Drug Development Services

Transcription

1 Drug Development Services

2 Speaker Introduction Nik Burlew Vice President Regulatory and Strategic Development 25 Years in Pharma: Development, MFG and QA. Consulting for the last 13 years primarily to small/virtual companies seeking to enter the clinic as well as those looking towards commercial marketing.

3 Clinipace: Broad Expertise Phases Drug Development including Early Non-Clinical Clinical Global Strategy Regulatory & Development Strategy Much More Phase I Phase II Phase III Phase IV Other Therapeutic Areas Cardiovascular / Metabolic Central Nervous System Dermatology Gastroenterology Immunology Infectious Diseases Nephrology Oncology / Hematology Orphan Diseases Respiratory Disorders Vaccines

4 Global Service Organization ~800 Staff 16 Global Offices Operations in 39 Countries

5 RSD Services Strategic Consulting Product Development Manufacturing Operations & Quality Assurance Portfolio Management Development & Registration Strategy Needs/Gap Assessment Regulatory Agency Interactions, Scientific Advice Product Lifecycle Support Quality System Development & Implementation GMP, GLP Auditing & Inspections CMC Support Due Diligence Portfolio Development & Evaluation Product/Regulatory Intelligence Operations Regulatory Affairs Regulatory Publishing IND s & Clinical Trial Applications, IMPD NDA, BLA, ANDA, 505b(2), DMF (ASMF), MAAs Priority Reviews (Orphan Drug, Biosimilars, Fast Track) Lifecycle & Dossier Maintenance Study Reports, Journals & Manuscript Preparation Paper & Electronic Submission SPL CSR regulatory compliance advisement

6 Essential Elements of Drug Development: Identifying the Requirements Goals? Through to MKT and commercial distribution? Or just to POC? Territory: US, EU, global? What is the primary constraint - Time? Money? Other? Tasks/Spend/Timing/Partners all impacted Clinical/Marketing Requirements? Dosage form, package size, dosing regimen, storage and stability requirements, MFG costs Adequate Nonclinical program? Clinical program (dose) covered, indication covered Clinical goals: indication (Orphan?), medical need (fast track/break through) Regulatory Landscape? Comparable products, potential competitors (approved or under development)? Regulatory hurdles geographically, guidance Opportunities for contact with authorities (scientific advice, FDA meetings)

7 Essential Elements of Drug Development: Identifying Partners and Creating Plans CMO/Lab Selection Make or break decision Specialty product MFG or esoteric analytics? Timing/Costs Project plan/budget development (milestone identification, go/no go) Match burn rate to needs and resources Phase appropriate activities (data driven) When to execute supporting studies (e.g. interaction studies, carcinogenicity) Planning Match up pre-clin CMC Clin RA Distribution plans using realistic timelines and understanding that this is still development science

8 Essential Elements of Drug Development: Execution Management of contractors/vendors Hold accountable for quality, timing, costs Watchful attentive eyes Assist in troubleshooting along the way, go/no go decisions Act in interest of sponsor (and patient) at all times Copious notes frequent communication, clear decision making pathways.

9 Drug Development: Case Study 1 Conjugated peptide, DS already made very little planning at start (pre CPWW) Pre-clin, Method development, DP process/formulation development, RA strategy Write IND, defend to funding bodies Manage CMOs, Labs and Tox program contracts, Quality Agreements, activities, invoices; Drug ready for clinic

10 Drug Development: Case Study 2 Novel biologic, struggling with existing CRO/consulting staff Identify CMOs, co-manage relationships, set specifications, define characterization studies Manage setbacks, work to define ground-breaking characterization tools Negotiate with FDA Move program into Phase II ready for EU supply.

11 Thank you! If you would like to discuss your particular development needs and how we might help, please don t hesitate to contact me at: nik@clinipace.com