EPM January/February 2020

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January/February 2020



How Nemera’s extended capabilities in front-end innovation bring new advantages for pharma customers.

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Contents Jan/Feb 2020 | Volume 20 Issue 1


Why it’s time the UK government steps up when it comes to HIV funding in England.


A brief round-up of some of the latest developments in the industry.


The role of data science within genomics and pharma.


A short selection of stories from the world of science.


How Nemera’s extended capabilities in front-end innovation bring new advantages for pharma customers.


How one biopharma company wants to change the way we treat pain.


The first in a mini-series of articles examining the life sciences industry and its perceptions of women.

18: INNOVATION IN MANUFACTURING How new technologies and processes are changing pharmaceutical manufacturing.


Our guide to Pharmapack Europe will help you prepare for one of the world’s premier pharmaceutical packaging and drug delivery events.


A short outlook at what could be in store for pharma in 2020.

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I can’t say I was pleased when in January, health secretary Matt Hancock’s selfsatisfied face appeared on Twitter so soon after the general election. I was hoping the cold weather might deter him from more public appearances but alas.

n his typical style, Hancock posted a video talking about the recent data from Public Health England that shows HIV transmissions have been on the decline in England – particularly amongst gay and bisexual men (GBM). Indeed, without a shred of irony, Hancock stated that an ‘injustice’ was being reversed through the government’s efforts of reducing HIV transmissions by 73%. Of course, without context, this figure sounds commendable, if not outright positive. The reduction in transmission rates comes from the rise in use of PrEP – a drug which is readily available in Scotland and has been attributed to reducing the risk of transmitting HIV by over 90%. Out of 2,000 people in Scotland, less than 0.25% contracted HIV after taking PrEP. Some experts say it’s 100% effective at stopping HIV transmission. However, NHS England only started supplying PrEP in limited quantities through clinical trial sites - which now have major waiting lists - in 2017. And this was only after NHS England lost

EDITOR’S DESK a high court battle regarding the commissioning of PrEP services. The reason for NHS England’s complacency has been funding. Against my better judgement, I took a look at some of the opinions of Twitter users and regrettably found pockets of people who think

that funding a proven HIV drug is somehow morally irresponsible. It’s easy to see where these comments on social media come from. Take a look at the media coverage for topics relating to HIV and you’ll see hordes of articles talking about its impact on the LGBT+ community without any mention of its heterosexual impact. For instance, many have argued that funding PrEP will reduce the rates of condom use amongst GBM communities. A valid concern, though it must be said that condom use is actually higher for gay and bisexual men compared to heterosexual males. Sustaining condom use is of course important, but an awareness scheme that educates people about the need to use a condom alongside PrEP usage could be one answer to stemming any worries people have. And it’s not like heterosexual communities wouldn’t benefit from a fully funded PrEP service. The report states how late stage HIV diagnoses are particularly bad amongst heterosexual men – perhaps the stigma of the disease stops this section of society from getting tested. Don’t get me wrong, it’s brilliant that less and less people are getting HIV, but when a clear and proven alternative is readily available, it seems hypocritical of the government to claim they’re doing all they can to stop the disease. In fact, read Hancock’s statement in the media and you’ll be forgiven for thinking that he’s solely responsible for helping tackle the rise in HIV. So, thank you Matt for your unwavering commitment but you can do more.


A small dose AI partnership to improve drug discovery


artner to the biopharma industry Sartorius has launched a joint laboratory with the German Research Center for Artificial Intelligence (DFKI) in a bid to improve processes for the biopharmaceutical industry.



ontract drug manufacturer Catalent has completed the purchase of Bristol-Myers Squibb’s biologics, sterile, and oral solid dose product manufacturing and packaging facility. The facility, which is based in Anagni, Italy, gives Catalent access to capabilities in aseptic liquid and powder filling for biologics and sterile products. More so, the facility is equipped with primary and secondary packaging solutions, including serialisation, to support product launches for oral, solids, sterile and biologics products. Catalent plans to make further investments in the site’s growth and will

continue to manufacture the existing Bristol-Myers Squibb product portfolio currently produced at the site. “The Anagni facility supplements our European commercial supply capabilities and will integrate well with our existing global early development and clinical supply sites to smooth the transition from development to commercial supply,” commented Alessandro Maselli, Catalent’s president and chief operating officer. “Anagni provides our European customers with great biologics and oral dose capabilities that can help us reduce time-tomarket, simplify tech transfers, and minimise programme risk.”

Anagni provides our customers with great biologics and oral dose capabilities.

The Sartorius AI Lab (SAIL) will use artificial intelligence (AI), including machine learning, image recognition and other processes to benefit life science applications. Currently, researchers are working on new deep learning algorithms and methods for image

recognition of cells and organoids, alongside the modelling of biological systems, in order to simulate and optimise biopharmaceutical production processes. The laboratory is located on the DFKI campus in Kaiserslautern and will be open to Sartorius partners and customers as part of cooperation agreements, with the first projects already being underway. “So far, advanced methods of data analysis have been used only to a very limited extent in

Better use of data through AI is a particularly promising approach.

the biopharmaceutical industry, in drug research and in production. This is one of the reasons that development timelines and costs for medical drugs are ever increasing. Better use of data through AI is a particularly promising approach for making significant progress in this area,” said Sartorius CEO Dr Joachim Kreuzburg. SAIL is assigned to the DFKI research department of Smart Data & Knowledge Services headed by professor Andreas Dengel and uses DFKI’s deep learning hardware and expertise. Professor Andreas Dengel, DFKI site manager in Kaiserslautern, said: "The DFKI transfer labs are developing new service modules with artificial intelligence for various markets and target groups. For two years, we have been using our AI hardware equipment, which is unique in Europe, for applicationoriented research we conduct together with renowned companies such as Allianz, Continental, Hitachi and IAV. I am very pleased that we are entering the life science tools market as a partner with the global player Sartorius."



Software helps pharmacists' day jobs


oftware provider Wolters Kluwer, Health has updated its drug information resource Lexicomp to give pharmacists and physicians better decision-making tools at the point of care.

result of a collaboration between physician and pharmacist authors and editors to develop drug monographs with enhanced content from UpToDate – the company’s clinical decision resource tool.

Lexicomp is used by pharmacists, physicians and nurses to give them access to point-ofcare drug information. Now, the system has been updated with Clinical Insights, an enhancement powered by machine learning that is designed to mitigate care variability through aligned decision-making between care teams. Clinical Insights is the

“Embedding Clinical Insights within Lexicomp content lets care teams work off the same evidence-based playbook. This leads to better informed clinical decision making and helps reduce care variability and its attendant risks,” said Priti Shah, vice president, Products and Solutions, Clinical Effectiveness, at Wolters Kluwer, Health.

“It is the most recent in a series of enhancements made to Lexicomp with an eye toward advancing harmonised care.” The company has also integrated its Formulink with UpToDate, which enables clinicians to access formulary information prior to writing an order. The system is designed to help increase formulary policy adherence while also acting as a means of communication between the pharmacies and prescribers. “When prescribers cannot see the formulary before writing orders, they may inadvertently

order drugs that are not on-formulary or that are more expensive compared to those approved by the organisation’s P&T Committee,” said Shah. “Formulink eliminates that problem by

providing formulary information within referential content, enabling more efficient management of drug expenditures and improved formulary compliance.”

WuXi STA opens large-scale API facility


harmaceutical company WuXi STA has announced the opening of its largescale oligonucleotide active pharmaceutical ingredient (API) manufacturing facility in Changzhou, China.

The facility marks the establishment of a comprehensive one-stop platform which supports the R&D process and the manufacture of oligonucleotide APIs from preclinical to commercial.

Through the site, WuXi STA intends to help its customers accelerate new drugs to market. More so, it can better meet customer demands through increased manufacturing capabilities for APIs. The site is able to cover the development and manufacturing of a range of oligonucleotide modalities including DNA, RNA, Morpholino oligonucleotide (PMO) and peptide conjugates (PPMO).

The site is assisted by the company’s small molecule process chemistry organisation which adds further value in handling complex conjugation chemistry that involves oligonucleotide and other molecular modalities, as well as a combination of solid and solution phase chemistry to support next-generation oligonucleotide manufacturing technology development. “By leveraging our small-molecule CMC (chemical,

manufacturing, and control) technology and capability platform as well as global standard quality system, WuXi STA provides a robust one-stop shop for oligonucleotide innovators. The opening of this large-scale manufacturing facility will empower more global partners to expedite the development and commercialisation of oligonucleotide drugs to benefit patients worldwide,” said Dr Minzhang Chen, CEO of WuXi STA.


PERSPECTIVE ON PHARMA How this biopharma company wants to change how we treat pain


n 2017 the US department of Health and Human Services (HHS) declared the country to be in the midst of an opioid crisis. In doing so it confirmed what many already knew: that for over 20 years, the US healthcare system has been gripped in an epidemic that has cost the lives of hundreds of thousands of patients. The US has a long history of opioid abuse, with soldiers in the Civil War experiencing addiction after being administered morphine for injuries. More recently the country has been in the throes of an opioid crisis so severe, it’s estimated to have killed over 200,000 Americans between 1999-2017 - and that’s only from prescription opioids. “Right now, we’re in the worst healthcare crisis in the history of the United States because of the opioid crisis. More people died last year [2018] from opioids than HIV, guns and automobiles and the Vietnam war,” says Dr Steven Fox, founder of Akelos, a biopharmaceutical company that wants to change the way pain is treated.

Dr Steven Fox, CEO and chairman of biopharmaceutical company Akelos speaks to EPM about how his company wants to tackle the opioid epidemic through the development of nonaddictive drugs.



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More people died last year from opioids than HIV, guns and auto(mobiles) and the Vietnam war.


Akelos hopes that by developing a non-addictive, nonopioid alternative to treat chronic neuropathic pain, it can help combat the crisis that is costing so many lives across the US. Neuropathic pain isn’t a small condition. Dr Fox mentions how it affects millions of people across the world, “people with diabetes, people with shingles, people with chemotherapy pain,” and it’s an unaddressed condition with no specific drug to treat it. Currently, doctors prescribe everything from anti-depressants, anti-convulsants and of course, opioids, to try and help people with the condition. The difficulty of developing a treatment for chronic neuropathic pain lies with a part of the body known as the blood brain barrier (BBB). The BBB protects the brain from foreign substances – including many drugs – which makes it difficult to treat neurological disorders. Opioids are able to cross the BBB but in doing so release endorphins, neurotransmitters which dull our perception of pain and boost our feeling of pleasure. And of course, since the efficacy of opioids wears off through long-term use, users take more and more to treat their pain, and in doing so become dependant and addicted. Akelos’ answer to this problem is a drug which targets the HCN1 receptor. The company wants to inhibit the HCN1 receptor – a gene which is, in part, responsible for blocking pain signals within the central nervous system. If the company can successfully develop a drug which blocks the HCN1 receptor without crossing the BBB, then it will have a non-addictive treatment for millions of people. Dr Fox understands the stakes in which his company is operating, telling me how neuropathic pain is “an $8 billion a year unaddressed market”

and that for those working in the sector, the condition represents “the holy grail”. “Whoever develops a new drug for neuropathic pain will make medical history,” he tells me seriously. Of course, the need for a nonaddictive drug for chronic pain is borne from decades of suffering by patients who were never offered any other alternative. “For 40 years we’ve never had a good drug to treat chronic pain. The only thing we’ve [doctors] had is an opioid and unfortunately it became an issue with the pharmaceutical companies pushing drugs that they know were addictive to people – the lobbyists in Washington, the distributors around the country,” Dr Fox says. As a practising healthcare professional, Dr Fox has seen the opioid crisis first-hand, through family and friends, and even addicts breaking into his office to steal Vicodin. It’s an issue that isn’t going away anytime soon. “They’re still selling them [opioids], the FDA still approves them, so I don’t see a dramatic change.” Even counter measures such as educational awareness schemes aren’t enough to combat a dependence on opioids. As Dr Fox mentions, opioids and indeed addiction cuts across all socio-economic barriers. “It crosses the spectrum of all kinds of people. You know, you need a substitute for the issue not to exist and frankly if you’re in pain I’m not judging. If somebody is in pain, they’re going to take what they need to get out of pain.” In essence, this is why the epidemic has blown up over the past two decades. With no other alternatives, pharmaceutical companies understood the demand for effective pain relief, and supplied accordingly – with

or without all the facts. Now, US states are filing lawsuits against pharmaceutical companies and distributors that misinformed the public about their opioid’s addictive properties, and they’re winning. Landmark rulings have caused major players to pay out hundreds of millions due to their part in fuelling the opioid epidemic. And though the public’s perception regarding opioids might have changed, without an effective alternative, patients will still be at risk. “You can be aware of it, but it doesn’t mean you’ll solve the problem until you have a new drug,” Dr Fox says. That’s why he hopes Akelos will be able to develop something of an answer to the opioid epidemic. Even though the company is only targeting one condition, it’s a disorder which affects millions of people. “The reality is if you’re having chemotherapy and you’re in tremendous pain, you need a painkiller. I need people to get behind what we’re doing and develop a new painkiller,” he adds. The company, which is developing three alternatives to opioids, is raising capital on the investment platform WealthForge. And though it’s targeting what could be a potentially lucrative market, Dr Fox isn’t worried about competition. “Right now on the market there is no competition because there is no drug that you can write for the pain. When people invented Asprin, Tylenol and Ibuprofen, there was plenty of room for everybody. So right now there is no competition in the sense that nobody’s on the market yet approved by the FDA.” Let’s see if Akelos becomes the first company to change this.

Opinion Genome data is now at our fingertips, it can be sequenced in a few hours and for under ÂŁ1,000.

HOW DATA SCIENCE IS DRIVING GENOMICS AND PHARMA Author: Ramya Sriram - digital content manager at Kolabtree

Out of the three billion pairs of DNA molecules that make up the human genome, only 0.1% are unique to each person. To find patterns useful to medical research in such a vast sea of data, researchers can benefit from tools that cut through the noise. Fortunately, these are the same problems that big data has been trying to solve for almost a decade.


iotechnology, broadly encompassing technological applications using biological systems, finds itself in similar conditions to those that allowed big data to emerge. As the volume and variety of medical data grows, it becomes more advantageous to refine it into information that can be used to make decisions. In 2019, Nature published a paper exploring the current state of machine learning (ML) in drug discovery and development. Because of the vast quantity of patient data now readily available, ML has now become a valuable tool to model the behaviour of drugs and find potential applications for existing and new molecules. Big data is not just in the future of the pharmaceutical industry, it is shaping its present.



GENOMICS Think of big data in the context of biotechnology, and your first thought probably relates to genome sequencing. The Human Genome Project, which ran from 1990 to 2003, was a pioneering effort that gave us access to three billion bases of data, opening the door to information on mutations, genes and more. Genome data is now at our fingertips, it can be sequenced in a few hours and for under £1,000. Think carefully about how much data that is — how are we going to make the best use of it? To work with it effectively, data scientists use frameworks and tools to store, track, receive, analyse and interpret their data. Tools are now being built to automatically annotate specific genes, and software companies like DNAnexus, Knome and NextBio have sprung up to tackle genome interpretation. Interestingly, NextBio has even worked with Intel to improve its Hadoop platform for genomic big data analysis. The pharmaceutical and healthcare industries can use this insight to improve diagnostics, aid drug discovery or develop personalised medicine strategies. DRUG DISCOVERY AND DEVELOPMENT Bringing a new pharmaceutical product to market is a long process with many bottlenecks. Trials regularly fail to meet their objectives which can add further delay and increase the costs of an already expensive process. From finding a drug candidate to recruiting patients for a clinical trial, there are numerous data points, experiments and risk/benefit analyses to conduct, making the pharmaceutical industry a logical fit for big data analytics. We can now use automated software to screen millions of compounds to identify drug candidates for a clinical trial. Pharmaceutical professionals can let artificial intelligence (AI) do the hard work of sifting through a huge library of potential drugs, assessing what is likely to work against the trial’s specific criteria. Biotechnology company Numerate, for example, builds predictive models to help with small molecule drug design, making predictions on toxicity, metabolism, absorption, distribution and more. AI can also be used to come up with new combinations of compounds. Pharmaceutical companies can therefore screen drug candidates and pick the most likely ones to take to clinical trials. Big data in biotechnology is not only about genomics — the data may also be collected by sensors. Wearable, ingestible or implantable sensors can provide a continuous data stream for clinical trials. This data can reduce the gap between measurements taken at appointments, mitigate for human error, identify reasons for dropout and may

allow patients to go about their normal lives more easily. Any improvement in the drug discovery or clinical trial process can save millions of dollars in development costs and speed up the time it takes to bring a potentially life-saving drug to market. HEALTHCARE AND DISEASE MANAGEMENT One big data challenge facing the healthcare sector is the storage and management of electronic medical records. In fact, the US government is investing $19 billion into boosting the uptake of electronic records. With patient information stored in this way, the industry has a pool of data to work with to help improve diagnoses and treatments. As the number of commercial wearable devices capable of collecting medical data grows, so does the information that doctors could use to assist patients. Apple has demonstrated the possible benefits this could bring by collaborating with the American Heart Association to produce a cardiology study on how heart rate relates to heart related hospitalisations. Using wearable technology, researchers of chronic conditions can acquire a constant high volume of data to analyse. If systems are in place to store enough valuable data, medical institutions could make more informed diagnosis and treatments. In New York, the Partnership to Advance Clinical Electronic Research is working on a system to enable investigators and sponsors to use electronic patient records to help find patients for clinical trials. Oracle has also unveiled cloud-based applications that support the sharing of anonymised patient data between the health system and pharmaceutical companies. AN INTERDISCIPLINARY SOLUTION According to an analysis published in the Journal of Health Economics, the cost of producing new drugs was over $2 billion in 2014 and has been steadily growing in recent decades. Accessing the potential of new data, from genomics to wearable devices, could drastically increase our understanding of a substance or medical device before any trials are conducted. Finding innovative ways to use this new abundance of medical information could play a role in reducing the growing cost of R&D. The line between data science and medical biotechnology is fading, leaving a grey area of research in the future of the pharmaceutical industry. The skills that will be needed to carry on data aided medical research might seem unattainable, but they can be easily incorporated using specialists. While 0.1% difference might not seem like much, it could represent the difference between billions of dollars in research.



Epilepsy patients face shortage of important drug


he Epilepsy Society has warned patients that UK pharmaceuticals supplier Accord has run out of the anti-epileptic drug phenytoin. The Department of Health and Social Care (DHSC) issued the warning, stating that the manufacturer expects stocks of its phenytoin sodium NRIM 100mg capsules to be depleted until May this year. The issue has been caused by a regulatory change at Accord’s manufacturing site. Under the Medicines and Healthcare products Regulatory Agency’s (MHRA’s) guidance, epileptic patients require a constant supply of phenytoin and in ideal circumstances, should not be switched to a different version of the same drug. The MHRA is now recommending patients to be switched to another version of the drug, produced by UK-based drugs manufacturer, Flynn Pharma. More so, healthcare professionals have been told that patients should be monitored and may require specialist support. Flynn Pharma has confirmed it has sufficient supply of the drug to meet demand.

How a nasal spray could treat concussion


new nasal spray developed between biotech platform ATAI and early-stage company Neuronasal could be a short-term treatment for mild traumatic brain injury (mTBI) and concussion.

supply, and which also causes inflammation and the release of excessive amounts of glutamate – a neurotransmitter which plays an important role in strengthening and weakening neural circuits.

The Neuronasal spray works by delivering low-doses of N-acetylcysteine (NAC) to the brain to combat the harmful effects following physical trauma to the head.

Neuronasal’s intranasal approach can be given in lower doses which reduces the chance of side-effects such as nausea and diarrhoea, which are common with oral doses of NAC. Another problem with the use of NAC is bypassing the blood-brain barrier, which shields the brain from many drugs. An intranasal approach however is able to deliver the dosage directly to the brain.

NAC contains glutathione, the most abundant endogenous antioxidant known to prevent oxidative damage to cellular components. Concussions are typically the result of physical trauma that disrupts brain tissue and blood

just uncomfortable,” said Dr Matthias Luz, chief medical officer of ATAI Life Sciences. “In the hours and days after trauma, these injuries trigger a pathophysiological cascade that can result in significant, lifelimiting conditions if not adequately addressed.”

Concussions are typically the result of physical trauma.

“It’s clear that concussions and other mTBIs are more than

Did you know?

There are currently no approved treatments for concussion or other forms of TBI.

In the US, an estimated 1.6 – 3.8 million sportsrelated concussions occur every year.

It’s thought that around Concussions are associated with depression, posta quarter of concussions fail to get assessed by traumatic stress disorder and other psychiatric conditions. medical professionals.


WOMEN IN PHARMA Reimagining the glass ceiling A scientist by training with a PhD in organic chemistry, Barbara Morgan is responsible for the Pharmaceutical and Nutraceutical businesses, including the CDMO division of the Lubrizol Life Science Health unit. She is passionate about women in leadership and science and is the co-chair for Women in Lubrizol Leadership (WILL). In this series, she discusses key themes around women in the industry and offers advice for aspiring female leaders and their wider teams.

Author: Barbara Morgan - global business director, Pharmaceutical Solutions and general manager, CDMO services, Lubrizol Life Science Health.


henever I’m asked about the ‘glass ceiling’, the answer is never straightforward. Of course, obstacles exist to women reaching leadership positions, but it doesn’t all boil down to gender. There are other factors to consider. An often-missed point is that a glass ceiling can exist for different leadership styles irrespective of gender. In the corporate world, many of the recognised leadership qualities are typically some combination of decisiveness, dynamism and assertiveness. When an individual embodies these qualities, they align with the industry leadership ideal and is at an advantage regardless of gender. However, those with a different approach to leadership - and women often fall into this category - may be exposed to more obstacles as their characteristics go against the status quo. For more women to reach the top positions, it’s important that the industry works towards redefining its understanding of leadership by embracing different styles. The highly extroverted and assertive leadership style that we are accustomed to in business may show up differently in women. We have to be inclusive and open to allow female leaders to be authentic to themselves and

not feel pressured to personify the accepted leadership style.

often counter-productive to the end goal.

Adding to the complexity, the glass ceiling is often unintentional as people are unaware that they are putting it in place or why. To address the issue a larger cultural shift must occur. Questions and uncertainties will undoubtedly arise: how can we best accommodate for the change? What will it look like when we are there? It can be difficult to know where to begin, and even when companies are paving the way for a balanced culture, there can still be a level of uncertainty around the topic and how to encourage an open and inclusive dialogue amongst employees. And to be honest, these are not always comfortable conversations, and most have a strong desire to ‘get it right’, which often makes them hesitant.

At Lubrizol, we are committed to addressing these issues and strengthening our diversity profile through initiatives designed to facilitate female career progression. Women are supported through a number of mentoring and leadership programmes. During my own career at the company, I have received support since day one through development programmes, mentorship, and having sponsors unlock access to the right people and opportunities. This has given me a multitude of growth experiences and exemplifies how with the right support and initiatives in place, there are no barriers to moving toward the top.

Because of this hesitancy, teams may need a little push to have these conversations. And with that encouragement, it is helpful to provide a reminder that the quickest way to shut down future conversations on the topic, is to react with judgement and a zero-sum approach. Openness and curiosity lead to collaboration, while judgement puts up walls. Interpreting questions of inquiry negatively or responding with a “change is difficult” comment is

While individual companies play a role, the issue needs to be addressed on a wider level with consistent effort across the industry to create waves of change. Things won’t change overnight, but the push for change is a positive step. We’ve now gone beyond simply discussing the issue and businesses are taking clear action and setting goals. At the same time, we cannot only focus on the senior management positions and neglect the rest of the talent pipeline. We must engage women at the very first



We cannot only focus on the senior management positions and neglect the rest of the talent pipeline. We must engage women at the very first promotion and ensure they are not falling off along the way. promotion and ensure they are not falling off along the way. Finally, and most importantly, we need to recognise that this isn’t a women-only issue. Everybody needs to rally round and come together. We need to be united in the drive towards diversity and inclusivity in the workplace. That requires an inclusive approach where all genders are part of the discussions and actions, where they look to share their experiences, offer opportunities to aspiring employees, and seek diverse perspectives. So, in that spirit, my main advice for aspiring female leaders at any stage of their career journey would be: •

Have confidence in yourself and your abilities. Statistics show that women don’t apply for roles until they are 100% ready while men are happy to apply at just 60% ready - it’s up to you to aim high and achieve the career goals that you want. And managers, take note of this stat. Your approach to hiring women may look different because of this.

Authenticity is key. You will hear a lot of advice about leadership but not all of it will be suited to you. Everyone is different and

you must figure out what works. You may not agree with or appeal to everyone along the way, but if you lead with integrity in a way that you have chosen and are comfortable with then that’s ok. •

Create your own roadmap. Don’t wait around for someone to tell you what route to take to achieve your goals. Work out how to get there and go for it. It doesn’t necessarily have to be a linear progression - you may need to take some detours - but eventually all of the dots will connect in retrospect.



How Nemera’s extended capabilities in front-end innovation bring new advantages for pharma customers.


I Author: Craig Scherer - marketing director for Insight Innovation Center at Nemera


n today’s hyper-competitive market, pharma companies cannot afford to ignore three critical success factors: reduced time to market, reduced project and product risk, and an increased focus on patient outcomes. These goals, if they are not already at the centre of every pharma company’s business strategy, soon will be. Providing design research, human factors engineering, user experience design, and design for manufacturing, the Insight Innovation Center at Nemera can help customers navigate their device strategy to achieve these strategic goals. REDUCING TIME TO MARKET In today’s increasingly competitive market, time is money. Delays in development mean lost revenue and market share – getting to market quickly is critical to pharma companies’ success.

Having complete-end-to-end capabilities, under one roof, capitalises on efficiencies and promotes more frequent communications throughout development. The Insight Innovation Center offers front-end innovation, design research, human factors, user experience design, lab services, and engineering development all linked to Nemera’s quality good manufacturing practice (GMP) capabilities for clinical and commercial manufacturing. This full suite of offerings provides efficiencies which can greatly reduce time to market.

between disciplines. Insight Innovation Center’s director of Business Development Mark Tunkel says: “The way our user experience, technical and commercial teams interact and support each other throughout the product development process completely alleviates the potential for critical information to get ‘lost in translation.’ As projects are passed between the different disciplines or even between different companies participating in the programme, there isn’t a point where the key players are not intrinsically involved in some way at every step.”

We employ one quality system so product requirements stay consistent as they travel through development. Additionally, having access to all disciplines during development ensures that there is input across all stages of development. For example, during early engineering, manufacturing continuously weighs in on assembly and cost. Likewise, it’s critical for human factors engineers to stay involved from early concepts through to commercial ramp up to ensure that user needs are supported and that all FDA requirements are satisfied.

Conversely, companies that shortcut their design and development process simply to accelerate speed to market run the risk of discovering core device functionality issues at later stages when these deficiencies are much more costly in time and money to correct.

REDUCING PROJECT AND PRODUCT RISK Having all the teams working in close proximity optimises efficiency to reduce overall time in development. The other primary value is continuous communication

User experience prototypes can help with feature selection, user preference selection and early usability feedback. Research and human factors play a huge role in ensuring that the right features and patient support characteristics

Another way that the Insight Innovation Center helps to mitigate risk is by leveraging a wide variety of prototyping tools at every step of development to uncover other areas of risk well in advance of industrialisation.


are in place. They confirm and document that the device is designed to be safe, effective and support optimal user experiences. Technical prototypes can be developed to minimise risk in the highest risk components and subsystems. Prototypes are used throughout development to reduce risk as early as possible, when changes can be made quicker and easier resulting in a more agile development process. These early stage tools help to prove how well certain designs or technologies address the functional requirements before core to function assemblies are integrated into the system design. Ensuring manufacturing input is provided early to get early buy-in to the industrialisation plan is another value to all capabilities being under one roof. By securing early stage input from manufacturing, technical details like tooling strategies are shared to ensure that proof of design prototyping is done the right way. Incorporating input on geometries, materials and functionality early on can have a significantly positive impact and result in more cost effective, efficient and robust manufacturing solutions. This focus on risk mitigation by obtaining manufacturing input early in the development cycle once again illustrates the value of end-to-end offerings under one roof. Delivering robust and reliable commercial manufacturing outputs requires a detailed understanding of the product and associated manufacturing processes and makes sure that these industrialisation factors are considered early in development. INCREASED CAPABILITY TO REINFORCE PATIENT CENTRICITY Nemera’s mantra has long been “We put patients first”. The integration of the two companies better positions Nemera to deliver

highly patient-centric solutions that encourage adherence and provide better healthcare outcomes. Extending capabilities further upstream with user research, user experience design and human factors engineering allows Nemera to integrate more patient information into design and gain a deeper understanding of user needs. This sensitivity to the needs of the patient also guides the design team as they identify potential for use errors or experiential gaps that can be addressed through the development of materials beyond the device such as better instructions for use (IFUs), novel training methods, or value-added packaging.

Nemera’s CEO Marc Hämel agrees, “...understanding patient needs and translating that into impactful product designs aligns perfectly with our purpose to ‘put patients first’. We take patients’ needs into account at every stage of the product development cycle…”.

Having complete-end-to-end capabilities, under one roof, capitalises on efficiencies and promotes more frequent communications throughout development.

“By executing a robust user verification testing process, we’re better able to understand how users interact with our devices which ultimately lead to safe and effective products,” says Bernhard Rohn, VP of marketing and strategy. “In addition, the keen understanding of the user experience can help us design products that can make a real difference in the quality of our patients’ lives by supporting every stage along the patient’s journey.”

NEMERA AND ITS NEWLY BRANDED INSIGHT INNOVATION CENTER Nemera is a world leader in the design, development and manufacturing of drug delivery devices for the pharmaceutical, biotechnology and generics industries. Nemera’s newly branded Insight Innovation Center, provides consultative services to support customers' overall device strategy. The Insight Innovation Center leverages a crossdisciplinary team of 150 to develop tailored solutions across multiple device platforms. Users are at the centre of everything that Nemera does in its effort to always put patients first.




Making it to market With more and more cell therapies entering the market, Thermo Fisher Scientific outlines how to comply with regulatory standards to ensure quality and safety, and ultimately make it to commercialisation.

I Author: Dr Maitry Ganatra, global market development director, Thermo Fisher Scientific

n recent years, sophisticated cell therapies have emerged to treat a broad range of cardiovascular, neurological and autoimmune diseases, among others. The complexity and variability of these therapies present unique challenges for the transition from the research phase to commercialisation. Thorough consideration of current good manufacturing practice (cGMP) requirements and regulatory compliance early in the process, even during the research stage, can help alleviate the challenges involved in scaling up. Additionally, applying quality by design (QbD) principles to the production process can ensure high quality and safety of new therapeutics, making commercialisation easier.

Fundamental considerations when transitioning from research to commercialisation of cell therapies Commercialisation of cell and gene therapies, whether allogeneic or autologous, can be challenging. In allogeneic cell therapy, where a single cell type is mass produced for treating multiple patients, the challenge is that of scaling up a thousand-fold from the research phase, while still maintaining the necessary physiological conditions. When processes get scaled up, laboratory instruments, such as centrifuges and CO2 incubators used during the research phase, may not be compatible with the requirements of the cGMP environment. Typically, when equipment designed for research purposes are used in a cGMP compliant facility without

consideration of validation and documentation requirements, this can pose a huge issue during commercialisation. Scaling up could introduce inconsistencies across multiple factors, including incubator temperature, composition of reagents, such as media or growth factors, as well as cell culture parameters, such as incubation time. Even the slightest change in production conditions upon moving from research level to the multi-litre scale can have an impact on how the cells behave, ultimately affecting the quality and safety of the therapy. In adapting research workflows to meet commercial cGMP requirements, cell therapy manufacturers often realise too late that processes that work well at the research stage are incompatible with the cGMP environment. Furthermore, they often underestimate how involved the regulatory compliance process can be; each piece of equipment needs to be validated to ensure it meets the highest standards and relevant documentation should be produced. In autologous cell therapy, where each batch of cells is produced for only one patient, modified and reintroduced into the same patient, the challenge is that of scaling out and producing multiple batches corresponding to multiple patients, while maintaining due diligence throughout the process-heavy workflow. Scaling out in autologous cell therapy demands more space and a large number of

instruments, each being compliant with regulatory standards. The challenges here involve managing the complexity of working with multiple sets of equipment, having sufficient space for all these systems and keeping track of which instrument is used for a specific therapy. When processing multiple batches in autologous cell therapy, every patient sample needs to be tracked as it goes from the hospital to the manufacturing site and back to the patient, thereby adding logistical burden to the process. On the whole, scaling out relies on having the operational capacity to accommodate all the equipment as well as the materials, manpower and time involved in the process. Recognising these challenges, many technology vendors offer advice and guidance around cGMP compatible instrumentation, including centrifuges, biological safety cabinets, cold storage equipment and CO2 incubators. A standard laboratory CO2 incubator, for example, cannot be moved to a cGMP environment without temperature mapping or testing for installation, operational and performance qualifications (IQ, OQ and PQ). To this effect, some vendors even offer customisable solutions to help meet cGMP requirements. Applying quality by design principles to cell therapy manufacturing Increased testing does not necessarily improve the quality of the final product. A more robust solution is to build quality into entire production workflows. The


US Food and Drug Administration (FDA) encourages implementation of the Quality by Design (QbD) principles into the production, manufacturing and regulation processes.

testing, sterilisation, and electrical checks. By inspecting the overall safety and configuration of the instrumentation, the required factory end-of-line testing is completed.

In adopting the QbD principles, every step of the process, starting from raw materials to the operating plant, clean room, and water and materials used, all should adhere to high-quality standards. Every piece of equipment used in the manufacturing process needs to meet quality requirements, such as being certified by the International Organisation for Standardisation.

Vendors also provide the relevant documentation required in adhering with the cGMP standards, for example, issuing the certificate of conformance and providing instrument calibration documentation, equipment drawing and critical component specifications. To ensure that each piece of equipment is installed per vendor specifications, meets the quality requirements, and offers consistent and reproducible results, IQ, OQ and PQ validation protocols are performed, followed by issuing the respective documentation.

Recognising the challenges posed when transitioning from research to commercialisation of cell and gene therapies, many instrument vendors apply the QbD principles and undertake all of the necessary performance testing to deliver equipment that meet the requirements of cGMP compliant facilities. Some of the steps involved in performance testing include temperature testing, ramp up/ramp down

In addition to testing for compliance and offering documentation, some vendors provide user and maintenance training to ensure best practices are upheld in the day-to-day workflow.


Scaling out relies on having the operational capacity to accommodate all the equipment as well as the materials, manpower and time involved in the process. Planning ahead for successful cell therapy commercialisation As pharmaceutical manufacturers transition cell therapies from the research to the commercialisation phase, they start acknowledging the complexity that comes from scaling up and expanding workflows, while staying compliant with the regulatory requirements. Carefully planning cell therapy production processes beforehand, understanding the needs of cGMP compliance and collaborating with knowledgeable technology vendors who offer solutions adhering to QbD principles, can set cell therapy manufacturers up for successful commercialisation.

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Leading the pack Our guide to Pharmapack Europe will help you prepare for one of the world’s premier pharmaceutical packaging and drug delivery events.


n recent years, the pharmaceutical industry has brought a flurry of new and innovative products to market, benefitting both patients and companies’ profit margins.

more advanced packaging and drug delivery solutions. Advances in the industry is what Pharmapack is all about and this year’s show is set to be no exception.

For packaging and drug delivery solutions suppliers, this has meant a demand for more multifaceted products that are able to both transport and deliver medicines to patients. This, coupled with the introduction of new packaging regulations, has led to contract packaging organisations taking a more significant role to produce

WHAT TO EXPECT With over 410 exhibitors expected to be attending the show, not to mention the 5,550+ visitors from over 100 countries, Pharmapack is set to represent the very best of its associated industries.

WHERE AND WHEN Venue: Paris Expo, Porte de Versailles, France Date: 5 & 6 February 2020 Showtimes: Wednesday 09:00 / 18:00 Thursday 09:00 / 17:00

Visitors to the show will be able to see a who’s-who of pharma

packaging innovators, with companies including Aptar, Baumann, Nemera, SFM Medical Devices, SHL, Vetter and West Pharmaceutical Services, all attending to highlight their latest offerings and innovations. It isn’t just big players though. Placed in the centre of the show will be the 2020 Start-up Hub, which is set to celebrate the young companies making an impact in the fields of pharmaceutical packaging, labelling, drug delivery device design and engineering.


Pharmapack’s Start-up Pitch will see exhibitors given the chance to pitch their company to a panel of experts, as well as a live audience of industry professionals.


To help showcase emerging companies’ products, Pharmapack’s Start-up Pitch will see exhibitors given the chance to pitch their company to a panel of experts, as well as a live audience of industry professionals.

For those wanting a more in-depth look at what’s on offer, be sure to take a guided Innovation Tour delivered by industry experts to highlight the exceptional array of exhibitors throughout the Innovation Gallery.

AWARD TIME Once again, the Pharmapack Awards return to celebrate the latest innovations from the pharmaceutical packaging industry.

AGENDA With 40 content sessions delivered by industry-leading experts, visitors will find a vast wealth of knowledge awaiting them once they arrive at the show.

Entrants featured across two categories - Health Product & Exhibitor Innovations - will be judged by a panel of independent industry experts, with the winners announced on the first day of the show.

Expect to see all of the key challenges within the industry covered across the show’s two days including: patient centricity; biologicals and biosimilars; drug delivery devices; sustainability and pharmaceutical packaging devices.

This year, the two health product and exhibitor innovations categories will be judged by a jury of independent industry experts. Last year, companies targeting connected health and drug delivery were especially recognised for how they adapted to increased manufacturing demands and patient needs, respectively. Since last year’s show, important topics such as sustainability, patient centricity and connectivity have become more prevalent throughout the industry. It will be interesting to see how companies have responded and if those that have are recognised during the awards. INNOVATION Speaking of awards, every exhibitor innovation submitted to the Pharmapack Awards will be presented in this year’s Innovation Gallery, giving visitors a way to see the latest advances taking place across the industry.

More so, the 2020 Technical Symposium, designed to promote

exhibiting companies, will provide insight from pharma industry leaders on tackling the challenges and technical problems associated with novel approaches. This will include case-studies on pre-filled on body injectors, drug-device combinations, drug repurposing, glass pre-fillable syringes, QBD and nasal delivery innovations. This year will also feature the Learning Lab, situated directly on the exhibition floor, which is designed to inform visitors on the latest exhibitor products and services. Session highlights include a presentation by Hiroki Hasegawa, researcher at Mitsubishi Gas Chemical Company, on the best plastic vial & syringe for oxygen sensitive drugs and a talk from Arnaud Guillet, business development director at Biocorp on how smart devices are changing drug delivery.



EPM’s five things to look out for at Pharmapack With this year’s Pharmapack set to be bigger than ever, here are some of the biggest trends that are bound to feature at the show. Kicking off this year’s show is a talk from IQVIA on digital value-added medicines and visitors can be sure to learn more about connectivity and pharma as the show goes on.

CONNECTIVITY The rise and adoption of digital technologies has permeated into almost every sector of healthcare and pharma is no exception. Companies are now utilising digital solutions in ways that impact the supply chain, how products are packaged and most importantly how patients respond to treatments.

SUSTAINABILITY Being environmentally friendly is a must these days especially for a sector with as high emissions as pharma. Thankfully, pharma companies are now starting to take more responsibility for their carbon footprint through new sustainability plans. Some are targeting a zero environmental impact policy whereas others are simply starting out on their journey through increased recycling rates. Whilst the industry as a whole has largely ignored the issue, this year’s Pharmapack certainly highlights the steps pharma companies are now taking to be more eco-friendly. EU MDR

With the EU’s Medical Device Regulation (EU MDR) coming into effect in May this year, manufacturers will be wanting to make sure they haven’t missed out any important details stopping them from being compliant with these new regulations.

Manufacturers wanting to make sure they’re ready should check out the Wednesday morning workshop by Anteris Medical, which will outline market readiness; the requirements of drug manufactures; comparisons between the EU and US markets; and everything else companies need to ensure they’re compliant by 26 May. PATIENT CENTRICITY It used to be that packaging was simply a vessel to transport medicines to the patient but more and more we’re seeing manufacturers really consider how patients take their treatments. With companies starting to focus on the end-use of their product, things like smart packaging design and connected devices which can track medicine adherence are emerging onto the market,

highlighting how patients are being put at the forefront of drug delivery device design and packaging. Pharmapack is set to feature a host of companies talking about this topic, but if you really want to see how the market is changing, go and check out all of the products being demoed on the show floor.

INNOVATION Innovation may be a term that is thrown around a lot – especially in life sciences – but Pharmapack is a show which always delivers on that front. With over 400 exhibitors, visitors will be able to check out some of the companies leading the way in their respective fields. Whether you want to see how the big industry players are adapting to changing market conditions, or how smaller companies are developing next-generation products, Pharmapack is sure to have you covered.


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Thinking smart How pharma companies can ensure they’re successful when implementing an IoT project.


rom smart insulin pens to pills with ingestible sensors, the pharma sector is on the cusp of an internet of things (IoT) revolution that could transform the patient experience and unlock lucrative new business models for the industry.

With IoT in healthcare projected to be worth over $534 billion by 20251, technologies such as remote monitoring, real-time analytics and seamless data flow between devices and people can improve both decision-making and the efficiency of medical ecosystems. However, recent years have seen many IoT projects fail to even get off of the ground. Method has worked on numerous IoT projects aimed at patients with complex health conditions. Experience tells us that IoT initiatives generally hit the buffers for three reasons: companies lack a coherent strategic direction, they overestimate the ability of emerging technology to solve a patient problem and, worst of all, they lose sight of the end-user. Against this backdrop, our view is that the following considerations will help pharma firms reap the full benefits of IoT. GET CLOSE TO THE END USER One of the biggest challenges for pharma manufacturers designing patient-centric solutions is that they are often one stage removed from the coal face of the patient experience; engaging with them via hospitals, doctors, reps and pharma retailers. For IoT projects to succeed, pharma brands need

to get much closer to patients and develop a deep understanding of their everyday lives and empathy for the challenges of living with their specific health condition. How patients engage with their healthcare system and obtain their medication can depend on their age, where they live and their

financial means. Are they rural or urban? Do they live in a market like the US, where health insurers stipulate what drugs people are entitled to? Is the solution likely to be administered by the patient or by their primary carer (their partner for example)? While focus groups and speaking to subject matter

Author: James Steiner design director, Method


1. https://www. grandviewresearch.com/ press-release/ global-iot-inhealthcare-market


experts can provide useful insights, there’s no substitute for design and innovation teams embedding themselves in the real world and online communities of patients to get first-hand knowledge of the patient experience and where potential solutions might fit. FIND A PATIENT PROBLEM TO SOLVE WITH REAL IMPACT Regardless of sector, successful IoT devices either solve a human problem or meet a human need. From insomnia to asthma, pharma companies that immerse themselves in the patient experience will have a better understanding of the difficulties they face, how the products and services they rely on can be improved, and how service delivery impacts on patient engagement levels. For example, can IoT help patients with cognitive conditions such as Alzheimer’s remember to take their medication or keep a GP appointment? Does it have any relevance to an arthritis sufferer who struggles to open a jar of pills? IoT design can fundamentally transform the interactions that patients have with their medication and with their healthcare providers – as long as it is based on rigorously-derived insights. For example, one intriguing area being explored in the private sector and the research community is the role that smart contact lenses could play in healthcare, including for glaucoma diagnosis and for helping people with diabetes to monitor glucose levels in their blood. VERIFY THAT TECH IS REALLY THE ANSWER With hot topics like IoT, it’s important to avoid confirmation bias – the untested belief that IoT is the best/only tool to solve a business problem. By beginning

with what the tech can do, rather than focusing on patient needs, pharma companies risk overcomplicating the issue at hand. This may then lead to push back, higher than expected costs or a missed opportunity. Part of the process of making IoT work is ensuring that it can uniquely solve or contribute to the solution – and be willing to recognise that there may be better alternatives. For example, is developing a dedicated smart device for diagnosing chronic obstructive pulmonary disease (COPD) the best approach, or is there a simpler, more accessible solution - such as an app which can access a smartphone’s microphone and detect the disease by listening to cough sounds? CHECK THE SOLUTION STACKS UP COMMERCIALLY While patient need should drive IoT pharma innovation, solutions must also deliver the expected ROI. In tandem with understanding the patient, understanding the market is key. This includes analysing alternative solutions, assessing future-facing trends and legislation, and researching how purchasing works in different markets. It’s important to hypothesise, visualise and develop business models; but it is also crucial to stress test them against real market conditions. Diabetes is one area where an entire IoT ecosystem has developed that

addresses a genuine consumer need, while also representing a commercially viable suite of products and services. BE PREPARED TO TAP INTO A WIDER IOT ECOSYSTEM The challenges of IoT means pharma companies are best positioned to unlock value if they collaborate and share data with other organisations in the healthcare system. By seamlessly collecting and sharing patient data with approved third parties, IoT can make patient progress and treatment adherence visible to clinical providers and carers in real time. This provides much greater insight into changes to medication or treatment plans that may be required or to any additional support that may be needed. This openness to collaboration can be extended to adjacent sectors. Just look at the work AstraZeneca is doing with software giant Microsoft in supporting the development of AI-based healthcare. Or Sanofi’s partnership with Google to set up a virtual innovation lab to explore how data can help in developing drugs. Investing in IoT innovation doesn’t come without risks. But if pharma companies can embrace this technology with a human-centred mindset, the potential value to their businesses is huge and could help to ensure the sector is in rude health for years to come.

Regardless of sector, successful IoT devices either solve a human problem or meet a human need.


Lu Rahman speaks to George I’ons, head of product strategy and insights at Owen Mumford Pharmaceutical Services about the findings of its recent report scoping the near-term competitive biosimilars market in the USA and Europe, and its impact on drug delivery device design.

In perfect

harmony T

he available market for biosimilar manufacturers seeking to compete with original reference biologics coming off patent between late 2018 and 2023 in the USA and Europe, is considerable. However, says Owen Mumford, even where clinicians encourage the use of biosimilars for the patient, there remain some key considerations to overcome. This includes clinical confidence in the biosimilar; competitive pricing of drugs through greater competition; and patient confidence in the drug delivery device. Owen Mumford’s study reveals the size of the near-term opportunity in competitive biosimilars markets for biologics coming off patent 2018-2023, and offers evidence that device design is a key differentiator in addressing patient adoption. To maximise on this opportunity, biosimilar manufacturers need to think seriously about drug delivery. Molecular size and viscosity creates issues around the volume of drug being delivered, as well as potentially causing pain upon administration. We are seeing an increase in self-administration across the globe. As a result, precision dosing, ease of use, comfort, and convenience have

become key in ensuring patient adherence. Familiarity and comfort with a particular delivery device also has to be taken into account as it can hinder switching from treatment despite the advice of healthcare professionals. LR: Why is device design for biosimilars so important in relation to patient adoption and what are the main considerations in drug delivery design for biosimilars compared with other drugs? GI: The device component is increasingly seen as integral to the therapy as a whole with

biologics rather than a secondary consideration, especially since the design of the delivery device may have an impact on patient adherence. Testament to this is the position the FDA has taken by creating a specific category for approval of combination products i.e. the device and drug. Biologics and biosimilars present specific challenges with respect to formulation development due to the nature of the molecular structure as these




It is now widely accepted that the design of a drug delivery device is a crucial consideration. types of treatments are typically administered subcutaneously. Typical considerations are the trade-offs between medication volume, viscosity and injection frequency, and delivery time. Higher viscosity formulations may allow less frequent dosing for the patient but increase the complexity of device design. Higher volume injections may mean looking at different options in prefilled syringes and autoinjector design, or even considering wearables as alternatives. Injection time, ease of use, lack of pain and needle protection are all key drivers for increased patient acceptance. It is now widely accepted that the design of a drug delivery device is a crucial consideration. When switching to a new biosimilar, patients may experience difficulties if they are using a different device that is too unfamiliar. On the other hand, improvements in design and ease of use may be a persuasive factor.

LR: How can drug delivery designers and manufacturers seize upon the opportunities available in this market? GI: A key element in device design is a thorough and robust human factors (HF) programme. The HF process will test user acceptance of a new device and importantly determine the level of risk associated with each step in its use. Results from formative HF studies can provide key insights as to how device design can be modified to create more usercentric product features. Also important for device manufacturers is the ability to be able to offer flexibility in design so that different sizes and configurations of primary containers can be accommodated to allow for varying drug volumes and viscosities. With low volumes typical of biologics the device also needs to ensure that the full dose is delivered to the patient and that the residual volume in the device is as low as possible. Another key consideration is the requirement to ensure that device designs comply with sharps injury prevention regulations and incorporate safety features that prevent needlestick injury and reuse. With many pharma companies creating different doses and formulations of the same molecule, as part of lifecycle management, the ability to have a platform device that can be used for all these variations with minimal design changes is a key factor. LR: Is it important for device companies to collaborate with drug manufacturers and how easy is this process? GI: The collaboration between pharma and device manufacturers is essential to developing and bringing a successful combination product to market. This relationship is key throughout the drug development process with horizon scanning for devices often taking place well before initiation of clinical studies. Most

large pharma companies employ dedicated device teams who work closely with other internal departments such as formulation chemistry, clinical, sales and marketing as well as creating a close working relationship with the device suppliers. Smaller pharma companies without device teams often need additional technical support and guidance throughout the process so good collaboration - whether large or small - is central to a smooth launch. LR: You highlight selfadministration devices - how important is this market and what are the future opportunities? GI: We’re seeing selfadministration become increasingly important across the world. There are many drivers of this trend: in particular, selfadministration helps to ease the burden on hospitals and makes treatment more convenient for patients. This is creating opportunities for manufacturers to favour the production of devices which prioritise ease of use and safety features. There is a growing demand for pre-filled syringes while safety-engineered devices can be seen to dominate the pre-filled market, with three in every four devices offering safety mechanisms. LR: Are there any differences between the US and UK markets? GI: Approval of biosimilars is far more progressed in Europe compared with the US, with over 60 approved by the European Medicines Agency to date compared to 25 approved in the US by the FDA. Both US and EU markets have well established regulations in place concerning the requirement for employers to provide safety devices designed to prevent needlestick injury. These regulations apply to employees regardless of the place of work and so cover acute and home settings.

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Untangling the web What pharmaceutical manufacturers should be doing to prepare for new and important regulations surrounding medical devices.

S Author: Elizma Parry director, Global Clinical Practice at Maetrics

ome pharmaceutical manufacturers are simply unaware of their entanglement within the EU Medical Device Regulation (MDR) or EU In Vitro Diagnostic Regulation (IVDR) web. Yet, businesses manufacturing combination products or companion diagnostics will inevitably be affected by the new regulations that are coming into effect in May 2020 and 2022 respectively. With little time on their hands, it is vital that pharmaceutical manufacturers commence the preparatory steps towards compliance now. As such, some pharmaceutical manufacturers may have assumed exemption from the new regulations that target medical device products. They are, however, mistaken. From here on, pharmaceutical companies will undergo oversight for both the device and medicinal components of their combination products. This represents a big change, given that liaising with a national Competent Authority (CA) was the only thing required of them until recently. Indeed, the EU MDR asks that all medical devices have a CE mark in order to continue circulating on European markets. Under the new EU MDR and EU IVDR, no medical device can evade regulatory scrutiny, regardless of its size or function. Previously immune to such strict requirements, it is understandable that pharmaceutical manufacturers producing combination products or companion diagnostics may

not realise the obligation they now have under the new medical device and/or in vitro diagnostic regulations for the European market. Given this unprecedented change in regulation, pharmaceutical manufacturers are most likely going to be unfamiliar with the process of liaising with a notified body and gathering the clinical data necessary to achieving compliance. If any given business fails to meet the deadline for compliance, their products may effectively be required to be removed from the market, causing unwanted repercussions on market access and company reputation. With such severe consequences at stake, pharmaceutical businesses are advised to take the issue of compliance seriously and get an early start on preparing for the imminent deadlines. Combination products, which can be composed of any combination of an ancillary drug, a device or biologically active product, will fall under the scope of the EU MDR. Some examples of such products are insulin injector pens and metered dose inhalers, in which the device serves as the delivery system of the integral drug component. This type of combination product, where the medical device has an ancillary function, is currently regulated as a medicinal product under the EU Medicinal Product Directive 2001/83/EC (MPD) but will now also fall under Article 117 of the EU MDR, which serves as an

amendment to Annex I of the EU MPD. Their inclusion under the EU MDR regulation stems from the increasing complexity of combination products and the need to regulate ancillary device components with the equivalent scrutiny as stand-alone medical devices. Lacking the data required to submit a compliant clinical evaluation report, most pharmaceutical companies may need to plan for gathering additional clinical data. This will be costly and timely. It is therefore crucial that manufacturers start sooner rather than later with their initial assessments of what data they are missing. Investing resources in this process can only be beneficial for businesses, helping to ensure a smooth and timely transition as well as facilitating the task of keeping clinical data up-to-date and easily accessible for the future. Manufacturers should be aware that products holding a CE mark under the current Medical Device Directive 93/41/EEC are granted a two years grace period for the completion of this transition – although they will need to be recertified under the EU MDR if any changes are applied to the products in question. In the same vein, pharmaceutical manufacturers will presumably be reaching out to a notified body for the first time and may not be aware of the current shortage of designated organisations in Europe. Presently, there are only


four notified bodies available to review technical documentation under the EU MDR. Given these limited resources, it is expected that designated notified bodies will find themselves at over-capacity and delays will most likely ensue. Such circumstances should further prompt manufacturers to submit their documentation as early as possible to make sure they receive their approval under the MDR before the applicable cut-off dates. Regarding companion diagnostics, these will now fall under the remit of the EU IVDR. Companion diagnostics are IVD devices which help strengthen the safety and efficacy of a medicinal product by assessing which patients would most benefit from treatment, and which may experience adverse effects from it. The IVDR has established a new risk-based classification, where Class A is the lowest risk and Class D, the highest. Falling under Class C, companion diagnostics will be subject to a high level of clinical requirements and scrutiny from notified bodies. The IVDR sphere is worst affected by the notified body shortage, as there is currently no designated notified body to review documentation. Manufacturers should be smart about this. It is encouraged that manufacturers begin to investigate, and approach notified bodies awaiting designation from their national competent authority for their specific product area in order to secure a place in line. Companies solely manufacturing medical devices may be aware of what the EU MDR and IVDR entail, but pharmaceutical manufacturers producing products that contain an ancillary device component may not be so fortunate. Considering the EU MDR and IVDR’s stricter regulatory requirements for combination products and companion diagnostics, in comparison to the

current directives, pharmaceutical manufacturers will find themselves equally affected as medical device companies. On the other hand, pharmaceutical companies will be treading into unchartered waters when collating the necessary documentation and liaising with a notified body, and should therefore allow for extra time to do so. Companies must give the compliance process its due importance or be prepared to deal with the negative outcomes of non-compliance.


Given this unprecedented change in regulation, pharmaceutical manufacturers are most likely going to be unfamiliar with the process of liaising with a notified body.



Introducing artificial intelligence to pharmaceutical visual inspection.

Safer with AI

W Author: Andreas Gross - global product manager Inspection Technology, Syntegon Technology

hether in automated driving, computer games or face recognition – artificial intelligence (AI) is transforming our everyday lives. The required software and algorithms are already used in many domains, including visual inspection of manufactured components. So why not apply them to an area where safety plays a crucial role: the production and inspection of drugs for human use.

of dense solutions with small containers do not promote the movement of particles, which reduces detection probability. Moreover, agglomerations or other types of inherent morphological features that are similar to particles, as well as bubbles resembling glass particles can cause false rejection of good containers. Especially for high-cost products, every single false reject is one too many.

One of the main challenges in introducing AI consists in transferring applications to complex processes and developing suitable implementation and validation concepts for the strictly regulated pharmaceutical industry. Inspection is a very challenging process. This is especially true for products with difficult characteristics, such as highly viscous parenteral solutions. Those cases usually require long development and optimisation times for vision algorithms before achieving a balanced operational level of detection and false reject rates. AI has the potential of shortening this development period and optimising the desired results more quickly.

THE ONE MAIN DIFFERENCE IN PHARMA While many drug producers and machine manufacturers are considering the use of AI and have issued first studies, reservations about implementation and validation are keeping most companies from using these applications in real production environments. In parallel, machine vision software companies are already offering deep learning vision tools. Hence, manufacturers of automated vision inspection machines must not necessarily develop their own algorithms or neural networks. In fact, existing solutions only require moderate software modifications. Additionally, an upgrade of the vision computers with higher processing power can be realised with GPUs, which are widely available in the gaming industry.

Though there are many successful automated visual inspection techniques on the market, in some cases the combination

Inspection technology experts can easily perform the required upgrades for visual inspection usage, as was discussed at the 2019 PDA Visual Inspection Forum in Washington D.C. However, there

is one crucial point that must be considered to enable validation: in contrast to many other industries, the deep learning model for pharmaceutical use must be “frozen” once the development phase is finalised. It must be static and can no longer change to make it version-controlled for validation. A recent discussion paper published by the FDA about the regulatory framework for Software as a Medical Device (SaMD) provides a good reference for application in areas different from pharmaceutical production. AI IN VISUAL INSPECTION – FAR MORE THAN A VISION There is much more to AI in automated visual inspection than just potential. In fact, some pilot projects have already reached a stage close to production implementation. Syntegon Technology, formerly Bosch Packaging Technology, is currently working on a project to implement deep learning algorithms for the inspection of syringe stopper edges on its AIM 5023 inspection machine. The pharmaceutical industry is known for its conservative approach to innovation. This is mainly due to the very strict regulatory guidelines for process validation – overall a highly positive attribute since the manufactured products have a direct impact on the health and safety of patients. “It takes a lot of courage and experience regarding software implementation and process validation to push the concept


beyond the finish line,” as Dr Jose Zanardi, who is responsible for vision inspection development and applications at Syntegon Technology and closely involved in the project, likes to put it. Here, the company’s longstanding experience in the development of automated visual inspection machines since the early 1970s, combined with the profound expertise in processes, implementation and validation is an important prerequisite. NO “ONE SIZE FITS ALL” APPROACH Typically, a “one size fits all” approach will not work in deep learning projects for visual inspection. Instead, the first step should consist in a pre-assessment based on a large amount of images from reference samples. In our example this could be images of good units with bubbles, different stopper positions, products and fill volumes for body inspection, as well as different types of particles intrinsic to the process. Based on the available image data, offline verification studies provide the basis for the integration of deep learning models into the existing software. In the second step, a customerspecific project should be defined with parameters such as product, existing machinery, expectations and timeline. The principle process does not change, and the recipe parameters are still validated according to GMP requirements. The only changes are the tool used to develop the process and the required hardware. As mentioned above, even the hardware only changes slightly: deep learning requires PCs with GPUs, which are able to process very complex and large amounts of data. In a deterministic deep learning model, small packages are trained up to a certain “level of

intelligence” and then frozen. This is especially important regarding validation, regulatory approval and inspection. A POTENTIAL TRENDSETTER FOR THE PHARMACEUTICAL INDUSTRY “We believe that this technology has the potential to achieve detection rates close to 99% in the future while reducing false reject rates dramatically by half or more,” says Zanardi. He is confident that the deep learning application can be implemented in a GMP environment – and will obtain regulatory endorsement for both the qualification strategy and implementation. This will significantly improve the inspection of products that are difficult to inspect, such as lyophilised products or those filled into complex primary packaging such

as syringes or double-chamber systems. This will reduce reject rates and subsequently costs in the production of expensive products such as orphan drugs. USP chapter 1790 specifies that “validation of the automated inspection equipment should be based on comparison with the compendial manual inspection process with an expectation that alternative inspection methods demonstrate equivalent or better performance.” This is definitely true for the current deep learning project. Since the guidelines for implementation of automatic visual inspection machines are applied to AI and all its subsets, the pilot project stands a good chance of advancing into serial production – and of becoming a trendsetter for an entire industry.


The pharmaceutical industry is known for its conservative approach to innovation.



BIOSIMILARS The biosimilars market is expected to contribute to cost savings in the US pharmaceutical industry this year, according to a new report by GlobalData. The report predicts that biosimilars will gain a strong foothold in the US due to the expiration of a number of biological patents. In particular, pharmaceutical companies will be looking to build on the success seen by Amgen and Pfizer’s biosimilar strategies. Bonnie Bain, global head of pharma at GlobalData, said: “Even though the price differential between biosimilars and their branded counterparts is only around 15%-30%, which is significantly less than the cost savings seen with the average generic drug, we still expect that biosimilars will start to contribute cost-savings in the US in 2020. Uncertainty still exists for reimbursement, automatic substitution, competition from


next-generation biologics and litigation but the fact that insurers such as United Healthcare placed Amgen’s biosimilar mAbs on the primary tier of its formulary bodes well for future biosimilars.” OUTSOURCING Pharmaceutical companies will continue looking towards specialists to diversify their offerings to customers and enable them to focus more on in-house activities. Andrew Henderson, sales and marketing director at Sterling says: “It’s likely that both the outsourcing and M&A trends will continue into 2020 as the CDMO market becomes increasingly more competitive in these areas. As big pharma firms are likely to continue outsourcing non-core requirements to specialists, it will be interesting to see how CDMOs continue to develop their capabilities to provide customers with better services and meet demand.” DIVERSITY Diversity is an area in which the life sciences industry struggles and this problem extends to clinical trials. Indeed, Christian Hebenstreit, senior VP and general manager, EMEA at Medidata says that “only 3% of patients have access to participate in clinical trials (and therefore access to potentially lifesaving drugs).”

“This is due to a range of factors – lack of knowledge, geographical location, financial constraints, background or ethnicity – and means that certain groups are massively underrepresented. This is something that the industry needs to address on a global scale immediately as it will lead to flawed and misrepresentative clinical outcomes,” he adds. A FOCUS ON THE PATIENT Patients are at the core of what drives the pharmaceutical industry, but historically, they haven’t been factored into how clinical trials operate. Sascha Sonnenberg, global head of business development at Sharp Clinical Services, says: “Patient centricity is for sure the biggest trend the industry is following. Having a well-defined strategy in this area will assure patients are recruited and stay engaged in a compliant and adherent way in clinical trials. “First and foremost for pharma companies and sponsors, patient-centric trials practices will help them make savings - faster recruitment and lower drop-out rates will shorten trials and deliver earlier revenue streams. There is also a groundswell of regulatory focus and support for patientcentricity with the FDA in particular showing a keen interest in understanding how this model can help bring therapies to patients more quickly and efficiently.”

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