Your guide to the pharmaceutical world Volume 10 Issue 5 Machinery and equipment Dealing with demand Logistics The future of logistics Traceability Tracked and traced Machinery and equipment Dealing with demand Logistics The future of logistics Traceability Tracked and traced www.pbiforum.net 01.qxp_Layout 1 10/10/2022 13:17 Page 1 NTERN NATION AL an on nt d export Import and oading baLay doors spotlight sy and ackPaging doors ARY2022 T FEBRUA£2.95 hthearts Healing inspiti Valentin you’ll lov Fashion on ’ workout Winter i t WWW.LINCWWW.LINC COLNSHIRETOCOLNSHIRETO ODAY.NETODAY.NET BLM G FEBRUARY 2022 EAST MIDLANDS LEA £3.50 EADING BUSINESS MAGA AZINE UK www.blmgroup.co.uk The power of print Investing in the Indus e e futur ANDSBUSINE stry level up ESSLINKCOU w EMPOWER Your Business y erstor v Co rld o our guide to the pharmaceutical wY olume 9 Issue 6V Globa w varia A ne e C l Mk educing theR ade tr t hdt The digital resear e M l h rc t e www .pbiforum.net y 2022 februar yorkshire & lincolnsh £3.50 shire’s leading business ma magazine VOLUME 37 ISSUE 2 .blmgroup.co.ukwww s all ab It’ ow Let your business gr Levelling up bout the print V w Often Imitated - Never Equalled www.blmgroup.co.uk 02.qxp_Layout 1 10/10/2022 13:17 Page 114 18 22 30 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. Peli BioThermal Q&A8 We speak with Paul Terry, sales director - EMEA at Peli BioThermal, about renting versus buying temperature-controlled packaging products. M&A round-up10 Though sightings of mammoth deals have been lacking since our last issue, smaller acquisitions have been fruitful in the pharma industry, with inorganic growth on the cards as firms look to strengthen their portfolios. Traceability14 The traceability market is experiencing high levels of growth, driven by a need to combat ever more pervasive counterfeit drugs, and the ever more cunning criminals that are pushing them to market. Machinery and equipment18 The pharmaceutical industry is a high-demand one, not only at the consumer end but at every manufacturing and processing stage along the way. Attention to quality and cleanliness is crucial, from mixing and blending to preparing dosages, and all the way through to packing and transport. Vision, inspection and detection22 Pharma Business International explores the importance and growing prevalence of vision inspection and detection systems. Environmental26 The pharmaceutical industry has a major role to play in addressing the climate crisis. Logistics 30 With the complexity of pharma logistics only growing, investing in modern technology is critical. 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/gearstd 03.qxp_Layout 1 10/10/2022 13:18 Page 14 Pharma Business International www.pbiforum.net Latest news Syros receives FDA orphan drug designation for pancreatic cancer treatment The U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Syros Pharmaceuticals’ SY-5609 for the treatment of pancreatic cancer. SY-5609, a highly selective and potent oral cyclin-dependent kinase 7 (CDK7) inhibitor, is currently being evaluated in combination with chemotherapy for the treatment of patients with relapsed metastatic pancreatic cancer. “This orphan drug designation underscores the urgency of our efforts to develop SY-5609 for patients with pancreatic cancer, one of the most devastating and difficult to treat malignancies,” said David A. Roth, M.D., chief medical officer of Syros. “Based on the early data we reported last year, which demonstrated single-agent activity in heavily pre-treated patients, as well as compelling preclinical data and a strong mechanistic rationale, we believe SY-5609 could deliver meaningful benefit to people with pancreatic cancer, whose tumors have otherwise eluded therapeutic intervention. We look forward to sharing initial data from the safety lead-in portion of our ongoing Phase 1 study later this year.” FDA and NIH launch public-private partnership for rare neurodegenerative diseases The U.S. Food and Drug Administration and the National Institutes of Health (NIH) have launched the Critical Path for Rare Neurodegenerative Diseases (CP-RND) – a public- private partnership aimed at advancing the understanding of neurodegenerative diseases and fostering the development of treatments for amyotrophic lateral sclerosis (ALS) and other rare neurodegenerative diseases. The FDA and NIH have selected the Critical Path Institute (C-Path) as the convener of this partnership. “There is a crucial need to develop new treatments that can improve and extend the lives of people diagnosed with rare neurodegenerative diseases, including ALS. Collaboration across public and private sectors can accelerate the progress to address this urgent need,” said FDA chief medical officer, Hilary Marston, M.D., M.P.H. “The partnership we are announcing today will leverage the shared expertise of all participants to create a path towards new breakthroughs in treating these diseases. We look forward to working with NIH, C-Path, and other public and private partners to carry out this important effort.” © stock.adobe.com/ Chinnapong © stock.adobe.com/SciePro miRecule enters into strategic collaboration with Sanofi for facioscapulohumeral muscular dystrophy treatment miRecule has announced a strategic collaboration and exclusive license agreement with Sanofi to develop and commercialize a best-in-class antibody-RNA conjugate (ARC) for the treatment of facioscapulohumeral muscular dystrophy (FSHD). The collaboration marks miRecule’s first licensing transaction leveraging its proprietary DREAmiR platform. FSHD is the second most common type of muscular dystrophy – affecting more than one million individuals worldwide with no approved treatments. Patients with causative genetic mutations experience lifelong deterioration of muscle function and progressive disability. The collaboration will combine miRecule’s anti-DUX4 RNA therapy (discovered through its proprietary DREAmiR platform) with Sanofi’s proprietary muscle-targeted NANOBODY technology to join the two molecules into an ARC utilizing miRecule’s NAVIgGatorTM conjugation and formulation chemistry. The potential resulting best-in-class therapy may become a disease-modifying treatment that selectively targets and suppresses the underlying cause of FSHD in muscle tissue. This groundbreaking approach would enable FSHD patients to resume their normal course of aging free from the debilitating effects of this progressive disease. © stock.adobe.com/ 24K-Production 04-07.qxp_Layout 1 10/10/2022 13:20 Page 1Pharma Business International 5 www.pbiforum.net Latest news Advanco partners with Vantage to deliver the first interoperable pharmaceutical traceability solution Advanco, one of the globe’s leading pharmaceutical track and trace solution providers, has announced the launch of ARC/QU4RTET, the pharmaceutical sector’s first open, interoperable, and secure traceability solution. Delivered in partnership with Vantage, the leading manufacturing productivity company, the ARC/QU4RTET bundle will offer the technology demanded in the digitally driven Industry 4.0 era. It will also remove the serious operational issues caused by companies operating out-of-date serialization software. Current serialization solutions in the pharmaceutical industry can be as much as 20 years old. However, during these two decades, pharmaceutical traceability solutions have matured considerably, leaving these antiquated systems difficult for modern products to interact with. Alf Goebel, advanco CEO, said: “With Industry 4.0 on the horizon, a digital-first approach will become the norm. The time is right for advanco and Vantage to jointly offer ARC/QU4RTET as a bundled L3/L4/L5 solution. ARC/QU4RTET is fully integrated to provide the Level 3 ARC platform serialization engine with the Level 4/5 QU4RTET traceability solution. This allows a fully flexible, seamless integration from line systems through ERP and warehouse solutions.” The combined bundle allows packaging sites to seamlessly add a different serialized case aggregation vendor to their existing line systems. Users can also completely integrate their existing ERP/WMS solutions with the serialization solution, thus avoiding the need for multiple interfaces associated with segregated systems. The complete solution is available immediately from advanco and Vantage, and both will offer a wide range of options including enterprise-level SaaS solutions. More information can be found at www.advanco.com Aspire Pharma acquires Morningside Pharmaceuticals Aspire Pharma Limited has acquired Morningside Pharmaceuticals (Loughborough), Morningside Healthcare (Leicester) and Morningside Healthcare (India); privately owned, speciality generic pharmaceutical organisations. Morningside delivers Aspire added talent, increased in-market range, and an industry leading pipeline, complementary to Aspire’s. The acquisition establishes Aspire as a premier Speciality Pharma organisation in the UK, with new opportunities to support international growth ambitions. Richard Condon, Chief Executive Officer of Aspire Pharma, said: “We are excited to welcome the Morningside team to the Aspire family. This is a transformative opportunity for both companies to expand and enhance our market position as a result of both companies’ highly complementary product portfolios. “The combination will create one of the largest and fastest growing UK pharma companies and see further accelerated growth potential in our current and future product portfolio, in the UK and internationally. Our commitment remains with our team, patients, and our partners in the NHS and beyond, to ensure a smooth integration of businesses.” © stock.adobe.com/ vichie81 © stock.adobe.com/auimeesri Manus Bio receives additional funding to fight malaria through biotechnology Manus Bio, the biomanufacturer of natural products, has received a fourth award from the Bill & Melinda Gates Foundation to develop a scalable production route for the potential antimalarial drug, artemisinin. The $2 million award will enable Manus Bio to begin scaling up the unique biological process it has developed towards the key chemical intermediate, dihydroartemisinic acid. Economical and scalable access to this compound will enable process simplification for large-scale, commercial manufacturing of artemisinin. “We are grateful for the longstanding support from the Bill & Melinda Gates Foundation on developing a sustainable and low-cost manufacturing route for artemisinin,” says Dr. Christine Santos, chief technology officer at Manus Bio. “Ready access to this life-saving drug is such an important tool in the global fight against malaria. The additional funding we have received will enable us to translate a robust technology built with our BioAssemblyLineTM cell factory engineering platform into a fully scaled process.” 04-07.qxp_Layout 1 10/10/2022 13:20 Page 26 Pharma Business International www.pbiforum.net Latest news Transdermal Diagnostics raises £1.1 million in pre-seed round Transdermal Diagnostics (TD), a MedTech spin-out company, has raised £1.1m to develop a needle-free blood sugar monitor. The investment will enable the establishment of a state-of-the-art laboratory facility and help accelerate the technical and commercial development of TD’s proprietary technology. The pre-seed round was financed by an £800k equity investment, which was led by QUBIS, an innovation fund focused on spin-out companies, and includes the venture capital arm of Pioneer Group, the UK’s largest developer and operator of lab space. Immetric, a fund specialising in growing IP-based, high potential life science ventures also took part, alongside Angel networks Bristol Private Equity Club and Science Angel Syndicate. Additional to the round was funding of almost £300k from Innovate UK. TD has developed a wearable smart-patch for non-invasive and real-time monitoring of health biomarkers. The technology uses an array of miniaturised biosensors to sample, via preferential pathways, the fluid bathing the living cells of the skin and quantitatively measure vital health biomarkers, including sugar, at levels which are very similar to those in the blood. This means the technology can be used to measure blood sugar without puncturing the skin. AVROBIO receives rare pediatric disease designation from U.S. FDA for first gene therapy in development for cystinosis The U.S. Food and Drug Administration (FDA) has granted rare pediatric disease designation to AVROBIO’s AVR-RD-04, an investigational gene therapy for the treatment of cystinosis, a life-threatening disease that causes progressive multi-organ damage, including early, acute kidney disease progressing to end-stage kidney disease. FDA’s Rare Pediatric Disease Designation and Voucher Program is intended to facilitate the development of new drugs and biologics for the prevention and treatment of rare pediatric diseases. Companies that receive approval for a New Drug Application (NDA) or Biologics License Application (BLA) for a rare pediatric disease may be eligible to receive a voucher for a priority review of a subsequent marketing application for a different product. AVR-RD-04 is designed to genetically modify patients’ own hematopoietic stem cells (HSCs) to express the gene encoding cystinosin, the protein that is critically deficient in people living with cystinosis. Preliminary data from the ongoing University of California San Diego Phase 1/2 clinical trial suggest that this approach is well tolerated, with no adverse events (AEs) related to the drug product reported to date. © stock.adobe.com/Sundry lexiconimages © stock.adobe.com/WindyNight Ventus Therapeutics enters exclusive development and license agreement with Novo Nordisk for NLRP3 inhibitor program Ventus Therapeutics has entered into an exclusive worldwide license agreement with Novo Nordisk A/S to develop and commercialize candidates from Ventus’ portfolio of peripherally-restricted NLRP3 inhibitors. “This is an important collaboration for Ventus that validates our structural biology capabilities to discover and develop highly differentiated molecules with novel chemical structures,” said Marcelo Bigal, M.D., Ph.D., president and CEO of Ventus. “We believe Novo Nordisk is the ideal partner to advance our lead NLRP3 program in a broad range of systemic disease areas in which they have deep expertise, such as cardiometabolic diseases.” Under the terms of the agreement, Novo Nordisk will make an upfront payment of $70 million in cash to Ventus and provide research and development funding. In addition, Ventus will be eligible to receive up to an additional $633 million in potential clinical, regulatory, and commercial milestones as well as tiered royalties. In exchange, Novo Nordisk will receive exclusive worldwide rights to develop and commercialize Ventus’ lead NLRP3 inhibitor program for a broad range of diseases, including nonalcoholic steatohepatitis (NASH), chronic kidney disease, and other cardiometabolic conditions. © stock.adobe.com/ JHVEPhoto 04-07.qxp_Layout 1 10/10/2022 13:20 Page 3 FDA approves RELYVRIO to treat ALS The U.S. Food and Drug Administration (FDA) has approved Amylyx Pharmaceuticals’ RELYVRIO (sodium phenylbutyrate and taurursodiol) for the treatment of adults with amyotrophic lateral sclerosis (ALS). RELYVRIO (previously known as AMX0035 in the U.S.) significantly slowed the loss of physical function in people living with ALS in a randomized, placebo-controlled clinical trial. RELYVRIO can be taken as a monotherapy or with existing approved treatments. “[The] FDA approval of RELYVRIO is an exciting milestone for the ALS community and is a major step toward achieving our mission to one day end the suffering caused by neurodegenerative diseases,” said Joshua Cohen and Justin Klee, co-CEOs of Amylyx. ALS is a relentlessly progressive and fatal neurodegenerative disorder caused by motor neuron death in the brain and spinal cord. Motor neuron loss in ALS leads to deteriorating muscle function, the inability to move and speak, respiratory paralysis and eventually, death. More than 90% of people with ALS have sporadic disease, showing no clear family history. Tezspire approved in Japan for the treatment of severe asthma AstraZeneca’s Tezspire (tezepelumab) has been approved in Japan for the treatment of bronchial asthma in patients with severe or refractory disease in whom asthma symptoms cannot be controlled with mid- or high-dose inhaled corticosteroids and other long-term maintenance therapies. The approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) was based on efficacy and safety results from the PATHFINDER clinical trial programme. The application included results from the pivotal NAVIGATOR Phase III trial in which Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy. Tezspire is the first and only biologic for severe asthma that acts at the top of the inflammatory cascade by blocking thymic stromal lymphopoietin (TSLP), an epithelial cytokine. Tezspire consistently and significantly reduced asthma exacerbations across the PATHWAY Phase II and NAVIGATOR Phase III clinical trials. RYALTRIS approved in Canada for seasonal allergic rhinitis Bausch Health and Glenmark Specialty’s RYALTRIS (olopatadine hydrochloride and mometasone furoate nasal spray) has been approved by Health Canada for the symptomatic treatment of moderate to severe seasonal allergic rhinitis (SAR) and associated ocular symptoms in adults, adolescents, and children aged 6 years and older. RYALTRIS is a fixed-dose combination therapy that provides relief for the symptoms of SAR, both nasal and ocular, in one easy-to-use nasal spray. The onset of action for nasal symptom relief occurs within 15 minutes after administration of RYALTRIS. The efficacy and safety of RYALTRIS were established in a clinical studies program conducted by Glenmark in over 3,000 patients with SAR. Twice-daily RYALTRIS provided statistically significant improvement in both nasal and ocular symptoms vs. placebo, as well as statistically significant onset of action in nasal symptom relief vs. placebo at 15 minutes, across three randomized, double-blind phase 3 studies. EC approves Vabysmo for two leading causes of vision loss The European Commission (EC) has approved Roche’s Vabysmo (faricimab) for the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME). These retinal conditions are two of the leading causes of vision loss worldwide, affecting more than 40 million people. Vabysmo, a bispecific antibody, is the only injectable eye medicine approved in Europe with phase III studies supporting treatment at intervals of up to four months for people living with nAMD and DME. With the potential to require fewer eye injections over time, while also improving and maintaining vision and anatomy, Vabysmo could offer a less burdensome treatment schedule for individuals, their caregivers and healthcare systems. The approval is based on results across four phase III studies in two indications, involving 3,220 patients: TENAYA and LUCERNE in nAMD at year one, and YOSEMITE and RHINE in DME up to two years. The studies showed that people treated with Vabysmo, given at intervals of up to four months, achieved similar vision gains and anatomical improvements compared to aflibercept given every two months. New treatment for rare cancer cholangiocarcinoma approved in Australia A new targeted therapy to treat a rare bile duct cancer called cholangiocarcinoma has been approved for use in Australia. PEMAZYRE (pemigatinib) has been provisionally approved by the Therapeutic Goods Administration (TGA) for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after at least one prior line of systemic therapy. The decision to approve this indication has been made on the basis of overall response rate (ORR) and duration of response (DOR). Continued approval of this indication depends on verification and description of benefit in confirmatory trials. PEMAZYRE, developed by Incyte and partnered with independent pharmaceutical company Specialised Therapeutics (ST) for commercialisation in Australia, New Zealand and Singapore, belongs to a class of drugs called kinase inhibitors and works by blocking the abnormal FGFR2 protein in bile duct tumour cells and preventing cell growth. www.pbiforum.netPharma Business International 7 04-07.qxp_Layout 1 10/10/2022 13:20 Page 4PELI BIOTHERMAL Q&A 8 Pharma Business International www.pbiforum.net What are the key considerations for companies utilising temperature-controlled packaging solutions when looking whether to opt for purchase or rental options? Cold chain packaging and logistics perform a vital part in the safe shipment of pharmaceutical payloads worldwide. To ensure efficacy of high value, life giving pharmaceutical products requires high performance cold chain thermal shipper solutions. Whether purchased or rented, temperature-controlled packaging is a crucial component within the cold chain. The industry of cold chain logistics requires specific, specialist handling end to end as well as adherence to regional regulatory compliance criteria when shipping products from manufacturer to end destination. There are key considerations when selecting suitable shipping solutions for temperature sensitive payloads, including the type of thermal packaging needed, insulation required, its quality/thickness/weight of Phase Change Materials (PCMs) and qualified durations. What are some of the current pharma logistics market trends? The sector is seeing a rising rental requirement which is not limited to bulk shipments but applies also to parcel payload packaging as companies continue to outsource their cold chain. There’s a trend to own fewer, or zero, boxes or eliminate managing the associated requirements of maintaining owned thermal packaging products. Other ways of utilising temperature- controlled packaging include long term leasing or pay-per-use options. These options also remove the need to purchase, manage and maintain a large fleet of product. Increasingly companies are looking to enlist the services of thermal packaging specialists who own the packaging products companies require for their pharmaceutical shipments. Selected vendors, such as Peli BioThermal, can manage the responsibility of conditioning and repairing packaging products, which means companies only need to pay a per trip fee. Rental is a good option for both bulk and parcel shipments with applications available for higher volume commercial pharmaceutical transportation options as well. Whatever option is selected, be it to buy, single trip rental or longer-term lease, there is a corresponding emergence of advancements in associated track and trace capabilities with the development of more advanced software platforms that are continually being enhanced. All packaging products need to be high-performing and reliable to ensure they mitigate any potential temperature excursions on the journey from manufacturer to clinic or patient. Therefore, when selecting a temperature-controlled packaging supplier they, like Peli BioThermal, should offer a broad range of products and support services for both purchase and rent with a global footprint with an extensive network and infrastructure in place worldwide, including where key pharmaceutical hubs are located. Can you outline some of the considerations when purchasing products? Opting to purchase temperature- controlled packaging means the product can be used immediately or added to stock for the future deployment of pharma payloads, providing greater flexibility. If the packaging product is reusable, it can be utilised to make multiple trips. The purchaser will need access to conditioning equipment and processes required to ensure the packaging Q&A Purchase or rental temperature-controlled packaging for pharma logistics – one size doesn’t fit all We speak with Paul Terry, sales director - EMEA at Peli BioThermal, about renting versus buying temperature-controlled packaging products. Paul Terry, sales director - EMEA at Peli BioThermal 08-09.qxp_Layout 1 10/10/2022 13:20 Page 1Pharma Business International 9 www.pbiforum.net PELI BIOTHERMAL Q&A continues to comply with global regulatory requirements. These necessary maintenance measures make sure the packaging product continues to perform properly, providing protection to mitigate any potential temperature excursions on future journeys. From a financial perspective, once an investment has been made to buy boxes for pharma shipments, after it has been used it will then need to be stored. So, as well as taking into consideration capital costs, there is the need to consider any storage space and inventory costs alongside logistics costs. What are the rental rewards for businesses? Rental is a major growth area in the sector. Renting a passive temperature- controlled shipping container from Peli BioThermal gives the flexibility to choose the service and application that best suits a customer’s requirements, logistics profile and budget. Peli BioThermal offers two, highly customisable programs. Cr?do™ on Demand, a short-term rental program, and Cr?do™ on Reserve, a flexible, longer-term program, usually for periods of two years or more. Both programs are supported by a comprehensive global network, offering easy implementation, the ability to monitor outbound shipment, return receipt, inspection and refurbishment. Replacement of damaged or expired components is also available via our service centers. The following Peli BioThermal products are available on: Credo On Demand - Crēdo™ Cargo, Crēdo Xtreme™ and Crēdo Cube™ Credo On Reserve - Crēdo Cube™ and Crēdo™ Go Rental programs offer several advantages including spreading the cost over time while delivering the performance needed for global pharmaceutical payload requirements. Rental can be more cost effective especially if a company makes regular shipments on a regular route or plans to make high volume shipments. Rental and leasing options provide all the benefits of access to thermal performance technology with greater flexibility to help lower the cost-per-use, alongside experiencing payload volume efficiency and lower distribution costs. Rental options provide access to packaging products and cold chain logistics services when they are required, mitigating the need to provide capital for purchased packaging products and the need to store products within warehouse space when not in use. What developments do you see for the industry going forward? Whether opting to purchase or rent, the transportation of temperature controlled, time-sensitive pharmaceutical payloads pose challenges. To meet pharmaceutical manufacturers’ requirements and achieve regulatory compliance, it is vital to utilise established lanes. An integrated supply chain with predictable and repeatable shipping and receiving performance is imperative whether utilising rental or purchased shipper solutions. We will continue to see improvements to existing networks including increased availability of flights offering more options to use single use or return rental shipper solutions. Ultimately, whether renting or buying packaging products, when selecting a temperature-controlled packaging vendor for pharma logistics, the extent of their global network and the scale of the fleet of products provided should be a critical consideration. Peli Biothermal 10050 89th Avenue North Maple Grove, MN 55369 USA https://pelibiothermal.com/ 08-09.qxp_Layout 1 10/10/2022 13:20 Page 2Next >