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Conference Speakers

We've assembled some of the industry's leading experts at INTERPHEX 2013. Whether you participate in the conference sessions the keynotes or the technical workshops, you'll gain valuable information and education while improving your professional development.

Speaker TitleCompany
Jean-Pierre Allard Product Manager Serialization
Michalle J. Alleman Adkins Manager, Life Science Industry Consulting Emerson
Par Almhen President ModularPartners
David Armbruster Global Program Manager DePuy Synthes
Carl Anderson Associate Professor Duquesne University, Center for Pharmaceutical Technology
Keith Bader Sr. Director of Technology Hyde Engineering + Consulting, Inc.
Padam Bansal, Ph.D. Vice President, Research & Development Amneal Pharmaceuticals
Fidelma Callanan Sr. Director, Contract Pharma Services Alkermes
Cetin Cetinkaya Professor Clarkson University
Bikash Chatterjee President and CTO Pharmatech Associates
Gabrielle Cosel Project Manager, Drug Safely Project Pew Charitable Trusts
Richard Creekmore US Technology Manager AstraZeneca Pharmaceuticals
John Cunningham Design Partner ACi
James K. Drennen III Associate Processor Duquesne University, Center for Pharmaceutical Technology
Robert Dream Principal HDR Company LLC
Stephen J. Fadden, P.E. Sr. Director Johnson & Johnson
Roy R. Fennimore Jr. Research Fellow Product & Process Scientific Solutions (P2S2) - Johnson & Johnson
Alan Fisher Business Development Manager/Contamination Control Specialist Dycem USA Limited
Curtis Gingles Vice President, Business Development Jubilant HollisterStier Contract Manufacturing & Services
David Gleeson Associate Director, Manufacturing Systems Bristol Myers Squibb
Lee Goldberg Director, Syndicated Research The Zitter Group
Dave Goswami CEO/Managing Director IPS-Integrated Project Services
Joel Grosser Associate Booz Allen Hamilton
Victor Hernandez Project Engineer III EMD Millipore
Benoit Igne Research Coordinator Duquesne University, Center for Pharmaceutical Technology
Hank Jibaja Project Manager Nephron Pharmaceuticals
Erik Johnson Sr. Application Specialist Umetrics - An MKS Company
Detlef Kehm Vice President, Maintenance and Engineering Services Grifols
H. Steven Kennedy Director, Life Sciences + Chemicals M+W U.S., Inc. (A Company of the M+W Group)
Chuck Krumwiede Vice President/Managing Partner Malcom Associates
Sandra Lueken Sr. Director Quality Assurance MedImmune
Jim Miller President PharmSource Information Services, Inc.
Jennifer Markarian Manufacturing Editor Pharmaceutical Technology
Jason R. Money Senior Director for Federal Government Affairs Generic Pharmaceutical Association
Walt Murray Director of Quality and Compliance Services MasterControl Inc.
Rajesh Nair President Indegene
Morgan Palmer Chief Technology Officer EtQ, Inc.
Adrian Pask OEE Expert Vorne Industries
Tom Piombino Director of Operations IPS – Integrated Project Services
Edward Price President and CEO PCI Synthesis
Elizabeth Rivera Technical Service Specialist STERIS
Mike Salinas Director of Manufacturing Technology M+W U.S., Inc. (A Company of the M+W Group)
Craig Sandstrom Director, Process Engineering Fluor
Joe Scioscia Vice President VAI (Vormittag Associates, Inc.)
Jaspreet S Sidhu Ph.D. Vice President Business Development & Pharmaceutical Microbiology Molecular Epidemiology
Nirav Shah Sr. Application Specialist Umetrics - An MKS Company
Josef Trapl Technology Manager Pharma/Medical Devices M+W U.S., Inc. (A Company of the M+W Group)
Glenn Van Buskirk Managing Partner Nonclinical Drug Development Consulting Services. LLC
Christopher Verbicky, PhD, MBA Director of Business Development and Marketing Coldstream Laboratories, Inc.
Veda Walcott Vice President of Quality Cook Parmica LLC
Shane Yount Principal / Author Competitive Solution, Inc.

Jean-Pierre Allard

Product Manager
Serialization

Mr. Jean-Pierre Allard has 12 years of experience in the vision industry. Mr. Allard began his career in Spectrometer Design and R&D project management. Mr. Allard is the Serialization Solution Manager for Optel Vision and is working on the design and road map for vision and software solutions to address serialization needs for numerous countries and products. Working closely with various global implementations projects and as an active member in GS1 US Healthcare, Mr. Allard is recognized as one of the serialization subject matter experts.

Track: Mini-Course: Serialization

Presentation:Manufacturing Intelligence: Serialization to Improve Processes

Presentation:Wrap Up Panel: Understanding the Complexities of Serialization

Michalle J. Alleman Adkins

Manager, Life Science Industry Consulting
Emerson

Michalle Adkins has over 20 years of pharmaceutical industry related experience including 13 years with Merck & Co, Inc. She has been a life sciences consultant with Emerson for 8 years, and was recently appointed as manager of the life sciences industry consulting team. In consulting engagements Michalle uses her varied experiences including project management, planning, manufacturing, automation, and engineering. Michalle has worked with several top pharmaceutical and biotech companies providing consulting services in operational excellence related activities, project justification & definition, system & technology upgrade planning, and front end engineering & design definition. Ms. Adkins has a B.S. in Chemical Engineering and an M.E. in Industrial Engineering both from The Pennsylvania State University and a Lean Six Sigma Master Black Belt Certification from Villanova University. She has been a speaker at conferences and has authored several articles for trade journals including Trimming Technology Transfer with Automated Solutions published in Life Science Leader in November 2011

Track: Manufacturing & Packaging

Presentation: Panel: Road Map to Implementing EBR

Par Almhen

President
ModularPartners

Pär Almhem is the Co-Founder and President of ModWave LLC. ModWave is a solutions provider to the Pharmaceutical, Biopharmaceutical, Food and Process Industries in North America, partnering with world class suppliers to these industries. ModWave's partners include Lödige and Hecht of Germany, Telstar of Spain, and ModularPartners.

Pär Almhem is also the President and Co-Founder of ModularPartners, a leading supplier of modular and hybrid process and facility solutions to the Life Science, Process and High-Tech Industries worldwide.

Prior to his current engagements, Mr. Almhem was President of Pharmadule, Inc., the U.S. entity of Pharmadule AB of Sweden who was the pioneer supplier of high-tech modular production facilities to the Pharmaceutical and Biotech industries.

Almhem holds a Master of Science Degree in Applied Physics and Electrical Engineering from Linköping University, Sweden.

Track: Facility & Process Design

Presentation: Panel: Getting Excited About The Modular Experience!

David Armbruster

Global Program Manager
DePuy Synthes

BS in Materials Engineering, MS in Biology and MSE in Bioengineering. 18 years experience in the medical device industry, primarily in cardiology and orthopedics. the last 13 years with DePuy Synthes in various roles in R&D, Development Engineering, and project and program management. Currently manage a group of scientists and engineers focused on polymeric biomaterials and drug delivery technologies.

Track: Product Development

Presentation: Combination Product Development: Drug Products for Device Companies

Carl Anderson

Associate Professor
Duquesne University, Center for Pharmaceutical Technology

In addition to his 10-year focus on analytical methods capabilities assessment and pharmaceutical manufacturing while at Duquesne University, Dr. Anderson spent the previous 7 years working in the pharmaceutical industry. During this time, he was directly responsible for implementing process analytical technology solutions.

Track: Product Development

Presentation: Regulatory Strategy for Implementation of QbD and PAT in a Pharmaceutical Manufacturing Environment

Vlasois Andronis


Abbott

Bio Coming Soon!

Track: Product Development

Presentation: Presentation Coming Soon!

Keith Bader

Sr. Director of Technology
Hyde Engineering + Consulting, Inc.

Keith Bader is the Sr. Director of Technical at Hyde Engineering + Consulting, Inc. He is responsible for the implementation of quality and technical standards for Hyde Engineering + Consulting, Inc. on a corporate-wide basis. In addition, Keith serves as project manager for validation and engineering projects, as well as providing high level strategic consultation to Hyde Engineering + Consulting, Inc.'s clients. Since joining Hyde in 1999, as a Control Systems Engineer, Keith has gained experience on a variety of projects ranging from project engineering and commissioning to process and cleaning validation projects. Keith has experience working with biopharmaceutical process equipment ranging from stand-alone unit operations such as CIP and Ultrafiltration skids, to entire process trains. Keith earned his bachelors degree in Chemical Engineering from the University of Colorado at Boulder in 1995.

Track: Facility & Process Design

Presentation: Establishing a Design Space Cleaning Process Development and Validation

Dr. Padam Bansal

Vice President, Research & Development
Amneal Pharmaceuticals

Dr. Bansal received his Ph. D. in pharmaceutics from the University of Kansas in 1976. He started his career at Pfizer where he served as a scientist in the formulation of aerosol drug products for inhalation and improving drug therapeutics. Then Dr. Bansal joined Ortho Pharmaceuticals where he was instrumental in developing solids, semisolids and liquid dosage forms for NDA submissions. In 1982, Dr. Bansal joined Berlex Laboratories (Schering AG) where he served as a director of pharmaceutical development. In 1988 Dr. Bansal joined Long Island University as a professor of Pharmaceutics and Program Director of Industrial Pharmacy. In 2007, Dr. Bansal joined Amneal Pharmaceuticals where he is currently serving as a Vice President of Research & Development. He has successfully directed and facilitated submission of over thirty ANDAs towards solids, semisolids, solution, suspensions and nasal spray products. He continues to add value to the Amneal's Product-Portfolio.

Track: Regulatory QA/QC

Presentation: Panel: Understanding GDUFA

Fidelma Callanan

Sr. Director, Contract Pharma Services
Alkermes

Fidelma Callanan is Senior Director of Marketing and Commercial Development at Alkermes Contract Pharma Services. She has over 20 years experience in the Pharma industry and has held numerous roles over her career in marketing and business development. Ms Callanan joined Alkermes as part of the merger with Elan Drug Technologies in September 2011. Prior to that, she held numerous managerial roles of increasing responsibility in Elan including her most recent role prior to the merger as Head of their Drug Delivery Marketing group. Other roles over her pharma career have included that of Business Analyst, Client Relationship Management and Market Intelligence positions. Ms Callanan received a Bachelor of Education degree from University of Limerick, Ireland and a Masters in Business Administration from Coventry University in the UK.

Track: Manufacturing & Packaging

Presentation: Highly Potent, Poorly Soluble Product Manufacturing Contract, with 100% OTIF

Cetin Cetinkaya

Professor
Clarkson University

Professor Cetinkaya's technical background is in acoustics, vibration and thermoelasticity, and nano/micro-scale adhesion. His research projects are in the areas of mechanical property characterization and quality monitoring of drug tablets, motion and adhesion/removal of nano/micro-particles, and specialized sensors and algorithms for non-contact/non-invasive process monitoring, and characteriza-tion/testing/analysis of drug tablets and pharmaceutical materials, transdermal drug delivery,. These externally funded projects for the Photo-Acoustics Research (PAR) Laboratory focus on a set of critical applications in pharmaceuticals manufacturing, health care and nanotechnology as well as semiconductor manufacturing and MEMS sensors. These research projects have been funded by various federal, state and industrial sources the National Science Foundation, Intel, SEMATECH, Xerox Corp., Wyeth Pharmaceuticals, Pfizer Inc., Consortium for the Advancement of Manufacturing in Pharmaceuticals (CAMP), Praxair/Electronics, and the US Army. He is an ASME Fellow.

Track: Manufacturing & Packaging

Presentation: Mechanical Characterization, Testing and Defect Monitoring of Tablets: A Review

Bikash Chatterjee

President and CTO
Pharmatech Associates

Mr. Chatterjee has more than 30 years' experience in the pharmaceutical, biosciences, medical device/diagnostic and nutraceutical/dietary supplement industries. He has held senior management positions in operating companies for more than a decade and has successfully brought multiple drug and product platforms through the FDA regulated development process to market. Throughout his career he has been responsible for product development, technology and process transfer and technology and established global supply chain processes in over 40 different countries around the world and been responsible for the commercialization of over a dozen products.

Mr. Chatterjee sits on several scientific advisory boards for pharmaceutical and medical device companies. He is a standing member of the editorial advisory board for Pharmaceutical Manufacturing, the premier journal for the U.S. pharmaceutical industry and writes a recurring column for several magazines on industry trends and challenges. He has published over 60 articles and editorials throughout his career in peer reviewed journals.

Mr. Chatterjee is a Certified Lead Assessor and a Lean Six Sigma Master Black Belt. He holds a BA in Biochemistry and a BS in Chemical Engineering from the University of California at San Diego.

Track: Supply Chain

Presentation: Securing Information as Part of the Global Supply Chain

Track: Thursday Presentation

Presentation: Framework and Case Study for Implementing the New Process Validation Guidance

Gabrielle Cosel

Project Manager, Drug Safely Project
Pew Charitable Trusts

As Project Manager of the Drug Safety Project, Gabrielle manages initiatives to protect consumers through reforms related to the safety and oversight of the U.S. pharmaceutical supply chain. Pew's supply chain work examines issues related to global and outsourced manufacturing, pharmacy compounding, drug shortages, FDA regulatory activity, and drug distribution system risks. Gabrielle is co-author of the Pew report, After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs. Prior to joining Pew, Gabrielle worked on issues of pharmaceutical safety and appropriate prescribing for national advocacy organization Community Catalyst. Gabrielle holds an MSc in Human Rights from the London School of Economics (2007) and a BA from Yale University (2002).

Track: Mini-Course: Serialization

Presentation: Economic Impact Of Implementing A National Serialization And Traceability System

Richard Creekmore

US Technology Manager
AstraZeneca Pharmaceuticals

Richard Creekmore is currently the US Technology Manager at AstraZeneca Pharmaceuticals in Wilmington, DE. He has over 25 years of experience in pharmaceutical industry working in the area of formulation and technology transfer. Dr. Creekmore has worked at AstraZeneca for 24 years. At AstraZeneca, Dr. Creekmore led a formulation team that developed products from early development which culminated in technology transfers to Operations including two high revenue products. He is a member of AAPS and ISPE and has served on the USP Excipient Monograph 2 Committee, PQRI Technical Group for Risk Management, and is currently serving as a member of the IQ Consortium Drug Product Leadership Group. Dr. Creekmore received his Ph.D. in Pharmacy from the University of Iowa. He received his B.S. in Pharmacy and M.S. in Pharmacy (specializing in Nuclear Pharmacy) from The University of North Carolina at Chapel Hill.

Track: Product Development

Presentation: Process Robustness: From Development to Life Cycle Management

John Cunningham

Design Partner
ACi

As design partner at ACi, John Cunningham has earned local and national acclaim throughout his nearly 30-year career for design contributions to various projects integrating authentic architecture with art and landscape. John has in-depth national projects to his credit on landmark projects including national memorial parks, cities, revitalization districts, transit-oriented development, public-private partnerships and historic preservation. Adding to his portfolio of life sciences institutes, academic facilities and hospitals, John recently worked with Nephron Pharmaceuticals Corporation to develop the design of its 1,200,000-square-foot manufacturing facility in South Carolina. Currently under construction and slated to earn LEED Gold certification, the facility will serve as the company's second headquarters and include space for research and development. John is an adjunct professor at Rollins College where he teaches Florida Architecture-Urban design and Placemaking for the Master's Program of Civic Urbanism. He received his Bachelor's and Master's degrees in Architecture from Oklahoma State University.

Track: Facility & Process Design

Presentation: Purpose-driven Design: Savings for Pharmaceutical Facilites

James K. Drennen III

Associate Processor
Duquesne University, Center for Pharmaceutical Technology

Dr. Drennen is the Associate Dean for Research and Graduate Programs in the Mylan School of Pharmacy and Graduate School of Pharmaceutical Sciences at Duquesne University, and the Noble J. Dick Endowed Chair in Academic Leadership. He has 25 years of experience in analytical spectroscopy and pharmaceutical processing.

Track: Product Development

Presentation: Regulatory Strategy for Implementation of QbD and PAT in a Pharmaceutical Manufacturing Environment

Robert Dream

Principal
HDR Company LLC

Robert F. Dream is an industry leader, 29+ years of experience in the biopharmaceutical industry. Management leadership, lead projects, improved processes, scaled up products through operations and technology knowledge, through developing, translating, and executing supply chain and manufacturing strategies. Business minded and functional knowledge of manufacturing, warehousing, logistics, supply chain, risk mitigation and risk management. Experience includes Upstream and Downstream Processing, Aseptic manufacturing, Process Scale-up, Process Yield Optimization, and Program Management, cGMP regulatory GAP Analysis and Audits. Extensive global experience in the field. Numerous Publications, presented at conferences for ISPE, PABIO, INTERPHEX, AIChE, and ASME, and Universities. He is a registered professional engineer and is an active member of ISPE and PDA. He is a member of the Pharmaceutical Processing Editorial Advisory Board, Pharmaceutical Manufacturing Editorial Advisory Board, and INTERPHEX Advisory Council. He is a graduate from Illinois institute of Technology (BS and MS) and Drexel University (PhD) Program.

Track: Manufacturing & Packaging

Presentation: Biopharma's Flexible Imperative

Stephen J. Fadden, P.E.

Sr. Director, Process Engineering
ohnson & Johnson

Steve has over 30 years experience in the biopharmaceutical industry, the last 16 years with Johnson & Johnson/Centocor. He has played key roles in the engineering, design, construction, and start-up of several large biological production projects in the US and Europe totaling nearly $1 billion in installed capital. He is a grdualte of the Pennsylvania State Univeristy and a register Professional Engineer.

Track: Supply Chain

Presentation: Commercialization Outside The Us: What are the Challenges

Roy R. Fennimore Jr.

Research Fellow
Product & Process Scientific Solutions (P2S2) - Johnson & Johnson

Research Scientist (28 yrs.) in the R+D Pharmaceutical/Biotech/Medical Device Industry focused on Consumer/Medical/Pharmaceutical Products/Processes. Career experience includes Formulation/Process Development. Technical Support/Troubleshooting for Manufacturing. Scale-up/Technology Transfer/Process Validation of products to commercial manufacturing. J&J Certified Black Belt.

Track: Product Development

Presentation: Pharmaceutical Technology Transfer Practices into Design Control for Convergent Products

Alan Fisher

Business Development Manager/Contamination Control Specialist
Dycem USA Limited

Alan is a Contamination Control Specialist who has been involved in working with and advising Pharmaceutical and Medical Device Manufacturers on controlling contamination in the USA, UK, Europe and Asia. He is a seasoned and experienced Speaker who serves on several Working Committees globally relating to Risk Management in controlled and critical environments particularly ISO14698. Alan is also on the Management Committee of the Pharmaceutical and Healthcare Sciences Society and an active member of IEST.

Track: Manufacturing & Packaging

Presentation: Risk Management of Contamination and Cross Contamination in Pharmaceutical Manufacturing

Curtis Gingles

Vice President, Business Development
Jubilant HollisterStier Contract Manufacturing & Services

Mr. Gingles has a proven, impressive track record as an individual contributor, a manager and a leader in securing new business and building lasting relationships with customers. Mr. Gingles has over 12 years of managerial experience in the pharmaceutical industry, in various Quality, Manufacturing, R and D and Marketing and Sales roles. He is currently the Vice President of Business Development at leading contract manufacturer, Jubilant HollisterStier. Mr. Gingles has served in varying Marketing and Sales positions at DSM Pharmaceuticals, Inc., starting as a Business Development Director, then leading the Business Development group, and most recently leading the Business Development and Account Management groups. Before DSM, Mr. Gingles was recognized at Abbott Laboratories, Hospital Products Division and Hospira, Inc. for significant contributions in process and program management. Mr. Gingles has a Bachelor of Science degree in Business Administration from Gardner Webb University. Curtis joined Jubilant HollisterStier in 2011.

Track: Supply Chain

Presentation: Supply Agreements; Strengthening the Linchpin of Your Outsourcing Partnership

David Gleeson

Associate Director, Manufacturing Systems
Bristol Myers Squibb

David Gleeson is currently Associate Director, Manufacturing Systems at Bristol-Myers Squibb's (BMS) Large Scale Cell Culture (LSCC) facility in Devens, MA. David received a Bachelors Degree in Chemical Engineering from University College Dublin, Ireland. His career began as a project engineer in the food / dairy industry before transitioning to the pharma sector at Bristol-Myers Squibb in 1999. David has worked in a number of functions at BMS including Manufacturing Operations, Process Engineering, Projects and Technical Services. In 2009, David relocated from Ireland to the US to BMS facility in Devens.

Track: Manufacturing & Packaging

Presentation: Road Map to Implementing EBR

Lee Goldberg

Director, Syndicated Research
The Zitter Group

Lee Goldberg, Director, Syndicated Research is responsible for managing The Zitter Group's syndicated primary research products. With each syndicated product surveying one-hundred decision makers in managed care organizations twice each year, few, if any people have a greater number of interactions with key payer professionals. Across the Managed Care Oncology Index, the Managed Care Benefit Design Index, and the Managed Care Biologics and Injectables Index, The Zitter Group analyzes payers' thoughts and policies on oncology therapies, specialty medications, and commercial benefit design, with an eye toward understanding how they impact patient access. Lee joined The Zitter Group in 2010 as its Senior Manager of Syndicated Research. Previously, Lee worked at Medco Health Solutions where he consulted corporate clients, helping them align the financial structure of their pharmacy benefits with their human resources philosophies. Lee holds an MBA from Rutgers and a Bachelor of Arts from the University of Virginia.

Track: Supply Chain

Presentation: How Commercial Payers Restrict the Specialty Supply Chain

Dave Goswami

CEO/Managing Director
IPS-Integrated Project Services

Dave has more than twenty-four years leadership experience in facility design and engineering for hi-tech, high performance facilities. Prior to joining IPS, he held the position of Chief Mechanical Engineer at a major architectural/engineering firm. Throughout his career, he has specialized in biohazard facility design, hi-tech laboratories, large corporate headquarters, animal facilities, data centers, utility plant design, wastewater recovery and energy based projects for a broad range of industries. He is a registered engineer and involved with many industry-specific associations, such as the International Society of Pharmaceutical Engineers (ISPE), American Society of Mechanical Engineers (ASME), and the American Society of Heating, Refrigeration and Air-conditioning Engineers (ASHRAE). Dave has been published in several industry and trade publications and has presented as a subject matter expert for a number of national organizations and associations.

Track: Supply Chain

Presentation: Business Continuity for Biopharmaceutical Companies: Real Implementation of Operational Excellence

Joel Grosser

Associate
Booz Allen Hamilton

Joel Grosser is an Associate with Booz Allen Hamilton, a major consulting firm based in Virginia. Mr. Grosser's consulting projects have included: an analysis of prescription drug counterfeiting, theft, and diversion in the U.S.; medical device spend, and supply chain and strategic sourcing recommendations for a major government client; unique device identification in the U.S. medical device market; and supply chain strengthening in developing nations. Prior to Booz Allen, Mr. Grosser managed strategic and tactical procurement for a major public health project funded by USAID. He also led raw material supplier management, strategic sourcing, and supply security initiatives for a major supplier to the biotech, pharmaceutical and laboratory markets.

Track: Mini-Course: Serialization

Presentation: Economic Impact Of Implementing A National Serialization And Traceability System

Presentation: Wrap Up Panel: Understanding the Complexities of Serialization

Victor Hernandez

Project Engineer III
EMD Millipore

Víctor J. Hernández is Senior Project Engineer III in charge of Capital Projects and Validation Consulting for EMD Millipore Corporation in Jaffrey, NH Site. He has over 25 years experience in the Pharmaceutical, Biotechnology, Medical Device and Food industries. Has held numerous roles over his career in Engineering, Technical Services, Validation and QA. Before becoming an EMD Millipore employee, Víctor managed his own consulting firm in Puerto Rico (Global Industry Integrated Services) for 15 years performing important projects for Merck (USA, PR, México, Colombia and Brazil), Abbott (USA & PR), Bristol Myers, Roche, MOVA, Eli Lilly, Wyeth (PR & México), Pfizer, Stryker and AMO. As a consultant, he has been offering services at 58 different sites. Was employed by Eli Lilly, Bristol and Schering Plough before becoming a consultant. A pioneer on the validation field and currently a pioneer establishing the new industry standards and trends (FDA Risk Based, ICH and ASTM 2500E). . Mr. Hernández has a Bachelor in Chemistry and 4 years attending Chemical Engineering (prior to his US Army Special Forces Service) from the University of PR Mayagüez. Also, has an associate degree in digital electronics and instrumentation from the PR government.

Track: Product Development

Presentation: Current Continuous Process Validation Program (CCVP) Following FDA Current Guidelines

Benoit Igne

Research Coordinator
Duquesne University, Center for Pharmaceutical Technology

Benoît Igne is an industrial research coordinator at Duquesne University, Pittsburgh, Pennsylvania, U.S.A. He received his Ph.D. in Agricultural Engineering from Iowa State University, Ames, Iowa, U.S.A., in 2009. He specializes in the application of Near–Infrared and Raman spectroscopy to Process Analytical Technologies in the pharmaceutical industry.

Track: Product Development

Presentation: The Role of Process Analytical Technologies in the Current Quality By Design Framework

Hank Jibaja

Project Manager
Nephron Pharmaceuticals

Hank Jibaja is responsible for information systems and process design at Nephron and a contributor to developing and implementing strategic goals at Nephron. In the last 14 years he has worked at Nephron playing a key role in Nephron's growth as a worldwide leader in pharmaceutical BFS manufacturing through the development of technological capabilities for the firm. He has detailed experience in all areas of the company from manufacturing to distribution. He worked on behalf of the owners to manage the initial requirements and design for a new 500K square foot manufacturing facility currently under construction in Cayee, South Carolina. Hank's managed the initial project design so the CEO's strategic vision for a new factory with efficient and high quality manufacturing processes and LEED certification was achieved. Hank has a BSBA in Accounting from the University of Central Florida.

Track: Facility & Process Design

Presentation: Purpose-driven Design: Savings for Pharmaceutical Facilites

Erik Johnson

Sr. Application Specialist
Umetrics - An MKS Company

Bio Coming Soon.

Track: Regulatory QA/QC

Presentation: Application of Quality by Design in API Process Development

Detlef Kehm

Vice President, Maintenance and Engineering Services
Grifols

Detlef Kehm, PhD. VP of Maintenance and Engineering Services Grifols. Detlef is the Vice President of Maintenance and Engineering Services for Grifols. He has over 25 years of industry experience and has held a variety of executive assignments in Maintenance and Engineering Services on a global basis. Detlef began his career with Bayer AG, Chemical Division in Leverkusen, Germany. He holds a Masters in Chemical Engineering from the University of Aachen and a PhD in Chemical Engineering from the University of Dortmund. He resides in Apex, NC with his wife and two sons.

Track: Facility & Process Design

Presentation: Panel: Getting Excited About The Modular Experience!

H. Steven Kennedy

Director, Life Sciences + Chemicals
M+W U.S., Inc. (A Company of the M+W Group)

H. Steven Kennedy is a recognized expert with over 30 years of experience in the delivery of Life Sciences manufacturing facilities around the world and provides industry clients with his professional project expertise in consulting, design, construction, and CQV services. He is currently the Director of Business Development for Life Sciences and Chemicals for M+W Group, a global EPC firm focused on the delivery of technically challenging facilities. In this role, he is responsible for client development and retention by recognizing client needs and matching them with solutions. Mr. Kennedy is active in the ISPE and is a member of the ISPE Boston Chapter Board of Directors and a former member of the Biotech Community of Practice Steering Committee. He is also an inveterate traveler and student of foreign cultures having visited 72 countries.

Track: Mini-Course: Serialization

Presentation: Wrap Up Panel: Understanding the Complexities of Serialization

Chuck Krumwiede

Vice President/Managing Partner
Malcom Associates

Mr. Krumwiede is currently a managing partner and vice president of business development for Malcom Associates. He has over twenty years of consulting experience developing and implementing solutions to the pharmaceutical, medical device, bio-technology, animal health, nutraceutical, and healthcare industries. He has held executive positions in business development and operations, In these capacities, Mr. Krumwiede managed projects to simplify documentation and business processes enhancing cGMP, GLP, and ISO compliance, designing new manufacturing layouts, change control workflows, and develop user requirements/specifications for Manufacturing Execution Systems (MES), Electronic Batch Records (EBR), Electronic Document Management Systems (EDMS), and automation interfaces and integration. He has managed numerous documentation and work flow redesign programs from clinical to commercial environments for solid dose, semi-solids, transdermal, parenteral, biotech, nutritional, combination, animal health, diagnostic, human tissue, and medical device product lines.

Track: Manufacturing & Packaging

Presentation: Panel: Road Map to Implementing

Jim Miller

President
PharmSource Information Services, Inc.

James C. Miller is the founder and president of PharmSource Information Services, Inc. A preeminent expert in bio/pharmaceutical outsourcing, Jim established and presides over the pharmaceutical outsourcing industrys principal online information database of contract service providers, PharmSource ADVANTAGE. He is editor and publisher of two newsletters, Bio/Pharmaceutical Outsourcing Report and Emerging Markets Outsourcing Report. Jim serves as an editorial advisory board member for Advanstar Communications Pharmaceutical Technology and BioPharm International magazines. A member of the judging panel for the annual European Outsourcing Awards, Jim also is a member of the Board of Directors of the American Type Culture Collection (ATCC), and also serves on its Technical Committee. Jim formerly was vice president of sales and marketing at Circa Pharmaceuticals, Inc., a solid dose manufacturer. Prior to that, he was president of St. Anthony Publishing, a provider of database information services for the health care industry. Jim also was a consultant in corporate strategy with the Boston Consulting Group. He holds an MBA degree from the Stanford University Graduate School of Business.

Track: Keynote

Presentation: Recalibrating The Pharmaceutical Services Opportunity

Sandra Lueken

Sr. Director Quality Assurance
MedImmune

With more than 20 years of industry experience, she is responsible for developing, deploying and maintaining the overall quality system within the manufacturing facility. Her role includes managing a diverse group of 200+ individuals responsible for all aspects of Quality Control and Quality Assurance operations supporting the manufacture of liquid and lyophilized vials, syringes, and cartridges for more than 40 clients.

As a Quality/Regulatory professional with expertise in contract manufacturing production, Sandra's experience includes process/product/assay transfer and validation activities, aseptic drug product manufacturing, project management, CAPA, laboratory operations, and leading/managing FDA and international regulatory inspections resulting in numerous PAI approvals and several successful clinical to commercial product launches.

Educated in Biochemistry with a Masters Degree in Business Administration from the Eller School of Business, University of Arizona, Sandra's career path includes positions with HollisterStier Laboratories, Ventana Medical Systems, Inc., Systems Integration Drug Discovery Company, and the Jerry L. Pettis Memorial VAMC.

Track: Facility & Process Design

Presentation: Panel: Getting Excited About The Modular Experience!

Jennifer Markarian

Manufacturing Editor
Pharmaceutical Technology

Jennifer covers drug delivery, formulation, analytical testing, and equipment for Pharmaceutical Technology and is the editor of PharmTech's Equipment and Processing Report, a monthly eNewsletter featuring trends in pharmaceutical manufacturing and practical help for processors. Jennifer holds a bachelor's degree in chemical engineering from The Pennsylvania State University. She has over a decade of experience as a writer and editor for the pharmaceutical, chemical, and plastics industries and industrial experience as a technical service engineer for the former Mobil Chemical's polyethylene business.

Track: Regulatory QA/QC

Presentation: Panel: Lessons Learned: Successes And Challenges In Implementing Quality By Design

Walt Murray

Director of Quality and Compliance Services
MasterControl Inc.

Walt Murray is a specialist in the quality and regulatory professions with more than 25 yearsâ experience to his credit, working with nationally-recognized organizations including Aventis- Pasteur, Merck, Pfizer, Stryker, USANA, Del Monte Foods and the American Red Cross National Labs. He is certified in quality systems auditing, problem solving, and process control using Six Sigma principles that support lean enterprise, including kaizen improvement and advanced planning principles. His extensive audit experience covers several industries and heâs successfully brought several medical device companies to full registration under the ISO process model standard. Murray has also worked extensively in risk and supplier management. A graduate of the University of Richmond, Murray is a member of the Society for Manufacturing Engineers (SME); Regulatory Affairs Professions (RAPS); the American Society for Quality (ASQ); and the Intermountain Biomedical Association (IBA).

Track: Regulatory QA/QC

Presentation: Become a Better CAPA Sleuth

Rajesh Nair

President
Indegene

Dr. Rajesh Nair is the President of Indegene, a leading global partner to Top 20 pharmaceutical companies. Indegene, with more than 1000 employees spread across 4 continents and 12 offices, is building transformational partnerships with pharmaceutical companies worldwide leveraging a portfolio of productivity, revenue and innovation services. Indegene's solutions are integrated with a suite of proprietary IP based platforms that drive R&D effectiveness, commercial RoI as well as patient and HCP engagement. Indegene's customers in North America, Europe and Emerging Markets are serviced by a network of global delivery centers in US, Canada, Basel, Bangalore and Shanghai. Dr. Nair practiced as a physician before moving on to Management and Entrepreneurship, where he worked across global healthcare and pharmaceutical markets over the past 15 years. He is currently based out of Princeton, NJ.

Track: Keynote

Presentation: Reorganizing For the Future : Succeeding In The New Pharmaceutical Industry

Tom Piombino

Director of Operations
IPS – Integrated Project Services

Tom Piombino, PE has extensive experience focused on the design and delivery of technically complex biopharmaceutical facilities from conceptual process architecture to process design studies to detailed facility/process engineering. His technical background includes project management of construction, cGMP facility engineering, design projects as well as estimating, process architecture and HVAC/Mechanical systems engineering.

Track: Facility & Process Design

Presentation: Implementing Single-Use Biomanufacturing Systems into Traditional Stainless Steel-based Facilities

Morgan Palmer

Chief Technology Officer
EtQ, Inc.

Morgan Palmer has over 20 years experience delivering software solutions. Morgan joined EtQ to create the company's first software application and is now responsible for Reliance, EtQ's flagship product for quality, environmental and safety management. As EtQ's Chief Technology Officer, Morgan continues to drive the innovation and strategy that make EtQ the leading provider in the markets it serves.

Track: Supply Chain

Presentation: Establishing Quality Agreements with a Unified Approach for all Suppliers

Adrian Pask

OEE Expert
Vorne Industries

Adrian Pask is the lead OEE Consultant with Vorne Industries. Adrian is the primary author behind www.oee.com and www.leanproduction.com. Adrian loves helping teams use data to get great results. He started his career as a continuous improvement manager for Coca-Cola in London, England with a task of establishing a process for using a new OEE system to drive improvement across the site. Over the next 3 years the team increased OEE from 54% to 82% by establishing leader standard work for using information to drive improvement actions. After Coca-Cola, Adrian spent seven years as an OEE Improvement Consultant. He specializes in helping teams to take action based on great quality data. His team at Vorne Industries have implemented thousands of monitoring systems across 36 countries.

Track: Manufacturing & Packaging

Presentation: OEE Master Class: How to Increase Production Time by 20%

Edward Price

President and CEO
PCI Synthesis

Ed Price serves as President and CEO PCI Synthesis, a 12 year-old chemical manufacturer of new chemical entities (NCEs), generic active pharmaceutical ingredients (APIs), and other specialty chemical products. With 20+ years of experience in chemical operations, engineering, and cGMP manufacturing, Ed has grown PCI from a basic chemical manufacturer into the leading CMO that it is today. With a robust product pipeline, PCI provides emerging and mid-sized pharmaceutical companies access to the expertise needed to develop and manufacture complex small molecules and APIs used in generic pharmaceuticals. As an industry thought-leader, Ed also serves as co-chair of the MassBio CMO/CRO Cluster. Numerous publications have written about PCI Synthesis, most recently the Boston Business Journal, Mass High Tech, Chemical & Engineering News, and BioSpace, among others. He holds a B.S. in Chemical Engineering from the University of Massachusetts, Amherst.

Track: Regulatory QA/QC

Presentation: Panel: Understanding GDUFA

Elizabeth Rivera

Technical Service Specialist
STERIS

Elizabeth Rivera holds a Bachelor and Graduate degree in Chemical Engineering from the University of Puerto Rico. Currently, she is a technical services specialist for the Scientific Division of STERIS® Corporation in the city of St Louis, MO USA. She has previously worked at companies like Eli Lilly, and Bristol Myers Squibb. She provides technical support in the areas of formulated detergents, disinfectants for critical environments, and sterility assurance products. In addition, specializes in engineering, cleaning and validation processes, lectures and technical seminars, among others. Her primary focus is on the proper selection of detergents, disinfectants, and sterilization assurance products including the technical support in implementing and/or using these in the pharmaceutical, biopharmaceutical, cosmetics, medical devices, dietary supplements, and other industries.

Track: Facility & Process Design

Presentation: Effective Cleaning Procedure for Medical Devices Using Laboratory Studies

Mike Salinas

Director of Manufacturing Technology
M+W U.S., Inc. (A Company of the M+W Group)

Mike Salinas is Director of Manufacturing Technology for M+W U.S., Inc. He has over 25 years of diverse production, process development, facilities planning, design, project management and construction experience for Owner Operating and Engineering Design & Construction firms. At M+W, he specializes in applying consistent, leading-edge manufacturing technology and converting technological know-how into feasible, compliant and operationally efficient design concepts for M+W's global Life Sciences clients. He earned a Bachelor of Science in Industrial Engineering (BSIE) degree from Columbia University, New York, and a Master of Science in Engineering Management (MSEM) degree from Drexel University, Pennsylvania. He can be contacted by telephone at 610 427 3310, by email at mike.salinas@mwgroup.net or visit www.mwgroup.net.

Track: Mini-Course: Serialization

Presentation: Implementing Unit-Level Serialization on a New Packaging Line

Presentation: Wrap Up Panel: Understanding the Complexities of Serialization

Craig Sandstrom

Director, Process Engineering

Craig has 18 years of experience in biopharmaceutical process development and design. He has worked on design projects including feasibility studies, preliminary engineering, detailed engineering, and thorough start-up. He is a Fluor Fellow and one of Fluor's resident biotechnology experts. He has worked on multiple projects that have extensively employed modular construction approaches.

Track: Facility & Process Design

Presentation: Panel: Getting Excited About The Modular Experience!

Joe Scioscia

Vice President
VAI (Vormittag Associates, Inc.

Joe Scioscia oversees VAI's global sales efforts across the company's key vertical markets. His responsibilities include direct and indirect sales, worldwide field support, field strategy and planning, sales operations and product development. Scioscia joined VAI in 1989 and has led the development and implementation of the company's reseller channel. Since joining the company, Scioscia has facilitated the development of key strategic partnerships with technology leaders such as IBM, Avnet, Arrow, and Symbol Technologies, helping solidify VAI's position in the mid-sized enterprise software market. With over 20 years of information technology and sales experience, Scioscia is an IBM Certified Specialist and has spoken at numerous industry events. He has helped VAI launch into new vertical markets and has formulated, and executed, numerous sales to key VAI accounts, driving strong yearly revenue growth for VAI.

Track: Manufacturing & Packaging

Presentation: Warehouse Management Systems - Achieve a Warehouse of the Future

Jaspreet S Sidhu Ph.D.

Vice President Business Development & Pharmaceutical Microbiology
Molecular Epidemiology

Vice President, Business Development & Pharmaceutical Microbiology
Molecular Epidemiology
Dec 2004 - present

Principal Scientist/Laboratory Research Director
University of Washington, Seattle, WA
Aug 2001-Dec 2004

Senior Research Scientist
University of Washington, Seattle, WA
1996-2001

Visiting Scientist
University of Washington, Seattle, WA
1993-1996

Post-Doctoral Fellow
University of Washington, Seattle WA
1990-1993

Education, Certifications and Interests
PhD, Biochemistry, 1989, Brunel University and Max-Planck Institute for Biophysical Chemistry, Goettingen, Germany

BS (Honors), Applied Biochemistry, 1985, Brunel, University of West London, UK

Professional Memberships

  • PDA

Past Memberships

  • ISPE
  • RAPS

Track: Thursday Presentation

Presentation: Pushing the Limits: Questioning the Methodology

Nirav Shah

Sr. Application Specialist
Umetrics - An MKS Company

Nirav Shah works as a Senior Application Specialist with Umetrics Inc. He works with customers from diverse industries including bio-pharma to implement real- time process monitoring and fault detection system, training and strategies for both batch and continuous processes. He is an expert of building multivariate data models. He teaches courses on Multivariate Data Analysis, Design of Experiments, and Quality by Design. His prior work experience is as a controls and automation engineer, prior to that he worked as a process engineer. He has an MS in Chemical and Computer Engineering from University of Massachusetts and a BS in Chemical Engineering from Mumbai University. He recently graduated with an MBA from Babson College.

Track: Regulatory QA/QC

Presentation: Application of Quality by Design in API Process Development

Josef Trapl

Technology Manager Pharma/Medical Devices
M+W U.S., Inc. (A Company of the M+W Group)

Josef Trapl is a Global Technology Manager within the M+W Group based in Stuttgart, Germany with responsibility for the Pharma and Medical Device industry. He holds a Master of Chemical Engineering (MChE) degree from Graz University of Technology, Austria and a Master of Business Administration (MBA) degree from the Mannheim Business School, Germany. He has been with the M+W Group since 2000 in varying leadership positions and provides professional project expertise in serving the Life Science industry with consulting, design and build capabilities. He specializes in consultancy for Fill & Finish and Oral Solid Dosage (OSD) facilities. In his actual corporate function, he focuses on new technologies, technology transfer, operational efficiencies, regulatory requirements, and strategic development within M+W's global footprint.

Track: Facility & Process Design

Presentation: Design Aspects for a Bio Fill and Finish Facility

Glenn Van Buskirk

Managing Partner
Nonclinical Drug Development Consulting Services. LLC

Glenn Van Buskirk is the Managing Partner of Nonclinical Drug Development Consulting Services (NDDCS), LLC. Dr. Van Buskirk has over 40 years of international product development and management experience.

Prior to establishing NDDCS, Glenn held senior management positions at Purdue Pharma, Novartis and the Ortho-McNeil Pharmaceutical companies where he gained experience in the development, analysis and control, registration, and approval of over 30 marketed products. These represent a broad range of dosage form types including oral solids (immediate and controlled release), semisolids, parenteral, transdermal, biotech, and DPI products.

Dr. Van Buskirk holds a Ph.D. degree in Pharmaceutical Sciences from Rutgers University. He is a member of the Council of Experts for USP and the Manufacturing Technical Committee of PQRI.

Track: Regulatory QA/QC

Presentation: Current Development Best Practices for IR & MR Dosage Forms

Christopher Verbicky, PhD, MBA

Director of Business Development and Marketing
Coldstream Laboratories, Inc.

Dr. Verbicky is currently Director of Business Development and Marketing at Coldstream Laboratories, Inc. and has nearly15 years of experience in the high pressure contract manufacturing industry. He earned his a PhD in Synthetic Organic Chemistry from the University of New Hampshire and also has a BS in chemistry and an MBA. Prior to joining Coldstream, Verbicky held various leadership positions at AMRI and Johnson Matthey in Business Development, Project Management and Chemical Development. Throughout his career he has contributed to leadership and problems solving in areas spanning business and science.

Dr. Verbicky has written or contributed to numerous publications, patents, and presentations in the areas of Pharmaceutical Development, Organic Synthesis, and Project Management. Verbicky currently serves as editorial reviewer for several scientific publications. He joined Coldstream Laboratories, Inc. in 2010.

Track: Regulatory QA/QC

Presentation: Panel: Understanding GDUFA

Veda Walcott

Vice President of Quality
Cook Parmica LLC

Veda Walcott serves as the vice president of quality for Cook Pharmica. Ms. Walcott holds a BS in clinical laboratory science from Indiana State University and a master's in business administration from Indiana Wesleyan University. She began her career as a medical technologist in a clinical laboratory setting before continuing her career in the pharmaceutical industry as a microbiologist and in quality control management. She also served as a microbiology consultant in Indianapolis, advising new life science companies on market trends, assisting with presentation preparation for venture capital requests, and providing support services for CGMP aseptic processing facilities. Veda ensures that effective quality systems are in place and that responsibilities and authorities are defined, communicated and implemented throughout Cook Pharmica.

Track: Regulatory QA/QC

Presentation: New Product Assessment in a Multiproduct Environment – A Risk-based Approach

Shane Yount

Principal / Author
Competitive Solution, Inc.

Shane Yount is a Principal/Author with Competitive Solutions, Inc. Shane is a highly respected performance improvement consultant in the areas of strategic business solutions, work team implementation, and employee and leadership development. He brings extensive experience in the food processing industry, having joined Perdue Farms, Inc. the nation's third largest poultry grower, and processor. Shane blends both a comical and a no-nonsense approach to his presentation style. Popular on the lecture and leadership development circuit, Shane energizes his audience through the power of real life situations and innovative business solutions that all leaders and employees can immediately implement. Shane is the author of numerous training programs and implementation modules currently being taught in corporations throughout the country.

Track: Supply Chain

Presentation: Managing Your Suppliers with Scorecard Metrics

Jason R. Money

Senior Director for Federal Government Affairs
Generic Pharmaceutical Association (GPhA)

Jason R. Money is currently the Senior Director for Federal Government Affairs at the Generic Pharmaceutical Association (GPhA). In this capacity, Jason manages the federal affairs division and develops key working relationships with Members of Congress, Congressional Staff, and Industry Representatives on issues related to pharmaceutical policy. Jason joined GPhA in January 2007. Prior to working for GPhA, Money served as Health Legislative Assistant for Senator George Allen (R-VA). Preceding his Senate service, Money was a Research Analyst for the National Republican Senatorial Committee (NRSC) where he performed research for various Senate races during the 2002 cycle, which aided in the recapturing of the majority. Jason holds a MS in Health Policy from George Mason University and a BA in Political Science from St. John Fisher College.

Track: Regulatory QA/QC

Presentation: Panel: Understanding GDUFA

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