Insights – PassionBio.tech

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I worked with Helmut twice in my career. The first time as early as 1995 when Helmut joined the Sandoz plant “Biochemie Kundl” in Austria where he established his first footprint in the development of biosimilars. Our second interaction started 18 years later when I hired Helmut as a consultant for Polpharma’s biologics business. At that time, Polpharma was ready to launch a state-of-the-art bio-manufacturing facility in Gdansk. Helmut’s support was much needed in managing the many scientific and commercial aspects Polpharma had to deal with in Latin America, the Middle East and in Asia. Helmut always proved his ability to be a strong manager who delivered the expected results. He combines excellent planning and organizational skills with good analytic thinking. Helmut is a powerful, honest and fair partner in any pharma project.

Hannes Teissl, Chief Business Officer, Polpharma Biologics, Poland

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Helmut worked with USV Biologics since his time at Kwizda Pharma. Following his visit to our biologics manufacturing site in Mumbai, we continued to maintain the contact with him and finally hired him as a consultant for our biosimilar program. Subsequently, he accompanied our team with the goal to identify suitable Clinical Research Organizations in the United Kingdom, Germany, Hungary and Austria. In addition, Helmut significantly added business intelligence as to marketing strategies, pricing and regulatory processes of biosimilars in Europe. His management summaries are unsurpassed and with his competent consultancy advice, Helmut always delivered a reliable basis for USV’s management decisions regarding our biosimilar program. We can highly recommend Helmut as a consultant in the biosimilar field.

Dr. Esmail Samiwala, Senior Vice President, Biologics. USV Biologics, India

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This reference highlights the pivotal role of Helmut Brunar and his team in our collaborations, where their expertise in conducting thorough due diligence on MedTech and Biotech assets has been instrumental in guiding our investment decisions. Helmut’s approach is comprehensive and versatile. He is adept at analyzing technologies, assessing potential markets, and critically evaluating business plans. His skill in simplifying complex technical details for our management team has been invaluable. Additionally, his proactive efforts to ensure alignment with industry standards have safeguarded our fund from potentially unsatisfactory investments. Based on our experiences, we confidently recommend Helmut and the team at PassionBio for their exceptional ability in navigating complex investment decisions within the MedTech and Biotech sectors.

Ultra-High-Net-Worth Individual and Owner of MGFO Private Investments

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I worked with Helmut and his team to identify investment opportunities for Valenta Pharm in Russia and in Europe. In this context, Helmut prepared several assessments of target companies and products with special emphasis on market value, regulatory and development status. With pleasure I can confirm that his valuation expertise as well as his analytical sense for compiling thorough business intelligence information is unsurpassed. I can highly recommend Helmut and his team for similar tasks where a quick answer regarding the net present value of an asset is needed.

Dr. Dmitry Reykhart, Forte Pharma Fund, Luxemburg

Boosting Growth of Asian CDMOs Expanding into the West

01/20/2024 / PassionBio

I had the pleasure of working with Helmut when Amega Biotech hired him as consultant for our manufacturing plants in Buenos Aires and Santa Fe. He supported our regulatory team with procedures and documentation for GMP-compliant master cell bank preparation. In this context, he helped to clarify whether analytical methods were state-of-the art, in line with Health Authority expectations and suitable to demonstrate process and product consistency. In addition, Helmut organized and guided two full-week training audits to evaluate whether current manufacturing processes were in line with EU and US regulatory expectations. Helmut is an outstanding professional and a great leader with excellent people skills. We would instantly hire him again.

Francisco Molinari, Pharma/Biotech Executive, Entrepreneur & Investor, Argentina

Transformation of academic team into a clinical-stage biotech

10/04/2023 / PassionBio

A mandate for an investor-owned biotech focused on the transformation of an academic research team into a clinical-stage development company and serious player in the fight against chronic hepatitis B virus infection. The mandate included the implementation of several strategic initiatives aimed at optimizing the workforce, streamlining development targets, and enhancing overall efficiency. It involved reconfiguring of existing collaborations and building of new alliances with industry partners particularly in China and the United States.

Turnaround of a private equity backed contract manufacturer

10/04/2023 / PassionBio

A mandate in turnaround management includes a role for a private equity-backed Contract Manufacturing Organization (CMO). The CMO played a crucial role in the niche market of supporting clinical trial sponsors with packaging, labeling, and storage of clinical trial material. In 2021, Ardian, a private equity firm managing over €100 billion in assets, acquired a majority stake in the company which became part of a holding structure connecting 39 locations and 44 laboratories, employing over 2,000 professionals. The mandate focused on implementing operational enhancements, particularly in proposal and key account management.

Technology transfer of cell therapy and vaccine manufacturing processes

10/04/2023 / PassionBio

Technology transfer mandates include a role as Quality Site Head at a manufacturing facility in Germany (DRK Blutspendedienst) which was contracted by Kiadis Pharma, an Amsterdam-based cell therapy company. This role included transfer of development processes from the originator site in the Netherlands to a commercial production site in Germany, as well as management of quality engineering processes until PPQ runs. Additionally, the role included collaboration with external engineering companies to manage the project from planning to commissioning. Another important part of the mandate was the oversight of aseptic work practices, cleanroom techniques, and GMP inspection readiness. Other mandates in technology transfer include a role at Johnson & Johnson aimed at transferring the small-scale in-house COVID-19 vaccine production to an external CMO. This role emphasized planning and execution of a seamless collaboration between CMC- and supply chain teams, while facing the challenges of a high-pressure environment during the pandemic.

Late-stage vaccines and biosimilars operations

10/02/2023 / PassionBio

Technical and commercial operations mandates include roles at Bavarian Nordic to oversee late-stage vaccine programs for RSV and COVID-19. This role required guidance of cross-functional teams across Europe and the USA to execute a challenging development and launch strategy. The role also entailed commercial market aspects and an end-to-end strategy to safeguard a competitive advantage of the vaccines against established products. Similarly, a technical operations mandate at Intas Pharmaceuticals focused on guiding development and launch of the first European-approved Indian-made biosimilar. Responsibilities included management of CMC, supply chain, regulatory, pricing, partnering and out-licensing activities.