Physician-Scientist & CMO | Neurology, Drug Development & Rare Disease Expert

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Summary

This Physician Scientist & CMO Expert is a senior executive physician/scientist, neurologist/neuroscientist with extensive experience in drug development and the design and execution of translational medicine and Phase 1 through 4 clinical trials. Extensive experience in rare disease, neurodegenerative diseases and fibrosis. This Physician Scientist & CMO Expert is understanding of both clinical and basic science problems and their solutions.

Highlights

  • Exceptional record of moving molecules from the bench to the bedside
  • Design and development of clinical trial protocols and guidelines
  • Indication selection through the design of algorithms to select appropriate trial designs
  • Biomarkers for patient stratification and therapeutic efficacy*GCP and GLP expertise
  • IND filing experience
  • Expert speaker and educator
  • Strategic alliance management
  • Worldwide experience in Europe, Latin America, APAC and Russia

Relevant Accomplishments

  • Provide oversight and leadership of clinical programs including strategic planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Entrada SOPs.
  • Support growth and management of Clinical Development function, including oversight of clinical leads, biostatistics, clinical pharmacology and biomarkers.
  • Partner with Clinical Operations to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH/GCP, and Entrada SOPs.•Review clinical data from all phases of development and assist in generating study reports and publications.
  • Serve as study medical monitor, as needed.
  • Develop and maintain relationships and serve as the main medical liaison with key opinion leaders and Principal Investigators.
  • Represent Entrada’s clinical team in interactions with regulatory agencies.
  • Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required.
  • Ensure compliance with all applicable regulatory standards related to global clinical trials and interactions with physicians.
  • Collaborate closely with internal research team to integrate translational research into development and clinical strategies, and regulatory submissions.
  • Responsible for the clinical content of all clinical and regulatory documents, including protocols,INDs, CTAs, investigator brochures, CRF’s, annual IND reports, CSR’s, ISS’s, ISE’s, and clinical expert reports
  • Organize and present at relevant clinical advisory boards, data monitor committees and medical/scientific meetings.
  • Clients have included large and medium pharmaceutical companies, biotechnology companies and an academic institution•Scientific consultant for Coherus Biosciences, a bio similar company/ Ex-officio member of SAB•Evaluation of intellectual property portfolio of academic institutions for clinical and commercial development
  • Performed opportunity assessment of new clinical candidates
  • Performed opportunity assessment of candidates for repurposing
  • Biotechnology NewCo design and formation
  • Performed due diligence review of neurology, ophthalmology and regenerative medicine drugs and technologies
  • Designed algorithms for election of a variety of clinical indication for Lundbeck Pharmaceuticals
  • Phase I, Ia/IIb, II, III and IV clinical trial design
  • Drug life-cycle maintenance of newly approved compounds
  • Review, evaluate and participate in the selection of new indications fora wide range of new and existing products
  • Design of scientifically rigorous, operationally feasible, and cost-effective clinical study protocols that form the substantive basis of the BBP-418 Clinical Development Plan•Participate with the development team in the conceptual basis for clinical data collection, review, and interpretation, including oversight of CRF design elements, database design, data management plans, biostatistics, data analysis, data review, reporting with support from ClinicalOperations, DataManagement, and Stats & Programming
  • Primary contributor to the clinical research content of regulatory submission documents, including amendments to INDs, Briefing Documents, the medical and scientific content of regulatory correspondence, NDA/MAA submissions, safety reports and updates, and annual reports (DSUR/PSUR). This role would also involve participation in regulatory meetings
  • Own clinical research planning, documentation, and communication
  • Contribute to the cross-functional development team from the clinical and scientific perspective toward accomplishing corporate goals
  • Provide clinical interpretation and integration of pre-clinical and early clinical findings into the evolving product development plan and TPP
  • Provide support to Clinical Operations in relevant aspects of study execution (e.g., patient recruitment) and manage and mentor other clinical development professionals in their role(s)
  • Have a leadership role in study team meetings and those with critical internal and external partners, including presenting study updates, interim results, and study progress and data to senior leadership
  • Lead the Safety Review Committee for ML Bio related to BBP-418
  • Develop clinical SOPs in collaboration with QA•Maintain a consistent patient-focused with a deep commitment to understanding the needs and improving the lives of patients through a passion for developing novel therapeutics•Consistently demonstrate the capability of prioritizing tasks and delivering on deadlines with high-performance standards and attention to detail
  • Lead the development of written reports and representations of the scientific program data toward the development of scientific publications and presentations
  • Have solid critical, strategic, and analytical thinking skills
  • Responsible for clinical development of late-stage products in neurodegenerative disease
  • Clinical lead and strategist for early development of new targeted therapies, including gene therapies, siRNA gene inhibition therapies, ophthalmologic (neovascular and dry AMD;Geographic Atrophy)and CNS targeting moieties to treat neurodegenerative diseases and neuro trauma
  • Clinical lead on Alzheimer Disease, Progressive Supra nuclear Palsy, ALS and Myasthenia Gravis programs
  • Development of a novel biomarker program that integrates fluid and tissue biomarkers and imaging with language acquisition and processing analysis based digital application for patient stratification and monitoring therapeutic efficacy in above indications
  • RTI is aclinical-stageregenerative medicine company committed to using our proprietary smallmolecule platform to restore form and function to adults that have undergone age-related loss offunctionin a range of tissues including the central and peripheral nervous systems, as well asskin and skin appendages.
  • Fund-raising
  • Invented a patented topical therapeutic, RT1640, that reverses and rogenic alopecia(male pattern baldness)and loss of pigment (achromotrichia)
  • Demonstrated in animal models and in anecdotal human subject efficacy ofRT1640•Developed a suite of follow-on neurologic indications for RTI therapies.
  • Selection of first and follow-on indication for commercialization•Design and execute clinical development plan•Phase 2Clinical trial design for the treatment of androgenic alopecia•Selection of clinical trial CRO•Selection of API and DP CROs
  • CMO for Phase 3 studies in post-surgical pain
  • Oversee clinical diversification and BD
  • Evaluate potential acquisitions of neurological therapeutics, including gene therapies, biologics and small molecules and work with team to design potential clinical trial and commercialization strategies.Early evaluation and clinical development of trofenitide
  • Hired as an outside consultant for the Janssen to evaluate opportunities in early stage Multiple Sclerosis interventions
  • Retained to assess the clinical opportunities the company’s lead compound,INT131, originally designed as an insulin sensitizing drug in Type 2 Diabetes Mellitus•Selection ofMultiple Sclerosis (MS) as an indication for repurposing INT131
  • Communicate with numerous institutional funding sources and potential strategic partners to“pitch” the product and the company through creation and presentation of PowerPoint slides
  • Held extensive discussions with potential strategic partners around the design of the INT131clinical trials to optimize the value of asset for post-trial partnering
  • Selection of additional neurodegenerative diseases as follow-on indications based upon susceptibility to treatment with INT131 and their designation as orphan diseases
  • Selection and oversight of both preclinical and clinical CROs
  • Oversee outside, academic and corporate collaborations
  • Prepared and submitted IND for the use of INT131 for the treatment of Relapsing/Remitting MS(RRMS)
  • Designed Phase 1b safety trial for INT131 in patients with MS
  • Designed and wrotePhase2b clinical trial designs for INT131 inRRMS•Successful Execution Phase 2B clinical trial in RRMS
  • Presentation of Phase 2 results at major meetings
  • Oversight of anex-US trial(Russia and CIS) in RRMS
  • Wrote a development award grant for the Russian Ministry of Manufacturing and Trade for 1Phase1and 1 Phase2trial studying INT131 as an mono therapy inRRMS (awarded)
  • Coordination with the National Multiple Sclerosis Society in the recruitment of key opinion leaders (KOLs)as SAB/CAB members
  • Chair,Data Safety Monitoring Committee
  • Medical Monitor for RRMS Study, including evaluation of AEs and SAEs
  • rote Data Safety Monitoring Plan
  • Data analysis from positive Phase 2 in RRMS
  • Target Product Profile for new MS drug
  • Selection and support of additional indications for Investigator Initiated Trials (IITs)
  • Participate in clinical development plan for lead CNS asset
  • ork with SBDC Consultants for clients in biotechnology, drug and medical device development, clinical practice models
  • Develop and teach a class in problem solving
  • Founded GliaMed, a biotechnology company, based on two technology platforms discovered inmy academic laboratory and licensed to GliaMed.
  • Successfully negotiated for the acquisition of Symphony Neuro Development Corporation, a shell that included a lead compound, GM1485, with an extensive human safety database (~600individuals treated with GM1485), a large and comprehensive RILs IP portfolio and $750,000 in cash. The acquisition was made for a cash payment of $25K, modest milestone fees, and modest, non-stacking royalties. The expenditures on the GM1485 development prior to the acquisition was $138MM.
  • Successfully negotiated a buyback of GliaMed equity, future rights and milestones from BarrLaboratories for the original investment price, resulting in a 5-year, interest free use of $500,000by GliaMed.
  • Raised in excess of $30MM from both VC and governmental sources through direct solicitation and grantsmanship
  • Work with intellectual property counsel to craft intellectual property strategy; draft and prosecute new patent applications
  • Collaborate on the management of an IP portfolio in excess of 100 patents and patent applications
  • Responsible for fund raising, including funds from institutional investors, angels and grants
  • Establishment of academic collaborations to investigate new therapeutic areas and routes of administration, focusing on new opportunities for the company
  • Mentoring company employees in both science and biotechnology business practices
  • Regenerative Immunophilin Ligands (RILs) are small molecules that promote the recruitment, proliferation and differentiation of autologous stem cells in situat sites of acute trauma.
  • Programs in Peripheral nerve disease; Parkinson’s disease
  • ultiple Sclerosis
  • Amyotrophic Lateral Sclerosiso Neuro-Regenerative Ligands (NRLs) include peptide therapeutics, small molecules and hybrid moleculesPrograms in
  • Glioblastoma Multiforme
  • Astrocytosis and neuroproliferative diseases
  • Stroke and neuro trauma
  • Amyotrophic Lateral Sclerosis
  • Oversaw Best Practices on a company-wide basis
  • Chairperson of the GliaMed Scientific Advisory Boards (SAB)
  • Rational design of small molecule and peptide therapeutic candidates
  • Preclinical development of the lead compounds
  • Work with CROs to manage preclinical studies and data required for IND•Selection of clinical indications
  • Chairperson of the GliaMed Clinical Advisory Boards (CAB)
  • Selection of lead drug candidates
  • Good Clinical Practices Training (GCP)-December 2009
  • Selection of CROs and CMOto support clinical trial
  • Responsible for the preparation of IND submission
  • Design Phase Ia/IIb trial of GliaMed lead regenerative medicine compound, GM1485
  • Sought and obtained FDA approval for an exploratory trial of GM1485 in wound healing underexisting IND while still in the Neurology Division
  • Worked with CRO’s to establish trial sites and work with IRBs
  • Director, the Rose F. Kennedy Center Molecular Biology Core Facility.
  • Investigator, Albert Einstein College of Medicine Comprehensive Cancer Center
  • Established and lead an independent research laboratory in which each post-doctoral and pre-doctoral member developed research programs in the areas of neuro development, neuropathology, neuro-oncology and regenerative medicine
  • Laboratory and clinical interests specifically in neuron-glial interactions in infectious pathologies of the peripheral nervous system, including leprosy, herpetic neuropathies, Guillain-BarreSyndrome (GBS)and cutaneous leishmaneisis
  • Applied for and was awarded ~ $1,000,000 per year in direct research support from outside sources, including the NIH, foundations and pharmaceutical companies
  • Mentored pre-and postdoctoral fellows
  • Mentored residents and fellows in Neurology and Pathology
  • Member of the Neuroscience Education Committee
  • Developed a graduate neuro developmental biology course•Taught Neurology, Pathology and Neuroscience to Medical and Graduate Students

Roles

  • Associate Professor
  • Drug Development
  • Chief Executive Officer
  • Senior Advisor
  • Chief Scientific Officer
  • Chief Medical Officer
  • Consultant
  • President Medical Officer
  • Senior Medical Director
  • Vice President of Clinical Development
  • CEO

Request Expert / Similar Expert

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To apply for this job email your details to haleymmagnani@gmail.com