Director Research Biology @ Responsible for all Pre-Clinical Activities at NEKTAR, including M&S, PKPD, Lead Optimization, training and mentoring staff, and providing strategic PK guidance. From May 2012 to Present (3 years 8 months) President & CEO @ Founder of PK/ADME Consulting, LLC. The consulting firm provides services in the field of pre-clinical and clinical pharmacokinetic to
Director Research Biology @ Responsible for all Pre-Clinical Activities at NEKTAR, including M&S, PKPD, Lead Optimization, training and mentoring staff, and providing strategic PK guidance. From May 2012 to Present (3 years 8 months) President & CEO @ Founder of PK/ADME Consulting, LLC. The consulting firm provides services in the field of pre-clinical and clinical pharmacokinetic to VC, law and virtual firms, start-up's, mid and large pharmaceutical / biotech companies as well as CRO's.
Recent accomplishments include but are not limited to:
1) Analysis of PK of Ab and generation of reports for expedited regulatory filings
2) Expert witness in patent litigation
3) Optimized TK design by means of M&S which resulted in improved safety margin
4) Proposed screening paradigm during LO was endorsed
5) Sci Advisor at SPARK
6) Provided training leading to increased efficiency From May 2010 to June 2012 (2 years 2 months) Assoc. Dir DMPK @ Scientist with a focus on applying advanced techniques, accelerating and reducing cost of drug discovery. Recognized for comprehensive data analysis and interpretation to project teams. Known as being effective and task oriented. Renowned for ”excellent team working skills”.
1. Advanced several compounds into human clinical trials through multidimensional PK optimization and integrated data analysis.
2. Supplied pharmacokinetic sections to four IND’s and/or CTA’s.
3. Proofed the utility of PBPK for predicting human PK of pro-drugs.
4. Contributed to toxicology and first in man studies by providing dose projections. From August 2006 to March 2010 (3 years 8 months) Dir. DMPK @ Accomplishments:
1) Advanced 2 compounds from lead identification into IND enabling studies.
2) Advanced 1 compound into Phase 1.
3) Developed formulations for PKPD studies.
4) Expanded DMPK department from two to six FTE’s and doubled in vitro and in vivo profiling capacity to 16 compounds per week. From May 2005 to August 2006 (1 year 4 months) Assoc. Dir. DMPK @ Accomplishments:
1) Established ADME group
2) Advanced 1 compound from lead identification into Phase 2. From September 2002 to May 2005 (2 years 9 months) Sr. Scientist @ Accomplishments:
1. Identified compounds with good absorption potential.
2. Identified P-gp substrates.
3. Used bDNA assay to assess P450 induction.
4. Established cell toxicity assays.
5. Organized internal Scientific Symposium Day. From January 2000 to September 2002 (2 years 9 months) Sr. Scientist @ Created and integrated a diverse range of in vitro assays to assess permeability, P-glycoprotein (P-gp) transporter interactions, hepatocyte toxicity, CYP induction and inhibition. Hired, trained, and mentored two scientists, which facilitated the expansion of the in vitro PK group. Designed, developed, and implemented a fully equipped hot laboratory and performed and analyzed/interpreted mass balance studies.
Career From January 2000 to January 2002 (2 years 1 month) Scientist @ 1. Discovered that proteins can permeate and cross human skin intact.
2. Demonstrated flux of biologics and small molecules across human colonic tissue using Ussing Chamber devices.
3. Mentored and served as advisor for two Ph.D. (ETH Zurich, Switzerland) and one M.S. (Univ. Oxford, MS) student. One Ph. D. project was awarded a prestigious scientific price in Germany.
4. Instituted metabolic stability and permeability assessments for newly founded small molecule discovery DMPK. From June 1991 to January 2000 (8 years 8 months) Post-Doc @ 1. Demonstrated flux of large molecules across intestinal tissues.
2. Enabled evaluation of absorption limitations of drug candidates by pioneering in vitro absorption systems. From September 1989 to May 1991 (1 year 9 months) Teaching Assistant @ 1) Thought principles of solid dosage formulations.
2) Demonstrated encapsulation of Interferon into liposomes.
3) Supervised and mentored graduate students. From October 1987 to August 1989 (1 year 11 months) Visiting Scientist @ 1) Incorporated reovirus sigma 1 protein into liposomes.
2) Established in vitro binding of sigma 1 coated liposomes to M cells on Peyer's patches. From August 1988 to October 1988 (3 months)
Dr. Sc. Nat, Drug Delivery @ ETH Zurich From 1982 to 1986 Werner Rubas is skilled in: Lead Optimization, Drug Discovery, DMPK, IND, ADME, Pharmacokinetics, Pharmacodynamics, Regulatory Submissions, In Vivo, Protocol Development, In Vitro, Lead Change, Assay Development, Clinical Development, Protocol
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