Neal Sharpe, Phd. Email & Phone Number

New York, Ny, Us

New Haven, Ct, Us

Overseeing and assuring Toxicology, DMPK and Preclinical Development to meet the needs of clinical development and regulatory requirements

New Haven, Ct, Us

Overseeing and assuring toxicology and preclinical development to meet the needs of clinical development and regulatory requirements.

Consultant to biotechs and pharma in preclinical safety and toxicology for discovery and development.• Provides toxicology, preclinical program development and study monitoring to meet the needs of clinical development and regulatory requirements. • Delivers support for small to midsize biotech and pharmaceutical companies across multiple therapeutic areas including CNS, oncology, immunology, CV, metabolic, anti-infectives and rare diseases. Experienced in oligonucleotide, small molecule and biologic toxicology program.

Responsible for managing all scientific, compliance, and operational issues across all programs and for hiring and developing a growing R&D organization.• Provided leadership to research, translational sciences, preclinical safety, DMPK and clinical pharmacology leading to the submission of first IND, a CTA, multiple orphan drug approvals and meeting of all preclinical commitments to meet CDP timelines. • Led, developed and maintained KOL, collaborator and partner relationships resulting in programs having strong scientific basis and support within the scientific community.• Drove multiple toxicology programs to successfully assure regulatory milestones were completed on time including preparing regulatory documents supporting IND and CTA submissions

Provided scientific and strategic leadership and assure scientific support for all preclinical programs across Toxicology, DMPK and Pharmacology in both discovery and development. • Oversaw the scientific and operational oversight of all preclinical programs, studies and staff.• Provided the scientific and operational oversight of all GLP/non-GLP toxicology and DMPK programs and studies. • Prepared preclinical sections for IND, IB and other regulatory documents for Health Authority review and approval.• Senior staff member contributing and providing leadership across research, early development and development including input on clinical plans.

New York City, Ny, Us

Provided scientific and strategic leadership and assured scientific support for all programs in both research and development. • Drove the scientific and operational aspects of programs across research, discovery including toxicology and DMPK studies to meet on the needs of programs • Prepared preclinical sections of IND, IB and other regulatory documents for Health Authority approval.• Provided leadership across research, early development and development including input on clinical plans.

Consultant to biotechs and pharma in preclinical safety and toxicology for discovery and development.• Provides toxicology, preclinical program development and study monitoring to meet the needs of clinical development and regulatory requirements. • Delivers support for small to midsize biotech and pharmaceutical companies across multiple therapeutic areas including CNS, oncology, immunology, CV, metabolic, anti-infectives and rare diseases. Experienced in oligonucleotide, small molecule and biologic toxicology program.

Cambridge, Ma, Us

Chosen as acting Head of the newly formed ALS Disease group upon departure of Department Head. • Led the activities of the team on the ALS initiative within the Innovation Hub to progress molecule to IND.• Drove the ALS long-term strategy forward, assured organizational alignment, and clearly communicated long-term strategy, goals, and targets. • Led team to create, deliver, and implement innovative approaches to bring new therapies from discovery through POC. This included potential oligonucleotide therapies.

Cambridge, Ma, Us

Led Preclinical Safety Program and Study Management group. Responsible for the scientific and operational oversight of all GLP/non-GLP toxicology studies for neurodegenerative programs. Managed PhD, Master’s, and Bachelor’s level individuals.• Developed and implemented new outsourcing strategy for Preclinical Safety Group resulting in 30% cost savings, establish priority study timing and minimized risk to the organization.• Provided leadership and guidance to the Study Manager Group by defining their career development path and clear responsibilities with job descriptions that led to hiring new talent and increasing morale of group. • Served as Preclinical Safety Leader on development teams assuring toxicology support was in place to support clinical development.

Rahway, New Jersey, Us

• Provided Safety Assessment (Toxicology) scientific and strategic leadership and assured scientific support for external discovery project teams and internal customers

Rahway, New Jersey, Us

• Served as a Toxicology Compound Director (Compound Manager), representing Toxicology on Discovery/Development teams.• Led multiple global integration projects for the Merck/Schering-Plough merger. • Served as the lead for the preclinical toxicology bench-marking (metric) effort, which included representation from eight global pharmaceutical organizations.

Kenilworth, New Jersey, Us

• Implemented process to assure development programs were appropriately resourced and aligned across R&D by interfacing with the R&D leadership team, chairs of the global governance committees, and group heads. • Served as a Toxicology Compound Director (Compound Manager) on project teams across multiple therapeutic areas.• Oversaw multiple groups supporting studies conducted within Global Toxicology while managing a group of greater than 45 individuals including study directors and support staff. • Served as a member of Global Toxicology Senior Staff responsible for managing all scientific, compliance, and operational issues and multiple Study Directors performing both GLP and Discovery Toxicology studies.• Developed and implemented a Project Manager (PM) role to provide project management support for compound managers within Preclinical Toxicology and Metabolism. • Managed the occupancy and steps required to implement GLP Toxicology studies in a new Toxicology facility at the Summit site. • Co-led the integration of two Preclinical Safety Groups and site closure when acquisition of Organon occurred merging organizations with cultural differences. Evaluated processes to select best common practices and integrated operations within 18 months.

Kenilworth, New Jersey, Us

• Managed Operations across Drug Safety, including planning/scheduling, data management, and the General and Reproductive Toxicology support staff. • Developed and implemented Toxicology Data Management group to support and manage multiple operational aspects across Toxicology managing a group of over 45 individuals. These groups included both study directors and support staff. • Interfaced with groups across the research organization including Early Clinical, Pharmaceutical Sciences, and Discovery to assure priorities and resources were aligned across the Research Institute.• Led and implemented the initiative to develop new reporting and IND process for Preclinical Safety, which led to increased efficiency and quicker turnaround of Toxicology reports and development of Pre-clinical Safety compounds for IND’s.

Kenilworth, New Jersey, Us

• Managed a group of over 40 individuals responsible for conducting the technical aspects of General and Reproductive Toxicology studies.• Combined two Toxicology technical groups of 40 resulting in significant increases in capacity and flexibility by cross-training staffs to be able to support General and Reproductive Toxicology and Safety Pharmacology studies.

Kenilworth, New Jersey, Us

• Oversaw 30 staff members conducting the In-life technical portions of General Toxicology studies.• Served as study director on exploratory and methods development studies. • Lobbied the functional manage r for funding and resources to bring data collection and management system in-house and led the project to completion.

Doctor Of Philosophy (Ph.D.), Neurobiology And Neurosciences

Master’S Degree, Biology/Physiology

Bachelor’S Degree, Biology/Biological Sciences, General