CSI is proud to set up The Vanessa Dekou Scholarship for Scientists to contribute to the education of the next generation of leaders in life sciences The Vanessa Dekou Scholarship for Scientists will help finance a Cambridge MBA education for candidates with advanced degrees in scientific fields such as biological sciences, chemistry and physics. It is funded through a generous donation from Vanessa Dekou, a Cambridge Judge Business School alumna (MBA 2002) who has forged a successful career in entrepreneurship and biotech. Gishan Dissanaike, the Interim Dean of Cambridge Judge Business School adds: We are very grateful to Vanessa Dekou for establishing this wonderful scholarship in her name to help fund a Cambridge MBA education for students with a scientific background. Cambridge Judge is proud to integrate vital areas such as healthcare, climate change and technology into our Business School curriculum and activities, so this scholarship will help us to attract people with diverse backgrounds in science who can use their Cambridge Judge experience to advance scientific knowledge. Vanessa Dekou says: When I arrived at the UK in September 1991 as an undergraduate, I had big dreams about my future. I educated myself to PhD/MBA level and through my education, perseverance and incredible hard work I managed to build CSI from scratch; to contribute to advances in healthcare and create employment and prosperity. I am thrilled and humbled that through Cambridge Judge Business School I am in the fortunate position to give back to our society and inspire other scientists to innovate and progress. The Scholarship will be awarded based on academic excellence, and while there is no fixed deadline early application is recommended.

How CSI’s flexible approach to global distribution ensured a large biotech’s three-year study across 15 countries could proceed without delay Challenge CSI was tasked with providing crucial support to a large biotechnology company in distributing medical devices for a three-year study spanning 15 countries in Europe (EU), the United States (US) and Asia-Pacific (APAC). A central sourcing approach was not suitable for the client due to import and export complications, as well as the high VAT of the required product. It was a particular challenge to find 15 warehouses that were able to accommodate the storage of the required medical devices within a short timeframe since they contained lithium batteries, which are classed as dangerous goods. The majority of GMP warehouses are limited to the storage of medication, which made qualification all the more complex. Solution After conducting a rigorous search and leveraging our networks, CSI identified suitable partner warehouses, auditing and qualifying them within the rapid timeframe required for the client’s study to progress without delay. Result With CSI’s outstanding supply chain solutions and expertise in import and export, we provided stock to all depots and sites across the world. We also managed the return of all devices, creating country-specific return kits for each location. CSI’s flexible approach to ancillary sourcing ensured we were able to supply all sites before the Site Initiation Visit (SIV), enabling the client’s study to commence on time.

This month, we are focusing on Oncology and have reflected on the notable advancements to oncology medications in recent years. Immunotherapy: Immunotherapy has been a significant focus in oncology. Checkpoint inhibitors, such as pembrolizumab and nivolumab have shown success in treating various cancers by targeting specific proteins that inhibit the immune system's response to cancer cells. CSI has longstanding experience sourcing these immunotherapy drugs for over 100 studies. Targeted Therapies: Advances in understanding cancer genetics have led to the development of targeted therapies that aim to disrupt specific pathways involved in cancer growth. Drugs like imatinib and bevacizumab, which CSI have sourced for more that 35 studies, have been successful in treating cancers with specific genetic mutations. CSI has procured a wide range of these targeted therapy drugs for clinical studies worldwide. PARP Inhibitors: Poly ADP-ribose polymerase (PARP) inhibitors, such as olaparib and rucaparib have shown efficacy in treating certain types of cancers, particularly breast cancer with BRCA mutations. Their mode of action is interfering with DNA repair mechanisms in cancer cells. CSI possesses a strong track-record sourcing this medication. ADCs (Antibody-Drug Conjugates): ADCs are a type of targeted therapy that combines monoclonal antibodies with chemotherapy drugs. Trastuzumab emtansine (T-DM1) is an example used in breast cancer treatment and CSI has good access, finding sourcing solutions for over 50 studies. CAR-T Cell Therapy: Chimeric Antigen Receptor T-cell (CAR-T) therapy has shown promise, particularly in haematological malignancies. This personalized treatment involves modifying a patient's T cells to express a receptor that targets cancer cells. Adjuvant Therapies: Advances in adjuvant therapies, including post-surgical or post-chemotherapy treatments, have improved the outcomes for some cancer patients, reducing the risk of recurrence. Precision Medicine: The concept of tailoring cancer treatment based on individual patient characteristics, including gene sequencing and other biomarkers has gained prominence, leading to more personalized and effective treatment strategies. This personalised approach is the future of cancer diagnosis and treatment. CSI has comprehensive expertise in oncology, biologics and biosimilar products and has provided solutions to more than 1000 clinical trials all over the world, in studies developing the many types of oncology drugs explored in this article. To find out more about how CSI can support your clinical trial, go to our Case Study and Our Services page.

Clinical Services International has a deep understanding of our industry and what lies ahead in 2023 and beyond. Read on to see our top trends in the pharmaceutical industry The pharmaceutical industry has seen a great deal of change over the last two years, with the COVID-19 pandemic playing a significant role. This is set to continue its evolution and provide more ways to improve patient outcomes in 2023. 1. Increased use of wearable devices for clinical trials A major trend for the pharmaceutical industry in 2023 will be the increased use of wearable devices in clinical trials. Wearable devices house biosensors that collect data that medical professionals can use to assess a patient’s responses to a particular treatment or therapy during a clinical trial. The increased use of wearable devices means collecting clinical trial data can switch to a remote model. As Kevin A. Thomas states, a decentralised model should help encourage more diversity in those participating in clinical trials. As a result, this should lead to improved patient outcomes, retention and recruitment. One example of this in practice is the digital glucose monitoring study completed by Kaiser Permanente in 2021, where medical professionals used wearable devices to help better manage their patients. 2. Stricter regulation of the pharmaceutical industry In 2023, stricter regulation of the pharmaceutical industry is likely, and this will lead to a greater emphasis on compliance. This will involve standardised training and certification for sales representatives and medical science liaisons (MSLs). To meet these regulatory requirements, training is expected to be conducted virtually due to the flexibility and cost-effectiveness it offers over traditional classroom training. Although, virtual training is not a new phenomenon in the industry. 3. The continued rise of specialty pharmacies The third expected trend in the pharmaceutical industry in 2023 is the rise of specialty pharmacies. Specialty pharmacies are channels set up to deal with and distribute drugs that are complex, expensive, or otherwise ‘special’, such as oncology drugs, a product CSI has successfully delivered all over the world. It is these pharmacies that will continue to drive the market as their growth continues well into 2023. 4. AI will fuel new products and processes This year, AI is expected to play an increasingly vital role in the pharmaceutical industry by fueling the development of new products and processes. It is already showing an impact on drug discovery and development. This is because AI-based tools - like machine learning algorithms and computer virtualisations - can help researchers identify new drug candidates more quickly and efficiently than traditional methods. For example, in 2020, an AI-powered drug discovery platform called Atomwise announced that its system had been used to identify new candidates for COVID-19 treatment. Additionally, AI can be used to analyse large amounts of study data, supplying researchers with new insights that they might not have been able to uncover otherwise. An example of this in practice is the 2020 partnership between AstraZeneca and BenevolentAI, where AI was used to identify new indications for existing drugs. 5. Genetic and genomic testing will become more widespread In 2023, the pharmaceutical industry is poised to see increased genetic and genomic testing across the board. This will enable a deeper understanding of the genetic causes of disease, leading to the discovery of new drug targets and the creation of more personalised therapies. Precision medicine is one area where the use of genetic and genomic testing is already proving to be valuable. By analysing an individual's genetic makeup, medical professionals can better understand how a patient's genes may affect their response to treatment. For example, Myriad Genetics' genetic test launched in 2020 helped predict the likelihood of a woman responding to certain breast cancer treatments. 2023 looks set to be an exciting year for clinical trials, and CSI can ensure that your studies are part of this by delivering supplies to your studies within budget and within the agreed timeframe.

Unwrap CSI's Twelve Case Studies of Christmas 2020 has been a challenging year, with product shortages, borders closing, more COVID-19-related difficulties, Brexit looming, and overall uncertainty. Despite this, CSI has had an enormously successful year. We have grown as a team and have risen to the challenges admirably. At the end of the year, we can proudly look back at the last 12 months and review our success stories to see how we have supported our clients. Don't forget to speak to a member of our team to understand how CSI can support your clinical trial. 1. The gold standard in clinical trial supply: Rare cancer medication supply A request for a large quantity of rare and expensive cancer medication for use as a comparator can be very challenging to pull off. There are few patients in the world so there was the dual challenge of ensuring supply was able to cover the recruitment period with the expiry of the product and getting enough supply from a manufacturer who had limited stock. By leveraging our relationship with the manufacturer, we managed to successfully align the two interests for the benefit of the trial. Find out how CSI can support your oncology trials 2. Streamlining supply, resulting in savings of logistical and human capital: Sourcing eye drops Although eye drops are a very cheap medication, they can be very difficult to source in multiple countries. CSI took on a project that needed eye drops as a treatment for IMP side effects. The trial was running across nine countries and needed two different types of product from each country. With CSI’s guidance and thanks to our local knowledge and scientific expertise, the client moved to centrally sourcing from a single country that could support the quantity needed and all documents for import. Over the duration of the trial, the sponsor will enjoy significant savings in logistics and human capital. Please get in touch if you would like to discuss your clinical trial requirements with CSI 3. Operationally excellent: 35 medicines for a multi-country trial CSI has been successfully running a just-in-time supply chain model for a clinical trial running across several countries. With a range of 35 medicines needed for the best available therapy arm, we set up a comprehensive tracking tool to ensure timely delivery of products to sites. Learn more about CSI's supply management and distribution 4. Advancing drug development: Glucose sensor distribution Our scientific expertise and clinical trial skills ensure we support the advancement of drug development. Partnering with a major supplier of medical devices in the field of diabetes, CSI has streamlined the supply of high-tech glucose meters to clinical trials throughout Europe. Find out how we can support your clinical trials 5. Mission impossible delivered: Sourcing, packaging, labelling and distributing medication in three weeks CSI is an expert in quick turnarounds. A client came to us needing us to source comedication and packaging with a three-week turnaround. We reacted in the most efficient way possible, ensuring patients had the medicines they need and delivering them with pride! If you require support in sourcing and distributing medicines, get in touch with CSI 6. Operationally excellent, science-based solutions: Tremendous savings for a leading biotechnology company A leading biotechnology company requested CSI to source ancillary products (saline and human serum albumin) from several countries with different bag material requirements. We took a science-based approach, researching options and providing a solution that offered tremendous cost savings for the client. Discuss your biotech company's cost-saving requirements with our team 7. Biosimilar supply: Massive savings, innovative solutions CSI is always looking for innovative solutions to clinical trials and ways to optimise trial supply. We were approached to supply a large quantity of a biologic oncology product for a long-term global clinical trial. We saw an opportunity to provide the biosimilar at a cost-saving of over £1million to the sponsor. We provided scientific expertise and rationale to satisfy all regulatory requirements. Find out how CSI can support your biotech company's requirements here 8. Delivering mission impossible: Oncology product batch hunting At CSI, we pride ourselves on implementing effective sourcing strategies for even the most complex trial. We were approached to supply an expensive oncology product for a trial with a caveat: a sample from the batch had to be tested before purchasing the bulk. That meant hunting for specific batches across several European markets. This requires a high level of market knowledge, which we successfully delivered to ensure the trial never ran dry. Understand how CSI can support your oncology product requirements 9. De-risking a clinical trial: Allergy testing We carried out an extensive review of the available literature to de-risk a client's clinical trial. We suggested a suitable product for central sourcing of a grass pollen allergen test for a global trial. This proved a sustainable solution rather than relying on local sourcing in many difficult countries. Find out how CSI can support your clinical trial, no matter how complex 10. Overcoming drug shortages: Flexible sourcing options Several products that CSI has been providing routinely have had shortages in availability due to COVID-19. Our major goal was to ensure that no study was left without medicine. By being flexible in our approach, having a truly global reach, and providing innovative solutions, we were able to ensure all trials were supported fully. Read how CSI can optimise your operations and save resources 11. Accelerating drug development: Flu vaccine Due to the seasonal nature of the flu virus, vaccine production and distribution is concentrated in the early summer months and, usually, quantities are booked in advance. CSI was able to leverage our relationship with a major European manufacturer to support the success of a client's trial. We secured stock at short notice for a global trial, as well as sourcing medications locally in some APAC countries. Without this strategy, the trial would have been delayed by one year – at the great expense to the sponsor. Speak to our team to understand how we can support your clinical trial 12. Delivered with pride: Propofol in a pandemic We specialise in supplying clinical trials and routinely use our scientific expertise to ensure patients get the medicines they need for trials to run smoothly. However, during the first wave of lockdown, we were asked to step outside our area of expertise and assist with an urgent need for propofol for hospitals in several EU countries. We were very happy to do our part during the pandemic to support hospitals and patients by delivering over 750,000 vials of propofol. If you require support in sourcing medicines, please speak to our team

The development of the coronavirus vaccine has dominated the pharmaceutical industry over the past year With the Pfizer-BioNTech vaccine being the first drug rolled out across the UK to protect against the virus, we expect to see further advancements in 2021. Over 200 vaccines are in development for COVID-19 globally, with 47 in clinical development and 10 in Phase III clinical trials. More trials will begin to move into Phases II and III of clinical trials with the goal to improve the effectiveness of coronavirus vaccines and therapies. 1. Coronavirus vaccine development We predict that coronavirus vaccines and therapies will encourage more collaboration between organisations. Organisations will share research and development findings to tackle the worldwide pandemic as effectively and efficiently as possible. Joint ventures and alliances between organisations will create more value and opportunities for coronavirus response and preparation. The Pfizer-BioNTech vaccine is the first effective roll-out we have seen, and as other COVID-19 vaccines start filtering out, there will be a number of challenges to face. Organisations must be able to keep up with drug supply to meet global demand. The cold storage of the drug must be upheld in distribution. There is a concern with the affordability and financial responsibility for some countries to supply the entire population with the correct dosage. 2. Digital transformation of the industry The digital transformation of the industry is something that continues year on year, with technological innovations set to impact drug development and the supply chain. We expect companies to make investments in digital to help them gather data and insights to execute business strategies. Digital insights will help organisations improve patient access and support, provide value for sponsors, shorten the length of the production process, and distribute products to market more efficiently. There is an opportunity for machine learning and artificial intelligence in the supply chain to shorten the production cycle. This advanced technology is helping manufacturers reduce downtime and product waste, as well as improving logistics in terms of safe product storage and distribution. This will make costs and processes more efficient and streamlined, helping to get drugs to market sooner and improve patient outcomes. While many companies have adopted some technology to improve business strategies, there is much progress to be made in the industry. Through 2021 we expect to see more organisations experimenting with technology and data to improve efficiency and streamline the supply chain. At CSI all our offerings are based on detailed data analysis and evaluation. 3. Growth in biosimilar adoption The popularity of biosimilars has been growing since 2018 and market share has increased significantly. A biosimilar is a biological medicine that is highly similar and clinically equivalent to existing biological medicine. Biosimilars are being adopted now more than ever, particularly due to the fall in prices which makes these medicines more affordable. For countries in which patients have to pay for their own healthcare, such as America, many are facing difficulties affording the originator biological medication. Some patients are skipping doses to make the medication last longer, and some are failing to fill in prescriptions for new medication. This results in poor outcomes for patients and impacts data that can improve drug development and patient support. To improve patient outcomes, it is important that biosimilar medicines reach the market around the world to make medication more affordable and accessible. According to leading manufacturers, CSI has handled more biosimilar products for oncology indications for clinical trial use, than any other company in Europe. 4. Investment in innovative breakthrough therapies The pharmaceutical industry is experiencing pressures on pricing, the cost of drug development and changing business models. To combat that, it is expected that organisations will look to invest in innovative breakthrough therapies to diversify their portfolios. It is predicted that there will be a focus on gene therapies and oncology. We know that oncology is at the forefront of research in clinical trials. Gene and cell therapies could make strong advancements in 2021 providing a new approach to treating diseases. Cancer treatments have been advancing at an accelerated pace, offering clinical benefit and increased specificity through engineered cell or gene therapies. Over 700 hundred cancer drugs are in late-stage development, and with over one-third of trials using biomarkers to stratify patients, there will be more personalised and effective cancer treatments in the future. At CSI we have extensive experience with biologics and have worked with some of the most innovative products as soon as they receive market authorisation. 5. Increasing global market presence Global market presence is expected to be a growth point for organisations in 2021. As Japan is one of the most rapidly growing pharmaceutical markets in the world, organisations are turning their attention to the country. The research, development, and manufacturing capabilities that are growing in Japan and developing are expected to compete with some of the most established markets, such as the US. CSI’s global reach and expertise in clinical trials and comparator sourcing can ensure your organisation has an effective 2021. We have well-established relationships with all leading manufacturers and can provide cost-efficient and timely solutions and design a robust supply chain to advance your trial. Contact us to discuss how we can advance your clinical trials in 2021. Summary The pharmaceutical industry has faced many challenges and changes in 2020. The coronavirus pandemic and lockdowns caused organisations to reconsider their business approach to ensure supply shortages and limitations were overcome. The drug advancements and collaboration between organisations this year has encouraged companies to adopt innovative methods to progress in a virtual manner. Here are our top five predictions for the pharmaceutical industry in 2021.

Innovation in oncology drug development is granting cancer patients access to life-changing therapies. The industry continues to conduct incredible research and clinical trials to improve patient outcomes globally. Why do we need innovative drug development? More progress has been made in the past 5 years than ever before. Over the past five years, 61 cancer drugs, each approved in one or more tumours, have impacted the treatment of 23 different cancer types. The rise in immuno-oncology drugs since 2014 has been largely centred on the PD-1 and PD-L1 mechanisms which are used across 23 different tumour types. The range of clinical benefits from new medicines includes several with total remission rates above 50% and significant extensions of overall survival. As well as some with incremental survival benefits in tumours where those rates were already extremely high. However, despite detection and prevention improving for most cancers, some remain resistant to treatment. Innovative new medicines are required to attack cancers in ways that existing medication on the market does not. New therapeutics can work alone or in unison (combination) to overcome cancer types that appear to be resistant to drugs. Technology improvements and access to patients with different cancer types provide a deeper understanding of cancer. This presents opportunities to create approvable drug development processes for new therapeutics. Even where innovative new drugs are created, they must be able to reach patients efficiently and cost-effectively to make the investment into drug development worth the risk. What is the risk to innovation? While innovation in oncology drug development is needed, there are many risks that make the development process challenging for companies to overcome. Return on investment One of the biggest challenges with innovation in oncology drug development is proving that investment into drug development is worth the risk. Companies often view the risks of innovation too high which makes the benefits questionable. . There is a critical need to bring new, innovative medicines to market quickly and safely while generating a return on investment. In addition, clinical trials are complex and costly and reimbursement can be very challenging for the already under stress health systems all over the world. Regulatory and approval processes Typically, the higher the level of innovation of an oncology drug, the longer it takes to pass through the clinical trial pipeline and into approval processes, Strict regulations slow down the ability to push treatments through the clinical trial to ensure it gains approval in a timely manner. According to an assessment conducted by The Institute of Cancer Research in 2020, the most innovative cancer drugs took a further 3.2 years to reach NHS patients after filing the patent of the drug. There is a need to streamline regulatory requirements and licensing for the most innovative drugs to ensure they move through the clinical trial pipeline efficiently. This would allow time for appraisal and approval and minimise the time patients must wait to receive treatments for rare cancers. Providing early efficacy Knowledge and understanding of cancer is advancing as technology improves and patients with cancers likely to respond to new treatments come forward. Researchers often take on early drug discovery work as the risk is lower compared to companies that must develop the drug and take it to trial. Often innovation comes from academia. Providing early evidence of efficacy may support the approval process (fast track) while clinical benefit based on absolute evidence is established. In addition collaboration and partnerships between academia and industry are vital for successful and timely drug development. How do we overcome the risks to innovation? Sharing the risk of innovation in oncology drug development has been suggested as a way to encourage more drugs are brought to clinical trials. Responsibility could be shared between the government, charities, industry, and academia to minimise risk to one stakeholder. All have a role to play in supporting innovation in drug development so working together to make the process more efficient and cost-effective will improve rates of success. CSI safeguards the progress of oncology development. CSI is committed to supporting innovation in oncology drug development through our supply chain design and management services. We minimise wastage and ensure sites have sufficient medication so the clinical trial supply chain is seamless and delivers value. We also have outstanding expertise in branded, generic and biosimilar oncology medicines and direct access to almost all major manufacturers. Contact us to discuss how CSI can proactively manage your studies so you can focus on delivering innovative therapies to patients in need. Summary We continue to expand our knowledge to bring better therapies to market efficiently and effectively. Treatments for cancer have been advancing at an accelerated pace in recent years. Offering significant improvements in clinical benefit and increased specificity through selection according to biomarkers or through engineered cell or gene therapies.

The growth in the biosimilar market since 2006 has been significant. Biosimilars have no meaningful clinical differences between the originator medicine in terms of safety and efficacy and are typically less expensive than the originator. These factors lead to the popularity of biosimilars to help bring safe and effective drugs to market at an affordable price What are biosimilars and biological medicines? A biosimilar medicine is a type of biological medicine that is developed to be highly similar and clinically equivalent to the existing biological medicine. A biosimilar contains a version of an active substance of an already approved biological medicine, which is referred to as the ‘reference medicine’ or ‘originator medicine’. It is similar to reference medicine in terms of quality, structure and biological activity. To understand the key features of biosimilars, you should first understand the class of medicines that they are part of – biological medicines. Biological medicines, or biologicals, contain active substances that are derived from a biological source, for example from living cells or organisms. Biologicals are used in clinical trials and crucial in the treatment of many serious conditions such as cancers, diabetes and autoimmune disease. Did you know 8 of the top 10 selling pharmaceuticals were biologicals? Many of the biologicals licensed are proteins that can vary greatly in size and structure from simple proteins such as insulin to complex antibodies. Biosimilar medicines are those that have a high degree of similarity to another biological medicine already licensed. Biosimilar companies can gain market approval for their biosimilars when market protection of the original biological has finished. The approval of the biosimilar is supported by evidence proven in clinical trials demonstrating no meaningful clinical difference between the biosimilar and the originator medicine. What is batch variability and why does it occur? The manufacturing of complex biologicals is significantly more intricate than chemically-derived molecules. Most of them are manufactured by sophisticated biotechnology processes such as cell systems or recombinant DNA technology. The complex nature of these molecules and the manufacturing process means there is a degree of variability called ‘microheterogeneity’. This means that there are subtle differences in the structure of the active substance within and between batches. To ensure efficacy and patient safety with this variability in mind, the microheterogeneity must be within an acceptable range. This can be achieved by adjusting manufacturing processes to guarantee consistency among batches. However, there may be a small variability within or between batches of the same biological medicine. This can occur during manufacturing if the process is modified during the commercial life of the medicine, for example when increasing the scale of production. Manufacturers apply strict measures and regulations to make sure that, despite variability, there is consistency between batches, and that any differences present in the batches do not affect the safety or efficacy of the medicine. Typically when using the same manufacturing process, variability within a batch or between batches batch-to-batch is very low. What are the key regulatory considerations of biosimilar development? To ensure consistency and quality of all biological medicines, including biosimilars, the EU legislation upholds strict requirements for the manufacture of all medicines: Manufacturers in the EU must hold a manufacturer’s license and are legally obliged to comply with Good Manufacturing Practice (GMP), the agreed standards to obtain a medicine with proven quality. National regulatory authorities in the EU regularly inspect manufacturing sites for compliance with GMP requirements. If some manufacturing steps take place outside the EU, then non-EU manufacturers, importers and wholesale distributors are obliged to follow the same strict requirements and are also regularly inspected. For biological medicines, some of the GMP requirements have been adapted to take into account their specific nature (e.g. use of appropriate aseptic techniques, refrigeration and other storage conditions, stability, transport etc.). What does this mean for biosimilars in clinical trials? Clinical trials are carried out to prove that the active substance is highly similar to the reference medicine, this is known as biosimilarity. Clinical trials aim to demonstrate high biosimilarity so that the biosimilar can rely on the efficacy and safety experience of the reference biological medicine, therefore avoiding the repetition of clinical trials. Clinical trials for biosimilars do not need to include all of the studies that are needed for the reference medicine in order to prove safety and efficacy for patients. It is important to note that biosimilars are not considered generics of biologicals. This is because of the natural variability caused by the complex manufacturing of biologicals as discussed above. CSI has experience in sourcing biosimilars for clinical trials CSI has extensive experience in sourcing products for biosimilar studies even in countries where strict government regulations exist. Want to find out more about sourcing biosimilars for your clinical trial? Get in touch with us to discuss your requirements. Summary A biosimilar medicine is a type of biological medicine that is developed to be highly similar and clinically equivalent to the existing biological medicine. A biosimilar contains a version of an active substance of an already approved biological medicine, which is referred to as the ‘reference medicine’ or ‘originator medicine’. It is similar to reference medicine in terms of quality, structure and biological activity.

Globalised clinical trials face a number of challenges when it comes to sourcing, supplying packaging and labelling and distributing clinical trial supplies and comparator products Supply chains are facing disruptions when importing and exporting medicines, maintaining regulatory compliance across countries, and controlling temperature conditions. These supply chain inefficiencies can prove very expensive and more importantly, put patient safety at risk. The comparator sourcing supply chain requires expert planning and management to ensure successful delivery. Successfully managing the clinical trial supply chain helps to improve efficiencies, minimise risk and maximise cost savings. Here are 5 reasons why clinical trial supply management is crucial in today’s clinical trial climate: Improve efficiencies In a complex clinical supply chain, it only takes one element to fall out of place for the whole process to be negatively impacted. These inefficiencies most often include manufacturing delays, quality control, temperature deviation, changed import and export regulations, and site storage conditions. Proactive management identifies opportunities where the supply chain can be optimised and puts processes in place to improve efficiencies and anticipate challenges. This ensures consistent quality assurance processes, storage and distribution solutions and temperature controls are implemented; remaining compliant with regulatory requirements at every stage. Minimise risks Successful clinical trials need effective supply chain management procedures. This ensures risks are identified and managed in a timely manner, and the required medication is available at the site when needed. Taking a holistic approach to assessing and managing risks prevents issues that impact the trial and the data generated. Looking at the different phases of the study and the complexities each one encompasses is a great way to identify where risks may arise. Employing a 6 step risk management process - identify, evaluate, control, communicate, review and report - ensures costs and trial data can be protected. Maximise cost savings Delays and inefficiencies can equate to significant financial loss. For example, if product acquisition is delayed, the window to package, label and distribute is shortened and there might be no medication available at the site for patients. Calculating shipping times and costs at the protocol design level enables supply chain managers to forecast the feasibility of the study and iron out design flaws before implementing them. Knowing all of the study information, such as the countries the products are being sourced from and distributed to, can ensure the most efficient and cost-effective transport route, therefore saving money along the way. Reduce product waste Accurate supply chain planning reduces unnecessarily high levels of stock and avoids oversupply. Having full visibility of the number of trial participants, the dosages required and the clinical distribution sites ensures the right product reaches the right site at the right time. By using flexible solutions, such as just in time deliveries and packaging and labelling products on an as-needed basis, companies can reduce product waste, reduce costs and prevent a negative impact on the conduct of the trial. Maintain regulatory compliance Collaborating with suppliers and manufacturers across the world ensures companies can leverage regulatory and country-specific expertise. Regulations are ever-changing and can differ greatly from country to country. This puts companies at risk of having their products blocked from entering the trial country or recalled entirely. Comparator sourcing partners apply global regulatory knowledge when acquiring documentation, understanding import and export regulations, and overcoming language barriers to ensure companies remain compliant throughout the trial process. Partnering with CSI at the protocol design stage optimises your supply chain, implements effective processes and technology. There is no one size fits all approach - we devise a bespoke supply chain management strategy that caters to your trial requirements. With more than 1000 trials successfully supplied with medicines all over the world, we have the experience, expertise and knowledge to deliver value to your studies.

Clinical trials are designed in different ways depending on primary and secondary endpoints and the product being investigated Clinical trial designs determine the way the trial is structured and the impact it has on the participants. The trial design significantly affects how the investigational products, comparators and concomitant medication must be sourced and supplied. This includes where the product is sourced from, how quickly it can be supplied, how it is packaged, stored and distributed. Understanding the different types of clinical trials and designs is crucial to creating a sourcing strategy that effectively supplies the most suitable products for your study. There are 5 main types of clinical trial design: randomised trials, single-blind trials, add-on trials, open-label trials and double-blind trials. Randomised clinical trials A randomised clinical trial refers to randomly allocating trial participants to one or multiple treatments under the study. This is done to compare the outcomes of the different treatments or one treatment compared to a placebo. Randomised clinical trials are the most common trial design as they produce unbiased results. When it comes to sourcing products for randomised trials, it is crucial for clinical trial suppliers to have all of the relevant information. This includes the number of participants in each arm of the study, the dosages required, the quantity of the medication, and the clinical distribution sites. This allows the supplier to locally or centrally source the products and supply them at the right time and place. Single-blind clinical trials Single blinding refers to the participants involved in the clinical trial being unaware of the medication they are taking. Only the investigator is aware of the product and cannot disclose any of the product information to the participants. If a study is blinded, the clinical trial supplier must make a number of considerations. As well as blinding the active comparator drugs, the product documentation must be blinded, which can cause difficulties when it comes to importing and exporting products. Double-blind clinical trials In double-blinded clinical trials, neither the participants nor the investigators know which participants are receiving the treatment being investigated, and which are receiving the placebo or comparator. This is done to remove any bias and produce objective results. Double-blinded studies can cause further challenges for suppliers because the study personnel must be unaware of the investigative product. This means the way products are shipped and stored must be considered. If the storage and shipping conditions are different for each product, blinding must be maintained to ensure the study staff cannot identify the products used. Open-label clinical trials In open-label clinical trials, both the participants and the investigators know the medication that is being studied. For this type of study, clinical trial suppliers do not have to take blinding requirements into consideration. Suppliers can locally source products without the need to repackage them as they are already in the local language. There is also less regulatory pressure surrounding import and export, as the product is commercially available in the country of the trial and documentation can be obtained. Local wholesalers can often supply the comparator at a lower cost with shorter lead times than the manufacturer. Add-on clinical trials In add-on clinical studies, all of the participants receive the commercially available treatment, but some also receive an additional experimental product. The rest of the participants either do not receive the additional treatment or are given a placebo. The purpose of add-on trials is to test a mechanism in the additional treatment that has a different action from that of the established treatment. When supplying products to add-on trials, great consideration must be applied at the protocol design level to ensure that the right products reach the right participants at the correct stage of the trial. Especially if the products are blinded, it is crucial to review the treatments to ensure they do not have adverse effects on the patients when combined. Partnering with CSI, a world-leading comparator sourcing partner and clinical trial supplier, at the protocol design stage ensures that your trial runs efficiently and successfully. There is no one size fits all approach to comparator sourcing. We devise a bespoke sourcing strategy that caters to the type of trial and its design to find the most effective solution. Contact us to discuss how we source comparators globally to ensure the successful supply of your clinical trials.

Distribution is a crucial part of the clinical trial supply chain Following the globalisation of clinical trials, ensuring investigational medicinal products (IMPs) requires overcoming challenges including import, export, regulatory requirements, and transport logistics. Establishing an effective clinical trial distribution strategy ensures the right IMPs reach the trial site, distribution agency or patient at the right time while maintaining product quality. Partnering with an experienced distribution partner is the most effective solution. As distribution experts, we use our experience to forecast the supply chain and minimise risks that may arise during the process. This ensures we overcome challenges, stick to budget and timeframes. Here are three key reasons why an effective clinical trial distribution strategy is crucial 1. Maintain compliance with regulatory requirements Regulations can differ from country to country. When clinical trials are conducted in multiple countries and regions, it is vital to be aware of the different regulations and how to comply with them. This may include import, export, data protection, packaging and ethics. Having strong relationships with distribution partners, suppliers and manufacturers with the relevant global expertise ensures you can understand and maintain compliance with country-specific regulations. Leveraging access to real-time data and knowledge across the globe provides a solution to the challenges companies face when distributing IMPs worldwide. 2. Ensure the quality and safety of IMPs It is vital to maintain the quality and therefore safety of the IMP as required by the standards set out by the Medicines and Healthcare Products Regulatory Agency (MHRA). A distribution strategy considers the relevant quality standards and maintains a robust quality assurance process throughout the clinical trial supply chain. At CSI, we have expertly controlled storage facilities, are licensed by the MHRA and have a quality management system that ensures full compliance with distribution requirements. Our storage and distribution service is fully integrated and monitored at every step of the supply chain, including: Good Distribution Practice (GDP) Good Storage Practice (GSP) Temperature-controlled cold (2–8°C) Ambient storage (15-25°C) Stock batch traceability, products recall in place Vaulted storage for controlled medications (Schedules CII–V) Secondary labelling and assembly if required Highly secure environment 3. Ensures a cost-effective supply chain A well defined clinical trial distribution strategy will maximise cost savings throughout the supply chain. By forecasting the supply chain, you can identify risks and mitigate them prior to conducting the trial. This will help to prevent making changes during trial conduct which can incur significant costs. With a well-forecasted clinical supply chain, you can include detailed consideration of trial design, or study-specific lead times, kit designs, country-specific challenges, and logistics associated with manufacturing, packaging, and distribution of supplies, particularly where product blinding is involved. CSI is an experienced distribution partner CSI has extensive expertise in supply chain management and distribution. We understand where your supply chain can be optimised and implement effective processes and technology that improve your operations. We efficiently and cost-effectively distribute IMPs to packaging agents, trial sites, patients, or warehouses to ensure your products are ready for use. Our supply management and distribution solution ensures pharmaceuticals, CROs and CMOs can operate efficiently. This helps to save time, money and resources across the entire clinical trial supply chain.

Pharmaceutical companies and CROs must have robust comparator sourcing strategies in place to ensure that comparator drugs are supplied to all clinical trial sites without disruption Working with a comparator sourcing partner like Clinical Services International (CSI) will streamline your clinical trial supply chain and ensure high-quality comparator drugs are sourced in a timely and cost-effective manner. Partnering with CSI at the protocol design stage ensures that your trial runs efficiently and successfully. There is no one size fits all approach to comparator sourcing. We devise a bespoke sourcing strategy that caters to your trial requirements. With 25 years of experience in comparator sourcing, we have gained expert insight into how to develop the most effective comparator sourcing strategies. Here are our top 3 contributing factors: 1. Global reach Clinical trials are not often isolated to one location. Most clinical trials span a number of regions and countries which requires comparator sourcing partners to have a global reach. It is essential to leverage country-specific expertise and source comparator drugs across the world while maintaining regulatory compliance. A global reach allows CSI to identify opportunities for cost savings by using the most appropriate strategy, be it local, central, market, manufacturer or hybrid sourcing. This means your company can save resources by sourcing from the market that the trial is conducted in, or sourcing products in one country and shipping for use in other countries. 2. Excellent supplier and manufacturer relationships Not being able to source the comparator in the desired quantity within the trial timeline can prevent your trial from proceeding. Excellent relationships with audited suppliers, originators and dedicated wholesalers allows CSI to overcome product shortages and unavailability on the open market. Direct relationships also help to minimise disruption to the supply chain and improve efficiencies. Working closely with suppliers and manufacturers helps to understand where there are challenges in the supply chain, such as logistics, quantity or expiry, and devise solutions to optimise them. CSI has outstanding relationships and direct account with all big pharmaceuticals and as such we also have intelligence about product changes well before they happen. 3. Compliance and regulatory expertise Clinical trials are subject to strict regulations surrounding product import, export, distribution, logistics, data and ethics. All of these factors can be human capital intensive for your company and cause difficulties when it comes to maintaining compliance without the relevant regulatory expertise. CSI understands the dynamic clinical trial approval processes, regulatory requirements, language barriers and has access to experienced clinical research staff to ensure you remain compliant throughout the trial process. Working with regularly audited suppliers and manufacturers ensures you adhere to quality and patient safety standards required in the supply chain at every stage of the clinical trial. CSI is a leading global comparator sourcing partner We improve trial success rates by securely sourcing comparator drugs in short supply with the longest expiry, ensuring comparators are available for trial participants at the right place and time. We leverage our global network of over 95 manufacturers to source high-quality comparator drugs and ensure the efficient, effective delivery of your studies. While our headquarters are in London, we operate in the UK, Germany, Denmark, Japan and the USA and have an extensive network of depots all over the world. Our excellent relationships with suppliers and manufacturers across the world help us source medications from Europe, the USA, Latin America and Asia Pacific (APAC). By partnering with CSI, your sourcing strategy takes the most appropriate route to improve the speed and agility of your clinical trial. Contact us to discuss how we source comparators globally to ensure the successful supply of your clinical trials.