Stay healthy and keep moving forward! 🏃‍♀️🏃‍♂️


Here at Biopharma Excellence we have a team full of bright and talented biopharmaceutical professionals to support your drug development programs. In order for us to stay as fit as we are, our team has once more joined over 30.000 participants for the annual Munich B2 run in Munich’s Olympic Park, Germany’s biggest corporate running event.

Platform technologies for vaccines – why is there still no regulatory guidance available?

by Michael Pfleiderer

The recent widespread, long-lasting and recurrent outbreaks of Ebolavirus, Chikungunyavirus, Denguevirus, Zikavirus once more prove the need for rapid availability of vaccines and appropriate platform technologies. Read Michael Pfleiderer’s expert opinion on a matter of the highest relevance.


What’s the risk? - How to approach the risk management process of a medical device

by Liron Sarid-Krebs

Risk management is an essential part of any pharmaceutical development. This is even more true in the context of medical devices potentially used by the patient himself. In this article, we present a holistic overview over device specific risk management - covering everything you need to keep in mind.

Four Tips for Successful MAA Preparation based on Real-World Experience

by Brenda Rascon

A Marketing Authorization Application (MAA), New Drug Application (NDA) or Biologics License Application (BLA) is the grand finale of several years of work for any pharmaceutical. Make sure you get it right - and read our insights on the most relevant aspects of a successful dossier preparation.

How Artificial Intelligence (AI) can boost biopharmaceutical development

Biopharma Excellence has supported numerous biopharmaceutical development projects that employ innovative or first in class technologies. One particularly disruptive innovation is the use of artificial intelligence (AI) technology in drug development.

 We have experienced how powerful AI technology is from one of the pioneers in the medical AI space: This picture shows us with the Laralab team who develop an AI-augmented software system that supports heart catheter surgery.

 If you are interested in biopharmaceutical innovations, you should read the following articles:

How Biologicals Have Changed the Paradigm of How We Treat Diseases Today and in the Future

by Diane Seimetz

Biologics have been gaining importance rapidly over the past 30 years. Over this time, new developments revolutionized the treatment of diseases repeatedly and continue to do so even today. In this article, Diane Seimetz provides her view on the history of biologics and outlines exciting future trends.

Artificial Intelligence – A Revolution in Biopharmaceutical Development

by Michael Firgens

As Artificial Intelligence (AI) is becoming more and more present throughout industries, first applications of AI have demonstrated how promising this technology can be for drug development. In this article, Michael Firgens provides an overview of potential and already used AI approaches for the drug development process.

Continuous Progress in Continuous Manufacturing

by David Koziel

As manufacturers of biopharmaceuticals face growing challenges in the development and commercialization of products, advanced technologies, e.g. continuous manufacturing, promise increased process efficiency and economics. In this article, David Koziel gives you an overview over current technical developments and the evolving regulatory environment.

Biopharma Excellence at the Most Beautiful Places Around the World

We do not only enjoy supporting exciting and special development projects. Our projects also bring us to the most beautiful places in the world, including Europe, America and Asia. 

Can you guess where the places are that we visited in the picture below? The winner with the best guess will receive a surprise from us. Please mail your guess to (until May 31th 2019).

EMA’s Article 58 procedure and WHO’s prequalification procedure – pathways to licensure worth to consider for vaccines and other medicinal products

by Michael Pfleiderer

There are challenges and opportunities for developers of vaccines and other medicinal products needed outside the EU but having a high potential of becoming essential medicinal products also within the EU. The Article 58 procedure is reserved for products that are not (or not yet) foreseen for EU markets. The EU Article 58 procedure and the WHO prequalification procedure have been revised and now provide excellent opportunities to drug manufacturers. In this article, Michael Pfleiderer provides a detailed overview on the Article 58 procedure and WHO’s prequalification procedure.

Five tips to streamline paediatric investigation plan (PIP) preparation

by Linsey Reavie

In order to receive approval for a marketing authorisation application (MAA) in the European Union, Sponsors must present an approved paediatric investigation plan (PIP) for their product. In this article, Linsey Reavie gives 5 key tips to consider when preparing a paediatric investigation plan (PIP) application.

Newly approved second generation of CDK4/6 inhibitors give hope to breast cancer patients

by Ilona Baraniak

Breast cancer is the most common type of cancer in women worldwide, with nearly 1.3 million new cases each year. It is the fifth most common cancer-related cause of death for women, and current predictions estimate a continuing rise of cases. CDK4/6 inhibitors provide promising options for the treatment of breast cancer. In this article, Ilona Baraniak provides insights into the area of newly approved second generation of CDK4/6 inhibitors.

Harnessing the power of the immune system: from bispecific antibodies to CAR-Ts and beyond

by Diane Seimetz

The first class of therapeutic products harnessing the power of T cells for target-specific treatment of oncological diseases was bispecific antibodies. Eight years later, the first autologous chimeric antigen receptor (CAR)-T cells received regulatory approval. In this article, Diane Seimetz reviews the current landscape of CAR-Ts, recent approvals  and further important developments in the cell- and gene therapy space.

Let’s Celebrate! – Success Stories from Biopharma Excellence 🍾

Already in the beginning of 2019, the Biopharma Excellence has several good reasons to celebrate. The highlights with major contributions by the Biopharma Excellence team were:

  • An IND for a first-in-class product was approved by the US FDA.

  • Two products where Biopharma Excellence was making significant contributions during drug development, dossier preparation and the authorization process obtained marketing authorization in the EU.

 Together with our clients, we have been very delighted, and we congratulate the entire team to these great achievements. These are just the first success stories in this year, there are more to come! 🍾

biopharma excellence

Pregnant women and vaccines against emerging epidemic threats

by Michael Pfleiderer

Vaccines have one of the highest live saving potentials amongst all medicinal products licensed around the globe. One commonality of all these vaccines is that they are developed for all age and risk categories except pregnant women. Although some vaccines are specifically recommended for use in pregnancy, access to novel vaccines is generally blocked for pregnant women. Michael Pfleiderer summarizes which advances have been made to overcome this dilemma.

Drug repurposing: how to protect your asset by an integrated regulatory strategy

by Michael Firgens

Drug repurposing is an alternative cost-effective approach to drug development which builds on already approved drugs and compounds. However, the actual commercial success of a repurposed drug depends on achieving effective protection against competitors such as generics and other products with the same active pharmaceutical ingredient. In this article, Michael Firgens explains the key strategies for the protection of a repurposed drug.

Season’s Greetings and a Happy New Year from Biopharma Excellence 🎅

2018 has had many great memories, such as the BIO Europe 2018 in Copenhagen, and this year is coming to an end soon.

We would like to express our sincerest gratitude to all our clients and cooperation partners, and in this past year we have grown with our clients’ projects. More colleagues have joined the Biopharma Excellence team and support biopharmaceutical development projects with passion.

We are confident that in 2019 many new adventures and successes lie ahead of us. We wish you happy and peaceful holidays and a great start in 2019.


Cell and gene therapies are changing the face of modern medicine – But how to find the right dose?

by Diane Seimetz

Finding the right dose for the first in human study can be a challenging undertaking for biopharmaceuticals. For cell and gene therapy products (commonly referred to as ATMPs), this is even more challenging. In this article, Diane Seimetz reminds us what Paracelsus’ toxicology principle has taught us, and she explains what the key questions for ATMPs are to guide a tailored dose-finding exercise.

Cutting costs for cutting edge therapeutic products: ATMP process optimization

by Elena Meurer

The affordability of ATMPs for the health care system and patients lies among the important aspects that clearly require further improvement. The overall high price of cell-based therapeutics, as known today, is driven by specific factors involved in development, manufacturing and clinical logistics. In this article, Elena Meurer explains where to cut costs in the manufacturing process of ATMPs.

Four important considerations for the successful development of an in vitro or companion diagnostic test

by Linsey Reavie

In vitro diagnostic (IVD) and companion diagnostic (CDx) tests are crucial for the rapid diagnosis, response and treatment of diseases. IVD and CDx developers must satisfy a diverse set of evaluators to ensure commercial success, such as regulators, health care providers, physicians, and reimbursement organizations. While these sectors have recently seen significant growth, they have also been met with an increased demand from regulatory bodies to demonstrate the clinical utility for patient treatment. Linsey Reavie explains what to consider for a successful development of in vitro or companion diagnostic tests.