Novel Excipient Pilot Program Review

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

Ensuring accurate potency testing and maintaining product purity are crucial in antibody-drug conjugate (ADC) development, scale-up, and commercialization. Innovative solutions, including effective tools and streamlined processes, are necessary for efficient production of ADCs for clinical trials and commercial launches. Reagents such as dehydroascorbic acid (DHAA) and tris(2-carboxyethyl phosphine) (TCEP) play vital roles in conjugation chemistry, enabling efficient and precise antibody-drug conjugation. This presentation will explore leveraging CGMP grade materials and a trusted supply chain partner to help teams achieve the highest quality outcomes for ADC their projects to overcome challenges in potency testing and product purity.

Pharma is often perceived as lacking innovation outside its core R&D operations. However, the venture capital arms of major pharmaceutical companies play a crucial role in driving innovation and tackling significant healthcare challenges. Join this panel discussion to gain the latest insights into the current investment and acquisition dynamics within the pharmaceutical industry.

Discover how digital health is transforming the pharmaceutical industry. Explore the expanding role of technology across the pharma value chain and its implications for the future

The evolving landscape of the pharmaceutical industry, marked by significant breakthroughs in advanced treatments and relentless pressures for speed and innovation, has fundamentally transformed the role of Contract Development and Manufacturing Organizations (CDMOs). As the industry faces challenges from supply chain disruptions, regulatory shifts, capacity deficits, and cost pressures, CDMOs are increasingly operating as strategic partners who play a critical role in helping to bring new therapies to market through innovative service models and customizable solutions across different scales and modalities.
Attendees will gain insight into the evolution of CDMOs from transactional service providers to essential collaborators, enabling biotech and pharmaceutical companies to streamline the path to Investigational New Drug (IND) submission, optimize their supply chains, reduce risks, and accelerate the development and commercialization of new therapies to market.
Discussion points include: Leveraging integrated CRO/CDMO capabilities and a robust global network for enhanced stability, flexibility, and reliability in uncertain times Dynamic scaling and pivoting of operations in response to market shifts, global health crises, and changing business models Driving innovation and efficiency with advanced technology platforms and collaborative project management Navigating complex regulatory landscapes to comply with changing global standards and market access requirements Future-proofing manufacturing processes through adaptive strategies"

Testing for Mycoplasma is essential to ensure safety of biopharmaceutical products. With over 200 recognized species, Mycoplasmas are common contaminants in manufacturing facilities and cell-derived biologics. Existing compendial methods are complex and lengthy. PCR-based methods, while faster, can be limited in sensitivity. To overcome these challenges, we have developed novel protocols based on the Applied Biosystems™ MycoSEQ Plus quantitative PCR method combined with automated DNA extraction. Our protocols were validated with live Mycoplasma species to meet regulatory requirements. The sensitivity, sample volume and turnaround time surpass compendial culture method results. Our testing protocols are suitable for testing a variety of samples, including raw materials & final products, samples that interfere with traditional culture and PCR method, and complex samples such as cell and gene therapy products.
This session discusses how our new testing protocols can benefit biologics companies and help accelerate the manufacturing process for cell and gene therapies.

Africa stands at the cusp of unprecedented growth, offering a wealth of opportunities for strategic partnerships and investment.  Unprecedented momentum in catalytic initiatives for ecosystem development offer potential for unlocking aggregate commercial opportunity greater than $20Bn.  By fostering collaborations between global health actors, local institutions, investors, and international companies, Africa can harness its vast potential. Join us as we explore opportunities that Africa can offer to the Global Pharma Industry  Establishing strategic partnerships between local institutes, investors and international companies  Initiatives around regulatory capacity, local infrastructure and value chain to help attract foreign investment

The recent acquisition of Catalent is driving significant transformation in the CDMO space within the pharmaceutical landscape. This shift has led CDMOs to expand beyond manufacturing, incorporating development services into their offerings. This evolution is redefining their role in the supply chain, providing integrated solutions that boost efficiency and foster innovation. At the same time, larger pharmaceutical companies entering the CDMO sector are changing market dynamics, increasing competition, and diversifying service offerings. Why traditional CDMOs are broadening their scope by taking on development roles alongside manufacturing, reshaping their role within the pharmaceutical supply chain. Assessing the impact of larger pharmaceutical companies entering the CDMO sector, and the resultant shifts in market dynamics, competition, and service offerings. Reviewing the evolving relationships between CDMOs and Pharma, and what it means changing landscape.

Explore the use of digital twin technology to simulate pharma manufacturing processes, allowing for optimization of processes, scale up, faster validation and training for faster to market and without risking actual production and quality. We scratch the surface of what it takes in respect to digital technologies, the complexity and some of the barriers that is still missing to unlock the hype in pharma. Rooted in some use cases we look into some of the value drivers and where Novo Nordisk see some of the challenges – e.g. when to interact with authorities, do we have sufficient guidelines and building trust of digital models.

A new drug substance and drug product production route using integrated continuous manufacturing has been developed for a Roche drug. This new manufacturing process successfully addresses supply chain constraints and patient needs, reducing the lead time from 15 months down to 50 hours. Equivalent yield, and greater purity Production costs reduced by 37% 400% smaller carbon footprint

A talk with a cyber security professional, sharing valuable insights gained from a career in the UK intelligence community. A look at the potential threats that the pharmaceutical industry faces and how risks can be mitigated. Including an introduction to the complexities of using AI securely.

During pharmaceutical product development, Boehringer Ingelheim generates hundreds of thousands of documents, each containing valuable knowledge and problem-solving strategies. The challenge is to make this knowledge accessible within the company to avoid redundant efforts. To address this, Boehringer Ingelheim developed iQNow, an AI-supported knowledge management system. iQNow employs various methods and technologies, with AI playing a crucial role, to deliver the right knowledge to the right person at the right time in a scalable, efficient, and universal manner. The introduction of GPT technology has been transformative for iQNow. In just nine months, the user base has grown to 26,000, and the system has enabled the reallocation of over 700,000 work hours to more productive activities. In this conference, we will provide insights into the iQNow system and share our experiences of implementing AI in a large company. Join us as we explore the intersection of AI and innovation within the context of pharmaceutical development in Germany.

Pharma thrives on innovation but requires strict regulations for safe and effective drugs. In today's age, navigating compliance for complex new technologies, drug manufacturing and patient safety adds to the challenge. How compliance management systems such as digital documentation can reduce errors and enhance consistency processes. What does efficient auditing look like and how to achieve it Insights into efforts towards regulatory harmonization and its impact on international manufacturing and market access

Join our session on navigating outsourcing partnerships for start-ups, where we'll explore effective strategies and best practices for collaborating with external partners to accelerate growth and innovation. Learn how to leverage outsourcing to optimize resources and drive success in your startup journey

Join our opening keynote and gain insights into emerging trends, sustainability initiatives, and the transformative potential of Industry 5.0. This session will explore what the future looks like for pharma manufacturing.