Large molecule biologics

With CPHI Milan just around the corner, we sat down with some of the sponsors for this year’s conference tracks to discuss the most pressing topics in pharma. 

A contract research organization (CRO) supports biopharma companies by providing a wide range of early-stage drug research and development offerings, whereas a contract development and manufacturing organization (CDMO) supports sponsors by providing later-stage drug development and manufacturing services. In the pharmaceutical industry, it’s not uncommon for sponsors to independently collaborate with both a CRO and a CDMO partner at various stages of drug development, which can create unnecessary complexities and unanticipated challenges.

Our new infographic explains the benefits of working with an end-to-end, integrated CRO/CDMO partner that provides a wide range of innovative research, development, and manufacturing capabilities. It also illustrates how a single, centralized vendor can offer improved simplicity, speed, and scalability on the journey from molecule to medicine to market.

During CPHI Barcelona 2023, insightful content sessions offered attendees the chance to explore trending topics with expert speakers and panellists. Here, we summarise what the pharma industry and supply chain are talking about the most. 

Cell and gene therapies have the potential to fundamentally change treatment paradigms for patients living with a wide range of diseases, including genetic disorders, rare cancers, and neurological conditions.

However, to prove their safety and efficacy, cell and gene therapies must make it through a series of clinical trials. Currently, the clinical trial process can be overly complex, which may negatively impact the patient experience of participating.

Some of these challenges can be addressed through innovative research, development, and manufacturing strategies, as well as through patient-centric protocols, which fall under the purview of integrated CRO and CDMO partners.

Our new whitepaper takes a deep dive into these topics, specifically covering:

The overall importance of patient journey mapping to clinical trial successThe role of manufacturing in delivering cell and gene therapies ...

This year at CPHI Barcelona (24–26 October, 2023) we sat down with C-suite executives and HR professionals to discuss the looming talent crisis in the pharmaceutical industry. With hybrid working persisting post-pandemic and a growing skills gap, how can the pharmaceutical supply chain adjust to a changing labour force? 

Collaborations between contract development and manufacturing organisations (CDMOs) and contract research organisations (CRO) are on the rise. With complex therapeutics in the pipeline and the need for supply chain resiliency, these collaborations can offer more capabilities and services. With such collaborations proving to be more than just a current trend, what will the effect be on patients? In our latest report, in partnership with Thermo Fisher Scientific, we explore how CDMO and CRO collaborations with a strategic focus and the right intentions can only drive the industry towards a patient-centric future.

Pharmaceutical collaborations are nothing new to the industry. Increasingly complex drug development programs, calls for supply chain resiliency, and the involvement of all key stakeholders throughout a drug’s development lifecycle are pushing contract development and manufacturing organisations to partner with their counterparts in research.

As global awareness of environmental concerns deepens, so does our responsibility to ensure that our endeavors align with sustainability goals and allow us to serve our customers on a green and sustainable way. Joint us to discuss the real life examples of how Thermo Fisher Scientific approaches green chemistry to ensure sustainable API development and manufacturing, why green chemistry it is important for the demand measurement and how does it used to serve customers on a sustainable way. During this session we will discuss: What is green chemistry and why it is important? How do we measure materials demand? How do we use it to serve our customers? Case studies

 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, and the University of California, San Francisco (UCSF), will accelerate advanced cell therapies for difficult to treat conditions, including cancer, rare diseases, and other illnesses, from a newly opened cGMP manufacturing facility adjacent to UCSF Medical Center’s Mission Bay campus.

The following session has been SOLD OUT. For any inquiries, please contact a member of staff on the day Discover the latest trends and developments in outsourcing over lunch and connect with your peers in this exclusive session What’s new in outsourcing? Find out in our CDMO panel discussion and networking event, where you’ll have the opportunity to hear from an impressive line-up of leading CDMOs on the current market outlook, and the chance to ask your questions and explore service offerings during a dedicated networking session. From technological advancements, capacity and supply chain challenges, to strategic partnerships, this interactive roundtable will help you meet prospective partners, explore outsourcing opportunities, and provide a platform for networking with leading CDMOs.

Follow along for live updates from the Content team as we bring you the latest from CPHI North America 2023 - from session talks, panel discussions, interviews, and more, there's a lot to discover with CPHI Online at the Pennsylvania Convention Center! 

This session will provide a comprehensive overview of the challenges and opportunities in decarbonizing pharmaceutical supply chains, showcasing the potential of industry-wide programs like Energize and the practical guidance offered by the PSCI Decarbonization Maturity Model. Assessing the challenge of Supply Chain Decarbonization within the US pharma Landscape Delve into the Energize program and its role in addressing decarbonization within the pharmaceutical supply chain Introduce the (PSCI) Decarbonization Maturity Model and discuss its purpose, structure, and how it serves as a comprehensive guide for companies and their suppliers

To assist with the growth of the biotechnology industry and support newly emerging biotech companies, Thermo Fisher Scientific have made the move to be a founding sponsor of Momentum Labs in Alachua, FL, USA. 

A holistic view of the environmental impact of drug delivery devices. Exploring the challenges, obstacles, and opportunities to decarbonize the value chain and embed circularity. A call to action for collaboration across all stakeholders

Thermo Fisher Scientific are to open a new cGMP facility in China, including the latest technology so that they can assist in the accelerated provision of medicines to patients. 

In today's rapidly evolving pharmaceutical landscape, sustaining progress through periods of uncertainty is paramount. To navigate the unknown successfully, pharmaceutical companies need to adapt, innovate, and prioritize sustainability. Join our Q&A and listen to our experts discuss best practices on how to keep your sustainable journey on track during turbulent times. The importance of a pledge – committing to change Understanding how best to manage unpredictable changes and stay committed to sustainability goals. What steps can you take to make environmental and social responsibility a personal commitment?

In The Future of Outsourcing - Strategies for Partner Selection, experts from across the pharma industry look at current trends impacting the contract services landscape and gauge the merits and drawbacks of the most common outsourcing strategies in use

Join our opening keynote to review the current state of sustainable practices, environmental impact, and the road towards a greener future for pharma – how do we get there faster?

Expected increase in approvals for gene therapies, gene-modified cell therapies and recombinant vector vaccines will also increase pressure on manufacturers to build new capacity

Ten questions you're likely to face from investors and how to respond to them.

The pressure to file an IND makes accelerated Phase I safety testing a priority. With the Quick to Clinic™️ program, Thermo Fisher Scientific can help deliver your large molecule drug substance for First-in-Human studies in as little as 13 months from the start of transfection. Platform available for mAbs, bispecifics, and FC fusion molecules. 

Now you can meet important milestones—such as filing for IND—or secure additional funding with all the confidence your project needs and, we can supply.

Quick to Clinic™ is an integrated early development offering designed for biotech companies looking for a dependable solution to scale up recombinant antibodies from discovery to first-in-human (FIH) trials.

How can innovators select the right outsourcing partners to work with their in-house teams? This report will examine current outsourcing strategies, and assess which approaches work best for specific products, and for particular development/manufacturing pathways. In a market where CDMOs and development partners are in incredibly high demand, this report considers current market trends, the changing development goals for biotech and pharma, and how outsourcing strategies are now evolving. Calling on market experts from across the outsourcing sector, this report will collate expertise for a comprehensive overview of the manufacturing, outsourcing, and partnering landscape.

Focus on Medicines for All's work in process improvements for COVID therapeutics, including work done thus far on remdesivir and molnupiravir. The session will also describe how Medicines for All shares its results with the global market and how this has led to uptake of its processes on critical COVID drugs. The Medicines for All Institute (M4ALL) is part of Virginia Commonwealth University; M4ALL is committed to improving access to high-quality medications across the globe by driving down production costs. M4ALL does this by optimizing active pharmaceutical ingredient (API) production and providing access to manufacturers around the world to enhance the security of medicine supply chains. This session was broadcast as part of the CPHI North America show.

As clients seek to gain maximum benefit from each clinical stage, the advantages offered by contract partners with integrated services are making these higher returns tangible. This presentation will highlight key activities under Thermo Fisher’s integrated drug substance and product development services for the clinical development of small molecule APIs that decrease development risk, decrease timelines, and enable success in Phase 1 and beyond. This session was broadcast as part of the CPHI North America show.

Managing the biopharma supply chain is a highly complex undertaking that is becoming ever more so as the number of new products rises and new process technologies are introduced. Moving with ease from one step to the next (R&D, production, distribution) while adhering to regulations and meeting customer demands involves managing many moving parts. It also requires managing a growing number of channels through which data needs to be sent, received, and tracked. Awareness and oversight over every activity and relationship along the continuum is critical for avoiding disruptions that can negatively influence distribution processes This presentation will provide insight into some of common blind spots that threaten supply chain quality, including: Supply chain vulnerabilities Insufficient demand signals Under-nurtured supplier relationships Supply chain network customization Attendees will learn about the measures that should be embedded throughout the supply chain, from procurement through last-mile delivery, to avoid these blind spots and build customer trust and confidence

Join Asklepios BioPharmaceutical's former CEO Shelia Ann Mikhail, where she will Set the Scene for the latest innovations and developments affecting the Biomanufacturing Landscape Ensuring quality and compliance in bio-manufacturing Closing gaps in development data prior to the first GMP production Adjusting manufacturing processes throughout the course of a site-to-site transfer Fulfilling special requirements on container closure systems for biologics Transferring analytical methods for drug products and drug substances