Peter Mays Email & Phone Number

Horsham, Pa 19044

Program management for the Prescription Drug Labeling Improvement and Enhancement Initiative (PDLI-EI) program. The program was a contract with FDA to convert FDA approved Prescribing Information to conform to the standards of the 2006 Physicians Labeling Rule (PLR) requirements. Responsibilties:• Evaluation of safety data for labels.• Recruiting contractors – 10 independent groups for a total of 60 contractors – trained and monitored contractors performing the medical and regulatory writing associated with the PLR-conversions. • Managed an internal group of seven professionals.• Primary FDA contact. FDA contractor Level 5 clearance.• Managed a $4M budget. Successfully delivered 35 PLR conversions.• Program put on-hold by FDA due to complexity of the medical issues raised by PLR-conversions.

Horsham, Pa 19044

Consultant supporting the PDLI-EI program, a contract awarded to Reed Tech, Inc., from the US FDA. Responsible for project management, research and medical writing to support PLR-conversions.

Downingtown, Pa.

Independent contractor performing medical literature review and data cross-checks to support Core Data Sheet updates to support global drug labeling for global pharmaceutical clients.

Wayne, Pa

Assisted in maintaining on-going programs to allow for further venture funding or licensing of programs.

Wayne, Pa

FemmePharma is a specialty pharmaceutical company developing drugs for women’s healthcare utilizing transdermal and intravaginal drug delivery. Leadership role directing the strategic vision and tactical implementation in development activities for three programs in pain associated with endometriosis (FP1096), overactive bladder (FP1097) and pain associated with fibrocystic breast disease (FP1198).- Successfully managed three drug development programs advancing the drug candidate pipeline from project initiation through proof of concept and End of Phase 2.- Built and lead collaborative teams both internally and externally with contract vendors.- Responsible for development and implementation of project plans using MS Project, forecasting timelines and budget, including reporting updates to senior management.- Acted as Sponsor’s representative to FDA, including submitting original INDs, CMC updates, Annual Reports and safety updates for the programs and leading the End of Phase 2 meetings.- Managed all clinical programs advancing drug candidates through initial safety evaluation and clinical proof of concept.- Managed all CMC activities to support drug development programs, including sourcing drug substance (API), drug product development, formulation, analytical, packaging, release specifications and stability studies.- Identified and selected Contract Manufacturing Organizations (CMO) to supply cGMP-compliant clinical supplies and commercial products, including technology transfer of programs between formulation group and contract manufacturers.- Designed and conducted under GLP of all preclinical activities to support FP1097 and FP1198, including 90-day whole body toxicology and local irritation (dermal and vaginal) irritation.- Authored Clinical Protocols, Investigator Brochures, Clinical Study Reports and CMC documentation to support regulatory filings.- Contributed to intellectual property portfolio, including face-to-face prosecution at USPTO.

Wayne, Pa, Usa

West Chester, Pa

Checkpoint Genetics developed small molecule pharmaceuticals based on sea-vegetable metabolites to treat atherosclerosis, restenosis and stroke. - Responsible for all preclinical R&D programs. Successfully managed the program moving the lead candidate (CPG603) through the preclinical drug development process. - Regulatory responsibilities including preparing preclinical data for pre-IND meeting. - Built out new laboratory space in a 3,000-sq. ft. facility

Buena, Nj, Usa

IGI is a diversified company utilizing its Novasome® (non-phospholipid liposomes) technology to formulate pharmaceutical and consumer products. - Managed external testing laboratories to perform safety and efficacy evaluations to support product claims of new products.- Supported products in EVSCO veterinary pharmaceutical division, including formulation issues, manufacturing trouble-shooting and regulatory support.

Branchburg, Nj, Usa

Hydromer is a medical device company developing lubricious coatings and hydrogels for medical, cosmetic and consumer applications.

Beverly, Ma, Usa

Collagenesis was a tissue engineering company focusing on medical and cosmetic applications for allogeneic human collagen as a biomaterial. - Headed an R&D team that developed an allogeneic injectable human collagen for repair of deep dermal defects (DermalogenTM) and the treatment of urinary incontinence caused by intrinsic sphincter deficiency (UrologenTM). - Responsible for technology transfer to manufacturing from R&D, resulting in the successful commercial launch of DermalogenTM in September 1998.- Responsible for ISO-10993 safety and biocompatibility testing of injectable human collagen, as well as viral inactivation studies.- Prepared the preclinical sections of the IDE for Urologen and of the PMA for Dermalogen. - Presented pre-clinical data for Urologen at the pre-IDE meeting.- Technical officer on supply contract for cadaveric tissue with the Musculoskeletal Transplant Foundation (MTF; Successfully developed relationship with MTF counterparts and presented the program to MTF affiliated tissue banks.- Led a team of eight scientists, including one Ph.D.

Camden, Nj, Usa

Responsibilities included:- Day-to-day management of the workload of the cell biology laboratories, including cryopreservation, and cell culture media production.- Preparing, implementing and auditing ISO9002 protocols.

Canton, Ma

Organogenesis develops tissue engineered constructs to influence tissue repair. Achievements and responsibilities:- Developed a method to produce human collagen in vitro.- Biochemical analyses of collagenous implants, including ApligrafTM and GraftarteryTM.

Philadelphia, Pa

I worked on the regulation of collagen gene expression in transgenic mice and on genetic markers for human collagen.

Phd, Biochemistry

Bsc, Chemistry And Pharmacology