QUALITY BY DESIGN

Direxa

Consulting

Direxa provides statistical strategy and support for biopharmaceuticals from nonclinical development through submission, approval, and the commercial lifecycle.

Value Delivered

Build investor and health authority confidence to accelerate submissions. Design robust processes and assays. Conserve materials and analytical resources.

CMC Statistics

Statistical applications in the context of nonclinical biopharmaceutical development and Chemistry, Manufacturing & Controls (CMC). Work spans the continuum from policy and strategy development to implementation.

Strategy + Execution

Breadth and depth of knowledge in applied statistics coupled with a knack for translating to the language of regulatory science. Track record supporting accelerated approvals.

Elected Fellow of the American Society for Quality, November 2020.

TRACK RECORD

Where Direxa Has Delivered

FDA training & seminars

Developed and delivered sessions on CMC statistics for FDA Staff College; specification setting for Office of Tissues and Advanced Therapies; process capability for CBER vaccines division; by invitation.

Seasoned industry leader

Ten years in Merck Regulatory & Analytical Sciences and Technical Operations. Led the team to design and implement global Continued Process Verification monitoring for Keytruda and all vaccine manufacturing.

Accelerated approvals

Direct support for first-in-class gene therapies, vaccines, and other novel biological products. Authored Control Strategy, Justification of Specifications, Quality Summary, et al. Represent sponsors in regulatory review discussions and responses to questions.

Professional network

CASSS Associate Director and Scientific Organizing Committee for WCBP (Well Characterized BioPharmaceuticals). Editorial Boards of Quality Engineering and Life Science Leader. BioPhorum Operations Group Continued Process Verification team.

Analytically Speaking

Principal Consultant Julia O’Neill’s approach to bridging statistics and science developed from early training with George Box, Bill Hunter and Stu Hunter, highlighted in this interview with JMP’s Anne Milley.

Watch the Video

Working with Direxa

Partnership

Long-term collaboration

Mentoring

Coaching to build your team’s skills

Responsive

Statistics resource available on demand