Discover how a US-based vaccine developer reached Phase 3 clinical trials in just 4 years by partnering with Actelion Pharmaceuticals Deutschland GmbH. Learn how we can help you overcome complex Fill & Finish manufacturing challenges and accelerate your path to approval.

What you will discover:

This case study reveals the journey of overcoming complex manufacturing and analytical challenges, and provides actionable insights on how to:

• Managing over 30 unique Active Pharmaceutical Ingredients (APIs) with full traceability and compliance.
• Implementing customized documentation and rigorous aseptic processing.
• Establishing analytical protocols aligned with USP and EP standards.
• Achieving maximum production efficiency while maintaining uncompromising quality.

See how our flexibility in planning, dedicated operator training, and ongoing process optimization enabled swift progression through clinical phases, ultimately supporting innovation and safety in vaccine development.

Ready to learn more? Download the full case study now and gain actionable insights to drive your next clinical manufacturing success.

Key topics:

• General Information about Japan: Discover what makes Japan a strategic choice. From its aging population to a world-class healthcare system driving pharmaceutical demand.
• Requirements for the Japanese Pharmaceutical Market: Navigating into the Japan’s Pharmaceutical Regulations: MHLW, PMDA, MAH.
• How To Enter The Japanese Market: Understand what you need to do to meet the highest Japanese quality standards.
• Case Studies: Real-world examples demonstrate different scenarios, such as how a European biopharmaceutical company successfully launched in Japan and how Marketing Authorization Holder (MAH) transfers are practically managed between international companies with Japanese subsidiaries.

Overall, the guide serves as a practical reference for foreign pharmaceutical companies, offering actionable strategies and best practices to ensure successful compliance and market access in Japan.

Download the e-book now to learn how we can help you and facilitate the entrance to the Japanese market

The People Behind the Vision takes you beyond the headlines and into the heart of the pharmaceutical industry. Each episode reveals the personal journeys, insights, and expertise of the remarkable individuals behind the scenes at actelion. In an industry often defined by scientific papers and clinical results, we believe the human stories deserve to be told.

Hosted by Lydia Marinou, our podcast connects you with industry veterans who share their:

• Leadership philosophies and strategies that drive organizational success
• Career paths and pivotal moments that shaped their professional journeys
• Perspectives on industry challenges and how they navigate complexity
• Visions for the future of pharma and healthcare innovation
• Personal motivations that fuel their dedication to improving patient lives

Whether you are a pharmaceutical professional, healthcare partner, or simply curious about the people shaping modern medicine, these conversations offer valuable perspectives on leadership, innovation, and purpose-driven work in the pharmaceutical landscape.

Meet Your Host

Lydia, brings both scientific expertise and business insights to her role as host of our podcast. With a doctorate in Biomedical Engineering and experience in biomaterials innovation, she bridges the technical and commercial worlds of pharmaceuticals. After transitioning from academia to industry, Lydia now serves as a Business Development Associate at Actelion Pharmaceuticals Deutschland GmbH, where she identifies growth opportunities and supports commercial initiatives.

In each episode, Lydia creates a relaxed yet insightful atmosphere where guests can share their stories. Her combined scientific background and business perspective allow her to dive deep into technical discussions while making them accessible to all listeners. Whether chatting with laboratory scientists, corporate executives, or industry pioneers, Lydia’s curiosity bring out the human side of actelion. Join her as she uncovers the passion, challenges, and personal journeys of the people shaping Actelion Pharmaceuticals Deutschland GmbH.

Featured Episodes

Embracing Change: Conversations with our Team

 In this episode, we welcome Bastian, Global Head of Digitalization & IT to talk his journey that lead to actelion, and embracing change as we enter the new digital era of AI. Bastian shares his favorite tips and tricks for using AI tools effectively, offers practical advice on finding your own super power at work, and dives into strategies for overcoming resistance to digital transformation in pharma.

As someone born and raised in Munich, Bastian also reveals his personal recommendations for experiencing the city like a local.

Whether you are interested in the future of pharma, digital innovation, or just want some insider tips for Munich, this episode has something for you! 

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Culture, Ambition, and Balance: Conversations with our Team

In this episode, we welcome Nicole, our dynamic Business Development Manager in Barcelona, to share her unique story and perspective.

Join host Lydia Marinou as she sits down with Nicole to explore the contrasts and connections between Chinese and European business cultures. Nicole opens up about balancing her personal interests, building a family abroad, and shaping a professional journey that spans continents. She dives into how her Chinese upbringing and values have influenced her work ethic, resilience, and approach to growth, both at work and in life.

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Key Learning Points

Learn essential criteria for choosing a Fill & Finish CDMO, focusing on technology, compliance and scalability to align with your development goals

Explore strategies to streamline Fill & Finish processes, enhancing efficiency and reducing product launch timelines

Understand evolving industry trends and identify challenges and opportunities in the Fill & Finish sector.

Agenda:

Understanding the Role of CDMOs in Fill and Finish​

• Importance of CDMOs for F&F
• When to start involving a F&F CDMO? The earlier: the better

Criteria for Selecting a Good CDMO​

• Highly Specialised Expertise​
• Risk Management​
• Regulatory Expertise​
• Intellectual Property​
• Speed to Market​
• Scalability and Flexibility​
• Cost Transparency

Real Case Studies​

Our Key Speakers

We are honored to welcome our expert speaker, leader pharmaceutical innovation and Clinical Trial Manufacturing, who will share insights on how to chose the correct Fill & Finish CDMO.

Marie-Sophie Quittet, Head of Strategic Projects, Actelion Jura

Marie-Sophie holds both a Doctor of Pharmacy (PharmD) and a Doctor of Philosophy (PhD), showcasing her expertise in the pharmaceutical industry. As Head of Customer Relationship and Strategy Partnership Expert, she has over a decade of experience, spearheading clinical production projects in Europe and the US. Her leadership in implementing clinical and commercial projects highlights her strategic acumen. Beyond her professional life, Marie-Sophie balances her career with being a devoted mother. Her love for human relationships enhances her customer relations role, while reading and cooking provide creative balance. With her wealth of experience and a profound understanding of both the scientific and interpersonal aspects of the pharmaceutical industry, Marie-Sophie continues to make significant contributions, fostering innovation and collaboration within her field.

Discover More About Clinical Manufacturing

The Future of Pharma: Understanding Lyophilisate Technology and Its Applications

One technology that has revolutionized the industry is lyophilisation (freeze-drying), which produces lyophilisates—a highly stable, easy-to-reconstitute dosage form.

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Clinical Trials: Essential Insights into Clinical Trial Services for Patients

This comprehensive guide explores various aspects of clinical trials, offering valuable insights for patients and pharmaceutical professionals alike.

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What’s on the agenda?

• An overview of Japan’s pharmaceutical market, with a look at why this is such a critical market
• Key regulatory requirements for entering the Japanese market
• How to ensure compliance and drive product success
• What supply chain strategy and processes make most sense for the Japanese market
• Common challenges and solutions to overcome them
• Best practices for smooth market entry

… and more!

Our Key Speakers

We are honored to welcome our expert speakers, leaders in healthcare and pharmaceutical innovation, who will share insights on Visual Inspection and Packaging, focusing on regulations, quality, and the secrets to enter the Japan market.

Masako Hirota, Head of Quality Operations

Masako is the Head of Quality Operations. She has more than 15 years of experience in quality management and assurance with multinational pharmaceutical companies in Europe and America. With a Master’s degree in Pharmacy, she deeply understands the differences between Western regulatory requirements and Japanese practices. As the head of the quality department at a foreign-affiliated manufacturing site, she has effectively led efforts to close these gaps, ensuring compliance and operational excellence, and successfully delivering medicine to the Japanese market.

Hideyuki Tanaka, Head of Commercial US & APAC

Hide serves as actelion’ Head Commercial US & APAC and brings over two decades of experience within the pharmaceutical and CDMO industry. He has an extensive global background spanning the United States, Europe, and Japan. Throughout Hide’s career, he has excelled in roles covering sales, marketing, business development, corporate governance, project management, and medicinal chemistry.  Possessing a Master’s in Pharmaceutical Chemistry and an MBA from Bond University in Australia, Hide exemplifies an unwavering commitment to professional growth.

Discover More About Visual Inspection

Dive into the world of Visual Inspection and gain valuable insights and knowledge about the key actions to enter the Japan market.

Pharma Visual Inspection: What Is It and Why You Need It

Discover the future of pharma visual inspection with our cutting-edge technology and navigate excellence in quality control like never before.

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Japan’s Pharma Market Entry Process: An Essential Overview

Master the Japan Pharma Market Entry Process with our detailed overview. Gain a competitive edge and succeed in this dynamic market.

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VAMs stand at the intersection of innovation and practicality, offering tailored solutions to improve stability, efficacy, and patient adherence. For healthcare providers, these medicines are an opportunity to improve outcomes while optimizing resources in a competitive pharmaceutical landscape.

This guide takes you through the multifaceted journey of VAMs, from initial concepts to approval, with insights into the challenges and opportunities encountered along the way. It is structured as follows:

1. Understanding Value-Added Medicines (VAMs)
   Explore how VAMs differ from generics, including examples of improved formulations, repositioned drugs, and innovative combinations.
2. Regulatory Pathways for VAM Development – Navigating EU and US Approvals
   Learn about the regulatory frameworks guiding VAM approvals in the European Union and the United States.
3. Key Development Concepts in VAMs: Enhancing Patient Care
   Delve into the core principles of VAM development, such as tailored dosage forms and patient-centered innovations.
4. Formulation Challenges in VAM Development
   Gain insight into key formulation hurdles, from stability and sensory considerations to release profiles and administration methods.
5. Clinical Development and Bioequivalence in Value-Added Medicines (VAMs)
   Understand the critical role of clinical trials and bioequivalence testing in ensuring safety and efficacy.
6. The Role of CDMOs in VAM Success
   Discover how partnerships with Contract Development and Manufacturing Organizations (CDMOs) drive innovation, reduce risks, and accelerate time-to-market.

Whether you are a pharmaceutical professional, regulatory expert, or healthcare stakeholder, this eBook offers a comprehensive roadmap to navigate the exciting world of Value-Added Medicines. Join us as we examine how VAMs are enhancing patient care, streamlining development, and shaping the future of pharmaceuticals.

This webinar will include examples of successful developments of value-added medicines in Europe, aiming to provide an in-depth exploration of the key regulatory and development aspects of value-added medicines, with a focus on the European context.

What You Will Learn

1. Regulatory Frameworks And Pathways In Europe

· Understanding the European regulatory environment for VAMs.
Navigating regulatory challenges and opportunities.
· Case studies illustrating successful regulatory strategies and approvals within Europe.

2. Development Strategies

· Key considerations in the development of VAMs, including formulation science, clinical trial design, and patient-centric approaches.
· Innovations in drug delivery systems and their impact on the development process.

Our Key Speakers

We are honored to welcome our expert speakers, leaders in healthcare and pharmaceutical innovation, who will share insights on the transformative impact of Value-Added Medicines.

John Kytariolos
Head of Clinical & Scientific Affairs, Athens

Konstantinos Apostolou
R&D Senior Manager, Athens

Discover More About Value-Added Medicines

Dive into the world of Value Added Medicines (VAM) and gain valuable insights and knowledge about these transformative healthcare solutions.

Value Added Medicines (VAM): Everything You Need To Know

Let’s dive into what Value Added Medicines (VAM) really means, its incredible benefits, the challenges it faces, and how it’s navigating the complex world of regulations.

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Exploring 505b2 Value-Added Medicines: A Complete Overview

This article delves into the 505(b)(2) pathway, its benefits, and its critical role in drug development, showing pharmaceutical companies how to optimize their strategies.

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In our exclusive e-book, “Three Crucial Reasons to Select the Right CDMO,” we dive into how partnering with the right CDMO can save you time, reduce costs, and ensure compliance with regulatory standards. Whether you’re looking for formulation development, clinical trial manufacturing, or commercial-scale production, the right CDMO can be the difference between success and costly delays.

Download the e-book now to learn how to choose a CDMO that meets your needs and drives your business forward.