Elim Pediatric Pharmaceuticals, Inc. is a socially conscious company that was originally formed in 1999 under the name of Globalfarma International, Inc. The name was changed in 2008, and the focus sharpened to develop quality drug products for children's diseases, including rare and neglected illnesses. The founder of EPPI, Dr. Adeyeye, has over 30 years of experience in pharmaceutical material science testing and preformulation, quality drug development, clinical trials, and associated regulatory requirements.
EPPI currently has pediatric HIV and AIDS drug products in the FDA pipeline, and we are seeking investors to help fund their creation and distribution. Our other products under R&D include pediatric medicines for malaria and sickle cell disease. EPPI develops products for rare and neglected diseases, including:
• HIV & AIDS • Tuberculosis • Autism • Infection |
• Cataract • Malaria • Cancer • Sickle Cell Anemia |
• Pain Management • & More |
EPPI's Executive Board
Nkere Ebube, PhD
Dr. Nkere Ebube is currently the President and a Board Member at PharmOPS, Inc., a Specialty Generic Pharmaceutical Company, where he provides executive leadership and strategic oversight for development of complex generics and 505(b)(2) product. He also manages contract product development and manufacturing including CTMs, analytical laboratories and stability services. He has extensive product development experience from concept to commercialization for small molecules and biologics. He has a diverse background with expertise in product design & development, bioavailability enhancement, controlled release & abuse deterrent technologies, quality-by-design and risk management & control.
He has over 20 years’ experience in scale-up, technology transfers and commercial manufacturing of various dosage forms including oral solids, liquids, semi-solids, and sterile products for branded, generic, and OTC products. He is very versatile with background in Business Development, Controlled Substance, DEA Compliance, Quality Assurance and Compliance, Product Launch and CMO Alliances Management. He has profound knowledge of global drug regulation, and has supported submission of over 130 products across various global regulatory agencies including EMEA, LATAM, APAC, MEENA, etc. Dr. Ebube has held various executive leadership positions in R&D, Technical Operations and Quality at different pharmaceutical companies including Wyeth (Pfizer), Hospira, Wockhardt, Biovail and Alpharma.
He is an author, and has also published many peer-reviewed scientific manuscripts and presentations. He is a member of the Advisory Board at Warren County Community College, Research Advisory Board at Roosevelt University, and on the Board of various Professional and Philanthropic Organizations. Dr. Ebube is an Adjunct Professor of Pharmaceutics and Pharmaceutical Technology at Florida A&M University and Roosevelt University respectively.
Anthony Palmieri. PhD
Dr. Palmieri is retired from the faculty at the University of Florida College of Pharmacy in the Department of Pharmaceutics. He has authored of over 80 publications and presentations on pharmaceutics, intellectual property, dosage forms, dissolutions, pharmacy education and the history of pharmacy. He has interacted extensively with USAN and WHO to obtain non-proprietary names for Pharmacia and Upjohn. Dr. Palmieri is Past Chairman of the USAN Council and he is presently on the USAN review board. He consults as Expert Witness on litigation involving dose forms, excipients, bioequivalence, and dissolution for numerous litigations. He is also an expert witness before the Office of Generic Drugs.
Tony has an extensive twenty-five year's experience of progressive responsibilities in an intellectual property management and technology transfer position coupled with over fifteen years as a professor of pharmaceutics at major universities. Dr. Palmieri has successfully led projects across management lines where reporting relationships were often difficult to establish, no precedent existed and the use of creative problem solving and communication skills were necessary.
Dilip Parikh
Mr. Dilip Parikh is the President of DPharma Group Inc., Ellicott City, MD. Mr. Parikh is a highly effective pragmatic manager with business development, technical and organizational management experience with large and small pharmaceutical companies. He has technical skills that include extensive knowledge of solid dosage process technologies, formulation, drug delivery technologies, cGMP, tech transfer, scale up, plant operations, regulatory compliance and packaging. His company specializes in product development, process scale up, tech transfer, facility design, providing subject matter expertise in process technologies such as fluid bed granulation and coating, spray drying, extrusion/ spheronization, high shear wet granulation and roller compacting.
He was the Vice-President, Operations and Technology, Synthon Pharmaceuticals Inc. RTP, NC from 2003-2006. He was the Vice-President, Vice President and General Manager, Atlantic Pharmaceutical Services, Owings Mills MD from 1996-2001. He has held various positions at different companies such as Sandoz Canada, Ontario, Canada, McNeil Pharmaceuticals, Ontario, Canada, Ortho Pharmaceutical, NJ and Niro Inc. Columbia MD from 1973-1996.
Sam Rasty, PharmD, MPH, BCPS, RAC
Dr. Sam Rasty is the director of medical and regulatory affairs at One Source Regulatory and Senior consultant to multiple pharmaceutical organizations. He performs Regulatory & Medical advertising and promotion review work, other work around the advertising and promotion review process including drug product labeling development. His responsibilities include review, approval, and utilization of Advertising and Promotional Materials and Activities for both Medical Devices and Pharmaceutical agents.
He is a medical and regulatory expert within the promotional review committee (PRC) providing strategic guidance on advertisement and promotion at key stages of medical device development; managed care, health economics and outcomes research in compliance with Food and Drug Administration (FDA) and Federal Trade Commission (FTC) regulations and guidance. Over the past 17 years he has had multiple academic and clinical appointments within the higher education and teaching hospitals and has been actively involved in research and practice.
Michael Stevens, PharmD
Michael Stevens, PharmD is an accomplished results-oriented, science-based executive with a well-diversified career in the pharmaceutical/biotechnology industry over more than thirty years. He has served in a number of positions in “Big Pharma” and “Small Biotech” ranging from entry level to C- Level executive in the areas of Market Research, Oncology Marketing, Medical Nutritionals Marketing, Drug Discovery, New Product Development, Phase 1 through 4 Clinical Trials in HIV/AIDS and Clinical Nutrition, Medical Market Development in the hepatitis B market, and Medical Affairs. A former Vice President of Virology Medical Affairs at Bristol-Myers Squibb and Executive Council member of the Forum for Collaborative HIV Research,
Michael has extensive experience in designing, implementing, analyzing, and publishing clinical trials and retrospective analyses and has authored/co-authored more than 50 publications, posters, and abstracts. Dr. Stevens received both his undergraduate and PharmD degrees from Purdue University. Michael is the Fire Police Captain for West Windsor Fire Company No.1 where he also oversees the submission of FEMA grants for local volunteer firefighters.
CHIEF SCIENTIFIC OFFICER
Tom Catalano, PhD
Dr. Catalano has 33 years in the Pharmaceutical Industry in various positions including the Global Director of Analytical R&D, with major companies such as G.D. Searle, Pharmacia and Pfizer, which led to a multitude of experience in providing analytical support to dosage forms and drug substances including biologicals. Additionally, he worked for a biopharmaceutical company, Theravance, as Sr. Director of Technical Operations. He has made significant contributions to the development and registration of many products such as NutraSweet, Cytotec, Arthrotec, Celebrex, Bextra, Dynastat, Inspra and Vibativ (glycopeptide antibiotic). He has also worked and is currently working for generic drug companies, where he has been part of submitting several ANDAs.
He focuses on analytical pharmaceutical chemistry and provides consulting, training and technical writing services for all stages of the pharmaceutical development. His major areas of expertise include Systematic Method Development (Relevant to Phase of Development), Validation of Analytical Methods (Relevant to Phase of Development), Technology Transfers, Specification Development, Quality Risk Assessment, Due Diligence on Potential Acquisitions, Expert Witness, Statistical Design of Experiments, Stability Management and Data Interpretation, CRO/CMO Management, Project Management, Writing / Review of CMC, Writing / Review of SOP's and Guidelines, Writing and Review of Technical Documents, Knowledge of Regulatory Guidance's , Guidelines and Compendia, and Response to Regulatory Agency questions.