Skill set
Industry fields of expertise
Manolo in a few words
Hope is not a strategy!
As a transformative Chief Medical Officer with over 28 years of experience, I specialize in aligning clinical development, regulatory, and commercial strategies to drive innovation and ensure market success in Pharma, Biotech, and CROs.
𝗖𝗼𝗿𝗲 𝗦𝘁𝗿𝗲𝗻𝗴𝘁𝗵𝘀:
- Clinical Development Excellence: Expertise across Phases I-IV, PASS, epidemiological studies, and HE&OR strategy integration.
- Regulatory Mastery: Proven track record in FDA and EMA submissions, ensuring compliance and accelerated approvals.
- Commercial Vision: Strategic insights into competitive landscapes, enabling successful product launches.
𝗪𝗵𝗮𝘁 𝗦𝗲𝘁𝘀 𝗠𝗲 𝗔𝗽𝗮𝗿𝘁:
My holistic approach considers the medical perspective to ensure clinical value, regulatory compliance to achieve market readiness, and commercial strategy to position products for competitive success. By integrating these domains, I enable organizations to:
- Select optimal preclinical models targeting promising indications.
- Streamline development timelines while minimizing risks.
- Achieve faster, more impactful market entry.
With extensive experience leading clinical trials (100+), designing protocols (50+), and reviewing proposals (500+), I help organizations innovate and succeed in a rapidly evolving healthcare landscape.
Let’s connect to explore how I can help transform your clinical development strategy into measurable success.
Website: manolobeelke.com
Experience
- Manolo Beelke & PartnersChief Medical Officer, Founder and Managing DirectorJuly 2017 - Today (7 years and 11 months)Herscheid, Germany• Established a specialized consultancy delivering integrated medical, regulatory, and commercial strategies for 30+ global clients, including Argenx, BioEQ, and Bionorica.• Secured €50M+ in client funding and facilitated FDA and EMA approvals through strategic advisory services.• Provided operational services as Medical Lead, Medical Monitor, and Pharmacovigilance Physician for diverse projects.• Conducted Phase I unit audits, ensuring full compliance with GCP and regulatory standards.• Led the strategic restructuring of a CRO, optimizing workflows post-merger for greater efficiency.
- verum.deChief Medical OfficerJuly 2022 - Today (2 years and 11 months)Herscheid, NW, Germany• Lead medical and scientific oversight for global clinical trials, optimizing timelines and improving operational efficiency by 15%.• Develop and implement innovative trial designs, strengthening sponsor engagement and regulatory compliance.• Cultivate Key Opinion Leader (KOL) networks to enhance the CRO's scientific credibility and industry influence.
- IndegeneSenior Medical AdvisorDecember 2021 - Today (3 years and 6 months)Princeton, NJ, USA
- Designed and optimized clinical development strategies across multiple therapeutic areas, including Neurology, Oncology, and Rare Diseases, enhancing trial efficiency and regulatory success.
- Conducted due diligence assessments for biotech investments, providing critical insights into product viability, risk assessment, and strategic positioning.
- Advised pharma and biotech firms on accelerated regulatory pathways, FDA/EMA submissions, and compliance strategies to streamline approval processes.
- Supported trial design for biosimilars, small molecules, and novel therapies, ensuring scientific rigor and regulatory alignment.
- Engaged with investors and key stakeholders, identifying high-value assets and guiding funding decisions and partnerships.
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Education
- MDUniversity of Genoa, Italy1990Medicine and Surgery, whith doctoral thesis in Neurology and Sleep Medicine
- PhDUniversity of Bologna, Italy2002Research and Thesis in Sleep Medicine
- Board certification as Neurologist and Clinical NeurophysiologistUnivesity of Genoa2003Residence Training in Clinical Neurophysiology and Neurology
- Board certification as Expert in Sleep MedicineItalian Association for Sleep Medinice2004Training in Sleep Medicine