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Committee & Speaker Biographies

Committee & Speaker Biographies

2019 PDA Annual Meeting

March 11-13, 2019, San Diego, CA

  • Ghada Haddad, MBA

    Merck & Co., Inc.

    Ghada Haddad is currently an Executive Director, leading the Global cGMP and Compliance Auditing Organization at Merck & Company. Prior to that she was the Head of the Global Quality Risk Management Center of Excellence, building a team of experts to develop and implement a robust and sustainable QRM program. She holds a chemistry degree and an MBA with over 22 years of experience, working in the Biotech and Pharmaceutical industries in the areas of Quality Risk Management (QRM), Validation, Quality Systems and Regulatory, including research, management (people and projects), process development, auditing, regulatory agency inspection, change control and validation. Haddad was the chair of the Paradigm Change in Manufacturing (PCMO) initiative: QRM in Packaging and Labeling, QRM for the Design, Qualification, and Operation of Manufacturing Systems task forces, a member of the Manufacturing of Drug Products Task Force, and co-chaired the Aging Facilities Points to Consider. She is also a faculty member for PDA’s Training and Research Institute and a Science Advisory Board member and a member of the PDA Board of Directors.

  • Melissa Seymour

    Melissa S. Seymour, MBA

    Biogen, Inc.

    Melissa Seymour is the Vice President of Global Quality Control for Biogen, Inc., assuming responsibility for the comprehensive strategy and implementation for Global QC testing of Raw Materials, Drug Substance, Drug Product and Finished Goods worldwide.   Prior to this, Melissa served as the Vice President of Corporate Quality with responsibility for global compliance and quality systems including management of Quality Systems, Internal and External Auditing and Global Affiliate GMP oversight.  Melissa holds BS degrees in both Biological Sciences and Biochemistry from North Carolina State University and an executive MBA from Duke University.  Melissa has over 20 years of experience in the quality arena including quality positions at Novo Nordisk pharmaceuticals and Glaxo Smith Kline.  Melissa has been highly active in the Southeast chapter of PDA for the last 5 years as a member of the local board, serving as Vice-President, President, and most recently, Past President.   She was recently elected to the Board of Directors for PDA.  Melissa is an ASQ Certified Quality Engineer, Certified Quality Auditor and Certified Quality Manager and has previously served on the Board of Directors for the Rx-360 Consortium focused on supply chain security.

  • Magaly Aham

    Magaly E. Aham

    Takeda

    Magaly currently works at Takeda as a Senior Director Quality Compliance for the Global Oncology & Biologics Division. Prior to joining Takeda she worked in consulting for Pharma-BioServ US Inc., MedImmune, Pfizer, Wyeth and Schering Plough in positions of increased responsibility. She holds a Bachelors Degree in Chemistry from the University of Puerto Rico and a Master Degree in Bioscience and Regulatory Affairs from the Johns Hopkins University in Maryland, US. She has comprehensive management experience in Quality Assurance, Quality Systems, Compliance, Quality Control, Validation and Manufacturing Operations. Magaly has participated as a lead in companies undergoing remediation efforts such as Consent Decrees and Warning letter environments in which she has developed expertise in quality systems design and implementation and Risk Management. She is Kepner-Tregoe Problem Solving Decision Making(PSDM) Certified Trainer, former ASQ Quality Auditor (CQA), US-RAC, and a PR Licensed Chemist. She was the PDA QRM IG Coordinator for the past couple of years and recently was appointed Co-Lead of this QRM IG.

  • Tia Bush

    Tia L. Bush

    Amgen Inc.

    Tia Bush is the Vice President of Site Operations at Amgen Rhode Island. She is responsible for all operations at Amgen’s 75-acre West Greenwich, RI campus where staff contribute to the manufacture of Enbrel, Vectibix and Repatha and clinical trial materials. She started her career at Amgen in 1992, after obtaining her Biological Sciences and Chemistry degree from the University of Southern California. She is the recipient of Amgen’s Excellence in Quality Award, Providence News “Women in Business-Industry Leader” Award, 2012 Healthcare Business Association Rising Star Award, and in 2017 received Providence Business News’ Outstanding Mentor recognition and in that same year received an award from Governor Raimondo and Million Women Mentors Rhode Island with a Stand Up for Stem award.

  • Ursula Busse, PhD, MBA

    Novartis

    Ursula is currently the Global Head of Quality Intelligence and External Affairs at Novartis. She drives the Novartis external engagement strategy in quality, technical and regulatory topics and leads global GxP regulatory intelligence.  Prior to her current role, Ursula held leadership roles in CMC Regulatory Affairs for biologics and in Biopharmaceutical Operations. Before joining Novartis in 2006, she worked for startup biotechnology companies in Canada for 10 years, in R&D, Quality Assurance and CMC Regulatory Affairs.  Ursula has been a long time member and volunteer of PDA. She received several PDA awards and served on PDA’s Board of Directors from 2012 to 2017. She is actively involved in a number of PDA committees and initiatives such as PDA PAC iAM, the PDA task force for post-approval changes. Ursula holds a Master’s degree in Biology from Tübingen University (Germany) and a PhD in Cellular and Molecular Biology from Laval University (Québec, Canada), coupled with an MBA she earned with honors.

  • Austin Caudle

    Austin Caudle

    IQVIA

    Mr. Caudle is Associate Director of Emerging BioPharma R&D Solutions at IQVIA, the Human Data Science Company™ that mobilizes unparalleled data, analytics, technology, and expertise through solutions connecting stakeholders to improve health. He has business experience across pharmaceuticals, biotech, and medical devices helping clients to proactively interpret regulations, understand processes and product technologies, make sound decisions, facilitate change, and drive business benefit. He assists Emerging BioPharma companies plan and implement highly targeted, data-driven clinical trials to advance an asset from first-in-man through global Phase III studies.  Mr. Caudle currently serves as President-Elect on the Board of Directors for the Parenteral Drug Association in the Southeast U.S. and on several conference planning committees.  He holds an MS in Food Science and a BS in Nutrition Science from Auburn University.

  • Carolyn Cohran

    Carolyn Cohran, PhD

    FDA

    Carolyn Cohran, Ph. D., serves as a Policy Lead in the Office of Policy for Pharmaceutical Quality (OPPQ) in the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) at the FDA.  The Office of Policy for Pharmaceutical Quality (OPPQ) is responsible for developing and communicating science and risk-based policies related to drug product quality.  Carolyn has led development of MAPPs and guidances and provided guidance to industry in the area of generic drug development.  Prior to joining OPPQ, Carolyn was a Quality Assessment Lead in the Division of Lifecycle API in the Office of New Drug Products (ONDP) in OPQ.  She has spent more than twelve years with the FDA.  Carolyn received her B.S. in Chemistry from Tougaloo College in Jackson, Mississippi, and her M.A. and Ph.D. in Chemistry from Washington University in St. Louis.

  • Steve Dawson

    Steve Dawson, MBA

    Genentech/Roche

    Steve Dawson is Head of Site Compliance at Genentech/Roche's Vacaville Manufacturing Drug Substance Facility. He has over 26 years of experience in pharmaceutical manufacturing, Quality, and regulatory compliance. He has held numerous positions in management and technical operations in both drug substance and drug product biotech manufacturing facilities. He is the President of the Parenteral Drug Association (PDA) West Coast Chapter.  Steve holds an MBA in Management from  the University of California, Davis, and a B.S. in Biology from California State University, Humboldt.

  • Michael R. De Felippis, PhD

    Eli Lilly and Company

    Michael R. De Felippis, PhD joined the Lilly Research Laboratories of Eli Lilly and Company in 1990 after completing his doctoral studies in biochemistry at The Ohio State University.  He is currently a Senior Research Fellow working in the Bioproduct Research and Development division.  His work is focused on development of protein and peptide biopharmaceutical products with particular emphasis on characterizing physicochemical properties, defining delivery options, developing control strategies, executing technology transfers and preparing data packages to support worldwide product licensing applications and post-launch registrations.  Dr. De Felippis has lectured and published manuscripts, review articles and book chapters on the subjects of protein and peptide structural characterization, comparability, analytical testing and formulation design/delivery strategies.

  • Randy George

    Randy J. George

    Randy George currently serves as the West Coast Sales / Account Director for ValGenesis, a position he has held since February 2018. ValGenesis is the leading provider of validation software to the life science and regulated industries; and the only company to receive PDA’s New Innovative Technology Award for being a first innovative software platform for electronic validation. 

    His experience in the life science industry began in 2007 working in various sales and business development roles, offering products, capital equipment, automation, quality management software, and services.  As a member of PDA and the SoCal PDA Board of Directors, he has held various positions and responsibilities supporting the chapter’s programs and initiatives. From vendor out-reach and vendor night coordinator, to membership and corporate outreach, he credits his time with PDA for making a successful career transition into the life science industry.

    Randy earned a degree in Public Justice form SUNY at Oswego with minors in Sociology, Psychology and Social Work, and spent 8 years with the Los Angeles Police Department as a reserve police officer. He also worked in the wine industry and was previously involved with Gulleyan Winery, Paso Robles, California.

    Prior to his involvement in life sciences, Randy has over 15 years’ experience in various management positions, including sales and business development. His experience also includes consumer product manufacturing, packaging, capital equipment, automation, quality assurance and quality control.  Benefiting from an extensive amount of management and sales training throughout his career, Randy has spent many years working with European companies developing new markets and sales opportunities in the US.

    Randy is currently the SoCal PDA Chapter President and on the planning committee for the 2019 PDA Annual Meeting.

  • Aaron Goerke

    Aaron R. Goerke, PhD

    Hoffmann-La Roche

    Aaron R. Goerke has over 15 years of industry experience in supporting pharmaceutical and biotechnology companies in the areas of process development, manufacturing and quality systems.  In his various roles, he has been responsible for developmental projects ranging from discovery to Phase III and supporting internal and external Biologics and Vaccine manufacture.  Aaron’s recent roles include Head of Global Engagement and Deployment at Hoffmann-La Roche and as Head of Downstream Global MSAT at Genentech, which included responsibility for CMO technology transfers ensuing supply agility, maintaining Make-Assess-Release efforts ensuring supply to patients, and ownership of various network strategic initiatives.  Efforts include serving as the Head of the Roche Process & Product monitoring program, establishing a Global Performance Analysis program spanning Large and Small Molecules and conceptualizing an IT solution in the age of “big data.”  Aaron is currently Director of MSAT at Roche Singapore Technical Operations.  He holds a Ph.D. in Chemical Engineering from Stanford University and has published a large number of peer-reviewed journal articles and patents, had numerous external presentations and has been presented a number of academic and professional awards.

  • Morten Munk

    NNE

    Morten Munk’s career is comprised of more than 30 years of experience within the global biopharmaceutical industry. 

    One common denominator for his work has been to ensure a holistic and broad perspective on biomanufacturing challenges from idea to established facilities. His key focus is to ensure compliant and cost-effective production through an optimal use of all relevant and available knowledge and technologies, such as PAT, Single Use Systems and continuous processing.

    Morten joined NNE as Global Technology Partner in 2015. In 2001 he was one of the co-founders of CMC Biologics (now AGC Biologics), after working 14 years at Novo Nordisk.

  • Diane M. Paskiet

    West Pharmaceutical Services, Inc.
    Diane Paskiet has over twenty years of experience with qualifying packaging and delivery systems for use with pharmaceutical products.   She is Currently Director of Scientific Affairs at West Pharmaceutical Services where she is involved in science and regulatory programs associated with safety and compatibility of packaging systems.  Previous to this role she was in charge of site operations for West-Monarch Analytical Laboratories. She is a co-recipient of the United States Pharmacopeia (USP) award for Innovative Response to a Public Health Challenge and Expert Committee member.  She serves as Vice Chair of Product Quality Research Institute (PQRI) Development Technical Committee (DTC) and Chair of Parenteral and Ophthalmic Drug Product Leachables and Extractables Working Group.

    Ms. Paskiet is also on the faculty of the Parenteral Drug Association Training Institute and author/co-author of papers related to pharmaceutical packaging. 
  • Shelley Preslar

    Shelley Preslar

    Azzur Group South East

    At Azzur, Shelley Preslar is responsible for establishing and maintaining client and personnel relationships within the Southeastern United States. Shelley has over 22 years of experience in the life sciences industry partnering with companies of all sizes and manufacturing capacity. Her projects have ranged in size and technical scope from small start-up validation projects to multimillion dollar remediation projects.

    Shelley has been a member and volunteer within PDA for over 15 years. She has held numerous positions on the Board of Directors for the PDASE chapter, including President. After being Chapter President, Shelley started spending more time supporting multiple projects at the international level.

    Currently, Shelley leads the PDA Facilities and Engineering Interest Group, whose mission is advancing understanding of existing and cutting-edge facilities and engineering developments internationally by promoting scientifically sound, practical technical information and education for industry and regulatory agencies. Additionally, she serves as a co-chair of two Task Force projects looking at various aspects dealing with Isolators and sits on the PDA Annual Meeting Planning Committee.

    Shelley holds a BS in Marine Biology, graduate studies in Physiology and Microbiology, and an MBA in Global Management. She has also served in the United States Army and Marine Corps.

  • Kelly Waldron

    Kelly Waldron, PhD

    Valsource LLC

    Kelly Waldron is currently a senior consultant with ValSource and a member of the Pharmaceutical Regulatory Science Team (PRST) at the Dublin Institute of Technology in Dublin, Ireland. She has particular expertise and a specialized focus on the development and implementation of innovative approaches to quality risk management (QRM) and has authored numerous industry and academic papers on the topic. Her expertise extends to various quality functions in the pharmaceutical, biopharmaceutical, and medical device industries, including quality system design, quality strategy and planning, deviations/investigations, CAPA, change management, data integrity, audit and inspection programs and response, stability programs, and design control. She holds a BA in biology from Boston University, an MBA in pharmaceutical management from Fairleigh Dickinson University, and a Ph.D. in pharmaceutical regulatory science (thesis in QRM) from the Technological University Dublin.

  • Karen Walker

    Karen Walker

    Seattle Genetics

    Karen Walker, VP of Global Quality for Seattle Genetics.  Karen brings >30 years’ experience in the biotech industry, holding positions in Technical Development, Regulatory Affairs and Quality. She has worked in a number of companies including Seattle Genetics, Novartis, Amgen, Bayer, and several other small to mid-sized biotech companies.

    Prior to joining Seattle Genetics, she held the role of VP and Global Head of Technical Development and Manufacturing for Novartis’ Cell and Gene Therapy Unit where she led the CMC teams through the formation of the strategies and the execution of those strategies to develop CTL019 (a CAR-T product) through the pivotal trial stage and to filing of the first CAR-T BLA in Pediatric ALL.

    Karen’s years of experience in Biopharma Technical Development, Quality, Regulatory CMC, and Manufacturing (including Cell and Gene Therapy), both within the US and Europe have contributed to honing a mind-set and approach that is strategic, forward looking and adaptive.  The challenges that are here in the Drug Development space, including shortened development time (4 years faster), complex supply chains, implementation of new and enabling technology and changes to the way we work, are all inspiring and energizing to Karen as the Pharma/BioPharm Industry evolves in the 21st Century.

  • Claus Abildgren

    Claus Abildgren

    Bigfinite Inc.

    Claus Abildgren is an accomplished business leader with more than 20 years of experience in manufacturing technology and engineering services across sales, business development, and marketing. He leads the global business development efforts at Bigfinite Inc and has deep domain expertise in Manufacturing Information Systems for the life sciences industries. His focus and passion is the next generation (Pharma 4.0) cloud-based manufacturing intelligence SaaS solution using Big Data and AI.  Prior to joining Bigfinite, Claus was launching sales in North America at Callisto Integration, following a role as Consulting Partner at NNE Pharmaplan where he was helping biotech and pharmaceutical manufacturers bring products to market more effectively. He also led the sales team at Brightidea, a bootstrapped and profitable enterprise B2B SaaS startup, serving some of the largest (Fortune 50/500) companies in the world, helping them innovate how they innovate. Claus holds a Master of Science degree in Engineering from the Technical University of Denmark, as well as a Master of Business Administration from the University of Southern California, Marshall School of Business.

  • John Ayres

    John D. Ayres, MD

    Pharma Safety Solutions, LLC

    Dr. John Ayres received his undergraduate degree in chemistry from Butler University in 1979 then received his Doctor of Medicine degree from Indiana University School of Medicine in 1983. He completed his residency at the Indiana University Medical Center and is Board Certified in Internal Medicine.

    Subsequently, Dr. Ayres obtained a Law Degree from Indiana University Bloomington in 1993 and was admitted as member of the Indiana and Federal bar before returning to the Indiana University School of Medicine as a faculty member.

    In addition to his clinical duties, Dr. Ayres established a risk management department and served on the Medical Center's Institutional Review Board (IRB). He has had clinical practices in both internal medicine and occupational and environmental medicine and has served in various consultative roles to both industry and government agencies. 

    For 15 years, Dr. Ayres has served as the Health Hazard Evaluation physician and Sr. Medical Fellow, Product Safety Assessments for a multi-national pharmaceutical company. In this role he worked closely with product development, manufacturing, quality, and pharmacovigilance to evaluate the human safety risk potentially associated with Critical Quality Attributes (CQAs), manufacturing and environmental excursions, linked to product complaints, or related to counterfeit medication issues including surveillance, risk assessment and management, and regulatory-compliance functions. Dr. Ayres now provides limited consultative assessments on these issues. He currently serves on the USP Visual Inspection Expert Panel and PDA’s Scientific Advisory Board.

  • Hal Baseman

    Hal Baseman

    ValSource LLC

    Hal Baseman is chief operating officer and a principal at ValSource LLC and ConcordiaValsource LLC.  He has over 39 years of experience in pharmaceutical operations, validation, and regulatory compliance. He has held positions in executive management and technical operations at several drug manufacturing and consulting firms.  He is the current Co-chair of the PDA Annex 1 commenting team.  He was the Chair of the PDA (Parenteral Drug Association) Board of Directors, the Co-Chair of the PDA Science Advisory Board, the Co-Leader of the PDA Aseptic Processing Points to Consider Task Force and the Co-Leader of the PDA Process Validation Interest Group, as well as a long-time member of the PDA Training Research Institute faculty. He has been a leader, author, editor and contributor to numerous technical reports, articles, books, and presentations on subjects related to Quality Risk Management, Validation, and Aseptic Processing. Hal holds an MBA in Management from LaSalle University and a B.S. in Biology from Ursinus College.  

  • Maria Bednar

    Maria M. Bednar, PhD

    Biogen, Inc.

    Maria is a scientist at Biogen, located in Research Triangle Park, North Carolina.  As part of the Analytical Technology department for the Quality Control organization she is responsible for the development and validation of NGS methods and implementing new assays for the global Quality Control Virology group. Maria joined Biogen in 2017 after receiving her Ph.D. in Chemistry from Duke University and completion of a Postdoctoral fellowship at the University of North Carolina at Chapel Hill.

  • Jon Coffman

    Jon Coffman, PhD

    Boehringer Ingelheim

    Dr. Jon Coffman is Global Head Innovation, Technology at Boehringer Ingelheim in Fremont, California. Jon and his team are instrumental in driving the implementation of BI’s bioprocessing innovation vision.

    Jon is an internationally recognized expert in bioprocess and technology development. Jon has more than 25 years of industry experience, mostly from his work at Genetics Institute/Wyeth and Pfizer, and now at Boehringer Ingelheim. Prior to 2009 Jon led a team in the area of downstream purification development, as well as CMC drug development teams. From 2009 on, as Associate Research Fellow, he coordinated Technology and Innovation for Bioprocess R&D, and led Pfizer’s monoclonal on demand team, developing concepts for faster, lower cost antibody process development.

    At BI, Jon heads the global innovation program in Biopharma, evaluating and guiding technology development in analytical, upstream, downstream, and formulation. He also leads a group of upstream and downstream scientists developing an integrated manufacturing platform in collaboration with Pfizer.

  • Beth Haas

    Beth Haas

    CAI

    Beth has focused much of her 20 year career performing new product introductions and technology transfers. She has commercialized 20+ products across a variety of industries including small molecule APIs, drug product, specialty chemicals, thin film, and commodity chemicals Using her knowledge of ICH guidances, she enjoys helping both large pharma and virtual companies identify key focus areas for product development, transfers, and scale-up. Her in-depth understanding of criticality enables her to guide organizations in defining accurate critical quality attributes, critical process parameters, and critical aspects for process equipment and laboratory systems. Beth joined the PDA Technology Transfer Interest group in 2015 where she has focused on building a generic tool for guiding technology transfer program management. She wants to build the PDA TT IG community with cross-functional expertise where knowledge on technology transfer strategies and best practices can be shared.

  • Polly Hanff

    Polly M. Hanff

    Saint-Gobain Life Sciences

    Polly Hanff is the Global Regulatory Affairs and Quality Director at Saint-Gobain Life Sciences with overall responsibility to assure the quality and compliance of single use systems manufactured for the pharmaceutical industry; including the cell therapy market. Polly has 15 years of experience in quality, compliance, risk management and regulatory affairs at several pharmaceutical operating companies. In her role at Saint-Gobain, Polly brings her experiences in pharma to the critical supplier where she collaborates toward increased partnership among the suppliers and pharma as a means to mitigate both business and quality risks.

  • Sven Hauptmann

    Sven Hauptmann, PhD

    F. Hoffmann-La Roche Ltd.

    Sven is the Global Head of the Drug Product Manufacturing Unit of Roche Pharma. In this role he is accountable for all drug product manufacturing and packaging operations performed within the company and by external partners. Sven has been with Roche since January 1997, holding various roles of increasing responsibility with Roche in Mannheim, Germany, before moving to Basel, Switzerland in 2002, Boulder, Colorado, in 2008, Clarecastle, Ireland in 2010 and back to Basel, Switzerland in 2012. His experience covers supply chain management, finance, project management, strategy and planning, as well as site management. Sven holds a PhD in Chemistry from the Technical University Darmstadt, and an MBA from Northwestern University in Evanston, Illinois.

  • Brian Hawkins

    Brian J. Hawkins, PhD

    Pluristyx, Inc.

    Dr. Hawkins is Chief Technology Officer at Pluristyx, Inc, which provides stem cell contract development and manufacturing services along with knowledge support to companies in the field of drug development, regenerative medicine, and cellular therapies. Dr. Hawkins received his Ph.D. in Molecular Cell Biology and Biotechnology from Virginia Tech and completed his postdoctoral training at the University of Pennsylvania, where he investigated how alternations in metabolism influence human disease and ultimately death. Dr. Hawkins is currently President-elect of the PDA Pacific Northwest Chapter and team lead on the PDA Cryopreservation Standards Task Force. Dr. Hawkins is also a current member of the International Society for Cellular Therapy, Biomedical Excellence for Safer Transfusion (BEST) Collaborative, AABB, Cord Blood Association, and Society for Cryobiology. Dr. Hawkins began his career as an assistant professor and founding member of the Mitochondria and Metabolism Center in the University of Washington School of Medicine where he focused on how alterations in cell metabolism influence both health and disease. Dr. Hawkins transitioned to industry in 2014 and served as Scientific Applications Director at BioLife Solutions. He retains an affiliate faculty position in the Department of Anesthesiology and Pain Medicine at the University of Washington.

  • Art Hewig

    Arthur Hewig

    Amgen Inc.

    Art Hewig is an Executive Director of Process Development at Amgen where he leads an integrated group that is designed to deliver early phase end-to-end drug substance processes. His team bridges the R&D and Manufacturing organizations and serves them by enabling fast to clinic approaches as well as developing state-of-the-art processes to manufacture molecules in Amgen’s synthetics and biologics pipeline. This team incorporates and develops the best technical advances and combines them with extensive commercial process development experience to develop robust processes. This includes developing manufacturing platforms for new modalities entering Amgen’s early phase pipeline. Art has been with Amgen since 2002 and has held numerous scientific and leadership roles for both early and late phase Process Development. Art holds a PhD in Chemical Engineering from Carnegie Mellon University.

  • Paige Kane

    Paige E. Kane, PhD

    Merck & Co. Inc.

    Paige Kane PhD, is a Director in the Merck Manufacturing Division, and a member of the MMD Knowledge Management (KM) Center of Excellence, joining in 2016 from Pfizer.  She is an industry leader with over 25 years in biopharmaceutical experience; including Genetics Institute, Wyeth, Pfizer, Monsanto and the US Government spending the past 11 years’ leading KM programs and approaches for the Pharmaceutical Industry.  Prior to her work in KM, Dr. Kane led Quality Systems Groups focusing on Automation Compliance Strategies, Change Control, Document Management, Computer/Equipment Validation and Data Integrity for during operations and new biotechnology facility startups in the US and Ireland. 

    Dr. Kane has been a member of the author team for several industry guidance documents (GAMP 5 and Electronic Records and Signature) as well as lead global ISPE Communities of Practice (GAMP and Biotech) and several strategic teams for industry organizations.  Dr. Kane currently Co-leads the ISPE/ PQLI Task Team on Knowledge Management.  She is a co-editor and multi chapter contributor for ‘A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry’ (2017) and holds a PhD in Pharmaceutical and Regulatory Science from Dublin Institute of Technology (Dublin, Ireland).

  • Sadik Kassim

    Sadik H. Kassim, PhD

    Mustang Bio

    Dr. Sadik Kassim has served as Chief Scientific Officer of Mustang Bio since March 2018.  Sadik joined Mustang in March 2017 as Vice President of Process and Analytical Development, where he led process development, analytical development and manufacturing strategy for Mustang’s CAR T therapies and oversaw preclinical research and pipeline expansion activities. Prior to Mustang, Sadik was Head of Analytical Development for Novartis’ Cell and Gene Therapies Unit in Cambridge, Massachusetts where he contributed the Biologics License Application filing for Kymriah™ (CD19 CAR T) in pediatric acute lymphoblastic leukemia and diffuse large B-cell lymphoma.  Earlier in his career, Dr. Kassim was a research biologist in the Surgery Branch at the National Cancer Institute, where he was involved in early research and CMC work that led to the development of Kite’s Yescarta™ (CD19 CAR T) for lymphoma.  Sadik held a senior research position in the Discovery Immunology Group at Johnson & Johnson and was a research fellow in the University of Pennsylvania’s (Penn) Gene Therapy Program where he led the initial discovery efforts and pre-clinical studies for an AAV8 gene therapy for familial hypercholesteromia.  This program is now in the clinic as part of RegenexBio’s RGX-501 program.

  • Douglas Kiehl

    Douglas Kiehl

    Eli Lilly and Company

    Douglas Kiehl is a Research Advisor at Eli Lilly and Company and leads the Characterization Mass Spectrometry, Extractables/Leachables and Elemental Impurities team.  He is responsible for Lilly’s global E&L strategy supporting development and qualification of container/closure and manufacturing systems and drug delivery devices.  His team’s responsibilities include performing structural characterization of process impurities, related substances, degradation products and contaminants across development and commercialization phases for the small and large molecule portfolios.  Mr. Kiehl has over 36 years' experience with application of advanced mass spectrometry in characterization of diverse chemical entities, 24 years of which are in the Pharmaceutical Industry.  He is a member of the USP Packaging and Distribution Expert Committee, the USP Expert Panel on Biocompatibility of Materials Used in Packaging Systems, Medical Devices and Implants, the USP Expert Panel on Elastomeric Closure for Injections, the ELSIE (Extractables/Leachables Safety Information Exchange) Board of Directors, the SPIE Defense and Commercial Sensing Committee and AAPS Impurities Steering Committee.  His research interests include the development of advanced mass spectrometry based mapping and visualization techniques to enable the rapid and comprehensive characterization of highly complex mixtures of structurally diverse chemical entities.

  • Amy Kim

    Amy A. Kim

    West Pharmaceuticals, Inc.

    Amy received her B.A. in Biology from Haverford College and has several years of experience as a scientist at various medical research institutes in Philadelphia.  Amy joined West and the Scientific Communications team to lead and execute commercially-oriented R&D projects in support of West products.  Amy specializes in component performance evaluation studies, product container closure integrity, and formulation characteristics. 

  • Garnet Kim

    Garnet Kim, MBS

    Gilead Sciences, Inc.

    Garnet joined the Regulatory Rotational Development Program at Gilead Sciences, Inc. upon graduating with a Masters in Bioscience in 2015. After 3 years in several Regulatory Affairs groups (Chemistry Manufacturing & Controls, Compliance, HIV Liaison, and Labeling), she has continued her career in Pharmacovigilance and Epidemiology. Currently, Garnet works as a Risk Management scientist for HIV products within the Medical Safety Sciences group.

  • Chester Kitchen

    Chester Kitchen

    Merck & Co., Inc.

    Chet Kitchen is a Director in Corporate Development at Merck & Co., Inc. supporting R&D, commercial, manufacturing, and business development functional areas.  Chet joined Merck in 2000 and held additional roles of increasing responsibility in Clinical Drug Metabolism, Project Management, and Medical Affairs and Policy.  Chet also worked in medical examiner facilities as a Forensic Investigator, Forensic Toxicologist, and Autopsy Technician prior to joining Merck.  While in his mid-40s, Chet was diagnosed with Stage 4 squamous cell carcinoma of the head and neck and was treated with the standard of care including multiple surgeries, chemotherapy, and radiation.  A year later, Chet faced his second battle with Stage 4 head and neck cancer and started additional treatments with a very poor prognosis.

  • Philip Kuhl

    Philip R. Kuhl, PhD

    Merck & Co., Inc.

    Dr. Philip Kuhl, earned his B.S. in Engineering from The Cooper Union and PhD from MIT. He started his career with Merck in 1997 in small molecule process development and pilot plant scale up. Thereafter he transitioned to large molecules, where he served as a design engineer, FAT, commissioning and qualification lead for a new drug substance facility, and then moved into start up lead and finally Integrated Process Team (Manufacturing Operations) lead for that facility. He has led technology transfer projects in the U.S., Singapore, Puerto Rico, and Ireland for both small and large molecule drug substances. Today, he leads a late stage process development, characterization and technology transfer group for candidate vaccines; he specializes in vaccine drug substance processes involving chemical reaction steps.

    Philip received an Executive MBA from Wharton in 2011 and served as a Merck Fellow for Global Health in 2014 at Bayalpata Hospital, Nepal, where he led a supply chain redesign effort for Possible, an NGO dedicated to providing free health care to the underserved of Achham province.

  • Greg Larsen

    Greg Larsen

    Civica Rx

    As a Business Partner on the Civica team, Greg works to build infrastructure and direct general business services and operations. He has previous experience directing company operations, establishing policies and procedures, and building strong mutually beneficial business relationships for the past 12 years. Most recently and over the past five years since completing his MBA and MHA studies at the University of Utah, he has worked in the outpatient healthcare environment of the University of Utah Health. There he established their outpatient project management office which included growth strategy, feasibility studies, design leadership, end user representation, research and establishment of system building standards, shared policies and documentation processes, equipment standards and procurement, as well as stakeholder communication and coordination leadership.

    To the Civica team Greg offers a generalist’s direction amongst the essential leadership of its long-standing industry professionals.

    Aside from his work, Greg and his wife raise their four young children in Utah where each are able to volunteer at their local Community Arts Theatre where Greg co-Chairs the annual fundraising gala.

  • Martin Lipa

    Martin J. Lipa

    Merck & Co. Inc.

    Martin (Marty) Lipa is an Executive Director in Merck Manufacturing Division (MMD) where he leads the Knowledge Management Center of Excellence. Lipa has over 10 years of KM experience, and related experience in Lean Six-Sigma and transformational change management.  Prior to working in KM, Lipa has experience in chemical, electrical and control systems engineering, Technical Operations, shop floor automation, SDLC, new GxP facility start-up and Information Technology in the US, Ireland and Singapore.  Lipa is an active member of the KM community a regularly invited speaker on KM, including engagements at APQC, NASA, Corning, Columbia University, Dublin Institute of Technology, the World Bank, and various industry groups including ISPE, PDA and CASSS, and as a planning member for several KM conferences.  Lipa has published several industry specific works, most recently as contributing editor to ‘A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry’ (2018), as well as works in ISPE Pharmaceutical Engineering and OD Practitioner.

  • Heather Prichard

    Heather L. Prichard, PhD

    Humacyte

    Dr. Prichard has been with Humacyte since 2008 and brings over 15 years of scientific, pre-clinical, and clinical leadership experience in the fields of tissue engineering, extracellular matrix biology, and biological response to implantable biomaterials. At Humacyte, Dr. Prichard oversees the development, qualification, and clinical translation of the bioengineered blood vessel platform for hemodialysis. She currently leads the product development organization with overall responsibility for vascular research and development, pre-clinical testing, process development for commercial manufacturing, and analysis and quality control testing of manufactured vessels. Dr. Prichard also works closely with our key vascular surgeons and nephrologists to develop their roles as PI’s for Humacyte. Prior to joining Humacyte, she received her Ph.D. from Duke University in Biomedical Engineering with a focus on investigating the healing response to implantable tissue engineered biomaterials. Prior to her doctoral studies, Dr. Prichard completed her Bachelors of Chemical Engineering at the Georgia Institute of Technology and worked as a Research and Development Engineer for Proctor & Gamble.

  • Linda Pulli

    Linda Pulli

    Merck & Co. Inc.

    Linda Pulli is the Chief of Staff; Executive Director of Global Supply Chain of the pharmaceutical company Merck & Co.  (known as MSD outside of North America). 

    After graduating from The Pennsylvania State University; Business Logistics she was hired by Merck & Co. in their Global computer procurement , after completing the installation of consolidated supply chain for global computer purchases, she was then accepted into the first class of the Merck Manufacturing Management Leadership Development Rotational Program, upon completion of the program she worked in roles of increasing responsibilities in  Animal Health,  Pharmaceutical and Sterile Manufacturing over 12 years. 

    In 2010 Linda became the Chief of Staff for Global Vaccines, Sterile & Biologics Operations for 5 years after the merger of Schering Plough and during the time of significant operational changes allowing Vaccine growth from $3B to $6B in revenue.  She was the Value Chain leader for Women’s Health products and Vaccines prior to her current role as the Global Supply Chain, Chief of Staff.

  • Divakar Ramakrishnan

    Divakar Ramakrishnan

    Eli Lilly and Company

    Divakar Ramakrishnan recently assumed the role of Chief Digital Officer of Eli Lilly and Company to lead enterprise level digital health strategy development and implementation. He also serves as Vice President of Delivery, Devices and Connected Solutions in Lilly Research Laboratories with R&D groups located in both Cambridge MA and Indianapolis, IN. Over the past 4 years, his team has delivered drug delivery and software devices for Lilly’s insulin and biotech portfolio, namely Humalog U200, Kwipen Junior, Humulin U500, Trulicity autoinjector, Taltz autoinjector, Trulicity app and GoDose Titration app. In addition, his team is now focused on next generation technologies spanning drug delivery and software/algorithm enabled connected systems. Divakar joined Lilly in 1998 as a senior scientist in Bioprocess R&D and has since held leadership positions in R&D and Manufacturing. He was also General Manager of Lilly S.A.in Ireland and Vice President at Lilly’s animal health unit, Elanco. Outside Lilly, Divakar has served in two start-ups, namely: Cook Pharmica, LLC and Moderna Therapeutics Inc. Divakar holds a Ph.D. in Chemical Engineering from the Penn State University and an MBA from Harvard Business School.

  • Nitin Rathore

    Nitin Rathore, PhD

    Amgen Inc.

    Nitin Rathore, Ph.D., is currently Head of Core Technologies, Process Development organization at Amgen Inc., Thousand Oaks, California. Dr. Rathore has expertise in formulation and fill-finish including process characterization, scale-up and technology transfer of early to late stage biopharmaceuticals. His group focusses on advancing novel manufacturing, automation and digital technologies in support of commercialization of liquid and lyophilized drug products. He has authored numerous publications including original research articles, book chapters and scientific presentations on drug product development and innovation in biomanufacturing. Prior to Amgen, he worked in the process optimization group at Novozymes, North America. Dr. Rathore received his Ph.D. degree in Chemical and Biological Engineering from University of Wisconsin-Madison, Madison, WI.

  • Yaritza Rodriguez

    Yaritza M. Rodriguez

    Amgen Manufacturing Limited

    Yaritza Rodriguez is Risk Management Manager at Amgen Manufacturing Limited. During her 13-years in the pharmaceutical industry, Yaritza has led Business Continuity & Crisis Management programs, establishing, maintaining and improving it for complex manufacturing environments. Oversaw recovery activities after hurricane María and multiple emergency response events over the last decade. Before this role, Yaritza was Project Manager at the Resource Center for Science & Engineering at the University of Puerto Rico where she was in charge of the Biotechnology and Neuroscience grant programs sponsored by the National Institutes of Health (NIH). Yaritza holds a master's degree in Risk Management, Security & Business Continuity from Boston University and is Certified Business Continuity Professional (CBCP) from Disaster Recovery Institute (DRI). In her spare time, she enjoys traveling and spending time with her family.

  • Michael Thien

    Michael P. Thien, Sc.D.

    Merck & Co., Inc.

    Dr. Thien has worked in new product and process development at Merck for over 25 years. After receiving his B.S. in Chemical Engineering from Caltech (1982), an Sc.D. from MIT in biochemical engineering (1988) and a post doc at the Whitehead Institute of Biomedical Research, Mike joined the Merck Research Labs, working in vaccines and recombinant proteins.  Mike was process development leader and plant start-up leader for the first effective commercial HIV protease inhibitor, CRIXIVAN (for which he was given the division’s top recognition) and made key contributions to Merck’s JANUVIA (a treatment for Type II diabetes) and Merck’s efforts in Quality By Design and Knowledge Management.

    Dr. Thien has worked in new product and process development at Merck for over 25 years. After receiving his B.S. in Chemical Engineering from Caltech (1982), an Sc.D. from MIT in biochemical engineering (1988) and a post doc at the Whitehead Institute of Biomedical Research, Mike joined the Merck Research Labs, working in vaccines and recombinant proteins.  Mike was process development leader and plant start-up leader for the first effective commercial HIV protease inhibitor, CRIXIVAN (for which he was given the division’s top recognition) and made key contributions to Merck’s JANUVIA (a treatment for Type II diabetes) and Merck’s efforts in Quality By Design and Knowledge Management.

  • Steve Thompson

    Steve Thompson

    Science 37

    Mr. Thompson has a Bachelor of Science in Computer Information Systems and has worked in Life Sciences for over 20 years. Steve was certified as a PDA computer systems auditor, has audited hundreds of companies globally, is a published author, and frequently speaks at conferences. Currently he is Director Computer Quality Assurance at Science 37 and is responsible for all regulated systems including NORA, the Network Oriented Research Assistant developed by Science 37, which is cloud-based technology that brings research directly to patients in their homes through telemedicine.

  • Per Vase

    Per Vase, PhD

    NNE

    Per Vase is an acknowledged data analysis expert with more than 30 years of experience. His focus is on applying Six Sigma in good manufacturing practice (cGMP) environments, combining compliance and process optimization efforts to ensure both high quality and low costs. Per Vase holds a Ph.D. in materials science from the Technical University of Denmark and an M.Sc. in experimental physics from Aarhus University.

  • Leo Vaytsman

    Leo Vaytsman

    Takeda

    Leo Vaytsman is currently the Regional Manager for Takeda’s Global Product Protection team. Leo’s focus is on driving the Supply Chain Security strategy for the organization by engaging in risk-based, holistic product protection activities to protect patients and safeguard Takeda’s products.

    During his tenure with Takeda, Leo has proactively partnered with international and local law enforcement, regulatory agencies, other pharmaceutical companies and industry organizations to combat counterfeiting and illegal trading, while also educating patients, supply chain partners and customers on the dangers associated with these activities.

  • John Wass

    John D. Wass

    CAI

    John Wass is responsible for directing a services portfolio catered to helping the industry rapidly deploy safe, efficacious drug products to the market and maintain strategic on-market product supply. Over the past 13 years he has participated in many stages of the product development lifecycle from concept to new market commercialization, and has implemented enterprise quality data management and manufacturing process control systems in support of these product processes. John focuses primarily on large, complex tech transfer programs and has transferred numerous products from CMOs to In-house domestically, as well as within network to international greenfield facilities employing a retrospective QbD approach. Previously he served in site project lead roles focusing on off-market and drug shortage product re-launches, as well as global expansion of on-market products to new international markets. Prior to CAI, he worked for a start-up medical device company specializing in the development of in situ polymerizing hydrogels as internal sealants, where he actively participated in the development, characterization, and commercialization of novel products. John earned his B.Sc. in Biochemistry at the University of Virginia, where he researched solid phase extraction techniques for application in a fully integrated microdevice capable of genetic analysis.

  • Staci Williams

    Staci Williams

    Adaptimmune, Inc.

    Staci Williams, MS joined Adaptimmune as a Microbiologist in March 2018. Staci supports the clinical manufacture of Adaptimmune's autologous T-cell therapy products, as well as the implementation of cGMP systems and methods in the microbiology laboratory. Staci led the implementation of the MODA-EM software to allow for the electronic documentation of Environmental Monitoring and QC Microbiology laboratory testing. Prior to Adaptimmune, Staci has worked in various roles within Quality and Microbiology at Spark Therapeutics, AstraZeneca, and Johnson & Johnson.

    Staci received her B.A. in Biochemistry and Psychology from New York University and her M.S. in Regulatory Science from Johns Hopkins University.

  • Andrew Wood

    Andrew M. Wood, MS

    Voyager Therapeutics

    Andrew Wood is a chemical engineer with over 10 years of biotechnology industry experience, focused on bioprocess development, clinical and commercial manufacturing support, and process validation. Andrew joined Voyager Therapeutics in 2018 as the Lead of Downstream Process Development. Andrew most recently was a Senior Manager at Axcella Health, where he was responsible for the purification, formulation, manufacturing, and supply chain of APIs and proteins from various bacterial expression systems.  Prior to Axcella, Andrew worked at Sanofi Genzyme as part of the Manufacturing Sciences and Technology (MSAT) group and Pfizer as part of the Purification Process Development group, both of which focused on protein biologics.  Andrew holds a BS in Chemical & Biological Engineering and a MS in Biotechnology Engineering, both from Tufts University.

  • Arne Zilian

    Arne Zilian, PhD

    Novartis Pharma AG
    Arne has 20 years of experience in the Pharmaceutical Industry. He has worked in Analytical Development, Chemical Development, Pharmaceutical Development, Manufacturing Operational Excellence and Manufacturing Science and Technology.

    In Novartis, he is the global program lead for ‘Predictive Processing’ and for Continued Process Verification. He serves as the lead author for the cross-divisional quality standards process validation and for CPV. Over the last years, he was instrumental in building the Manufacturing Science and Technology organization.

    In PDA, he is engaged in the interest groups for CPV and Manufacturing Intelligence.

    Arne holds a Ph.D. in Analytical Chemistry and a Master in Chemistry. He is also a certified Kepner Tregoe trainer for situation, decision and problem analysis.