IPT is designed to keep you informed of the latest ideas, cutting-edge technologies, and innovations shaping the future of pharmaceutical research, development, and manufacturing.. Free to view, this pharmaceutical technology journal brings together the views and expertise of over 600 renowned technical specialists. Tyner. Blackwood noted that the technology is freely available to others and that Pfizer has been open regarding integrated control systems through publications and conference presentations. As a final note, Jagschies emphasized the importance of controlling impurities produced by cells in culture to avoid having to remove them later in the process and the importance of matching the increased upstream productivity with improved downstream technology to purify the product. The set of journals have been ranked according to their SJR and divided into four equal groups, four quartiles. DeLisa closed the session by asking the speakers about lessons that they have learned regarding regulatory approval of innovative technologies. In midstream processing, there will be a direct link between the reactor and the first downstream purification step; the centrifuge will become obsolete. He agreed with Nyberg that the industry needs to continue pursuing alternative expression systems for making biologics and suggested that the industry might learn some valuable lessons from other industries, such as ones that produce industrial enzymes. He noted some of the challenges in delivery of biologics: many require refrigeration, they typically have poor physical stability and poor oral bioavailability, their portability often requires a temperature-controlled supply chain from production to delivery, and most are administered parenterally. Drug delivery from an innovative LAMA/LABA co-suspension delivery technology fixed-dose combination MDI: Evidence of consistency, robustness, and reliability. Further more, this could be the end of animal or human experimentation. 4.3. The Conference will carry out upon the theme “New Challenges in Pharma Industries and Growth of Pharmaceutical … Furthermore, imaging technologies and tools can help to determine whether nanoparticles are going where intended. However pharma industry is still known as slow adopter of innovation. In Ancient Greece, pharmacy was about studying the medicinal properties of plants. Lechuga-Ballesteros stated that one way to create microparticles is by using spray drying and noted that low-density, spray-dried microparticles are ideal for pulmonary delivery. The coronavirus pandemic and recent natural disasters have exposed the fragility of the current drug supply chain. Bhambhani emphasized the reduction in drying time with this technology—typically from days to hours. The software used is not complex; Rao noted that it does not take sophisticated software, for example, to read a chromatograph or to monitor output from various sensors. The drug’s unique structure allows it to dissolve considerably faster than the average pill, which is a big help to seizure sufferers who often are prescribed large, hard-to-swallow pills. An audience member noted the resistance to using multiple sensors to collect more data and posed the question, What happens when two sensors that measure the same parameter disagree? It leads to the trends, to which Pharma companies either have to respond to, or then to vanish. School of Pharmacy, GNITC has organized the 2nd International Conference on Innovations in Pharmaceutical Sciences (ICIPS-2017) on 28th & 29th July 2017 with an aim to provide a unique platform for researchers, professionals, academicians and the experts of Pharma industry and allied fields of health care from the global village to interact/share their experiences & knowledge on the … To accelerate digital innovation, Prior concluded, the industry needs to invest in digital infrastructure and integration, there needs to be a joint effort to advance agile software validation, and FDA innovation-promotion programs and efforts in global regulatory harmonization need to continue. DeSimone, and B.W. Innovation in pharmacy and pharmaceutical sciences Drivers Research can feed into policy development and support positive changes and outcomes. 20th World Congress on Pharmaceutical Sciences and Innovations in Pharma Industry Pharmaceutical Conference 2020 is among the world's leading pharmaceutical conference. Washington, DC: The National Academies Press. Bommarius stated that he typically teaches his students that quality and cost are the two most important factors in pharmaceutical manufacturing but that the workshop has demonstrated to him that the two most important factors are drug shortages and the complexity of the supply chain. It slows down the processes dramatically. It creates an opportunity for the empowered patients to take responsibility for their health and find the solution that would help with their illnesses or other medical conditions. He noted the evolution of technologies from low to high resolution and said that technologies today can provide foundational knowledge on critical quality attributes (CQAs) that can be monitored to ensure safety and efficacy of biopharmaceuticals. PrEP can stop HIV from taking hold and spreading throughout the body. Managing small steps in that process can make a big difference. 2018), nasal delivery of various products (Tiozzo Fasiolo et al. 2017; themed issue of The AAPS Journal7) that she hoped the committee would review. Another research uncovered that radical innovations here build on more basic scientific knowledge than do incremental innovations, confirming that new technological trajectories are rooted in scientific discoveries (Sternitzke, 2010). Lastly, Schiel noted various technologies that can be used to evaluate conformational ensembles (Castellanos et al. Woodcock closed by noting that the committee’s input will be crucial in protecting the nation’s drug supply. An audience member questioned whether substantially increased productivity in the context of biologics production will come from implementing some control measure or from better understanding of cell physiology. Lack of redundancy in manufacturing sites, the absence of surge capacity, and the complexity of supply chains create serious vulnerabilities in our drug supply, she said. Castellanos, M.M., S.C. Howell, D.T. Adiga, R., M. Al-adhami, A. Andar, S. Borhani, S. Brown, D. Burgenson, M.A. CDER has also approved several continuous manufacturing applications. emphasized that accelerating process development will require aggregating data into a central repository that can be accessed by various users in development and manufacturing and require development of the analytics to leverage those data. To close the drug product session, Matthew DeLisa, William L. Lewis Professor in the Robert Frederick Smith School of Chemical and Biomolecular Engineering at Cornell University, moderated a panel discussion with the speakers and the workshop audience. He noted two examples in which Pfizer leveraged real-time connectivity and data. 410(8):2141-2159. It allows process intensification, which enables miniaturization of systems that have small footprints and reduced energy consumption. Several speakers from different countries viz. Huang hoped that there would be continued innovation in the development of digital-twin technology. Timothy Charlebois, vice president of Technology and Innovation Strategy for BioTherapeutics Pharmaceutical Sciences at Pfizer, moderated a panel discussion with the session speakers; Gregg Nyberg, associate vice president of Biologics Process Research and Development at Merck Research Laboratories; Jorg Thommes, head of chemistry, manufacturing, and control at the Bill & Melinda Gates Medical Research Institute; and Andreas Bommarius, professor of chemical and biomolecular. Top 10 Innovation Trends in Pharmaceutical Industry is an exquisite opportunity to learn how Pharma Industry is shifting to more digitized, customized and personalized era. And we feel that this type of innovation should be recognized. He then described three realities of data analytics for biological processes. Publisher country is . The Journal of Pharmaceutical Innovation (JPI) publishes in the areas of the pharmaceutical sciences such as drug development with a focus on manufacturing, process control, and technology, among many other subfields of research. Like in any innovative technology, risk and responsibility also demand attention of professionals. Furthermore, the sources of variation are often not contained in the data. REVIEWERS: To ensure that it meets institutional standards for quality and objectivity, this Proceedings of a Workshop—in Brief was reviewed in draft form by Matthew Bio, Snapdragon Chemistry; Kelvin Lee, University of Delaware; and Robert Meyer, Merck & Co. Copyright 2020 by the National Academy of Sciences. He suggested that the industry and FDA consider the Industrial Internet of Things to enable connectivity, that is, to build contemporary data infrastructure to aggregate data in a central location and to use distributed analytics to enable automation and data-driven decision-making at all levels. Tom emphasized that there are challenges given the different regulatory requirements for various drug substances and products and mentioned again the issues that her company has faced with co-processed APIs. Blackwood next discussed Pfizer’s experience with continuous direct compression in the manufacture of several solid oral drug products. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project. Department of Pharmaceutical Sciences, University of Jordan, Jordan. He predicted new technologies to enable reduction in cost of goods. Bhambhani highlighted the need to minimize the number of variables that change in a process to ease regulatory approval and the need to start discussions early, not only with regulatory groups but with manufacturing colleagues, to judge feasibility. Basic research is similar with applied research for linking pharmaceutical innovation Tom concluded by saying that there needs to be a global approach to avoid being limited by the most conservative approach. The workshop Innovations in Pharmaceutical Manufacturing held in Washington, DC, on February 27—28, 2020, provided a venue for discussing potential technologies that are on the horizon in the next 5—10 years in the pharmaceutical industry. In order to tackle this problem, it winds up in developing Open Innovation practices, such as Structural Genomics Consortium. She noted that advanced manufacturing has moved from the laboratory feasibility stage to commercial applications, that innovative technologies are in the pipeline, and that proposals are being submitted to the CDER Emerging Technologies Team from all types of companies throughout the pharmaceutical sector. New innovations in pharmacy are driving the war against opioid abuse, through such innovations as electronic prescribing (ECPS). As a final question, an audience member asked the speakers what talents or skills their companies need. In this interview, part of our Biopharma Frontiers series on how the pharmaceutical industry is evolving and how leaders can adapt, Epstein discusses the next horizon of innovation, critical elements of an effective business, and the kind of culture he tries to foster. Given that perspective and especially the need to supply solutions at a cost that can be borne by low- and middle-income economies, he emphasized that both the large, fixed infrastructure and the modular, continuously operated manufacturing systems might yield potential solutions for addressing global-health needs for biologics. Global pandemics and the increasing severity and frequency of natural disasters have highlighted the vulnerabilities of drug supply chains and have underscored the need to modernize pharmaceutical manufacturing. He first envisioned a future state in which manufacturing plants have central data repositories that connect all plant operations and the supply chain and that increase visibility and predictive capabilities. The International Conference on Innovation in Pharmaceutical sciences is aimed to provide a unique platform for researchers, professionals, academicians, experts of Pharma industry and allied fields of Pharmaceutical health care from the global village to interact/share their experiences & knowledge on Innovations in Pharmaceutical Sciences. Anyone who wants to use the articles in any way must obtain permission from the publishers. To achieve that goal, Merck will rely on portable manufacturing units, robotics to improve compliance, data analytics and information technology integration, and continuous manufacturing. Innovations in pharmaceutical Sciences Indore (M.P. Innovation Professional Certification (CIP), Chief Innovation Officer Certification (CCIO), HR Training for High Performance Innovation, Top 10 Innovation Trends in Pharmaceutical Industry, Crowd-sourcing the Solutions: Empowered and Know-How Patients, Artificial Intelligence and Cognitive Computers, HOME – THE WORLD’S LARGEST INNOVATION PROFESSIONAL ORGANIZATION, INNOVATION CERTIFICATION PROGRAM OVERVIEW, The Innovation Mindset – Expert Interview #2, with Muhammad Chbib CEO Tradeling.com Co-founder Tajawal.com, The Innovation Mindset – Expert Interview #1, with Professor Ron Jonash Chairman of the Board Global Innovation Management Institute, HOME – THE WORLD’S LARGEST INNOVATION PROFESSIONAL ORGANIZATION /, INNOVATION CERTIFICATION PROGRAM OVERVIEW /. JIPBS publishes Original Research Articles, Reviews/Mini-Reviews, Opinions & Perspectives, Book Reviews for the Pharmaceutical Sciences, Short Communications, and Research Notes. en Pharma executives say big data, radio frequency identification, automation and other innovations used in supply-chain tracking and tracing will be the most important digital innovation for their companies in the next five years, according to a recent Bain & Company survey. In one, Pfizer replaced end-product testing with a soft sensor to reduce drying-cycle time and increase productivity; in the other, Pfizer used advanced process control for fully automating and controlling pH in a production process and thus reducing product variabilities. Sign up for email notifications and we'll let you know about new publications in your areas of interest when they're released. The third step is to have sensors at the column outlets. Furthermore, most of pharma companies have extremely strict internal policies, which restrict them from sharing the data with the others. An audience member asked the panel how to implement major improvements so that drug prices could decrease to a level affordable by the global population. real-time data to models so that needed corrections can be made quickly. Manniello, E. Tratta, F. Buttini, A. Rossi, F. Sonvico, F. Bortolotti, P. Russo, and G. Colombo. Journal of Innovations in Pharmaceutical and Biological Sciences is a peer reviewed Open Access International Journal of best quality dedicated to various disciplines of pharmaceutical and biological Sciences. The“Innovations in Pharmacy and Pharmaceutical Technology”is intended for scientists and specialists at research institutes, universities, and other educational establishments; for students at institutions of higher education; and for analysts working in industry, agriculture, medicine, and environmental services. Mater. The trends of healthy life style, fashion of healthy-looks and unlimited data, enabled people to prevent certain diseases, if they adjust their life-style. The problem is that in many cases the variables cannot all be measured, so a good and reliable estimation about, for example, a particular quality attribute is not possible. Huang said that Pfizer uses a stage-gate process in which a project is divided into stages; at each stage, a decision is made as to whether to proceed. Govind Rao, a professor of chemical and biochemical engineering at the University of Maryland, Baltimore County, continued the discussion of drug product manufacturing by describing a portable, agile system for producing FDA-approved biologics in less than 24 hours. The International Conference on Innovation in Pharmaceutical sciences is aimed to provide a unique platform for researchers, professionals, academicians, experts of Pharma industry and allied fields of Pharmaceutical health care from the global village to interact/share their experiences & knowledge on Innovations in Pharmaceutical Sciences. Of the Top 50 most innovative companies, only three pharmaceutical companies made the top list. As an aside, Prior noted that there are concerns regarding measurement of more process characteristics because it might require companies to meet more specifications in their processes and thus more opportunity for process failures. Publishers own the rights to the articles in their journals. A lot of professionals from Pharma Industry hope that Nanotechnology is going to unleash breakthroughs in genetic engineering, medicine, diagnosis and in various types of dosage forms in pharmacy. Second, biological processes are nonlinear and time-variant, and the industry needs to move away from multivariate analyses. Coffman also recommended sensors at the inlets to allow real-time modeling to provide assurance that the system is operating as intended. 2018. The workshop Innovations in Pharmaceutical Manufacturing held in Washington, DC, on February 27-28, 2020, provided a venue for discussing potential technologies that are on the horizon in the next 5-10 years in the pharmaceutical industry. Those realities cause companies to be risk averse because they understand the. In their 2016 paper entitled “Innovation in the Pharmaceutical Industry: New Estimates of R&D Costs,” DiMasi et al estimated that the average cost of developing a … Bommarius noted that there is little recognition for improving, for example, productivity of an antibody production process; therefore, fundamental changes are needed in the research landscape in the United States and elsewhere. Today the pharmaceutical industry discovers myriad of drugs to prevent and treat even most complicated illnesses, while facing challenges of attaining regulatory approvals, confidentiality and pressure from patients. Canada, P.N. Cambridge, MA, USA 02141 The Nanotechnology Characterization Laboratory of the National Cancer Institute also can serve as a resource in the development of new nanotherapeutics. Prior to that, for thousands of years people relied on medicinal properties of plants, animals, and minerals. 20th World Congress on Pharmaceutical Sciences & Innovations in Pharma Industry 2020 - 01-02 Apr 2020, London, United Kingdom (79901); 19th World Congress on Pharmaceutical Sciences & Innovations in Pharma Industry 2019 - 25-26 Feb 2019, Best Western … Now same thing is about to happen in Pharma Industry. Scroll down to find out what are the Top 10 Innovation Trends that are shaping Pharmaceutical Industry. To assist the agency, Woodcock stated, the committee has been asked to produce a consensus study report that will identify emerging technologies—such as product technologies, manufacturing processes, control and testing strategies, and platform technologies—that potentially could advance pharmaceutical quality and modernize manufacturing of products regulated by CDER. The first step, he said, is to install an alternating tangential-flow filtration system that enables continuous harvest from the bioreactor. Article 941243:10. On conclusion of the opening remarks, Charlebois prompted the audience for comments or questions. Specifically, one first needs to assess compelling business needs and problems and align the innovative technologies with corporate strategies, priorities, and fundamental value propositions. He noted that much enabling technology exists but that the key is to identify applications that justify sophisticated approaches. He added that antibody-targeted particles and microfluidic processing might also be on the horizon. 2018. 2011). These topic labels come from the works of this organisation's members. The main objective of the international conference on “Recent innovations in Pharmaceutical Sciences” is to provide a platform that allows leading international and national scientists and researchers to share their ideas and work about modern trends in pharmaceutical research. In light of the current coronavirus pandemic, the question of production location is probably going to become much more important. Another participant asked Blackwood whether Pfizer has considered licensing the technology or the quality systems associated with its modular approach to ease barriers to other companies in adopting the approach. He said that his company wants to create flexible manufacturing with new technology that has the ability to produce small product batches. He added that many technologies are available and that the goal is to replace some of the older technologies with newer ones to increase product knowledge, decrease cost, and increase speed of drug development. Nat. They have developed the Artificial Intelligence based Judgement Correlation System (JACS), which is able to review billions of sentences and paragraphs from millions of scientific research papers and abstracts. 2018), and oral delivery of proteins and peptides (Brown et al. An audience member raised the idea of an industry consortium to share process data as a possibility for improving models or data analytics. Plants are the source of food and they give us the oxygen. 2020), which has posed a substantial challenge because of the harsh environment of the gastrointestinal tract. She said that acceptance depends on the organization. The discovery and development of new pharmaceutical substances are among the most interesting of innovation processes. Second, one needs to identify case studies that can demonstrate the success and value of the technologies. The study showed that the approach provides a sensitive impurity test and that false positives and false negatives can be mitigated with proper controls. It was hosted by the National Academies of Sciences, Engineering, and Medicine Committee to Identify Innovative Technologies to Advance Pharmaceutical Manufacturing and served as its first information-gathering activity for this committee.1 This Proceedings of a Workshop—in Brief summarizes the presentations and discussions that took place during the workshop. E-mail: info@giminstitute.org, The Global Innovation Management Institute (GIM Institute or GIMI) is a global, nonprofit organization with a mission to make innovation a management discipline. Hart, T.F. Mascia added that “end to end„ should encompass the path from raw material to delivery to patients. 65(11). He added that Merck has also developed lyospheres for targeted oral delivery by adding a coating that resists disintegration until it reaches the target site. What innovations are most likely to help stakeholders achieve these goals and transform health care over the next 10 years? It is a sterile, lyophilized polymeric micellar formulation of paclitaxel that employs a colloidal carrier system to allow intravenous delivery of paclitaxel. Now patients who live in hope to get their drug on time, will be able to get it much sooner. Eur. 2018. The scientific journal Innovations in Pharmaceutical Technology is included in the Scopus database. Patel, A. Rodriguez-Granillo, S.A. Robaire, E.C. Jaworski, C.P. Design of an in vitro biocatalytic cascade for the manufacture of islatravir. e2970. In closing, Korsmeyer emphasized that nanoparticles are materials whose surfaces affect behavior and performance and that their characterization has implications for design and manufacture. Although senior FDA leadership might support innovation, reviewers tend to be more conservative, and this means extra scrutiny and greater resistance to unfamiliar technologies. J. Which Digital Innovations Are Most Important to Pharma? Coley, C.W., D.A. Porous microparticles can also be designed to be effective carriers of crystalline active pharmaceutical ingredients (APIs), and cosuspensions have been shown to be more robust, consistent, and reliable than crystal-only suspensions (Doty et al. GURU NANAK INSTITUTIONS TECHNICAL CAMPUS SCHOOL OF PHARMACY (Autonomous) 1st- INTERNATIONAL CONFERENCE on INNOVATIONS IN PHARMACEUTICAL SCIENCES (ICIPS-2016) Sponsored By Department of Science and Technology (DST), Government of India Conference Dates : 29th & 30th July, 2016 [adsense:336x280:8701650588] ABOUT GNI GNI is one of the premier … 2020. He closed by stating that many innovative products for delivery of proteins and peptides are in the pipeline and briefly described pulmonary delivery for topical applications (Bodier-Montagutelli et al. Another audience member suggested that the committee investigate advances in aseptic manufacturing given the importance of sterility assurance in parenteral drugs. The 9 th World Conference on Pharmaceutical Science and Drug Manufacturing endeavors to render a unique platform for researchers, specialists, academics, pharmaceutical industry authorities and associated fields of global community pharmaceutical healthcare to trade and distribute their phenomenal experiences and critical knowledge and innovations are being made in the pharmaceutical sciences. An audience member noted that identifying inhibitory metabolites through transcriptomics and metabolomics and better sensing technologies might lead to increases in productivity, but large gains will likely result only from the use of alternative hosts. Romero-Torres opened by asking the speakers to elaborate on the business process for successfully implementing innovative technologies. He added that Pfizer also has made incremental innovations in existing technologies, for example, by incorporating sensors to monitor mixing processes and enabling integrated control with real-time decision-making. Nyberg noted that requirements or levels of scrutiny will depend on how a model is being used. This initiative is supported by the president of Mauritius Ameenah Gurib. This trend has started in countries like Mauritius, which have broad diversity of distinctive plants. John Schiel, a research chemist in the Biomolecular Measurement Division of the National Institute of Standards and Technology (NIST), described analytical technologies for characterizing and monitoring therapeutic proteins, primarily monoclonal antibodies (mAbs). He described the digital plant-maturity model proposed by the BioPhorum Operations Group and emphasized the role of analytics in ultimately creating the “adaptive„ plant.4 In achieving the vision, Huang said that it is important to accomplish incremental wins that demonstrate the value of the technology—think big, start small, and scale fast. 7 See https://link.springer.com/journal/12248/topicalCollection/AC_d31a4b0d2a9cdc71d616967defca50c9. challenges inherent in introducing innovative processes and do not want to compromise filing timelines. He noted that interest in continuous manufacturing arose several decades ago as the industry began to prepare for patent expiry of its blockbuster, high-volume medicines. Richard Korsmeyer, president of Korsmeyer Consulting and former executive director of Advanced External Projects in Pharmaceutical Sciences at Pfizer, discussed innovations in dosage forms. highlight: In these times of rapid changes, for Pharma companies it is not enough to focus solely on selling drugs and medications. He noted that this method is a powerful analytical tool in that the dataset contains information about each amino acid and the conformational location of each amino acid in the protein. Jamison, and K.F. It is well-understood in the healthcare industry that over half of patients do not adhere to medication prescriptions, and this is responsible for over $290 billion of additional healthcare costs in the US alone. D’Mello, S.R., C.N. A third is related to hybrid products—ones that blur the lines between what has traditionally been considered a small molecule and a large molecule; regulatory compliance for these new types of products can be unclear. Such technology might make it possible for pharmaceutical companies to share space and possibly some operations if precompetitive agreements are in place. Show this book's table of contents, where you can jump to any chapter by name. One out of many nanomedicine examples is Genexol-PM by Samyang – the anticancer nanomedicine. She provided two references (D’Mello et al. Garcia, A., P. Mack, S. Williams, C. Fromen, T. Shen, J. Tully, J. Pillai, P. Kuehl, M. Napier, J.M. Blackwood stated that focusing on portable, continuous, miniature, and modular technology will allow Pfizer to transform how it develops, manufactures, and distributes its drug products. Doty, A., J. Schroeder, K. Vang, M. Sommerville, M. Taylor, B. Flynn, D. Lechuga-Ballesteros, and P. Mack. In downstream processing, there will be improvements in product capture, for example, by using affinity membranes and better connections and simplifications in product purification so that intermediate storage capacity is not needed. Developing open innovation practices, such as structural Genomics Consortium companies, and the and... Ranked twenty-fifth, Bayer ranked twenty-seventh, and productivity on models, see https: //www.nationalacademies.org/our-work/identifying-innovative-technologies-to-advance-pharmaceutical-manufacturing improving. Also can serve as magic bullets reduced energy consumption technology fixed-dose combination MDI: Evidence of consistency,,! … Innovations in Pharma industry D costs in the early stages of the data with the others asked... Produce drugs critical to the articles in any innovative technology, risk and also... 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