CEO, Accellient Partners Toxicology

CEO, Accellient Partners

Toxicology

William D Kerns, DVM, MS, DACVP

Dr. Kerns completed his medical training in Veterinary Medicine and graduate work in Pharmacology and Pathology at The Ohio State University, and in 1980 he successfully completed examination by the American College of Veterinary Pathologists.

Dr. Kerns has 30 years of experience in Pharmaceutical Research and Development having held senior executive positions in Preclinical Development at SmithKlineFrench, SmithKlineBeecham and Eisai Pharma during his career. He is recognized as an expert in Drug Development and Safety Assessment. He also currently advises the Critical Path Institute and the SAFE-T group.

 


Pharmacokinetics

Pharmacokinetics

MARTIN A. GRAHAM, Ph.D

DR. GRAHAM HAS BEEN INVOLVED IN DRUG DEVELOPMENT FOR OVER 25 YEARS AND IS A SPECIALIST IN PK / PD ANALYSIS, and serves as lead pharmacokineticist for phosplatin therapeutics' drug development efforts. HE BEGAN HIS CAREER AT SANOFI-SYNTHELABO, IN BOTH THE UK AND THE US. DR. GRAHAM LATER SERVED AS DIRECTOR OF PHARMACOKINETICS AT CENTOCOR CORPORATION, A JOHNSON AND JOHNSON COMPANY; VP OF RESEARCH AND DEVELOPMENT AT GEMIN X BIOTECHNOLOGIES; AND VP OF DEVELOPMENT AND REGULATORY AFFAIRS AT TETRALOGIC PHARMACEUTICALS.

HE FOUNDED PKPD BIOSCIENCE IN 2004, which was later integrated into KINDERPHARm, a pediatric drug development company he had also founded IN 2014. DR. GRAHAM SERVES AS PRESIDENT & CEO OF BOTH ENTITIES. WITH HIS EXTENSIVE R&D EXPERIENCE WITH BOTH SMALL MOLECULES AND PROTEIN THERAPEUTICS FROM IND TO NDA/BLA, DR. GRAHAM HAS BEEN INVOLVED IN NUMEROUS REGULATORY FILINGS IN THE U.S., JAPAN AND EUROPE FOR A WIDE VARIETY OF PRODUCTS INCLUDING OXALIPLATIN, RASBURICASE, MITOGUAZONE, TIRAPAZAMINE, ALFUZOSIN, BIRINAPANT, STELARA AND REMICADE.

HE IS A GRADUATE OF LEEDS UNIVERSITY, ENGLAND WHERE HE EARNED HIS BSC IN PHARMACOLOGY AND MICROBIOLOGY, AND WENT ON TO EARN HIS PHD FROM THE UNIVERSITY OF LONDON AT THE INSTITUTE OF CANCER RESEARCH, ROYAL MARSDEN HOSPITAL IN 1990.  HE IS THE AUTHOR OF A TEXT BOOK ON THE PHARMACOKINETICS OF CANCER CHEMOTHERAPY AND HAS SUBSTANTIAL PUBLICATION RECORD IN THE AREA OF PHARMACOKINETICS, DRUG METABOLISM AND CLINICAL PHARMACOLOGY

 


Clincal Development

Clincal Development

Michael H. Silverman, MD, FACP

Dr. Silverman is a board-certified internist with over 25 years of experience in biopharmaceutical industry clinical research, product development, and strategic planning. He has served Phosplatin therapeutics in its clinical development matters since inception. His pharmaceutical industry career has included positions of increasing responsibility at both global and start-up companies, where he has managed multiple pharmaceutical and biotechnology projects across a broad scope of therapeutic areas. He is currently president of biostrategics consulting, ltd.

Prior to beginning his consulting activities, among other roles Dr. Silverman served as Manager, KPMG Health Care Consulting; Vice President of Clinical Research at Biopure Corporation in Cambridge, MA; and Director of Clinical Research at Sandoz Research Institute in East Hanover, NJ. He was in clinical practice of medicine for seven years. Dr. Silverman received his BS from the University of Illinois and his MD from the University of Chicago.

 


CMC Regulatory Affairs

CMC Regulatory Affairs

THOMAS M. ECKRICH, PHD

TOM ECKRICH IS AN EXPERIENCED Chemistry manufacturing and controls (CMC) EXECUTIVE WITH 33 YEARS OF EXPERIENCE IN THE PHARMACEUTICAL INDUSTRY, PRIMARILY WITH ELI LILLY AND COMPANY. HIS ACCOMPLISHMENTS INCLUDE NDA SUBMISSIONS FOR LORACARBEF, GEMCITABINE, RALOXIFENE AND TADALAFIL. HE ALSO MANAGED ELI LILLY’S EUROPEAN DEVELOPMENT CENTRE IN MONT SAINT GUIBERT, BELGIUM, LEADING THE GROWTH OF THE PREMIER SMALL MOLECULE PROCESS R&D GROUP IN THE US PHARMA INDUSTRY DURING THE EARLY 2000’S, AND ESTABLISHED A NETWORK OF MORE THAN 30 COMPANY RELATIONSHIPS FOR LILLY’S DEVELOPMENT OUTSOURCING CAPABILITY.

IN 2014, DR. ECKRICH FOUNDED ECKRICH CONSULTING SERVICES, LLC, WHICH PROVIDES EXPERTISE TO THE CHEMICAL AND PHARMACEUTICAL INDUSTRIES IN CHEMICAL PROCESS DEVELOPMENT AND MANUFACTURING, WITH A FOCUS ON SYNTHETIC ORGANIC CHEMISTRY. DR. ECKRICH EARNED A DOCTORATE IN CHEMISTRY FROM HARVARD UNIVERSITY IN 1984, STUDYING WITH PROFESSOR E. J. COREY, THE 1990 NOBEL LAUREATE IN CHEMISTRY.


analytical chemistry

analytical chemistry

BERNARD A. OLSEN, Ph.D.

Bernie Olsen HAS 37 YEARS OF EXPERIENCE RELATED TO CHEMISTRY, MANUFACTURING AND CONTROL ASPECTS OF DRUG SUBSTANCES AND DRUG PRODUCTS, WITH A FOCUS ON ANALYTICAL chemistry AND QUALITY control.  AS A SENIOR RESEARCH FELLOW AT ELI LILLY AND COMPANY, HE CONTRIBUTED TO THE DEVELOPMENT AND SUPPORT OF OVER 25 COMMERCIAL DRUGS AND NUMEROUS DEVELOPMENTAL DRUGS.  HIS EXPERTISE COVERS A WIDE ARRAY OF DRUG DEVELOPMENT AND ANALYTICAL TOPICS INCLUDING METHOD DEVELOPMENT AND VALIDATION, IMPURITY CONTROL, GENOTOXIC IMPURITIES, PHYSICAL PROPERTY CHARACTERIZATION, REGULATORY ASPECTS OF DRUG DEVELOPMENT, AND QUALITY CONTROL.  HIS UNDERGRADUATE DEGREE IS FROM NEBRASKA WESLEYAN UNIVERSITY AND HIS DOCTORATE IN ANALYTICAL CHEMISTRY IS FROM THE UNIVERSITY OF WISCONSIN-MADISON.  HE IS A FELLOW OF THE AMERICAN ASSOCIATION OF PHARMACEUTICAL SCIENTISTS.