Carving Out a Career in Pharmacovigilance

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The sixth CPHI Annual Survey will explore the perspectives of some 400 pharma executives, evaluating the likely trends in 2023 and the reputations of all major pharma markets. The analysis spans insights from some 35 questions and is a key bellwether of industry prospects in the year ahead. The second component of the CPHI Annual Report – now in its 10th edition – features the detailed analysis of 11 global experts who explore all facets of the industry today and look ahead to predict the major trends

The annual report from Pharmapack 2023 covering the drug delivery market trends across Europe and the US, and how Pharmapack acts as a bridge between the global markets.

TBD

As a direct result of various environmental and socio-political events in the last 2 years, the pharmaceutical industry is grappling with the rise in API pricing across the globe. This report will mainly consider factors in the recent hike in API prices and how these might be directly and indirectly addressed by manufacturers and CDMOs in order to meet their existing and future development goals. A separate section will review how external bodies such as governments of certain member states and regulatory bodies can aid in relieving the pressures of increased API pricing. Gathering insights from experts and manufacturers in the pharmaceutical industry, this report will offer a comprehensive report on the market trends, challenges and potential solutions to increased API pricing. .iiris-banner-imagecontainer { display: none !important; }

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.

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 ninth year and launched at CPHI Worldwide in Milan, the report is an essential read for executives looking to get a head-start today on the shape of tomorrow’s industry.

The fifth CPHI Annual Survey explores the perspectives of some 370 industry executives from over 35 countries. Evaluating the likely trends in 2022 and the reputations of all major pharma markets across more than 10 metrics. The data provides an annual insight into the growth and development of the industry globally.

The second component of the CPHI Annual Report features the analysis of 10 global experts who explore all facets of the industry today and look ahead to predict the major trends of tomorrow.

This year’s expert submissions include contributions from ten experts spanning topics as diverse as CDMO future prospects for capacity and M&A, innovation in manufacturing, mammalian biomanufacturing, COVID-19 deals for contract manufacturers, biologics CDMOs in China, nutraceuticals, regulatory and excipients.

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.

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, which will include 4 further articles and executive survey results, looking ahead to 2021.

A starting point to address a big issue, hear from three pharma leaders on paving the way for sustainability in pharma.

In this short report, Informa presents a call to action from its sustainability lead, three contributions from CPHI sustainability experts, as well as a short review of the recent CPHI Sustainability Index.

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.

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.

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’.

In this session you hear from Johannes Galatsanos, Head of Data - Lean Digital Core ERP Transformation from Novartis.

What is the best strategy to access novel therapeutic approaches and technologies? Licensing vs M&A? How to build a stake in competitive future therapies and innovations How to beat competitors to your desired goals Exploiting innovation arising in non-medical fields and other industries

Cell and gene therapies are at the forefront of personalised and precision medicines. By better understanding and harnessing the human body’s own biological/immunological processes to fight or even cure disease, these “living drugs” hold tremendous promise for millions of patients with high unmet medical needs. Delivering on that promise, however, requires navigating product and patient journeys that are unique from those that have long-dominated pharmaceutical development. From manufacturing and complex logistics to regulatory pathways and patient recruitment, multiple sectors, entities, and processes must be carefully and consistently aligned to patient-critical pathways.

In this session, attendees will gain insights into the complexities of the CGT ecosystem and the challenges that must be overcome to successfully move these therapeutics from the laboratory to the patient. The presentation will outline best practices, tools, and integrated solutions for streamlining CGT development and discuss key areas of focus for improving the journey of patients enrolled in CGT clinical trials and beyond.

Key takeaways will include: An understanding of the scale of complexity of products and patient journeys for cell and gene therapies Best practices for aligning clinical and commercial processes and workflows to patient-critical pathways Integrated approaches and solutions for accelerating the journey from laboratory to patient

The pipeline for advanced genetic therapies has grown exponentially since 2014, and now totals over 3,500 different developmental candidates. This session provides a comprehensive global snapshot of this R&D landscape, spanning gene, cell, and RNA-based drug modalities. This includes analysis of drug pipelines and active clinical trials for prominent classes such as gene transfer, gene editing, genetically modified cell therapies, messenger RNA, and non-coding RNA. The common diseases targeted and sponsors leading these advances will also be reviewed, as well as important investment trends.

The presentation will help professionals involved in any aspect of developing and commercializing advanced therapeutics stay abreast of the latest developments.

mRNA has been called the software of life. It can help treat everything from cancer to cardiovascular diseases and can be used on high-scale as well as for niche indications. Covid-19 has put mRNA technology in the spotlights. The technology is therefore appealing to investors. However, how are these medicinal products regulated - are the vaccines differently regulated or are we taling about gene therapy altogether.

After this talk: you’ll understand why this topic is relevant in the development of mRNA based therapies you’ll feel empowered as to where to place vaccines, ‘ordinary’ medicinal products and ATMPs (gene therapy, somatic cell therapy) in the legal space

The human microbiome enlists all the microorganisms and their related metabolites/products identified in and on the human body. Technological advancement has enabled the assessment of the pleiotropic effects of the human gut microbiome in health and diseases. With the extensive role of microbes in human health, they have an enormous potential to be used as therapeutics for disease management and acts as the potential source to achieve the objective of personalized therapy by overcoming key issues like interpersonal variability and stability in every type of environment.

This presentation aims to address the current knowledge and landscape of microbiome therapeutics, provides examples of existing health-and-disease applications and discusses the potential future directions of microbiome modulations.

The acceleration of digital transformation across industries has been a prominent theme in the wake of COVID-19. In the pharmaceutical industry, the pandemic highlighted the need for agility and resiliency within the supply chain, fueling an increased urgency for the adoption of Pharma 4.0 technologies that bring together the workforce, customer, equipment, supplier, and environment to help businesses gain greater organizational clarity and process reliability.

Digitally enabled systems that improve performance through integrated business process, manufacturing automation, and supply chain integration are essential for responding to industry and environmental challenges and ensuring that safe, high-quality products get to patients when and where they need them.

This presentation will share our perspective for achieving digital transformation and digital culture enablement, focusing on: Innovative solutions for meeting market demands and managing increasing complexity through integrated business process Opportunities for attaining new levels of operational excellence through proven technologies to drive digital transformation and Pharma 4.0 journey Key considerations for transforming the traditional supply chain model into a digitally integrated value chain network

A review of how big pharma has reacted to the trend: who is going virtual with their trials? The usage data of virtual trial elements pre and post pandemic Predictions for the future

Have you wondered what value digital health brings to health systems?

This session will cover the ~25 main digital health value pools on health system level and show what value digital health solutions provide. In addition, digital health reimbursement is addressed, with a particular focus on the new digital therapeutics' reimbursement process in Germany (the so-called “DiGA process”).

Digitalization in biopharma is more complex than just replacing paper documents with electronic counterparts or hiring data scientist In the context of bioprocessing, the industry needs a better way to transition quickly from lab to clinical to commercial manufacturing Speed to clinic requires training of personnel in simulated GMP context, just as pilots are trained on simulators More importantly, cross-training will be required to enable common technical conversations through the training of IT professionals and other support roles Just as every employee is now trained on using computers, they will be expected to be data savvy – self-service dashboards, design of experiments To achieve its strategic goals, NIBRT continues to partner with other leaders in the space through collaboration with Siemens and BCG

This short session answers the most pressuring strategic questions with regards to sustainability: Why does it matter? Where to focus? How is it measured? What is the current industry status? How to improve?

Did you enjoy this session? If so, you might like to visit our Connect to Frankfurt platform, where you can browse our collection of 30+ on-demand webinars and learn about our upcoming CPHI Frankfurt event, taking place 1-3 November in Frankfurt, Germany.

Bringing together the global supply chain under one roof, CPHI Frankfurt puts you at the heart of pharma. Can’t attend in person? You can access many of the event offerings online! Browse our exhibitor list, arrange meetings, view on-site content and network – all from home.


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This session will help you understand real-world life as a student entering the Pharma industry post-pandemic. We will learn more about the role a CDMO plays in the pharmaceutical industry and the importance of hiring university and school early careers from the lens of a business leader. Finally, we will hear from an industry leader in talent acquisition on those tips and tricks that every student should be doing to secure their first job tomorrow!

Did you enjoy this session? If so, you might like to visit our Connect to Frankfurt platform, where you can browse our collection of 30+ on-demand webinars and learn about our upcoming CPHI Frankfurt event, taking place 1-3 November in Frankfurt, Germany.

Bringing together the global supply chain under one roof, CPHI Frankfurt puts you at the heart of pharma. Can’t attend in person? You can access many of the event offerings online! Browse our exhibitor list, arrange meetings, view on-site content and network – all from home.


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Introduction-Pharmaceutical Industry Review Magazine- Svitlana Havrylenko, Editor in Chief, Pharmaceutical Industry Review Magazine Ministry of Health - Oleksandr Komarida, First Deputy, Minister of Health of Ukraine Ukrainian Pharma Market overview for the 1st half of Y2022. Market in war turbulence Iryna Gorlova, General Manager, SMD «If You're Going Through hell, Keep Going». Pharmaceutical Business in the Face of Real Force Majeure Anatoliy Reder, General Director, INTERCHEM SLC “Resilience in the Time of War: How Sustainable Pharmaceutical Business Can Survive Deepest Crisis and Demonstrate Tendencies for the Future Growth” - Volodymyr Kostiuk, CEO, Farmak JSC "Lekhim" Group of Pharmaceutical Companies - Mykhailo Renskyi, Director of Development Department, "Lekhim" Group of Companies
Did you enjoy this session? If so, you might like to visit our Connect to Frankfurt platform, where you can browse our collection of 30+ on-demand webinars and learn about our upcoming CPHI Frankfurt event, taking place 1-3 November in Frankfurt, Germany.

Bringing together the global supply chain under one roof, CPHI Frankfurt puts you at the heart of pharma. Can’t attend in person? You can access many of the event offerings online! Browse our exhibitor list, arrange meetings, view on-site content and network – all from home.



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According to the WHO, “Increasing the effectiveness of adherence interventions may have a far greater impact on the health of the population than any improvement in specific medical treatments.”

Unfortunately, many of the available interventions are cumbersome, inaccessible and or too expensive to be applied, even at scale. In my talk I will present FebriSol, an innovative and cost-effective packaging intervention that helps patients remember to take their chronic medication.

The design, journey and challenges I faced in the development of FebriSol; Treatment adherence as a shared value business model; My vision for the future of the product.


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In the throes of the COVID-19 pandemic, global healthcare systems increased their focus on providing medicines outside of a hospital setting, whether that be in outpatient clinics, mobile clinics, pharmacies or at-home care. As a result, pharma companies have a unique opportunity to seize on this momentum by engaging with policymakers to diversify the locations a patient can receive care. This will allow flexibility within the healthcare system and give patients the best experience possible.

This session will explore the dynamics of how medicines are moving nearer to the home and highlight how pharma can both champion the movement and achieve success in the space.


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Technological innovation in Pharma and Life Science is happening now!

Metaverse, Artificial Intelligence, Data Analytics, Machine Learning, Digitalization: these topics are ranking high on the agenda of the business leaders who understand the competitive advantages that can be seized by moving now into the future of this sector.

Infomineo's presentation focuses on some of the most relevant steps taken by manufacturers and service providers who are leading the way in this technological evolution.


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Future Predictions on Drugs from Sales & Forecast Looking ahead to see the shape and direction of the Pharma market. Using Sales and Forecasts to see which areas are predicted to lead or lag. Identifying key therapy areas and indications as well as molecule types that may come to dominate the market. Seeing which companies are most likely to reap the rewards of future sales and positioning


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Bringing It Home: The New Generation of Clinical Trials


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Antheia is a synthetic biology company developing rapid-response biomanufacturing processes for Active Pharmaceutical Ingredients and Key Starting Materials. In this session, Christina Smolke, PhD, CEO and co-founder of Antheia will dive into synthetic biology as a manufacturing technology and its potential to build more resilient and efficient pharmaceutical supply chains.

Join to learn more about Antheia’s platform approach, synthetic biology, and the future model for pharmaceutical manufacturing.


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Novai is commercialising DARC, a combination biomarker consisting of Annexin A5 conjugated to a fluorophore (Dy776). ANX776 binds to stressed/apoptotic retinal cells which are visualisable as white spots using equipment routinely used by opticians, optometrists, and ophthalmologists. The images are then analysed to detect cellular level of disease activity.

When a therapeutic retards disease activity and reduces cell stress/death, DARC signal goes down in real time, providing prompt indication of drug effectiveness within days. DARC is a platform technology, currently being developed as a biomarker, with future potential as a glaucoma prognostic/diagnostic and a drug delivery theragnostic.


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Asymmetrex® markets the first and only technology for routine counting of therapeutic stem cells, like those in life-saving bone marrow transplants. The patented technology, “kinetic stem cell (KSC) counting,” tells physicians the dosage of stem cells in such treatments. KSC counting also improves biomanufacturing of stem cell and gene therapy products; improves stem cell science research; and reduces the cost of drug development by early detection of drug candidates that fail later because of stem cell toxicity.

Despite these many benefits, industry and market adoption of KSC counting has been challenged by entrenched non-quantitative practices and misinformation. Asymmetrex® will present three strategies deployed to overcome these barriers to its vision of establishing KSC counting as a new era for stem cell science and medicine: Demonstration of compelling medical, biomanufacturing, stem cell research, and pharmaceutical utility Establishing KSC counting as an industry standard for stem cell medicine Industry education campaigns


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Recognizing that upstream Scope 3 greenhouse gas (GHG) emissions constitute a major share of a chemical or pharmaceutical company’s emissions, increasing emission data transparency and accuracy is crucial to drive emission reductions along the value chain.

In September 2022, Together for Sustainability (TfS) launched the Product Carbon Footprint (PCF) Guideline. It enables companies to calculate the PCFs of their chemical materials more precisely in a way that is harmonized across the industry, while remaining fully compliant with less specific international standards for GHG accounting. The PCF Guideline is open source.

Did you enjoy this session? If so, you might like to visit our Connect to Frankfurt platform, where you can browse our collection of 30+ on-demand webinars and learn about our upcoming CPHI Frankfurt event, taking place 1-3 November in Frankfurt, Germany.

Bringing together the global supply chain under one roof, CPHI Frankfurt puts you at the heart of pharma. Can’t attend in person? You can access many of the event offerings online! Browse our exhibitor list, arrange meetings, view on-site content and network – all from home.


Click here to register

This session was originally broadcast as part of the CPHI Worldwide 2021 digital content programme Adrian van den Hoven, Director General of Medicines for Europe, explores the European regulatory outlook for pharma Discussion points: The pharmaceutical industry as a key asset to the EU economy Pharmaceutical strategy for Europe Supporting a competitive & Innovative EU Pharmaceutical Industry Highlight initiatives on manufacturing competitiveness and regulatory efficiency Pharma driving sustainable post-pandemic growth Considerations for the future EU pharmaceutical strategy

This session was originally broadcast as part of the CPHI Worldwide 2021 digital content programme. When patients self-administer their medications, 60% do not take them as intended, and over half of all patients are non-adherent. The resulting cost of non-adherence and non-optimised therapy is steep, and everyone pays the price, from pharmaceutical companies and payers to HCPs and their patients. The cost of non-adherence alone is US$300 billion per year, with $188 billions of US pharma revenue lost. The rules around healthcare engagement are now being rewritten with connected ecosystems and the ability to link self-administered medications to disease management solutions. Technology has the potential to augment patient care, deliver value across the digital health ecosystem and deliver

This session was originally broadcast as part of the CPHI Worldwide 2021 digital content programme. The CPHI Pharma Awards celebrates the thinkers and creators driving the industry forward through innovations, technological advancements and strategies across 10 distinct categories - from manufacturing excellence to sustainability. The Awards were open to all Pharmaceutical and Biopharmaceutical companies engaged in the design, development, manufacture, production and distribution of large and small molecule drug products. This year's winners were announced via a networking reception at the Fiera Milano on 9 November. This year's headline sponsor was Rentschler Biopharma: Your trusted partner for high-quality biopharmaceuticals

This session was originally broadcast as part of the CPHI Worldwide 2021 digital content programme. Milano&Partners is the Milano official investment promotion agency, founded by the city and the local Chamber of Commerce. It supports the soft landing of foreign investments in the metropolitan area with a broad offer of free of charge services and promotes Milano's excellence worldwide. Milano Greater Region generates 33% of the Italian registered patents in the EU and supplies 5% of the world's active ingredients. Local Life Sciences production is worth €71 bln with 356,000 people employed. All the main national and EU trade bodies and regulators, including the EFSA (Parma) and EU JRC (Ispra), are based nearby the area. Milano ecosystem for Life Sciences session explores the macro data and performance of the region and introduce you to a few examples of excellence in the territory.

This session was originally broadcast as part of the CPHI Worldwide 2021 digital content programme. This session covers: Delivering Complex Technologies to End-Users Characteristics for Smaller, Smarter, Electronic, Connected Real-World Case Studies of Device Design and Development The Next Generation of Drug-Delivery Devices Medical Device vs Wellness Device - FDA Regulatory Requirements and Determining Category

This session was originally broadcast as part of the CPHI Worldwide 2021 digital content programme. This session explores: Characteristics of an ideal peptide drug and peptide drug target Lessons from earlier approaches that are still relevant today High-Throughput Discovery and Parallel Optimization of Peptide Therapeutics Emerging strategies broadening horizons for peptide drug discovery Discuss the Therapeutic Potential of Peptides Analyse the barriers that need to be addressed for them to reach their full potential and possible solutions

This session was originally broadcast as part of the CPHI Worldwide 2021 digital content programme and delivered in collaboration with BioProduction. The session explores: Utilising Data for Process Development and Optimisation Applying data-driven models in biopharmaceutical manufacturing to improve real-time decision-making Approaches for the Design and Selection of Single-Use Assemblies in a Clinical Drug Substance Manufacturing Facility Selection of single-use assemblies and materials requires the thoughtful assessment of process requirements, the material of construction compatibility, supply chain considerations, modularity vs customisation, and cost of goods implications. Harmonise assembly designs across multiple operations and reduce total SKU counts.

This session was originally broadcast as part of the CPHI Worldwide 2021 digital content programme. The session provides a snapshot of the current trends of the cosmeceuticals industry and provide an analysis of the market touching upon: Characterise opportunities and risks around cosmeceutical marketing, including regulatory considerations COVID impacts, implications of global trends (natural demand, sustainability) Possibilities posed by legislation in the US to modernise cosmetics regulations

This session was originally broadcast as part of the CPHI Worldwide 2021 digital content programme. Top pharma companies are leading environmental sustainability initiatives in a sector that has been slow to react. Continued public and private cooperation is required to drive transparency, accountability, and action across the entire sector to meet international targets. The session touches upon some of the challenges and initiates and potential solutions taking place within the Environmental Sustainability in Pharma scenario Historical perspective and importance for healthcare Policy drivers and industry initiatives Commercially successful Green products Areas of unmet need Recommendations for the industry

This session was originally broadcast as part of the CPHI Worldwide 2021 digital content programme and delivered in collaboration with BioProduction. The session explores: The Economics of Seed Train Intensification A Technical End-to-End Project Review to Ensure Commercial Viability of Biologic Products Developability to Ensure Streamlined Manufacturing Predictive manufacturability testing prior to development in order to ensure the selection of compatible molecules

This session was originally broadcast as part of the CPHI Worldwide 2021 digital content programme. India, with a population of almost 1.4 billion, is becoming ever more vocal about access to good quality healthcare, which will have a huge impact on the fortunes of the country’s pharmaceutical sector going forward. While India is the largest global producer of generic drugs, there is also a rising interest in drug discovery and development for innovator products, and this session will examine India's potential to become celebrated as an innovator market. Discussion points: Opportunities and challenges in the Indian pharma market Key innovations and growth drivers Forthcoming challenges and changing skill-sets for the Indian pharmaceutical industry Potential breakthroughs in next-generation innovator products The future of Indian pharma

This session was originally broadcast as part of the CPHI Worldwide 2021 digital content programme The next generation of pharma manufacturing is already here, and 'Pharma 4.0' represents an exciting opportunity to optimise engineering processes with a more streamlined, digital approach. This session explores the latest in automation, connectivity and digitisation: Current Market Trends Pharma 4.0 and digital transformation Benefits of modular manufacturing in pharma Automation and digitization for device manufacturing

This session was originally broadcast live on 25th October as part of the CPHI Worldwide content programme, it is now available to view on-demand. API sourcing and supply chains have been key areas of focus over the past 18 months, with the pandemic raising questions of where APIs should be manufactured. As the global demand for quality and increasingly novel APIs continues to grow, what does the future look like? This panel discussion brings together leading market experts to discuss the lay of the land: Market Outlook for APIs Key driving factors & challenges in the global API market Emerging product trends & market opportunities Impact of COVID-19 on the global API industry What does 2022 hold for the API Market?

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?

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

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

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

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

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.

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.

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

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

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

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 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 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 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 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 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 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

Innovation in the design and development of large volume drug delivery devices can solve the challenge of accommodating the increasing trend towards patient self-administration and home care while at the same time ensuring that drugs that require intravenous administration are delivered correctly and safely. This was just one of the messages that came out of a recent CPHI Webinar, Latest Approaches for Large Volume Drug Delivery, sponsored by Cambridge Design Partnership.

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.

GUCY2C is a mucosally-restricted, immunologically compartmentalized self-antigen overexpressed in GI adenocarcinomas GUCY2C Vaccination in MRD (minimal residual disease) setting for recurrence prevention GUCY2C adoptive cell therapy for treatment of metastatic GI cancers

M&A plays a pivotal role in pharma growth as it enables companies to streamline their operations and strategies while reducing overhead costs, which can contribute to profit growth. To understand more, join our informative session, where our market experts will highlight and discuss the latest trends in the market and the expectations for the market: Discussion Points: Reviewing M&A trends in the North American Pharma Market Optimization of API process and selection of primary and secondary suppliers Drug development considerations for product development understanding scale, formulations for large volume Analytical Method optimization

With the industry digitally evolving, you and your team need to keep up and not be left behind. Join and take part in our panel and learn how to equip and prepare yourself with the latest digital tools in pharma: Assessing what resources and training services are available Introducing practical assessments for understanding current and new hire skill sets and experience Why building skills and not compliance training will provide better insight into your team How universities can play their part by merging traditional subjects with technology

Finish off your day by hearing the latest trends and excitement occurring in Philadelphia. Join our panel, where our speakers will dive into the current state of the industry and why Philadelphia is a hotspot for C>: Overview of the C> market in Philadelphia, investments, launches and developments Why Philadelphia is such a hotbed for C> How to ensure success as an emerging biotech

With constraints on clinical supplies due to high demand, the industry is scrambling to find a solution. Join our focused panel, where our experts will offer insights and tips for designing a supply chain to help meet current supply needs: Investing in smarter processes and forecasting technology to avoid timely delays Establishing why having local and international suppliers will help reduce the burden of scarce materials Re-aligning your business practices to ensure you stay within budget and meet global sustainability initiatives Reviewing current technological solutions to help address supply chain constraints

Companies must have the right partner to avoid potential setbacks in clinical development. To avoid disappointment, join our panel and gain expert analysis and best practices in sourcing the right CDMO for your study: Strategies for getting the most out of our CDMO partnership – mapping objectives, defined ways of working and clear communication Understanding what services and resources you need to ensure your targets are met Why mapping out deadlines is crucial to avoid untimely delays Assessing why having multiple partnerships can help manage expectations

With US Pharma pledging to become net-zero by 2050, you must have the right processes. Join our focused panel where our experts will discuss the best ways to implement ESG in your organization: Defining ESG in Pharma to understand what makes it different from other industries Establishing what is needed for implementing ESG practices in your organization Reviewing common pitfalls and how to avoid them Evaluating the role of the Chief Substantiality Officer in helping the industry move in the right direction What will ESG in pharma look like in five years? What should the industry’s KPIs be?

Pharmaceutical and other healthcare innovations have extended and improved countless lives in recent decades. Today, advanced manufacturing technologies such as pharmaceutical continuous manufacturing are gaining increasing interest for their potential to serve as one more way to improve global health by bolstering medicines supply chain resilience and bringing products to market faster. However, obstacles to industry adoption remain. Recognizing the need, USP is working with partners like Phlow Corp., a U.S.-based public benefit corporation and contract development and manufacturing organization, to lower technical and knowledge barriers to advanced and enabling technologies adoption through quality-focused solutions. Working together, pharmaceutical and biotech companies are now positioned to reduce production costs, decrease development time, and lower their environmental impact through the use of advanced manufacturing technologies.

AI an ever growing in pharma and is playing a prominent role in drug development. Listen to the latest developments in AI and what you need to know to utilize its potential in drug development. Join our focused session to get key takeaways from our expert: Understanding what AI can bring to your organization and identifying the areas you want to implement the technology. Reviewing regulatory considerations for successfully implementing AI into your business. Forecasting cost-effective measures to stay within budget.

Watch this fireside chat, where Stephen Chen of Tevogen Bio will go through the opportunities and challenges in Allogeneic Cells: Current quality and manufacturing procedures Reviewing short- and long-term challenges Forecasting the opportunities for Allogenic Cells

Manufacturers face unique quality challenges that can hinder progress. In this session hear about quality challenges in Cell and Gene Therapy (CGT) and learn common practices for overcoming them: The amc was formed in 2010 to focus on manufacturing when everything at the time was focused on clinical How CGTs have different challenges from a quality perspective to other biologics and small molecules Challenges over the last 13 years of the amc being in existence and how they've been overcome Current challenges o How to achieve the right quality at the right time with manufacturing readiness o Cell line development for allogeneic cell therapies o Variability of starting materials for autologous cell therapies o Analytical challenges in viral vector manufacturing

Join our focused session, where our market expert will provide an insightful analysis of the supply chain set-up from the pandemic to now. Understand the industry learnings from Covid and what has evolved within the supply chain industry: Reviewing current developments in pharmaceutical supply chain security and data integrity Why remote pharmaceutical auditing will play a key role in supply chain set-up Comparing pharmaceutical supply chain Integrity and Material quality during and after the Pandemic (COVID-19) Joint Audit Programs® for the Pharmaceutical Industry

Join our case study to learn more about the current supply chain set-up across the industry and gain takeaways on how to reduce your environmental footprint: How does the PSCI make a positive impact towards the creation of sustainable supply chains? Audit Program Capability Building Special Projects

The European ban on the use of titanium dioxide for food use has called into question its use in pharmaceutical products because its pharmaceutical use was predicated on its approval for food use. The European ban is not based on hard science or a real safety issue, but on the precautionary principle. This presentation will help participants: Understand the real facts about TiO2 safety and the possibilities of the precautionary EU food ban being extended to pharmaceuticals Realize what this could mean to patient access to critical drugs in the EU and what the potential for a similar ban occurring in other countries Identify what a ban of TiO2 in pharma would mean to the potential for serious drug shortages in the EU and global pharmaceutical development regarding the reformulation of thousands of existing products and the associated regulatory reviews which would be needed

With the industry shifting to become more sustainable, it is crucial for both end-users and vendors to work together when sourcing greener raw materials. Join and learn about the need for global collaboration and what you can do to adopt green chemistry practices to your business: Assessing the current state of sourcing sustainable materials, what changes are needed? Identifying the common pitfalls within the industry and what can be done to avoid them Reviewing the latest technologies available and how they can be best applied to traditional chemistry Improving communication with suppliers to ensure the right materials are sourced

As we bring in 2023, pharmaceutical companies will undoubtedly be looking ahead. But how will the events of the past two COVID years influence future aspirations? In the past, pharmaceutical companies used a mix of bottom-up and top-down processes to budget for the next fiscal year, and then made quarterly revisions during the year. Nowadays, both on the revenue side and on the expense side, volatility is more of a rule than the exception. Brands in different diseases are impacted differently in terms of demand by COVID-19: some experience an increased need; others are temporarily less needed, and demand will spike again once hospitals are able to take on less urgent cases. The timing of the impact of post COVID-19 era varies by country and is hard to predict, which makes strategy and financial forecasting more of a crystal ball exercise. Finally, various payers in health care systems will have budget issues themselves, having to redirect their budgets on the fly. How the market is bouncing back and forecasting is aligning itself to the new normal will be understood better by this presentation The presentation will cover: A typical forecasting process- cross functional process How do you value / forecast a drug / company’s pipeline? What techniques to use? What are the forecasting models and best practices for early-stage assets in drug/IP commercialization processes? Who are the stakeholders in the forecasting process and how to influence them?

Join our thought leadership session to understand the current state of Psychedelics in the pharmaceutical industry. Delve into the potential psychedelics can bring and why the industry needs to take notice of its growing importance: How psychedelics can play a role in the treatment of mental health conditions Emerging investigator initiated and sponsored clinical trials Drug development and regulatory challenges to counter before mass adoption

Get the inside focus on the latest drug pricing developments in the US market. Listen to the current legislator updates and how it will affect patient costs while reviewing the rising manufacturing costs from inflation and supply constraints and the market’s reaction: Examining current manufacture drug costs vs patient costs and how this reflects in current market pricing Reviewing legislator updates in the market and expected changes to the industry Calculating rising inflation and supply constraints, what will be the impact on the cost of manufacturing?