Manufacturing Product Development
Resume:
RÉSUMÉ
Bill Ristevski
Oakville, Ontario, Canada
L6M 3P1
Business: 905-***-****
Mobile: 905-***-****
E-mail: ********@*****.***
PROFILE
Summary
Over 15+ years of hands-on experience in pharmaceutical and biotechnology industry with a track record of success in development of therapeutic, diagnostic and medical device products.
Excels at i) building and leading highly motivated and successful scientific/ manufacturing groups with emphasis on managing product development processes, of API’s, pharmaceutical/ biological drug products, drug delivery systems, and ii) pre-formulation, formulation, manufacturing (CMC), process design and optimization, technology transfer, regulatory and drug product launch processes (Solaraze).
PROFESSIONAL EXPERIENCE
REMETAR Inc., Oakville Canada 2009 - Present
Founder
Remetar Inc., as Startup Company is engaged in licensing and developing of new drug product candidates from an early through preclinical to multiphase stage.
Present activities:
Remetar Inc as a sole owner of the IP is looking for a seed capital for the development of a new drug delivery system (solid dosage) through the oral portal targeting lipophilic molecules. This invention relates to a new composition of drug delivery system for improving the absorption, penetration, stimulating chylomicrons formation and consequently the improved bioavailability of orally administered lipophilic drugs via lymphatic transport system. The patent application is ready to be submitted to the patent offices.
A negotiation of licensing of a new technology for treatment of AMD by repurposing of an old molecule is in process. The development of a new IP for this technology is in its completion and initial animal studies with new formulation for efficacy are in advancement.
Achievements: The Company successfully completed licensing of two early stage projects:
‘A new series of antagonist peptides targeting IL-1 and SYK receptors for regulation of inflammation in low grade inflammatory diseases’
‘Novel anti-angiogenic small molecule for regulation of Choroidal Neovascularisation’
HSN (AMRIC Institute), Sudbury Canada 2012 -2014
VP Product Development
The Advanced Medical Research Institute of Canada (AMRIC) supports research at the interface of basic and clinical research focusing on developing new and
safer medicines as human vaccines for chronic disease indications.
Achievements:
Positively negotiated licensing and technology transfer of HEK293 cells as platform cell line for recombinant protein production.
Successfully completed the negotiation of the design of new vaccine manufacturing facilities, with third parties (architects and builders)
LOB ORDEINS Inc., Toronto Canada 2008 – 2009
Co-founder, VP Business Development& CSO
LOB Ordeins Inc (formerly LOB Pharma) biopharmaceutical Startup Company located in Toronto engaged in licensing and developing of new drug delivery technologies through GIT.
Achievements:
Successfully identified and negotiated licensing of few new drug delivery platform for delivery of small (kinase inhibitor) and big molecules (insulin) through GIT.
VASOGEN Inc., Mississauga Canada 2004 - 2008
Director, Pharmaceutical Manufacturing
Vasogen Inc. as a medical device/pharmaceutical company was engaged in research and development of therapies (medical device therapy and drug product) that target the damaging inflammation associated with cardiovascular and neurodegenerative disorders (Alzheimer, Parkinson, Huntington).
As Pharmaceutical Manufacturing and R&D Director with an operating budget of $6.0MM and 10 staff, responsibilities encompassed:
Organising 510k, PMA/PDP and CE submissions
Design of new drug product formulations (nano-size particles) and optimization of manufacturing process,
Manufacturing of APS’s using freeze drying/lyophilisation process
Scaling up,
Technology transfer,
Manufacture and release of preclinical and clinical trial materials,
Review and approval of IND (CMC) applications,
Coordination of Failure Investigations and Assessment of CAPAs/Changes,
Performing Audits,
Overseeing Quality Systems and ensuring sustained compliance in accordance with cGMP, company policy, and regulatory requirements,
Dealing with FDA and Health Canada
Lean manufacturing & Six sigma
Licensing and evaluating of new drug candidates,
Achievements:
Developed and implemented manufacturing strategies
Successfully optimized the new patented liposomal formulation VP025 (nano-size particles)
Developed five new patent applications
Reviewed and approved numerous preclinical and clinical GMP batch records
Manufactured and released preclinical, Phase 1 and Phase 2, GMP clinical trial materials
Performed the scale-up and tech transfer to commercial CMO
Delivered CMC Quality Documents
Effectively negotiated manufacturing strategies with FDA and Health Canada
Performed numerous audits on external contractors
DELEX Therapeutics Inc. Mississauga Canada 2001 - 2004
Executive Director – Product Development & Pharmaceutical Manufacturing,
DELEX Therapeutics Inc. was an emerging drug delivery company using liposomes as drug carriers. As a senior Manager/Director with an operating budget of $8.0MM/year and 15 staff, responsibilities encompassed design and set up of R&D, analytical, stability laboratory and manufacturing pilot plant for drug product and optimization of scaled up manufacturing process. In addition the responsibilities included development of new formulations for preclinical testing and manufacturing and release of clinical trial material (cGMP CT) for Phase1, and Phase2. All related activities regarding manufacturing outsourcing as; Identifying, evaluating and selecting CMOs for manufacturing of drug substance and finish drug product, quality agreements, budgeting, releasing of CT materials, CMC filing, negotiating contracts, changes and amendments with external parties, tech transfer and FDA negotiation was performed under my direct supervision
Achievements:
The technology was successfully out licensed to YM Biosciences Inc. Toronto in 2006 and sold to Gilead in 2012.
EDUCATION
B.Sc., Chemical Engineering + B.Sc., Inorganic Chemistry, University of Ss ‘Cyril and Methodius’, Skopje Macedonia (former Yugoslavia)
Kings College, University of London UK 1999, PhD in Pharmaceutics (PhD work completed – 60%)
Area of study: ’Natural biopolymers as drug carriers’, under the mentorship of professor, Dr. Marc Brown. Left early for financial and visa reasons
2001 Mixing fluid technology course at University of Toronto
2013 Project Manager Course at Humber College
PROFESSIONAL MEMBERSHIP
2012 ISO (SCC) – Standard Council Committee Member
(Aseptic processing-sterile manufacturing of health care products – working group)
SCIENTIFIC ACCOMPLISHMENTS
Principal Author of patent: ‘Stable Liposome Compositions Comprising Lipophilic Amine Containing Pharmaceutical Agents’ granted 2007
LANGUAGES
English, Macedonian, Serbo-Croatian, Bulgarian and Russian
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