Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Felicity Thomas

The total pharma development pipeline is set to exceed 20,000 drug candidates in 2022, which has grown by 8.22% and seen more than 1500 new drugs added to the pipeline from the prior year (1). When looking at biological versus non-biological drugs, there has been more ground gain for the former type of drug in the pipeline with the proportions coming close to 50:50—biologics are now consuming 44.7% of the development pipeline (1).

This strong development pipeline representation is also translating into impressive growth for the biologics market, which is projected to grow at a rate of 10.7% annually up until 2025 and then 9.6% annually from 2025 until 2030 (2). Driving this growth are factors such as an increasingly geriatric population, rising need for immunology, and more government initiatives (2).

However, the majority of the pipeline drugs are still in preclinical phases (1), which means there are still attrition rates to be wary of and some work to be done for commercial success to be achieved. Formulating a biologic drug is a potentially problematic area, as the molecules are inherently large and complex, and also have stability issues to overcome.

“For a successful biological formulation, choosing the right formula and a process that will ensure the biological stability and activity while also maintaining sufficient drug concentration without aggregation is key,” explains Jim Huang, PhD, founder and CEO of Ascendia Pharmaceuticals. “And using the correct drug delivery system to deliver the biologicals to the target organ while minimizing enzymatic degradation during body circulation 

A common issue encountered when developing biologics is degradation, which can occur due to changes in a variety of external factors, such as temperature and pH. Huang stresses that many formulation errors can occur due to insufficient studies being performed “to test the biologicals under a variety of physical and chemical stresses in order to provide a good understanding of the degradation products and mechanism.”

Although regulatory bodies demand stress testing be performed on all drug substances and drug products, there aren’t well established selection protocols for such tests available (3). This is an area where an outsourcing partner can prove invaluable, as they have access to a greater pool of knowledge and experience than a company typically would in-house.

“Outsourcing partners should not only function as an extension of the client’s chemistry, manufacturing, and control labs, but also can contribute to its in-house proprietary technologies, formulation skills, and know-how to address the issues arising from the development process of complex biologicals,” Huang adds.

Delivering a drug effectively is key, and, nowadays there are many possibilities for developers to explore. “Non-vector drug delivery technologies such as lipid nanoparticles or polymeric nanoparticles have been applied to delivery of biologicals,” says Huang. “For example, lipid nanoparticle technology has made delivery of COVID-19 vaccines possible.”

“There is a tendency to use more complex drug delivery technologies to address the complex nature of biologicals,” Huang continues. “For example, Ascendia has started to use long acting injectable, in-situ depot, lipid nanoparticles, liposome, and polymeric nano/microparticles to deliver biologicals in order to achieve the pharmacokinetic profiles requested for the biologicals.”

However, nanoparticles are not without their own challenges—safety being a major consideration to factor in (4). When combining a drug with a nanoparticle carrier, it is important to understand whether or not the carrier will impart some side effects for the patient in addition to the potential effects of the active molecule.

The route of administration is, of course, an important factor when considering the delivery of a drug. For the most part, biologic therapies are developed as injectable formulations, mainly because the molecules have poor permeability across the mucosal layer and suffer destruction when introduced to the gastrointestinal (GI) tract (5). However, for patients, non-invasive routes of administration, such as oral, are preferred.

On the matter of oral administration of biologics, Huang points out that it is possible and alludes to the fact that Ascendia has successfully delivered biological-like molecules orally via its EmulSol technology, which increases the molecular bioavailability. “Key to the success of orally administered biologicals is to protect them from GI tract degradation and to enhance the permeability of the biologicals through GI gut membrane,” he summarizes.

Pharma R&D Annual Review 2022 Navigating the Landscape

 (May 2022).
2. Research and Markets, ~, Market Report (February 2022).
3. E. Tamizi and A. Jouyban, 

, 28, 1100–1102 (2022).
5. B. Homayun, X. Lin, and H.-J. Choi, 

Felicity Thomas is the European/senior editor for Pharmaceutical Technology Group.

When referring to this article, please cite it as F. Thomas, “Formulating Biologics: A Learning Curve,” 

Articles

Biologics are forming a greater proportion of the development pipeline, but there are still some formulation difficulties to overcome to ensure clinical and commercial success.

Formulating Biologics: A Learning Curve 

In late June 2022, podcast presenter and campaigner Dame Deborah James passed away after battling stage IV bowel cancer for five years. James was diagnosed at the age of 35 and since that time had championed the cause to raise awareness of bowel cancer and funding to help research in the area (1).

Despite the sad news, James’ efforts in raising the profile of bowel cancer will definitely not go unsung. In fact, since James’ diagnosis in 2016, some promising developments in the field of bowel cancer therapies have already surfaced.

Immunotherapies have been around since 2014 within the oncology sector and have seen therapeutic success in cancer patients, particularly checkpoint inhibitors when combined with chemotherapy (2). However, recent results of a small clinical trial, performed at the Memorial Sloan Kettering Cancer Center in the United States, have shown a 100% complete response rate in 14 patients after being treated with the immunotherapy dostarlimab as a first-line treatment for mismatch repair-deficient (MMRd) locally advanced rectal cancer (3). For this small study, the participants received dostarlimab alone at regular intervals for six months and as all those involved achieved a clinical complete response, none of the patients required follow up chemoradiation or surgery.

Researchers from Queen’s University Belfast have stimulated a viral-like response within tumours to reawaken the body’s own defences, allowing for the immune system to attack the cancer cells and reducing the risk of the disease spreading (4). Currently, this research is in very early stages, but the scientists are designing a clinical trial to test the approach, and it is hoped that it could lead to new treatments that are targeted for bowel cancer in the future.

In a slightly earlier study, the results of which were presented in September 2021, university researchers from the United Kingdom found that it was possible to slow tumour growth in bowel cancer patients through treatment with a small-molecule, protein-inhibitor drug, adavosertib (5). Although this trial was also small and further research in larger patient populations is required, the results are still encouraging because a subset of patients involved had tumours with two common mutations—representing a third of all bowel cancer patients.

Through her work, James has raised millions of pounds, which is continuing to rise posthumously and has reached, at the time of writing, more than £7 million. With the support of Cancer Research UK, the monies raised will be used to fund clinical trials and research into personalized medicine, as well as continuing to raise awareness of cancer.

1. R. Williams, “Dame Deborah James Dies Age 40 After Cancer Battle,” 

, 28 June 2022.
2. D. Crow, “Big Pharma on Mission to Bring Immunotherapy to More Patients,” 

, 1 June 2018.
3. Memorial Sloan Kettering Cancer Center, “ASCO 2022: 100% Complete Response Rate in MMRd Locally Advanced Rectal Cancer Seen in Pivotal ‘Immunoablative’ Neoadjuvant Immunotherapy Clinical Trial,” Press Release, 5 June 2022.
4. Queen’s University Belfast, “Scientists Awaken Viral Response to Target Bowel Cancer,” Press Release, 27 April 2022.
5. NIHR, “New Drug Shows Promise in Slowing Growth of Bowel Cancer,” Press Release, 20 Sep. 2021.

When referring to this article, please cite it as F. Thomas, “Bottoms Up!” 

Dame Deborah James’ legacy and the millions raised through her campaigning will undoubtedly be a big boost to clinical research, ultimately providing new and promising treatments for bowel cancer patients. 

Bottoms Up! Research into Bowel Cancer Therapies Gain Funding Boost

A major component in the success of a therapeutic product is whether the patient actually takes the medicine—an aspect that is particularly pressing in patients with chronic and long-term illnesses. It has been well reported that non-adherence to medication regimens is significantly burdensome on healthcare systems and, ultimately, countries’ economies.

One way to improve patient adherence to medication is by ensuring the dosage form is patient-centric or user-friendly. “Patient centricity is gaining more focus and importance in drug development,” confirms Anil Kane, PhD, MBA, senior director, global technical scientific affairs, pharma services, Thermo Fisher Scientific. “Problems related to polypharmacy and patient non-adherence is critical to healthcare. Patient-centric pharmaceutical drug product is increasingly important to gain patient adherence in pediatrics, adults, and geriatric patients.”

Ideally, a dosage form should incorporate multiple facets to be patient-friendly, notes Anita Solanki, lead—White Papers, Formulation R&D (Pharma and Nutra), ACG Group. “The ideal, patient-friendly, dosage form is one that is easier to swallow, non-invasive, with no taste or odor, has quicker brand recall and is easier to handle and carry, with suitable packaging materials,” she says. “So, throughout the process—right from dosage form selection, through to excipient selection, appearance, packaging, and material selection—every step needs to be considered with the patient in mind.”

Cornell Stamoran, PhD, vice president of Strategy and co-chair of the Catalent Applied Drug Delivery Institute, also agrees that key decisions made during drug development, such as molecule design, formulation, dose form, device selection, and packaging, can have an impact on how successful the therapy will be for patients. Stamoran confirms that through discussions with physicians and payors that were performed at Catalent’s Applied Drug Delivery Institute there is a belief “that those companies that more effectively incorporate patient-focused thinking into drug product design, and provide evidence from the resulting clinical trials, will increasingly have a significant advantage in the market, and ultimately this will benefit patients.”

In terms of dosage form, Thomas B. “Brad” Gold, PhD, vice president, Pharmaceutical Development, Metrics, specifies that oral solid dosage (OSD) forms are preferred by both patients and payers. As such, OSD forms are dominant within drug development and payer schedules. However, despite the fact that OSD forms are preferred there are still issues with compliance, he continues.

“Depending on the formulation and treatment course, orally administering a drug to patients can become problematic and contribute to poor health outcomes,” Gold adds. “Individual dose size, as well as dose frequency all have an impact on the patient centricity of an oral drug. Fortunately, formulation and manufacturing techniques like amorphous solid dispersions, multiple unit particle systems, mini-tablets and other systems are helping to make OSDs more patient centric than ever.”

Kane concurs that OSD forms continue to be market-leading, not least because of the preference by patients, but also due to cost savings and efficiencies afforded by the dosage form in the small molecule market. “Strategies for improving adherence need to consider the characteristics of the individual therapeutic regimens according to the needs of the patients. In particular, geriatric, and pediatric populations have special needs/preferences that should be considered when designing drug products,” Kane continues. “Introducing patient centricity into drug product design offers the opportunity to meet the needs and preferences of patients.”

Providing some examples, Kane explains that through employing taste-masking to create palatable dosage forms will allow for improved patient compliance in geriatric patients with dysphagia, which is a difficulty in swallowing. Other considerations to improve patient centricity of a dosage form for the pediatric segment of the population include the size of the dose, ease of administration, volume of fluid required to be administered, and dosing frequency or frequency of administration, he confirms.

“Innovative ideas and formulation strategies including fixed-dose combinations, modified release dosage forms, orodispersible formulations, multi-particulates, and minitablets in capsules or tablets will support patient-centric drug products,” Kane states.

For Ali Rajabi-Siahboomi, vice president—chief innovation officer, Colorcon, another factor to consider is the potential differentiation between tablets, which is being sought by regulators and marketers. “Unique designs are important because they help make medicines memorable to patients, caregivers, and pharmacists, and may also make a tablet easier to take. From an anti-counterfeiting perspective, unique designs also make products more difficult to copy,” he says. “There are production benefits as well. A unique design offers differentiation on the packaging line, making it easier to visually spot a mix-up and prevent product recalls before it even happens.”

Furthermore, Rajabi-Siahboomi reports that the FDA has also acknowledged the advantages of better design, a fact that is apparent through its guidance documents—Safety Considerations for Product Design to Minimize Medication Errors and Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules (1,2). “In essence, too many products and dosages look the same and there’s a risk dispensers may distribute the wrong product, or people taking more than one medicine (increasingly common in our aging population) will get their pills mixed up,” he explains. “Regulators now expect companies to consider aspects such as size, shape, color, and differentiation between dosage strengths before marketing. Similar-looking dosages, especially plain white tablets, may not get through the regulatory process. Your tablet needs to be different.”

Adding to these thoughts, Hanns-Christian Mahler, CEO of ten23 health agrees that regulatory focus on patient-centricity will further increase, albeit to ensure the therapeutic product is being used adequately and to understand potential liabilities when products are used incorrectly. “Additionally, connectivity (to e.g., smartphones) and sustainability are in my view key topics in relation to patient-centricity for drug/device combination products,” he says.

In concurrence, Rajabi-Siabhoomi also points out that the connection with smartphones or smart medicines can provide a significant opportunity with on-dose authentication technology. “Imagine a patient scanning their pill with a smartphone that not only confirms the identity of the medicine but also connects the patient directly to support materials, such as the product leaflet, information that explains the benefits of the medicine, the importance of adherence, what to do if there are side effects, and even the ability to opt into reminders to take the medicine at the right time,” he states.

In March 2022, a panel of experts were interviewed by 

 for a Drug Solutions Podcast episode, focusing on the topic of drug dosage form trends that have had an impact on the bio/pharma industry in recent years.

The panel of experts involved in the discussion were Anita Solanki and Dr. Jnanadeva Bhat, both from ACG Group; Cornell Stamoran, from the Catalent Applied Drug Delivery Institute; Dr. Ali Rajabi-Siahboomi from Colorcon; Brad Gold, from Metrics Contract Services; Hanns-Christian Mahler, from ten23 health; and Anil Kane, from Thermo Fisher Scientific. Amongst the talking points, the panel broached the topic of patient-centricity as well as overarching development trends and the potential effect of novel excipients on dosage forms.

If you would like to listen to the episode in full, visit 

www.PharmTech.com/view/drug‑dosage‑form‑trends

As was specified earlier, poor adherence to a therapeutic regimen not only impacts the effectiveness of a drug but also has a financial impact on healthcare systems, economies, and patients. “Prescription drug medication adherence is a growing concern for public health, and poor adherence to therapy has been associated with poor health outcomes and higher costs for patients,” notes Kane.

Solanki believes that the influence of patient-centricity on the pharma industry will continue to grow and is leading to a big shift in priorities during the development of most dosage forms. “The patient centricity trend is fueling the focus on developing patient-friendly dosage forms. This trend has to be accomplished whilst maintaining optimum therapeutic efficacy and safety,” she says. “Concept transformation has led to the integration of patient-centricity into all aspects of R&D—including formulation design and dosage form development.”

However, there is more work to be done, according to Stamoran. “Through Catalent’s Applied Drug Delivery Institute, we have been advocating for an intentional, patient-focused approach to these areas for the last 10 years. There are important signs of progress, but there remains substantial opportunity to improve patient usability of both new and existing treatments,” he states.

Mahler hopes that patient-centricity and product usability remain priorities for the pharma industry and even that they grow in relevance. “After all, patient-centric drug development all about the patient and to enable them to have an effective and safe treatment,” he concludes.

Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules

Safety Considerations for Product Design to Minimize Medication Errors

Felicity Thomas is the European editor for Pharmaceutical Technology Group.

When referring to this article, please cite it as F. Thomas, “Focusing on the Patient in Drug Development,” 

Putting the patient at the forefront of drug development is essential, particularly to ensure medication compliance is optimized.

Focusing on the Patient in Drug Development

Potential elemental impurities in drug products have been analyzed for many years, with various methods presented in pharmacopeias across the globe. As the world has become more connected, safety and quality compliance within the pharmaceutical

industry has begun to harmonize. For elemental impurities testing, this harmonized work is apparent in the International Council for Harmonisation’s (ICH’s) Q3D guidance documents (1,2).

To learn more about elemental impurities analysis, including the importance of this analytical process, the techniques that are commonly employed, limitations of current techniques, and potential next steps, 

 spoke with Alan Cross, technical specialist at RSSL.

 Why is the analysis of elemental impurities so important in bio/pharma?

 Any analytical testing performed on pharmaceutical and biopharmaceutical materials is primarily to ensure that patient safety is maintained. This is performed either by confirmation that the correct dose of the correct drug substance is being administered or that the dose has no physical or chemical contaminants that may cause harm, or if there are contaminants, that they are below a defined acceptable exposure level. Elemental impurities are no different from any other contaminant, but until recently, the control of these potentially harmful species has been somewhat lacking.

The current elemental testing requirements came into force in 2018 in both the European and United States pharmacopeias following the ICH Q3D document on elemental impurities. This document defined permissible daily exposure (PDE) limits for 24 elements based on robust medical data, which considered the toxicity of the elements and route of administration, and it is written as such to allow for consistent evolution of potential elemental impurity contamination across all pharmaceutical and biopharmaceutical products. This approach has greatly improved patient safety, as it allows for a common approach to controlling elemental impurities based on health risks. Prior to this, elemental testing and limits were often based on the analytical capabilities of the instrumentation or reliance on a colorimetric ‘Heavy Metals’ test, which was insensitive, unspecific, and prone to poor recoveries (500 parts per million [ppm] of mercury in a sample could still give a passing result).

 What analytical techniques are commonly employed to measure elemental impurities in bio/pharmaceutical products?

 Although ICH guidelines do not include any specific recommendations on instrumental methods, the following analytical procedures are suggested in United States Pharmacopeia (USP) <233> dependent on the expected concentration of the elemental impurity in the product or component: inductively coupled plasma–mass spectroscopy (ICP–MS)—parts-per-billion (ppb) concentrations; and inductively coupled plasma–optical emission spectroscopy (ICP–OES)—ppm concentrations. The chapter also sets out recommended analytic procedures for measuring elemental impurities to these methods.

Both techniques are ideally suited to elemental impurity analysis, as they are able to measure multiple elements simultaneously. Therefore, if a full analysis of the 24 elements is required, these techniques are ideal. Both ICP–MS and ICP–OES also allow for a simple screen to take place whereby samples are analyzed against a simplified calibration. This can be powerful in performing risk assessments on samples, as described in the ICH Q3D guideline in which 30% of PDE can be set on a product. If three lots of in-production or six lots of development product tested by the screening method and are shown to be below this level, then further testing may not be required.

As the regulations insist that methods are validated prior to use, this allows flexibility for alternative methods to be used. These methods may be considered based on existing capability, specific chemistry of samples, or simplification of analysis if only one or two elements require testing. Examples might include, atomic absorption spectroscopy (AAS), typically a flame AAS would struggle to achieve the required levels of detection for elemental impurities control but for some elements other forms of AAS can be used which will provide the required detection limits. Vapor generation AAS is sensitive to ppb levels for elements such as arsenic and mercury, and graphite furnace AAS is easily applied to detect lead and cadmium at low levels.

Other techniques that may be employed might be microwave plasma atomic emission spectroscopy, a relatively new technique to the market which uses nitrogen as a plasma gas so has relatively low running costs, when compared to ICP-OES which uses expensive argon as a plasma gas.

Specific mercury analyzers utilize the volatile nature of mercury to allow untreated whole samples as solids or liquids to be analyzed directly by heating and measuring the mercury gas evolved, this simplifies testing and reduces analysis time and preparation costs.

 Could you share any best practices in terms of analyzing elemental impurities in development?

 Preparation of the samples is as important as the analysis itself. Understanding the behavior of the analytes and the sample matrix will allow for robust methods to be developed.

 Are there any limitations with current analytical techniques for the analysis of elemental impurities?

 Traditionally, the main issue with elemental analysis, particularly in ICP–MS with chemical interferences affecting the accuracy of the results, is that over time many modifications to the basic ICP–MS system have allowed for better resolution—with systems such as collision cells and kinetic energy discrimination to remove interferences from the samples. These methods are now also commonly being combined into triple quadrupole systems, which allow for even greater discrimination and reduction in detection limits.

All analytical techniques, with the exception of graphite furnace AAS, use solution volumes in excess of 1 mL for analysis. This is not problematic if there is a large amount of sample, but it can cause issues when the amount of drug product or substance produced is very small, which is becoming more typical in the bourgeoning biologics and biosimilars field. This means that novel preparation techniques need to be employed that can work with small sample amounts and final volumes to maintain the required detection limits, as well as further use of sample introduction systems that can work with small volumes, which are currently employed in some instrumental set‑ups.

 How about the advantages of the current techniques? Could you run through some of those?

 The advantage of the key analytical techniques, such as ICP–MS, ICP–OES, and AAS, is that they are truly multi-elemental techniques. These systems can analyze, either simultaneously or sequentially, the majority of the periodic table. The instrumentation manufacturers are constantly working towards lower detection limits and better resolution, as well as interference control.

 What trends do you foresee impacting elemental impurity analysis in the future?

 The food industry has had a particular interest in the speciation of certain elements, such as arsenic and mercury, where the form (organic or inorganic) has a big impact on the toxicity, and this consideration is also included in the USP/EP/ICH guidance. If a drug product is found to have levels of arsenic or mercury exceeding the PDE levels, speciation could be used to discriminate between toxic and less toxic forms to demonstrate compliance with the regulations.

When referring to this article, please cite it as F. Thomas, “Ensuring Patient Safety Through Elemental Impurity Analysis,” 

Analyzing elemental impurities in drug products is—much like other analytical testing—primarily aimed at ensuring patient safety.

Ensuring Patient Safety Through Elemental Impurity Analysis

The bio/pharma industry, despite being renowned as a slow adopter of novel technologies, is experiencing a boon in innovation—be that in the therapeutic modalities under investigation, the techniques being employed for drug development and manufacturing, or advances in materials used for packaging and drug delivery devices. A major driver for innovation within the bio/pharma sector has been the COVID-19 pandemic, which propelled advances such as the approval of messenger RNA (mRNA) vaccines at record-breaking speeds and led to many companies pivoting to deal with the urgent requirements for capacity and supply chain flexibility needed to overcome pandemic challenges.

A major contributor in the efforts to combat COVID-19 was the European bio/pharma industry, with players from European countries providing key services and making important development breakthroughs. However, despite the various life sciences and biotech hubs and clusters located within the European region, there has not necessarily been a translation of expertise into commercial success, particularly in terms of biotech (1).

Exhibitions and conferences are potential avenues for companies within the bio/pharma industry to showcase their expertise and broaden their potential commercial reach. In line with this type of entrepreneurial opportunity, event organizer Easyfairs is launching the Connect in Pharma event in September 2022 in Switzerland. “We’re really excited to be launching this event in Geneva, Switzerland, as we think it’s the ideal meeting place to bring together leading pharmaceutical companies, biotechs, and suppliers,” explains Josh Brooks, marketing & community director, Packaging at Easyfairs.

“Before deciding on a location, we conducted extensive market research, and it quickly became clear, just by the sheer proximity of so many biopharmaceutical companies, associations, and research centres, that the event had to be in Geneva. This city is at the heart of a number of leading European pharma and biotech clusters in France, Switzerland, Italy, and Germany,” Brooks continues. “There was nothing serving this market already in the centre of Europe, and we thought the Easyfairs team, with our deep experience in running events in the packaging world, could serve this segment of the market well. The event is perfectly placed to bring together key influencers from leading pharmaceutical groups, biotechs, industry clusters, and suppliers.”

To gain a greater understanding about this new event, 

 spoke in more detail with Brooks about the event’s main areas of focus, things for visitors to look out for, the reasoning behind the formation of the event, and the prospects for the future.

 Why have you chosen the four key areas—Innovative Packaging, Drug Delivery Systems, contract manufacturing organizations/contract development and manufacturing organizations (CMO/CDMO), and Filling & Assembling Processes—for the event?

 The pharmaceutical and biotech markets are experiencing incredible advances across the sector. With an array of new developments in the field, including personalized treatments, biologics, nanotechnology, and increasing digitalization across the supply chain, to name just a few, we knew this was the right time to launch an event that would be geared towards looking at the future of innovation in the sector. Understanding the shifting landscape of European regulations and trends in innovation of drug design and delivery systems has never been more important.

What we’re doing is creating an event that looks at everything downstream of the molecule. In other words, once the science has been done, there’s a lot of resources that need to go into getting that molecule into a form that can be delivered in a safe way to a patient. Having the right drug delivery system, filling and finishing vials in a sterile environment, packaging, and outsourcing are all important components that are part of that process.

There’s a vibrant community in Europe making extraordinary advances in all these areas. Businesses are looking for the most effective way to bring their products to market against the backdrop of shifting regulations and an expanding and ageing population. We believe this biotech and pharmaceutical community is underserved, and we’d like to help bring key players together.

We’re very focussed right now on working with our newly formed advisory board to put together the details of the programme, but participants can expect to hear from experts on a range of subjects, from sustainability to patient-centred design to the impact of industry 4.0 on production and supply chains, to name just a few.

 What can visitors experience while at the show?

 After more than two years of cancelled events, we think it’s a really exciting time to be bringing people together. First and foremost, it will be an opportunity for visitors to discover the latest products and services that will help them solve their packaging and production challenges. Many of the world’s leading suppliers of devices, packaging, and CMO/CDMO services will be exhibiting—companies like BD, Gerresheimer, Catalent, Unither, Essentra, and many more—so it will be a perfect opportunity to meet these companies in one place.

Connect in Pharma aims to ensure that people have multiple opportunities to meet and network—like a champagne bar right in the centre of the event, VIP areas, and we’re planning a party on the evening of the first day. It’s about fun, but it’s also about making new connections and seeing old colleagues and friends—all in the interest of driving new collaborations, ideas, and innovations.

We’re also very happy to be able to share that we will be hosting the presentation of the inaugural Sustainable Medicines Packaging Awards, which are given by the Sustainable Medicines Partnership. It’s a new awards programme from a new organization that is aiming to drive a reduction in the environmental footprint of the whole pharmaceutical industry supply chain—more details can be found on the event website.

In addition to all that, visitors will find a conference programme that includes a range of opportunities to see and hear about advances and trends through plenary talks and workshops.

The plenary conferences aim to help the market think about the pharmaceutical Europe of tomorrow. This high-level and non-commercial conferences programme will give the floor to experts from labs including Roche, as well as consultants, corporates, and manufacturers at the forefront of future developments in the world of biopharmaceuticals. Organized as four half-days, they will each address a theme related to the four main areas of the supply chain present in the exhibition area: pharmaceutical packaging (primary and secondary), medical devices, pharmaceutical sub-contracting, and pharmaceutical equipment.

Visitors can also register for 45-minute workshops where experts in packaging, medical devices, pharmaceutical equipment manufacturers, and CMO/CDMO will provide insights and advice. These workshops are all about finding technical solutions to problems. It will be less of a product pitch, and more solution focused. This part of the programme is intended to provide representatives from pharmaceutical and biotech companies with the opportunity to interact with different suppliers to better understand best practices and challenges of their suggested solutions.

Furthermore, we are dedicating a portion of exhibit space to highlight innovation. This will allow participants to hear from exhibitors who will be demonstrating their latest innovation or technology within short, 15-minute segments. We think this will be a great tool to learn about the latest innovations in the market and find new suppliers and partners. 

The event is taking place at Palexpo, the international exhibition and congress centre located within a two-minute walk from the Geneva airport in Switzerland, between 14 and 15 September 2022 Registration for the event is free.

More information about the event, exhibitors, and how to sign up to receive updates by email can be found at 

 What are you hoping to achieve with this inaugural event? Are there any particular targets/outcomes you have in mind?

 As this is the first edition of this event, our biggest challenge and measure of success will be around the extent to which we bring this community together. It will take a few years to build the brand so that Connect in Pharma becomes associated with connecting people and is recognized as the place to go to discover new clients and suppliers.

The dream scenario, the real measure of success, is when a product comes to market that happened as a result of a meeting or discussion that took place at our event. That can take a long time, but we’ve seen it happen time and again with our other trade shows, and that’s when you really know you’ve succeeded.

If we can create a new platform where people can meet, build their business, feel inspired and come away with new ideas, then we’ve done our jobs. For exhibitors, that means new business opportunities and new clients. For others, it will mean finding inspiration for what the future looks like and discovering new solutions.

 Have you already started planning future events? Will the event be an annual occurrence or a different frequency perhaps? Will you expand the exhibition or change location, etc?

 We have created Connect in Pharma as the first edition of an annual event. It is our ambition to grow the event in terms of scale. We expect to have about 100 exhibitors this year, but the venue at Palexpo has the capacity to accommodate larger exhibitions, and we expect the event to grow in the future. The location of Geneva will be maintained for any future events. We are always looking at ways to build our community. That means we will be looking at opportunities to develop the digital offering and exploring other meaningful and useful information services around the event.

1. J. Smyth, “Finance, Culture, Talent: Why Europe Struggles to Commercialize its Biotech Expertise,” 

Felicity Thomas is the senior editor/European editor for Pharmaceutical Technology Group.

When referring to this article, please cite it as F. Thomas, “Connecting the Dots for Pharma,” 

The inaugural Connect in Pharma event will take place on 14 and 15 September in Geneva, Switzerland.

Connecting the Dots for Pharma

In May 2022, the World Health Organization (WHO) received reports of monkeypox cases in countries where the virus is not endemic and that have no direct travel links to endemic countries, which is ‘highly unusual’ (1). Despite the recent outbreak, it is considered unlikely that monkeypox will become a pandemic threat (2).

Preparations into ways of tackling the current monkeypox outbreak have already begun. The therapeutic options that are on the table to help in this outbreak have been, for the most part, originally developed for smallpox (3).

So far, at the time of writing, there are four main players working and making deals to ensure treatments and vaccines are available for the monkeypox outbreak. These companies are Bavarian Nordic, Siga Technologies, Emergent BioSolutions, and Moderna.

 has already signed several supply contracts for its smallpox vaccine (MVA-BN, IMVANEX) with deliveries expected to start immediately to try to curb the current outbreak (4).

 has received requests for its antiviral treatment (TPOXX [tecovirimat]), which is a treatment for smallpox and can be used to treat monkeypox and cowpox in the European Union (5).

 has entered into a definitive agreement with Chimerix for the acquisition of the worldwide rights to TEMBEXA (brincidofovir)—an antiviral treatment for smallpox (6).

 has announced via Twitter that it is investigating potential monkeypox vaccines at a preclinical level (7).

Additionally, other companies, such as Roche and Abbott Laboratories, are working to develop diagnostic tests.

The silver lining of this recent and unusual outbreak, however, must be the fact that the bio/pharma industry and regulatory bodies have indeed learnt from the COVID-19 pandemic and are capable of acting rapidly to mitigate the potential risks associated with a viral concern.

1. WHO, “Multi-Country Monkeypox Outbreak in Non-Endemic Countries,” Press Release, 

, 21 May 2022.
2. M. Kortepeter and Coronavirus Frontlines, “Will Monkeypox be the Next Deadly Pandemic? It’s Unlikely,” 

, 19 May 2022.
4. Bavarian Nordic, “Bavarian Nordic Enters Additional Vaccine Contracts with Governments in Response to Monkeypox Outbreak,” Press Release, 30 May 2022.
5. M. Mishra, “Siga Gets Requests for Smallpox Drug in Europe as Monkeypox Spreads,” 

, 19 May 2022.
6. Emergent BioSolutions, “Emergent BioSolutions to Acquire from Chimerix its Exclusive Worldwide Rights to TEMBEXA (brincidofovir), the First FDA-Approved Smallpox Oral Antiviral for All Ages,” Press Release, 16 May 2022.
7. Moderna, “Our Official Statement on Monkeypox,” Posted on Twitter 23 May 2022 [Accessed 1 June 2022].

When referring to this article, please cite it as F. Thomas, “An Unusual Threat,” 

Cases of monkeypox are rising around the world, but it is unlikely the virus will become a pandemic problem.