While CMO's have traditionally been used to play a critical role in the manufacture of drug product, Althea has evolved beyond being a role player to a strategic development and manufacturing partner that can drive added value to a client's product or product candidate.
SHABBIR ANIK, PH.D., MBA
President and Chief Executive Officer
Dr. Anik brings over thirty years of experience in the biotech, pharmaceutical and contract services industry, with specific expertise in aspects of drug development, pharmaceutical technology, operations management, and business and organizational leadership. He began his career at Syntex, where he led a multidisciplinary management team (CMC, Clinical, Regulatory & Commercial) that had responsibility for global product development of line extensions and new indications for marketing products in the Rx, OTC and Generic businesses. He also served as Senior Director of Pharmaceutical Development and Operations for the biotechnology company Neurex, where he built a Pharmaceutical R&D and Operations outsourcing strategy in preparation for its first product registration and launch. Most recently, Dr. Anik served at Patheon, Inc., where he was responsible for building and managing Patheon’s global Pharmaceutical Development Services (PDS) business. Dr. Anik has been credited with 5 issued patents, holds a bac helor of Pharmacy from the University of Bombay’s Institute of Chemical Technology,a Ph.D. in Pharmaceutical Sciences from University of Wisconsin and an MBA from Santa Clara University.
BILL KACHIOFF
Vice President of Finance and Chief Financial Officer
Mr. Kachioff serves as Vice President of Finance and Chief Financial Officer; he has overall responsibility for Althea’s financial affairs. Additionally, he has responsibility for our Information Technology function. Mr. Kachioff is experienced in corporate finance, investor relations, corporate governance and manufacturing accounting and systems. He has twenty years of life science industry experience, having most recently served as CFO Partner with Tatum LLC, a national Executive Services firm focused on the Office of the CFO where he served a variety of life science industry clients in senior financial management roles. Prior to joining Tatum, Mr. Kachioff was CFO at MicroIslet, a publicly traded biotech company developing cell transplant therapies for insulin dependent diabetes. He was Director of Finance at Cutera where he helped prepare the Company for the commercial launch of its first product and its Initial Public Offering. Mr. Kachioff has also served in a variety of financial management roles at Coulter Pharmaceutical, Vivus and Abbott Labs. He began his professional career as an auditor with Deloitte & Touche LLP. Mr. Kachioff has a B.S. in Management from the State University of New York at Buffalo and is a member of the American Institute of Certified Public Accountants and the Association of Bioscience Financial Officers.
ALAN C. HERMAN, PH.D.
Vice President of Product Development & Chief Scientific Officer
Dr. Herman has over 30 years in the biopharmaceutical industry. He has been a pioneer in the biotechnology field beginning with Heptavax development while at Merck. From Merck, Dr. Herman moved to Genentech where he was actively involved with the development of several early bio-tech products while in the Process Development Department and, later, in Pharmaceutical R&D. He eventually went to Amgen where he served as Director of Analytical Research and Development. His department was responsible for the development of all protein analytical assays as well as product characterization. Following Amgen, Dr. Herman was Senior Director of Quality Control at Tercica. Most recently, Dr. Herman was the founder and president of WindRose Analytica, Inc., a contract analytical laboratory specializing in protein analysis and characterization. Dr. Herman has been involved in the establishment of the specified biologics concept since its inception and is often invited to speak on this and related topics at international meetings. He received his Ph.D. in protein chemistry from the microbiology department at Duke University Medical Center and remained at Duke for his post-doctoral work studying RNA tumor viruses.
CHRIS DUFFY
Vice President of Operations
Mr. Duffy serves as a Corporate VP and has line management responsibility for all contract manufacturing divisions including the Biologics Manufacturing group and the Fill & Finish operations. He has over eighteen years of experience managing the operation of clinical research and manufacturing laboratories for complex biological products, gene-based medicines, immunotherapies and vaccines. From 1988 to 2000 he was a Senior Manager at The Immune Response Corporation where he managed the operation of a biosafety level III laboratory conducting Phase III clinical research. He was also responsible for clinical research and manufacturing activities associated with the company's cancer vaccine products including IND submissions, protocol development, and data evaluation of pre-clinical and Phase I clinical trials. Mr. Duffy has broad experience in all phases of biologics manufacturing with extensive experience in the manufacturing of bacterial-based recombinant protein therapeutics, vaccines, and combination products.
E.J. BRANDRETH
Vice President of Quality and Regulatory
Mr. Brandreth brings over twenty years of experience in the regulatory and quality assurance fields for the biotechnology and pharmaceutical industries. Prior to joining Althea Technologies he was Vice President of Quality at Favrille, Inc., where he had oversight of QC, QA, Validation and Metrology. He has managed the validation of 11 biotech facilities over the past 17 years, and led the Process Validation Programs for five CBER/EMEA product launches. Previous to Favrille, Mr. Brandreth was Senior Director of QA at BioMarin Pharmaceuticals, Inc. where he supported a variety of clinical and the launch of two commercial products. He held management positions in QA, Validation and Regulatory Affairs at IDEC Pharmaceuticals from 1992-1999, where he assisted in the development and launch of Zevalin® and Rituxan®, CBER’s first approved monoclonal antibody for cancer. He is an author of PDA TR 42, Process Validation of Protein Manufacturing, and is the Co-Chair of PDA TR 14, Validation of Chromatography Based Systems. He holds a BS in Biology and a Masters in Business Administration and was a Director for 10 years and President of ISPE, San Diego Chapter.
biotech and pharmaceutical companies from pre-clinical development through commercial supply.
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