Andrei Blasko, Phd, Frsc Email and Phone Number
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Founder of Clearview Pharma Solutions LLC, a consulting company for drug development (small molecules and biologics). Recognized Pharmaceutical Industry leader, expert at both discovering and developing new drugs (small molecules and biologics-mAbs/Fabs, proteins). 25 years of experience inspiring creation of optimal formulations with breakthrough preformulation approaches. Advance drug substance candidates’ strategies, leading discovery teams in profiling and assessing physicochemical properties of the drug candidates, providing feedback to medicinal chemistry on molecular structural liabilities, and facilitating compound transitions to development, including Phase I/II clinical trials and Phase III registration.Member of the Senior Leadership Team at Novartis. Large & small company experience: Roche; Sugen/Pharmacia/Pfizer; Celera; Pain Therapeutics (Cassava Sciences Inc.); and Novartis. Advance drug development innovation, influencing company vision by strengthening research operation, partnering with CEOs, VPs, CROs, and field experts, on cross-disciplinary teams and through independent contributions. Increase shareholders’ values by developing multimillion dollar products that improve patients’ lives, with marketed product successes such as SUTENT®, a leading VEGF inhibitor for renal cell carcinoma.Professional project manager consultant for full cycle of drug discovery and development (small molecules and biologics): Drug substance/product stability, forced degradation protocol, impurity identification, formulation optimization of drug candidates and commercial products; CMC sections for IND and NDA submissions, FDA complete response letters; FDA, EME and ANVISA regulations. ACHIEVEMENTS:• Developed and discovered pharmaceutical drugs; numerous patents (drug discovery, salts and polymorph selection, dissolution, micronization, enzyme processes) and market successes including oncology drug SUTENT®• Led and contributed to key pharmaceutical drug development of 25+ products from lead selection and optimization to late-stage NDA submission; authored CMC Analytical sections of Investigational / New Drug Applications.• Identified degradation products in pharmaceutical formulations and elucidated the reaction mechanisms.• Drove $1M savings by conducting drug discovery programs of 300+ new compounds, supported by patents• Established leadership legacy of next generation teams built with improved performance and increased organizational capabilities
Clearview Pharma Solutions, Llc
View- Website:
- clearviewpharmallc.com
- Employees:
- 1
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Clearview Pharma Solutions, LlcPlano, Tx, Us
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President And CeoClearview Pharma Solutions, Llc May 2021 - PresentClearview Pharma Solutions, LLC (www.clearviewpharmallc.com) offers consulting on full cycle of drug development (small molecules and biologics): Drug substance/product stability, impurity identification, strategies for long-term formulation development of drug candidates and commercial products; IND and NDA submissions, FDA complete response letters, CMC sections on analytical method development, validation/transfer and stability assessment, physicochemical characterization, and structural elucidation of degradation products; Forced degradation study protocol to meet FDA, EME and ANVISA regulations.
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Fast AdvisorCalifornia Life Sciences (Cls) Sep 2019 - Dec 2022South San Francisco, Ca, UsAdvising start-up Pharma/Biotech companies to help some of the most innovative young life science national and international companies FAST-track their way to funding and success. -
Senior Fellow (Sme Physicalorganic/Bioorganic Chemistry)Novartis Aug 2010 - Jul 2018Basel, Baselstadt, ChMember of the Senior Leadership Team. Group Leader and recognized expert in organic chemistry, analytics, pre-formulation, and high-performance team building, charged with resolving $46B Swiss multinational company’s combination respiratory disease drug product stability problems.Specification Committee Chair. Analytical development and tech transfer lead. Direct and lead up to 11 reports, including scientific activities and planning oversight; including formulation, process chemistry, stability studies, device leachables and extractables (PQRI guidelines), and regulatory filing documents support. Report to Head of Inhalation Technical Development, US.Novartis Novel Delivery Technology and Science & Technology networks site representative. Manage innovation activities as core engagement track member, overseeing early novel therapeutic product analytical and preformulation development. Identify impurities and elucidate reaction mechanisms for drug product degradation.• Reduced analytical development cycle from 6 to 2 months: Improved overall data reliability 20%; introduced 2D-LC (first within Novartis) and fast-LC. Led development and validation of 40 analytical methods (small molecules, mAbs/Fabs, and therapeutic proteins)• Brought organization to analytical “gold standard” within 1 year, by creating and building entire analytical development team, recruiting and hiring 4 industry leaders, and elevating development performance capabilities.• Led department to reach the highest level of quality, safety, and efficacy by applying highest scientific standards, using physicochemical properties of API and excipients, introducing new discoveries, and complying with ICH and FDA/EMA regulations. -
Director/Associate Director, Analytical Method DevelopmentCassava Sciences, Inc. (Formerly Pain Therapeutics, Inc.) 2005 - 2010Promoted to Director in Dec. 2005 to lead cross-functional Project Teams in developing novel therapeutics for $250M biopharmaceutical company that invents novel nervous system disorder drugs. Oversaw 12 contract labs’ activities (CRO and CMO), in virtual company environment.For Phase III clinical trials, created, validated, and transferred 15 HPLC analytical methods to CMOs. Co-led full-cycle drug discovery and development project team, concept to final submission. Protected company’s intellectual property by reviewing patent submissions. Coordinated with pre-clinical research and in-vitro/in-vivo toxicity screening; selected top 10 candidates.• Presented all methods and validations for NDA submission with 0 (zero) FDA reviewer observations.• Led Project Team in conducting new API drug discovery with dual CNS binding mode; delivered 300+ new compounds in collaboration with CROs.• Saved $1M in costs by accelerating drug discovery from 3 years to 1 and selecting most appropriate CRO.• Reduced development timeline 50% (1 year to 6 months) by leading process chemistry optimization and re-engineering scale-up protocols for GLP manufacturing of lead and back-up drug candidate.• Published patents; 7 of 10 granted.
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Staff Scientist - Pharmaceutical DevelopmentCelera Corporation 2003 - 2005 -
Senior Scientist - Formulation And Process ChemistryPfizer/Pharmacia/Sugen 2001 - 2003New York, New York, Us -
Research Scientist - Cmc DevelopmentRoche Bioscience 1997 - 2001Switzerland 🇨🇭 , Ch
Andrei Blasko, Phd, Frsc Skills
Andrei Blasko, Phd, Frsc Education Details
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Uc Santa BarbaraPhysical-Organic/Bioorganic Chemistry -
Gheorghe Asachi Technical University Of IașiChemical Engineering With Specialization In Enzyme Kinetics And Processes
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Gheorghe Asachi Technical University Of IașiChemical Engineering
Frequently Asked Questions about Andrei Blasko, Phd, Frsc
What company does Andrei Blasko, Phd, Frsc work for?
Andrei Blasko, Phd, Frsc works for Clearview Pharma Solutions, Llc
What is Andrei Blasko, Phd, Frsc's role at the current company?
Andrei Blasko, Phd, Frsc's current role is President and CEO.
What is Andrei Blasko, Phd, Frsc's email address?
Andrei Blasko, Phd, Frsc's email address is ab****@****ble.com
What schools did Andrei Blasko, Phd, Frsc attend?
Andrei Blasko, Phd, Frsc attended Uc Santa Barbara, Gheorghe Asachi Technical University Of Iași, Gheorghe Asachi Technical University Of Iași.
What are some of Andrei Blasko, Phd, Frsc's interests?
Andrei Blasko, Phd, Frsc has interest in Chemical Biology, Education, Science And Technology, Drug Discovery And Drug Development, Preformulation, Analytical, Formulation, Health.
What skills is Andrei Blasko, Phd, Frsc known for?
Andrei Blasko, Phd, Frsc has skills like Drug Discovery, Pharmaceutical Industry, Drug Development, Validation, Gmp, Formulation, Glp, Biotechnology, Chemistry, Analytical Chemistry, Chemical Biology, Intellectual Property.
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