Gennaro Pagano

Prof. Gennaro Pagano is a physician-neuroscientist and pharma medical director with over 10 years of experience in translational research and early clinical development. He holds a Doctor of Medicine, Master in Epidemiology, Doctor of Philosophy in Clinical Neuroscience, and has postdoctoral training in PET molecular imaging with a focus on genetics, preclinical, and prodromal Parkinson's disease. He has a h-index of 39 on Google Scholar, and has published over 100 peer-reviewed publications in the field of neurodegeneration (common and rare movement disorders, and dementia).

Born

April 2, Naples, Italy

Nationality

Italian

Education

Medical Doctor (MD), Federico II University of Naples

Master in Epidemiology, Cochrane Systematic review and Meta-Analysis (MSc), University of Milan, Italy

Doctor of Philosophy in Clinical Neuroscience (PhD), King’s College London, Institute of Psychiatry, Psychology & Neuroscience, UK

Fields

Parkinson’s disease; Alzheimer’s disease; Neurodegeneration; PET molecular imaging; Meta-Analyses

Institutions

Federico II University of Naples, Italy (2003-2011)

University of Milan, Italy (2011-12)

Cedars Sinai Medical School, Los Angeles, California (2012-13)

Imperial College London (2013-2014)

King’s College London (2015-2018)

F. Hoffmann - La Roche Ltd, Roche Pharma Research and Early Development, Basel, Switzerland (2019-Current)

Notes

Top Italian Scientist in Neurosciences & Psychology

Prof. Pagano currently works as an Expert Medical Director and Group Leader at Roche Pharma Research and Early Development in Switzerland and serves as also the Chair of the Medical Directors Fellowship program in Neuroscience and Rare disease (NRD). He is also Honorary Clinical Associate Professor in Neurology and Neuroimaging at the University of Exeter Medical School, and former Chair of Parkinson's Progressive Markers Initiative (PPMI) Partner Scientific Advisory Board.

Before joining Roche, Gennaro was the Lily Safra Senior Clinical Fellow in Neurology and Research & Development Leader of the Neurodegeneration Imaging Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience at the King’s College London. In this role, he designed, implemented and led several Phase 0, 1 and Phase 2 proof-of-concept trials, and published his research on peer-reviewed International journals, such as New England Journal of Medicine, Lancet Neurology, Movement Disorders, Brain, Neurology, Annals of Neurology, European Journal of Neurology, Journal Clinical Investigation among others.

Education and career

Education

• 2019-2021: European Course Diploma in Pharmaceutical Medicine (ECPM) | University of Basel, Basel

• 2018-2020: Executive Master in Business and Administration (eMBA) | Quantic School of Business and Technology, US

• 2015-2018: Doctor of Philosophy in Clinical Neuroscience (PhD) | Institute of Psychiatry, Psychology & Neuroscience, UK

• 2010-2015: Residency in Geriatrics (first-in-class with honors) | Federico II University, Italy

• 2011-2012: Master in Epidemiology, Cochrane Systematic review and Meta-Analysis (MSc) | University of Milan, Italy

• 2003-2009: Medical School (first-in-class with honors) (MD) | Federico II University, Italy

Career

• 2020-ongoing: Expert Medical Director & Group Leader | Roche Pharma Research & Early Development, Basel, Switzerland.
  • Line management responsibility of 10+ direct reports including Medical Directors, Medical Directors Fellows, Senior Clinical Scientists, Clinical Scientists and Patient Partnership Directors.
  • Squad Lead of Parkinson’s disease Strategy.
  • Clinical and scientific leadership of clinical expert teams for the development of drugs for Parkinson’s, Alzheimer’s, Neurodevelopmental and Sleep disorders, and Rare diseases.

• 2021-ongoing: Movement Disorders Network Clinical Leader | Roche Pharma Research & Early Development, Basel, Switzerland.
  • Developing the clinical strategy for drug development in Movement Disorders (Parkinson’s, Huntington’s, and Movement. Disorders)
  • Participating in partnering activities providing feedback on in-licensing or acquisition of therapeutic solutions for Movement Disorders.

• 2021-ongoing: Honorary Clinical Associate Professor in Neurology and Neuroimaging | University of Exeter Medical School, London, UK.
  • Supervising 2+ clinical fellows or MSc/PhD students and dissemination (e.g. publications) of the results of studies completed at University of Exeter Medical School
  • Co-leading strategy for the development of novel neuroimaging biomarkers for neurodegeneration.

• 2020-2021: Chair of Parkinson's Progressive Markers Initiative (PPMI) Partner Scientific Advisory Board (PSAB) | The Michael J. Fox Foundation, New York, United States.
  • Member of the Parkinson's Progressive Markers Initiative (PPMI) Steering committee as representative of the Partner Scientific Advisor.
  • Leading PPMI Partner Scientific Advisor Board meeting and strategy for 2020/2021 representing all Industry and Partners in the consortia.

• 2020-ongoing: Chair of Medical Directors Fellowship | Roche Pharma Research & Early Development, Basel, Switzerland.
  • Reshaped the NRD Fellowship programs towards a Pharmaceutical Medicine Training for potential future Medical Directors.
  • Line management responsibility of up to 4 Medical Directors Fellows.

• 2020-2020: Senior Principal Medical Director | Roche Pharma Research & Early Development, Basel, Switzerland.
  • Line management responsibility of 6+ direct reports including Medical Directors, Medical Directors Fellows, Senior Clinical Scientists, Clinical Scientists and Patient Partnership Directors - completed PASADENA phase 2 study within timelines and involved on the extended Prasinezumab Lifecycle team towards next steps in development.
  • Clinical and scientific leadership of clinical expert teams for the development of drugs for Parkinson’s (e.g. Prasinezumab - ph2-go), Alzheimer’s, Neurodevelopmental and Sleep disorders, and Rare diseases.
  • Voting member for F. Hoffmann-La Roche Ltd in Parkinson’s disease & Movement Disorders International Consortias (e.g. Michael J. Fox Foundation for Parkinson’s disease consortia and Critical Path for Parkinson’s disease).
  • Explored long-term opportunities and threats in the area of movement disorders, in collaboration with Partnering and Global Product Strategy Competitive intelligence, evaluating options, and taking proactive steps to address them and to shape the competitive landscape.

• 2019-2022: Visiting Researcher | Institute of Psychiatry, Psychology & Neuroscience, King’s College London, London, UK.
  • Supervised 2+ PhDs students and dissemination (e.g. publications) of the results of studies completed at King’s College London.

• 2019-2020: Translational Medicine Leader | Roche Pharma Research & Early Development, Basel, Switzerland.
  • 'Co-lead of movement disorders strategy workstream, interfaced with each department (e.g. Discovery, Biomarkers and Translational Technologies) and global function (e.g. Therapeutic Modalities, Pharmaceutical Sciences, Late Stage, Partnering).
  • Clinical and scientific leadership in Prasinezumab (large molecule in Parkinson’s disease) and undisclosed small molecules in Alzheimer’s disease F. Hoffmann-La Roche Ltd.
  • Represented the Prasinezumab team at International Congresses (ADPD 2020, MDS 2019).
  • Multiple regulatory interactions and face-to-face meetings (e.g. EMA, EunetHA, etc).
  • Organized global ad boards for clinical development plans and biomarker strategies.
  • Main driver of clinical development plans in several Due Diligences and pre-Due Diligences.

• 2016-2019: Research & Development Leader for Neurodegeneration | UK National Parkinson Foundation Centre of Excellence for Parkinson’s & Movement Disorders.
  • Supervised 35+ clinical trials with focus on: (1) protocol development, in line with GCP regulations; (2) study set up; (3) study design; (4) regulatory and ethics submission, providing advice and assistance in the preparation of documentations for Ethics, HRA, ARSAC and for the submission and expedition of all necessary approvals for research protocols; (5) extensive experience in the recruitment of a high number of patients with a variety of neurodegenerative disorders and high retention rate into longitudinal and complex research studies.
  • Participated in defining the strategy of the Neurodegeneration Group.
  • Primary drafting, coauthoring, reviewing protocols and grants/funding applications.
  • Disseminated results to media and the press.
  • 5+ direct reports and matrix coordination of 40+ individuals among MSc, PhDs, clinical research fellows, post-doc, clinicians and young PIs from diverse academic/scientific backgrounds.

• 2015-2019: NHS Consultant & Lily Safra Senior Fellow in Neurology | King’s College London & King’s College NHS Hospital.
  • 15+ clinical trials (e.g. opened the Parkinson’s Progressive Markers Initiative – Genetics in UK) and neuroimaging projects using multimodal MRI imaging and PET tracers (e.g. [11C]UCB-J, [11C]PE2I etc.) in common (e.g. Parkinson's disease, progressive supranuclear palsy) and rare (e.g. multiple system atrophy, Huntington’s disease, mutation carriers of LRRK2, A53T SNCA, GBA, PDE10A etc.) movement disorders.
  • Neurology lectures to medical students, consultants, and Parkinson’s disease nurses.
  • Advanced movement disorder outpatients’ clinics and led multidisciplinary team at the UK National Parkinson Foundation Centre of Excellence for Parkinson’s disease & Movement disorders and at King’s College NHS Hospital.
  • 4+ direct reports (MSc and PhD students, each of those published a first name paper on top Neurology journals).

• 2014-2015: NHS Consultant & Medical Research Council Clinical Research Fellow in Neurology | Imperial College London & Imperial NHS Trust.
  • 5+ phase 1 and phase 2 clinical trials and neuroimaging projects using PET imaging (e.g. [11C]PHNO tracer in Parkinson's Disease patients with Dyskinesias and the Parkinson’s Progressive Markers Initiative).
  • General neurology & movement disorders & deep brain stimulation outpatients’ clinics.
  • 3+ direct reports (MSc students, each of those published a first name paper on top Neurology journals).

• 2013-2014: Fellowship in movement disorders | Cedars-Sinai Medical School, Los Angeles, US.
  • Movement disorders & deep brain stimulation training and held movement disorders outpatients’ clinic.
  • 2+ research projects and filed a patent invention on ‘’the role of noradrenergic system in Parkinson's disease’’.

• 2010-2014: Residency in Geriatrics | Federico II University, Naples, Italy.
  • Memory & movement disorders outpatients’ clinics.
  • 10+ phase 1 and phase 2 clinical trials in Alzheimer’s and Parkinson's disease testing potential disease-modifying treatments.

Research interests

Disease understating, a journey from fluids to molecular imaging of Neurodegeneration

Prof. Pagano academic research was focus on developing novel objective and sensitive biomarkers of neurodegeneration, from Parkinson’s to Huntington’s and Alzheimer’s disease. In the early years, he focused on diagnostic and prognostic blood and CSF biomarkers. During his period at Cedars-Sinai Medical School in Los Angeles, he develop novel methods to measure the autonomic nervous system, investigating the link between systemic/metabolic disorders (e.g. heart failure, diabetes) and neurodegeneration. He quickly realise that the best way to measure the brain in vivo is to use PET molecular imaging. During his period at Imperial College London and King’s College London, his research studies have been focusing on genetics, preclinical, and prodromal population of neurodegenerative diseases (e.g. Parkinson's, Hungtington’s, Alzheimer’s diseases).

Drug development, from small to large molecules, gene therapy and antisense oligonucleotides

Prof. Pagano's current research focuses on the development of novel drugs for Parkinson's, Alzheimer's, neurodevelopmental and sleep disorders, and rare diseases, as a Expert Medical Director and Group Leader at Roche Pharma Research and Early Development in Switzerland where also serves as the Chair of the Medical Directors Fellowship program in Neuroscience and Rare disease (NRD). He has a decade experience in drug development both in Industry and Academia, with broad hands-on experience across multiple therapeutic areas, including Parkinson’s disease, Alzheimer’s disease, common and rare movement disorders (e.g. Huntington’s disease), epilepsy and sleep disorders.

He has been the Chief Investigator on several studies including the A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease (PASADENA) [4] and the Principal Investigator on the Hybrid-NIG - Longitudinal Study of Molecular Pathology and Neuronal Networks in Neurodegenerative and Movement Disorders using Positron Emission Tomography and Multi-modal Magnetic Resonance Imaging. He has also been a Sub-Investigator on several studies such as the In vivo investigation of familial Parkinson’s disease as presymptomatic and symptomatic models of idiopathic Parkinson’s disease, The role of phosphodiesterase 10A in early de novo sporadic PD: An in vivo positron emission tomography, The role of Synaptic vesicle protein 2A (SV2A) in patients with early Parkinson’s disease and cognitive impairment: An in vivo positron emission tomography study, Imidazoline-2 Binding Site as a novel neuroinflammatory target in Parkinson’s disease: An [11C]BU99008 Positron Emission Tomography study, A 12-Week, Multicenter, Randomized, Parallel-Group Study to Assess the Safety, Tolerability, Pharmacokinetics, Biomarker Effects, Efficacy, and Effect on Microglia Activation, as Measured by Positron Emission Tomography, of AZD3241 in Subjects with Multiple System Atrophy. Sponsor: AstraZeneca Pharmaceuticals AB - Protocol: D0490C00023 - EudraCT: 2014-004902-13, D3 and D2high dopamine receptor function in Parkinson’s disease patients with levodopa-induced dyskinesias, A Phase 3, Randomized Study Investigating the Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena) Compared to an Observational Cohort Control, Parkinson's Progression Markers Initiative: [18F] Florbetaben-PPMI.

Prof. Pagano is applying to drug development, the knowledge and experience acquired during the years of academia, where he focused on target identification and assessment. His current research focus is on to discover of novel fluid and imaging biomarkers that enable early diagnosis of neurodegenerative diseases and identification of the patients who will benefit the most from novel drugs, and potentially prevent the onset of these devastating disorders, for people who are experiencing the early signs.

Notable pubblications

1. Pagano G, Taylor K, Cabrera J, et al. Trial of Prasinezumab in Early-Stage Parkinson’s Disease. New England Journal of Medicine. 2022; 387 (5), 421-432.
2. Wilson H, Pagano G*, Mitochondrial complex 1, sigma 1 and synaptic vesicle 2A in early drug-naïve Parkinson’s disease. Movement Disorders. 2020 29 April;10.1002/mds.28064
3. Wilson H, Dervenoulas G, Pagano G*, et al. Serotonergic pathology and disease burden in the premotor and motor phase of A53T α-synuclein parkinsonism: a cross-sectional study. Lancet Neurology. 2019 Aug;18(8):748-759.
4. Pagano G, Niccolini F, Wilson H, et al. Comparison of phosphodiesterase 10A and dopamine transporter levels as markers of disease burden in early Parkinson's disease. Movement Disorders. 2019 Oct;34(10):1505-1515.
5. Wilson H, Dervenoulas G, Pagano G, et al. Imidazoline 2 binding sites reflecting astroglia pathology in Parkinson's disease: an in vivo 11C-BU99008 PET study. Brain. 2019 Oct 1;142(10):3116-3128.
6. Schulz J, Pagano G*, Bonfante J, et al. Nucleus basalis of Meynert degeneration precedes and predicts cognitive impairment in Parkinson’s disease. Brain. 2018 May 1;141(5):1501-1516.
7. Pagano G, Ferrara N, et al. Age at onset and Parkinson's disease phenotype. Neurology. 2015 Apr 12;86(15):1400-7.
8. Qamhawi Z, Towey D, Shah B, Pagano G, et al. Clinical correlates of raphe serotonergic dysfunction in early Parkinson’s disease. Brain. 2015 Oct;138(Pt 10):2964-73.

Awards and honours

• Top Abstract Presentation for the PASADENA study at the International Congress Parkinson's disease and Movement Disorders (2020).

• Ranked in the Top Italian Scientist in Neurosciences & Psychology (2020).

• European Academy of Neurology Tournament – Runner-up Clinical Award for imaging in LRRK2 genetic movement disorders (2019).

• Italian Professorship ’Abilitazione Scientifica Nazionale per Professore di seconda fascia’ (2019).

• Fellow of the Italian Society of Gerontology and Geriatrics (2016).

• Lily Safra Hope Foundation PhD award in Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience (2015).

• Federico II University award for a visiting Fellowship in Movement Disorders at Cedars-Sinai Medical Center (2013).

International Society Membership

• International Parkinson and Movement Disorder Society.

• European Academy of Neurology.

• American Academy of Neurology.

Patents

• TREATMENT OF PARKINSON`S DISEASE (co-inventor) – Case No. P36394 - 2020-09-10 Priority to US202063076913 - 2021-03-08.

• Adrenoceptors Antagonists for the Prevention and Treatment of Neurodegenerative Conditions (co-inventor) – US10632124B2 - 2013-06-27 Priority to US201361840381P - 2018-09-26. Application filed by Cedars Sinai Medical Center - 2019-03-21. Publication of US20190083507A1 -2020-04-28. Application granted: 2020-04-28. Status: Active. Anticipated expiration: 2034-06-27.