Pharma Airports: A Key to Global Success?

Setting the Scene

The past year has proven that the medical world is at the forefront of human innovation. The pharmaceutical industry is our weapon of choice against the COVID-19 pandemic, whilst simultaneously tackling other diseases, treatments and cures, thus extending our life expectancy age.

Whilst the developments and manufacturing of recent biopharmaceuticals are groundbreaking, the logistics behind it are often overlooked and ignored at board level, resulting in an undervaluation of a well-organised supply chain. With an ever-growing global population and rising demand in biopharmaceuticals, the logistics chain is coming under enormous pressure to fulfil. Add temperature requirements and fast delivery to the mix and you have a recipe for disaster.

One area where multiple pharmaceutical logistic stakeholders meet is an airport, where pharmaceuticals are shipped to all four corners of the world. At the airport stage we have multiple handover points between shippers, trucking companies, freight forwarders, ground handlers and airlines. All these handover points are critical stages where temperature excursions, damages, paperwork issues etc. can happen. Not all airports have the right type of infrastructure, transparency and standardised ways of working to handle time- and temperature-sensitive shipments. So it is vital to select the right partners.

The aviation industry is slowly adopting and listening to the pharmaceutical shippers, but it has to do it as a community, and not on an individual basis.

The Brussels Airport Story Over the past ten years, the cargo area of Brussels Airport (BRUcargo) has been investing and innovating into the pharmaceutical airport eco-system, not only because of its ideal central location within Europe and its proximity to major pharmaceutical manufacturers, but because of its clear company strategy on enhancing the pharmaceutical supply chain at its airport premises.

The first gap that needed to be filled over a decade ago, was the clear understanding of the pharmaceutical manufacturer’s logistics requirements. Apart from networking and building relationships at pharma conferences, the airport kickstarted a forum that invited pharmaceutical manufacturers in one room, the BRUcargo pharma shipper forum, a bi-annual event. In this setup, the airport was able to identify key weaknesses, listen to essential desires and identify where it could add innovation.

A key topic that was evident in the BRUcargo pharma shipper forums was the lack of pharma standardisation in the air cargo industry. In collaboration with IATA and other stakeholders, a taskforce was launched to compile and create an encompassing programme that trains and validates pharmaceutical stakeholders in the air cargo industry, better known as IATA CEIV. BRUcargo currently holds the largest concentration of CEIV certified companies globally and has implemented this programme into its strategy.

Besides working on the CEIV programme, investments have been made in modernising our infrastructure. Currently, over 30,000m2 of pharma-dedicated cold storage facilities are in operation at BRUcargo, with the vast majority being brand new. A pooled fleet of airside pharma transporters has been added to a list of airside investments, along with a clear focus on digital innovation through the BRUcloud. Digital solutions such as the Pharma Acceptance Dashboard allows stakeholders to visualise pharmaceutical shipment performance at the airport and intervene when issues arise, making transparency a key priority.

These recent innovations and investments gave us a pole position during the COVID-19 pandemic, making Brussels Airport the first airport to distribute the COVID-19 vaccines globally, with millions of doses currently flying out on a weekly basis. And it doesn’t stop there: an investment has been made in an enhanced digital solution to fully map and visualise the journey of each pharma shipment at BRUcargo. This will enable stakeholders to react before issues arise and add full transparency towards the pharmaceutical manufacturer.

Collaboration – Key to Optimising Pharmaceutical Logistics by Air Apart from local airport initiatives into the pharmaceutical supply chain, international collaboration within the air cargo industry is key to further optimise pharmaceutical logistics. One organisation in particular, Pharma.Aero, is pushing to achieve global pharmaceutical excellence in the air cargo industry by launching select projects.

One of these recurring projects, for instance, is the corridor mappings, where a route is mapped between airport A and airport B, thus identifying weaknesses and strengths. This enables all parties involved in the project to improve or strengthen their pharmaceutical supply chain and make that specific lane robust and reliable for the move of sensitive pharmaceutics.

After all, building relationships with customers and airport stakeholders will evidently lead to fruitful partnerships. Just like Jeff Bezos once said, the same applies to the air cargo industry; “we innovate by starting with the customer and working backwards. That becomes the touchstone for how we invent”.

Samuel Speltdoorn

Samuel Speltdoorn is a Cargo Business Development Manager at Brussels Airport. His main responsibilities are the future developments of the pharmaceutical segment, one of the key strategic focus areas at Brussels Airport. Samuel is actively involved in various Pharma.Aero initiatives, such as the airport to airport corridor validations, Project Sunrays and Project CEIV 2.0. Samuel chairs the BRUcure COVID-19 vaccine taskforce and moderates the Air Cargo Belgium pharma steering group.

Zolgensma Shows Promise in Presymptomatic SMA Patients Novartis’ gene therapy Zolgensma has shown benefit for presymptomatic spinal muscular atrophy (SMA) patients, according to new data presented at the annual European Academy for Neurology (EAN) virtual congress.

The Phase III SPR1NT study was designed to evaluate the safety and efficacy of a one-time intravenous (IV) infusion of Zolgensma (onasemnogene abeparvovec) in presymptomatic children with a genetic diagnosis of SMA, and two or three copies of SMN2.

All patients in the study achieved the primary endpoint of sitting independently for 30 seconds, with 79% of participants achieving this milestone with the World Health Organization (WHO) window of normal development.

In addition, 100% of patients met the secondary endpoint of survival without ventilatory support of any kind at 14 months of age, versus 26% of patients in the Pediatric Neuromuscular Clinical Research (PNCR) natural history cohort.

On top of that, 79% of patients could stand independently, 64% could walk independently and 100% of patients were independent of nutritional and respiratory support for the duration of the study.

In the second Phase III STR1VE-EU trial, Zolgensma demonstrated improvements in motor function and most patients achieved motor milestones not observed in the natural history of SMA Type 1. Source: Inhouse Staff Writer

Pfizer’s JAK Inhibitor Xeljanz Shows Benefit in COVID-19 Pneumonia Pfizer’s JAK inhibitor Xeljanz reduced the risk of severe outcomes in hospitalised adult patients with COVID-19 pneumonia who were not on ventilation, according to new study data.

The STOP-COVID trial was conduction by Pfizer and the ARO from the Hospital Israelita Albert Einstein in Sao Paolo, Brazil, which was also the trial coordinating centre.

Patients were randomised to receive either Xeljanz (tofacitinib) 10mg twice daily plus standard of care (SoC) or placebo twice daily plus SoC for up to 14 days or until hospital discharge.

The trial demonstrated a reduced cumulative incidence of death or respiratory failure through day 28 with Xeljanz (18.1%) compared to placebo (29.9%).

In addition, death from any cause occurred in 2.8% of Xeljanz-treated patients compared to 5.5% in the placebo group.

In the study, serious adverse groups occurred in 14.1% of patients in the Xeljanz group and 12% in the placebo group.

Protocol-specified adverse events of special interest included deep vein thrombosis, acute myocardial infarction, ventricular tachycardia, and myocarditis in the Xeljanz group. Source: Inhouse Staff Writer

Government Announces £36m AI Research Funding Boost for NHS The UK government has announced a hefty £36bn funding boost for artificial intelligence (AI) research technologies in a bid to help the ‘NHS transform quality of care’.

The funding will go toward the winners of the second wave of the NHS AI Lab’s AI in Health and Care Award. The 38 projects with NHSX and Accelerated Access Collaborative (AAC) backing include projects aiming to improve care and the speed of diagnoses for conditions including lung cancer, heart attacks and mental health difficulties.

The AI award package also includes funding to support the research, development and testing of early phase, promising ideas which could be used in the NHS in the future. Since the first round of the AI in Health and Care Award in September, where £50m was given to 42 AI projects, over 17,000 stroke patients and over 25,000 patients with diabetes have benefitted from the new technologies.

“AI has the potential to completely revolutionise every part of how we approach healthcare, from how we diagnose diseases and the speed at which our doctors and nurses deliver treatments to how we support people’s mental health,” said Health and Social Care Secretary Matt Hancock.

The AI in Health and Care Award is set to distribute £140m over three years – the next round of applications will open in late June.

It is managed by the AAC in partnership with NHSX and the National Institute for Health Research (NIHR). Source: Inhouse Staff Writer

Study Demonstrates Safety and Efficacy of Co-administering COVID-19 and Flu Vaccines A study conducted by Novavax has found that co-administering a COVID-19 vaccine with a flu vaccine is safe and effective, with the efficacy of both jabs appearing to be preserved.

The study, co-authored by Seqirus, was conducted as part of a Phase III clinical trial of Novavax’s COVID-19 vaccine NVX-CoV2373 in the UK.

The co-administration sub-study enrolled a total of 431 volunteers, all of whom had received a flu vaccine provided by Seqirus.

Following this, approximately half of the volunteers also received NVX-CoV2373, while the rest received a placebo jab.

The study results, published on the pre-print server medRxiv, suggest that the efficacy of both the flu vaccine and the COVID-19 vaccine appeared to be preserved, with no additional safety concerns appearing with co-administration.

In a statement, Seqirus said certain limitations of the study include the small patient population, the lack of formal pre-specified non-inferiority statistical assessment of immunogenicity and the lack of randomisation in recruiting the sub-study, immunogenicity and reactogenicity cohorts. Source: Inhouse Staff Writer

Novartis’ Radioligand Therapy Granted US Breakthrough Therapy Designation Swiss pharma company Novartis has scored a Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration for its investigational radioligand therapy Lu-PSMA-617.

The BTD has been granted for Lu-PSMA-617 as a potential treatment for metastatic castration-resistant prostate cancer (mCRPC).

It was granted based on data from the Phase III VISION study, evaluating LuPSMA-617 plus standard of care (SoC), versus SoC alone, in patients with progressive PSMA-positive mCRPC.

In this study, Lu-PSMA-617 demonstrated a significant improvement in overall survival (OS) and radiographic progression-free survival (PFS) for men with progressive PSMA-positive mCRPC.

In the Lu-PSMA-617 arm, there was an estimated 38% reduction in the risk of death compared to the best SoC only arm.

Patients receiving Lu-PSMA-617 also demonstrated a statistically significant 60% risk reduction for radiographic PFS or death compared to best SoC only arm.

However, there was a higher rate of drugrelated treatment emergent adverse events reported in the Lu-PSMA-617 treatment arm – 85.3% – compared to SoC alone – 28.8%.

Novartis also has two additional studies with Lu-PSMA-617 in earlier lines of treatment for metastatic prostate cancer ongoing.

One of these studies is investigating the potential clinical utility of the radioligand therapy in the mCRPC pre-taxane treatment setting, while the second study is evaluating Lu-PSMA-617 in the metastatic hormonesensitive setting. Source: Inhouse Staff Writer

Biogen, Eisai’s Alzheimer’s Drug Aducanumab Makes History with US Approval The US Food and Drug Administration (FDA) has granted Biogen and Eisai’s aducanumab and accelerated approval, making it the first new treatment approved for Alzheimer's disease in over a decade.

The accelerated approval for aducanumab – now known as Aduhelm – is supported by three studies of the drug involving 3,482 patients.

In these studies, patients receiving the treatment had significant dose- and timedependent reduction of amyloid beta plaque, whereas patients in the control arm experienced no reduction.

Although the exact causes of Alzheimer’s are not fully known, it is characterised by changes in the brain, including amyloid plaques and neurofibrillary or tau tangles.

“This historic moment is the culmination of more than a decade of groundbreaking research in the complex field of Alzheimer’s disease. We believe this first-in-class medicine will transform the treatment of people living with Alzheimer’s disease and spark continuous innovation in the years to come,” said Michel Vounatsos, chief executive officer at Biogen. Source: Inhouse Staff Writer

FDA Approves Alkermes’ Lybalvi for Schizophrenia and Bipolar I Disorder Alkermes’ oral atypical antipsychotic drug Lybalvi has received approval from the US Food and Drug Administration for the treatment of schizophrenia and bipolar I disorder.

Lybalvi (olanzapine and samidorphan) has been authorised as maintenance monotherapy of adults with schizophrenia or bipolar I disorder, for the acute treatment of manic or mixed episodes and as monotherapy or an adjunct to lithium or valproate.

In clinical trials, Lybalvi demonstrated antipsychotic efficacy, safety and tolerability, including statistically significantly less weight gain than olanzapine in patients with schizophrenia in the ENLIGHTEN-2 study.

In the ENLIGHTEN-1 study, which evaluated the antipsychotic efficacy, safety and tolerability of Lybalvi compared to placebo, the drug demonstrated statistically significant reductions from baseline in Positive and Negative Syndrome Scale (PANSS) scores compared to placebo. "Lybalvi represents an important new treatment option for adults with schizophrenia or bipolar I disorder, their clinicians and caregivers, and reflects Alkermes' commitment to developing new therapies that support patient-centred care," said Richard Pops, chairman and chief executive officer at Alkermes. Source: Inhouse Staff Writer

Takeda’s Dengue Vaccine Bags Positive Longterm Efficacy Results Japanese pharma company Takeda has announced that its dengue vaccine candidate TAK-003 demonstrated continued protection through three years after vaccination, regardless of previous exposure to the disease.

The Phase III TIDES trial enrolled over 20,000 healthy children and adolescents aged four to 16 years in dengue-endemic countries in Latin America and Asia. The safety and efficacy results from the 36-month follow-up exploratory analysis of TIDES found that, through three years after vaccination, TAK-003 demonstrated overall vaccine efficacy of 62% against virologically confirmed dengue (VCD).

The jab also demonstrated 83.6% vaccine efficacy (VE) against hospitalised dengue, with 86% VE in seropositive individuals 77.1% VE in seronegative individuals.

“Our dengue vaccine candidate continued to provide protection against dengue throughout three years, and was especially robust in preventing hospitalisation,” said Derek Wallace, VP, dengue global programme leader at Takeda. "These results reinforce my confidence that TAK-003 can help address the significant global burden of dengue,” he added. Source: Inhouse Staff Writer

Almac Creating up to 100 New Jobs in Londonderry Northern Ireland pharmaceutical firm Almac is planning to establish a project management and software engineering facility in Londonderry. It could create up to 100 jobs in the city over the next three years.

Alan Armstrong, its chief executive, said the business was continuing to grow. "We are fortunate to be able to locate our employees anywhere we choose, offering greater flexibility and access to our various range of services," he said. "Given the skills pipeline coming from Ulster University at Magee and Coleraine, combined with the excellent choice of workspace available in the Derry/ Londonderry area, we have decided to explore this region as our next Almac location." The firm said that experience of the pharmaceutical industry was not an essential requirement for the roles as onthe-job training would be provided. Source: Almac Group Medicine Supply Chains into NI post-Brexit a 'High Risk Area' The chief pharmaceutical officer has warned that without mitigation, the supply of medicines and medical devices into Northern Ireland would be considered a "very high-risk area".

Cathy Harrison was speaking to the NI health committee about the implications of Brexit and the NI Protocol for the pharmaceutical industry.

The industry currently has a 12-month grace period to prepare.

Until this year, there has been no separate supply chain for NI. It was treated as part of the UK supply chain.

Ms Harrison told the committee an "enormous amount of work" was being done in the area. "Without us taking action, and without a very proactive approach being taken, and if we did nothing at all until the end of this year, then there would be a high level of risk and it would be considered a very high-risk area," she said.

Many medical devices, and about £600m of medicines, are brought into Northern Ireland every year, with around 98% coming from Great Britain. Source: Inhouse Staff Writer

UK Government ‘Concerned’ over Elliott Management’s Plans for GSK The UK government has concerns over activist investor Elliott Management’s plans for GlaxoSmithKline (GSK) after the hedge fund acquired a ‘significant’ stake in the British drugmaker last month.

Britain’s Secretary of State for Business, Energy and Industrial Strategy is believed to have asked government officials to back GSK’s chief executive officer Emma Walmsley, in particular her ongoing restructuring of the company.

There is speculation over what exactly Elliott Management’s plans for the company could entail – with potential scenarios being the sale of GSK or its pharmaceuticals or vaccines divisions.

Walmsley has come under increasing pressure to improve GSK’s performance ahead of a planned split of the company’s consumer health and pharma divisions, which is 'well underway'.

Following the planned completion of the separation, due in mid-2022, GSK will remain solely focused on pharmaceuticals and vaccine products. Source: In-House Staff Writer

Page 51 Page 31 Page 77 & 78 Page 37 Page 100 Page 5 Page 101 Page 14 & 15 Page 23 Page 7 Page 47 Page 93 IBC BC Page 69 Page 35 Page 61 Page 43 Page 91 Page 63 Page 3 Page 86–90 IFC Page 95 Page 11 Page 29 & 39 Page 83 Aurena Laboratories Avantor Inc Bausch + Ströbel Biopharma Group Brussels Airport BSP Pharmaceuticals S.p.A Controlant Foodmek FUJIFILM Wako Chemicals U.S.A. Corporation Kahle Automation Kraiburg TPE Krautz Temax LTS Lohmann Therapie-Systeme AG Natoli Engineering Company Nemera Nipro Europe Group Companies Omya AG Owen Mumford Ltd Peak Scientific Instruments Pharma Publications R.G.C.C Schott SPL Scientific Protein Laboratories Thermo King Topra Valsteam ADCA Woolcool

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