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© 2021 Luckwel Pharmaceuticals Inc. All rights reserved.
Design and development by RainCastle Communications.
Mark Corrao is appointed as our Chief Financial Officer in Sept, 2021. Prior to joining the Company, Mr. Corrao served as the CFO of Neuropathix Inc.(OTC: NPTX). beginning in January 2012. Mr. Corrao currently serves as the Managing Director of The CFO Squad LLC, a CFO and accounting consulting business, and as CFO of Generex Biotechnology Corporation, Inc. (OTC: GNBT)beginning in January 2017. Mr. Corrao was formerly a founder and CFO of Strikeforce Technologies, Inc.(OTC: SFOR), a publicly traded software development and services company specializing in the development of a suite of integrated computer network security products. In addition to the ten years of his service at Strikeforce, Mr. Corrao has spent numerous years in the public accounting arena specializing in certified auditing, SEC accounting, corporate taxation and financial. Mr. Corrao’s background also includes numerous years on Wall Street with Merrill Lynch, Spear Leeds & Kellogg and Greenfield Arbitrage Partners. While on Wall Street, Mr. Corrao was involved in several initial public offerings and has been a guiding influence in several startup companies. Prior to joining StrikeForce, he was the Director of Sales at Applied Digital Solutions from December 2000 through December 2001. Mr. Corrao was the Vice President of Sales at Advanced Communications Sciences from March 1997 through December 2000. Mr. Corrao has a B.S. in Accounting from The City University of New York. Mr. Corrao’s business and public company financial reporting experience is invaluable to the board of directors.
Mr. Keith Bentlage, Acting Vice President, Head of Program and Alliance Management
Keith joined as Acting vice president, Head of Program and Alliance Management;
Keith most recently served as President at Simurgh Consulting, where he was responsible for strategy, clinical development, regulatory affairs, business development, and portfolio and alliance management consulting. He led drug development teams, driving collaboration among employees, consultants, academic experts, vendors and partners. Prior to Simurgh Consulting, Keith held a variety of program and alliance leadership positions at Shire, BMS, Merck, Emergent Biosolutions, and Pfizer. In these roles, Keith led a range of leading drug development programs including BMS’ Early Stage (Myostatin ®and Late Stage (Baraclude®, Opdivo®) & Merck’s Lotrim®, Afrin PureSea®,Pfizer’s Aricept®, Rebif®, Relpax® and Zoloft®.
Keith earned master’s degrees in biotechnology from Johns Hopkins University, an MBA degree in Washington University (St. Louis), and his undergraduate degree in Biochemistry at the University of Missouri.
Ph.D. & MBA, CSO
Sharon Ayd, Ph.D., MBA, joins Luckwel as Acting Chief Science officer.
Dr. Ayd is the former Global Vice President, Innovation & Development of Fresenius-Kabi (DAX: FRE) a $7B global healthcare company based in Frankfurt, Germany. Previously, Sharon was Global Vice President, Research & Development of Hospira/Pfizer (NYSE: HSP) a $4.5B provider of pharmaceuticals and medical devices.
Dr. Ayd also has experience in venture-backed biopharmaceutical companies. She was a founding member of Transcend Therapeutics (NASDAQ: TSND), Chief Operations Officer at Advanced Life Sciences (NASDAQ: ADLS) and Chief Science Officer at Pinnacle Biologics (private).
Dr. Ayd’s previous international experience included orchestrating international submissions simultaneously to multiple regulatory agencies such as FDA (US), EMA (EU), MHRA (UK), Health Canada (Canada) and TGA (Australia). She is recognized for her contributions resulting in ~100 global drug approvals (A/NDA, sNDA, 505(b)(2)).
Dr. Ayd obtained her Ph.D in Pharmaceutics from the University of Illinois; MBA in Marketing and Finance from Lewis University Graduate School of Management. She is an Adjunct Professor of Northwestern Pritzker School of Law and University of Wisconsin-Madison, School of Pharmacy.
Ph.D. Acting Chief Manufacturing Officer
Dr. John Amedio serves as Acting Chief manufacturing officer at Luckwel.
Dr. Amedio’s experience spans more than 30 years in the pharmaceutical industry. Prior to joining Luckwel, Dr. Amedio most recently served as Sr. VP of Technical Operations at ArQule (wholly subsidiary of Merck & Co.), where he was responsible for global manufacturing operations and drug supply.
Dr. Amedio has worked extensively in the pharmaceutical industry, delivering profitable and patented drug substance and drug product from pre-clinical through commercial phases. He has authored/co-authored CMC sections for numerous regulatory filings (INDs, IMPDs, Amendments, Annual Updates, and NDAs). As Principal at Amedio CMC Consulting, he specialized in providing strategy for the technical and regulatory CMC development processes for biotechnology and pharmaceutical companies working to bring drugs through to market.
Previously Dr. Amedio served in several manufacturing guidance leadership roles, including positions at Samus Therapeutics, Seaside Therapeutics, ZIOPHARM Oncology, EPIX Pharmaceuticals and Sandoz Research Institute.
He holds a Ph.D. in Organic Chemistry from the University of Delaware and earned his B.S. in Chemistry from Manhattan College. Dr. Amedio completed his post-doctoral research in Natural Product Synthesis and Organic Chemistry at Oregon State University.
SVP-regulatory affair
Priya Jambhekar has over twenty years of experience in the areas of product development, product safety, quality assurance, quality compliance, clinical operations, supply chain management and US and international regulatory affairs for small and large molecules, medical devices and combination products. She has extensive experience in establishing regulatory strategy and electronic publishing for Chemistry, Manufacturing Controls, Clinical and Nonclinical development for First in the class products and operational excellence for optimal success during all aspects of pre- and post- approval phases of new drugs, devices and biologics development and marketing of products covering various therapeutic areas.
Proven experience in handling FDA pre-approval inspections and product plant compliance,Priya has managed over 250 NDA / IND / ANDA / PMA / 510(k) projects in various stages of development for registration around the globe (US, EU, Japan, Canada, Asia, Australia, South and Latin America; Prior to consulting, Priya has held positions such as Global Sr. VP of Regulatory & Quality at Paramount Biosciences, Global VP at Ethicon, a J&J company and Alkermes. Some of the other positions include Baxter ACC as regulatory head and Bristol-Myers Squibb. Priya was a part of the management team at CardioVations & GyneCare, J&J companies and Alkermes.
Priya holds a M.Sc. in Organic & Biochemistry and holds M.S. in Pharmacy from St. John’s University. She is also certified by Regulatory Affairs Professional Society and NJ Pharmaceutical Quality Control and Assurance Society.
Founder & CEO B.A.
Kingrich Lee is the founder of Luckwel Pharmaceuticals Inc. and has more than 20 years’ experience in pharmaceutical operations. Prior to Luckwel Pharma, Kingrich was director of Luckycom Pharma for UK/India/Singapore/Hong Kong operations. Earlier, he was marketing manager for Holleykin Pharma for the Asian and American markets for antimalarial drug Artekin®. Before Holleykin, he was marketing manager for Star Lake Biosciences Ltd, where he developed markets for around 20 countries and facilitated Star Lake becoming the Roche HCV drug COPEGUS®’ (ribavirin) API supplier with FDA approval.
Kingrich received his merge and acquisition diploma in HKU school, and undergraduate degree from Guangdong University of Finance and Economics.
SVP-QA/Qc
Richard has 34 years of experience in the pharmaceutical, biotech and medical device industries with expertise in Quality Assurance for non-clinical development, early phase pharmaceutical manufacturing, device manufacturing, quality systems and quality management.
Richard has handled thirty (30) FDA inspections as both a participant and lead. He also has experience with other USA agencies (EPA, USDA etc.) and foreign regulations (OECD, EMA etc.). Richard is a long-time member of SQA and a Fellow within the British Society of Research Quality Assurance (RQA). Richard most recently served as President at RLS consulting, where he Provide Quality Assurance services to the Pharmaceutical, Biotechnology, Medical Device and Nutraceutical industry.
Prior to consulting, Richard has worked as corporate director-quality compliance in Charles River Laboratories, Primedica, and Director-QA at Biodynamic. Richard achieved his B.S. Biology at Mount St. Mary’s University
Ph.D.- Pharmacology and Toxicology; serves as SVP-Preclinical safety
Dr. Steele’s experience spans 28 years in the pharmaceutical industry. Dr. Steele most recently serves as President at Non-clinical Safety Solution, where he specializes in providing strategy and guidance for the Pharmaceutical and Biotechnology industries in the nonclinical safety evaluation of novel small molecule and biological therapeutics in multiple therapeutic areas. Dr Steele has authored or co-authored the nonclinical sections of numerous successful regulatory applications, and peer-reviewed publications.
Prior to consulting, Dr. Steele served in several non-clinical safety guidance leadership roles, including Head of Toxicology at Ariad Pharmaceuticals, Associate Vice President (Toxicology) at ImClone System (subsidiary of Eli Lilly), and Head of Nonclinical Safety Science and Strategy at Hoffmann-La Roche for ten years; Before that, Dr. Steele has worked as pharmacologist and toxicologist in FDA for three years. Dr. Steele obtained his Ph.D. in Pharmacology and Toxicology from Purdue University, and completed his postal doctoral research in physiology at the University of Maryland School of Medicine, and postal doctoral research in neurology in Johns Hopkins University.
M.D&FACP; Acting Chief Medical officer
Dr. Michael Silverman serves as acting chief medical officer.
Dr.Silverman ’s experience spans more than 30 years in the pharmaceutical industry. Dr. Silverman founded and serves as President at Biostrategic Consulting, where he specializes in providing strategy for pharmaceutical and biotechnology clinical development strategy and management, especially for development-stage companies, at the senior management level. Projects include IND planning and preparation; FDA interactions; Phase 1, Phase 2, first-in-man, and proof-of principle clinical trials; small molecules, biotechnology products, and vaccines /immunotherapeutics.
Prior to founding his own consulting firm, Dr. Silverman served in several clinical guidance leadership roles, including positions at Biopure, Telor Ophthalmic, Sandoz Research institute, Sterling Winthrop research Institute. Before that, Dr. Silverman was in the private practice of rheumatology.
Dr. Silverman obtained his M.D. in Medicine from the University of Chicago, the Pritzker School of Medicine. Dr. Silverman is Fellow of American College of Physicians (FACP), and a member of the Massachusetts Medical Society.
CPA, interim CFO
Tom McGauley brings more than 20 years of experience in financial strategy, accounting, and operations to Luckwel Pharmaceuticals. As a director at CBIZ & MHM he regularly advises public and private life science companies on financial and accounting issues. He has served as the chief financial officer, director of financial reporting, and consultant CFO and advisor to life science and biotechnology companies, ranging from start-ups to publicly traded companies, including Galectin Therapeutics (Nasdaq:GALT) and deCODE genetics, as well as numerous private companies.
Tom has played a key role in several initial public offerings, convertible debt offerings, and an uplisting of a company to the Nasdaq. Prior to his financial career Tom served in the U.S. Army as a captain and company commander. Tom holds a B.S. from Stonehill College and is a licensed CPA in Massachusetts.