CPhI Webinar Series: Latest Approaches for Large Volume Drug Delivery

Milan is home to an internationally competitive pharmaceutical, biotechnology and functional foods hub, with strong growth prospects and a commitment to innovation across its entire supply chain. Italy is also home to one of the most advanced and efficient healthcare systems in Europe - making it an exciting destination for the 2021 CPhI Worldwide event.

Ahead of the return of CPhI North America, Informa Markets has commissioned an in-depth report into the US pharma market focusing on how the pandemic has affected public discourse and political priorities, and how it could alter the pharmaceutical supply paradigm in the medium term. Analysis from six leading US experts – following extensive interviews and data collection – provides an essential guide to near-term priorities, medium-term capacity constraints and longer-term shifts underway in the US pharmaceutical market supply chain.

The COVID-19 pandemic has meant scientists, together with pharmaceutical companies, have had to reinvent how to bring vaccines to market faster without impacting product quality, safety, or efficacy, according to experts speaking at a recent CPhI webinar.

In interviews with key industry experts, this report identifies ten major and emerging trends that are sure to be prominent in 2021, as US pharmaceutical manufacturing and outsourcing continue to respond not only to the challenges that the ongoing global crisis has presented, but also to evolving obstacles and hurdles that are typical in such a highly-regulated sector.

Today, Informa Markets is pleased to announce the launch of the all-new CPhI Online Dashboard, which will allow CPhI clients to quickly and easily track awareness and interest in their company, products and content as well as view and download leads to start building new partnerships.

This special CPhI Report is split into two halves featuring an expert roundtable, global survey data analysis, and detailed expert contributions.

In Part one there is an in-depth write-up of the recent Post-Pandemic Roundtable, as well as analysis of the CPhI executive survey data on ‘opportunities in the latter half of 2021 and implications for pharma manufacturing’.

Part two includes three expert contributions on ‘the implications of QbD for excipients’, ‘Blockchain in Pharma Trends’, and ‘Crystal Ball Predictions for Pharma in 2025’.

Opportunities for contract development and manufacturing organisations (CDMOs) in China continue to grow but many questions remain over what the future of the sector will look like in the world's second largest pharmaceutical market.

Clinical Development Success Rates and Contributing Factors 2011-2020

Biologics have 9.1% likelihood of making it through the clinic to approval, compared to 5.7% for new molecular entities, according to this analysis of 10 years of Biomedtracker drug development data by BIO, Informa Pharma Intelligence and QLS, available for download here.

Biologic products advance through clinical development with a higher success rate than traditional small molecules, a new analysis of clinical development success from Informa Pharma Intelligence, the Biotechnology Industry Organization and the Quantitative Life Sciences shows.

“Biological complexity in drug modalities generally leads to higher LOA,” or likelihood of approval, the analysis concludes. New molecular entities – conventional small molecules – have a 5.7% chance of moving through all three phases of clinical trials to US Food and Drug Administration approval, while biologics had a 9.1% probability. Vaccines – with 10 times fewer candidates than other biologics – clocked in with a 9.7% chance of a Phase I candidate eventually gaining approval.

Informa and BIO analyzed a decade of data collected by Informa’s Biomedtracker database, identifying 12,728 clinical phase transitions, which mark a program’s movement out of a clinical phase, commonly by advancement or suspension. QLS Advisors applied machine learning to “uncover underlying drivers of success” in the 9,704 clinical drug development programs included in the study, “Clinical Development Success Rates and Contributing Factors, 2011-2020,” published 17 February 2021.

Overall, for all modalities, the LOA from Phase I was 7.9% for the 2011-2020 period.

Speaking at CPhI North America, Dr Scott Gottlieb shares insights into how the US should prepare for future pandemics by building out vaccine capacities

2020 has been one of the most turbulent years in recent history and has cast a shroud of uncertainty over the future. While pharmaceutical supply chains have proved resilient to the unprecedented shock of COVID-19, many more questions will be asked of the industry over the coming months. Pharma’s response to the pandemic in terms of vaccines development and distribution of treatments has grabbed the majority of the headlines but the major issues facing the industry are by no means exclusively coronavirus related. In interviews with key industry experts, this report identifies the major and emerging trends that are sure to be prominent in 2021, as pharmaceutical manufacturing and outsourcing continue to respond not only to the challenges that the ongoing global crisis has presented, but also to evolving obstacles and hurdles that are typical in such a highly-regulated sector.

For pharma manufacturers and service providers, attending face-to-face events and exhibitions has always been a crucial tool for meeting existing clients, signing contracts, and gathering leads for new business. But with events unable to trade over the course of the pandemic, connecting with clients in an online environment and evolving to become more digitally astute has become a necessity.

The CPhI Annual Report is a comprehensive and critically important publication that analyses key trends and innovations forecast by our panel of world class experts, as well as the CPhI Pharma Industry Rankings (an annual executive survey of pharma professional). Now in its eight year and launched at the CPhI Festival of Pharma, the report is an essential read for executives looking to get a head-start today on the shape of tomorrow’s industry.

The rankings compile the answers from nearly 40 questions for 550 global executives, covering perceptions across the leading pharma economies for a range of indices including: ‘quality of API manufacturing’, ‘quality of FDF manufacturing’, ‘innovativeness’, ‘growth’ and ‘biologics manufacturing’ amongst many others.

This year’s expert submissions include contributions from ten experts spanning topics as diverse as CDMO capacity forecasts, biologics manufacturing, AI, and sustainability to macro supply chain geo-realignments, digital adoption and patient centricity. Running as a series of opinions and articles, the CPhI experts call upon their considerable commercial and technical acumen to prophesize the future direction, technologies, opportunities and threats in pharma.

The CPhI Annual Report 2020 includes 15 pages of survey data analysis – including the CPhI Pharma Index, executive supply chain concerns, COVID implications, and the national pharma rankings – 10 expert contributions, spanning 30,000 words and 74 pages of insights.

Still to come: Not content with one edition, later this year, CPhI will also be issuing a second supplementary CPhI Annual Report 2020, post the CPhI Festival of Pharma spanning 4 further articles and executive survey results looking ahead to 2021.

Our virtual CPHI Discover event (17th-28th May) is just around the corner, full to the brim with three main content tracks. Here, we explore the major trends in APIs, Ingredients & Formulation

Our virtual CPHI Discover event (17th-28th May) is just around the corner, full to the brim with three main content tracks. Here, we explore the major trends in Drug Delivery and Packaging.

The availability of of biologic therapies to treat oncology disease conditions has led to improved clinical outcomes, but the high cost can create barriers and disparities in treatment access, and therefore outcomes. The use of biosimilars can improve patients' access to care by decreasing treatment costs and creating price competition between the originator product and biosimilar competitors. Watch this webinar from Clarivate on-demand now to understand the following: What is the current landscape of biosimilars in oncology? How do biosimilar approvals and market access differ between the United States and Europe? What is interchangeability and what is its impact? What are the barriers to uptake of biosimilars in oncology? What is the future of biosimilars in oncology?

Our virtual CPHI Discover event (17th-28th May) is just around the corner, full to the brim with three main content tracks. Here, we explore the major trends and issues surrounding Manufacturing and Outsourcing.

This webinar originally aired as part of CPhI Discover - 17-28 May 2021 An overview of global CDMO markets – positioning, strengths and weaknesses of the Chinese CDMO industry. The Evolution of the Chinese CDMO industry, from CMO to CDMO, from starting materials, intermediates to API, drug substance to drug products, generic drugs to NCE/NME – what innovations are on the horizon? The challenges and opportunities of the Chinese CDMO industry – Growth dynamics, the competitive landscape and regulatory barriers. Building a successful CDMO amidst fierce competition, what are the critical attributes of a successful CMC team? How to strategically build technology platforms and capabilities which meet global compliance standards, what are the key requirements for facilities and systems? Langhua Pharma’s own strategy towards becoming a leading CDMO in China, what does the future look like?

Read this new CPhI Trend Report which, via interviews with key industry experts, explores the state of India's API manufacturing issue and how it is being impacted by the country's ambitious healthcare reform programme as well as efforts by the government to support domestic manufacturing and reduce supply dependence on rival China.

This podcast originally aired as part of CPhI Discover - 17-28 May 2021 While hot melt extrusion was developed in the 1930s and initially used in the plastics and food sector, the pharmaceutical industry has now firmly embraced this technology platform in its manufacturing as a way of solving formulation challenges, particularly those around solubility enhancement. Advantages of the approach include the ability to use a wide range of excipients and the ease with which process analytical technology can be incorporated. In this podcast, we explore how HME has developed as a proven technology for bioavailability enhancement of poorly soluble active pharmaceutical ingredients, and how it stacks up against other formulation options in terms of cost and scalability in order to deliver high quality, commercialised pharmaceutical products.

With CPhI North America fast approaching, we ask Karen Flynn (President, Biologics & Chief Commercial Officer, at Catalent), Hamilton Lenox (Senior Vice President of Business Development, Sales & Marketing, at LGM Pharma), and Mike Kleppinger, Chief Commercial Officer, at AMRI) to weigh in on strategies the industry can use to build supply chain resiliency which ensure uninterrupted access to medicines

In Europe, questions have arisen about the use of nanoparticle titanium dioxide (TiO2) which has led to concern regarding TiO2 as an ingredient in foods, additives, and — by extension — as a color in film coating formulations for vitamin and dietary supplements, and potentially, pharmaceutical products. In this podcast, David Schoneker, President of Black Diamond Regulatory Consulting and Vice Chair for Science and Regulatory Policy, IPEC will discuss the current status and assess the potential market impact for the pharmaceutical industry. The discussion reviews the current legal situation, the position of the different regulatory bodies, the science-based facts influencing the industry response and provides insight into the possible implications on the use of TiO2 in pharmaceutical products, as well as food supplements. This podcast provides listeners with a clear understanding of the situation relating to the use of TiO2, based on facts and science. Key Learning Objectives: What’s all the noise about TiO2, a widely used material across the food and pharmaceutical industries? Navigating through the current market uncertainty surrounding use of TiO2 Gaining clarity and understand viable alternatives to meet film coating needs This session was originally broadcast live as part of CPhI North America 2021

2020 will go down in history as a pivotal year for the US pharmaceutical manufacturing sector. Firstly, the emergence of the global coronavirus pandemic provided a seismic shock to the industry and forced major rethinking on several lines. And secondly, a bitter and hard-fought Presidential election saw Joe Biden defeat Donald Trump to usher in a complete change of approach towards pandemic management and healthcare delivery.

With over $1 trillion in M&A deals in the previous eight years, this trend in activity shows no signs of slowing with private equity firms capitalizing on the highly fragmented CDMO space and a predicted surge in activity in the biologics and cell & gene as more treatments are approved. This webinar will address the benefits of private equity ownership, in triggering new growth, enabling greater strategic focus, increasing prioritization on M&A and better utilization of internal funds for organic growth initiatives. Discussion points: Update on current M&A landscape How to optimally position a company for first-time external investment Life under PE: strategic support to the company’s management team, The investor view: financing organic growth This session was originally broadcast live as part of CPhI North America 2021

Informa Markets' first in-person trade show of the year welcomes attendees in Tokyo as face-to-face interaction recommences among pharma community

Vaccines are considered to be one of the greatest public health achievements of the last century, so when the COVID-19 pandemic brought the world to a stop, all energies were focused on bringing a vaccine to market. With multiple vaccines now approved and being manufactured in record time, we celebrate this accelerated pace of development in the field. Exploring the different vaccine technologies to understand their mode of action, benefits, risks, and potential real-life impact on protection. The challenges in manufacturing enough doses to vaccinate the world and the potential impact the WTO’s IP waiver proposal will have on future innovation. Discussion Points: Vaccine Science: Two Centuries of Continuous Research, Improvements, and Achievements Future Potential of mRNA Where are the facilities equipped for these new molecule types? What problems are arising and how is the industry working to fix them? Vaccinating the world, a look at WTO’s proposed IP waiver and what it could mean for future innovation This session was originally broadcast live as part of CPhI North America 2021

While pharmacovigilance was originally used to describe the drug safety monitoring system in place once pharmaceutical products had made it to market, the definition has expanded somewhat to reflect not only its role as a monitor of changing risks and benefits in both post- and pre-marketing but also that of its use as an interventionist risk management tool. This expanded field has given rise to a breadth of career opportunities for scientists interested in joining it. In this podcast, Jan Petracek, Director at the Institute of Pharmacovigilance, talks about his work at the International Society of Pharmacovigilance (ISoP), where he is leading a Special Interest Group to develop a global Career Framework for Pharmacovigilance Professionals. This session was originally broadcast live as part of CPhI North America 2021

Twelve pharma market trends we anticipate across 2021 for the drug development, manufacturing and outsourcing sectors.

This panel discussion is led by Global Business Reports, alongside contributors to their 2021 US Biopharmaceuticals Report. With all eyes on science and pharma for solutions and treatments for COVID-19, 2020 was a colossal year for the industry. Thanks to unprecedented levels of collaboration, vaccines and therapeutics have been approved at record speeds. Amidst a global pandemic, CDMOs were active in making acquisitions and investments. Our expert panellists discuss those deals, the challenges closing them and reflect on their relation to some of the broader themes and future trends for the US Pharmaceutical market. In Partnership with GBR This session was originally broadcast live as part of CPhI North America 2021

Virtual Expo Connect to empower access for international pharma to the world’s largest pharma ingredients market

When the world went into lockdown in early 2020, manufacturing of critical ingredients came to a standstill, and companies were forced to re-evaluate their supply chains. Forward to 2021, and companies are still dealing with port closures and shipments of expensive ingredients sat in a backlog, many are faced with the decision of either waiting weeks for deliveries or the faster, yet more expensive domestic production to ensure the continuity of supply of essential medicines. Discussion Points: Creating a geographically robust supply chain is critical for reducing drug shortages, Ensuring essential medicines security through public-private partnerships Risk management and the pivot to regional manufacturing hubs In Partnership with PSCI This session was originally broadcast live as part of CPhI North America 2021

This panel session will discuss the importance of intersectional diversity across all levels of leadership in life sciences, to help ensure that under-served patients groups are fairly represented in all areas, from drug development to employee healthcare. Discussion Points: Lack of diversity in clinical stages The correlation of the effects of racism, poverty, and social instability of health and health outcomes. The employer's role in healthcare quality and health care costs and the future of healthcare plans post COVID-19 This session was originally broadcast live as part of CPhI North America 2021

In this Fireside chat with Dr David Nash of Jefferson College of Population Health, we discuss the inequities of the current US healthcare system highlighted by the pandemic and the role pharma plays in the future of population health. Discussion Points How might Pharma get ahead of the price transparency curve by promoting public availability of prices? What role can Pharma play in improving some of the SDOH that limit our ability to improve the health of the population? How can we really harness patient-centred outcomes and Real World Evidence so that patient committees will actually pay attention? In the healthcare system of the future, what expanded role might Pharma play to actually promote health? This session was originally broadcast live as part of CPhI North America 2021

The Women in Leadership Forum is a place for women across the pharma supply chain to come together to connect, network and share ideas for successfully working and succeeding in the industry. This year attendees will hear inspirational stories from our panel and learn about various methods and routes to securing funding for female founders in pharma.

Moving away from traditional, costly, time-consuming and often unsuccessful R&D methods, innovative companies are looking to AI and machine learning to reduce costs and improve success rates in drug development. This session will explore the different types of AI currently being used by Pharma companies, projects that identify novel pathways, targets and biomarkers and discuss the challenges of biometric data security, and how companies can work alongside existing regulations. Discussion Points What are the different types of Artificial Intelligence and use cases? A look at current regulations and how to make them work for you Federated learning in AI development How biocatalysts are reshaping the synthesis of chemical entities. The power of 3D molecular modeling In Partnership with AAPS This session was originally broadcast live as part of CPhI North America 2021

We apologise for the background music for the first two minutes of broadcast. Many years before the pandemic the industry has highlighted the importance of a globalized supply chain and in particular the heavy reliance on Asian suppliers. The situation fueled calls from political leaders and lawmakers for U.S. manufacturers to start producing critical supplies domestically. But what will be the cost of bringing manufacturing home, and who will the burden lie on? Discussion Points: What will the “Made in America” pledge deliver? Can AI/Digitalization of facilities reduce costs? Addressing the skills and facilities gap Near-shoring – reducing dependence on Asian suppliers.

Discussion Points: Patent expiry opportunities 2021-2026 Catching up with Europe This session was originally broadcast live as part of CPhI North America 2021

Packaging solutions for cosmeceuticals and pharmaceuticals share many similarities; for both, packaging needs to be functional, protective and accessible for the end user. With cosmetics however, branding plays a huge role in attracting and engaging consumers – who now have an increased consciousness and desire for eco-friendly design, zero-waste and refillable solutions. For pharma packaging innovators, adherence is at the heart of product development, but this has historically been less of a consideration on the cosmetics side – what can cosmetic companies learn from pharma in terms of accessible and adherent packaging offerings? This webinar, produced in partnership with Euromonitor International and BEAUTYSTREAMS explores some of the key trends affecting the cosmetic packaging market, and the parallels between pharma and cosmetics. Watch on-demand now!

This webinar originally aired as part of CPhI Discover - 17-28 May 2021 Africa is an exciting emerging market with significant investment potential. While pharmaceuticals are currently manufactured across South Africa, Kenya, Nigeria, Algeria, Morocco and Egypt, the continent still relies on imports for over 70% of pharmaceutical and medical consumables. Discussion points: Current outlook for African pharma manufacturing What are the obstacles to growth? How can the right infrastructure for domestic manufacturing be nurtured? Facilitating R&D and innovation

This podcast originally aired as part of CPhI Discover - 17-28 May 2021 Spray drying is used in various pharmaceutical applications and has become an increasingly popular technique in the production of formulations of poorly soluble APIs and inhalable dry powder formulations. This remarkable technology involves spraying a liquid formulation onto a surface which is then allowed to dry to produce a powder in one single step. In pharmaceutical manufacturing, spray drying is suited to the production of peptides, proteins or poorly water-soluble APIs, particularly antibiotics, because it allows them to be co-processed with solubility enhancement excipients. Another advantage is that the approach reduces the number of unit operations, potentially lowering manufacturing costs. This podcast explores how spray drying can overcome the problem of low aqueous solubility that all too often stall clinical testing programmes.

This webinar originally aired as part of CPhI Discover - 17-28 May 2021 The Cosmeceuticals market is projected to grow 8.9% in the period 2020-2026, driven primarily by conscious consumers who are looking for increased potency in products which offer better efficacy than standard OTC solutions. Beyond this, consumers are also increasingly concerned about potentially harmful chemicals in cosmetics, leaning instead towards natural and plant-based solutions. This session will address cosmeceutical market dynamics and identify opportunities for growth. Discussion points: What are the key growth drivers for the Cosmeceuticals market? Formulating plant-based ingredients - challenges and opportunities Responding to the demand for plant-based ingredients Regulatory considerations for natural ingredients and cosmetics Developing sustainable solutions to differentiate your business for the conscious consumer

This session originally aired as part of the CPhI Webinar Series and was repurposed for CPhI Discover - 17-28 May 2021 Increased adoption of digital technologies can offer a multitude of benefits for pharma companies –from data optimization and analysis to increased productivity in R&D, to sourcing candidates for clinical trials. How can pharma companies take a more active approach to implement digital innovation, to help cope with new challenges in the healthcare industry? One approach to speeding up adoption is to engage with start-ups and established technology companies who can bring different expertise and a more agile approach. This webinar will look explore the relationship between Pharma companies and start-ups, as the key to unlocking digital transformation. What can digitalization do for Pharma companies? What are the benefits? Has the Covid-19 pandemic accelerated digital innovation in the pharma industry? Partnering for success –how engaging with start-ups and tech companies can help acquire expertise and accelerate development A review of successful solutions, initiatives and Start-Ups helping to solve healthcare challenges What does the future look like? Can we expect to see increased digital transformation?

This webinar originally aired as part of the CPhI Webinar Series and repurposed for CPhI Discover - 17-28 May 2021 The global market for the outlook and manufacture of APIs is shifting as more complex or potent ingredients evolve which present specific handling and manufacturing challenges. What are the latest technological approaches for these products, and how can quality, safety and cost be managed and improved? A key impact of the COVID-19 pandemic has been to question the reliance and dependence on Asia as the global leader of API manufacturing. Do we expect to see specific regions implement reshoring of manufacturing efforts? How will global supply chains be impacted? Market Outlook for APIs Can we expect a reshoring of API manufacturing? Will hubs shift from Asia? Continuous API manufacturing –for cost, quality and safety benefits Manufacturing considerations for complex formulations and high potency APIs, what are the latest approaches? This session was originally broadcast as part of the CPhI Webinar Series.

This webinar originally aired as part of CPhI Discover - 17-28 May 2021 Vitamin markets have seen growth spikes in the past year, both globally and in China - the largest manufacturing region for vitamin products.Sales of conventional products such as Vitamin C and D have risen in the midst of the COVID-19 pandemic, as consumers look to boost immunity. This session will address key trends and developments in this sector in the past year, and examine new products such as CoQ10 and NMN, which are creating fresh market opportunities. This webinar will comprise of two presentations: China Vitamins Market: what’s new and what’s to come? Ellie Adams, Managing Director, QIVA CoQ10 Market in Japan and New Water-Soluble Product Trend Yukihiro Miyazaki, Managing Director, Jupiter Bioscience Japan

This webinar originally aired as part of CPhI Discover - 17-28 May 2021 As the pharmaceutical industry keeps on growing, and medical technology keeps on advancing, drug delivery devices are increasingly facing challenges to keep up to date and adapt accordingly. Drug delivery device manufacturers are not only increasingly looking to other industries but also to start-ups to identify novel technologies and new innovative products that are not only patient-friendly and cost-effective but also innovative and functional. Considering the growth of market demand and technological advancements. It is an exciting time to be a start-up working in the drug delivery landscape. This session will feature start-ups providing novel technologies and innovative solutions to current challenges in the drug delivery technology landscape. And it will tackle some of the main trends and challenges ahead for this industry. Emerging start-ups on the Drug delivery landscape The role of Drug Delivery tech start-ups in improving patient access and driving innovation A look into the future of drug delivery: regulation, capital raising, and investments

This session was originally broadcast as part of the CPhI Webinar Series and aired during CPhI Discover - 17-28 May 2021 Building a comprehensive track-and-trace system for medicines, which is aligned with the European Falsified Medicines Directive and to ensure compliance is a must in today’s environment. Pharmacies, hospitals, HCPs, caregivers, and patients now expect a completely secure and traceable delivery process, which requires buy-in from pharmaceutical companies and distributors involved in the supply chain of Investigational Medicinal Products (IMP), SKU’s and unique doses. This webinar provides an overview of the key trends and developments to improve the security of drug delivery direct-2-patient in 2021. Key discussion points: A global overview of regulations on traceability of medical devices and medicines Technical challenges when tracking medicinal products along the product life cycle, from clinical trials to post-marketing authorization What does the future look like? The potential of delivering Direct-to-Patient unique doses

This podcast originally aired as part of CPhI Discover - 17-28 May 2021 Co-crystals are crystalline materials composed of two or more different molecules, typically active pharmaceutical ingredients and co-crystal formers in the same crystal lattice. Tailoring of co-crystals can provide opportunities to not only enhance bioavailability and stability but also the processability of APIs during drug manufacturing. In 2018, the US Food and Drug Administration published guidance clarifying the regulatory classification of pharmaceutical co-crystal solid-state forms for companies planning to submit new drug applications. This move has generated a lot of interest in the co-crystal field. In this podcast, we take a look at how the use of co-crystals have evolved and what are the best approaches to screening and selecting co-crystals to identify the most viable ones to help find suitable development candidates.

This webinar originally aired as part of CPhI Discover - 17-28 May 2021 Innovative biotherapeutics and novel technologies are currently being developed and commercialised at record levels, providing practical treatments for patients with cancers and autoimmune diseases across the world. In 2019 the FDA approved 48 novel drugs, several of which represent advanced, first-in-class therapies. It comes as no surprise then to hear that venture capital funding into US-based biotech firms was $3.5 billion+ for each of the last eight quarters leading into 2020, according to Pitchbook data. Today, in the fight against the novel COVID-19 virus all eyes are on the global scientific community who have come together to work on and produce various treatments and vaccines at record speed, and we are reminded just how important scientific innovation is. Join us for the webinar Trends in Biomanufacturing and hear from industry experts to discuss the following: Product pipeline - what is the latest overview? Which products post key manufacturing challenges? Securing and sustaining the right talent pool to support growth Innovation in manufacturing techniques - bioanalytical capabilities, cell line development, aseptic manufacturing, downstream/upstream Continuous biomanufacturing - significant support for this in the small molecule space, what

This webinar originally aired as part of CPhI Discover - 17-28 May 2021 In January 2021, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) started operating under the new U.S. administration. The 2020 presidential campaign and global leaders prioritised COVID-19 vaccines, treatment, and new technologies to identify, cure and reduce the transmission of the virus. Therefore, without doubt, these topics will continue to have a profound relevance during the coming years. However, there is also a great interest to see what changes lie ahead in other broader areas, namely reshoring manufacturing, partnering, drug pricing, patient access and M&A. This session will bring together experts to analyse the global landscape and forecast what this new era means for Pharma. Key issues for the global regulatory agencies to address new diseases and financial challenges worldwide: Transition and differences in policies and priorities Generic and Biosimilar Competition Landscape: Efforts to modernize drug manufacturing Approach to patent and exclusivity issues Promote generic and biosimilar competition to reduce drug prices Regulatory modernization and globalization responses Supply Chain, Re-shoring, Drug Shortages: Plans to address shortages/disruptions and promoting risk readiness for manufacturing capacity COVID-19 highlights the importance of innovation and flexibility in health system preparedness

This webinar originally aired as part of CPhI Discover - 17-28 May 2021 Throughout the last decade, the importance of sustainable manufacturing increased rapidly in the biopharmaceutical industry.The process mass intensity (PMI) is a metric, which mainly displays the water consumption in a process. Based on continuous antibody production, we analyzed the correlation between the reduced cost of goods and a reduced PMI to align economic and ecological benefits.

This webinar originally aired as part of CPhI Discover - 17-28 May 2021 The application of modelling tools to better understand and control bioprocess development and manufacturing became a hot topic within the last few years. But what do we actually need? Is it just about data and powerful modelling algorithms or might a shift in focus towards “why” rather than “how”, speed things further up? Discussion points: The overall goal Experimental design concepts Different modelling approaches for different requirements Solutions to speed up both up- and downstream development Model transfer along scales Model usage for real time monitoring and control

This webinar originally aired as part of CPhI Discover - 17-28 May 2021 The United Kingdom left the European Union on December 31st, 2020. Before this, the EMA had already relocated its European HQ from London to Amsterdam, and there was considerable uncertainty on how the European Pharma Market would be impacted. This session will provide an analysis of the challenges presented by Brexit, and the impact on British Pharma. What is the impact of the UK leaving the EU on Pharma to date? What has changed? Security of supply for medical and pharmaceutical products Recent policy discussions on increasing the resilience of global supply chains How are manufacturers going to ensure continuity of supply in a post-Brexit world? How will innovation be impacted? What are the long-term implications of Brexit?

This webinar originally aired as part of CPhI Discover - 17-28 May 2021 Proteomics and mass spectrometry are key technology to the understanding of biological systems. We are using proteomics to characterise recombinant mammalian cell lines (Chinese hamster ovary) in order to gain insights into improving the productivity of biopharmaceuticals. Discussion points: Overview of advanced proteomic and mass spectrometry technologies How they can be utilised to enhance the efficacy of production of biotherapeutics Potential application of proteomics and mass spectrometry in other industries to enhance research capabilities and to potentially improve production capabilities

This webinar discusses the evolution of R&D models, the outsourcing landscape and how to de-risk your development and maximise ROI.

This recently recorded CPhI Webinar in association with Pharmapack delves into the vitally important world of traceability of medicines and what the packaging industry is doing to address the issues of medication errors, security and drug wastage. Click the link above to access the on-demand session.

Providing a regulatory outlook, Nathalie Wardé, Chief Executive Officer, D4P pharma, said that with 50% of medication errors coming from dispensing and administration, improving traceability of medicines for direct-to-patient delivery is a must.

“Traceability is a global trend in healthcare B2B,” she said “Over the last seven to ten years, it has started to be a real concern for all the health authorities mainly to fight against counterfeit (or ‘falsified’) medicines or medical devices and to facilitate the recall process.”

Arguing the case for why global standards are needed across healthcare and providing an introduction to GS1 and Gs2 standards, Tania Snioch, Director Healthcare Operations, GS1 Global Office said that “never has a global, secure and efficient supply chain been more important than today,” citing the current pandemic situation.

“We’ve learned in these difficult times that global standards have a role to play; we’re all looking for an efficient supply chain that operates across countries and across continents and to have that, we need to be able to talk to each other in a language everybody understands,” she added. “ We need to be sure we’re talking about exactly the same products and it needs to be unambiguous; a global standard is the way to achieve that.”

Providing insights into the management of clinical supply chains, Pierre Fernandez-Barbereau, R&D Clinical Supply Chain Operations, Industrial Development, Sanofi, said that two key objectives are to ensure alignment between clinical demand and to design a clinical package in order to protect the dose and ensure the ‘blinding’ of the medicinal product.

“But the third objective, which is also the most important one, is to package on the production line and distribute throughout the world to clinical sites and patients, ensuring quality and traceability of these medicinal products,” he said.

Featuring three speakers from leading market intelligence organisations, this webinar outlines the key trends and developments in the pharma sector to be aware of over the coming twelve months. Daniel Chancellor, Thought Leadership Director, Informa Pharma Intelligence, provided a snapshot of pharma pipeline activity during 2020, with oncology being the therapy area that continues to dominate clinical trial activity, with immune and central nervous system jockeying for second and third position.

He also shone a light over the disruption that the COVID-19 pandemic has wrought over trials and the industry’s rapid response to the crisis in terms of developing both vaccines and therapeutics against the virus.

“We have around three and a half thousand clinical trials initiated or planned against COVID-19 since the start of the year, with around 700 pipeline drugs and not to mention some of the repurposed efforts that have been run by academic groups, too,” he told the webinar.

Sarah Rickwood, Vice President European Thought Leadership, IQVIA presented nine key issues that are going to drive change in 2021 and beyond, a blend of some directly accelerated by the current pandemic and others that were issues already in existence prior to the pandemic, “but are really going to see their full impact on changing the shape of pharma and health care in 2021 and beyond regardless.”

She told the audience that the industry is actually dealing with three crises rather than one, and that the first half of the 2020s is likely to be flavoured by the pandemic and its consequences.

“We have the infection crisis, which we hope will be addressed by the vaccines which have come through with such an amazing effort from the pharmaceutical industry,” she said, adding that the challenge is that the infection crisis has triggered two other crises which will stretch through 2021 and beyond.

“The first is a crisis of healthcare systems, the non-COVID treatments of patients in healthcare systems have been delayed, changed and negatively impacted by the fact that healthcare systems have had to pivot to COVID treatment and addressing those patient backlogs which vary by country and by therapy area, is going to take a long period.”

She also pointed to the beginning of the economic crisis, with really worrying drops in GDP in Q2: “The full impact of mass employment has yet to be realized and that will mean health care system budgets will be constrained. So at best I can say is that we’re not living in a post-pandemic environment in 2021, we're living in a vaccine plus environment.”

And rounding off the webinar, Saman Kay, Solutions Consultant for Regulatory Intelligence at Clarivate Analytics, took a look at the future of drug manufacturing technology and assessed the opportunities and challenges of adopting continous manufacturing processes in place of traditional batch manufacturing.