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Why Simultaneous Voting Makes for Good Decisions

How can organizations make robust decisions when time is short, and the stakes are high? It’s a conundrum not unfamiliar to the U.S. Food and Drug Administration. Back in 2021, the FDA found itself under tremendous pressure to decide on the approval of the experimental drug aducanumab, designed to slow the progress of Alzheimer’s disease—a debilitating and incurable condition that ranks among the top 10 causes of death in the United States. Welcomed by the market as a game-changer on its release, aducanumab quickly ran into serious problems. A lack of data on clinical efficacy along with a slew of dangerous side effects meant physicians in their droves were unwilling to prescribe it. Within months of its approval, three FDA advisors resigned in protest, one calling aducanumab, “the worst approval decision that the FDA has made that I can remember.” By the start of 2024, the drug had been pulled by its manufacturers. Of course, with the benefit of hindsight and data from the public’s use of aducanumab, it is easy for us to tell that FDA made the wrong decision then. But is there a better process that would have given FDA the foresight to make the right decision, under limited information? The FDA routinely has to evaluate novel drugs and treatments; medical and pharmaceutical products that can impact the wellbeing of millions of Americans. With stakes this high, the FDA is known to tread carefully: assembling different advisory, review, and funding committees providing diverse knowledge and expertise to assess the evidence and decide whether to approve a new drug, or not. As a federal agency, the FDA is also required to maintain scrupulous records that cover its decisions, and how those decisions are made. The Impact of Voting Mechanisms on Decision Quality Some of this data has been analyzed by Goizueta’s Tian Heong Chan, associate professor of information systems and operation management. Together with Panos Markou of the University of Virginia’s Darden School of Business, Chan scrutinized 17 years’ worth of information, including detailed transcripts from more than 500 FDA advisory committee meetings, to understand the mechanisms and protocols used in FDA decision-making: whether committee members vote to approve products sequentially, with everyone in the room having a say one after another; or if voting happens simultaneously via the push of a button, say, or a show of hands. Chan and Markou also looked at the impact of sequential versus simultaneous voting to see if there were differences in the quality of the decisions each mechanism produced. Their findings are singular. It turns out that when stakeholders vote simultaneously, they make better decisions. Drugs or products approved this way are far less likely to be issued post-market boxed warnings (warnings issued by FDA that call attention to potentially serious health risks associated with the product, that must be displayed on the prescription box itself), and more than two times less likely to be recalled. The FDA changed its voting protocols in 2007, when they switched from sequentially voting around the room, one person after another, to simultaneous voting procedures. And the results are stunning. Tian Heong Chan, Associate Professor of Information Systems & Operation Management “Decisions made by simultaneous voting are more than twice as effective,” says Chan. “After 2007, you see that just 3.4% of all drugs and products approved this way end up being discontinued or recalled. This compares with an 8.6% failure rate for drugs approved by the FDA using more sequential processes—the round robin where individuals had been voting one by one around the room.” Imagine you are told before hand that you are going to vote on something important by simply raising your hand or pressing a button. In this scenario, you are probably going to want to expend more time and effort in debating all the issues and informing yourself before you decide. Tian Heong Chan “On the other hand, if you know the vote will go around the room, and you will have a chance to hear how others’ speak and explain their decisions, you’re going to be less motivated to exchange and defend your point of view beforehand,” says Chan. In other words, simultaneous decision-making is two times less likely to generate a wrong decision as the sequential approach. Why is this? Chan and Markou believe that these voting mechanisms impact the quality of discussion and debate that undergird decision-making; that the quality of decisions is significantly impacted by how those decisions are made. Quality Discussion Leads to Quality Decisions Parsing the FDA transcripts for content, language, and tonality in both settings, Chan and Markou find evidence to support this. Simultaneous voting or decision-making drives discussions that are characterized by language that is more positive, more authentic, and more even in terms of expressions of authority and hierarchy, says Chan. What’s more, these deliberations and exchanges are deeper and more far-ranging in quality. We find marked differences in the tone of speech and the topics discussed when stakeholders know they will be voting simultaneously. There is less hierarchy in these exchanges, and individuals exhibit greater confidence in sharing their points of view more freely. Tian Heong Chan “We also see more questions being asked, and a broader range of topics and ideas discussed,” says Chan. In this context, decision-makers are also less likely to reach unanimous agreement. Instead, debate is more vigorous and differences of opinion remain more robust. Conversely, sequential voting around the room is typically preceded by shorter discussion in which stakeholders share fewer opinions and ask fewer questions. And this demonstrably impacts the quality of the decisions made, says Chan. Sharing a different perspective to a group requires effort and courage. With sequential voting or decision-making, there seems to be less interest in surfacing diverse perspectives or hidden aspects to complex problems. Tian Heong Chan “So it’s not that individuals are being influenced by what other people say when it comes to voting on the issue—which would be tempting to infer—rather, it’s that sequential voting mechanisms seem to take a bit more effort out of the process.” When decision-makers are told that they will have a chance to vote and to explain their vote, one after another, their incentives to make a prior effort to interrogate each other vigorously, and to work that little bit harder to surface any shortcomings in their own understanding or point of view, or in the data, are relatively weaker, say Chan and Markou. The Takeaway for Organizations Making High-Stakes Decisions Decision-making in different contexts has long been the subject of scholarly scrutiny. Chan and Markou’s research sheds new light on the important role that different mechanisms have in shaping the outcomes of decision-making—and the quality of the decisions that are jointly taken. And this should be on the radar of organizations and institutions charged with making choices that impact swathes of the community, they say. “The FDA has a solid tradition of inviting diversity into its decision-making. But the data shows that harnessing the benefits of diversity is contingent on using the right mechanisms to surface the different expertise you need to be able to see all the dimensions of the issue, and make better informed decisions about it,” says Chan. A good place to start? By a concurrent show of hands. Tian Heong Chan is an associate professor of information systems and operation management. he is available to speak about this topic - click on his con now to arrange an interview today.

Expert Research: The Surprising Source of Next-Gen Antibiotics: Oyster Blood

Antimicrobial resistance (AMR) is a growing concern across the world and it has doctors worried and scientists working hard to find a solution Basically, AMR is when bacteria and viruses no longer respond to antimicrobial medicines. The result is making infections harder to treat and increases the risk of spreading disease. Recently, Texas Christian University researcher Shauna McGillivray commented on exciting new research in this area that was featured in the media: The search for a solution to antimicrobial resistance found something. And researchers found it in a true “it’s always the last place you look” location. Australian oysters. Or more specifically, Australian oyster blood. Antimicrobial proteins and peptides (AMPPs) “… are an exciting area with a lot of potential,” said Shauna McGillivray, professor of biology at TCU with an emphasis on host-pathogen interactions. “[They] are by themselves very potent but, as has been noted in multiple studies, they can also synergize with existing antibiotics, thereby improving efficacy of antibiotics, even in some cases to antibiotics to which there are high levels of resistance.” Feb. 22 -Phamed.com This is an amazing find and could be groundbreaking for the pharmaceutical industry and health care. And if you're looking to know more about this research and what it means for health care - then let us help. Shauna McGillivray, associate professor of biology is available to speak with media about her recent research - simply click on her icon now to arrange an interview today.

Shauna McGillivray
1 min. read

3D-printed lung model helps researchers study aerosol deposition in the lungs

Treating respiratory diseases is challenging. Inhalable medicines depend on delivering particles to the right lung areas, which is complicated by factors like the drug, delivery method and patient variability, or even exposure to smoke or asbestos particles. University of Delaware researchers have developed an adaptable 3D lung model to address this issue by replicating realistic breathing maneuvers and offering personalized evaluation of aerosol therapeutics. “If it's something environmental and toxic that we're worried about, knowing how far and how deep in the lung it goes is important,” said Catherine Fromen, University of Delaware Centennial Associate Professor for Excellence in Research and Education in the Department of Chemical and Biomolecular Engineering. “If it's designing a better pharmaceutical drug for asthma or a respiratory disease, knowing exactly where the inhaled aerosol lands and how deep the medicine can penetrate will predict how well that works.”that can replicate realistic breathing maneuvers and offer personalized evaluation of aerosol therapeutics under various breathing conditions. Fromen and two UD alumni have submitted a patent application on the 3D lung model invention through UD’s Office of Economic Innovation and Partnerships (OEIP), the unit responsible for managing intellectual property at UD. In a paper published in the journal Device, Fromen and her team demonstrate how their new 3D lung model can advance understanding of how inhalable medications behave in the upper airways and deeper areas of the lung. This can provide a broader picture on how to predict the effectiveness of inhalable medications in models and computer simulations for different people or age groups. The researchers detail in the paper how they built the 3D structure and what they’ve learned so far. Valuable research tool The purpose of the lung is gas exchange. In practice, the lung is often approximated as the size of a tennis court that is exchanging oxygen and carbon dioxide with the bloodstream in our bodies. This is a huge surface area, and that function is critical — if your lungs go down, you're in trouble. Fromen described this branching lung architecture like a tree that starts with a trunk and branches out into smaller and smaller limbs, ranging in size from a few centimeters in the trachea to about 100 microns (roughly the combined width of two hairs on your head) in the lung’s farthest regions. These branches create a complex network that filters aerosols as they travel through the lung. Just as tree branches end in leaves, the lung’s branches culminate in delicate, leaf-like structures called alveoli, where gases are exchanged. “Those alveoli in the deeper airways make the surface area that provides this necessary gas exchange, so you don't want environmental things getting in there where they can damage these sensitive, finer structures,” said Fromen, who has a joint appointment in biomedical engineering. Mimicking the complex structure and function of the lung in a lab setting is inherently challenging. The UD-developed 3D lung model is unique in several ways. First, the model breathes in the same cyclic motion as an actual lung. That’s key, Fromen said. The model also contains lattice structures to represent the entire volume and surface area of a lung. These lattices, made possible through 3D printing, are a critical innovation, enabling precise design to mimic the lung's filtering processes without needing to recreate its full biological complexity. “There's nothing currently out there that has both of these features,” she explained. “This means that we can look at the entire dosage of an inhaled medicine. We can look at exposure over time, and we can capture what happens when you inhale the medication and where the medicine deposits, as well as what gets exhaled as you breathe.” The testing process Testing how far an aerosol or environmental particle travels inside the 3D lung model is a multi-step process. The exposure of the model to the aerosol only takes about five minutes, but the analysis is time-consuming. The researchers add fluorescent molecules to the solution being tested to track where the particles deposit inside the model’s 150 different parts. “We wash each part and rinse away everything that deposits. The fluorescence is just a molecule in the solution. When it deposits, we know the concentration of that, so, when we rinse it out, we can measure how much fluorescence was recovered,” Fromen said. This data allows them to create a heat map of where the aerosols deposit throughout the lung model’s airways, which then can be validated against benchmarked clinical data for where such aerosols would be expected to go in a human under similar conditions. The team’s current model matches a healthy person under sitting/breathing conditions for a single aerosol size, but Fromen’s team is working to ensure the model is versatile across a much broader range of conditions. “An asthma attack, exercise, cystic fibrosis, chronic obstructive pulmonary disorder (COPD) — all those things are going to really affect where aerosols deposit. We want to make sure our model can capture those differences,” Fromen said. The ability to examine disease features like airway narrowing or mucus buildup could lead to more personalized care, such as tailored medication doses or redesigned inhalers. Currently, inhaled medicines follow a one-size-fits-all approach, but the UD-developed model offers a tool to address these issues and understand why many inhaled medicines fail clinical trials.

4 min. read

Cosmetic or Drug? The FDA's Classification of Sunscreen Limits Which Products Hit US Shelves

As stifling rays of sunshine beat down across the United States, it’s the time of year citizens flock to the store to load up on sun protection. It’s also the time of year consumers and media raise the annual question of why Europe is able to market sunscreen that contains more potentially effective ingredients, but the U.S. isn’t. The answer is not related to sunscreen or its ingredients, but rather how the country’s regulatory body – The Food and Drug Administration (FDA) – legally operates. “In order for the FDA to legally regulate products, those products are given classifying labels,” said Ana Santos Rutschman, a professor of law at Villanova University who studies health law. “A toothbrush, for instance, is labeled a medical device. That’s because it has to fit in one of the sources of authority of the FDA and the FDA, per the law, regulates drugs or medical devices.” Here is where it gets tricky. The FDA does not have to approve cosmetics, aside from certain color additives, before those products go to market. In the European Union’s European Medicines Agency (EMA), sunscreen is labeled as a cosmetic. Many other countries also classify it as such. In the U.S., however, sunscreen is labeled a drug because it has a therapeutic effect, and thus falls under the authority of the FDA. To make the classification system even more convoluted, some items are labeled as both a cosmetic and drug by the FDA. Shampoo, for instance, is inherently cosmetic. “But if it’s anti-dandruff shampoo, then it’s also a pharmaceutical,” said Santos Rutschman. “It’s super common for this to happen with a lot of products that you and I would not think are classified as drugs. It’s very natural under the regulatory regime that we have, but then it is very hard to bring anything to market – harder than other countries.” Case in point, sunscreen used in the EU that contains ingredients which may be more effective against certain types of ultraviolet rays cannot simply just come to market in the U.S. “If sunscreen fits the definition of a drug, then it must meet drug requirements,” said Santos Rutschman. “If you want a new drug to enter the U.S., you have to show efficacy and safety. But in order to do that, there must be clinical trials, and if those trials happened elsewhere, they would not conform to our domestic protocols. “Even if another country performed their own clinical trials, the odds the FDA would utilize the data are not incredibly high. If you think another country recognizes something we should, based on their data, then immediately this is going to raise questions of why we are deferring to a foreign regulator.” The FDA could go through the process of approving ingredients in question – and has indicated it will do so – but it’s a complicated process, and there is “also a matter of risk,” according to Santos Rutschman. “The FDA has always been less risk averse than its counterparts in Europe. I understand the market concerns, but this seems about right from a regulatory perspective… We aren’t talking about a specific drug that people need and cannot access. Sunscreen is available for the average American to purchase.” Barring an overhaul to the regulatory system in the U.S. to include an agency for cosmetics – an idea some argue has merit, but Santos Rutschman described as “not feasible” with the available funding – the only way Europe’s sunscreen would be available for Americans to purchase is if the FDA moved forward in regulating the ingredients. And that will continue to take time. “The FDA has never moved quickly on anything,” said Santos Rutschman. “It just can't.”

Ana Santos Rutschman, SJD, LLM
3 min. read

Aston University spin-out wins start-up prize at life sciences and medical technology industry awards show

MESOX, a spin-out from the pharmaceutics group at Aston Pharmacy School, develops drug carrier technology to improve medicine formulations The company won the Start-Up prize at the Medilink Midlands Awards 2024 The prize is awarded to a new company that shows a promising future. A spin-out company from Aston University’s pharmaceutics research group has won a medical technology and life sciences industry award. MESOX, which was founded by Aston University pharmaceutics lecturer Dr Ali Al-Khattawi, won the Medilink Midlands Start-Up Award, which is presented to a newly established company that shows a promising future. The Medilink Midlands Business Awards showcase the best collaborations between industry, academia and the NHS across the Midlands. This year’s ceremony was held at the Athena in Leicester on 9 May. The awards were established by Medilink Midlands, which provides specialist business support to boost the region’s economic output from the life sciences industry. Working alongside the Midlands Engine and other strategic alliances, it helps stimulate additional and value-added growth of the Midlands as a prosperous community for life sciences. With in-depth expertise in particle engineering for drug delivery and pharmaceutical spray drying, MESOX uses IP-protected carriers to improve the bioavailability and efficacy of pharmaceuticals, partnering with pharmaceutical and biotechnology companies to bring challenging therapeutics to market. In its citation, Medilink Midlands described MESOX as “transforming pharmaceutical formulation with its game-changing carrier technologies.” As a winner of a Medilink Midlands award, MESOX will now be entered into the UK National Awards, the ceremony of which takes place on 11 July 2024 in London. Dr Al-Khattawi said: “We are delighted to have won this prestigious award, which highlights the outstanding research and development work being done by the MESOX team and the immense potential of our company to transform the medicine formulation development landscape. Through collaboration with other pharmaceutical companies, clinicians, academic researchers, and by engaging directly with patients to understand their needs, we aim to innovate and advance drug delivery science into life-saving therapeutics. “At MESOX, our ambition is to be a global, research-based pharmaceutical company rooted in the Midlands, dedicated to developing life-saving therapeutics at speed and resource-efficiency. Our ultimate goal is to enable healthier lives for patients worldwide and ensure better global access to essential medicines.”

Ali Al-Khattawi
2 min. read

Aston University pharmaceutical spin-out company shortlisted in life sciences industry awards

MESOX is a spin-out from the pharmaceutics group at Aston Pharmacy School The company partners with pharmaceutical and biotechnology companies to bring challenging therapeutics to market It has been shortlisted in the Medilink Midlands Awards 2024. A spin-out company from Aston University’s pharmaceutics research group has been shortlisted for a life sciences industry award. The Medilink Midlands Awards aim to showcase the very best collaborations between industry, academia and the NHS across the Midlands. The company, MESOX, founded by Dr Ali Al-Khattawi, a lecturer in pharmaceutics at Aston Pharmacy School, is competing in the Start-Up category for newly established companies that show a promising future. With in-depth expertise in particle engineering for drug delivery and pharmaceutical spray drying, MESOX uses IP-protected carriers to improve the bioavailability and efficacy of pharmaceuticals, partnering with pharmaceutical and biotechnology companies to bring challenging therapeutics to market. Medilink Midlands provides specialist business support to boost the region’s economic output from the life sciences industry. Working alongside the Midlands Engine and other strategic alliances, it helps stimulate additional and value-added growth of the Midlands as a prosperous community for life sciences. The awards winners will be announced at a ceremony taking place on Thursday 9 May at the Athena in Leicester. To celebrate Medilink Midlands’ 20th year anniversary of delivering business support, one finalist will be announced as the 2024 ‘Winner of all Winners’ and presented with a £5,000 prize for innovation development. Dr Ali Al-Khattawi, founder and CEO of MESOX, said: “We are excited to be nominated as a finalist for this award, which is a testament to the innovative research at Aston University that has led to MESOX and a great way to recognise the efforts of our team. “MESOX is expediting the development of life-saving therapeutics through cutting-edge carrier technologies. Our vision is to be a leading research-based pharmaceutical company in the Midlands one day and we hope this opportunity brings us a step closer to this goal.” Luke Southan, technology transfer manager at Aston University, said: “Aston University’s School of Pharmacy has always been a hotbed of innovation and entrepreneurship. This is most often seen through our many students who end up running their own independent pharmacy stores, but it is also the school that has created the most Aston spinouts. “MESOX is the latest example of this, and it is a company that is on track to be generating significant revenue and region impact over the next five years. This award nomination evidences the potential the company has to offer.”

Ali Al-Khattawi
2 min. read

Aston University partnership with medicine manufacturer improves oral medicine formulation development process

Aston University and medicine manufacturer Catalent formed a Knowledge Transfer Partnership to identify more effective formulation additives The new selection matrix makes choosing the right additive quicker and the medicine development process shorter The project has been rated as ‘outstanding’ by Innovate UK A partnership between Aston University and contract medicine manufacturer Catalent has led to a faster process to identify the best ingredients for optimal medicine formulations, and has been rated as outstanding by Innovate UK. Catalent is a global leader in enabling pharma, biotechnology and consumer health partners to optimise product development, launch and full life-cycle supply for patients around the world. Its proprietary Zydis orally dissolving tablet (ODT) technology enables the absorption of drugs or active pharmaceutical ingredients (APIs) through the mouth tissues, which is much faster than absorption through the gut. However, many APIs have poor pre-gastric absorption and need to be combined with suitable excipients, or additives, to bind the active ingredients and speed up the process of dissolving and absorbing via the pre-gastric route. Identifying suitable excipients for the formulation is difficult, and so the Knowledge Transfer Partnership (KTP) between Aston University and Catalent was set up to develop a faster, more efficient approach. A KTP is a three-way collaboration between a business, an academic partner and a highly qualified researcher, known as a KTP associate. The UK-wide programme helps businesses to improve their competitiveness and productivity through the better use of knowledge, technology and skills. Aston University is a sector leading KTP provider, with 80% of its completed projects being graded as very good or outstanding by Innovate UK, the national body. The project was led by Aston University’s Afzal Mohammed, professor of pharmaceutics in the School of Pharmacy and associate dean (impact and knowledge exchange) for the College of Health and Life Sciences, who has expertise in the design and optimisation of orally dissolving tablet formulation. He was supported by other colleagues from Aston Pharmacy School including Dr Daniel Kirby, whose main area of research is the formulation of age-appropriate medicines for the extremes of life, Dr Affiong Iyire, who has research expertise in mucosal drug delivery, and Dr Raj Badhan, who is a pharmacokinetics expert with research interests in analytical approaches to predict oral drug absorption. Dr Ruba Bnyan, who has a master’s degree and a PhD in pharmaceutical drug formulation, as well as experience in cell-based models, was the KTP associate for the project. The KTP partners developed a selection matrix, whereby, based on the API properties, Catalent formulation scientists can quickly identify excipients that will improve the absorption of the drug through the mouth. Adopting this novel tool allows for quicker and more efficient drug development and has the potential to increase the number of Zydis ODT candidates in the pipeline for future development. Desmond Wong, product development supervisor at Catalent, said: “This project has exceeded our initial expectations and has the potential to accelerate product development for our clients. Our strong relationship with the Aston University team on this KTP project highlights the transformative potential of collaborative research and its impact on pharmaceutical innovation.” Professor Mohammed said: “This has been a very successful project, which has been rated as ‘outstanding’ by Innovate UK. We plan to put it forward for a KTP award and are looking forward to continuing working with Catalent on our next KTP project.” For more information on the KTP visit the webpage.

Dr Afzal-Ur-Rahman MohammedDr Raj Badhan
3 min. read

Oprah Hosts Primetime Special About Weight Loss Drugs on ABC | Media Advisory

Oprah Winfrey, a revered media mogul and advocate for health and wellness, is set to host a groundbreaking primetime special on ABC, focusing on the burgeoning field of weight loss drugs. The new special follows Winfrey’s exit from the board of weightwatchers, where she served for nearly a decade after acquiring a 10% stake in the company. This special promises to shed light on the science behind popular weight loss medications Ozempic, Mounjaro and Wegogy. As obesity rates continue to climb globally, the discussion around weight loss solutions becomes increasingly pertinent, touching on public health, self-image, and the pharmaceutical industry's role in shaping health standards. Key topics of interest include: Science and Effectiveness of Weight Loss Drugs: Exploring how these medications work and their success rates. Personal Stories of Transformation: Individuals' journeys with weight loss drugs, including challenges and triumphs. Ethical and Societal Implications: The debate over body image, health standards, and drug dependency. Regulatory Perspective and Safety: How these drugs are approved and monitored for public use. Impact on the Healthcare System: The potential effects on healthcare costs and accessibility. Cautions and Concerns: Are there serious side-effects and what are the risks related to taking these drugs? Future of Obesity Treatment: Innovations and next steps in treating obesity with pharmaceuticals. For journalists seeking research or insights for their coverage on this topic, here is a select list of experts. Rebecca Puhl, Ph.D. Professor of Human Development and Family Studies · University of Connecticut Professor Paul Gately Carnegie Professor of Exercise and Obesity and Co-Director of the Applied Centre for Obesity Research · Leeds Beckett University Rebecca Pearl Assistant Professor · University of Florida Jan D. Hirsch Founding Dean, School of Pharmacy and Pharmaceutical Sciences · UC Irvine Amy Gorin, Ph.D. Professor, Department of Psychological Sciences · University of Connecticut James Lenhard, Jr., M.D., FACE, FACEP Medical Director · ChristianaCare To search our full list of experts visit www.expertfile.com. Photo by Total Shape

2 min. read

Statement from Dr. Eric Kmiec About Expected FDA Approval for CRISPR-Driven Treatment for Sickle Cell Disease

Below is a statement from Eric Kmiec, Ph.D., founder and executive director, ChristinaCare Gene Editing Institute, regarding the expected approval by the Food and Drug Administration of exa-cel (Casgevy), the CRISPR-driven treatment for sickle cell disease and betta thalassemia. If you wish to interview Dr. Kmiec, please contact Mak Sisson, Makenzie.sisson@christinacare.org,302-623-5306 or Anna Chen, achen@burness.com, 215-262-7670. “As scientists, the fact that we have arrived at a potential curative treatment for sickle cell disease in a relatively brief period is a testament to the power of resolute researchers in this field who have never stopped. And the FDA’s expected approval comes with many firsts. For the first time we have what appears to be a safe and curative treatment for one of the most painful diseases that cuts life short. And it is remarkable that finally we are focusing on the Black population first, who are most affected by this disease. This priority is long, long overdue. The challenge, however, is the very people we want to help may not be able to get access to or afford the million-dollar treatment and the length of time it will take to be treated — weeks and weeks in the hospital. The numbers of people who can be treated are limited. We must work with the health care industry and pharmaceutical companies who will market produce and deliver the treatments to make sure that all people can get access. What can they do to make treatments more affordable and more available? What can they do to support continued research to assess the long-term effects this treatment may have? And how can we make this easier to deliver? As important as it is to have developed this new treatment, right now we must do our best to communicate well to the public what new findings like this mean. Take the time to explain it all. It cannot be oversold. We must make the communication about this first CRISPR-driven treatment as important as the science itself.” Eric B. Kmiec, Ph.D., is the founder and executive director of the Gene Editing Institute at ChristianaCare. He is also co-founder and chief scientific officer of CorriXR Therapeutics. Widely recognized for his pioneering work in the fields of molecular medicine and gene editing, Dr. Kmiec has developed CRISPR based genetic therapies for Sickle Cell Disease and Non-Small Cell Lung Cancer. He is Editor-in-Chief of the journal, Gene and Genome Editing.

Eric Kmiec, Ph.D
2 min. read

Aston University wins grant to make research more sustainable and environmentally friendly

University awarded grant to develop more sustainable separation method through AstraZeneca’s Open Innovation CoSolve Challenge at ELRIG Dr Vesna Najdanovic will explore use of the solvent ethyl lactate It is a biorenewable and environmentally friendly alternative. An Aston University scientist has won a $25000 grant in the AstraZeneca Open Innovation CoSolve sustainability challenge to help to make research more sustainable and environmentally friendly. Dr Vesna Najdanovic, senior lecturer in chemical engineering at the University’s Energy and Bioproducts Research Institute (EBRI), successfully pitched her idea to explore a new method using ethyl lactate as a solvent. Ethyl lactate is a biorenewable and environmentally friendly alternative solvent produced from lactic acid and ethanol, both obtained by fermentation of biomass. Currently hazardous organic solvents such as acetonitrile are widely used instead. Dr Najdanovic won the AstraZeneca’s Open Innovation CoSolve Sustainability Challenge at the European laboratory research & innovation group (ELRIG) Research and Innovation meeting. She said: “Throughout my research career, I have been working with various green solvents, such as supercritical fluids, ionic liquids and biosolvents, to improve chemical and separation processes. “I am delighted to be selected by the expert judging panel and the highly engaged audience to apply my knowledge to develop greener analytical methods using ethyl lactate as a solvent for liquid chromatography. “I hope this project will pave the pathway to use this environmentally friendly alternative solvent while reducing carbon footprint and pollution”. The pharmaceutical industry generates the highest amount of waste per mass of products compared to other chemical industry sectors, such as the petroleum industry, bulk and fine chemicals. Dr Kelly Gray, CoSolve sustainability programme lead at AstraZeneca, said “In order to protect people, society and planet we have to identify and develop solutions to deliver sustainable science. The goal of the CoSolve sustainability programme was to do just that and identify innovative ideas to practical challenges faced by researchers across scientific disciplines in R&D.” Sanj Kumar, CEO of ELRIG, said “Ensuring that drug discovery processes become sustainable is a priority issue to the ELRIG community, so partnering with AstraZeneca on the CoSolve initiative, by hosting the pitching and final award ceremony, is not only an honour, but raises the awareness of sustainability to our community. Dr Najdanovic and her innovation are a worthy winner and ELRIG is proud that we are able to share her success story.” As much as 80% of this waste presents hazardous organic solvents obtained from petrochemical sources. For example, the pharmaceutical industry consumes 50% of globally produced acetonitrile, of which 20% is a solvent for liquid chromatography, a widely used analytical tool in research and development laboratories. After its use, most acetonitrile is discarded as chemical waste and subsequently incinerated, generating greenhouse gases and other pollutants such as nitrogen oxides and highly toxic hydrogen cyanide. The CoSolve sustainability challenge award builds on Dr Najdanovic’s previous work employing ethyl lactate as a solvent for various separation processes. Her new project supports EBRI’s wider objectives of using bioproducts to deliver low-carbon and environmentally sustainable solutions.

3 min. read