CEO to Chair Session on Cancer Drug Development
Detroit, Mich.—April 8, 2010—Vince Ammoscato, Vice President of Operations at Ash Stevens Inc. (ASI), will present on the development and manufacture of the highly potent myeloablative agent busulfan used to treat chronic myelogenous leukemia (CML). The presentation will take place at the American Association for Cancer Research (AACR) annual meeting Saturday, April 17 in Washington, D.C. Mr. Ammoscato will present on the handling and manufacture of the highly potent busulfan active pharmaceutical ingredient (API) as well as provide an overview of the challenges and considerations central to developing and manufacturing highly potent cytotoxic agents.
Mr. Ammoscato's presentation is part of the Chemistry in Cancer Research Working Group (CICR) educational session. Chaired by ASI President and CEO Stephen Munk, PhD, the session will highlight the challenges of developing and manufacturing highly potent APIs used in anti-cancer drugs. In addition to Ash Stevens, ARIAD Pharmaceuticals, Infinity Pharmaceuticals, and The National Institutes of Health (NIH) will present methods of addressing challenges in discovering and developing anti-cancer drugs. A schedule for the session is included below.
Educational Session Details
Session Title: From Chemistry to the Clinic, Part 3: Chemical Development – Translating a Potent Agent into a Registered Product
Date: Saturday, April 17
Time: 1:00 p.m. to 3:00 p.m. EST
Location: Room 147, Walter E. Washington Convention Center Chairperson: Stephen A. Munk, President and CEO of Ash Stevens Inc. Presentations:
1:00 PM On the road from research to reality: Pharmaceutical product development concepts for potent compounds, including AP24534, a novel multi-targeted kinase inhibitor. Christopher K. Murray, ARIAD Pharmaceuticals, Inc., Cambridge, MA
1:30 PM Discovery and development of the indenoisoquinolines topoisomerase I inhibitors. Yves G. Pommier, National Institutes of Health, Bethesda, MD
2:00 PM Pharmaceutical development challenges of the Hsp90 inhibitor IPI-504: A case study in controlling impurity. Kristopher M. Depew, Infinity Pharmaceuticals, Inc., Cambridge, MA
2:30 PM The role of the chemical development team in the regulatory approval of a cancer drug. Vince Ammoscato, Vice President of Operations, Ash Stevens Inc., Detroit, MI
About Ash Stevens, Inc.
Ash Stevens, Inc. (ASI) is a full service Contract Pharmaceutical Manufacturer offering comprehensive small-molecule drug substance development and cGMP manufacturing services. Founded in 1962 and headquartered in Detroit, Michigan, ASI has extensive experience developing and manufacturing Active Pharmaceutical Ingredients (APIs) for commercial clients in the Life Sciences industry developing innovator small-molecule drugs. ASI is also a longtime provider of contract research services to the National Institutes of Health and the National Cancer Institute and has worked on many of the drugs developed through these government agencies. To date, ASI has received eleven FDA manufacturing approvals for innovator APIs, including Four Fast-Track manufacturing approvals for the active ingredients in the oncology drugs Velcade®, Vidaza®, and Clolar®. Services offered by Ash Stevens include: process development and scale-up; cGMP manufacturing; the development and cGMP manufacture of highly potent APIs using barrier-isolation technology; comprehensive analytical capabilities (including method development, stability studies and qualification of reference standards); and regulatory support for all phases of drug development and manufacturing. For more information, visit www.ashstevens.com.