Name
Douglas Ball
Educational Degrees
BS, MS
Certifications
DABT - Diplomate American Board of Toxicology
Education
B.S. Biology St. John's University
M.S. Biology St. John's University
Expertise
Drug/Pharmaceutical Development, Inhalation and Respiratory Toxicology, Metals Toxicology, Product Safety Assessment, Regulatory Toxicology, Risk Assessment
Specialties
D&B Chemtox, LLC provides expert toxicological services to qualify impurities related to the drug substance (process-related), drug substance manufacture (single-use system and non-process-related), and final drug product (leachables and extractables from the primary and secondary container closure system). Qualification entails safety assessment of inorganic (elemental impurities) and organic (volatile and semi-volatile impurities) chemicals to ensure doses and/or concentrations in the drug product have no to low risk to the patient.
Experience
1. Product Quality Research Institute (PQRI): Toxicology Lead for the development of L&E best practices for orally
inhaled and nasal drug products and parenteral and ophthalmic drug products work teams
2. Founding member and past Board Chair of the Extractables and Leachables Safety Information Exchange
(ELSIE)
3. PhRMA Deputy Topic Lead for the ICH Q3D (Elemental Impurities) Expert Working Group
4. USP Expert Panel member for Chapters <87>, <88>, <1031> (biocompatibility) and <381> (elastomeric
enclosures)
5. Key contributor to >15 IND submissions and 5 NDA/MAA approvals
6. Participant in multiple face-to-face and phone meetings with regulatory agencies (including FDA, MHRA, BfArM, ANSM, MPA, and Health Canada) pre-IND, Scientific Advice, Type C and pre-NDA meetings• Responsible for all aspects of nonclinical research
(pharmacology, DMPK, bioanalytical sciences, and toxicology) including regulatory submissions, due diligence
reviews, development planning and delivery
City
Southbury
State
CT
Zip Code
06488-2480
Telephone
8603894609