John Tillotson - Pharmaceutical Technical Business Director, ABITEC Corporation; Nathan Dormer - Director of Drug Product Development, Adare Pharma Solutions; Robert J. Bloder - Chief Business Officer, Ascendia Pharmaceuticals; Sandip Tiwari, PhD - Head of Technical Services NA, BASF Pharma Solutions; Brent Moody - Director Science and Technology, Catalent; Tom Quinci - Director of New Business Development and Partnering, Celanese; Shannon Kelly-Vice President Business Development and Formulation Technology, Colorcon; Bikash Chatterjee - CEO Pharmatech Associates—a USP company; Dr. Ali Rajabi-Siahboomi - Vice President - Chief Innovation Officer, Colorcon; Jim Huang, PhD – CEO, Ascendia Pharmaceuticals; Hayden Skalski - Lead Product Application Specialist – Biodetection, Sievers Analytical Instruments
Looking back at the past year, how has the pandemic and associated supply chain issues affected the development of controlled release products?
John Tillotson, Pharmaceutical Technical Business Director, ABITEC Corporation: Primarily, the pandemic has challenged supply chain logistics and increased the manufacturing costs of numerous excipients including controlled-release excipients. This includes the cost of developing controlled release products.
Nathan Dormer, Director of Drug Product Development, Adare Pharma Solutions: The pandemic has invariably affected every industry’s supply chain and Adare Pharma Solutions has been no exception.
Commercial products with more predictable manufacturing campaigns and backup raw material vendors have generally fared better than new research and development programs, since long-term planning and risk mitigation is integral to marketed products.
For new formulations undergoing prototyping, where excipients are less defined and constantly evolving, procuring samples or meeting minimum quantities has come with occasional delays. Overall, our equipment and material vendors have been very accommodating, and we are grateful for eff orts to maintain availability of their products.
Robert J. Bloder, Chief Business Officer, Ascendia Pharmaceuticals: Ascendia Pharmaceuticals has responded to the supply chain disruptions in a number of ways to protect our clients and projects. We have enhanced the communication and timing pertaining to our component suppliers and set-up processes to expedite and ascertain long-lead time items. We have also forged lasting relationships with qualified vendors and continue to build redundancies/back-up suppliers as needed. Ascendia champions transparency and openness with our client partners and suppliers.
Sandip Tiwari, Ph.D., Head of Technical Services- NA, BASF Pharma Solutions: The COVID-19 pandemic has caused severe disruptions to the global economy including the pharmaceutical industry, which exhibited a decline in overall activity including development during the lockdown because of the shutdown of manufacturing and R&D facilities, acute shortage in the supply of raw materials/packaging components and absence of potential manpower including forced remote working, lack of effective disinfection and personal protection equipment strategies for the new viral infection.
Though supply chain activities have experienced challenges during the pandemic, the pharmaceutical industry is projected to gradually recover post-COVID-19, which will present attractive opportunities for development of novel treatment modalities and controlled release products beyond small molecules including nucleic acids, peptides, proteins and antibodies.
Brent Moody, Director Science and Technology, Catalent: Unfortunately, supply chain challenges have become a way of life across all industries, and pharmaceutical development is no exception. Partly, this has been driven by demand. From the earliest days of the pandemic, Catalent observed a marked increase in the repurposing of old drugs (or drugs originally intended for other indications) against COVID-19 as well as other emergency, chronic, and general health care needs. Often, this has required modifying the pharmacokinetic profile through controlled release formulation. This led to a corresponding increase in demand for raw materials used in controlled release formulations, processing equipment and maintenance capabilities, and not least of all, for formulation development and manufacturing know-how. Fortunately, Catalent has been able to mitigate some of the impact through a robust and well-established network of vendors. Redundancy in qualified vendors, libraries of equivalent materials, and an agile global warehousing network have allowed us to meet the increasing demand and supply chain pressures. We have also relied on our global network of formulation scientists to meet the timeline pressures associated with increased demand for modified release product expertise.
Tom Quinci, Director of New Business Development and Partnering, Celanese: Development of controlled release products was directly impacted due to reduced staff working in formulation and analytical laboratories, while companies shifted focus to address the pressing issues of meeting their own supply demands. Accordingly, projects have been reprioritized and are taking longer in development, with some programs placed on hold. I have seen more development outsourced to CROs and CDMOs to keep projects moving forward.
CROs and CDMOs have stepped in as a solution to help pharmaceutical companies extend their development activities without accruing additional fixed overhead. Many large companies are doing what start-ups have been doing for years—conducting development outside of a brick-and-mortar infrastructure. Especially in the areas of early development and early proof of concept work, third party providers can accelerate capacity to explore new formulations, new technologies, and new drug delivery platforms. Celanese announced an expansion of our Feasibility & Development Lab to support preclinical R&D, and we anticipate that demand for early development support will continue to grow as the model proves to provide benefit.
Shannon Kelly, Vice President Business Development and Formulation Technology, Colorcon: The pandemic has highlighted vulnerabilities through the supply chain, from the starting materials through the entire logistics chain to the patient. The impact is not limited to materials and the supply chain as companies have struggled to keep R&D functioning due to personnel being impacted through lockdown and travel restrictions.
Companies are now looking for reliable supply closer to manufacturing locations and limiting the movement of products for further steps such as packaging and distribution to reduce risk. They are paying more attention to sustainability and the impact of materials, technology, and manufacturing locations.
Colorcon was in a unique position to continue to service the market through the early adoption of virtual platforms. Throughout the pandemic we utilized digital technology to collaborate and continue to support our customers through their formulation and development from lab to scale-up.
In general, what are some notable industry trends regarding controlled release product development that you have noticed over the past year?
Tillotson: The trends are towards advanced technologies in controlled release, such as combined release modalities including magnetic controlled release and light controlled release with nanoparticles. Additionally, targeted controlled release with lipid nanoparticles is an area that continues to be of interest.
Dormer: From the perspective of a technology driven CDMO, Adare Pharma Solutions is experiencing growing interest and demand for developing patient centric medicines by leveraging our solution portfolio.
Focus is on formulation development for vulnerable pediatric and elderly patients, but dysphagic patients likewise require a tailored formulation strategy.
In fact, multi-particulate formulations combining controlled release properties and eases of swallowing require the application of specialized, compatible technologies.
Bloder: Over the past year, Ascendia has noted an increased demand for controlled release expertise for sterile and oral product dosage forms. We are fortunate in that our technologies cover dosing regimens that range from bi-monthly to once a year for Long-Acting Injectables for CNS and cancer treatments. Additionally, we are experiencing an increase in demand for lipid nanoparticles for use in sustained release of small molecules and biologicals.
Tiwari: The rationale for development of a controlled release product of a drug is to enhance its therapeutic benefits, minimizing side effects, enhanced patient compliance while improving the management of the diseased condition and product life cycle. Given the benefits of the controlled release products and emerging need of repurposing existing drugs for the treatment of various viral diseases post COVID-19, several novel drug delivery systems and devices are likely to be developed and commercialized in the near future both for oral and parenteral applications.
Development of efficient therapies for chronic and non-communicable diseases such as cancer, diabetes, and hypertension are expected to boost the growth of controlled release products. The rising aging population globally is one of the major reasons contributing to the potential growth in this segment, largely due to non-adherence to the medication regimen. Patient compliance to medication is a challenge in the geriatric population and reducing the dosing frequency is the key to compliance and management of the diseased condition. Hence, the demand for controlled release drug delivery systems is expected to grow with the rising patient population with these diseases.
Moody: The pandemic has laid bare the need to better treat and control chronic conditions which may lead to adverse outcomes for patients. For example, a once-daily dosing option could offer greater convenience, potentially optimize compliance, and improve therapeutic outcomes for patients with chronic conditions. Unfortunately, some of these are quite widespread, which has placed a corresponding emphasis on scalability and continuous manufacturing techniques to meet large-scale global demand. For example, continuous processes such as Hot Melt Extrusion (HME) and twin[1]screw granulation have been increasingly utilized in the production of modified-release tablets. We have also witnessed increased demand for modified release products for pediatric patients, who present their own set of challenges, many of which vary with age. Finally, the pressure to get promising new modified release therapies to patients in an increasingly short time frame has led to an emphasis on the use of in silico tools such as physiologically-based pharmacokinetic (PBPK) modeling, to streamline product development.
Bikash Chatterjee, CEO, Pharmatech Associates—a USP company: Patient centricity has emerged as a central component of many drug sponsors’ development portfolio, translating to a resurgence of interest in the benefits of controlled and modified-release dosage forms. Patient centric strategies encompass many solutions according to what facet of the patient interaction you are trying to address or optimize but in general the intent is to improve the convenience and safety of administration, patient compliance with treatment, and general patient engagement. Because of this new strategic interest, controlled- and modified-release drug design has moved from a patent extension strategy to one that is central to marketplace advantage. Pediatric and geriatric markets alike have specific challenges with treatment compliance considering taste and swallowability considerations. For treatment regimens that require treatment multiple times a day, a controlled release solution can dramatically reduce compliance issues. Patient centricity in a drug sponsors portfolio development will increase in importance in the foreseeable future with controlled release design and technology solutions at the center of these strategies.
Dr. Ali Rajabi-Siahboomi, Vice President - Chief Innovation Officer, Colorcon: Many technologies that are used for oral controlled release formulations have been around for a long time, especially matrix tablets, multiparticulate formulations and osmotic technologies. These are still widely used, as companies have gained knowledge and experience with their formulation and manufacturing processes.
Developments have been seen through line extensions and reformulations that allow patent extension and provide different release profiles to improve patient acceptability, dosing, and overall therapeutic goals.
The use of extended-release technologies for Fixed-Dose Combinations (FDC) has allowed a significant number of new drug applications to be made under the 505(b)2 scheme with the US Food and Drug Administration (FDA). Some of these may be a combination of extended and immediate release in the same dosage form, like bi-layer tablets, or a mix of barrier membrane-coated multiparticulates that are loaded into a capsule. The FDC technology improves the patient’s experience by reducing the pill burden (taking one dose rather than two or more) and enables synergistic treatment of a condition with a single dosage formulation.
The application of a barrier membrane coating, such as Surelease®, ethylcellulose aqueous dispersion can be used to modify release for both tablet and multiparticulate formulations. This top-coat overcomes the so-called initial burst release for highly soluble drugs which is important to maintaining controlled release of the API (Active Pharmaceutical Ingredients). When applied for taste-masking, where dissolution and taste profile contribute to the acceptability criteria, the coating provides a barrier preventing release of an unacceptable tasting medicine until the API has left the mouth.
Are pharmaceutical companies that are developing controlled release products looking for more data from suppliers/service providers? If so, what are the reasons and what kind of data are they most interested in?
Tillotson: The most interesting data is applications data. Formulators have a need to know how a given controlled-release excipient will perform under differing conditions, such as location of the proposed controlled-release, performance in differing release media, and to what speed and extent the release from a given excipient occurs. Additionally, formulators are interested in novel release controlling excipients with multi-modal benefits, such as solid lipid nanoparticles which can control release as well as provide for specific therapeutic targeting, or solid SEDDS systems that can provide for increased bioavailability, controlled release, and ease of manufacturing. In all cases, the applications data and excipient performance under varying and relevant conditions is the information of most value. This allows for the evaluation of how a respective excipient will perform in identified applications.
Dormer: During development of specialty-controlled release products, we often evaluate non-standard uses of excipients to achieve the desired product profile. In those instances, there is a need for basic and advanced characterization of the formulation materials in combination with each other and during stability studies. Our lab appreciates any time a material vendor can support quick technical questions or provide “cutting edge” data on their own products. Of course, new products or excipients that reduce or eliminate legacy limitations are always welcome.
Jim Huang, PhD, CEO, Ascendia Pharmaceuticals: Pharmaceutical companies developing Controlled Release (CR) products want to increase the success rate of CR at the preclinical and clinical stages, as well as during commercialization and life cycle management. Formulation robustness is important in-vitro and in-vivo but also to establish IVIVR/IVIVC to reduce the biostudy burden in case of minor changes in formulation, process and other SUPAC changes. They are also looking to partner with a CDMO who can help create IP to further strengthen their marketing position and life cycle management.
Tiwari: Drug products including controlled release products are produced in a manner that ensures their identity, safety, strength, quality and purity. This requires consideration of the quality of all ingredients in a drug product, including excipients. Excipients in a drug product can impact drug substance solubility and permeability, stability, release rate, and absorption. Variability in excipients, especially controlled release excipients, therefore need to be part of the formulation risk assessment. Working with excipient supplier can facilitate the understanding of the impact of excipient variability on drug product performance and identification of critical material attributes for defining subsequent control strategy. Collaboration with Active Pharmaceutical Ingredient (API) and excipient suppliers is the key to avoid future challenges with material supply as the specifications for incoming raw materials need to be set based on the manufacturing capabilities and control strategies used by the supplier’s operations teams and not based on the sole assessment of pharmaceutical companies developing the products.
More recently US FDA has been mandating nitrosamine impurities risk assessment of all marketed products and those products with pending applications both for APIs and drug products. Such a risk assessment necessitates collaboration with suppliers of API, excipients, and packaging components so that information can be collected, and risk analysis performed for the finished product and if the risk is identified then control strategies are put in place to avoid costly recall scenarios. BASF as an innovator excipient company had taken an early lead in this area and made nitrosamine risk assessments available for its excipient products for use by the pharmaceutical companies.
Moody: Modern pharmaceutical companies are looking for more than a ‘pair of hands’ when it comes to development and manufacturing of modified release products. As a leading development partner for such companies, Catalent has, over many years, encountered a wide range of product challenges and has acquired significant knowledge in how to overcome them. Pharmaceutical company customers rightly expect to be able to leverage that experience to streamline their own product development programs. We also recognize that in the current environment, where redundancy of supply is so important, the modified release products that we develop at one site may have to be manufactured at multiple other locations around the world. So increasingly, our customers are looking for product and process design data for a robust package as well as information pertaining to raw materials and excipients that may impact product quality and manufacturability. Finally, there is an increasing expectation among pharmaceutical companies that their development partner use PBPK modeling to guide modified release product development decisions.
This often starts with in silico feasibility analysis to inform whether modified release is the right strategy. Once established, a robust model can be used to set specifications, analyze prototypes, and streamline final form selection.
Chatterjee: One area where there is sustained interest in controlled release solutions is the area of complex generics. Complex generics must demonstrate bioequivalence with the innovator product, just as any generic must do, but for drug formulators this is easier said than done. Small changes in pharmaco-chemical characteristics can manifest differently therapeutically. Complicating the picture is the need to do a bridging study for any modified or controlled release drug formulation since you cannot compare systemic bioequivalency directly.
These types of studies are larger and more costly than standard bioequivalency studies. So, it is paramount that the drug sponsor have confidence that their formulation will be comparable based upon characterization and testing before embarking upon a costly and potentially lengthy bridging study. Suppliers have not historically shared the details of their full formulations or manufacturing processes, leaving drug sponsors to design their processes based upon a very limited level window of the possible material variation they could encounter. As the industry begins to seriously consider the merits of continuous manufacturing for finished drug products a supplier’s ability to provide information relating to their formulation, raw material characterization and in-process tests will be essential to drug sponsors’ ability to consistently manufacture conforming product.
Kelly: Excipients with consistent quality and physical characteristics play an integral role in drug release from controlled release products. Drug release profiles may be affected by several factors including polymer type and level, drug particle size, dose and solubility, ratio of polymer to the drug, filler type and level, and ratio of polymer to filler. To ensure reproducible batch-to-batch consistency it is important to understand how any variability in these factors and the manufacturing process could influence the release performance if inconsistency occurs. A Quality by Design (QbD) approach is typically used to identify and characterize the impact of varying process parameters and determine the Critical Material Attributes (CMA) for the excipients and rate-controlling polymers.
Using the right technology and choice of excipients, it is possible to develop a stable formulation with reduced complexity and excellent reproducibility. Partnership with suppliers of ingredients and equipment is critical during the development phase to ensure that the formulation and process parameters used during development are transferable to commercial-scale equipment. Similarly, to avoid future supply issues, formulators should discuss with suppliers before putting in place any limiting specifications for ingredients.
Hayden Skalski, Lead Product Application Specialist – Biodetection, Sievers Analytical Instruments: Companies developing controlled release products, along with parenteral drug companies, will often request data from suppliers or service providers to help them make a decision on whether or not they will choose that particular supplier. These companies want to make sure the product from the provider works, that it is safe to use, and most importantly that it is compliant. From my experience, the data that these companies want to see is data to demonstrate how their specific product will work on the supplier/ service provider’s product, especially instrumentation and products for quality control laboratories. Controlled release product manufacturers and those who make APIs can have complex product matrixes, which often require different treatments in order to be successfully tested in the lab prior to release. Therefore, having the assurance that their products will work is a big reason why they want to see that data.
As the industry is global in nature – how do suppliers of controlled release products/technology meet the requirements to maintain consistent quality and regulatory compliance worldwide?
Tillotson: During the development of excipients, a Quality by Design approach should be employed to optimize towards a respective controlled release excipient’s quality target product profile. After development, c-GMP manufacturing is required and adherence to six sigma protocols also guarantee manufacturing reproducibility and consistent quality. Additionally good distribution practices should be observed to guarantee shipping and storage conditions are suitable to maintain the controlled release excipients Critical Quality Attributes (specifications) are maintained throughout the product supply chain. Overall, the manufacturing and supply must guarantee that the controlled release excipient provides highly consistent performance.
Dormer: Maintaining quality consistency in controlled release products versus simple tablets or capsules is not fundamentally different but does require added layers of process checks to monitor Critical Quality Attributes affected by complex manufacturing, specialized excipients or multiple intermediates. Process checks for controlled release products must satisfy the safety and regulatory requirements in the countries of distribution, like for any product. It often seems like a simple process on paper, but the complexity of controlled release products combined with supply chain variables can result in inconsistencies that are not readily apparent. Quality risk management should always be a core focus for organizations.
Huang: Ascendia has established quality and regulatory compliance systems that meet the requirements of major markets, including the U.S. and EU. When developing products, particular attention is given to using excipients, color, and final product image that are generally acceptable globally. We also conduct ICH stability studies, including different climatic zones by ICH, in the world for stability conditions. Examples are temperate, mediterranean/subtropical, Hot dry, Hot humid/tropical and higher humidity.
Tiwari: The suppliers of controlled release products use the best practice guidelines and appropriate current Good Manufacturing Practices (cGMP). Adherence to the cGMP assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of products adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company or a supplier of a raw material, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.
Moody: While our industry is united in the goal of delivering quality life-saving therapies to patients, exactly how each company does that – or more specifically, how we demonstrate that – may vary somewhat across regions and regulatory authorities. As a development and manufacturing partner, it helps to have global regulatory and quality teams with experience and insight into the specific guidance and regulations of various authorities. These groups can provide critical guidance to development and manufacturing sites in areas such as qualifying raw materials to ensure consistency across batch and grade, developing validation protocols, appropriate sampling and testing, changes in vendors, equipment, process, etc. And increasingly, our customers look to our global network of experts for guidance on importing and exporting between various regions.
Kelly: The pharmaceutical supply chain is a complex network that covers inbound materials to manufacturing plants, inter-company supply chains, packaging, and onward distribution to end-user customers.
One of the biggest challenges with pharmaceutical excipients, including controlled release technologies, is that most are made by chemical companies, which make materials for wider industrial use. Excipients for pharmaceutical use make up only a fraction of customers for the chemicals industry – and yet the pharma industry has specific GMP (Good Manufacturing Practice) regulations for excipients because of how they will be used.
To maintain consistent quality and regulatory compliance suppliers of technologies and materials need to have a deep understanding and knowledge of the regulatory needs of the pharmaceutical market around the world and ensure materials meet these requirements.
Globalization and increased outsourcing activities have led to some extraordinarily complex supply chains for pharma manufacturers. Companies need good insight into sources and channels for materials and a robust supply network is a critical consideration as companies plan to de-risk the threat of interruptions across the entire supply chain. For Colorcon, we continue to ensure our film coating manufacturing plants operate with the same raw materials, the same equipment, and the same processes; plus, a considerable amount of work has been done to validate the interchangeability of products from each of the sites, enabling continuity of supply.
Skalski: Global companies must test their product batches independently for specific laboratory assays in order to meet safety requirements prior to products being released to the market. These tests, also known as critical release tests, are a crucial step in examining the purity of products to ensure that patient safety will not be compromised. These can include Total Organic Carbon (TOC), Bacterial Endotoxins Testing (BET), and bioburden. These quality tests go through rigorous review upon completion, and results are analyzed by secondary lab analysts and Quality Assurance (QA). Products and results are often trended over time to examine any Out Of Trend (OOT) or Out Of Specification (OOS) results, which in turn will help identify any outlier in the manufacturing process or laboratory and can be investigated. Pharmaceutical companies have internal processes that must be adhered to in order to safely sign off on product release and also investigate any abnormal results prior to being released. These processes closely align with FDA and EMA regulations so that companies are being compliant and not risking any harm to patients.
Considering the last two years and looking ahead, what has the pharmaceutical industry learned and how will it apply these lessons in the future?
Tillotson: Certainly, given the COVID-19 pandemic, the pharmaceutical industry has learned a great deal over the past two years. Initially, the industry became quite agile formulating novel vaccines and delivery technologies to meet the challenge. Subsequently, the industry has had to adapt to certain outcomes resultant from the pandemic, such as supply chain issues, rising raw material costs, and supply scarcity. Overall, the industry has learned the value of agility and planning in the face of every-changing conditions, to ensure supply of the pharmaceutical goods and services that public health requires.
Dormer: Adherence to therapy is a driver for drug efficacy and should be facilitated by designing products unencumbered by complex administration procedures and cumbersome administration schedules.
The COVID pandemic further demonstrated the need and the value of drugs that are simple and easy to take.
Social distancing and isolation are significant obstacles to therapy adherence, especially for more vulnerable patients. It is therefore crucial to design and develop products, such as controlled and modified release medicines, that provide a simplified dosing schedule to reduce dosing errors and enhance lifestyle compatibility for the target patient population.
Bloder: I believe among the many learnings is that the pharma industry has recognized the importance of supply chain functionality and the profound impact it can have on the everyday lives, from life-saving vaccines to baby formula. We live in a fragile ecosystem and we all can contribute each day to achieve its success.
Tiwari: While the pandemic in the last two years posed several new challenges to the pharmaceutical industry, it also gave an opportunity to reassess the status quo and innovate for providing high-quality medicines with an unprecedented need and demand. Besides strengthening the supply chain, other key learnings from the pandemic for the pharmaceutical industry are:
Collaboration: The industry worked relentlessly to find novel treatment modalities for prevention and treatment of COVID-19 by collaborating and sharing information. Pfizer and BioNTech is a good example of collaboration that brought mRNA vaccine. Collaboration and strategic partnerships are expected to grow exponentially to address the needs of the future pandemic.
Digital transformation and machine learning tools are getting integrated into pharmaceutical manufacturing and research and development for faster drug product development, control of manufacturing processes, supply chain traceability and direct data submission to regulatory bodies. BASF’s virtual pharma assistant tools for drug product development, regulatory product information, interactive sustainability tool for its products and e-commerce are good examples of digital transformation.
Innovation: In the area of drug delivery, classical drug delivery approaches are being applied to improve the emerging therapeutic modalities such as controlled release (initially developed for small molecules) across the therapeutic spectrum. While technologies and drug delivery strategies for new therapeutic modalities are being adapted to improve the delivery of older drugs with repurposing applications. Use of polyethylene glycol conjugation with proteins first and then for improving delivery of small molecules latter is a good example of innovation in drug delivery space.
Moody: If the past two years have taught us anything, it is that the most important organizational resource is people. Well-qualified and experienced people can adjust and adapt to changing paradigms in communication, workspace, travel, and lifestyle in general. Resiliency and flexibility are the new norms. Within the highly regulated framework that we understand, companies must find innovative ways to allow employees to do their jobs better and faster in a post-pandemic world. This includes using tools such as remote learning, automation, enhanced communication platforms, and a general openness to innovative ideas and change. As the pandemic recedes, we all look forward to returning to something resembling normalcy. But given our technological capabilities and what we have learned, it is unlikely that things will ever go back to exactly the way they were. The successful companies of tomorrow will be the ones that quickly adapt and put the best tools in place to support their people.
Quinci: With the rapid development and commercialization of the COVID vaccine, the pharmaceutical industry has learned how fast innovation can happen. Moderna proved a relatively new entrant can disrupt large pharmaceutical companies and bring innovation to market quickly. BioNTech brought an entrepreneurial drive to their partnership with Pfizer, helping to speed time to market with their version of the vaccine. I believe the success of the COVID vaccines raises the bar on what is an acceptable time to market and proves what can happen when industry, regulatory agencies, and governments are motivated and united behind a common cause.
More than ever, innovation is needed to develop improved drug modalities and overcome longstanding therapeutic hurdles. For example, novel controlled release technologies offer an opportunity to address effectiveness and safety issues encountered with traditional treatments. The overly risk-adverse mindset of the past doesn’t have to be the norm moving forward and long timelines that were once accepted can be questioned as the industry takes on the challenges of the future.
Siahboomi: The rapid increases in computing power and the emergence of new capabilities in AI (Artificial Intelligence), virtual modelling, automation, and data analytics, are accelerating the pace of innovation not only for new chemical entity (discovery, but also for drug dosage design. 3D printing technologies to manufacture solid dosage forms is gaining momentum, allowing for complex designs with regards to flexible shapes and precise release profiles. This technology is still in development with some success in the nutritional market and limited approvals in pharma.
The use of AI is already starting to have an impact through drug discovery and bio-simulation that enables the pharmaceutical industry to narrow down the most efficacious compounds, de-risk R&D decisions, predict preclinical outcomes before human trials, reduce animal testing, and therefore facilitate speed to market at a lower cost.
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