Who we are

At MSBC, we provide client-centered guidance through a personalized and flexible approach.

Led by Dr. Michael Soldan, Founder and Principal Consultant, MSBC offers high-level expertise across the biotech and biosimilar industries. 

With a proven track record as a former CEO and Board Member, Dr. Soldan specializes in strategy development, clinical and regulatory affairs, due diligence, and investment recommendations. He ensures that every client engagement is tailored to meet your unique goals and benefits from deep industry insights.

Why choosing MSBiotechConsulting?

With a strong experience across multiple areas of biotech and biopharmaceutical development, including biosimilars, orphan drugs, immunology, oncology, and strategic leadership, I offer unparalleled advise and hands-on experience that can drive your business forward.

1. Biosimilars Expertise

As a former CEO and board member in the biosimilar industry, I’ve successfully led the development and commercialization of biosimilars in highly regulated markets. My deep understanding of the regulatory landscape, clinical comparability studies, and market access challenges equips me to provide:

• End-to-End Development Oversight: From portfolio decisions to early-stage development to market launch, I’ve managed biosimilar programs through the entire lifecycle.
• Regulatory Expertise: Extensive experience in navigating global biosimilar regulatory pathways, ensuring compliance with agencies like the FDA, EMA, and others.
• Market Strategy & Commercialization: Proven success in designing go-to-market strategies and positioning biosimilar products for maximum commercial success.

2. Orphan Drugs Expertise

In the niche and highly specialized field of orphan drugs, I’ve spearheaded projects targeting rare diseases. I understand the specific challenges of this sector, from gaining orphan drug designation to overcoming clinical development hurdles. I offer:

• Development Plans and Regulatory Strategy for Orphan Drugs: Strong experience with orphan drug processes and the unique regulatory pathways involved.
• Clinical and Market Challenges: Expertise in managing the clinical trials and patient recruitment challenges associated with small patient populations.
• Stakeholder Engagement: Experience in working closely with patient advocacy groups and healthcare providers to enhance market acceptance and adoption.

3. Immunology Expertise

I have a broad background in immunology, working on therapeutics targeting autoimmune diseases and immune-related conditions. My experience in this area includes:

• Product Development: Leading teams in developing biologics and biosimilars targeting immune system specific targets.
• Clinical Strategy in Immunology: Designing clinical trials to evaluate immune responses, safety, and efficacy in autoimmune diseases, including leveraging biomarkers and advanced diagnostic tools.
• Regulatory Knowledge: Deep understanding and management of the immunology regulatory requirements and approval processes.

4. Oncology Expertise

Oncology is one of the most dynamic areas in biotech, and I’ve had extensive involvement in the development of both innovative and biosimilar oncology products. My experience includes:

• Oncology Clinical Development: I’ve successfully managed and overseen clinical trials and regulatory procedures for innovative products (ADC) in oncology and oncology biosimilars, navigating the specific challenges of proving biosimilarity in complex biological products.
• Strategic Product Positioning: I have experience in defining strategies for oncology biosimilars and novel products in an increasingly competitive space, identifying market access opportunities, and overcoming payer and reimbursement hurdles.

5. Strategic Leadership in Biotech

Throughout my career, I have demonstrated leadership in shaping business strategies, guiding product pipelines, and steering companies towards growth and success in the biotech industry. My strategic expertise includes:

• Business Strategy Development: As a CEO and board member, I’ve developed and executed business strategies that align scientific innovation with market and financial goals.
• M&A and Licensing Expertise: Proven success in negotiating strategic partnerships, in-licensing and out-licensing deals, and managing mergers and acquisitions.
• Portfolio Management: Experience in evaluating, prioritizing, and managing complex biotech portfolios, ensuring optimal resource allocation and long-term value creation.

6. Start-up Experience

I understand the unique challenges faced by biotech start-ups and have helped guide emerging companies through critical growth phases. My start-up support includes:

• Leading Start-ups: I’ve been deeply involved in leading statically and operationally biotech start-ups, ensuring they are positioned for growth and investment.
• Fundraising and Investor Relations: Expertise in creating investor-ready pitch decks, securing funding, and managing relationships with venture funds, PE firms, and other investors.
• Operational and Strategic Advisory: Offering hands-on guidance in building management teams, refining business models, and scaling operations effectively.

Where appropriate, MSBC taps into a dynamic network of seasoned biotech professionals to provide additional support. These experts are brought in to handle specialized tasks or when a broader, multifunctional approach is required. This allows us to remain nimble and deliver top-tier solutions, whether you need targeted advice or a comprehensive project team.
Our approach combines personalized leadership with the ability to seamlessly integrate external expertise, ensuring your project is guided by the right specialists every step of the way.