Product Innovation & Sustainability Theatre

1-3 November Stand 30J20, Hall 3.0 Messe Frankfurt, Germany

1st November

Product Innovations (Day 1)

Time	Session Details
10.30 - 10.55 AM	What if a New Generation of LBEs Could Lift Advanced Pharmaceutical Drug Development with Poorly Soluble APIs to its Next Level by providing a Built-in Fit-for-Purpose Feature for Advanced Processes such as Hot Melt Extrusion and 3D-Printing? More than 75 % of new chemical entities are poorly soluble and require bioavailability-enhancing excipients. The application of excipients in advanced pharmaceutical processes, such as hot melt extrusion and 3D-printing, aligned with advanced approaches towards personalized medicine, requires special features. Lipid-based excipients (LBEs) are “natural contenders” for these tasks. However, until now, it has not been possible to fully exploit the potential of LBEs. The main challenge is the unstable solid state of current LBEs, e.g., polymorphism, leading to instability of the final dosage form. Compared to polymers, the low melting temperature of lipids, combined with highly crystalline arrangement, limits their application in advanced pharmaceutical processes such as hot melt extrusion and 3D-printing. Dieter Scherer, Senior Advisor in Pharma Consulting Sharareh Salar-Behzadi Principal Scientist, Research Center Pharmaceutical Engineering GmbH
11.00 - 11.25 AM	Build or Buy: What are the Key Considerations in Choosing the Right CDMO Partner? In recent years, the standardization of biologics manufacturing processes has given product developers multiple viable options for producing biologics. These options include building an in-house production system or partnering with a contract biologics manufacturer. Although building in-house does offer the advantage of direct control; the time, labor, and spend required to implement this often makes it the inefficient choice. On the other hand, working with an experienced contract manufacturer can help you save time and costs by leveraging a deep pool of industry experience. However, the process of selecting the right CDMO partner needs to be performed after careful analysis of many factors: any of which, if overlooked, can create risk of delay or cost overrun. In this session, we will discuss the key parameters that you can easily assess when choosing the right innovative CDMO partner that will keep you competitive in a rapidly evolving market. Kevin Sharp, Vice President, Head of Global Sales Strategic Operations, Samsung Biologics
11.30 - 11.55 AM	Container Closure Integrity Testing Deterministic Methods Container closure integrity (CCI) testing is determined by evaluating whether a given container maintains its sterile barrier. It is a mandatory step in the design verification phase of a drug – device combination product development. Several methods exist with different advantages and limitations. During this session, we will address the following points: Probabilistic vs deterministic CCI Testing1 Presentation of the different deterministic CCI testing methods with applications and limitations What to consider when selecting CCI testing method At the end of the session, attendees should have a better understanding the influence of the drug specificities to select the most suitable technical option for Container Closure Integrity testing activities based on the advantages and limitations of different techniques available on the market Kayla Kaspar, Services Technology Development Manager, ZebraSci
12.00 - 12.25 PM	Design of a New Elastomer Formulation for Lyophilization Applications 4040/40 elastomer formulation was designed with ‘future in mind’ to meet the ever-increasing performance & quality standards expected of primary drug packaging. The presentation will summarize the extensive Quality by Design (QbD) process that was undertaken to develop this new formulation as well as considerations taken for closure design dedicated for Lyophilization applications. Details of the extensive characterization that was performed as part of product development as well as data to demonstrates the overall performance of the new rubber formulation for lyophilization stoppers with respect to Extractables/Leachables, Particulates, Moisture, Container Closure Integrity (CCI), Particles and Manufacturability will be presented. Francis Carroll, Spec. Technical Customer Support, West Pharmaceutical Services
12.30 - 12.55 PM	Latest Data of OXYCAPT Multilayer Plastic Vial OXYCAPT is a multilayer plastic vial that consists of three layers, COP/New Polyester/COP. The product has achieved excellent oxygen & ultraviolet (UV) light barrier, very low extractables, high pH stability, low protein adsorption, high transparency, high break resistance, lightweight, etc. For example, the oxygen barrier is about 20 times better than the COP monolayer vial, and the UV barrier is much better than the transparent type-1 glass and COP monolayer vials. We will show many new useful data such as ultra-low temperature resistance, quick defrosting test, photo-stability test on antibody drugs, etc. We believe that OXYCAPT can offer many benefits to the rapidly growing field of biologics and gene/cell therapies. Yasuaki Yoshimura, Researcher, Mitsubishi Gas Chemical Company, Inc.
	LUNCH BREAK/VISIT EXHIBITION
13:30-13:55 PM	Taking Secondary Packaging for Vials to the Next Level Innovative Ready-to-Use Vial Platform for the Pharmaceutical Industry. Gerresheimer AG and Stevanato Group are addressing rising demand for RTU vials in the market and the partnership serves as a market enabler to fully support customers’ evolving needs and establish a gold standard in the industrial filling process. The new RTU solution platform will share the same secondary packaging, production process and sterilization method. A hallmark of the new RTU platform is a significant reduction in particles, improving the overall quality and performance of the RTU solutions. Wenzel Novak, Senior Global Director Business Development MDS, Gerresheimer AG
14.00 - 14.25 PM	Biologics for Nasal Delivery: A Whole New Ball Game to Hit the Target Despite being widely commercialised as injectable formats, “biologics” are now creating lots of excitement in the orally inhaled and nasal drug product (OINDP) segment of the pharma industry. But compared to small molecules, one biologic can be fundamentally widely different from next in their properties and behaviour, so this all-encompassing classification can also create confusion for companies trying to navigate the complexity of turning their molecule into a viable nasal drug product. This session will explain the wide ranging properties of the main types of biologics (peptides, nucleic acid based molecules e.g. mRNA, larger proteins e.g. monoclonal antibodies) using easy-to-understand analogies, whilst introducing how these might impact – and be impacted by – the formulation itself as well as the physiological environment of the nose. A special consideration will also be made around the potential to exploit the nose-to-brain pathway, and particularly the interest in the use of nanoparticle encapsulation or conjugation technologies to facility the molecule’s journey to its target. Gemma Budd, Director of Business Development, Nanopharm, an Aptar Pharma Company
14.30 - 14.55 PM	Moving Patients Training from Clinical to Home Settings The COVID-19 pandemic brought on a new age of connected health, with telehealth utilization rates spiking 78 times higher than in February 2020. Telehealth utilization has now stabilized and remains 38 times higher than in February 2020. As new biologic drugs are launched onto the market; more patients can receive treatment in their home as opposed to going to a clinic for an IV infusion. For patients receiving care at home vs. in-clinic a significant challenge that must be overcome is proper training. The presenters of this abstract have developed and launched training devices, Instructions For Use, and instructional videos to provide patients with the necessary training for success. HCPs typically have 15-20 minutes to onboard a patient. Lack of time paired with the nuances and differences of each device make it nearly impossible to provide effective training and onboarding. Patients that do receive training are still faced with the effects of the forgetting curve, where memory retention drops off over time. Joe Reynolds, Senior Manager, Strategy and Patient Insights Noble, an Aptar Pharma company
15.00 - 15.25 PM	The next generation vaccine syringe - BD Effivax™ Glass Prefillable Syringe As the vaccine market continues to grow, vaccine manufacturers are looking to differentiate themselves by seeking solutions for critical challenges that: Offer end to end vaccine container reliability1 Consider cost sensitivity Support documentation for regulatory scrutiny2 Ensure continuity of supply3 BD Effivax™ Glass Prefillable Syringe has been designed in collaboration with leading pharmaceutical companies to meet critical needs such as product integrity, cosmetic quality, and product consistency. It sets new standards of performance that improves end-to-end syringe reliability and can translate into lower total cost of ownership. Vincent Hérin, Associate Director, R&D Product Development, BD Medical-Pharmaceutical Systems
15.30 - 15.55 PM	Clinical Evaluation of an Investigational 5mL Wearable Injector An investigational large volume subcutaneous wearable injector delivered 5mL viscous placebo injections to healthy adults with favourable subject tolerability and acceptability. This session will outline: An investigational large volume subcutaneous wearable injector was evaluated for feasibility of 5mL, ~8cP non-Newtonian placebo injections in abdomen and thigh of 52 healthy adults of two age groups (18-64, 65+ years), with and without movement Assessment of device performance, tissue effects, depot location and user-reported pain and acceptability Benefit: Greater understanding of clinical performance and user perception of this investigational wearable injector may de-risk clinical outcomes as more biotherapies for chronic disease transition from intravenous to subcutaneous administration Natasha Bolick, Associate Director, Translational and Clinical Sciences Center of Excellence -BD Medical-Pharmaceutical Systems
16:00 - 16:25 PM	Selection of a Primary Container Closure System Capable of Maintaining Closure Integrity during Cold Storage at -80°C Advanced therapies are rapidly becoming a reality, targeting unmet patient needs and treatments for diseases with limited therapeutic options. Some advanced therapies, such as gene therapy and mRNA, require cryopreservation due to their fragile nature at room temperature, putting unprecedented expectations on the packaging systems to maintain Container Closure Integrity (CCI) during storage at -80°C. The quality, patient safety, and high value of these therapeutics can be jeopardized if the chosen containment system doesn’t consistently maintain a sterile barrier from when the drug is packed through to administration to the patient. During cooling between room temperature and -80°C, common vial system components such as glass vials, elastomeric closures, and aluminium seals exhibit contraction and changes in physico-mechanical properties. These changes in material properties and component dimensions may affect the system’s ability to maintain closure integrity, resulting in the formation of transient leaks. In this joint study conducted by West and Corning, we discuss results from four experiments that explore the influences of capping pressure, cooling rate, dimensional changes, and long-term storage at -80°C on the system’s ability to maintain closure integrity. Both Helium leak testing and laser-based gas headspace analysis were used to monitor the closure integrity. The key result of the study is a combination of vial system components and capping conditions that maintain container closure integrity when cooled to and stored at -80°C Jennifer Roark, Technology Manager, Container Closure Integrity, West Pharmaceutical Services
16:30 - 17:00 PM	Welcome to the future of Value Added Solutions for the Pharma Industry – Discover the Future Sustainable Brenntag! Brenntag developed a long-term strategy and strives for the vision to become a “Future Sustainable Brenntag”. Join our session and get inspired by Dr. Andreas Kicherer and Wolfgang Edel. Our Session will highlight: 1. Innovation meets Sustainability → meet our NEW green products and solutions 2. Circular economy for API production → our hands-on solution 3. Brenntag ESG framework → Footprint Reduction and Handprint Increase as a Distribution company Listen to our initiatives and actions to create Value Added Solutions for the Pharma Industry! Andreas Kicherer, Vice President Sustainability Brenntag Group, Brenntag Wolfgang Edel, Senior Manager Sustainable Products and Solutions, Brenntag

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SUSTAINABILITY

2nd November

Time	Session Details
10.45-11.15 AM	Keynote Teresa Rodo, Head of Global Healthcare Operations and a Member of the Healthcare Executive Committee of Merck
11.20-11.45 AM	Why Biopharma CDMO Companies Must Transition with Long-Term Sustainability in Mind Today, leading companies are not only centered on creating values, but they also focus on developing strategies to foster a company's longevity. Therefore, many companies have become more engaged in sustainable activities to make progress and are now joining the race. Acknowledging the importance of sustainable development, Biopharma CDMO companies are also finding ways to show their best performances in sustainability. In this session, we will discuss the importance of why pharmaceutical CDMO companies should make their transition with long-term sustainability in mind. Explaining how the pharmaceutical industry (and innovative initiatives) should put effort into improving outcomes for patients, employees, the environment, and the wider community. Learn how Samsung Biologics, as one of the leading CDMO companies, is committed to making a sustainable future by creating ESG values through climate change responses, entry into the carbon neutral society, and transparency in the governance structure. James Choi, Executive Vice President, Chief Information & Marketing Officer, Samsung Biologics
11.50-12.15 PM	Indena's Commitment to Sustainability: From Responsible Supply Chain Management to Smart Use of Energy, we aim to Protect Nature, People, and Business Indena is relentlessly working to generate a sustainable impact on its stakeholders, cultivating with care its own precious circle: Nature, Technology, and People. In terms of actual projects and actions, Indena's commitment in sustainability includes responsible supply chain management, a circular economy in product design, and very smart use of energy in its plants. As for energy use, which is linked to climate change, one of the most urgent global sustainability challenges, Indena has been working for years to reduce consumption, save energy, and achieve high levels of energy self-production. All the actions taken for sustainability allow Indena to be fully reliable in terms of business continuity and thus be a solid partner for all its clients. Carlo Aloni, Group Industrialization & Technology Transfer Director, Indena Francesca De Rensis, Marketing Director, Indena
12.20-12.45 PM	Sustainable API’s of Aspen API: From Manufacturing to End Users All manufacturers are obliged to control and reduce their ecological footprint. With regard to drug manufacturing, the main part of this footprint is responsibility of the API supply chain. As an API manufacturer, Aspen API is taking sustainability very seriously. In this presentation Aspen API will give an insight to their sustainability program, their goals and their targets. At Aspen API we truly believe that sustainability should be managed throughout the complete supply chain, from suppliers of raw materials and chemicals up to the final API. However, we think are responsibility does not stop at the final API. Many hormones, such as Estradiol, end up in the environment by secretion via the end users. Therefore, Aspen API is participating in a broad consortium led by Wageningen Food & Biobased Research in the so called MEDALE project.” In this MEDALE project, Wageningen Food and Biobased Research is going to look at the potential of natural micro-organisms to biodegrade specific compounds of high concern. Many indications have been found in literature that micro-organisms are able to degrade specific compounds. However, these activities have not yet been tested in the environment in which these compounds are present. We will test and naturally select the best performing micro-organisms for use in bioremediation or biodegradation. This will be a co-presentation between Aspen API and Wageningen Food & Biobased Research. Dirkjan van Zoelen, Manager Development and Technical Operations, Aspen API Martijn Bekker, Project Leader, Wageningen Food & Biobased Research
12.50-13.15 PM	Why the Pharma Industry Must Address their Carbon Footprint Rapid climate change has direct impacts on human health. These arise from multiple causes, including severe weather, changing ecology of disease vectors, increased allergens, and geopolitical conflict over scarce resources. Healthcare itself contributes to climate change because of its sizeable carbon footprint. It follows that health systems should be frontrunners in reducing its carbon footprint to limit the impact of climate change and mitigate poorer health outcomes and inequity. Many health systems have identified medicines as one of the largest single contributors to their carbon footprint. This session will evaluate the pharma industry’s carbon footprint and provide recommendations on what we can do to reduce emissions, meet environmental targets, and consequently open a new path to supporting human health. Aurelio Arias, Engagement Manager, Thought Leadership, IQVIA
13.20-13.45 PM	The iGAL 2.0 Metric for a Greener Future in Drug Manufacturing – A Supply Chain Perspective You will learn about best practices in Green Chemistry metrics for evaluating the impact of waste in pharmaceutical drug substance manufacturing, and their limitations, in the context of API lifecycle assessment. You will also be informed about the new iGAL 2.0 metric as a valuable extension to the existing waste metrics, allowing evaluation of relative process greenness and the sustainable innovation impact by scientists. Finally, you will learn about opportunities to effectively integrate the new metric into Pharma-CDMO partnerships for the benefit of their business and the planet. The presentation will be based on these recent publications: Improved iGAL 2.0 Metric Empowers Pharmaceutical Scientists to Make Meaningful Contributions to United Nations Sustainable Development Goal 12 A Green Chemistry Continuum for a Robust and Sustainable Active Pharmaceutical Ingredient Supply Chain Frank Roschangar, Highly Distinguished Research Fellow, IU Sustainability, Boehringer Ingelheim Pharmaceuticals, Inc. Michael Umberto Luescher, Process R&D Chemist - Environmental Sustainable Process Design, Novartis Pharmaceuticals
	LUNCH BREAK/VISIT EXHIBITION
14.00-14.30 PM	Sustainability – What Does it Mean for Excipient Makers and Users? The pharmaceutical industry is not excluded from the need to progress towards sustainable development, including pharmaceutical excipients. Pharmaceutical manufacturers must qualify their excipient suppliers which requires a lot of information. As pharmaceutical manufacturers have their own systems to collect this information, this creates a significant workload for suppliers by filling in multiple forms with the same details. The IPEC Federation published the Excipient Information Package Guide (EIP) to aid the exchange of this information, allowing suppliers to maintain one form for all customers. As the need for awareness on sustainability grows, there is a proliferation of requests for suppliers to provide evidence that they have effective Environmental, Social and Governance (ESG) programs in place. A new section of the EIP is being developed to facilitate exchange of ESG Information. This comprises overviews of the organisation, ESG programs, procurement and supply chain, health and safety policies / practices and Business Continuity Plans. Geertrui Haest, Scientific & Regulatory Affairs Manager EMEA, Cargill. Representing the International Pharmaceutical Excipients Council Europe (IPEC)
14.35-15.00 PM	Sustainability, Quality and Supply Chain Integrity: A New View Understanding and challenging ourselves to think about the intersection of sustainability, quality, and supply chain integrity within pharmaceuticals. This relationship has become significant as we enter the post pandemic era in which the pharmaceutical industry strives to not only secure its supply chain and material quality, but in parallel ensure that its sustainable to protect around shortages. This presentation will discuss opportunities on how the three sectors align and how through best practices in one area the other two are improved. Jim Fries, CEO, Rx-360
15.05-15.30 PM	Sustainable Production of complex API Improving the sustainability in the CDMO industry is a multi-facetted approach covering environmental, economic and social tasks while having a strong focus on these areas where a company can make the highest impact. Bachem, the leading manufacturer of peptides and oligonucleotides is a good example for using this approach successfully. By innovating for better manufacturing the company could massively reduce greenhouse gas emissions and solvent consumptions: something that is also of utmost interest when searching for a partner for large-scale production of oligonucleotides and peptides." Dr. Tycho Leifels, Head of Product Management, Bachem
15.35-16.00 PM	Strategies to Achieve Sustainable Pharmaceutical Manufacturing in LMICs Reflecting on pharmaceutical supply chain vulnerabilities in low-and middle-income countries (LMICs) exposed by the Covid-19 pandemic and efforts to expand local and regional production to include vaccines and active pharmaceutical ingredients. Highlighting the new paradigm to develop sustainable pharmaceutical manufacturing, leveraging technology transfer, developing a skilled workforce, and installation of GMP-compliant facilities. Leveraging lessons learned through USP’s decades of experience supporting manufacturers in LMICs. Key principles to achieving sustainable pharmaceutical manufacturing in LMICs. Perrer Tosso, Senior Manager, Pharmaceutical Products Supply Services, United States Pharmacopeia
16.10-16.35 PM	Strengthening Diversity, Equity, and Inclusion in Pharma The pharma industry is aware that it needs to improve the representation of women and minority communities in its businesses. The benefits of diverse teams are clear, yet it isn’t an easy road. How can companies create an environment where people feel safe, thrive, and attract the best? Approaching Diversity and Inclusion as part of a wider Sustainability / Environment, Social, and Governance (ESG) performance is an essential indicator of pharma companies' commitment to driving I&D for a more diverse and successful workplace, which ultimately also ensures to better serve patients around the world. Archana Bhaskar, Chief Human Resources Officer, Dr. Reddy's Laboratories Ltd.

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SUSTAINABILITY

3rd November

Time	Session Details
10.45-11.15 AM	Keynote: Julien Tremblin, General Manager Europe, Terracycle Julien Tremblin, European GM of TerraCycle, an innovator in sustainability solutions, will share how companies large and small can drive change, in and out of the pharmaceutical industry and how retailers, brands and consumers are reacting, pushing and adopting as they transition from linear to circular solutions.
11.20-12.10 PM	Putting ESG into Practice - Creating Responsible Supply Chains in the Pharma Industry The complexity and risks found within the global pharma supply chain cannot be understated and key stakeholders from customers to regulators and investors are increasingly expecting the industry to both manage ESG risks and embed sustainability throughout the value chain. This can only be achieved through industry-wide collaboration that sets the standard for what a responsible supply chain looks like and provides support to suppliers to achieve these goals. The Pharmaceutical Supply Chain Initiative (PSCI) and our membership of 60+ pharma and healthcare companies are leading this collaboration to create harmonized approaches and standards for our value chains. Through our Principles for Responsible Supply Chain Management, shared audit program, and supplier maturity model, our members are putting ESG and sustainability into practice to create responsible supply chains. Regan Leahy, Secretariat, Pharmaceutical Supply Chain Initiative (PSCI) Sanjay Sharma, Global Head of Manufacturing, Dr. Reddy’s Birgit Skuballa, Head of HSE Audit & Supplier Management, Bayer Aditi Wanchoo, Senior Manager of Human Rights, Novartis Daniel Rehm, Lead HSE Advisor EEM-EMEA&API, Elanco Animal Health
12.15-12.40 PM	Developing a Sustainability Roadmap for the Biopharma Industry Despite broad agreement across the biopharma sector on common long-term environmental sustainability goals , there remains a lack of industry specific standards, regulations, and metrics. For the past year, BioPhorum members have collaborated across the value chain to chart a roadmap for the biopharma industry; setting out the key enablers necessary to deliver decarbonization and embed circularity. All disciplines: scientists, process engineers, procurement teams, facility designers, regulatory experts can begin to explore the vital role they play in maximizing the contribution the biopharma industry can make to repairing the planet whilst at the same time accelerating access to healthcare for all. Nicola Coles, Director Sustainability, BioPhorum Caroline Calmels, Sustainability Market Manager of Saint Gobain Life Sciences -BioProcess Solutions
12.45-13.10 PM	ESG Risks in Pharma and Biotech – How to Manage your Exposure Pharmaceutical and Biotechnology companies are exposed to more than their fair share of ESG risks, that, if not addressed properly, can have significant financial and reputational impacts in the long run. To measure a company’s level of exposure with industry-specific material ESG risks and how well a company is managing them, Sustainalytics’ multi-dimensional ESG methodology assesses at least eight different Material ESG Issues. Among them, Sustainalytics’ ESG Risk Rating includes Product Governance, Access to Basic Services and Carbon – Own Operations, but what other concepts and indicators should corporate pharmaceutical and biotech professionals consider in their ESG strategies? Understanding your company’s total ESG risk exposure relies on accurate, independent information, such as reporting, policies and programs to evaluate and improve corporate sustainability. Learn more about how the world’s leading companies leverage Sustainalytics’ ESG Risk Ratings to identify and understand the financially material ESG issues that can affect an organization’s long-term performance. Andres Barrera, Senior Sales Associate, Sustainalytics Corporate Solutions Morningstar
13.15-13.40 PM	Sustainable Talent Acquisition: Where has All the Talent Gone? Global drug sales have now hit $1 Trillion for the first time; the R&D pipeline has doubled in the last 10 years, CDMO market is expanding at a consistent 10% YOY. The pharma industry faces countless opportunities; however, there is a problem. Business leaders are asking where has all the talent gone? This session will explore real-world insights into why the industry is facing a talent crisis. He will share those critical factors any pharmaceutical business should be thinking about when preparing their organisation to sustainably grow, including some practical solutions, no matter what your size, to hire more effectively. Neil Kelly, Director & Founder, Vector Partners Limited

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