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Healthcare is undergoing a vital shift from a one-size-fits-all model to more personalized, precise, and patient-centered care. To keep pace, clinical trials also need to adopt a scalable, adaptive approach that better aligns with individual patient needs and real-world complexities.
By incorporati...

The field of advanced therapies, including cell and gene therapies, hold the promise for groundbreaking new ways to treat patients but, how do we fulfill the promise that they hold? How will we accelerate their path to patients who are waiting? - As the field of advanced therapies continues to grow, so d...

Sponsors and CROs are piloting and implementing numerous decentralized clinical trial solutions to drive efficiencies and speed, improve adherence and enhance investigative site and patient participation convenience. Direct-to-patient drug supply strategies and practices hold the potential to transform tra...

Amid growing global demands and complexities, resilience and agility have become essential for success in today’s pharmaceutical supply chains. The COVID-19 pandemic, geopolitical tensions, and reliance on foreign manufacturing have underscored vulnerabilities in the supply of APIs—the building blocks of m...

Pharmaceutical supply chains have evolved into a global ecosystem to optimize costs, volumes and capacities, and environmental regulations. However, there are still many vulnerabilities that make them unreliable, unpredictable, and unable to support the needs of a growing population.
Biomanufactur...

Excipients have an important role in the development, manufacture, and delivery of safe and efficacious drug therapies but are often of little focus. This session will explore a variety of hot topics related to excipients that may have regulatory or formulation impact on drug products. The presenters will ...

Pennsylvania is at the forefront of Biologics innovations. To fully realize its potential, the state and industry requires robust collaboration with academia. Universities and research institutions have a vital role to play, from cultivating talent and driving research to fostering technology transfer and ...

What is the impact of the excipient manufacturer in the nitrosamine world? During the presentation, the focus will be held on magnesium stearate. Magnesium stearate is used as an excipient in the pharmaceutical industry. For some years, the FDA and EMA have been looking at the nitrosamine content in phar...

In this talk we explore the role of AI and ML in modernizing manufacturing, particularly in pharma and biotech. Despite the immense potential, the industry is still transitioning from traditional processes to digitalization, overcoming hurdles like regulatory compliance, cultural shifts, fulfilment of gap...

mRNA was consequential for COVID. We are now moving past vaccines to gene editing with RNA. This talk will describe the use of RNA to edit DNA to cure rare diseases and cancer.

As regulations in healthcare grow more complex, U.S. pharmaceutical companies are turning to artificial intelligence to stay ahead. "Compliance By Design" highlights how integrating AI into daily processes can help pharma companies prevent compliance issues before they happen, streamline audits, and reduce...

Research and Development (R&D) programs rely heavily on the effective sourcing of high-quality materials under aggressive timelines. Maintaining a group of preferred suppliers that have been rigorously vetted to meet these standards is an essential element to assure the effective management of the CMC supp...

Are you ready to take your drug formulations to the next level? Don’t miss this game-changing presentation on how combining Wet Bead Milling with Spray Dried Dispersion—also known as spray drying of API nanosuspensions—can revolutionize your approach to drug delivery and improve the outcomes of your clinic...

Exploring how the growth of manufacturing capabilities in Latin America creates export opportunities, strengthens global supply chains, and offers new market access for U.S. pharma. Evaluating Latin America's potential to become a leading player in the pharmaceutical industry and how this growth translate...

Bringing a molecule to market is challenging, especially under tight timelines, limited budgets, and the constraints of sensitive and costly materials. Traditional process development and scale-up often relies on manual work, consuming significant resources and offering limited insights into CMAs~CPPs~CQAs...

As US pharma grapples with the need for sustainability, CDMOs are stepping up in driving change. From green chemistry and waste reduction strategies, to energy-efficient technologies, CDMO’s are investing to ensure they are meeting the needs for a greener future. • Assessing the latest cutting-edge gr...

In today’s evolving healthcare landscape, centering the patient voice is more crucial than ever. Join our keynote as we explore how integrating patient perspectives enhances clinical outcomes, drives innovation, and fosters trust across the industry.

Drug/device combination products are transforming healthcare, but many pharma companies face hidden challenges that slow their progress. Misaligned priorities, complex regulatory requirements, and gaps in device-specific knowledge create costly delays and inefficiencies.
This session explores the t...

Remote monitoring is transforming the landscape of clinical trials by making participation more accessible to patients, regardless of location. Home-based trials, supported by advanced remote monitoring technology, eliminate the need for frequent site visits, enabling patients to engage in trials from the ...

During the past several decades, drug development sponsors have implemented a number of approaches to reduce operating inefficiencies focusing largely on within-function process improvements.  Recently, sponsors have turned their attention to reducing the inefficiencies between  functional collaborations....

As clinical trials increasingly occur in remote settings or across the globe, it is essential for pharmaceutical companies to maintain a robust supply chain that ensures a consistent flow of clinical supplies without delays. Join our panel discussion, where industry experts will share best practices for na...

Developing small molecule drugs can be exceptionally challenging. Pharmaceutical companies face high costs, huge attrition rates and considerable risk. Therefore, understanding the pitfalls that can impede early development, and how the associated risks can be effectively managed, will ultimately drive a p...

Development of a holistic path to validation of bulk sterilized pharmaceuticals, from determination of the maximum dose through sterilization dose establishment and process qualification. This presentation provides guidance to optimize doses, testing strategies, and necessary considerations for a successfu...

The BioSecure Act, and the actions that Chinese companies have taken as a result, is much more than what meets the eye. It is reflective of the successes and failures of the Chinese biotech industry over the past decade, and provides lessons for the entire industry.

Sustainability is often viewed as a win-win. However, success requires a holistic, cross-disciplinary, and multidimensional approach that accounts for costs and benefits across life cycles to ensure “solutions” do not shift risks and offset social, economic, or environmental gains. Global energy production...

As the pharmaceutical and biotech sectors face mounting pressure to innovate, a new wave of start-ups is emerging with disruptive technologies, agile business models, and bold scientific approaches. This panel brings together leaders at the forefront of this transformation to explore how start-ups are driv...

Digital twins are rapidly advancing innovations in the pharmaceuticals industry. Digital twins facilitate real-time monitoring of manufacturing processes, enhancing quality control and reducing production costs.
The industry is already leveraging twins to simulate drug development processes in virt...

CDMOs are at a critical crossroads, facing increasing demands for onshoring to strengthen manufacturing resilience and a growing emphasis on biosecurity to protect global supply chains. Simultaneously, gaps in R&D funding pose significant risks to innovation, requiring bold and creative strategies to susta...

Pennsylvania is at the forefront of Biologics innovations. To fully realize its potential, the state and industry requires robust collaboration with academia. Universities and research institutions have a vital role to play, from cultivating talent and driving research to fostering technology transfer and ...

Discover the ROTOTHERM® MINI, Artisan Industries' newest innovation in thin-film evaporation technology - and your new R&D tool. This lab-scale evaporator offers a continuous, scalable, and cost-effective solution for R&D teams looking to enhance their separation processes while preserving product quality....

A review of various methods and instrumentation, including the benefits and limitations for each in biomanufacturing. Regulatory views, including description of use/acceptance at each phase of drug discovery from pre-clinical through BLA. Case Study.

As sustainability becomes a central focus for businesses, it's crucial to understand the true costs of "going green." While environmental responsibility is essential, the financial impact on both companies and their supply chains cannot be overlooked. This session will highlight the importance of balancing...

• Alternative Approaches to Boost Patient Enrolment Amid Recruitment Challenges • How the Rising Pressures of Patient Recruitment Are Challenging Traditional Enrolment Methods

Ensuring the stability, integrity, and long-term sustainability of samples is critical for successful drug discovery and therapeutic development. This session introduces the Integrated Stability & Sustainability Outsourcing Model (ISSOM), a strategic approach that combines ICH-compliant stability storage, ...

This panel brings together experts to discuss the latest technological breakthroughs revolutionizing advanced bio-manufacturing. From AI-driven automation to cutting-edge bioprocessing tools, we’ll examine how these innovations are enhancing scalability, precision, and efficiency in biologics production. ...

Every four years, a new administration brings changes that can significantly impact the pharmaceutical supply chain. From regulatory shifts and trade policies to public health funding and drug pricing reforms. These policy shifts not only affect supply chain resilience but also shape access to life-saving ...

Transitioning from in-house buffer preparation to outsourcing can be a transformative step for bioprocessing operations, offering numerous benefits including enhanced efficiency and improved focus on core competencies. Embarking on this journey requires careful planning and consideration. Join us for an ed...

Join Molly Klote, former Director of the Office for Human Research Protections (OHRP), as she closes out CPHI Americas, discussing the shifting dynamics of U.S. pharma. From regulatory pressures to policy uncertainty, this closing address offers a thought-provoking take on where the industry stands—and whe...

From "hope" to "hype" to "impact", the adoption curve for decentralized clinical trials has been greatly accelerated post pandemic. This session will separate fact from fiction and help reveal how decentralized methods are being used to improve study conduct, access, and resilience today (with clues for w...

The biotech industry is poised for recovery as IPOs and corporate dealmaking gain momentum in 2025, driven by renewed investor confidence and strategic activity within the sector. A combination of increased M&A interest, evolving investor preferences, and alternative capital-raising options highlights the ...

As GLP-1 therapies gain traction in combating obesity nationwide, their success is transforming the pharmaceutical landscape.

Discover how AI-driven conversational analytics is rewriting pharma’s R&D and commercial playbook. This session reveals actionable strategies to: Automate Complexity: Turn natural language queries into dynamic visualizations and calculations—no coding required—to decode molecular data, clinical trial tre...

Key discussion points: 1. Introduction of botanical prescription drugs, 2. Outline of a growing interest in evidence based natural products including stats from practitioners and patients, 3. Botanical prescription drug - clinical trial requirements, 4. Advancements in clinical trials in the research of co...

QS-21 is the Gold Standard vaccine adjuvant used in several blockbuster vaccines to stimulate the human immune system. QS-21 is extracted from an exotic tree growing predominently in the country of Chile. However, Chilean deforestation laws and supply chain challenges have pushed to cost of QS-21 up to the...

Unlock the potential of Research & Development with strategic process optimization. Explore the challenges of implementing operational excellence in the dynamic R&D environment and learn how to develop a tailored roadmap that enhances efficiency, fosters innovation, and drives sustainable growth. • Cha...

Explore how stronger supplier partnerships can help the pharmaceutical industry build resilient, sustainable supply chains. Learn strategies for reducing environmental impact, enhancing risk management, and aligning with global sustainability goals to ensure a robust, future-ready supply network.
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