"Pharma Consulting Company"
Accomplished pharmaceutical development leader with extensive experience in establishing and managing pharmaceutical development and validation labs for pre-clinical and clinical trial samples, and skilled project manager.
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Founder, Antecello Pharma LLC
To provide expert consulting services to pharma and 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, optimize resource allocation, and accelerate the path to successful regulatory submissions.
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.
Provided 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.
Designing, Planning, and Execution of Pre-clinical Studies and IND-enabling programs.
Assay Development and Validation — Pre-clinical studies, PK, ADA, Toxicity, 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.
Spearheaded Innovative Discovery Programs at Bristol-Myers Squibb, driving them to successful IND submission.
Developed and validated Assays for Pre-clinical Studies and Clinical Trial Samples.
Qualified Equipment, Created SOPs, Hired and Trained Technical Staff to support the lab operations.
Supported Manufacturing, Stability testing, FDA submission and Launch of a total of 16 Products.
For Early and Late-stage Products at Baxter, ThermoFisher, AbbVie, Ovation and NeoPharm. Resulting in Successful Project Completion within Budget and On time.
Led the Biologics License Application submission process, navigating complex regulatory requirements.
Haris was instrumental in 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.
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.
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.