Manolo Ernesto Beelke 🎗️🇺🇳 Email & Phone Number

As the Chief Medical Officer and Managing Director of Manolo Beelke & Partners, I lead a global healthcare consultancy with a focus on clinical development and medical affairs for small molecules, biologics, and cannabinoids. I provide both strategic and operational consultancy to pharmaceutical and biotech companies, ensuring innovative solutions for complex challenges.• Spearheaded the development of consolidated medical-regulatory-commercial strategies for small molecules, biologics, phototherapies, and cannabinoids, driving innovation across multiple therapeutic areas and advancing cutting-edge treatments in this rapidly evolving field.• Successfully advised on FDA and EMA meetings and CRO post-merger restructuring, driving 30% growth and generating over €60M in deal opportunities.• Guided investors through due diligence processes, ensuring informed decision-making in high-stakes healthcare investments.• Provided medical monitoring for clinical trials, optimizing outcomes and ensuring regulatory compliance for biotech and pharma clients.My leadership is defined by a commitment to innovation, growth, and delivering measurable results for our clients, positioning us as trusted partners in healthcare development.

Planegg, Bavaria, De

As a key member of the Executive Board, I lead global medical initiatives, driving strategy and execution across three major areas: Global Medical Leadership (GML), Global Medical Writing (GMW), and Global Pharmacovigilance (GPV). I am responsible for setting strategic direction, ensuring compliance, and fostering a quality-driven culture.Key Contributions:• Developed clinical trial study strategies for a wide range of indications, enhancing trial design efficiency.• Led cross-functional collaboration globally, promoting best practices in clinical trials, medical writing, and pharmacovigilance.• Guided business development strategies as the company’s medical representative, facilitating partnerships with external business stakeholders.Achievements:• Delivered a 30% growth in quality and compliance through leadership and training programs.• Managed critical projects like restructuring clinical development strategies for cannabinoids and facilitating FDA meeting preparations.• Fostered collaboration with global Key Opinion Leaders (KOLs) to enhance Verum’s influence in the medical community.

Princeton, New Jersey, Us

In my role as Senior Medical Advisor, I provide expert guidance on clinical development strategies, due diligence, and regulatory frameworks for global pharmaceutical and biotech firms. I specialize in translating complex medical data into actionable insights, helping companies navigate the intricacies of clinical development and regulatory compliance.Key Contributions:• Shaped clinical development strategies across multiple therapeutic areas, focusing on maximizing trial efficiency and regulatory success.• Conducted due diligence assessments for biotech investments, providing investors with critical insights into product viability.• Provided strategic regulatory support, advising on pathways to accelerate approval processes.

New York, Ny, Us

As a Regulatory Affairs Consultant, I provide expert guidance for ongoing studies in Huntington's disease, ensuring compliance with global regulatory standards and advising on submission strategies. My work supports the development of innovative treatments, and I collaborate closely with internal teams to align regulatory frameworks with clinical development.Key Contributions:• Advised on regulatory strategies that streamlined approval timelines for novel Huntington's disease treatments.• Provided regulatory oversight to ensure compliance with FDA and EMA standards.• Guided the submission process for investigational new drugs (INDs) and clinical trial applications (CTAs).

As the Co-Founder of ACE-REACT, I spearhead the development of innovative strategies that streamline clinical research and healthcare operations. Our consortium introduces a collaborative approach, bridging medical, operational, and marketing functions to enhance research efficiency.• Developed a synergistic model for delivering traditional CRO services, offering cost-effective, agile solutions tailored to client needs.• Led initiatives to restructure and innovate healthcare research frameworks, aligning with multi-partnership environments.• Directed consultancy services in study site selection, KOL management, and healthcare operational transformations.• Known for delivering fit-for-purpose projects, ensuring alignment with clients’ research goals and adaptability in dynamic environments.Our focus remains on creativity, efficiency, and cutting-edge solutions, propelling ACE-REACT as a leader in the evolving landscape of healthcare research.

Coimbra , Coimbra , Pt

As an Editorial Board Member, I contribute to advancing scientific knowledge in psychology and neuroscience by reviewing and evaluating original research articles, case studies, and reviews. My work ensures the integrity and quality of publications across key areas such as neuropsychology, neuropsychiatry, neurology, psychiatry, and neurodegenerative diseases. I provide expert guidance on manuscripts related to pain, stroke, sleep disorders, stress, and addiction, contributing to the journal’s mission to foster impactful clinical research.

As a Board Member at CASN, I support the development of innovative mental health and education programs rooted in applied social neuroscience. My role involves guiding research on non-invasive, non-pharmacological interventions for cognitive and behavioral disorders. CASN focuses on person-centered approaches to well-being, with recent publications such as The Enriched Environment in a Person-Centered Approach to Well-Being showcasing our commitment to optimizing cognitive outcomes for children and adults.

As a member of the editorial board for the Journal of Health and Social Sciences, I reviewed peer-reviewed articles and provide feedback to authors, contributing to the publication’s mission of advancing interdisciplinary research in medicine and social sciences. I support the Italian Society for Psychotherapy and Social Development (SIPISS) in promoting international research and education, ensuring high-quality scientific standards across health and social science disciplines.

At Immungenetics AG, I lead the development of Thiethylperazine (TEP), a potential treatment for Alzheimer's Disease, guiding its research and clinical advancement.Key Contributions:• Executive Board Member• Product Development: Led the development of TEP, overseeing R&D and ensuring compliance with regulatory standards.• Clinical Research: Directed clinical trial design and execution, including the TEPdrain study (NCT03417986) for Alzheimer's Disease.• Regulatory Affairs: Engaged with the European Medicines Agency (EMA), preparing briefing documents and managing regulatory discussions.• Fundraising: Played a key role in fundraising efforts, pitching to investors and applying for grants.• CRO Selection: Evaluated and selected Contract Research Organizations (CROs) to support clinical operations.• Strategic Direction: Provided advice on study design, helping align operations with the company’s strategic goals.

Malmö, Skane County, Se

As Medical Lead, I provided strategic medical leadership in clinical development, guiding the organization through key phases of product development. My role focused on ensuring the clinical viability of drug candidates and aligning trial designs with regulatory and industry standards.Key Contributions:• Led clinical development initiatives for investigational products, ensuring compliance with regulatory and ethical standards.• Collaborated with cross-functional teams to optimize study design and execution, enhancing clinical trial outcomes.• Provided expert medical guidance to support decision-making across clinical operations and regulatory affairs.

Boston, Ma, Us

As Senior Medical Director, I guided the clinical development of ARGX-113 for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). I provided medical leadership across various research projects, ensuring clinical trial success and regulatory compliance.Key Contributions:• Led clinical strategy for ARGX-113, driving trial design and development for CIDP.• Provided medical and scientific support for feasibility assessments, study protocols, and clinical development programs.• Collaborated on business development activities by offering clinical insights and medical expertise to support strategic decisions.

Princeton, New Jersey, Us

As Senior VP, I led the creation and management of the Medical & Scientific Affairs department, driving clinical trial excellence and business growth. I developed clinical strategies, ensured trial execution, and supported sales teams in expanding the clinical business.Key Contributions:• Established the Medical & Scientific Affairs department, boosting sales and client satisfaction.• Led clinical development strategies, optimizing operational execution across trials.• Supported business development with key client relationships, driving aggressive growth and closing major deals.Achievements: • Ensured growth performance increase of more than 30% and deal opportunities for more than 20 million.

Princeton, New Jersey, Us

As Head of Clinical BU - Europe, I led clinical services, managing P&L accountability, and driving revenue growth through service excellence.Key Contributions:• Responsible for a team of 84 people, with 7 direct reports.• Led the restructuring and repositioning of the Clinical Branch.• Grew clinical services, delivering full-service protocols, late-phase trials, and tech-led monitoring.• Directed clinical operations across multiple locations, building client relationships and driving business development.• Collaborated on SOPs with QA teams, ensuring high-quality service delivery.Achievements: • Established strong leadership culture encouraging engagement management accountability throughout all levels of departments.• Ensured deal opportunities for more than 7 million.

In this role, I contributed to advancing knowledge on multiple sclerosis and other demyelinating disorders. I review submissions covering various fields, including neuroimmunology, pharmacology, and neuroimaging. I help promote research in underrepresented areas such as the economics of MS clinical care and the role of advanced nursing. The journal’s mission aligns with my passion for improving understanding and treatment of these complex neurological conditions. The Journal has been closed and is not accepting anymore new articles. Published articles are avaialbe here: https://msddjournal.biomedcentral.com/articles

New York City, New York, Us

As a consultant for the clinical development of IMU-838 in Multiple Sclerosis at Immunic Therapeutics, I provided strategic and operational expertise to ensure the successful planning and execution of the Phase II clinical trial.• Conducted competitive landscape analysis, identifying key trends and positioning strategies for IMU-838 in the MS therapeutic space.• Developed the clinical development plan, offering feasibility assessments, study synopses with benefit-risk analysis, and strategic guidance based on preclinical data.• Authored the protocol for the Phase II study, integrating key clinical insights and aligning it with regulatory expectations.• Performed country and study site feasibility assessments, optimizing site selection and enhancing trial efficiency.• Trained staff on Multiple Sclerosis and the specific challenges of developing IMU-838, improving team readiness for clinical trial execution.• Provided strategic consultancy on CRO selection and operational execution, ensuring alignment with study goals.• Supported expert meetings and offered medical-scientific guidance on clinical and statistical issues for the study (P2-IMU-838-MST).These efforts contributed to the streamlined development process and laid the groundwork for the successful execution of the clinical trial.

As a consultant for Bionorica Research GmbH, I provided strategic consultation on the clinical development of cannabidiol oil for Multiple Sclerosis and symptomatic cancer treatment as a concomitant medication to chemotherapy.• Analyzed potential therapeutic indications for cannabidiol oil, delivering benefit-risk assessments for each use case.• Conducted a competitive landscape assessment to position cannabidiol oil effectively in the market.• Provided medical management and clinical research support, ensuring alignment with ethical standards and regulatory compliance.

Zug, Zug, Ch

In this role, I contributed to the clinical development strategy of PB006, a biosimilar of Natalizumab, providing key inputs for regulatory discussions and study documentation.• Researched and reviewed data on PB006 and its reference product, Natalizumab, to inform the clinical development strategy.• Developed the Investigator Brochure and contributed to the FDA briefing book, ensuring regulatory alignment and clinical accuracy.• Provided strategic guidance for FDA discussions, enhancing the likelihood of approval and successful trial execution.

Research Triangle Park, Nc, Us

As Senior Medical Director, I provided medical guidance, therapeutic advice, and medical monitoring for 25 clinical trials across Phase I, II, and III, focusing on diverse therapeutic areas.• Directed 25 Phase I. II and III trials for several conditions including Frontotemporal Dementia, Alzheimer’s Disease, Multiple Sclerosis, Multiple System Atrophy, Mixed Depression, Duchenne's muscular dystrophy, Acromegaly and Lymphorea.• Provided medical monitoring for a Post Authorization Safety Study (PASS) on smoking cessation.• Offered strategic advice to business development for 12 clients, supporting trial design, protocol development, and feasibility assessments.• Conducted SAE reviews and delivered therapeutic training to project teams, ensuring adherence to clinical protocols.• Contributed to the design of clinical development programs, research papers, and client-focused white papers.• Reviewed and assisted in the preparation of final study reports (CSRs), and other study documentation• Mentored successfully other medical staff (nurses, junior Physicians, and others)

Research Triangle Park, Nc, Us

As Director of Medical Monitoring, I provided medical guidance and monitoring for 25 clinical trials spanning Phase I-III, focusing on a range of neurological and rare diseases.• Oversaw trials in frontotemporal dementia, Alzheimer’s disease, multiple sclerosis, Duchenne’s muscular dystrophy, and more.• Led the Post Authorization Safety Study (PASS) for smoking cessation.• Delivered SAE reviews, protocol training, and strategic input into trial design and client development.• Supported business development through proposal generation, feasibility assessments, and client meetings, contributing to trial success.

Darmstadt, Hessen, De

As Director of Medical Affairs for Neurology, I led the establishment and development of the Medical Affairs unit, improving the scientific quality of initiatives across regions.• Built the Medical Affairs unit from the ground up, fostering scientific rigor and operational excellence.• Pioneered a new Medical Affairs strategy, differentiating the organization from competitors and optimizing budget allocation for cost-effectiveness.• Developed a site stratification process and refined clinical studies within Medical Affairs, significantly increasing the number and quality of study proposals, especially from emerging markets.• Designed and scientifically guided the first globally coordinated add-on study of Vitamin D with Rebif®44, a significant innovation in Multiple Sclerosis treatment.• Strengthened relationships with key opinion leaders (KOLs) through scientifically driven interactions, enhancing external engagement and credibility.

Darmstadt, Hessen, De

In this role, I bridged pre-clinical development with full clinical development for neurology, improving decision-making and operational efficiency.• Established the PoC Strategy Liaison Unit, streamlining the transition from discovery to clinical development and saving costs through selective compound screening.• Developed biomarker plans for neurological compounds, integrating translational research into clinical development.• Led the clinical indications review to identify early business development opportunities, leveraging data from genetics, genomics, and imaging.• Contributed to the clinical development plans for pegylated IFN beta-1a and Apitope, a novel immunotolerance treatment for Multiple Sclerosis.

Darmstadt, Hessen, De

As Medical Director of Neurology, I was responsible for both clinical trial execution and strategic business development.• Led risk mitigation efforts for the CLARITY study, accelerating recruitment and ensuring timely study completion.• Designed and guided the IMPROVE study and contributed to the design of the REFLEX and Atacicept PoC studies.• Provided due diligence assessments for biotech investments, offering critical insights into product viability and potential.

In this role, I focused on both clinical and business development strategies for Rebif® and Cladribine.• Accelerated recruitment for the CLARITY study, improving study timelines.• Designed the IMPROVE and REFLEX studies, driving innovation in Multiple Sclerosis research.• Provided due diligence assessments for potential biotech investments and identified business opportunities in Neurology.

As the Health Economics and Outcome Research Manager at Schering SpA, I represented Italy in a global team and led the development of strategies across therapeutic areas, being responsible for the entire Schering portfolio. My key contributions during this role were:• Established the Health Economics and Outcome Research Unit in Italy, setting the strategic direction for all therapeutic areas.• Developed health economics strategies for 7 therapeutic areas within a year, contributing to reimbursement and price negotiation success.• Contributed in the development of reimbursement dossiers and price negotiation. • Played a key role in creating global strategies, collaborating with the CORE global team for studies spanning from Phase II to Phase IV.

As Project Manager, I led international Phase III trials and observational studies for Multiple Sclerosis.• Managed Phase III studies BENEFIT and BEYOND, as well as BETAPLUS and BRIGHT on a country level, ensuring timely and efficient execution.• Designed 12 studies across various phases, establishing Schering SpA as a scientifically driven competitor in the MS market.• Trained sales forces on Betaferon®, improving scientific knowledge and fostering stronger relationships with external experts.• Guided the site stratification process to tailor medical affairs strategy to the different medical scientific needs of Multiple Sclerosis centers.• Selected the most strategically relevant Investigator Initiated Studies proposals for financial support.• Managed KOLs in Italy and served as the primary contact person for the most relevant KOLs at the Headquarter.• Contributed in planning of the national marketing strategy and development of national communication strategies.• Provided scientifically driven answers to medical questions as Medical Advisor for Betaferon®.

As a Clinical Trial Manager for CNS, I led international clinical trials in multiple sclerosis (MS), managing the country-level operations for BENEFIT and BEYOND, Phase III studies, and BETAPLUS and BRIGHT, observational studies. In this role, I developed strategies for site stratification to support medical affairs activities based on the specific scientific needs of different MS centers.One of my notable achievements was successfully differentiating Schering SpA as a scientifically driven company by designing 12 studies, including phase II, III, IV, and observational studies, for patients with MS. I also selected and supported strategically relevant Investigator Initiated Studies proposals, managed key opinion leaders (KOLs) in Italy, and served as the primary point of contact for the headquarters for the most important KOLs.Furthermore, I trained sales forces for Betaferon® and successfully distinguished them from competitors through superior scientific knowledge and stronger relationships with external MS experts. I contributed to national marketing and communication strategies and provided scientific support as a Medical Advisor for Betaferon® by delivering evidence-based answers to medical questions.

During my 7-year tenure, I specialized in Neurology, Clinical Neurophysiology and Sleep Medicine, conducting research on various neurological conditions.• Published over 40 peer-reviewed papers on topics including epilepsy, narcolepsy, obstructive sleep apnea, and restless legs syndrome.• Provided clinical and scientific training to medical students, postgraduates, and technicians in Clinical Neurophysiology.• Conducted recordings and clinical reporting using Ultrasound, Polysomnography, EEG, Video-EEG, VEP, ENG, and EMG, contributing to diagnostic and treatment protocols for relevant neurological disorders.• Played a pivotal role in the neurological outpatient department, delivering expertise in diagnosing and treating a broad spectrum of neurological conditions.

Board Certified Specialist, Neurology And Clinical Neurophysiology

Doctor Of Philosophy - Phd, Sleep Medicine

Md, Medicine And Surgery