Your guide to the pharmaceutical world Volume 11 Issue 2 Clinical trials Decentralisation - the future of clinical trials? Transport & logistics The sustainability question End of line packaging Optimising end of line packaging Clinical trials Decentralisation - the future of clinical trials? Transport & logistics The sustainability question End of line packaging Optimising end of line packaging www.pbiforum.net 01.qxp_Layout 1 11/04/2023 13:23 Page 1 NTERN NATION AL als spotlight eadyR mea ackPaging Microbiolog testing gy and T FEBRUA 295£ RY2023 Fabl Foundat B ti pitipositive Feeling fashion F gardens Homesa d COLNSHIRETODAY.NETCOLNSHIRETODAY.NET WWW.LINCWWW.LINC BLM G www.blmgroup.co.uk FEBRUARY 2023 EAST MIDLANDS LEA £3.50 EADING BUSINESS MAGA AZINE UK www.blmgroup.co.uk Closing the gap levelled up Has our en busine Making p? ngineering ANDSBUSINE oad ess abr g the most of ESSLINKCOU w EMPOWER Your Business Edf rld o our guide to the pharmaceutical wY Issue 60 olume 1V Looking bac succes E k2022kk ti ear Depos df a df s llll Outso tmea Accur rements Someone e business s’ l ss net www .pbiforum.n y 2023 februar yorkshire & lincolnsh £3.50 shire’s leading business ma magazine VOLUME 38 ISSUE 02 .blmgroup.co.ukwww g packaging V w eamlining Str e ravel once morrT engineering Levelling up our Often Imitated - Never Equalled www.blmgroup.co.uk 02.qxp_Layout 1 11/04/2023 13:25 Page 110 14 18 26 Steve Fisher (s.fisher@blmgroup.co.uk) Michael Fisher (m.fisher@blmgroup.co.uk) Tess Egginton (t.egginton@blmgroup.co.uk) Angie Cooper (a.cooper@blmgroup.co.uk) Vicky Hunt (v.hunt@blmgroup.co.uk) Tel: +44 (0) 1472 310302 Angela Sharman (a.sharman@blmgroup.co.uk) Gary Jorgensen, Mark Casson, (studio@blmgroup.co.uk) Tel: +44 (0) 1472 310305, Fax: +44 (0) 1472 310317 Armstrong House, Armstrong Street, Grimsby, North East Lincolnshire DN31 2QE England All rights reserved. No part of this publication may be reproduced, transmitted, photocopied, recorded or otherwise without express permission of the copyright holder, for which application should be addressed first to the publisher. While every reasonable care is taken, neither the publisher nor its participating agents accept liability for loss or damage to prints, colour transparencies, negatives or other material of whatever nature submitted to this publication. The views expressed in this publication are not necessarily the views of those held by the publisher. News4 Stay up to date with the latest industry updates from the global pharmaceutical technology industry. Beckman Coulter Diagnostics Q&A8 This month we reached out to Heather Read-Harper, Senior European Product Manager for Clinical Chemistry and Immunoassay of Beckman Coulter Diagnostics, to find out more about antipsychotic drug monitoring and its uses in patient care. M&A round-up10 Pharma Business International highlights some key acquisitions that have taken place since our last issue. Transport and logistics14 Pharmaceutical manufacturers are being encouraged to focus on sustainability wherever possible, and that may mean embracing a willingness to adopt more expensive measures in the transport and logistics of pharma products. Labelling, coding and marking18 Labels, coding and marking have long served to inform users of the directions and warnings of a given drug, but now they are also being employed in the unending fight between manufacturers and counterfeiters. End of line packaging22 The rapid rise of urbanisation and industrialisation in the Asia-Pacific region has led a boom in the end of line packaging industry, as ever expanding factories are working to become more efficient and cut costs. Clinical trials26 As clinical trials evolve and recover post-pandemic, decentralised studies may be the future for the pharmaceutical industry. Waste management 30 Where does pharma stand on reducing waste, and how much of what is said is being done actually is? Events 34 We give a rundown of pharma events happening around the world. @pbiforum www.pbiforum.net company/pbiforum Cover photo courtesy:stock.adobe.com/ leowolfert 03.qxp_Layout 1 11/04/2023 13:25 Page 14 Pharma Business International www.pbiforum.net Latest news BioNTech and DualityBio form global strategic partnership to accelerate development of differentiated antibody-drug conjugate therapeutics for solid tumors BioNTech and DualityBio, a clinical-stage biotech company focusing on the discovery and development of next generation antibody-drug conjugate (ADC) therapeutics to treat patients with cancer and autoimmune diseases, have entered into exclusive license and collaboration agreements for two ADC assets to develop, manufacture and commercialize the two assets globally, excluding Mainland China, Hong Kong Special Administrative Region and Macau Special Administrative Region. With this collaboration, ADCs will become an additional drug class in BioNTech’s oncology portfolio with the aim to further support BioNTech’s mission of developing highly efficacious therapies for cancer patients at every stage of disease. As part of the collaboration, BioNTech will gain access to DualityBio’s lead candidate, DB-1303, which is a topoisomerase-1 inhibitor-based ADC directed against Human Epidermal Growth Factor Receptor 2 (HER2), a target that is overexpressed in a variety of cancers, which contributes to the aggressive growth and spread of cancer cells. The DB-1303 program received the Fast Track designation from the U.S. Food and Drug Administration (FDA) and is currently in a Phase 2 clinical trial for HER2-expressing advanced solid tumors. BioNTech will also gain access to a second topoisomerase-1 inhibitor-based ADC candidate, DB-1311. GSK and SCYNEXIS enter into exclusive agreement for novel, first-in-class medicine to treat fungal infection GSK and SCYNEXIS have entered into an exclusive licence agreement for Brexafemme (ibrexafungerp tablets), a U.S. FDA approved, first-in-class antifungal for the treatment of vulvovaginal candidiasis (VVC) and for reduction in the incidence of recurrent VVC (RVVC). This exclusive licence agreement gives GSK rights to commercialise Brexafemme for VVC and RVVC while continuing to develop ibrexafungerp, which is in phase III clinical trials for the potential treatment of invasive candidiasis (IC), a life-threatening fungal infection. Infectious diseases and HIV represent around two-thirds of GSK’s pipeline. Brexafemme complements GSK’s first or best-in-class portfolio alongside late- stage antibiotics gepotidacin, potentially the first novel antibiotic for uncomplicated urinary tract infections (uUTI) in over 20 years, and tebipenem, a potential new treatment of complicated urinary tract infections (cUTI). Luke Miels, chief commercial officer, GSK, said: “The challenge of antimicrobial resistance includes increasing rates of multi-drug resistant fungal infections. Brexafemme is a novel, approved antifungal medicine with a broad spectrum of activity against existing and emerging resistant strains of fungi. In addition, the transaction consolidates GSK’s synergistic portfolio of innovative late-stage antibiotics.” © stock.adobe.com/ nmann77 Sustainability takes centre stage for Tower Cold Chain at LogiPharma Temperature-controlled specialist Tower is returning to LogiPharma in 2023 to showcase how pharmaceutical manufacturers are using its passive containers to improve their logistics infrastructure, in today’s sustainably inclined world. Visitors to Booth 71 & 72 at LogiPharma, held on April 25th – 27th 2023 at Centre de Congrès de Lyon, France, will have the opportunity to meet the team and see how Tower’s robust, reliable, reusable temperature-controlled solutions are significantly contributing to customers environmental credentials. “We are delighted to be exhibiting at LogiPharma again this year and speaking at the conference alongside industry leaders from around the world,” says Niall Balfour, CEO of Tower Cold Chain. “As our growth continues, it is important to continue to show new and existing customers the benefits of our robust, reliable and reusable cold chain solutions. We welcome visitors to come to Booths 71 & 72 and find out why leading pharmaceutical manufacturers and 3PLs have chosen Tower as their specialist shipping provider.” For full details on Tower’s presence at LogiPharma and exhibitions in 2023, visit https://bit.ly/406zRSv © stock.adobe.com/ huenstructurebio.com 04-07.qxp_Layout 1 11/04/2023 13:28 Page 1Sandoz signs MOU to build new biologics production plant in Slovenia Sandoz has signed a Memorandum of Understanding (MOU) to build a new biologics production plant in Lendava, Slovenia. The Sandoz investment is expected to be at least USD 400 million, supporting the company’s ambition to drive the future growth of its global biosimilars portfolio. This represents one of the largest-ever international private-sector investments in Slovenia. Glenn Gerecke, global head of Sandoz Technical Operations, said: “This state-of-the-art site will be a major new jewel in the Sandoz crown, enabling us to meet growing demand for our current and future biosimilars in the mid- to long-term. The location offers us a strong combination of political stability, proximity to our existing European-based production and commercial operations, and competitive costs.” Work on the new plant is set to begin this year, with full operations provisionally planned for late 2026. Pharma Business International 5 www.pbiforum.net Latest news © stock.adobe.com/ railwayfx Revolutionary new bone cancer drug could save children’s lives A new drug that works against the main types of primary bone cancer has been developed by researchers at the University of East Anglia and University of Sheffield. Cancer that starts in the bones, rather than cancer that has spread to bone, predominantly affects children and young adults. Current treatment is brutal, with outdated chemotherapy cocktails and limb amputation leading to life-long disabilities. Even after these gruelling treatments, the five-year survival rate is still poor at just 42 per cent – largely because of how rapidly bone cancer spreads to the lungs. These rates haven’t changed in nearly half a century. But a new study published in the Journal of Bone Oncology shows how a new drug called ‘CADD522’ blocks a gene associated with driving the cancer’s spread, in mice implanted with human bone cancer. The breakthrough drug increases survival rates by 50 per cent without the need for surgery or chemotherapy. And unlike chemotherapy, it doesn’t cause toxic side effects like hair loss, tiredness and sickness. eneva une 2023 g oss: als! makers of the industry acr | Processing & manufacturing 14 & 15 Jun Palexpo, Gen Calling all pharmaceutical & biopharmaceutical professiona Fostering a centralised hub for the future Packaging | CMO/CDMO | Drug delivery 230or 2f end ttoer tgistrea otThe QR code Scan Enquire now > connectinpharma.com © stock.adobe.com/SewcreamStudio 04-07.qxp_Layout 1 11/04/2023 13:28 Page 26 Pharma Business International www.pbiforum.net Latest news Galapagos and NovAliX enter into drug discovery collaboration Galapagos and NovAliX have formed a strategic collaboration in which Galapagos’ research and discovery capabilities and exclusively related employees based in Romainville, France, will be transferred to NovAliX, a drug discovery-focused Contract Research Organization. The agreement follows Galapagos’ renewed focus on its key therapeutic areas of oncology and immunology, and the strategic reorientation of the company into a fit-for-purpose research and development (R&D) organization which aims to accelerate innovation, reduce risks and shorten drug development timelines. Under the terms of the agreement, NovAliX will acquire Galapagos’ drug discovery and research activities conducted in Romainville, France. As a result of the acquisition Galapagos’ employees in Romainville who are exclusively dedicated to the operation of these activities will be transferred to NovAliX who is dedicated to assuming all ongoing research and discovery activities in Romainville. In return, Galapagos is committed to utilizing the research capabilities and expertise of NovAliX through a five year-collaboration and within the context of the company’s R&D portfolio. Predictive Oncology and Cancer Research Horizons partner to pursue development of cancer drugs Predictive Oncology together with Cancer Research Horizons, the innovation engine at the core of the world’s largest private funder of cancer research, Cancer Research UK (CRUK), have partnered to drive the development of oncology drugs utilising Predictive Oncology’s PEDAL™ platform. “Our collaboration with Cancer Research Horizons represents a fundamental shift in drug discovery that could lead to the accelerated development of cancer therapies using compounds originating from the CRUK network and developed by Cancer Research Horizons in partnership with their global network,” said Raymond F. Vennare, Chief Executive Officer of Predictive Oncology. “We now have the ability to impact the most critical stage of early drug discovery in a way that has never been done before.” The collaboration will utilise Predictive Oncology’s PEDAL technology to evaluate Cancer Research Horizons’ pre-clinical drug inhibitors of glutaminase in order to determine which cancer types and patient populations are most likely to respond to treatment with these compounds. PEDAL is an artificial intelligence and machine learning platform which makes high-confidence drug response predictions, enabling a more informed selection of drug–tumour type combinations for clinical development. © stock.adobe.com/Pitchy © stock.adobe.com/ StockPhotoPro Aitia and UCB form strategic drug discovery collaboration in Huntington’s disease UCB, a global biopharmaceutical company, and Aitia, a leader in the application of Causal AI and “Digital Twins” to discover and develop new drugs, have formed an early drug discovery collaboration focused on the discovery and validation of novel drug targets and drug candidates for Huntingdon’s disease. The collaboration seeks to validate novel drug targets that are causally linked to clinical endpoints in Huntington’s disease. Colin Hill, CEO and co-founder of Aitia, said: “At Aitia, our mission is to discover the next generation of breakthrough drugs to improve outcomes for patients where there is high unmet need. We believe that Huntington’s disease is overdue for major disruption and breakthroughs from our Gemini Digital Twins which are created from large quantities of multi-omic patient data and causal AI. We’re excited to collaborate closely with UCB to gain deeper insights into the underlying mechanisms of this complex disease and hope to drive major advancements in drug discovery and development faster than ever before.” © stock.adobe.com/ Yurii Kibalnik 04-07.qxp_Layout 1 11/04/2023 13:28 Page 3 EC approves Hyrimoz high-concentration formulation The European Commission (EC) has granted marketing authorization in the European Union (EU) for Sandoz’s citrate-free high concentration formulation (HCF; 100 mg/mL) of its biosimilar Hyrimoz (adalimumab). The approval includes all indications covered by the reference medicine: rheumatic diseases, Crohn’s disease, ulcerative colitis, plaque psoriasis, uveitis and hidradenitis suppurativa. “Living with a chronic disease can take a significant toll on a patient’s quality of life. Biosimilars help patients to gain broader access to effective and high-quality treatments that improve their disease therapies,” said Rebecca Guntern, head of Region Europe, Sandoz. “Today’s approval brings Sandoz one step closer to providing European patients with chronic conditions an additional treatment option that offers increased convenience and a reduction in injection volume.” The adalimumab citrate-free HCF (100 mg/mL) formulation offers a 50 percent reduction in injection volume compared to the 50 mg/mL concentration and potentially decreases the number of injections required for patients who need 80 mg/mL or higher dosing. The HCF formulation is presented in the same auto- injector as currently available to patients, aiming for an enhanced yet familiar patient experience. FDA approves first over-the-counter naloxone nasal spray The U.S. Food and Drug Administration has approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use – the first naloxone product approved for use without a prescription. Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. The approval paves the way for the life-saving medication to be sold directly to consumers in places like drug stores, convenience stores, grocery stores and gas stations, as well as online. “The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need,” said FDA Commissioner Robert M. Califf, M.D. The FDA granted the OTC approval of Narcan to Emergent BioSolutions. Takeda’s dengue vaccine approved in Brazil Takeda’s dengue vaccine, QDENGA, has been approved in Brazil by the National Health Surveillance Agency (ANVISA) for the prevention of dengue caused by any of the four virus serotypes that can be found in individuals from 4 to 60 years of age. QDENGA is the only dengue vaccine approved in Brazil for use in individuals regardless of previous exposure to dengue and without the need for pre-vaccination testing. “Brazil has a high prevalence of dengue, and the country needs effective and safe vaccine options to help manage the significant burden dengue places on its health care systems and its communities,” said José Manuel Caamaño, president of Takeda in Brazil. “We are proud to make our vaccine available to the Brazilian government and health care providers with the hope that it may become an important tool to help combat dengue as part of an integrated dengue management program along with vector control. Based on our clinical trial results, we are hopeful that QDENGA could have a positive impact on the incidence of symptomatic dengue in Brazil, including dengue cases that require hospitalization.” Libtayo in combination with chemotherapy approved by EC for the first-line treatment of advanced PD-L1 positive non-small cell lung cancer The European Commission (EC) has approved Regeneron Pharmaceuticals’ Libtayo (cemiplimab) in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ≥1% PD-L1 expression. This includes patients that have no EGFR, ALK or ROS1 aberrations and whose tumors are metastatic or locally advanced and not candidates for definitive chemoradiation. “Today’s approval considerably expands the number of people in Europe with advanced non-small cell lung cancer who are eligible for Libtayo-based first-line treatment, including those with PD-L1 expression ranges most commonly seen in real-world practice,” said Israel Lowy, M.D., Ph.D., senior vice president, Translational and Clinical Sciences, Oncology at Regeneron. “We are proud that Libtayo continues to distinguish itself among PD-1 pathway blockers, as just one of two PD-1 inhibitors to be approved for use across squamous and non-squamous forms of advanced NSCLC in both combination and monotherapy settings. This marks the fifth approval for Libtayo in Europe.” FDA approves Joenja as the first and only treatment indicated for APDS The U.S. Food and Drug Administration (FDA) has approved Pharming Group’s Joenja (leniolisib) for the treatment of activated phosphoinositide 3- kinase delta (PI3K?) syndrome (APDS) in adult and pediatric patients 12 years of age and older. Joenja, an oral, selective PI3K? inhibitor, is the first and only treatment approved in the US for APDS, a rare and progressive primary immunodeficiency. The FDA evaluated the Joenja application for APDS under Priority Review. Dr. Eveline Wu, MD, MSCR, division chief, Paediatric Rheumatology & associate professor of Paediatric Rheumatology and Allergy/Immunology at The University of North Carolina School of Medicine, said: “The FDA approval of Joenja is an exciting moment for the APDS community and offers to transform the treatment pathway for patients and families affected by this rare disease. This approval means that they will, for the first time, have access to an approved treatment, which has the potential to change the standard of care for the patient population suffering from APDS.” www.pbiforum.netPharma Business International 7 04-07.qxp_Layout 1 11/04/2023 13:28 Page 4BECKMAN COULTER DIAGNOSTICS Q&A 8 Pharma Business International www.pbiforum.net Can you tell us a little about Beckman Coulter and what you do? Beckman Coulter is a clinical diagnostics company developing innovative and scalable lab testing solutions. Our overarching mission is to relentlessly reimagine healthcare, one diagnosis at a time. In mental healthcare, we recognize that diagnosis plays a different role in guiding clinical decision making as the symptom-based diagnostic criteria do not distinguish between how medications are actually prescribed. As a key example, antipsychotic medications have proven helpful for treating both psychotic disorders and the manic episodes that occur in bipolar disorder. We have shifted focus in the mental healthcare space to rethinking how medications can be more effectively prescribed with the assistance of lab monitoring. We envision that this will provide actionable information for providers assessing symptom response, side effects, medication metabolism, and challenges in medication adherence. What is Beckman Coulter’s Antipsychotic Drug Monitoring, and what kinds of serious mental illnesses does it cover? Beckman Coulter’s antipsychotic drug monitoring panel measures blood levels of clozapine, risperidone, paliperidone, aripiprazole, olanzapine, and quetiapine. By contrast to mass spectroscopy, which can take days to weeks for results to be reported, the Beckman Coulter family of clinical chemistry analyzers can measure antipsychotic levels at lower cost in less than 15 minutes from arrival in the lab. Reliability of results remains high and may even be higher in some settings as the automated process is less dependent on operator training. The antipsychotics included in our drug monitoring panel are most commonly prescribed to individuals with schizophrenia and bipolar disorder. These forms of serious mental illness are diagnosed in just 1.3% of the European population 1 , but with a profound impact on the individuals they affect and on the systems that care for them. Healthcare costs for serious mental illness are high due to frequent hospitalizations when outpatient treatment fails. In fact, schizophrenia and other psychotic disorders ranked first in 7-day hospital readmission rates across all medical diagnoses. 2 Furthermore, it takes time to stabilize episodes of decompensated psychosis and mania, leading to average hospital stays over 10 days – double the average length of stay for nonpsychiatric hospitalizations. 3 In what ways can antipsychotic drug monitoring, and the assays that come from it, assist clinicians and psychiatrists in treating their patients? Antipsychotic drug monitoring can help identify when a medication is ineffective because its level is low and when a medication is causing side effects because its level is high. It can help providers titrating antipsychotic doses to the level that works best for an individual patient. Of particular importance in mental healthcare, antipsychotic drug monitoring can reveal when patients are not adhering to medications. Q&A Antipsychotic drug monitoring This month we reached out to Heather Read-Harper, Senior European Product Manager for Clinical Chemistry and Immunoassay of Beckman Coulter Diagnostics, to find out more about antipsychotic drug monitoring and its uses in patient care. Heather Read-Harper 08-09.qxp_Layout 1 12/04/2023 08:50 Page 1Pharma Business International 9 www.pbiforum.net BECKMAN COULTER DIAGNOSTICS Q&A Adherence is especially difficult to assess when a patient’s ability and willingness to take medications is impacted by mental illness, making self-reporting alone an unreliable measure. Antipsychotic drug monitoring will identify low adherence earlier, better positioning outpatient providers to partner with patients in exploring adherence challenges and treatment alternatives. In a world where the medical profession is under increased pressure, and with more focus on mental health than ever before, how can antipsychotic drug monitoring help fix the constraints medical professionals are under, and do you think it should become a staple factor in patient care? When a patient presents to the hospital with decompensated psychosis or acute mania, understanding why treatment failed can involve days of information gathering from the patient, family, and outside providers. Antipsychotic drug monitoring can constrain this search at its outset. When a medication history is unavailable, it can establish whether a patient was taking one of the common antipsychotics included in the panel. For a patient who has been prescribed an antipsychotic, it can determine whether treatment failed because the blood level is low, which can occur for patients on standard dosages if they are not taking the medication or are metabolizing it rapidly. Finally, as a new antipsychotic is titrated up over a relatively compressed time scale in the hospital, drug monitoring can ensure it is not increased to a toxic level. For these reasons, antipsychotic drug monitoring positions providers to act more quickly and effectively in times of mental health crisis, and ultimately to save patients days in the hospital. We believe antipsychotic drug monitoring should become a staple in treating mental illnesses in the way that antiseizure drug monitoring is part of the standard of care in treating seizures. How can psychiatrists make the best use of antipsychotic drug monitoring? Our vision is that psychiatrists will use antipsychotic drug monitoring as a step toward personalized and preventative mental healthcare. Ideally, outpatient providers will partner with patients to establish the level at which a given antipsychotic medication is effective, and to discuss whether dose changes are more likely to provide benefit relative to risk of side effects. Monitoring levels on a routine basis can help detect when levels are falling low, and with patient buy-in, may offer accountability around medication adherence. The ability to detect falling levels may help enable providers to catch decompensations before they happen, when medications are able to be adjusted safely in the outpatient setting. These approaches to outpatient antipsychotic monitoring may ultimately help reduce hospitalizations for treatment failures, which can have a significant negative impact on a patient’s life and which come at a noteworthy cost. In 2018, the estimated UK national cost of bipolar disorder was £6.43 billion 4 . As mentioned previously, when patients with schizophrenia are hospitalized, they stay twice as long in the hospital as patients with nonpsychiatric diagnoses and are more likely to be readmitted within the next week than patients with any other medical diagnosis. 2,3 Preventing hospitalizations with cost-effective, reliable antipsychotic monitoring would ultimately help to both relieve strain on our healthcare systems and improve the quality of care for individual patients. For more information visit www.beckmancoulter.com 1 https://www.oecd-ilibrary.org/promoting-mental-health-in-europe-why-and-how_5j8hb639qsbv.pdf 2 https://www.ncbi.nlm.nih.gov/books/NBK487973/ 3 https://pubmed.ncbi.nlm.nih.gov/26203493/ 4 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8553306/ 08-09.qxp_Layout 1 12/04/2023 08:50 Page 2Next >