ASHUTOSH PUDAGE

A Highly skilled and results-oriented professional with solid academic background, holding a Doctorate degree in Chemistry with 25+ years of cross-functional experience in Pharmaceutical Drug Research and Development. I have rich experience in managing complex product development, pharmacokinetics, pharmaceutical analysis, early phase pre-clinical development, Phase I Clinical Trails & BA/BE studies. In last 16 years, I have played pivotal role in setting up Bioanalytical operation for CRO, also been responsible in parallel for Business Development & Project Operations as Unit Co-Head. I am viewed as a strong troubleshooter, successful (result-oriented leader) in intense and demanding environments, providing decisive team leadership qualities, directing multiple projects effectively. I have played key role in planning and cracking high value multiple marketing authorizations in the US, EU for some of clients. Strong Believer in systems and process and has knack for setting up systems to defend regulatory needs. I have numerous publications and academic accreditations to my credit and have successfully faced multiple Regulatory Audits from global regulatory agencies including USFDA and EMA, WHO.

Successfully leading & facing 100+ system audits mostly from USFDA, WHO, EU, ANIVSA. Meeting regulatory agencies, presenting & defending client’s project specific cases studies for authorization. Done multiple meetings with ANVIZA, WHO and presented project protocols and secured approvals. Conceptualized, designed & set up a state-of-the-art bioanalytical laboratory for clinical development (BE/Phase I/PK) projects and Biosimilars labs for large molecules. Managing BE Business Unit of CRO (2014 -2018 ). Led the team of Business manager to rope in few of the most Marquee clients to name few Teva, Sandoz, Endo, Dr. Reddy’s Lab, Amneal to Accutest. Played a pivotal role in advancing lead NCEs for COPD and Diabetes during my assignment with Glenmark R&D. Both molecules subsequently out licensed by Glenmark to Forest Labs and Merck in multimillion dollar deals in 2004 and 2008, respectively.

A Highly skilled and results-oriented professional with solid academic background, holding a Doctorate degree in Chemistry with 25+ years of cross-functional experience in Pharmaceutical Drug Research and Development. I have rich experience in managing complex product development, pharmacokinetics, pharmaceutical analysis, early phase pre-clinical development, Phase I Clinical Trails & BA/BE studies. In last 16 years, I have played pivotal role in setting up Bioanalytical operation for CRO, also been responsible in parallel for Business Development & Project Operations as Unit Co-Head. I am viewed as a strong troubleshooter, successful (result-oriented leader) in intense and demanding environments, providing decisive team leadership qualities, directing multiple projects effectively. I have played key role in planning and cracking high value multiple marketing authorizations in the US, EU for some of clients. Strong Believer in systems and process and has knack for setting up systems to defend regulatory needs. I have numerous publications and academic accreditations to my credit and have successfully faced multiple Regulatory Audits from global regulatory agencies including USFDA and EMA, WHO.

• A simple, selective, and rapid validated method for estimation of anastrazole in human plasma by liquid chromatography-tandem mass spectrometry and its application to bioequivalence study., Biomed Chromatogr, Jangid AG, Pudage AM, Joshi SS, Pabrekar PN, Tale RH, Vaidya VV, 2010, 10.1002/bmc.1354, 19908206
• Validated LC-MS/MS method for determination of Alverine and one of its hydroxy metabolites in human plasma along with its application to a bioequivalence study., J Chromatogr B Analyt Technol Biomed Life Sci, Gomes NA, Laud A, Pudage A, Joshi SS, Vaidya VV, Tandel JA, 2009, 10.1016/j.jchromb.2008.12.013, 19110477
• Development and validation of UPLC tandem mass spectrometry assay for separation of a phase II metabolite of ramipril using actual study samples and its application to a bioequivalence study., Biomed Chromatogr, Pudage A, Kamat S, 2011, 10.1002/bmc.1500, 20812207
• Liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for simultaneous determination of tenofovir and emtricitabine in human plasma and its application to a bioequivalence study., J Pharm Biomed Anal, Gomes NA, Vaidya VV, Pudage A, Joshi SS, Parekh SA, 2008, 10.1016/j.jpba.2008.07.022, 18783908
• Application of UPLC-MS/MS for separation and quantification of 3α-Hydroxy Tibolone and comparative bioavailability of two Tibolone formulations in healthy volunteers., J Pharm Anal, Shinde VP, Pudage A, Jangid A, Mistri H, Patel PK, 2013, 10.1016/j.jpha.2013.02.006, 29403827
• High throughput LC-MS/MS method for simultaneous quantification of lamivudine, stavudine and nevirapine in human plasma., J Chromatogr B Analyt Technol Biomed Life Sci, Mistri HN, Jangid AG, Pudage A, Gomes N, Sanyal M, Shrivastav P, 2007, 10.1016/j.jchromb.2007.03.047, 17481969
• Rapid and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the determination of clonidine in human plasma., J Chromatogr B Analyt Technol Biomed Life Sci, Parekh SA, Pudage A, Joshi SS, Vaidya VV, Gomes NA, 2008, 10.1016/j.jchromb.2008.03.030, 18440879
• Simultaneous determination of hydrochlorothiazide, quinapril and quinaprilat in human plasma by liquid chromatography-tandem mass spectrometry., J Chromatogr B Analyt Technol Biomed Life Sci, Parekh SA, Pudage A, Joshi SS, Vaidya VV, Gomes NA, Kamat SS, 2008, 10.1016/j.jchromb.2008.07.046, 18723407
• Highly sensitive and rapid LC-ESI-MS/MS method for the simultaneous quantification of uroselective alpha1-blocker, alfuzosin and an antimuscarinic agent, solifenacin in human plasma., J Chromatogr B Analyt Technol Biomed Life Sci, Mistri HN, Jangid AG, Pudage A, Rathod DM, Shrivastav PS, 2008, 10.1016/j.jchromb.2008.10.050, 19010093
• HPLC-ESI-MS/MS validated method for simultaneous quantification of zopiclone and its metabolites, N-desmethyl zopiclone and zopiclone-N-oxide in human plasma., J Chromatogr B Analyt Technol Biomed Life Sci, Mistri HN, Jangid AG, Pudage A, Shrivastav P, 2008, 10.1016/j.jchromb.2008.02.004, 18313371