Principal Technical Manager
Genentech, a member of the Roche Group

Amy joined Genentech External Quality in 2009 as a Supplier Collaborations, Principal Technical Manager where she worked with suppliers to improve their component quality. In 2010, she moved to the Associate Director of Americas Region, Supplier Quality.  In 2011, Amy moved to the Corporate GMP Compliance Group in Roche as an auditor and response manager. Amy has worked in the chemical and pharmaceutical area for the past 18 years as a consultant for CROs such as Ricerca and Rosetech Consulting. She was the site Quality Manager at Research Organics from 1994-2009. Research Organics is a chemical manufacturing company in Ohio, USA that synthesizes excipients and critical raw materials used in diagnostic, medical device, biotech and pharmaceutical industries. Amy Mutere has a B.S. degree in Chemistry and a M.S. degree in Environmental Chemistry. Amy has worked a decade in not-for profit-organizations (NGOs) in scientific editing and desk top publishing of documents for WHO, UNEP, UNICEF, Habitat for Humanity and other UN organizations in Kenya, East Africa.

Senior GMP Inspector
MHRA

Andy Hopkins has been with the MHRA since March 2005 as a GMP Inspector and became a senior GMP inspector 2009. As an Inspector  he has inspected in areas including Sterile Pharmaceutical Manufacturing facilities, non Sterile Pharmaceutical Manufacturing facilities and biotechnology and is responsible for ensuring that the Companies inspected are compliant with EU GMP. He has also taken part in a number of discussion groups.

Andy has also been involved in a number of technological papers including the current version of the PDA Technical Report No.1 and the UK PHSS paper for non viable monitoring.

Prior to joining the Agency he worked in the Pharmaceutical industry for approximately 20 years in positions including Quality Control, Quality Assurance and Production.  He has a BSc Honours in Microbiology with Genetics, a Post Graduate Diploma in Industrial Pharmaceutical Science and is also a Member of the Institute of Biology.

Founder, Chief Executive Officer and Chairman
Triton Thalassic Technologies, Inc.

Barry Ressler, Founder, Chief Executive Officer and Chairman of Triton Thalassic Technologies, Inc, a company engaged in the non- thermal pathogen inactivation of blood products; photo-activation of therapeutic compounds and the treatment/control of micro-organism contaminated fluids for the industrial, food packaging, healthcare and pharmaceutical industries.

Mr. Ressler is also the founder and Chairman of EP Therapeutics, Inc. a bio-pharmaceutical company engaged in the development of a
new class of therapeutics as safer treatments for human cancers by eliminating the need for chemotherapy or radiation treatment protocols.

From 1975 to December 1993 he served as Chairman and CEO of Universal Voltronics Corporation, a public company (NASDAQ and AMEX) that developed high energy products and systems for scientific research, medical diagnostics/therapies and for industrial applications. In March 1990, UVC became a public subsidiary of Thermo Fisher Scientific.

Mr. Ressler served on the Board of Directors of StemCyte Inc., a company engaged in Umbilical Cord Blood Banking and stem cell therapeutics and also served on the scientific advisory board of the University of Connecticut Biotechnology center.

Mr. Ressler is the inventor of 6 patents in the field of monochromatic UV sterilization of opaque industrial fluids, blood products, injectables, ophthalmic and healthcare packaged products.

Senior Process Engineer
Grifols Therapeutics

Ms. Anderson has been an engineer and project manager at the Clayton, NC human plasma fractionation manufacturing site of Grifols Therapeutics since 2000. As part of the research and development department, she investigated manufacturing deviations and introduced process improvements. When the company decided to replace the main manufacturing building, she researched and tested prototypes of new technologies to replace current unit operations in the manufacturing process. Unit operations included centrifugation, precipitation, thawing and freezing. Engineering skills include experimental design, process transfer, process risk assessment, data analysis, validation, and equipment design/prototyping.

She has a Bachelor of Science in Chemical Engineering from the University of Virginia. She has a Professional Engineering Certification in North Carolina and is an ASQ Certified Quality Engineer.

Global Human Resources Business Partner
Roche/Genentech

Cheri has worked in the consulting, high-tech, and bio-tech industries.  Cheri began her career working as a Consultant for Accenture where she gained expertise in systems and management consulting.  She then worked at Oracle in their compensation department and was soon promoted to Manager of Operations for U.S. Sales.  During the dot.com boom in the San Francisco Bay Area, Cheri had the opportunity of working at a small start-up company which allowed her to gain further sales operations and human resources experience.  She then worked at Apple Computer in Human Resources and has worked at Genentech/Roche for the past 6.5 years and in the most recent years in a Global HR role.  Throughout her career she has supported clients in manufacturing (exempt and non-exempt), technical development, quality, engineering, and commercial sales.  She enjoys executive coaching and facilitating.  Cheri has supported clients in over 5 countries worldwide.

Cheri has also served on the Board of Directors for the Junior League of San Francisco and was an active member of the San Francisco Ballet Auxiliary.

Director of Upstream Operations
Shire HGT

Mr. Hart has been with the Operations group at Shire HGT for 3 years. Since 2010, he has served as the Director of Upstream Operations, responsible for managing all Cell Culture and Media Prep Operations at the new state-of-the-art manufacturing facility at 400 Shire Way in Lexington, Massachusetts. Prior to joining Shire HGT, Mr. Hart has had increasing roles of responsibility in Upstream and Downstream Operations at GSK, Wyeth, Amgen, and ImClone, with a previous role of Associate Director of Downstream Operations at ImClone. His experience encompasses 20 years in the Biopharmaceutical industry. In addition to his Biopharmaceutical industry experience, Mr. Hart has 5 years of experience in the Pharmaceutical industry and is a 1983 graduate of the Naval Nuclear Power School program.

Process Development Engineer
Grifols Inc

Ms. Frazier has been with Grifols Inc since 2006 in the Research and Development group supporting Technical Operations. At Grifols, she has been involved in new product process development during toxicological and clinical phases. She is currently responsible for providing engineering and developmental support to manufacturing operations, with a focus on implementation of new or modified systems for improved process yield, purity, control and operation. She has previous work experience at a medical device company and an academic research laboratory, and holds both a M.S. degree in Chemical Engineering and a B.S. degree in Biological Engineering from North Carolina State University.

Chief Scientific Officer
Dendreon Corporation

Dr. Urdal has been Chief Scientific Officer and a Director of Dendreon Corporation since he joined the company in July of 1995.  Dendreon (Nasdaq: DNDN) has been dedicated to targeting cancer and transforming lives through the discovery and development of novel products like Provenge®, an autologous cellular immunotherapy that was licensed in April, 2010, for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer.

From 1982 to 1995, he held various positions with Immunex Corporation, including President of Immunex Manufacturing Corporation, Vice President and Director of Development, and Head of the Departments of Biochemistry and Membrane Biochemistry.  At Immunex he participated in the discovery, development and commercialization of hematopoietic growth factors, cytokines and cytokine receptor drugs, like Leukine® and Enbrel®.   Dr. Urdal received an M.S. in Public Health and a Ph.D. in Biochemical Oncology from the University of Washington.  He is inventor on 16 patents and author on 79 publications.

Senior Process Engineer
Merck & Co., Inc.

David is a member of Merck's External Manufacturing Technology organization responsible for providing technical oversight for sterile products produced at contract manufacturing facilities worldwide. He has BS degrees in chemistry and microbiology from Arizona State University and an MS in chemical engineering from the University of Idaho. He began his career in 1986 manufacturing diagnostic reagents and human plasma controls in the area of blood coagulation. From there he moved into API manufacturing and then into sterile drug products, particularly lyophilized biologicals. He has over 30 years of experience in aseptic manufacturing and freeze-drying of lyophilized parenterals in vials as well as dual-chamber cartridges for use in a pen device.

Managing Director
ZRG Partners

David Fortier brings nearly ten years of executive search experience and an extensive record of senior level placements within the Life Sciences and Healthcare industry. In addition to C-Suite and Board-level placements, Dave has recruited senior operating executives including leaders for global manufacturing, engineering, supply chain, and quality functions. In recent years, Dave has developed an expertise in the areas of vaccine and biologics with several key placements of global operating and general management executives.

Dave has lived or worked in nearly 20 countries worldwide and uses this global perspective on each assignment to produce the best possible candidate slate. His clients range from pre-revenue start-ups to multi-billion dollar global industry leaders.

Dave began his career with the public accounting firm of Coopers & Lybrand serving global manufacturing clients and later joined Premark International, a $2 billion conglomerate comprised of thirteen premium-branded consumer and industrial manufacturers. There, he gained global finance, operations, and profit and loss experience. Premark deployed Dave to key subsidiary operations located in the U.S., Asia, South America and Europe.

Dedicated to the community at large, Dave has coached athletics, mentored for gang prevention organizations and has served on the Board of Directors of his local chapter of Habitat for Humanity. He is an active supporter of the Iraq and Afghanistan Veterans Association. A lover of the outdoors, Dave enjoys backcountry hiking, camping, competitive sailing and the occasional sandlot football game. Dave is based in ZRG’s Washington DC office.

President
Mary Crowley Cancer Research Centers

David is the President of Mary Crowley Cancer Research Centers, a cancer therapy charity specializing in gene and viral therapies. The non-profit company was established in honor of David's grandmother, Mary Crowley, who lost her fight with cancer in 1986. Mary Crowley has treated over 4,000 patients with advanced cancer therapies and is leading the field in clinical application of genomics and non-invasive tumor characterization.

David has advanced in record time a personal mission to expedite approaches that are transformative and potentially curative, defining the next generation of personalized medicine in cancer care. In 2005 he founded Gradalis, Inc., a biotech startup company manufacturing personalized cancer therapies for use in clinical trials. Gradalis is at the forefront of using genomic and proteomic analysis to understand the molecular makeup of a patient's cancer. By harnessing shRNA technologies, Gradalis is validating unique cancer targets and began clinical trials on these therapies in 2007.

Today David Shanahan lives out his grandmother's legacy as he executes the convergence of pioneering science while committing his personal time and resources to support the needs of today's cancer patients.

David Shanahan, his wife Salli, and their four children reside in Dallas.

Vice President, Research and Development
Noxilizer, Inc.

David Opie, Ph.D., Vice President, Research and Development, has extensive medical device development experience with both start-ups and industry leaders, including Johnson & Johnson and Cook Medical. He has employed a thorough knowledge of Good Laboratory Practices, Good Manufacturing Practices, and design control and product development procedures. He has experience with cardiovascular and urological implants as well as drug delivery market segments. Dr. Opie holds a Ph.D. and an M.S. in Physics from the College of William and Mary, and a B.A. in Physics from the University of Delaware.

Associate Director – Scientific Affairs
West Pharmaceuticals

In her 20 years of service at West, Ms. Paskiet's responsibilities have included supervision of laboratory operations and project advisor in support of method development and validation studies associated with container closure systems for IND and NDA filings.

She has a background in polymer analysis relating to deformulations, failures and migration studies with emphasis on drug packaging and medical devices. Her current responsibilities include coordination of studies for technical support and innovations as well as providing a forum for education of those technologies.

Ms. Paskiet holds a degree in chemistry from the University of Toledo and a QA/RA Graduate Certificate from Temple University School of Pharmacy. She has authored national and international papers on the subject of leachables and extractables and is a faculty member of the PDA Training Institute as well as a frequent speaker and organizer of conferences.

Principal
Packaging Science Resources LLC

Ed Smith is Principal at Packaging Science Resources LLC which provides consulting and training in packaging for the pharmaceutical, biotechnology, and medical device industries. 

Ed is a member of the PDA and American Chemical Society.  Within PDA, he leads the Packaging Science Interest Group, and served on the Steering Committee of the Pharmaceutical Cold Chain Interest Group (PCCIG) where he co-authored PDA Technical Reports 39 & 46 on cold chain best practices.  He is also a member of the PQRI Working Group on Parenteral & Ophthalmic Drug Products (Extractables/Leachables). He is a member of the faculty of the PDA Training and Research Institute.  He is also a member of the ACS Consultants Network.

He has published many articles and chapters on pharmaceutical packaging and is a frequent speaker at industry meetings and courses related to extractables/leachables and cold chain.

Prior to forming his consulting practice, Ed was associated with Wyeth Pharmaceuticals where he headed a team responsible for the development and qualification of cold chain packaging systems for transporting temperature-sensitive drug products. He also served as a technical expert on parenteral packaging issues particularly with respect to the management of extractables and leachables. Before that, he was associated with Helvoet Pharma Inc. and West Pharmaceutical Services in various technical management positions. He holds a B.S. in Chemistry from Villanova University and received his M.S. & Ph.D. in Analytical Chemistry from Seton Hall University (So. Orange, NJ).

Senior Director
VMSC BioAnalytics
MMD, Merck, Sharp and Dohme

Dr Takle is currently Sr. Director, Bioanalytics in the Vaccine Manufacturing Science and Commercialization group within the Merck Manufacturing Division. He received his Ph.D. in cell biology from the University of Glasgow in Scotland, U.K. in 1986 and completed postdoctoral work at Wellcome Biotech, U.K. and the Rockefeller University in New York. Dr Takle has held various roles of increasing responsibility in biotech discovery research and GLP/GMP testing and manufacturing services for biologics, including vaccines. Prior to his current position at Merck, he was Vice President, Operations at the WuxiAppTec, Philadelphia facility.

Director, Corporate Quality Assurance
Dendreon, Corp.

Greg has been with Dendreon Corporation since 2004, starting as the Manager of the Quality Control Laboratories and moving to Quality Assurance in 2009. He is currently the head of corporate Quality Assurance, with oversight of Quality Systems and responsibility for standardization of Quality Assurance across multiple manufacturing plants. Additionally, he is responsible for Third Party Manufacturing oversight in support of Dendreon's supply chain.

Principal Technical Manager
Genentech

Jenna Carlson is a Principal Technical Manager in Genentech, a member of the Roche Group, Pharma Technical Quality System, Validation department.  She is responsible for developing and overseeing governance activities for cleaning validation, including developing global standards and procedures for all Pharma manufacturing sites and support functions.  She has over twelve years experience focusing on validation and quality assurance. Jenna has held key roles at leading biotechnology firms including Allergan and Baxter focusing on validation of equipment, cleaning, process, and methods.  She was a co-author on PDA Technical Report No.49, Points to Consider for Biotechnology Cleaning Validation and PDA Technical Report No. 29 Points to Consider for Cleaning Validation revision.  She is also the author and column coordinator for the Cleaning Compliance Forum published in the Journal of GXP Compliance.  Jenna earned her Bachelor of Science in Chemistry from Southern Illinois University.

Senior Manager
Baxter Healthcare

John A. Williams is the Manager of the Corporate Sterility Assurance Research Center for Baxter Healthcare Corporation in Round Lake, IL. John has over twenty years of experience in the industrial applications of radiation for sterilization, nondestructive testing, and material modification. John has a Bachelor's degree in Medical Physics from Oakland University in Rochester, Michigan and an Executive MBA from Loyola University Chicago, Illinois. An active member of PDA, AAMI, and ASTM, John also serves as the US Overall Advisor to ISO TC85/WG3 on Dosimetry and on Loyola University Chicago's eMBA Advisory Board. A frequent lecturer, he has presented on various topics related to sterilization at many industry conferences both domestically and internationally. John has also authored several papers and co-authored a book chapter on radiation sterilization that can be found in Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices.

Senior Vice President Marketing
Sartorius Stedim Biotech Inc.

MAIK W. JORNITZ is Senior Vice President Marketing at the Sartorius Stedim North America Inc.. With over 25 years of experience, Mr. Jornitz supports the biopharmaceutical industry on a global basis, focusing in validation, optimization and training in sterilizing filtration. As Immediate Past-Chair of PDA, Jornitz has been part of multiple PDA task forces, committee member and conference chair. He is also member of ISPE, DIA, ASTM and multiple editorial boards. Jornitz is the author and co-author of over 100 professional papers, 9 books, 11 book chapters and recipient of 5 book awards. He holds several filter and single-use technology related patents and is the founder of Bioprocess Resources LLC. Mr. Jornitz received his M.Eng. in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished his PED at the IMD Business School, Lausanne, Switzerland.

Senior Managing Scientist
Exponent

Dr. Mittelman has over 25 years experience in academia, industry, and consulting. The majority of his research and consulting work has been in the area of microbiological contamination detection and mitigation for pharmaceutical/biotechnology, clinical, and industrial applications. Dr. Mittelman was previously an Associate Professor in the Faculties of Medicine and Dentistry, and director of the Centre for Infection and Biomaterials Research (CIBR), at the University of Toronto. He has also worked as a microbiologist in the pharmaceutical industry, directed microbiology and medical device engineering consulting practices, and has served as an expert witness in product liability cases. Dr. Mittelman is the author of over 80 scientific papers and books, and has lectured extensively on microbiological contamination control, with a focus on microbial biofilms. In addition to his consulting work at Exponent, he is also a visiting scientist at Harvard University, School of Engineering and Applied Sciences. He holds B.S. and M.S. degrees in microbiology from CSU-Long Beach, and a Ph.D. degree from the University of Tennessee, Knoxville.

Senior Principle Engineer
Baxter Healthcare Corporation

Dr. Pasmore has held the position of Assistant Research Professor at Montana State University, Department of Chemical Engineering. In his role at Montana State, he was the Medical Projects Supervisor at the Center for Biofilm Engineering where he studied biofilms in infection.

He has since held positions at STERIS Corporation where his research involved the evaluation and development of sterilization and decontamination technologies.

He currently works for Baxter Healthcare Corporation as a Sr. Principal Engineer in the Technology Resources Sterility Assurance department. His research includes biofilm analyses and biofilm methods, as well as rapid microbial methods, alternative sterilization techniques and new product development.

He has multiple publications and presentations in the field of biofilm research and he is involved in several professional and standards organizations related to bacterial control and sterilization.

Professor
Keck Graduate Institute of Applied Life Sciences

Matt Croughan is the George B. and Joy Rathmann Professor and Director of the Amgen Bioprocessing Center at Keck Graduate Institute (KGI).  In 2006, he founded the Bioprocessing focus track at KGI and, with the help of colleagues from industry who often now serve as adjunct professors, has built it into one of the largest masters-level programs in bioprocessing, with a unique emphasis on recruiting and educating the next generation of business leaders in bioprocessing.  He teaches several graduate courses and advises 30-40 masters and two doctoral students specializing in various areas of bioprocessing.  Prior to joining KGI, and still one day per week, Dr. Croughan works as an independent consultant providing expert guidance on biopharmaceutical process development and manufacturing to over fifty firms.  Previously Dr. Croughan was the chief scientist for Genentech’s cell culture facility in Vacaville, CA, built for the production of therapeutic antibodies. Earlier in his career at Genentech, he developed the first high-density, fed-batch cell culture process, a breakthrough platform technology now used throughout the biopharmaceutical industry.   Matt has a Ph.D. from MIT and a BS from UC Berkeley, both in chemical engineering.

President
Quantum Consulting, LLC

Dr. Wiebe is Founder and President of Quantum Consulting based in Redwood City, California. His consulting practice is focused on biotechnology development, biosafety, manufacturing, quality assurance and GMP compliance. He has 25 years of experience in the CMC aspects of biotechnology and has participated as a member of numerous product development teams that were successful in bringing new biotech products through the development pipeline and into commercial life. He has held positions at the following companies: Genentech, 1984-1998 (Senior Scientist, Cell Culture Development; Sr. Director, Quality Control); BioReliance, 1998-2001 (Chief Scientific Officer and Vice President of Quality & Regulatory Affairs); IDEC Pharmaceuticals, 2001-2003 (Vice President of Quality); Biogen Idec, 2003-2005 (Vice President of Corporate Quality & Drug Compliance); Novartis (formerly Chiron), 2005-2007 (Vice President of Quality Assurance for U.S. Biopharmaceutical Operations). Earlier in his career Dr. Wiebe held positions at Duke University Medical School (Research Fellow), Cornell University Medical College (Assistant & Associate Professor), and the New York Blood Center (Associate Investigator). He received his Ph.D. in Microbiology from the University of Kansas and his B.S. in Natural Sciences from Sterling College (Kansas).

President, Microbiology Consultants, LLC

Dr. Michael J. Miller is an internationally recognized microbiologist and subject matter expert in pharmaceutical microbiology and the design, validation and implementation of rapid microbiological methods.  He is currently the President of Microbiology Consultants, LLC (http://microbiologyconsultants.com). In this role, he is responsible for providing scientific, quality, regulatory and business solutions for the pharmaceutical industry and suppliers of new microbiology technologies.  Over the past 23 years, Dr. Miller has held numerous R&D, manufacturing, quality, consulting and business development leadership roles at Johnson & Johnson, Eli Lilly and Company, Bausch & Lomb, and Pharmaceutical Systems, Inc.

Dr. Miller has authored over 100 technical publications and presentations in the areas of rapid microbiological methods, PAT, ophthalmics, disinfection and sterilization, is the editor of PDA’s Encyclopedia of Rapid Microbiological Methods, and is the owner of http://rapidmicromethods.com, a new website dedicated to the advancement of RMMs. He currently serves on a number of PDA’s program and publication committees and advisory boards, and is co-chairing the revision of PDA Technical Report #33: Evaluation, Validation and Implementation of New Microbiological Testing Methods. Dr. Miller holds a Ph.D. in Microbiology and Biochemistry from Georgia State University (GSU), a B.A. in Anthropology and Sociology from Hobart College, and is currently an adjunct professor at GSU.

Biopharmaceutical Marketing Manager
Pall Life Sciences

Michael Moussourakis is a Biopharmaceutical Marketing Manager at Pall Life Sciences headquartered in Port Washington, NY. The Biopharm Marketing team provides tactical and product leadership to Pall customers for their processing needs. Mr. Moussourakis has over ten years experience in the Life Science industry. The last eight years of this have been with Pall where he has provided on site tactical and consultative support, product and technical training, and troubleshooting in various customer process applications. Michael has a B.S. and M.S. in biomedical engineering from Columbia University.

Vice President
Business Development, Technology Specialist
CMC Biologics A/S

Mr. Morten Munk holds a degree in Chemical Engineering, is co-founder of CMC Biologics A/S, and is currently holds a Vice President position in Business Development at CMC.

Morten had a key role in the design, commissioning and qualification of CMC's contract manufacturing facilities. His key areas of expertise are: Downstream Process Development, Process Scale-up, Facility Design and Process Validation.
Morten is a member of the board of ISPE Nordic Affiliate and several subgroups under ISPE. Furthermore, Morten has participated in several PDA special task force groups writing Technical Reports covering Process Validation and other regulatory subjects. Morten is currently co-chair for a new PDA Technical Report on Single Use Systems.

Prior to founding CMC in 2001, Morten held a position as Principal Scientist specializing in protein purification development and facility design at Novo Nordisk A/S.

Director, SteriPro Consulting
Sterigenics International

Niki Fidopiastis joined Sterigenics International in 1998, as SteriPro^TM Validation Specialist, after nine years with North American Science Associates (NAMSA). She is responsible for developing and implementing ISO and FDA compliant sterilization validations for E-beam, GAMMA and EO sterilization of disposable medical products and pharmaceuticals. Ms. Fidopiastis has a BA degree in Biology and a BA degree in Chemistry from California State University at Fullerton. She is an active member of the Association for the Advancement of Medical Instrumentation (AAMI), and is a member of the Radiation, Microbiology Methods, and Sterility Assurance Level AAMI committees. Ms. Fidopiastis is also a registered Microbiologist with the National Registry of Microbiologists (NRCM) and a member of the American Chemical Society (ACS).

Site Microbiologist
MedImmune, Inc.

Dr. Forng has been with MedImmune since 2009. He is the Site Microbiologist for MedImmune Frederick Manufacturing Center, responsible for clean utility system and environmental monitoring programs. He is also responsible for managing the QC Microbiological Testing Service Group, the evaluation and implementation of rapid microbial methods to improve efficiency, selection and qualification of contract research organizations for clinical and commercial product testing requirement, and the creation and implementation of Corporate Microbiology strategies and policies.

Executive Coach and Management Consultant
RJB Consulting

Roy J. Blitzer, an Executive Coach and Management Consultant, has 30+ years experience as a human resources and business management professional. Roy has been successful in preparing leaders for promotional positions, in enriching their key management skill sets and in working with teams at all levels to meet the changing organizational challenges and global business demands.

He has held numerous positions — Manager of Training and Corporate Communications, Founding Principal, Vice President, and Senior Executive Consultant — and has championed a variety of projects that range from creation and delivery of a world wide Management Training Program and Executive Coaching and Development Process to chairing a Human Resource function and establishing systems and support for service quality and self-managing team implementations.

Previously, he was a founding Principal and Vice President of Zenger-Miller, a training, education and consulting company (now Achieve Global International), a Senior Director at Spherion Corporation, and a Manager at Syntex Corporation (now Roche, Inc.). 

He is an adjunct faculty member at the University of San Francisco, San Jose State University, and Menlo College, sits on the Board of Directors for the Institute of Social Responsibility and the Institute for Effective School Leadership and is former chair the Palo Alto, CA Human Relations Commission.

Roy has lived in the Bay Area for over 35 years. He has earned a BA, English Literature, University of Massachusetts at Amherst. He also holds an MBA, Organizational Behavior, University of California at Berkeley. He is certified in various executive leadership development assessments and account management.

Principal Scientist, Analytical Biochemistry
MedImmune

Stephan O. Krause has a PhD in analytical biochemisry from the University of Southern California.  He has held leading roles for validation and quality for several biopharmaceutical firms.  He is currently MedImmune's subject matter expert for analytical qualification, validation, and transfers and the global specification coordinator for CTMs.  Before MedImmune, Stephan was a director of QA and QC operations for CTM manufacturers in California.  Prior to this, he was manager of QA/QC Technical Services at Bayer's (commercial) Biologics/Biotech Division.  As Bayer's primary external liaison for laboratory operations, he impacted industry standards by working closely with regulatory and industry representatives.  Stephan has published many articles on quality and validation in industry journals in the US, Europe, and Asia.  His book on risk-based method validation strategies (PDA/DHI Publications, April 2007) won the PDA Distinguished Author Award in 2008.  Stephan often serves as session chair and lecturer at major conferences worldwide.  He is a member of several Editorial and Scientific Advisory Boards.  He is PDA's task force leader for Analytical Method Validation and a PCMO task force leader for CTM manufacturing.

Chief Technical Officer
Vivalis

Stephen Brown is CTO and co-manager of CMO activities for Vivalis, based in Nantes, Western France. He has worked in the biopharmaceutical industry for 31 years. Prior to Vivalis, Dr Brown was Director, Biological Process Development for Merial and before that, responsible for the Gene and Cell Therapy Manufacturing site at Transgène, France. Stephen Brown held a postdoctoral position at the ETH Zurich, Switzerland, received his Ph.D. in Fermentation Technology from the University of Kent at Canterbury, UK and holds a B.Sc. in Microbiology from the University of Wales (University College Cardiff), UK. Stephen Brown is an active member of the Parenteral Drug Association, where he is a member of the PDA Biotechnology Advisory Board, a member of the Single Use Systems Task Force currently preparing a Technical Report on disposable manufacturing solutions and chairman of the Gene and Cell-Based Therapies Task Force.

Executive Vice President, Research & Development and Technical Operations
Onyx Pharmaceuticals

Ted W. Love, M.D. is Executive Vice President of Research & Development and Technical Operations at Onyx Pharmaceuticals, Inc. He was Chairman and Chief Executive Officer of Nuvelo, Inc., a biopharmaceutical company, from March 2001 to January 2009, having been appointed President and Chief Operating Officer of Nuvelo in January 2001. He served as a director of that company since February 2001 and became Chairman of the board of directors in September 2005. He joined Nuvelo from Theravance, Inc., a biopharmaceutical company, where he served as Senior Vice President of Development from February 1998 to January 2001. Prior to that, he spent six years at Genentech, Inc., a biotechnology company, holding a number of senior management positions in medical affairs and product development. Dr. Love serves as a director of several companies including Bio-Rad, Affymax, Inc., Santarus Inc., ARCA Biopharma and KaloBios Inc. He also serves on the 29-member California Independent Citizen's Oversight Commission, which oversees the $3 billion allocated to stem cell research authorized by California Proposition 71. Dr. Love holds a B.A. in molecular biology from Haverford College and an M.D. from Yale Medical School. He completed his internal medicine and cardiovascular fellowship training at Massachusetts General Hospital and Harvard Medical School.

Product Reviewer, Office of Cellular, Tissue, and Gene Therapy, CBER
FDA

Thomas Finn is a full time CMC reviewer in the Office of Cellular, Tissue, and Gene Therapies in the Center for Biologics Evaluation and Research, FDA.  He received his B.S. in Microbiology at Iowa State University, and his PhD in Cell Biology from Oregon Health Sciences University where he studied neuronal development.  He did his postdoctoral work on Multiple Sclerosis at the nearby Portland VA Medical Center, and then continued to pursue his interests in neuroimmunology as a Research Assistant Professor at Georgetown University in the Department of Neuroscience where he studied spinal cord injury in a rodent model.  He joined the Division of Cell and Gene Therapy at the FDA in early 2006 where he now evaluates a wide range of cellular therapies at all stages of product development.   His expertise is in neurodegenerative disorders, and his background includes microbiology, immunology, protein purification, cell culture, small animal models, and bioassays.  He was the BLA chair for Provenge, and is involved in numerous CBER internal working groups.  He also serves on the Neuroscience Steering Committee for the FNIH Biomarker Consortium, and is a member of the inter-center Neurology Across the FDA working group.

Head of Technology and Regulatory Policy
Roche

Thomas Schreitmüller holds a Diploma and PhD in Biochemistry from the University of Munich (Max Planck Institute for Biochemistry, Munich, Martinsried and Institute for Clinical Chemistry and Clinical Biochemistry University of Munich). In 1989 he joined Roche holding various positions in the biotech area (e.g. analytical development, technical project management).
Since 2003 Thomas was heading the department "Analytical R&D and Quality Control Biotech Products" at Roche Pharma Technical Operations in Basel, Switzerland. The department assumes responsibility for basic analytical research in the context of biotech products, is doing the analytical development and quality control of biotech development products and clinical supplies respectively, and is responsible for the quality control of Roche marketed biotech products (e.g. Roferon-A, Neupogen, Zenapax, Herceptin, Mabthera, Pegasys, Avastin…) manufactured at Roche Basel.

Since 2010 Thomas is the global lead for technical regulatory policy and strategy for biologics within Roche.