News Article | August 24, 2016
First, there was the pitching and rolling in an old Jeep for eight hours. Next came the river crossing in a slender canoe. When Nathalie Strub Wourgaft finally reached her destination, a clinic in the heart of the Democratic Republic of the Congo, she was exhausted. But the real work, she discovered, had just begun. It was July 2010 and the clinic was soon to launch trials of a treatment for sleeping sickness, a deadly tropical disease. Yet it was woefully unprepared. Refrigerators, computers, generators and fuel would all have to be shipped in. Local health workers would have to be trained to collect data using unfamiliar instruments. And contingency plans would be needed in case armed conflict scattered study participants — a very real possibility in this war-weary region. This was a far cry from Wourgaft's former life as a top executive in the pharmaceutical industry, where the hospitals that she commissioned for trials were pristine, well-resourced and easy to reach. But Wourgaft, now medical director for the innovative Drugs for Neglected Diseases initiative (DNDi), was confident that the clinic could handle the work. She was right. With data from this site and others, the DNDi will next year seek approval for a sleeping-sickness tablet, fexinidazole. It would be a massive improvement on existing treatment options: an arduous regimen of intravenous injections, or a 65-year-old arsenic-based drug that can be deadly. The DNDi is an unlikely success story in the expensive, challenging field of drug development. In just over a decade, the group has earned approval for six treatments, tackling sleeping sickness, malaria, Chagas' disease and a form of leishmaniasis called kala-azar. And it has put another 26 drugs into development. It has done this with US$290 million — about one-quarter of what a typical pharmaceutical company would spend to develop just one drug. The model for its success is the product development partnership (PDP), a style of non-profit organization that became popular in the early 2000s. PDPs keep costs down through collaboration — with universities, governments and the pharmaceutical industry. And because the diseases they target typically affect the world's poorest people, and so are neglected by for-profit companies, the DNDi and groups like it face little competitive pressure. They also have lower hurdles to prove that their drugs vastly improve lives. Now, policymakers are beginning to wonder whether their methods might work more broadly. “For a long time, people thought about R&D as so complicated that it could only be done by the biggest for-profit firms in the world,” says Suerie Moon, a global-health researcher at the Harvard T.H. Chan School of Public Health in Cambridge, Massachusetts, who studied PDPs and joined the DNDi's board of directors in 2011. “I think we are at a point today where we can begin to take lessons from their experience and begin to apply to them non-neglected disease,” she says. In that vein, the DNDi has started research on alternatives to pricey drugs for hepatitis C, and is spearheading an effort to create antibiotics for drug-resistant infections, a problem that pharmaceutical companies have been slow to contend with. If successful, the work could challenge standard assumptions about drug development, and potentially rein in the runaway price of medications. “We can't match our financial figures one to one,” says executive director Bernard Pécoul. “But we believe that DNDi can demonstrate that a different model is possible for R&D.” When medical charity Médecins Sans Frontières (MSF; also known as Doctors without Borders) won the Nobel Peace Prize in 1999, its members decried the lack of lifesaving drugs for diseases of the poor, and used the Nobel prize money to kick-start the DNDi. Pécoul, a soft-spoken Frenchman who had been with MSF for 20 years, took the helm when the initiative launched in Geneva, Switzerland, in 2003. Pharmaceutical executives were sceptical. Drug development is an expensive, complex, decade-long endeavour. “In the early days, we saw DNDi as a bit amateurish,” recalls François Bompart, a medical director at the Paris-based drug company Sanofi. “We thought, they cannot be serious.” Pécoul and his team started with a safe project. In 2001, the World Health Organization had called for malaria drugs that combined ingredients to slow the spread of resistance to the single best available agent, artemisinin. But the poverty of most people who need malaria drugs meant that the private sector had little incentive to create and test such combination therapies. Pécoul contacted Sanofi, which owned two malaria treatments: one based on artemisinin, and the other on the slower-acting amodiaquine. He proposed a deal in which the DNDi would pay for and run clinical trials on a pill that combined the two drugs. In return, Sanofi would not patent the pill and would sell an adult course of treatment for no more than $1, half that for children. “To me it sounded very aggressive and not reasonable, since the two drugs separately were two to three times that,” says Bompart. But Pécoul convinced Sanofi that the move would be good for the company's public image. He also compromised, allowing Sanofi to stipulate that it could reach the low price gradually. As it turned out, by the time the pills were approved in 2007, manufacturing costs had come down far enough for the company to meet the target price right out of the gate. Hundreds of millions of pills have since been distributed in Africa. All told, the project cost the DNDi about $14 million, a tiny sum in the world of drug development. It has since replicated the process to develop other combination therapies (see 'Discount drugs'). Although they improve on existing therapies, some of these combinations remain inadequate. The DNDi's sleeping-sickness therapy NECT, for example, reduces a standard treatment from 56 intravenous infusions to 14. That is still problematic in affected countries: clean needles can be hard to come by, and long hospital stays are often impossible. People need a pill. Drug development from scratch is arduous and expensive. It begins with experiments on hundreds of thousands of chemicals in the lab, looking for one that kills a pathogen without harming the host. The DNDi does not have a laboratory, so it does this through collaborations. It searches for promising leads in compound libraries generated by biotechnology and pharmaceutical companies. Many firms are willing to share access to these precious libraries because the diseases that the DNDi targets will not result in blockbuster drugs, so it is not infringing on their turf. The DNDi then contracts high-throughput screening centres, such as those at the Institut Pasteur Korea in Seongnam and the University of Dundee, UK, to test them out. “We use the same technique that pharma does,” says Rob Don, director of discovery and preclinical research at the DNDi, “but we do it for less.” In 2007, such efforts identified fexinidazole, a compound that had shown promise against single-celled parasites but was pulled from development before reaching clinical trials. The DNDi turned it into a tablet, and passed it to its clinical-development team two years later. The DNDi approached Sanofi again and promised to take care of trials if the company could file for regulatory approval. Sanofi warned that human trials would not be easy, because sleeping sickness is not common and people who get it tend to live in remote, unstable regions. But with the existing therapies being so dreadful, Wourgaft argued that any improvements from fexinidazole would be clear. “The delta between what we bring and what exists is huge. You don't need a magnifying glass on thousands of patients to see it.” She set up multiple small trial sites in the Democratic Republic of the Congo and the Central African Republic and pooled their data. Wourgaft says that the studies were the hardest she has ever run. In addition to logistical challenges, civil war erupted in the Central African Republic shortly after the study launched, and rebel groups repeatedly robbed a clinic there and threatened the Congolese surgeon leading the trial. “I squeeze all my energy into each project,” Wourgaft says. “It's as if I'm using forceps to deliver a baby — and the baby is an elephant.” The final trials on fexinidazole conclude this year, and Wourgaft is hopeful that the data will earn regulators' stamp of approval. The project has so far cost the DNDi about $45 million — and it stands to help 21 million people at risk of the disease in Africa. In a few months, Wourgaft will launch another trial, on a completely new oral drug — SCYX-7158 — that may cure people with sleeping sickness in a few days. The DNDi estimates that its development up to approval will cost around $50 million. For more than three decades, economists at the Tufts Center for the Study of Drug Development in Boston, Massachusetts, have collected proprietary data from pharmaceutical companies, and used it to calculate the average cost of developing a new drug. The most recent estimate is $1.4 billion. This is used to justify exorbitant drug prices — companies must recoup their investments. But many don't think it has to cost that much. Even the chief executive of London-based pharmaceutical giant GlaxoSmithKline, Andrew Witty, has called billion-dollar estimates “one of the great myths of the industry”. He attributed the huge sums to spending too much time on failures. Drug candidates can be killed as a result of safety concerns, poor efficacy or profitability worries, and he argued that companies could save money by dropping bad leads sooner. Others say that the figure is inflated by large and excessive trials done to prove that a new drug works just slightly better than an existing one. By averaging the cost of projects in its portfolio, the DNDi says that it can develop a new drug for between $110 million and $170 million. Like the Tufts estimate, these prices include a theoretical cost of failed projects. The DNDi admits to enjoying perks that pharma does not have. It keeps overhead costs low because its organization is virtual. The research organizations that it contracts probably charge the group less than they would a for-profit company. The DNDi also relies on scientific consultants who work for low pay because they relish the chance to make lifesaving drugs without considering competitors, investors and marketing. “DNDi gets a lot for free,” says Richard Bergström, director-general of the European Federation of Pharmaceutical Industries and Associations in Brussels. “My companies do a lot of pro bono work, and so do universities.” Still, the organization reckons that such in-kind contributions account for just 10–20% of its expenditure. It saves much more through efficient collaboration (avoiding duplicated effort by screening pooled libraries, for example) and a focus on desperately needed drugs. Clinical trials can be smaller, faster and cheaper when the people who run them don't have to struggle to show barely perceptible improvements. And the DNDi kills candidate compounds only if they fail on safety or efficacy — it doesn't have to worry about marketability. By contrast, a few for-profit companies froze candidate drugs for hepatitis C after Gilead Sciences of Foster City, California, brought powerful drugs to the market. “A lot of R&D failures in pharma are commercial rather than scientific,” says Don. “We keep going until it gets to market or scientifically fails.” The DNDi has earned respect from the industry, even though its founding organization has been antagonistic to big pharma. “Although DNDi came out of MSF, they don't let ideological viewpoints get in the way of making progress,” says Jon Pender, vice-president of government affairs at GlaxoSmithKline. He and others praise Pécoul's skills at negotiation, and the DNDi's pragmatic approach to development challenges. Policymakers have taken notice, too. Last year, the World Health Organization asked the DNDi to consider antibiotics for drug-resistant infections in the developing world; in May, the initiative announced that it would start the GARD (Global Antibiotic Research and Development) partnership with $2.2 million in seed funding. GARD will start by repurposing and combining existing antibiotics to treat a few diseases, including gonorrhoea and infections in newborn babies. Marja Esveld, a research adviser at the Netherlands ministry of health, is watching it closely. “We are worried about the rising costs of pharmaceuticals,” she says, “and so for us, GARD is also a kind of experiment to see if the DNDi model can work for the development of drugs in the Western world.” Not everyone is convinced. Economist Ramanan Laxminarayan, director of the Center for Disease Dynamics, Economics and Policy in Washington DC, says that pharmaceutical companies have an incentive to make antibiotics for multidrug-resistant infections because patients in the United States and Europe will pay to get them — and non-profit organizations cannot hope to compete. Once the drugs exist, he says, subsidies could ensure that they are affordable. Pécoul disagrees: he doesn't think that subsidies, donations or tiered pricing can ensure accessibility. “We need appropriate products and a sustainable market for those products,” he says. That environment has not materialized for other conditions: Gilead's hepatitis C drugs, for example, are listed at more than $74,000 for a course. And their potency against some strains of the virus is questionable, says Pécoul. When he and his team learned about other hepatitis drug candidates being frozen, he launched a project to turn them into treatments that more people could use and afford. They're also attempting to combine existing drugs. If the group succeeds with this and with antibiotics, it will have shown that its model can be applied to diseases that affect developed countries. “I hope we provide lessons that can be used by others,” says Pécoul. But companies won't simply adopt the DNDi's methods, because they do not generate profit. The investors who keep firms alive are concerned with the bottom line. Pécoul says that a transformation would require government involvement and a reorganization of the development process. It would need a system to prioritize what treatments are needed and which companies and organizations could collaborate; and it would require forethought about how the final products would reach those in need. It means shifting away from profit-based incentives to things such as prizes and government funding. Today's profit-driven approach is not only expensive, Pécoul says, it fails huge swathes of the population. When Wourgaft reflects on the differences between her career in pharma and her work at the DNDi, she thinks not about the cost of research and development, but about the value of a human life. She recalls one trip to a Congolese sleeping-sickness trial site. She sat on a cot beside a woman in the middle of a psychotic episode, and spoke to her desperate husband. Later, she learned that the woman survived because of the DNDi's treatment. “When you see that, you know the value of what you're doing,” she tells me. “We are trying to fix diseases that are lethal — this is really serious medicine.”
News Article | November 15, 2016
BOSTON, MA--(Marketwired - Nov 15, 2016) - Resources dedicated to creating medicines to meet the unique needs of children have grown steadily since legislation guiding pediatric drug development was enacted in the United States two decades ago, and the outlook for still greater development looks promising, according to a new analysis completed by the Tufts Center for the Study of Drug Development. Even though R&D complexity has grown more than 50% since 2008, resources dedicated to pediatric studies have increased across most R&D functions, according to the new Tufts CSDD study, which updates a similar assessment it completed nearly a decade ago. "Much has changed since 2007, including the need to conduct pediatric studies earlier in development across all age groups, with appropriate formulations, in the context of a changing, more complex research environment," noted Christopher-Paul Milne, research associate professor and director of research at Tufts CSDD at Tufts University School of Medicine, who conducted the analysis. Since the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were enacted in 2002 and 2003, respectively, more than 600 drugs and biologicals originally developed for adults have been labeled in the U.S. with specific information to inform safer administration and dosing in children. "Developing formulations for children was not achieved easily and remains a costly and complex undertaking," said Milne. He noted that pediatric R&D today must account for expanded data requirements and changes imposed by advances in pharmacogenomics, regulatory science, and multi-country clinical trial networks. Key findings from the analysis, based on a survey sent to more than two dozen drug development companies, reported in the November/December Tufts CSDD Impact Report and released today, include the following: ABOUT THE TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT The Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) at Tufts University provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. Tufts CSDD, based in Boston, conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums, and publishes Tufts CSDD Impact Reports, a bi-monthly newsletter providing analysis and insight into critical drug development issues.
News Article | February 17, 2016
London, February 17, 2016 - PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services organisation, today announced expanded services and capabilities in genomic-based drug development. The PAREXEL® Genomic Medicine team offers clients a variety of strategic and operational genomic research services to accelerate drug development and to support regulatory and payer approval processes. Biopharmaceutical companies are increasingly applying genomics to drug discovery and development to better understand the genetic basis of disease, drug targets, and drug response. Over the next five years, the number of personalised medicines in development is expected to increase 69 percent. Additionally, regulators and payers are increasingly seeking genomic information to inform decision-making and assure a product delivers clinical utility and value for the intended patient population. In 2015, 20 percent of FDA approvals were for targeted therapies. Researchers have also shown that drug mechanisms with genetic evidence may be twice as likely to receive regulatory approval. “Recently, the terms ‘precision medicine’ and ‘personalised medicine’ have become household terms, and genomic research is the key to developing targeted therapies. By applying innovative and state-of-the-art methodologies, we work with our clients to understand how genes impact an individual’s response to treatment – and why people who receive the same treatment may respond differently,” said Sy Pretorius, M.D., Chief Scientific Officer, PAREXEL. “PAREXEL’s Genomic Medicine team leverages genomic information across more than 10 therapeutic areas to help biopharmaceutical companies discover, develop, and secure regulatory and payer approval for their new medicines.” PAREXEL’s Genomic Medicine team is comprised of more than 15 scientists with an aggregate of nearly 300 years of combined experience in genomics, drug discovery, and drug development. The team joined PAREXEL from GlaxoSmithKline’s Genetics and Computational Biology departments. For more information about PAREXEL’s Genomic Medicine services, visit: www.parexel.com/genomics.  Tufts Center for the Study of Drug Development Impact Report, Volume 17, No 3, May/June 2015.  Tufts Center for the Study of Drug Development Impact Report, Volume 17, No 3, May/June 2015.  Nelson MR, et al. (2015) The support of human genetic evidence for approved drug indications. Nature Genetics, 47, 856-860. Accessed at http://tiny.cc/d2n67x January 14, 2016. About PAREXEL International PAREXEL International Corporation is a leading global biopharmaceutical services organization, providing a broad range of expertise-based contract research, consulting, medical communications, and technology solutions and services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. PAREXEL Informatics provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL has offices in 77 locations in 51 countries around the world, and had approximately 18,200 employees in the second quarter. For more information about PAREXEL International visit http://www.parexel.com/. PAREXEL is a registered trademark of PAREXEL International Corporation. All other trademarks are the property of their respective owners. This release contains “forward-looking” statements regarding future results and events. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects,” “intends,” “appears,” “estimates,” “projects,” “will,” “would,” “could,” “should,” “targets,” and similar expressions are also intended to identify forward-looking statements. The forward-looking statements in this release involve a number of risks and uncertainties. Such factors and others are discussed in the section entitled “Risk Factors” of the Company’s most recent Annual Report on Form 10-K and subsequent quarterly reports on Form 10-Q as filed with the Securities and Exchange Commission, which “Risk Factors” discussion is incorporated by reference in this press release. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company’s estimates or views as of any date subsequent to the date of this press release.
Reichert J.M.,Tufts Center for the Study of Drug Development
mAbs | Year: 2010
Monoclonal antibodies (mAbs) are a burgeoning class of therapeutics, with more than 25 approved in countries worldwide. Novel molecules are entering clinical study at a rate of nearly 40 per year, and the commercial pipeline includes approximately 240 mAb therapeutics in clinical studies that have not yet progressed to regulatory approval or been approved. of particular interest are the 26 mAbs that are currently at Phase 3, when safety and efficacy data critical to approval is established. Phase 3 study lengths are typically two to four years, so results for some studies might be announced in 2010, but data from others might not be presented until 2014. This overview of the 26 candidates provides a brief description of the background and the on-going Phase 3 studies of each mAb. Additional mAbs that have progressed to regulatory review or been approved may also be in Phase 3 studies, but these, as well as Fc fusion proteins, have been excluded. due to the large body of primary literature about the 26 candidates, only selected references are given, with a focus on recent publications and articles that were relevant to Phase 3 studies. Current as of october 2009, the results presented here will serve as a baseline against which future progress can be measured. © 2010 Landes Bioscience.
Nelson A.L.,Tufts University |
Nelson A.L.,Novartis |
Dhimolea E.,Tufts University |
Reichert J.M.,Tufts Center for the Study of Drug Development
Nature Reviews Drug Discovery | Year: 2010
Fully human monoclonal antibodies (mAbs) are a promising and rapidly growing category of targeted therapeutic agents. The first such agents were developed during the 1980s, but none achieved clinical or commercial success. Advances in technology to generate the molecules for study- in particular, transgenic mice and yeast or phage display- renewed interest in the development of human mAbs during the 1990s. In 2002, adalimumab became the first human mAb to be approved by the US Food and Drug Administration (FDA). Since then, an additional six human mAbs have received FDA approval: panitumumab, golimumab, canakinumab, ustekinumab, ofatumumab and denosumab. In addition, 3 candidates (raxibacumab, belimumab and ipilimumab) are currently under review by the FDA, 7 are in Phase III studies and 81 are in either Phase I or II studies. Here, we analyse data on 147 human mAbs that have entered clinical study to highlight trends in their development and approval, which may help inform future studies of this class of therapeutic agents. © 2010 Macmillan Publishers Limited. All rights reserved.
Reichert J.M.,Tufts Center for the Study of Drug Development
mAbs | Year: 2011
This overview of 25 monoclonal antibody (mAb) and five Fc fusion protein therapeutics provides brief descriptions of the candidates, recently published clinical study results and on-going Phase 3 studies. In alphanumeric order, the 2011 therapeutic antibodies to watch list comprises AIN-457, bapineuzumab, brentuximab vedotin, briakinumab, dalotuzumab, epratuzumab, farletuzumab, girentuximab (WX-G250), naptumomab estafenatox, necitumumab, obinutuzumab, otelixizumab, pagibaximab, pertuzumab, ramucirumab, REGN88, reslizumab, solanezumab, T1h, teplizumab, trastuzumab emtansine, tremelimumab, vedolizumab, zalutumumab and zanolimumab. In alphanumeric order, the 2011 Fc fusion protein therapeutics to watch list comprises aflibercept, AMG-386, atacicept, Factor VIII-Fc and Factor IX-Fc. Commercially-sponsored mAb and Fc fusion therapeutics that have progressed only as far as Phase 2/3 or 3 were included. Candidates undergoing regulatory review or products that have been approved may also be in Phase 3 studies, but these were excluded. Due to the large body of primary literature about the candidates, only selected references are given and results from recent publications and articles that were relevant to Phase 3 studies are emphasized. Current as of September 2010, the information presented here will serve as a baseline against which future progress in the development of antibody-based therapeutics can be measured. © 2011 Landes Bioscience.
Cohen J.P.,Tufts Center for the Study of Drug Development
New Biotechnology | Year: 2012
The number of personalized medicines and companion diagnostics in use in the United States has gradually increased over the past decade, from a handful of medicines and tests in 2001 to several dozen in 2011. However, the numbers have not reached the potential hoped for when the human genome project was completed in 2001. Significant clinical, regulatory, and economic barriers exist and persist. From a regulatory perspective, therapeutics and companion diagnostics are ideally developed simultaneously, with the clinical significance of the diagnostic established using data from the clinical development program of the corresponding therapeutic. Nevertheless, this is not (yet) happening. Most personalized medicines are personalized post hoc, that is, a companion diagnostic is developed separately and approved after the therapeutic. This is due in part to a separate and more complex regulatory process for diagnostics coupled with a lack of clear regulatory guidance. More importantly, payers have placed restrictions on reimbursement of personalized medicines and their companion diagnostics, given the lack of evidence on the clinical utility of many tests. To achieve increased clinical adoption of diagnostics and targeted therapies through more favorable reimbursement and incorporation in clinical practice guidelines, regulators will need to provide unambiguous guidance and manufacturers will need to bring more and better clinical evidence to the market place. © 2012 Elsevier B.V.
Reichert J.M.,Tufts Center for the Study of Drug Development
mAbs | Year: 2010
A wide variety of full-size monoclonal antibodies (mAbs) and therapeutics derived from alternative antibody formats can be produced through genetic and biological engineering techniques. These molecules are now filling the preclinical and clinical pipelines of every major pharmaceutical company and many biotechnology firms. Metrics for the development of antibody therapeutics, including averages for the number of candidates entering clinical study and development phase lengths for mAbs approved in the United States, were derived from analysis of a dataset of over 600 therapeutic mAbs that entered clinical study sponsored, at least in part, by commercial firms. The results presented provide an overview of the field and context for the evaluation of on-going and prospective mAb development programs. The expansion of therapeutic antibody use through supplemental marketing approvals and the increase in the study of therapeutics derived from alternative antibody formats are discussed. © 2010 Landes Bioscience.
News Article | November 14, 2016
REDONDO BEACH, CA--(Marketwired - Nov 14, 2016) - SECFilings.com, a leading financial news and information portal offering free real time public filing alerts, recently published an article discussing several new technologies that may decrease the prohibitive costs typically associated with drug discovery. Included in the report is Endonovo Therapeutics ( : ENDV) and its Cytotronics™ drug development platform based on bioelectronics technology. The cost to develop a new pharmaceutical drug has more than doubled over the past ten years to $2.6 billion, according to the Tufts Center for the Study of Drug Development, including an average out-of-pocket cost of $1.4 billion and an estimated $1.2 billion in returns that investors forego in the 10+ years that a drug candidate spends in development. These numbers don't include the $300+ million spent on post-approval costs like dosing and formulation. These high costs make a drug failure extremely detrimental to a company's financial outlook, particularly if it's a late-stage drug candidate. When drugs are approved, these high development costs also translate to higher costs for patients since drug companies must recoup the cost of the clinical trials (along with any failed drugs) within a patent window. Drug pricing, in many ways, is based on R&D costs rather than the value to patients. Endonovo's Cytotronics™ is being developed as a high-fidelity drug development and toxicology testing platform designed to catch problems early on. The platform uses bioelectronics to effectively grow and maintain three dimensional tissue/cell cultures for up to 180 days. Biotech firms can use these cell cultures to conduct toxicology testing to catch problems early on to avoid spending money to develop a toxic drug. "A Phase I trial can cost roughly $15 million and take several years to complete and over 40% of marketing candidate drugs are terminated as a result of unexpected toxic effects," said Alan Collier, Endonovo's CEO. "We are developing our Cytotronics platform to be a high-fidelity system enabling drug and cosmetic products to be tested for their ADME and toxicity. Our ultimate goal focuses on lowering drug development cost while increasing safety." About SECFilings.com Founded in 2004, SECFilings.com provides free real time filing alerts to over 600,000 registered members and offers services to help public companies grow their audience of interested investors. Disclaimer: Except for the historical information presented herein, matters discussed in this release contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Emerging Growth LLC, which owns SECFilings.com, is not registered with any financial or securities regulatory authority, and does not provide nor claims to provide investment advice or recommendations to readers of this release. Emerging Growth LLC may from time to time have a position in the securities mentioned herein and may increase or decrease such positions without notice. For making specific investment decisions, readers should seek their own advice. Emerging Growth LLC may be compensated for its services in the form of cash-based compensation or equity securities in the companies it writes about, or a combination of the two. For full disclosure please visit: http://secfilings.com/Disclaimer.aspx.
News Article | February 21, 2017
Investigative sites are the heart and soul of clinical trials, essential to ensuring the efficacy and safety of pharmaceutical compounds in humans. Site selection is pivotal to the successful execution of clinical trials, which are not only long and bureaucratic, but are also experiencing diminishing returns. Studies estimate that it costs upwards of $2B dollars to bring a new drug to market, with daily revenue losses in the range of $1M to $8M due to delayed market entry. Key to reining in budget overruns and delays, often resulting in fueling the growing rescue studies industry, is the selection of high performing sites that are ideally suited to running the study under investigation. The selection process is, however, often manual, cumbersome and error prone. According to research from the Tufts Center for the Study of Drug Development (CSDD), 37 percent of sites selected for clinical trial studies under-enroll, and 11 percent fail to enroll a single subject. Eventually, 89 percent of studies meet enrollment goals, but often at the expense of sponsors faced with doubling the original timeline due to poor enrollment. The industry has responded to these issues by engaging more sites than required for trials, in anticipation that some of these sites will underperform and may subsequently will be dropped. This dubious business practice has fueled a lack of trust and transparency between sites and sponsors/contract research organizations (CROs) and needlessly increased costs and timelines. According to Tufts CSDD about 40 percent of investigators each year choose not to conduct any further clinical trials1, at a time when typical multi-center studies require 30 percent new investigative sites2, and the clinical research industry is experiencing a concerning global shortage3 of experienced clinical research associates (CRAs), professionals whose main function is to monitor clinical trials. Other research cites slow patient enrollment as the top reason clinical trials are behind schedule. Overall, poor site selection, the inability of sites to predict the rate of enrollment, and the subsequent need for study rescue may increase cost of trials by 20 percent or more. And perhaps most disturbing is the fact that cycle time has not changed in more than two decades.4 Sponsors and CROs, often lack a transparent, evidence-based strategy for this task. Instead, they frequently rely on archaic paper-based or spreadsheet methods to identify sites across the globe with a reasonable chance of enrolling the contracted number of patients on schedule, and the ability to generate quality data. So what criteria can be used to help optimize site selection?