ENTREPRENEURIAL OPPORTUNITIES IN LIFE SCIENCE QUALITY & REGULATORY

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1 BIOANALYTICAL SOLUTIONS FOR BIOTHERAPEUTICS AND SMALL MOLECULE THERAPEUTICS ENTREPRENEURIAL OPPORTUNITIES IN LIFE SCIENCE QUALITY & REGULATORY MARCH 15, 2017 AIT BIOSCIENCE, LLC BIOANALYSIS TO SUPPORT DRUG DEVELOPMENT Located in Indianapolis Indiana 19,000 sq. ft. building completed in September 2011 State of the Art Laboratory Unique combination of Science & Innovation, i.e. Electronic Records 2 1

2 WHO WE SERVE INDUSTRY: Biotech Pharmaceutical Animal Health CLIENT FOCUS: Small to mid-size companies, up to large pharma Innovator companies and some generic (including biosimilars) BIOANALYTICAL SUPPORT: Lead Optimization/Discovery Pre-clinical, non-clinical Phase I III clinical development Method Development, Method Validation, Sample Analysis 3 ENTREPRENEURIAL CRO Unique combination of science and innovative technology Assay development expertise Assay quality Paperless Electronic Lab Notebook (ELN) process and lab automation Team of collaborative, problem solvers Accessibility (including scientific researchers) Strong collaboration and coordination with toxicology facilities, clinic sites and other partners Speed - faster delivery of QA data Requires deep scientific expertise and a strong Quality Assurance Unit Ligand Binding Assay LC- MS/MS 4 2

3 INNOVATIVE QMS AND ELN AIT Bioscience built a QMS for regulated bioanalysis intended to support IND, NDA and ANDA submissions. FDA and OECD guidelines form the basis of our quality systems. Use QA/QC resources up front instead of after the fact All electronic templates are validated and controlled Errors prevented and corrected in real time Focus on audit trails rather than spreadsheet reconstruction Fewer problems for the lab to address means faster turnaround Unstructured like a paper lab notebook, but also Structured method management system with controlled forms Validated templates for repetitive tasks Business and scientific rules enforced Error prevention during the lab activity Audit by exception 5 AIT BIOSCIENCE QUALITY UNIT Dedicated QA unit for: Quarterly Process Audits Individual Study Audits Quality/regulatory training Archiving Primary ELN Template Review Maintenance of the Master Schedule Vendor Audits Client and regulatory agency audits 6 3

4 WIDE RANGE OF SPONSOR NEEDS Averaging > 55 new molecule assays per year > 100 assays per year, inclusive of additional matrices and species for a given molecule Sponsor submissions will go to multiple global regulatory agencies Sponsors range from expertly staffed pharma/biotech to near virtual companies Guidance on design of experiments, assay rigor Guidance on sample handling instructions at Tox and Clinical sites Client and regulatory agency audit activities Specialties Include: Derivatization chemistries Chiral chemistry Macromolecule PK/TK assays Neutralizing Antibody assays (cell-based & LBA) Immunogenicity, ADAs Biomarkers Peptides Prodrugs Complex matrices (muscle, liver, kidney, brain, fat) Low level quantitation in tissues 7 STAFFING AND CAREER PATHS Staff: - Varied backgrounds, including experience in large pharma, CROs, biotech, AgBio and toxicology organizations, academia Quality Assurance: - There is no manual for QA - Regulatory/Compliance coursework, internships, auditing experience - - Solid life science audit experience isn t always easy to find - Good scientific foundation helpful to understanding the goal of scientists - Consultative mindset - Current R&D environment: everyone benefits from biology, immunology - Don t overlook the role of technology, IT systems in what you may audit, and in how you do your own job - The prophets and forecasters: stay current on industry trends, regulations, guidance SQA, BIRS, continuing education, industry publications, meetings/webinars Assess what s coming next Train your colleagues and clients 8 4

5 SUMMARY: THE CAREER JOURNEY Key Attributes: - Flexibility; openness to change, to try new roles - Organization, time management skills - Attention to detail, excellent documentation skills - Excellent communication skills bridge technical, regulatory, business discussions - Embrace technology - High impact personal interactions internal and external stakeholders Career Journey - Entrepreneurial roles offer variety; a broad range of experiences in short time - Understand the drug development process and regulatory expectations - Transitions from science to quality/regulatory or the opposite direction - Expect change, embrace it! Help your organization fare well during times of change - Understanding regulatory/compliance in the practical context of running a business is a differentiator for you! 9 5