biotech stock market value?." Nature biotechnology 33.8 (2015): 813-814.


August 1, 2015

Article:
Patterns of Innovation in Alzheimer’s Disease Drug Development: A Strategic Assessment Based on Technological Maturity

Abstract:

This work examines the current status of translational science for Alzheimer’s disease (AD) drug discovery using an analytical model of  technology maturation. Previous studies have demonstrated that nascent scientific insights and inventions generate few successful leads or new products until achieving a requisite level of maturity. We used the bibliometric-based Technology Innovation Maturation Evaluation (TIME) model to quantify the characteristic S-curve of growth for AD-related technologies including acetylcholinesterase, NMDA receptors, B-amyloid, APP, presenillin, APP secretases, ApoE, and TDP-34. This model quantifies the accumulation of knowledge as a metric for technological maturity, and identifies the point of initiation of an exponential growth stage, and the point at which growth slows as the technology is established. In contrast to the long-established AChE and NMDA receptor technologies, we found that amyloid related technologies reached the established point only after 2000, and the more recent technologies, such as TDP-34, have not yet approached this point. The first approvals for NMEs targeting AChE and the NMDA receptor occurred an average of 22 years after the respective technologies were established, with only the phenotypically discovered, mementine, entering clinical trials before this point. In contrast, the six lead compounds targeting the formation of amyloid plaques that failed in phase 3 trials between 2009 and 2014, all entered clinical trials before the respective target technologies were established.  This analysis suggests that AD drug discovery has followed a predictable pattern of innovation in which technological maturity is an important determinant of success in development.  Quantitative analysis indicates that the lag in emergence of new products, and the much-heralded clinical failures of recent years should be viewed in the context of the ongoing maturation of AD-related technologies. While these technologies were not sufficiently mature to generate successful products a decade ago, they may be now.       

Beierlein, Jennifer M., et al. "Patterns of innovation in Alzheimer’s disease drug development: a strategic assessment based on technological maturity." Clinical therapeutics 37.8 (2015): 1643-1651.                                                                                                          


Summer, 2015

Article:
Connecting Business and STEM Education Through Undergraduate Research

Abstract:

This report describes an undergraduate research program that engages business students in STEM research to foster an interdisciplinary understanding of science and business. Three scenarios are described: traditional research with science faculty, STEM research embedded in class-based projects and service learning, and research focused on integrating science and business to advance translational science. Business students exhibit attitudes towards science and learning styles that may be particularly conducive to informal science learning. Through undergraduate research, business students acquire a deeper appreciation of the application of science to business and society as well as the interdisciplinary literacy required to translate scientific advances into public value.

Bouldin, R. M., Hall, G. J., Oches, E. A., Szymanski, D. W., & Ledley, F. D. (2015). Connecting business and STEM education through undergraduate researchCUR QUARTERLY, 35(4), 17-23.


July, 2015

Article:
Algal biofuel production for fuels and feed in a 100-ha facility: A comprehensive techno-economic analysis and life cycle assessment

Abstract:

This techno-economic analysis/life-cycle assessment is based on actual production by the Cornell Marine Algal Biofuels Consortium with biomass productivity N 23 g/m2-day. Ten distinct cases are presented for two locations, Texas and Hawaii, based on a 100-ha production facility with end-to-end processing that yields fungible co-products including bio crude, animal feed, and ethanol. Several processing technologies were evaluated: centrifugation and solvent extraction (POS Biosciences), thermochemical conversion (Valicor), hydrothermal liquefaction (PNNL), catalytic hydrothermal gasification (Genifuel), combined heat and power, wet extraction (OpenAlgae), and fermentation. The facility design was optimized by co-location with waste CO2, a terraced design for gravity flow, using renewable energy, and low cost materials. The case studies are used to determine the impact of design choices on the energy return on investment, minimum fuel and feed sale prices, discounted payback period, as well as water depletion potential, human health, ecosystem quality, non-renewable resources, and climate change environmental indicators. The most promising cases would be economically competitive at market prices around $2/L for crude oil, while also providing major environmental benefits and freshwater savings. As global demands for fuels and protein continue rising, these results are important steps towards economical and environmentally sustainable production at an industrial scale.

Beal, C. M., Gerber, L. N., Sills, D. L., Huntley, M. E., Machesky, S. C., Walsh, M. J., ... & Greene, C. H. (2015). Algal biofuel production for fuels and feed in a 100-ha facility: a comprehensive techno-economic analysis and life cycle assessmentAlgal Research, 10, 266-279.


December 15, 2014

Article:
Positioning Genomics in Biology Education: Content Mapping of Undergraduate Biology Textbooks

Abstract:

Biological thought increasingly recognizes the centrality of the genome in constituting and regulating processes ranging from cellular systems to ecology and evolution. In this paper, we ask whether genomics is similarly positioned as a core concept in the instructional sequence for undergraduate biology. Using quantitative methods, we analyzed the order in which core biological concepts were introduced in textbooks for first-year general and human biology. Statistical analysis was performed using self-organizing map algorithms and conventional methods to identify clusters of terms and their relative position in the books. General biology textbooks for both majors and non-majors introduced genome-related content after text related to cell biology and biological chemistry, but before content describing higher-order biological processes. However, human biology textbooks most often introduced genomic content near the end of the books. These results suggest that genomics is not yet positioned as a core concept in commonly used textbooks for first-year biology and raises questions about whether such textbooks, or courses based on the outline of these textbooks, provide an appropriate foundation for understanding contemporary biological science.

Wernick, N. L., Ndung’u, E., Haughton, D., & Ledley, F. D. (2014). Positioning Genomics in Biology Education: Content Mapping of Undergraduate Biology Textbooks. Journal of microbiology & biology education, 15(2), 268.


February, 2014

Article:
Why commercialization of gene therapy stalled; examining the life cycles of gene therapy technologies

ABSTRACT:

This report examines the commercialization of gene therapy in the context of innovation theories that posit a relationship between the maturation of a technology through its life cycle and prospects for successful product development. We show that the field of gene therapy has matured steadily since the 1980s, with the congruent accumulation of >35 000 papers, >16 000 US patents, >1800 clinical trials and >$4.3 billion in capital investment in gene therapy companies. Gene therapy technologies comprise a series of dissimilar approaches for gene delivery, each of which has introduced a distinct product architecture. Using bibliometric methods, we quantify the maturation of each technology through a characteristic life cycle S-curve, from a Nascent stage, through a Growing stage of exponential advance, toward an Established stage and projected limit. Capital investment in gene therapy is shown to have occurred predominantly in Nascent stage technologies and to be negatively correlated with maturity. Gene therapy technologies are now achieving the level of maturity that innovation research and biotechnology experience suggest may be requisite for efficient product development. Asynchrony between the maturation of gene therapy technologies and capital investment in development-focused business models may have stalled the commercialization of gene therapy.

Ledley, F. D., McNamee, L. M., Uzdil, V., & Morgan, I. W. (2014). Why commercialization of gene therapy stalled; examining the life cycles of gene therapy technologiesGene therapy, 21(2), 188.


December 16, 2013

Article:
Translational Science by Public Biotechnology Companies in the IPO “Class of 2000”: The Impact of Technological Maturity

Abstract:

The biotechnology industry plays a central role in the translation of nascent biomedical science into both products that offer material health benefits and creating capital growth. This study examines the relationship between the maturity of technologies in a characteristic life cycle and value creation by biotechnology companies. We examined the core technology, product development pipelines, and capitalization for a cohort of biotechnology companies that completed an IPO in 2000. Each of these companies was well financed and had core technologies on the leading edge of biological science. We found that companies with the least mature technologies had significantly higher valuations at IPO, but failed to develop products based on these technologies over the ensuing decade, and created less capital growth than companies with more mature technologies at IPO. The observation that this cohort of recently public biotechnology companies was not effective in creating value from nascent science suggests the need for new, evidence-based business strategies for translational science.

McNamee, Laura, and Fred Ledley. "Translational Science by Public Biotechnology Companies in the IPO “Class of 2000”: The Impact of Technological Maturity." PloS one 8.12 (2013): e82195.


November 8, 2013

Article:
Making the biotech IPO work

Abstract:

The past decade has been a difficult time for biotech companies trying to access public markets.  As capital markets became more restricted, investors became less willing to invest in companies that were focused on preclinical science, as opposed to products in late stage clinical development. In fact, of the 28 biotech companies focused on therapeutic products that completed IPOs between 2011 and the Q1/2013,  25 had at least one product in phase 2 or beyond, and 16 had at least one product as far as phase 3, including 3 with products on the market.  In doing so, investors eschewed investments in translational science that have traditionally been the mainstay of the biotechnology enterprise.  What does this mean for investors and for the biotech industry?

McNamee, Laura, and Fred Ledley. "Making the biotech IPO work." Nature biotechnology 31.11 (2013): 969-970.


September 2, 2013

Article:
Assessing the history and value of Human Genome Sciences

Abstract:

Human Genome Science (HGS) aspired to dominate the emergent field of genomics by discovering expressed gene sequences and developing therapeutic and diagnostic products based on proprietary genes. While HGS’ accomplishments fell short of their own lofty expectations, by the time HGS was acquired by GlaxoSmithKline, the company had extensive intellectual property and had launched a product with >$1 billion market potential. Nevertheless, HGS’ acquisition price was less than the total capital investments in the company. This work examines HGS’ history and accomplishments in the context of the business plan described by the company at their IPO. We focus specifically on the company’s valuation over time, which was highly correlated with general market indices, but negatively correlated with metrics of technical or clinical progress. The history of HGS points to the challenge of accounting for the value created by a science-based business plan. Earnings-based metrics, present value calculations, and “fair value” assessments did not account for HGS’ progress in executing their stated business plan. This work highlights the critical need for accounting practices that credit value to the progress of translational science and enable investors to profit from such investments.

McNamee, Laura M., and Fred D. Ledley. "Assessing the history and value of Human Genome Sciences." Journal of Commercial Biotechnology 19.4 (2013).


November 15, 2012

Article:
Learning Objectives and Content of Science Curricula for Undergraduate Management Education

Abstract:

Business is progressively integrating technologies and R&D with corporate and business strategy. This trend is creating increasing demand for executives and managers who have sufficient technology-centered knowledge to work effectively in interdisciplinary environments. This study addresses how management education could address the growing need for such pluralistic training by embracing development of undergraduate science curriculum attuned to the needs of business students. We found that science courses are part of the required curriculum at 80% of BusinessWeek’s “top business schools.” To assess what content and learning objectives might best meet the needs of business students, we conducted a survey of educators from business, science, and arts and sciences in general and examined curriculum developed explicitly for business students at two freestanding business institutions. These results suggest that science courses could better serve business education by providing a broad picture of scientific principles and their presence in everyday life, promoting critical thinking and inductive reasoning, and enabling understanding of scientific research, technical innovation, and product development as well as their ethical and social implications. Development of such courses would require collaboration between management and science educators to ensure that the scientific content of the courses meet the highest standards of evidence-based science education and the business context is grounded in rigorous management principles and practices.

Ledley, Fred D., and Stephen S. Holt. "Learning objectives and content of science curricula for undergraduate management education." Journal of Management Education 38.1 (2014): 86-113.


November 15, 2012

Podcast:
Learning Objectives and Content of Science Curricula for Undergraduate Management Education

Summary:

Professor Fred Ledley of Bentley University talks with editor Jane Schmidt-Wilk about his paper, co-authored by Stephen Holt of Olin College, which argues that business programs should require science courses designed expressly to meet the needs of business students.


October 10, 2012

Article:
Patterns of technological innovation in biotech

Abstract:

Theories of innovation posit that effective product development and value creation require business models and strategies matched to the stage of technology evolution. Such theories are predicated on patterns of technology evolution observed in other fields, where periods of exponential advancement are followed by limits and obsolescence as new technologies emerge. In this paper, we describe analogous patterns of technological evolution for three classes of therapeutic biotechnologies—somatic gene therapy, nucleotide therapeutics, and monoclonal antibodies—and discuss the potential relevance of business innovation theories to the biotechnology industry.

McNamee, Laura M., and Fred D. Ledley. "Patterns of technological innovation in biotech." Nature biotechnology 30.10 (2012): 937-943.


August 1, 2012

Article:
Bridging the Boundary between Science and Business

" "Abstract: 

Theories of innovation posit that effective product development and value creation require business models and strategies matched to the stage of technology evolution. Such theories are predicated on patterns of technology evolution observed in other fields, where periods of exponential advancement are followed by limits and obsolescence as new technologies emerge. In this paper, we describe analogous patterns of technological evolution for three classes of therapeutic biotechnologies—somatic gene therapy, nucleotide therapeutics, and monoclonal antibodies—and discuss the potential relevance of business innovation theories to the biotechnology industry.

Ledley, Fred. "Bridging the Boundary between Science and Business." International Journal of Science in Society 3.3 (2012).


March, 2011

Article:
Use of Genomic Databases for Inquiry-Based Learning about Influenza, Journal of College Science Teaching, by Fred D. Ledley & Eric Ndung'u

Abstract:

The genome projects of the past decades have created extensive databases of biological information with applications in both research and education. We describe an inquiry-based exercise that uses one such database, the National Center for Biotechnology Information Influenza Virus Resource, to advance learning about influenza. This database contains genomic sequences of virus ranging from the strains that caused the 1918 pandemic and subsequent seasonal cycles of influenza, as well as the H1N1 "swine" flu, which has recently caused pandemic disease, and the H5N1 "avian" flu, which remains a potential threat. The web interface to this database allows retrieval of gene and protein sequences from selected strains of virus, alignment of these sequences, and construction of evolutionary trees. In this exercise, students develop hypotheses about the epidemiology or evolution of influenza originating from species, locations, or time periods. The hypotheses are tested by retrieving sequences from specified viral strains and constructing an evolutionary tree to visualize the origin of these strains. We describe the use of this exercise in a human biology course for nonscience majors as part of a unit about influenza.

Ledley, Fred, and Eric Ndung'u. "Use of Genomic Databases for Inquiry-Based Learning About Influenza." Journal of College Science Teaching 40.4 (2011): 53.