Accomplished pharmaceutical development leader with extensive experience in early-phase drug development. Proven track record of leading assay development and validation labs for pre-clinical and clinical trial samples, and skilled project manager.
To provide expert consulting services to pharma/ biotech companies for early-stage drug development, from pre-clinical studies to IND filing. Our strategic guidance and hands-on support help overcome technical hurdles, navigate complex regulatory landscapes, and drive successful product development. Additionally, we offer support with outsourcing, regulatory document review, and project management.
More than 30 years of experience in leading product development, analytical, bioanalytical, and biologics labs and supervising technical staff in supporting feasibility/discovery, pre-clinical studies, manufacturing, clinical trials, and regulatory submission of small molecule, peptides, and biologics therapeutics.
More than 12 years of experience in Project Management. Skilled in strategic planning, budgeting, outsourcing, and coordinating activities and resources with different functional areas.
Filed 3 INDs with Bristol-Myers Squibb and 1 BLA with NeoPharm, supported development of 16 generic products at Fresenius Kabi, supported development/validation 50+ pre-clinical/clinical project samples at Charles River, SGS, and NanoInk, and delivered efficient project management support for over 30+ projects at Baxter, ThermoFisher, AbbVie, Ovation, and NeoPharm, ensuring timely completion within budget.
Designing, Planning, and Execution of Pre-clinical Studies and IND-enabling programs
Small molecules, peptides, and biologics.
Pre-clinical studies, PK, ADA, Toxixity, and Clinical trial samples
Project Management and Budget Planning and Management
Coordinating Cross-Functional Teams, CMC activities management, etc.
Outsourcing, CRO/CMO Selection and Management
Regulatory Documents Review – IND, NDA, ANDA and BLA
Successfully Filed 3 INDs
Spearheaded Innovative Discovery Programs at Bristol Myers Squibb.
Led Biologics / Bioanalytical Department at Charles River, SGS and NanoInk (Pharma CROs)
Developed/validated Assays for Pre-clinical Studies and Clinical Trials for Pharma/biotech Companies
Established a New GMP Lab at SGS from Scratch
Qualified Equipment, Created SOPs, Hired & Trained Technical Staff, and Reached Profitability within 6 months
Led Analytical Assay Development and Validation Lab at Fresenius Kabi
Supported Manufacturing, Stability testing, FDA submission and Launch of a total of 16 Products
Provided Efficient Project Management Support for Early and Late-stage Products at Baxter, ThermoFisher, AbbVie, Ovation and NeoPharm.
Resulting in Successful Project Completion within Budget and On time
Haris was an excellent colleague and collaborator during our time working together at NanoInk, Inc. He managed teams developing custom biomarker assays using NanoInk’s proprietary Nanoarray assay technology. In addition to driving these projects to successful outcomes, Haris was also the point person for managing our relationships with key pharmaceutical clients. Haris was always a helpful and knowledgeable partner on numerous projects.
Mike Nelson
As our Lab Director Haris and I worked very closely sharing information back and forth regarding our product development progress, feedback from prospects/clients and new areas of interest. He was very responsive and engaging in our work together. He and I traveled to several prospective clients, gave technical presentations and worked trade shows. His ability to clearly present the technical advantages of our technology, answer questions and discussing unique and challenging projects was every Business Development Director’s ideal resource in closing opportunities. He was very professional in his business approach, personal in his client engagement and an expert scientific resource. I recommend Haris to any organization who is searching for a personable and knowledgeable leader for their scientific operations.
Jim jean
I collaborated with Haris Jamil at Bristol Myers Squibb for many years. He was a great colleague and terrific scientist. We worked together on a project that led to numerous publications and a drug, Juxtapid, which was developed and is currently marketed by Aegerion Pharmaceuticals.
John Wetterau
