Keynote Address: Setting the Scene for the CDMO Landscape

Anil Kane, PhD, MBA, serves as the Executive Director and Global Head of Technical & Scientific Affairs at Thermo Fisher Scientific, a global leader in scientific research and innovation. In this exclusive interview, Kane shares his and Thermo Fisher's experiences and insights gained from DCAT Week 2026, held in New York City from March 23-26, 2026.

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.

CPHI Frankfurt, to be held at Messe Frankfurt from October 28-30, 2025, will once again bring the pharmaceutical industry together for 3 days of collaboration and innovation. Our Track Sponsor interview series sits down with some of our conference track sponsors to discuss key themes and trends impacting the industry.

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 ...

April 28, 2025 | Enhanced platform technology and the addition of a robust, high-quality CHO K-1 cell line decreases lead time to Investigational New Drug (IND)

Quality is the underpinning of success in the pharmaceutical development and manufacturing industry.

A commitment to quality is not only required to meet regulatory guidelines, it’s also foundational to:

Accelerating time to marketReducing unnecessary riskImproving return on investmentCreating effective medicinesUltimately saving patient livesDespite its critical importance, quality is often mischaracterized, whether by conflating it with compliance, describing it as an end-of-the-line activity, or attributing responsibility to a single team.

In fact, quality is difficult to fully classify because it’s not defined by one single activity, role, process, strategy, or outcome. Rather, it’s a combination and culmination of all these factors — plus more.

This whitepaper takes an in-depth look at key indicators of CDMO quality, identifying tools and best practices to drive continuous improvement, strengthen collaboration, and ultimately cultivate trust.

April 17, 2025 | Innovative 6,000-square-foot facility enables clinical and commercial process development support to help cell therapy developers transition from research-scale to commercialization

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"

April 14, 2025 | First-of-its-kind bench scale bioreactor enabling productivity, scalability and efficiency supporting reduced environmental impact

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.

February 26, 2025

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

February 5, 2025

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.

June 16, 2025 | Time matters for patients in need, and new research shows integrated services can reduce Phase I-III study times by up to nearly three years, generating strong ROI for biotech and biopharma customers

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.

January 9, 2025 | UK Biobank Pharma Proteomics Project aims to create a comprehensive map of disease-associated protein levels in the human body to advance biomarker discovery

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.

February 4, 2025 | Company leads value chain partners in purchase agreement that adds 118 megawatts (MW) of solar energy to enable decarbonization across the pharmaceutical and healthcare industries

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.

February 25, 2025 | Highly Complementary to Thermo Fisher’s Bioproduction Business and Strengthens Offering in the High Growth Bioprocessing Market

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?

April 24, 2025 | Investment demonstrates confidence in America’s commitment to science and innovation

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

July 16, 2025 | Thermo Fisher to Acquire Sanofi’s Steriles Manufacturing Site in Ridgefield, New Jersey to Produce Critical Medicines for Sanofi

Enables Additional U.S. Manufacturing Capacity to Serve Increased Demand for Pharma/Biotech Customers

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

While CPHI Americas 2025 has wrapped, the learnings from on-site don’t stop. From exclusive interviews with leading industry experts, we bring you our Insider Insights from the Philadelphia show floor.

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

Our From the Floor live blog is back in Philadelphia for this year’s CPHI, this time under the new name CPHI Americas to embrace and represent the whole of the pharmaceutical supply chain from north to south.

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?

As we gear up for CPHI Americas from May 20-22, 2025 at the Philadelphia Convention Center, we sat down with Track Sponsor Thermo Fisher Scientific to discuss the future of bioproduction in pharma. 

The pharmaceutical landscape is undergoing a dynamic transformation, driven by technological advancements and a renewed perspective on collaborations. Central to this transformation is the role of CDMOs as strategic partners. In addition to providing access to the cutting-edge technologies that are reshaping drug production and supply chain management, CDMOs offer critical insights and guidance to ensure these technologies are leveraged to their maximum potential, delivering unparalleled value. This is especially critical in today’s evolving pharmaceutical ecosystem, where bringing next-generation therapies to market requires adapting and configuring solutions and processes to specific molecule and technology needs. As strategic partners in these endeavors, CDMOs must not only be willing to embrace new business models, but also have the dedicated infrastructures to support them. Beyond the tangible advancements in materials, engineering, and manufacturing processes that serve as the foundation for progress, the intangible elements of partnership—trust, collaboration, communication, agility, and foresight, among others—truly catalyze success. These qualities empower teams to navigate the unique demands of each development project, ensuring that innovation finds its way from concept to reality. Join us as we explore how CDMOs are embracing innovation and redefining the partnership paradigm. The discussion will revolve around three pivotal developments shaping the industry's future: Fully flexible manufacturing solutions. Explore how CDMOs are leveraging adaptable platforms to cater to diverse production needs Continuous manufacturing. Understand how transitioning from batch-based to continuous processes enables enhanced product consistency, scalability, and efficiency. Digital enablement and analytical capabilities. Discover how digital enablement is unlocking new frontiers in product quality, regulatory compliance, and operational efficiency
The value of a CDMO partner that delivers services from discovery to commercialization, maintaining scientific integrity and process efficiency
The role of CDMOs in managing both scalability and quality, ensuring seamless transitions from early-stage trials to late-phase development.

DCAT Week 2025, held March 17-20, 2025 in New York City, provides an opportunity for the global bio/pharmaceutical manufacturing value chain to come together and discuss the emerging trends and opportunities in the manufacturing supply chain.

This whitepaper identifies the key challenges faced at each stage of mAb development and provides guidance for streamlining pipeline progress of therapeutic mAb candidates, focusing specifically on the following:

- Leveraging technology in the early stages to accelerate development while reducing risk- Scaling processes and production to match clinical and commercial demands
- Integrating key regulatory considerations as a precursor to long-term success
- Accelerating the start-to-finish workflow

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. 

Whether changing manufacturing sites for scale up or passing from development to manufacturing, technology transfers are a critical process every drug must go through on its route to market. Done well, a successful tech transfer can improve productivity and efficiency, reduce program costs, optimize regulatory readiness, and accelerate time to market. Download the whitepaper to learn more about common pitfalls, best practices, and key elements to make your next tech transfer a success.

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. 

Once your vaccine is ready for production, there are critical considerations needed in regard to the handling and process for fill/finish. The right choices can help ensure the stability and purity of your vaccine as well as limit unnecessary waste and cost. View the infographic for details on best practices for fill/finish.

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? 

Thermo Fisher Pharma Services is a full-service CDMO that has the expertise and comprehensive capabilities to seamlessly manage every step of your drug development and manufacturing journey—streamlining your process so you can get to market quickly. As a collaborative partner, we have a shared goal of helping you succeed. We have the skills and experience to help you mitigate risk and respond with flexibility, from drug substance to drug product to clinical trials, and all the way to commercial manufacturing.

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.

Getting biological drug products to first-in-human (FIH) trials requires a deep and nuanced understanding of the scientific and regulatory challenges unique to these complex large molecule substances. Prioritizing regulatory CMC guidance and careful preparation of quality dossiers is integral to success from the very early stages throughout clinical development. This report identifies key strategies for developing a carefully executed, robust CMC dossier and avoiding common deficiencies that lead to clinical holds.

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! 

Switching delivery formats can be an effective strategy to enhance they lifecycle of your drug. This whitepaper provides insight into the benefits and challenges of transferring a therapeutic compound from one aseptic injectable format to another, focusing specifically on the following:

The material and process information and data needed to inform decision-makingTh...

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. 

With the rapid expansion of the cell and gene therapy market, innovators will require reliable supply chain solutions to enable the sage and efficient transportation of products to patients in need. 
The following article highlights several industry challenges and key considerations as clients prepare for commercialization of advanced therapy products including:
Ultra-low temperature controlManagement of stringent timelinesDocumentation and tracking requirementsScale-up capabilitiesCommunication strategy

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. 

This interactive infographic highlights Patheon’s capabilities for maintaining cold chain integrity across the supply chain. Utilizing our global network and expertise, our end-to-end cold chain management services can support your advanced clinical trial needs with:
Cold chain storage and distributionGlobal CryoHubsSecondary packaging and labelingKit productionLaboratory services

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

This interactive infographic provides a summary of Patheon's end-to-end clinical trial service capabilities. You can click on any service line pod and it will dynamically display information related to that service line. This is inclusive of clinical supply planning and project optimization, clinical ancillary supplies sourcing and management, comparator and co-medication sourcing, cold and ultracold clinical supply chain management, global clinical packaging and labeling, storage, distribution, and clinical logistics management, and decentralized trial capabilities.

Rise of innovative companies with high-risk portfolios will necessitate need for CDMOs, says Thermo Fisher senior executive

High biologics growth in Europe fuels the need for cold chain management. Check out this infographic to learn top tips on how to maintain cold chain integrity across the European supply chain, from molecule to medicine.

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

Learn how Thermo Fisher is meeting its environmental sustainability goals, and how we work in partnership with the pharma and biotech communities on shared environmental sustainability goals.

Investment will further expand CDMO's global network of SUT facilities to boost reliable supply of critical materials used to produce new biologics and vaccines

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.

Companies say earlier collaboration may speed development and introduction of targeted precision medicine therapies for patients.

The road to IND/IMPD isn’t always easy. Balancing speed, risk, and future needs is a challenge. So how do you get to IND/IMPD faster without sacrificing quality and future commercialization goals? Our experts have shared a few things to consider when thinking about accelerating and optimizing your early development process.

Drug sponsors face significant pressure to reduce the time required to move a new molecule through Phase I and into Phase II trials. If all goes well, identifying the quickest scale-up path for supplying efficacy trials and commercial demands is next. But at early stage, sponsors need to keep the formulation as simple as possible. This means identifying the desired critical quality attributes of a formulation and selecting only those must-have requirements that align closest to the objectives of each clinical trial stage.

We're working arm-in-arm with industry innovators, government agencies and academic institutions to provide scale, flexibility and expertise in the battle against COVID-19.

CDMO’s accelerating adoption Reshoring: CM can help when competing with Asian producers on price. Government investment during Covid to protect against supply chain issues & increased focus on critical drugs supply New guidance based on GMP - ICH Q13 will likely see smaller companies deciding to use CM Opportunities for generic manufacturers – cost savings, beyond production efficiencies Moderator: Wayne Weiner, Principal, Pharmatech Solutions LLC Panellists: Bikash Chatterjee, CEO, Pharmatech Associates- A USP Company Graziano Castaldi, President/CEO, Chemelectiva Kai Donsbach, Professor, Virginia Commonwealth University William A. Hein II, Senior Director Technical Operations Small Molecule Platform, Janssen

A disrupter event to many businesses and industries worldwide, what lasting impacts will be felt and what can pharma learn from the COVID-19 pandemic in terms of the acceleration of drug development and repurposing in the future; the broader impact on how trials are conducted, and the impact of virtual clinical trials for clinical supplies business. Discussion Points Fast-tracking R&D Emergency use approvals Drug Repurposing Diversifying Clinical trials This session was originally broadcast live as part of CPHI North America 2021

When working with the right partner and network, transferring production between sites allows companies to reap a variety of strategic advantages. Timeline and cost efficiencies can be gained when a trusted CDMO can take a product from development to commercial launch.

They can safeguard supply by producing at more than one site, and improve distribution by moving production closer to a critical market. Program costs and risk can be reduced by moving production to sites that are better qualified or better positioned to meet the needs of regulators. But this is not without challenges.

Learn how Thermo Fisher Scientific: Uses a network of technical experts and digital innovations for project management to overcome key industry challenges related to tech transfers Customizes the approach for the process transfer, stylizing it specific to our customers Takes the lead in effectively managing projects through the most complex regulatory strategies by executing consistent, quality manufacturing Applies an optimized governance model and an integrated network approach to de-risk and simplify the transition of the program to commercial stage In this learning lounge, we will showcase what differentiates Thermo Fisher Scientific in the technology transfer market and how the power of our network consistently delivers speed through efficiency.


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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.

In Dec 2021, Thermo Fisher completed the acquisition of PPD, Inc, a leading global provider of clinical research services to the biopharma and biotech industry. With the addition of PPD, Thermo Fisher will offer a comprehensive suite of world-class services across the clinical development spectrum – from scientific discovery, to accessing safety, efficacy, and health care outcomes, to managing clinical trial logistics, to the development and manufacturing of drug product.

Today a panel of executives from Thermo Fisher will discuss how the addition of PPD’s leading clinical research services differentiates Thermo Fisher and advances our work in bringing life-changing therapies to market, benefiting patients around the world.

Today’s learning lounge will provide insight into how a patient centric mindset influences: drug development and manufacturing decisions clinical trial recruitment, retention and trial management end-to-end processes, from early drug development to the patient


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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.

In this webinar, originally broadcast as a part of Pharmapack Europe 2022, speaker Nigel Langley, Director Technical Service & Scientific Affairs, BASF Pharma Solutions reviews the 'Novel Excipient Review Pilot Program'. Launched at the end of 2021, the voluntary Novel Excipient Review Pilot Program (Pilot Program) allows excipient manufacturers to obtain an FDA review of certain novel excipients before their use in drug formulations. Fundamental to the creation of the program, IPEC Americas talks us through the historical challenges that led to this first-in-kind program and an update from the FDA on the first four excipients approved in the pilot and what this means for the future of excipient manufacturing.

Take months off the development timelines of your large and small molecule discoveries. With Thermo Fisher Scientific's Quick to Care™ program, you can combine your drug substance and drug product development, demand planning and clinical trial supply execution into a single customized solution to simplify your supply chain and accelerate your discovery through clinical development. This session was broadcast as part of the CPHI North America show.

The percentage of parenteral drugs approved continues to increase as the overall drug market expands and new therapies for chronic and rare diseases enter the pipeline. In addition to this, swift advancement in biosimilars and biological products is projected to drive the parenteral drugs market growth in the years ahead. Manufacturers face increasing complexity, not just because of the drug substances but also due to formulations, patient-centric delivery technologies, and regulatory requirements, which are all further complicated by abbreviated development timelines. This session will aim to look at trends and challenges in today’s parenteral manufacturing and development market. Discussion will cover: Discuss key trends in the parenteral dosage development and manufacturing market Overcome complex formulation challenges: solubility, stability, process Navigate a complex regulatory environment (IND, filing, etc.) Build success in early development to enable commercial success Shorten timelines to get to market quicker Bolstering Capabilities for Parenteral Drug Development & Build a robust process development program Why attend? Parenteral Drugs: Recent Approvals and Growth Dynamics Key Trends and Issues Impacting Parenteral Development and Manufacturing Overcoming challenges getting drugs to market. WATCH FOR FREE

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 us as we dive into the key considerations of choosing a CDMO as a biotech, and how to select the perfect partner: Establishing a pre-partner checklist of what you need (regulation, manufacturing technology, and logistics) to avoid unnecessary costly measures Why understanding your molecule format will help drive the process pathway for your potential partner Creating clear communication lines and expectations from the start

How CDMO organizations can be designed differently from the traditional way, and how additional value can be realized How the Lean/Agile principles can be applied to organization design How the expectations from CDMOs are evolving.

Outlining collaborative and communication strategies that can help enhance an outsourcing partnership The importance of information sharing between client and vendor for effective situation response Case study showcase of a successfully implemented partnership strategy

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.

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

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.

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.

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

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.

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

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

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.

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. Challenges in Applying Operational Excellence in R&D Developing a Strategic Operational Excellence Roadmap for R&D

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 correlation. This approach results in high costs, lengthy timelines, and frequent quality issues. While the QbD framework promotes knowledge-driven development, its adoption remains limited. Developers often work with small datasets and lack mechanistic understanding, complicating scale-up processes that depend on transport phenomena and kinetics. Mechanistic modeling addresses these challenges by connecting materials, processes, and products through thermodynamics and kinetics. Extended into Digital Twins, it enables predictive analysis, optimization, and efficient scale-up.
This presentation will showcase the application of mechanistic modeling based Digital Twin, from fundamental concepts to real-world industrial case studies. We will explore its benefits, challenges, workflows, ROI, and applications in process development, scale-up, and technology transfer.

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.

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 creating an environment where science and industry can intersect productively.

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 does the need for groundbreaking strategies, resilient mindsets, the right talent, and collaborative efforts to overcome barriers. - Explore how the next generation of technologies and innovative approaches are transforming advanced therapies into more effective, accessible, and scalable treatment options.

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 educational presentation where we will guide you through the process of starting your buffer outsourcing journey. This session will cover: Initial Steps: How to begin the transition from in-house preparation to outsourcing. Critical Considerations: Key factors to evaluate, including quality control, supplier selection, logistics, and regulatory compliance. Common Pitfalls: What to avoid and common mistakes to watch out for during the transition. Benefits: The tangible and intangible advantages of outsourcing buffer preparation. This session will provide valuable insights to help you optimize your bioprocess operations.

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.
Biomanufacturing offers an opportunity to fundamentally change how critical pharmaceutical ingredients are produced on a global scale, drive equitable access to essential medicines, and end drug shortages.
In this talk, Dr. Christina Smolke will discuss biomanufacturing’s critical role in transforming pharmaceutical supply chains and the key benefits of this innovative approach over legacy methods, including response time, scale, cost and agility.

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.
Gain insights into how novel technologies are shaping the future of bio-manufacturing, enabling faster, more sustainable production of next-generation therapeutics.

Artificial Intelligence is no longer a distant promise — it’s already reshaping the Pharma industry in ways few anticipate. In this provocative keynote, Tech Philosopher and AI expert Bruno Fabre will reveal how AI is not evolving in small steps, but disrupting the very foundations of how we research, develop, and deliver healthcare. Packed with real-world examples and unexpected insights, this session will challenge assumptions, ignite curiosity, and push industry leaders to move from passive adaptation to proactive transformation. Attendees will leave with a renewed sense of urgency — and a clear vision of how to lead through the coming waves of change.

Got questions about AI in pharmaceutical manufacturing? This open-format panel is your chance to ask them. From implementation challenges to regulatory concerns and real-world results, our panel of AI experts and industry insiders are ready to answer it all—no jargon, no sales pitches, just honest insights.

Adopting AI in a CDMO environment is not just a technological decision; it’s a scientific, engineering, and regulatory challenge. In this session, we’ll demystify what AI truly means for pharmaceutical manufacturing and uncover why one-size-fits-all models fall short. You’ll learn why each product and equipment combination often requires dedicated models, and what it takes to scale and monitor them effectively within GxP constraints. We’ll explore how cloud-based platforms enable industrialization of AI while meeting strict regulatory requirements. Finally, a real-world case study will showcase how GxP-compliant AI was successfully scaled to improve yield and accelerate batch release. Join us to understand the real hurdles CDMOs face and how to overcome them.

This session will present a compelling real-world success story demonstrating how technology can provide CDMOs with a decisive competitive advantage in a market where efficiency and quality are paramount. The presentation will showcase how implementing Artificial Intelligence transformed a pharmaceutical manufacturing process, delivering tangible results within just three months. When faced with a sudden yield drop, the featured company integrated AI into their production workflows, supported by IoT technology and a secure GxP cloud infrastructure, gaining real-time visibility into inefficiencies while enhancing data integrity and enabling real-time insights for improved decision-making. Participants will learn practical strategies for identifying root causes of process inefficiency in GxP environments, achieving significant improvements such as a 1.5% yield increase in three months, and reducing Cost of Goods Sold by 2% to directly improve profitability. The session will also explore how to leverage technology as a powerful selling point to attract and retain clients, providing attendees with a practical roadmap for industrializing AI and leading digital transformation in their operations.

Advanced manufacturing technologies, such as 3-dimensional printing (3DP), for pharmaceutical dosage form development and manufacturing are gaining increasing attention and interest from the pharmaceutical industry, academia, governments, and regulatory authorities around the world. This is based on the potential of these innovative approaches to uniquely solve certain drug delivery challenges, decrease development time, improve quality through the use of process analytical technologies (PAT), develop personalized medicines, automate compounding, and operate in non-traditional supply chain models (e.g., distributed manufacturing). Aprecia pioneered the use of 3D printing in pharma by obtaining FDA approval of the first and only 3DP drug product. Since then, new innovations have advanced the technology, and other companies are using different 3DP modalities to support clinical programs and drug product manufacturing in hospital settings. This presentation will provide an overview of the current 3DP landscape for pharmaceutical drug product development and highlight the different modalities being used today. The principle of operation and advancement of binder-jetting 3DP will be discussed in more detail, including application of PAT to monitor product quality, product and data traceability (e.g., barcoding, digital infrastructure, Pharma 4.0), and process control. Selected case studies that highlight unique applications of 3D printing will be discussed, and the presentation will conclude with a consideration of future opportunities and challenges.

This session will explore how AI is revolutionizing launch excellence in the pharmaceutical industry by driving efficiency, innovation, and impact across the entire value chain. Participants will discover the transformative role of AI in enabling dynamic market segmentation, personalized healthcare professional engagement, and enhanced customer understanding through powerful AI-powered insights. The presentation will demonstrate how everyday AI enablement tools like MyGPT Assistants and AInstein are empowering teams to optimize processes, improve communication, and enhance training effectiveness. The discussion will dive into innovative patient solutions, showcasing AI-driven initiatives including lung cancer diagnostics, disease awareness campaigns, and chatbot support systems designed to deliver personalized patient care. Finally, the session will address how cultivating an AI-first mindset prepares pharmaceutical organizations for sustainable growth and groundbreaking launches, positioning them as future-ready companies in an increasingly competitive landscape.

This session will address the critical challenges facing today's high-pressure pharmaceutical development landscape, where every decision carries significant weight for companies ranging from emerging biotechs navigating investment challenges on their path to IND, to established biopharma organizations scaling complex programs toward commercialization. As companies across the spectrum face increasing pressure to innovate rapidly while delivering measurable value, traditional development models often slow progress, increase risk, and quietly drain time, money, and competitive advantage from programs. The presentation will examine an innovative development model that's reshaping industry expectations by unifying scientific, manufacturing, and clinical execution to unlock value at every stage of development. Attendees will learn to identify where disjointed execution models create unnecessary risk, delays, and added costs, while discovering what new data-driven insights reveal about the ROI and timeline benefits of coordinated outsourcing approaches. The session will also explore how companies are strategically adjusting their execution approaches to maintain momentum and competitive advantage under mounting industry pressures.

How can bioprocessing deliver life-changing medicines while protecting the planet? In this session, Thermo Fisher Scientific will showcase practical innovations that cut carbon, conserve resources, and reduce waste—without compromising performance. From zero-waste certified sites and renewable electricity to biobased single-use solutions, we’ll demonstrate measurable sustainability gains, including annualized carbon savings equivalent to taking dozens of cars off the road. Discover how freight optimization, process intensification, and next-generation single-use technologies can lower plastic, water, and energy use across the full bioprocessing workflow. Join us to explore how you can accelerate your journey to net zero while maintaining efficiency and reliability in biologics production.

Navigating the evolving terrain of biologics from development through commercialization requires a resilient and dependable supply chain. Dual sourcing, which involves procuring essential materials from two distinct suppliers, has emerged as a pivotal strategy to help mitigate risks and enhance supply chain resilience. This presentation delves into the dual sourcing model, integrating insights from Total Cost of Ownership (TCO) analysis to help optimize supply chain performance for bioprocessors. By striving to make your supply chain cost-effective and reliable—and ensuring it works as diligently as you do—you can better position yourself to meet the demands of today’s competitive market.
Key Takeaways: Understand the concept of dual sourcing and its impact on risk mitigation, flexibility, and supply chain resilience. Gain a basic understanding of how TCO analysis can enhance cost efficiency. Discover best practices from case studies on developing a dual sourcing strategy and conducting your own TCO analysis.

Continuous manufacturing: A view into the Future of Pharmaceuticals Production Pharmaceutical manufacturing is evolving. As the industry looks for ways to enhance efficiency, improve quality, and strengthen supply chains, continuous manufacturing is emerging as a powerful alternative to traditional batch production. Though adoption has been gradual, CM is gaining momentum across pharma and CDMOs — backed by growing regulatory support and real-world successes. L.E.K. Consulting together with a panel of industry expert will explore several topics around CM to bring a perspective on the current State-of-the-Art for continuous manufacturing , including: - Why and When Is CM Interesting? - What are the Challenges and Opportunities? - How are regulators reacting? - What is the Outlook for Continuous Manufacturing?

This session explores the evolving dynamics of pharma and biotech through the lens of capital markets. We will examine current sector trends, including share price performance, valuations, loss of exclusivity (LOE), biotech IPO activity, and capital raising. We’ll also discuss recent M&A developments and their implications for investment in R&D and capex. Finally, we’ll assess how these shifts shape market expectations for pharma services, highlighting growth opportunities and investment priorities across the sector.

Global pharmaceutical manufacturing is being redefined by a new era of trade friction, industrial policy, and strategic decoupling. As governments rethink supply chain security and impose new tariffs and incentives, capital is following a different path—away from traditional hubs and toward regionalized, politically aligned ecosystems.

Pharmaceutical manufacturing is undergoing a profound transformation. Geopolitical volatility, rising demand for specialized therapies, inflationary pressures, and shifting regulatory expectations are reshaping how and where medicines are made. In this keynote, we’ll explore the evolving market dynamics that CDMOs and pharma companies must navigate—from regionalization of supply chains and capital investment constraints to the rising need for strategic, flexible partnerships. This session will provide a high-level snapshot of the global manufacturing environment and outline what’s needed to compete—and thrive—in this next chapter of the industry.

The CDMO industry is at an inflection point. The explosive demand for GLP-1 therapies is straining manufacturing capacity, forcing rapid investment in specialized capabilities. Geopolitical tensions are disrupting supply chains, making regional diversification and de-risking strategies more critical than ever. Meanwhile, raw material shortages, rising costs, and labor constraints are challenging production efficiency—pushing CDMOs toward automation and digitalization. At the same time, pharma companies are no longer just looking for vendors; they need long-term strategic partners who can offer flexibility, scalability, and innovation.

All pharmaceutical or medical device companies with products destined for the United States (US) market, operate under strict manufacturing practices to ensure public safety, efficacy, and consistent product quality. The US Food and Drug Administration (FDA) plays a pivotal role in this oversight through the employment of Good Manufacturing Practices (GMPs).
Despite intensive internal controls and monitoring systems, these industries frequently receive FDA Form 483s—inspectional observations—and in the most serious cases, a warning letter. This SIA/LBG paper examines inspection findings most commonly related to documentation practices and procedures including SOPs, incomplete or inadequate deviations and non-conformances and outlines strategies to address and prevent regulatory non-compliance.

Thermo Fisher Scientific provides comprehensive solutions for advanced therapy development and manufacturing to support your unique therapeutic product from discovery through commercialization. With our extensive technical expertise, global supply network, and expanding capacity, we are well-equipped to help you navigate the complex journey from molecule to medicine and get your transformative treatment to market faster.

Cell and gene therapies (CGTs) provide the opportunity to transform medicine across diverse disease areas where there is significant need for new treatment options. Valued at $15.46 billion in 2022, financial analysts predict the global cell and gene therapy market will grow to $82.24 billion by 2032. Some of the key drivers for this growth include a robust clinical pipeline, new regulatory approvals, the development of innovative technologies to improve production, and strategic collaborations between biotech companies and research and manufacturing partners.

With over 20 years of experience manufacturing a broad range of viral vector products, VVS is well-equipped to handle your unique product needs. Our network of sites contains 400,000+ square feet of manufacturing space with morethan 40 suites and capacity to expand. In addition, our breadth of integrated services ensure smooth transitions andexpertise across your value chain.

Originally presented at BIO International 2025, this webinar explores how our novel Path to IND platform helps biotech companies move from DNA to first-in-human Phase I clinical trials in as little as nine months.* With integrated drug substance, drug product, clinical packaging and labeling, and regulatory and quality assurance support, our platform delivers unmatched speed, helping you reach key milestones quicker than ever before.

Gain insights into the advantages of leveraging artificial intelligence/machine learning, transposase technology, and the world-class CHO-K1 cell line—and see why drug developers choose Thermo Fisher Scientific as their CDMO and CRO partner. While the webinar focuses on early-stage acceleration, we also support downstream scale-up for clinical and commercial manufacturing, ensuring a seamless transition as your program advances.

Biologic therapeutics are inherently complex, but developing them doesn’t have to be. Increased demand for higher product yields requires the optimal use of existing manufacturing capacity. Process intensification is one way biopharma facilities can meet these industry needs by enabling fewer or smaller batches to produce the same amount of product within the same timeframe.

Our recent case study highlights how we developed a process intensification workstream aimed at increasing the titer of CHO processes by 20–50% while meeting the following criteria: 1) no effect on process timelines, 2) maintains comparable product quality attributes, 3) no additional equipment or training required, and 4) compatibility with all existing manufacturing facilities.

The recent introduction of the 5,000L single-use bioreactor (SUB) is helping to revolutionize biologics manufacturing by bridging the gap between small and large-scale production. This new technology choice offers biotech and pharma companies, as well as their CDMO partners, greater flexibility to respond to fluctuating demands quickly and efficiently. As the market for complex biologics grows, capacity planning becomes increasingly critical—and even more challenging.

This whitepaper outlines how to evaluate capacity needs and the benefits of using SUBs at different drug development stages. Key topics include the benefits of 5,000L SUBs, improvements in turndown ratios and oxygen transfer rates, and the efficiency and sustainability advantages they offer over stainless-steel bioreactors. Additionally, it highlights what to consider when selecting a CDMO partner for manufacturing with SUBs to ensure reliability, flexibility, and collaboration.

Your large molecule has the potential to revolutionize patient care. In an industry where timelines are critical, you need a reliable partner you can trust to help bring your drug to market. Thermo Fisher Scientific is your full service CDMO, offering the expertise and comprehensive capabilities to seamlessly manage every step of your drug development and manufacturing journey.

A partnership with Thermo Fisher can support you from discovery through commercialization, ensuring your large molecule's success with our integrated, end-to-end solutions. Our expansive global network of over 65 sites across five continents, can help accelerate your path to market.

As development costs climb and timelines tighten, the traditional outsourcing model is showing its age. Fragmented handoffs between CDMOs, CROs, and clinical supply vendors often create delays, inefficiencies, and missed opportunities. A new study by the Tufts Center for the Study of Drug Development offers fresh insight by quantifying the financial and operational impact of a fully integrated development model. This whitepaper explores the full study findings and highlights how aligning manufacturing, clinical, and supply services can reduce complexity, streamline execution, and unlock significant ROI.

This eBook focuses specifically on Accelerator™ Drug Development, Thermo Fisher Scientific’s 360˚ CDMO and CRO solutions, to support your aspiration to get treatments to patients faster. Key topics include: • Current state of the drug development market: A discussion of the current landscape and trends • Differentiated solutions and capabilities: A description of Thermo Fisher Scientific’s 360˚ CDMO and CRO solutions, and how these offerings can enhance the drug development process. • Case studies: Demonstrations of how streamlined and efficient processes can reduce risk and improve scalability helping Sponsors get therapies to patients, faster. • Industry Insights: Summary of key insights from industry leaders with respect to enhancing drug development efficiency, the value of integrated drug development, and regulatory challenges and solutions.