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.

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

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.

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.

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.

Responding to critical market capacity constraints, Thermo Fisher announces the official opening of new 67,000 sqft cGMP plasmid DNA manufacturing facility in Carlsbad, CA. This site expands clinical and commercial capabilities for cGMP plasmid DNA used as a critical raw material to develop and manufacture cell and gene-based therapies in addition to capabilities to produce large-scale plasmid DNA as a primary drug substance for DNA therapies.

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.

Thermo Fisher Scientific Inc., the world leader in serving science,  announced that it has assumed operational responsibility for a new biologics manufacturing site in Lengnau, Switzerland as part of its strategic partnership with CSL Limited announced last year. The Lengnau site will become part of Thermo Fisher's global biologics manufacturing network, and approximately 200 employees will join Thermo Fisher.

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.

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

Your molecule has the potentialto change lives and shape thefuture. That’s why you need apartner you can trust.

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

As the complexity of drug development increases, so does the industry’s focus on strategies and solutions that can help bring advanced products to market as quickly as possible. Lowering the cost of R&D is also a key factor, as new chemical entities and de novo drugs in clinical phases face high attrition rates, with companies losing significant investments in nonviable candidates. One approach to avoiding this fate is drug repurposing, where known clinical candidates or commercially approved molecules are evaluated for new targets and indications. Understanding drug repurposing, how it can significantly reduce your time to market, and the important role established and knowledgeable CDMOs can play in this journey is critical to finding success with this emerging strategy.

Accelerated efforts align with the Paris Agreement and Race To Zero to combat climate change

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.

A new media panel, gene kit and advanced resins help reduce manufacturing costs and increase the viability of gene therapies

In addition to the devastating impact the COVID-19 global pandemic has had on public health, the economy, and the overall quality of our day-to-day lives, it has also exposed significant risks in today’s pharmaceutical supply chain. Improvements in speed to market and quality assurance, among other factors, need to be made to ensure not only the timely delivery of safe and efficacious drugs but also the stability necessary to manage future risks and disruptions.

Expanded global capacity addresses growing demand for cell and gene therapy

Over the past decade, outbreaks of H1N1 influenza, Sars-Cov, Ebola, and MERS have triggered several discussions about traditional vaccine development methods1. For example, new platform technologies, such as the use of messenger RNA (mRNA) vehiculated through lipid nanoparticles, have been introduced, stimulating scientific discussions. With the spread of SARS-CoV-2 intensifying, scientists, together with pharmaceutical companies, are reinventing the approach of how to bring these life-saving drugs to market faster without impacting product quality, safety, or efficacy.

Two new facilities in Germany will provide clinical supply and cold chain services to support growing demand

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.

Thermo Fisher Scientific Inc., the world leader in serving science, announced the opening of its new Bioprocessing Collaboration Center (BCC) in St. Louis, Missouri.

In this report, we will review key insights derived from the development of mRNA-based COVID-19 vaccines and how they can be applied to accelerate progress in the manufacture of mRNA vaccines and therapeutics moving forward, focusing on the following:
The unique attributes of mRNA vaccine development The planning paradigm shift to address major process challenges and streamline workflow Global supply chain implications and the investments and innovations needed to manage them.

“Faster and better” has become the mantra for biopharmaceutical companies as they face intense pressure to get therapies to market quicker than ever before. The incentive of securing market share with first-to-market offerings is felt by all industry players. Pressure mounts from here for small companies, which often must meet certain milestones before receiving funding from investors. Quickly proving efficacy in first-in-human (FIH) trials is a make-or-break milestone for cash-strapped companies whose hopes for success hinge upon just one or two molecules.

Rising to the challenges of biologics development in this period of disruptive change requires an appreciation for the science, technology, and market forces driving the transformation and a willingness to adopt strategies that align with these changes. For most pharmaceutical and biotech companies, this means identifying trusted partners who can provide access to innovative technologies and methodologies, sufficient manufacturing capacity for growing biologics demand, deep expertise in navigating regulatory channels, and the operational efficiencies needed to accelerate speed to market. This report provides a roadmap for assessing and selecting the right partner to get promising biological therapies to patients quickly.

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.

Eight years after its adoption, the EU Clinical Trial Regulation (CTR) 2022 has come into full application, radically altering the regulatory landscape for conducting clinical trials in EU member states and European Economic Area (EEA) countries. This whitepaper provides insight into the key changes introduced by the regulation and guidance for managing anticipated challenges, focusing specifically on the following considerations:

The impact of the new regulation on existing clinical trialsThe implications for good manufacturing practice (GMP) guidance and the Clinical Trial Application (CTA) processNew labelling requirements, the challenges they may pose, and potential solutionsThe UK’s approach to clinical trial regulation and the impact of the EU CTR changes on Qualified Person (QP) requirements and other legislation

The COVID-19 pandemic accelerated the adoption of DCTs worldwide, but the rate of uptake has not been consistent globally. Some early implementation barriers, including immature digital infrastructures and sponsors’ limited experience with the approach, have been steadily receding as enabling technologies become more prevalent and knowledge of benefits grows. Other obstacles, such as the perception of regulatory barriers, are more challenging to navigate, especially in the EU, where EMA recommendations are not interpreted consistently across countries.

In this eBook we share the five key differences in the drug development and review process for companies hoping to gain market access through US Food and Drug Administration (FDA) or European Medicines Agency (EMA) approval—as well as tips for navigating these differences.

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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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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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

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

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.

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

A global leader with over 40 years of biologics manufacturing experience. Decades of partnerships with highly regarded pharmaceutical and biotechnology companies around the world, paired with scalable cGMP-compliant facilities and industry-leading technology, mean we have the knowledge and tools to provide solutions to our customers to move forward in this space. In this keynote, I will talk about the CDMO´s journey over decades, how the pivot came with COVID-19 and the technological advancements like Cell and gene therapies. It´s about addressing the industry challenge and being extended partner rather than mere service provider. Journey of the Global biotech Cooperations, Novartis CDMO to bring therapies to the patients

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.

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

De-risk your path to commercialization with flexible plasmid solutions backed by proven quality systems 

Combining technical expertise with agile execution to address your unique cell therapy project needs 

This whitepaper provides insight into the market trends influencing the manufacture and supply of pDNA for advanced therapies and offers an in-depth discussion of the key challenges associated with transitioning from GMP-like to full cGMP quality. Guidance is also offered to address these challenges, including recommendations related to critical quality attributes, upstream processing, formulation and fill/finish, analytics, and flexible capacity planning

Flexible, end-to-end mRNA service offering basked by decades of therapeutic manufacturing experience 

The rapid development and approval of COVID-19 vaccines has spurred a renewed interest in mRNA as a therapeutic strategy. An ideal platform due to the simplicity of manufacturing and robust immune response, mRNA-based drug products are being explored for use in infectious disease, protein replacement, and immuno-oncology applications, among others. Despite the advantages, challenges still exist around designing the template mRNA to properly balance the innate immune response with making a robust amount of protein, and ensuring the route of administration and vaccine form not only enable the desired therapeutic response, but also address storage and other logistical issues. This article details common challenges in the mRNA industry and explores avenues developers are researching to overcome them.

Overview of cell therapy development and manufacturing capabilities available at our state-of-the-art facility in San Francisco, CA

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.

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.

This article focuses on 10 red flags that could signal it is time to start looking elsewhere for a CDMO that can efficiently bring your project to commercialization while steering clear of potential roadblocks along the way.

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

Based on our unmatched experience with more than 1,000 molecules, including more than 50 large molecule (biologics) drug substances, Patheon pharma services brings deep scientific expertise to every challenge. We apply our comprehensive process development skills to significantly increase the batch yield and reduce processing time for your molecule. Our proven track record of scaling up biologics helps provide you with cost and time savings at every stage of development, with processes that ensure: 

RepeatabilityReliabilityHigh quality and low cost

An Independent Executive Research Study was done by ORC International to examine how large molecule drug substance manufacturing and demand forecasting is filled with complexity. The long cycle time and short shelf life of a biologic drug substance makes it difficult to adapt the supply chain with agility, even at the earliest stages of development. As a result, inaccurate demand forecasts can have significant implications for companies developing biologics. And with less industry-wide available capacity for biologic production, it is increasingly difficult to locate capacity to respond to demand changes and ensure products achieve commercial goals. Thermo Fisher has a global network of sites with solutions to capacity issues.

“Faster and better” has become the mantra for biopharmaceutical companies as they face intense pressure to get therapies to market quicker than ever before. The incentive of securing market share with first-to-market offerings is felt by all industry players. Whether biopharmaceutical companies have one candidate or 100, the directive is clear: moving quickly into FIH testing is essential. Learn key strategies for speeding time to clinic.

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.

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...

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.

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

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

The benefits offered by decentralized trials are driving wider adoption of this approach to clinical research. The introduction of novel solutions to facilitate adherence can support decentralized trials and mitigate potential concerns surrounding reduced patient-physician touchpoints.

This whitepaper highlights Thermo Fisher's solutions to drive high adherence in decentralized trials.

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.

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

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.

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.