Althea Technologies - Corporate Management Team - Althea Founded by Magda Marquet & François Ferré as an Innovative Pharmaceutical Contract Manufacturer

Althea offers cGMP plasmid production, protein production, formulation and filling services. Plasmid DNA and protein production are offered using both Althea’s industry-leading manufacturing process as well as client developed processes. A range of options are available for formulation and filling services ranging from semi- automated to fully- automated processes for vials and syringes. Althea is focused on offering highly responsive customer service, flexible scheduling, and rapid turnaround times to meet the requirements of both early stage clinical programs and commercial programs alike.

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Corporate

Dr. Ferré is a founder, co-President and co-Chief Executive Officer of Althea Technologies, Inc, a San Diego company that provides services and technologies to streamline drug development. He has over twenty years of experience in cancer research and HIV clinical development. Dr. Ferré has held management positions at Cytometrics and The Immune Response Corporation. Dr. Ferré is a leader in gene quantification and biomarker development with over fifteen years of experience in the field. He has published several authoritative reviews on the topic of gene quantification, co-edited a bestseller book on PCR with Dr. Kary Mullis and Dr. Richard Gibbs, and edited a book on the topic of gene quantification. Dr. Ferré received his Ph.D. in Molecular Oncology from the Pasteur Institute in Lille, France and did his post-doctoral training at the University of California, San Diego. Dr. Ferré was the winner of the 2005 E&Y Entrepreneur of the Year award in the Life Sciences category.

Dr. Marquet is a founder, co-President and co-Chief Executive Officer of Althea Technologies, Inc., a San Diego company that provides services and technologies to streamline drug development. Dr. Marquet has over twenty years of experience in the biotechnology industry in the United States and Europe. She was formerly Executive Director of Pharmaceutical Development at Vical Incorporated, where she patented several novel methods for the production of clinical grade DNA for use in gene therapy and DNA vaccines. Prior to joining Vical, Dr. Marquet held management positions at Amylin Pharmaceuticals, Protein Polymer Technologies, Syntro Corporation and Transgene. Dr. Marquet is a member of the board of Directors of BIOCOM and UCSD Athena. Dr. Marquet holds a Ph.D in Biochemical Engineering from the University of Toulouse/INSA, France. Dr. Marquet has received numerous prizes throughout her career. She was the winner of the 2005 E&Y Entrepreneur of the Year award in the Life Sciences category, the 2005 UCSD Athena Pinnacle award in Technology and the 2004 Women Who Mean Business award from the San Diego Business Journal.

Ms. Daniels has more than twenty years management experience and is a seasoned operations executive with extensive experience in high growth companies. Prior to Althea, Ms. Daniels held executive positions at Genetronics, Plexus Corporation and multinational companies like TDK before her most recent post at Vidacare Corporation, a medical device company offering innovative vascular access solutions for emergency medicine. She has extensive experience catalyzing company growth, assessing competitive positioning, strategic planning initiatives, and building effective operations. Ms. Daniels has significant experience in the contract manufacturing sector and at Althea she has overall responsibility for the clinical and commercial contract manufacturing operations as well as the supply chain, facilities management and logistics support activities within the company. Ms. Daniels is charged with etablishing additional system enhancements and organizational efficiencies to foster continued, sustainable growth.

Mr. Hancock has been involved in the biotechnology industry for the past twenty-four years, serving previously as Althea’s Executive VP, Europe and prior to that as Althea’s COO. Mr. Hancock has been a leading figure in the area of gene-based immunotherapies and DNA vaccines where he has presented at numerous scientific and business symposia. He has also directed the design, evaluation and regulatory assessment efforts for each of Althea’s current cGMP manufacturing facilities where he interacted heavily with consultants, QP’s and government inspectors. Mr. Hancock has held process development and GMP manufacturing positions at Hybritech, Genetics Institute (current Wyeth, Andover facility) and more recently as Senior Director of Operations at The Immune Response Corporation. He has extensive experience in production of monoclonal antibodies, recombinant proteins, vaccine development and gene therapy product development, and helped to establish Althea’s current fill/finish operations. Additional areas of expertise include issues related to regulatory compliance in multi-product facilities, design and implementation of appropriate aseptic process validation, and complex formulation processing.

Mr. Moore brings over twenty-five years of experience in the biopharmaceutical industry. Prior to joining Althea, he was General Manager of Biopharmaceutical Development Services at Charles River Laboratories in Rockville, Maryland, and before that, he was Vice President of Biopharmaceutical Development Services at Primedica Corporation. He joined the Genzyme subsidiary, Genzyme Transgenics Corporation in 1996 as President of Genzyme Transgenics Washington Laboratories and Senior Regulatory Coordinator with Genzyme Transgenics. He served as Director of Business Development for Microbiological Associates (BioReliance) after 16 years of positions of increasing responsibility including Director of the Biotechnology Services Division. Mr. Moore's experience includes development of corporate sales and business development strategies, including building strong international relationships. He also brings a wealth of experience in regulatory affairs concerning development of new biomedical products.

Mr. Gilmore has over 20 years experience in corporate finance including over 15 years as Chief Financial Officer in a variety of industries. Before joining Althea, he was Chief Financial Officer for Preventsys, Inc., an enterprise software development and marketing firm. Prior to that, he served as Chief Financial Officer for Holocom Networks, a network infrastructure company. He has also provided extensive management consulting services to Fortune 500 companies and start-up organizations. Recent consulting clients include Ligand Pharmaceuticals, Applied Micro Circuits Corporation, and Peregrine Systems. Mr. Gilmore’s experience includes strategic planning, venture capital fundraising, and design and implementation of systems to manage growth and profitability. Mr. Gilmore has spearheaded the design and implementation of an Enterprise Resource Planning (ERP) system at Althea which is supportive to continued growth with appropriate control and reporting efficiencies. He has been recognized by the San Diego business community for his accomplishments as a finalist in the CFO of the year award in 2007.

Mr. Lewis serves as Vice President of Sales where he has overall responsibility for client and relationship development at Althea. Additionally, he plays an active role in the project management team and marketing function, ensuring that company awareness is aligned with client needs and expectations. Mr. Lewis is experienced in client relations, go-to-market and product launch strategies, as well as talent development and workforce planning. He has over eleven years of industry experience, having most recently served as the Director of Global New Business Development for Baxter BioPharma Solutions (Baxter Healthcare Corporation) where he directed business development activities for the B2B contract manufacturing services of clinical/commercial scale manufacturing of parenteral injectables. Prior to this role he was the Manager of Global New Business Development, and earlier served as a Marketing Manager for Baxter’s BioSurgery division, where he played a pivotal role in executing successful product launches. Mr. Lewis started his career in Baxter’s Financial Development Program and spent several years in the finance function with varying roles of increasing responsibility. He is a seasoned business development professional with broad exposure to pharmaceutical development. Mr. Lewis has a B.S. in Finance from Indiana University—Kelley School of Business and an MBA from Northwestern University—Kellogg School of Management.

Dr. Monforte has been working in biotech and genomics for over fifteen years. Prior to joining Althea, he co-founded GeneTrace Systems, where he served as its Chief Scientific Officer for seven years. His experience also includes managing DOE’s portion of the human genome project and Biothreat-agent sequencing program at the DOE Joint Genome Institute. Previously, Dr. Monforte has held positions as Staff Scientist in the Toxicology department at SRI International and Visiting Professor of Chemistry at UC Berkeley. His career has focused on the development of new tools for genomic research and accelerating the drug discovery process. An author on numerous patents, his inventions and innovations cover high throughput processes for studying DNA, RNA and proteins, including Althea’s XP technology. Dr. Monforte has been the Principal Investigator on numerous federal grants totaling over $7 million in research funding, including two prestigious grants from the NIST Advanced Technology Program. Dr. Monforte holds a Ph.D. in biophysical chemistry from the University of California, Berkeley.

Manufacturing

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. Additionally, Althea’s Project Management Office, responsible for coordination of communication and technical liaison with clients reports to Mr. Duffy. 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.

Mr. Scott Dunckley, Director of Fill/Finish Operations at Althea Technologies, has over 15 years of experience in the pharmaceutical industry with extensive experience in aseptic manufacturing, process development, validation, and product launch. At Althea he directs all aspects of the Fill/Finish services supporting clinical and commercial filling programs. With more than fifteen years of experience in a broad array of biological products, small volume parenteral aseptic processing and lyophilization (freeze drying), Mr. Dunkley contributes a great deal of diverse experience to Althea’s Fill/Finish service. Prior to joining Althea, Mr. Dunckley was an Associate Director of Manufacturing at Amylin Pharmaceuticals, Inc.,where he oversaw the contract manufacturing department and successfully launched two “first-in-class” medications for diabetes. Prior to joining Amylin, he worked for Bayer Corporation, where he served as a senior process development scientist providing technical support to the aseptic filling, freeze-drying and packaging department. Mr. Dunckley focused on process improvement and efficiency in the manufacturing of recombinant FVIII products, and previously at Bayer directed sterile processing activities for filling and freeze drying at the Berkeley CA site as a General Manufacturing Supervisor.

Dr. Peterson is Althea’s Director of Biologics Manufacturing where he is responsible for all process development, cell banking, and manufacturing activities for the cGMP manufacture of recombinant proteins and plasmid DNA products. He has technical and management responsibility for both clinical and commercial biologics production facilities. Dr. Peterson has over fifteen years of experience in the pharmaceutical and biotechnology industries, specifically focused on bioprocess and biologics engineering . With a Ph.D. in chemical engineering from Purdue University, Dr. Peterson has a wide range of experience in bacterial, yeast and mammalian cell–expressed proteins for clinical administration. Dr. Peterson has lead the development of engineering teams at Althea that have optimized high-cell density methods for production of DNA-based vaccines, protein re-folding processes and large-scale purification schemes for challenging protein products. Previous to Althea, he was senior scientist at Applied Molecular Evolution (a subsidiary of Eli Lilly), where he was responsible for the engineering and the optimization for various protein products. Prior to joining Eli Lilly from 1998 to 2002, he worked at Celgene Signal Pharmaceuticals, where he established their bioprocess engineering core facility and established their structural biology drug design group. He has also held various rolls at Amylin Pharmaceuticals as a process engineer and at Bristol-Myers Squibb as a senior research investigator.

Regulatory

Mr. Brandreth brings over fifteen 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.

Ms. Sapinoso currently serves as Althea’s Quality Assurance Manager where she is responsible for managing all QA activities such as lot release, internal and external audits, calibration programs, internal training, and review of all QC data including stability reports. In this capacity she is the primary Quality liaison with client quality representatives and inspectors visiting Althea’s facilities. Ms. Sapinoso has over ten years experience in quality assurance for pharmaceutical and biotechnology companies. Previous to Althea, she was the Senior Quality Assurance Auditor at Artes Medical, Inc., where she, responsible for internal audits, deviation/investigations and performed QA management review for lot release. Prior to Artes, Ms. Sapinoso worked at Favrille, Inc. as a Quality Asurance Specialist performing batch release and disposition for clinical products and previous to that, held several quality assurance roles at a contract manufacturer, Molecular Medicine Bioservices. Additionally, she has held technical positions at Gen-Probe, Inc. and Bayer Corporation before moving into her Quality career.

Mr. King directs Althea’s Quality Control staff and has responsibility for the development and transfer of assays within Althea’s Quality Control-Analytical laboratories. Mr. King is responsible for development and implementation of quality control standards, and manages all of the stability testing supporting cGMP manufacturing operations. Mr. King has over twenty three years experience in various aspects of quality control and research chemistry. Previous to Althea he served as Study Manager at Cardinal Health (Magellan Laboratories) where he worked on biopharmaceutical product development including protein and peptide drug products. Previous to that, Mr. King served at Matrix Pharmaceutical as Senior Quality Control Chemist providing analytical support and stability program management to NDA submission. Additionally, he has held positions at Hybritech, Inc supporting monoclonal antibody products and Beckman Instruments, and Behring diagnostics in primarily production chemistry capacities.

Althea Technologies
A leading provider of contract services to
the pharmaceutical and biotechnology industries

11040 Roselle Street | San Diego, CA 92121-1205
Toll-free 1-888-4ALTHEA
info@altheatech.com