PDA Combination Products Workshop 2024
Breaking Boundaries: Faster, Better, Smarter
Registration Options
Individual Registration
Group Registration
Mastering the Combination Product Lifecycle from Development through Commercialization
Combination products, with their unique blend of drugs, devices, and/or biologics, present distinct challenges for teams and companies. Understanding the intricacies of the combination product lifecycle from development through commercialization is critical to ensure success.
PDA’s highly interactive Combination Products Workshop is designed and led by top industry experts and delivers the knowledge, practical application and best practices for navigating you and your team through the entire lifecycle of combination products from development through commercialization. The intent is to ensure retention and comprehension for immediate application of your learning.
During the workshop, you will have the opportunity to engage, explore and get your questions answered. A firmer grip on understanding the regulatory environment in relation to combination products is crucial for ensuring compliance and expediting approval.
Whether you are just starting out in the industry or an experienced professional, this workshop is for you.
Why Attend?
You will be equipped with essential knowledge and practical skills in risk management, verification and validation, developing comprehensive requirements, preparation for submission readiness, manufacturing and technology transfer best practices, and change management.
- Real-World Application: Engage in interactive case studies drawn from actual industry scenarios.
- Immediate Impact: Apply your newly acquired knowledge to your current projects right away.
- Global Perspective: Gain insights into navigating diverse regulatory frameworks across regions including the European Union.
- Networking Opportunities: Connect with peers and experts across the workshop to build a network of professionals.
- After the workshop, join PDA’s Combination Products Interest Group, chaired by industry experts to ensure you stay up to date with regulatory changes and innovations across the combination products lifecycle.
The entire workshop is structured to ensure you are immersed in substance, enlightened by analysis of real-world case studies, and given the opportunity to work and engage with your fellow attendees alongside the experts.
What Will You Gain?
- Comprehensive Lifecycle Knowledge: Ability to navigate the entire journey from development to commercialization with confidence.
- Risk Management Expertise: Skills to identify, assess, and mitigate risks effectively specific to combination products.
- Validation and Verification: Assurance that your combination products meet the highest standards of quality and safety.
- Regulatory Navigation Skills: The confidence to conquer the complex landscape of global regulations.
- Manufacturing Excellence: Discovery of the best practices in production and technology transfer.
- Change Management Proficiency: The perspective to adapt to industry shifts with agility and foresight.
- Access to industry experts and PDA’s Combination Products Interest Group.
Who Should Attend?
This workshop is ideal for professionals involved in development/engineering, regulatory affairs, quality assurance, lifecycle management, and manufacturing of combination products. Whether you are new to the field or seeking advanced insights, this highly interactive workshop will provide you with valuable knowledge and tools for success in the industry.
Secure your spot today to embark on this enriching experience to master combination product excellence!
Don't miss out! Limited spots available!
Secure your place now and take a transformative journey to combination product mastery from development to commercialization. Your career advancement awaits!
Register today and propel your expertise to new heights of success!
PROGRAM PLANNING COMMITTEE
- Maggie Bandel, Johnson & Johnson (Chair)
- Flora Felsovalyi, Lonza
- Akshay Kamdar, Eli Lilly and Company
- Lee Leichter, P/L Biomedical
Event Location
Contact
Program Inquiries
Exhibition/Sponsorship Inquiries
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Registration Customer Care
Standard Registration
Member Price
$2,095GovernmentMember Only
$995
Health AuthorityMember Only
$995
Early Career ProfessionalMember Only
$1,495
StudentMember Only
$695
AcademicMember Only
$995
Non-Member
$2,495
GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.
GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.
CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to registration@pda.org.
Thursday, 24 October MDT
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Continental Breakfast
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Registration Open
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P1: Navigating the Complexities of Risk Management for Combination Products
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Moderator: Lee Leichter, RAC, MBA, President, P/L Biomedical
Lee Leichter, RAC, MBA, President, P/L Biomedical
Lee Leichter has close to 50 years’ experience in the health care industry, providing direct, hands-on assistance to domestic and international Pharmaceutical, Biotechnology and Medical Device companies for the last 30. Projects have encompassed a multitude of business, technical, regulatory and quality issues, primarily related to drug delivery and combination products for marketing in the USA, Europe and Canada. He has worked with large multi-national companies, as well as start-ups, successfully navigating the challenges posed during the development, testing and marketing approval of products that merge pharmaceutical substances with high-tech device systems. He has been a subject matter expert working with the ISO and AAMI committees on drug delivery devices and Combination products, and convenor for the just published ISO On-Body Delivery Systems Standard. He is currently the PDA IG Leader for Combination Products.
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Welcome and Opening Remarks from Workshop Chair
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Chair: Maggie Bandel, MBA, Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson
Maggie Bandel, MBA, Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson
Maggie Bandel has extensive industry experience covering diagnostics, medical devices, combination products, novel drug delivery systems, and advanced therapies. Her experience spans all product life stages, from early-stage R&D through lifecycle management, covering a wide range of pharmaceutical products and processes throughout her various leadership roles.
Maggie spent the last three years leading a team of industry experts that formed the PDA Combination Products Steering Committee, providing input and oversight into critical areas within the industry. After spending the last few years leading various start-up R&D organizations, Maggie now leads a global team for lifecycle management activities in advanced therapies at Johnson and Johnson.
Maggie holds an MBA from Rutgers University and a BS in Biomedical Engineering from UNC/NC State University.
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Overview and Introduction
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Presenter: Edwin Bills, MEd, Principal Consultant, Edwin Bills Consultant
Edwin Bills, MEd, Principal Consultant, Edwin Bills Consultant
During his over 35-year career in quality and regulatory affairs in medical devices, Edwin L Bills has held a number of positions with major manufacturers including an assignment as Corporate Director of Risk Management. He also served as Director of Quality and Regulatory Affairs with responsibilities for FDA compliance and for pre-market submissions at multiple locations. For over 24 years, Mr. Bills has acted as a United States representative on ISO TC 210 JWG1, the author of ISO 14971, the international standard for medical device risk management and is also a member of AAMI Committee CP on Combination Products. Mr. Bills presently consults in Quality Systems and Risk Management for medical devices and combination products and provides expert witness support. Throughout his career he has been adjunct faculty for courses in risk management and quality systems including the graduate health product risk management program at Virginia Tech. Currently he also teaches college courses at Pathways for Patient Health and consults and provides training in the area of medical device quality systems, regulatory affairs and risk management.
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Practical Application of Risk Management Part 1: Intraocular Injections
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Presenter: Edwin Bills, MEd, Principal Consultant, Edwin Bills Consultant
Edwin Bills, MEd, Principal Consultant, Edwin Bills Consultant
During his over 35-year career in quality and regulatory affairs in medical devices, Edwin L Bills has held a number of positions with major manufacturers including an assignment as Corporate Director of Risk Management. He also served as Director of Quality and Regulatory Affairs with responsibilities for FDA compliance and for pre-market submissions at multiple locations. For over 24 years, Mr. Bills has acted as a United States representative on ISO TC 210 JWG1, the author of ISO 14971, the international standard for medical device risk management and is also a member of AAMI Committee CP on Combination Products. Mr. Bills presently consults in Quality Systems and Risk Management for medical devices and combination products and provides expert witness support. Throughout his career he has been adjunct faculty for courses in risk management and quality systems including the graduate health product risk management program at Virginia Tech. Currently he also teaches college courses at Pathways for Patient Health and consults and provides training in the area of medical device quality systems, regulatory affairs and risk management.
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Practical Application of Risk Management Part 2: On-Body Injectors
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Presenter: Arun Mathew, EMBA, Associate Director, AbbVie
Arun Mathew, EMBA, Associate Director, AbbVie
Arun is a highly skilled and experienced Risk Management professional with a wealth of knowledge and expertise in the field. He holds a master's degree from Coventry University, an executive Master of Business Administration from Quantic, and a Diploma in Electronics. Arun has led corporate-level teams in establishing robust Risk Management processes and procedures. His pioneering risk-based approaches have been implemented in design control, verification and validation, process validation, CAPA, change management and other quality management systems. Arun is an active member of the American Society for Quality and holds certifications as a CQA Certified Quality Auditor, CQE Certified Quality Engineer and Risk Management credential. Currently, Arun works as Associate Director, Quality Management Systems (Risk Management) at AbbVie. He is a co-author of the book Mastering Safety Risk Management for Medical devices and Invitro Devices released by ASQ.
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Networking Break in the Exhibit Area
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P2: Building a Strong Foundation: Defining Comprehensive Product Requirements
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Moderator: Lee Leichter, RAC, MBA, President, P/L Biomedical
Lee Leichter, RAC, MBA, President, P/L Biomedical
Lee Leichter has close to 50 years’ experience in the health care industry, providing direct, hands-on assistance to domestic and international Pharmaceutical, Biotechnology and Medical Device companies for the last 30. Projects have encompassed a multitude of business, technical, regulatory and quality issues, primarily related to drug delivery and combination products for marketing in the USA, Europe and Canada. He has worked with large multi-national companies, as well as start-ups, successfully navigating the challenges posed during the development, testing and marketing approval of products that merge pharmaceutical substances with high-tech device systems. He has been a subject matter expert working with the ISO and AAMI committees on drug delivery devices and Combination products, and convenor for the just published ISO On-Body Delivery Systems Standard. He is currently the PDA IG Leader for Combination Products.
We will then explore how to develop design inputs and specifications, including Essential Performance Requirements (EPRs), through practical case studies. Learn how to create precise requirements for scenarios like intraocular and on-body injections. These actionable strategies and valuable insights will enhance your approach to product development.-
Overview and Introduction
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Presenter: Lee Leichter, RAC, MBA, President, P/L Biomedical
Lee Leichter, RAC, MBA, President, P/L Biomedical
Lee Leichter has close to 50 years’ experience in the health care industry, providing direct, hands-on assistance to domestic and international Pharmaceutical, Biotechnology and Medical Device companies for the last 30. Projects have encompassed a multitude of business, technical, regulatory and quality issues, primarily related to drug delivery and combination products for marketing in the USA, Europe and Canada. He has worked with large multi-national companies, as well as start-ups, successfully navigating the challenges posed during the development, testing and marketing approval of products that merge pharmaceutical substances with high-tech device systems. He has been a subject matter expert working with the ISO and AAMI committees on drug delivery devices and Combination products, and convenor for the just published ISO On-Body Delivery Systems Standard. He is currently the PDA IG Leader for Combination Products.
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Case Study on Developing Inputs and Specifications Part 1: Intraocular Injections
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Presenter: Geoffrey Wise, Medical Device Platform Lead, Genentech
Geoffrey Wise, Medical Device Platform Lead, Genentech
Geoff wise is the Medical Device Platform Lead at Genentech’s Device and Packaging Development Group in South San Francisco. Geoff has over 18 years in the medical device industry and over 14 years developing and commercializing drug delivery systems. Previously, Geoff has held several roles over his time at Genentech including: senior manager, device team leader, and the head of product care - US (commercial products). Geoff is passionate about driving strategic direction of medical device/drug platforms, solving technical challenges, and bringing new products to market that serve unmet needs. Geoff holds a Bachelor’s degree in Mechanical Engineering with a Minor in Materials Engineering from Cal Poly Pomona University. Geoff is also a lean/six sigma black belt and has 9 issued patents with additional patents pending.
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Case Study on Developing Inputs and Specifications Part 2: On-Body Injections
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Presenter: Matthew J. Huddleston, MS, Chief Commercial Officer, Enable Injections
Matthew J. Huddleston, MS, Chief Commercial Officer, Enable Injections
Mr. Matthew J. Huddleston serves as Chief Commercial Officer for Enable Injections, responsible for leading Enable’s current marketing and business development operations and expanding commercial infrastructure. He is an experienced medical device professional with more than 30 years of experience in startup environments with emphasis in project management, design, development, manufacturing, regulatory, and intellectual property. He has several issued and pending patents in the medical device field, including soft tissue and cardiovascular fixation devices and delivery instruments, histologic automated embedding systems, laparoscopic visualization devices, and automatic injection devices. He is a professional engineer and a licensed patent agent. Matt holds a Bachelor of Science in Mechanical Engineering from Purdue University and a Master of Science in Biomedical Engineering from The Ohio State University.
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Report Out and Discussion
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Networking Lunch in the Exhibit Area
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P3: Technical Considerations for Health Authority Submissions
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Moderator: Lee Leichter, RAC, MBA, President, P/L Biomedical
Lee Leichter, RAC, MBA, President, P/L Biomedical
Lee Leichter has close to 50 years’ experience in the health care industry, providing direct, hands-on assistance to domestic and international Pharmaceutical, Biotechnology and Medical Device companies for the last 30. Projects have encompassed a multitude of business, technical, regulatory and quality issues, primarily related to drug delivery and combination products for marketing in the USA, Europe and Canada. He has worked with large multi-national companies, as well as start-ups, successfully navigating the challenges posed during the development, testing and marketing approval of products that merge pharmaceutical substances with high-tech device systems. He has been a subject matter expert working with the ISO and AAMI committees on drug delivery devices and Combination products, and convenor for the just published ISO On-Body Delivery Systems Standard. He is currently the PDA IG Leader for Combination Products.
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Defining Expectations and Best Practices Part 1: Intraocular Injections
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Presenter: Fran DeGrazio, President & Principal Consultant, Strategic Parenteral Solutions LLC
Fran DeGrazio, President & Principal Consultant, Strategic Parenteral Solutions LLC
Fran DeGrazio has 35+ years in vial container closure systems and prefillable systems for combination products. Currently Fran is President & Principal Consultant for Strategic Parenteral Solutions LLC. In her role she advises executives on strategy, growth, technical and regulatory opportunities. She is also Executive Editor for Drug Delivery Leader and Chief Client Solution Advisor to GessNet , producers of QMSpace software for the industry. Prior to this she held numerous strategic & technical roles at West Pharmaceutical Services, including R&D, Quality & Regulatory, Technical Customer Support, Analytical Laboratories, Marketing and Scientific Affairs. Her final role prior to retiring from West was as Chief Scientific Officer. Fran has presented and published numerous technical articles and book chapters, the latest being a chapter within The Combination Products Handbook-A Practical Guide for Combination Products and other Combined Use Systems published in May 2023 by CRC Press. She is an active member of the PDA Combination Product steering committee, ISPE Combination Products COP, and the AFDO/RAPS Combination Products Summit Steering committee. She is the recipient of the PDA Packaging Science Award for 2021, Philadelphia Business Journal 2018 Healthcare Innovators and the Healthcare Businesswoman’s Association Luminary Award for West in 2017.
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Defining Expectations and Best Practices Part 2: On-Body Injections
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Bettine Boltres, PhD, Director Scientific Affairs & Technical Solutions, Integrated Systems, West Pharmaceutical Services
As Director of Scientific Affairs & Technical Solutions, Glass Systems, Dr. Bettine Boltres is supporting the scientific exchange between West and the pharmaceutical industry. This complements her work as Product Manager for Schott Pharmaceutical Tubing, where she provided scientific consulting for glass primary packaging. Since 2015 Bettine has been an active member of the USP Packaging and Distribution Expert Committee as well as the ISO TC76/WG 2 on rigid container systems and WG 4 on elastomers. Additionally, in 2018 joined the European Pharmacopoeia Commission Group of Experts 16 (elastomers and plastics) and the GLS Working Party (glass). Since January 2019 she is also a member of the PDA Board of Directors, actively supporting the role of PDA in the global pharma world. She was part of the PDA Glass Handling Task Force finalizing TR 87, is actively involved in the Task Force working on an Annex to TR 73 addressing MDR GSPRs for PFS, and is part of the Pharmacopeia Interest Group. In 2015 she published the book "When Glass Meets Pharma", which builds the bridge between glass for pharmaceutical primary packaging and drug substances.
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Interactive Case Study
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Report Out and Discussion
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Networking Break in the Exhibit Area
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P4: Mastering Tech Transfer and Product Launch Readiness
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Moderator: Flora Felsovalyi, PhD, Associate Director, Lonza
Flora Felsovalyi, PhD, Associate Director, Lonza
Flora Felsovalyi has 18 years of experience and a deep passion for leading combination product development in the medical device and pharmaceutical industries, specializing in parenteral drug delivery. She has contributed to various stages of the development lifecycle: from conceptualizing and inventing new subcutaneous injection devices to commercial implementation of dual chamber and ocular injection devices.
She currently works in Drug Product Services at Lonza, and holds the position of Head of Pharmaceutical Services. Her team is responsible to developing and offering device-related services offerings to customers. Prior to Lonza, Flora worked at Roche for 8 years both as an early stage formulation scientist and device team leader.
Flora holds a Bachelor’s Degree in Agricultural and Biological Engineering from Cornell University, a Master’s degree in Biomedical Engineering, and a PhD in Chemical Engineering from Columbia University in the City of New York.
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Navigating a Successful Product Launch
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Presenter: Katelyn O'Neil, Senior Manager, Device Engineering, Pfizer
Katelyn O'Neil, Senior Manager, Device Engineering, Pfizer
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Hands-On Exercise: Preparing your Tech Transfer
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Presenter: Katelyn O'Neil, Senior Manager, Device Engineering, Pfizer
Katelyn O'Neil, Senior Manager, Device Engineering, Pfizer
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Report Out and Discussion
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Networking Reception in the Exhibit Area
Friday, 25 October MDT
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Continental Breakfast
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Registration Open
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P5: Impact of Post-Market Changes to the Medical Device and Best Practices for Submitting Variations in the European Market
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Moderator: Maggie Bandel, MBA, Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson
Maggie Bandel, MBA, Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson
Maggie Bandel has extensive industry experience covering diagnostics, medical devices, combination products, novel drug delivery systems, and advanced therapies. Her experience spans all product life stages, from early-stage R&D through lifecycle management, covering a wide range of pharmaceutical products and processes throughout her various leadership roles.
Maggie spent the last three years leading a team of industry experts that formed the PDA Combination Products Steering Committee, providing input and oversight into critical areas within the industry. After spending the last few years leading various start-up R&D organizations, Maggie now leads a global team for lifecycle management activities in advanced therapies at Johnson and Johnson.
Maggie holds an MBA from Rutgers University and a BS in Biomedical Engineering from UNC/NC State University.
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Overview and Introduction
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Anurag Patel, PhD, Director, Regulatory Affairs-CMC Device and Drug-Device Combinations, Merck & Co., Inc.
Anurag Patel is a Director of Device Quality & Regulatory CMC at Merck and is currently responsible for technical leadership, people management, and cross-functional team alignment on the regulatory strategy and submission requirements for autoinjector combination products. Anurag has 28 years of diverse pharmaceutical industry experience and started in Analytical R&D. Within Regulatory Affairs he has worked on projects at various stages, clinical, new product registration, and post-approval for a variety of combination products including reconstitution kits, pre-filled syringes, mechanical autoinjectors, drug-eluting implant, transdermal delivery systems, and inhalation products. Anurag holds a BSc in Industrial Chemistry and MSc in Industrial Polymer Chemistry from Sardar patel University, India, and earned his PhD in Pharmaceutical Sciences from University of Missouri-Kansas City, USA.
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Developing Strategies for Successful EU Market Submissions: A Hands-On Exercise
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Anurag Patel, PhD, Director, Regulatory Affairs-CMC Device and Drug-Device Combinations, Merck & Co., Inc.
Anurag Patel is a Director of Device Quality & Regulatory CMC at Merck and is currently responsible for technical leadership, people management, and cross-functional team alignment on the regulatory strategy and submission requirements for autoinjector combination products. Anurag has 28 years of diverse pharmaceutical industry experience and started in Analytical R&D. Within Regulatory Affairs he has worked on projects at various stages, clinical, new product registration, and post-approval for a variety of combination products including reconstitution kits, pre-filled syringes, mechanical autoinjectors, drug-eluting implant, transdermal delivery systems, and inhalation products. Anurag holds a BSc in Industrial Chemistry and MSc in Industrial Polymer Chemistry from Sardar patel University, India, and earned his PhD in Pharmaceutical Sciences from University of Missouri-Kansas City, USA.
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Report Out and Discussion
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Networking Break in the Exhibit Area
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P6: Navigating the Future: Unveiling Emerging Trends
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Moderator: Maggie Bandel, MBA, Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson
Maggie Bandel, MBA, Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson
Maggie Bandel has extensive industry experience covering diagnostics, medical devices, combination products, novel drug delivery systems, and advanced therapies. Her experience spans all product life stages, from early-stage R&D through lifecycle management, covering a wide range of pharmaceutical products and processes throughout her various leadership roles.
Maggie spent the last three years leading a team of industry experts that formed the PDA Combination Products Steering Committee, providing input and oversight into critical areas within the industry. After spending the last few years leading various start-up R&D organizations, Maggie now leads a global team for lifecycle management activities in advanced therapies at Johnson and Johnson.
Maggie holds an MBA from Rutgers University and a BS in Biomedical Engineering from UNC/NC State University.
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Unlocking Opportunities Through PDA Activities
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Presenter: Maggie Bandel, MBA, Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson
Maggie Bandel, MBA, Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson
Maggie Bandel has extensive industry experience covering diagnostics, medical devices, combination products, novel drug delivery systems, and advanced therapies. Her experience spans all product life stages, from early-stage R&D through lifecycle management, covering a wide range of pharmaceutical products and processes throughout her various leadership roles.
Maggie spent the last three years leading a team of industry experts that formed the PDA Combination Products Steering Committee, providing input and oversight into critical areas within the industry. After spending the last few years leading various start-up R&D organizations, Maggie now leads a global team for lifecycle management activities in advanced therapies at Johnson and Johnson.
Maggie holds an MBA from Rutgers University and a BS in Biomedical Engineering from UNC/NC State University.
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Exploring Key Trends with Expert Insights
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Interactive Discussion
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Closing Remarks from Workshop Chair
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Chair: Maggie Bandel, MBA, Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson
Maggie Bandel, MBA, Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson
Maggie Bandel has extensive industry experience covering diagnostics, medical devices, combination products, novel drug delivery systems, and advanced therapies. Her experience spans all product life stages, from early-stage R&D through lifecycle management, covering a wide range of pharmaceutical products and processes throughout her various leadership roles.
Maggie spent the last three years leading a team of industry experts that formed the PDA Combination Products Steering Committee, providing input and oversight into critical areas within the industry. After spending the last few years leading various start-up R&D organizations, Maggie now leads a global team for lifecycle management activities in advanced therapies at Johnson and Johnson.
Maggie holds an MBA from Rutgers University and a BS in Biomedical Engineering from UNC/NC State University.
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Presenters
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Maggie Bandel, MBA
Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson
Chair
Moderator
Presenter
Read Bio
Maggie Bandel, MBA
Johnson & Johnson
Maggie Bandel has extensive industry experience covering diagnostics, medical devices, combination products, novel drug delivery systems, and advanced therapies. Her experience spans all product life stages, from early-stage R&D through lifecycle management, covering a wide range of pharmaceutical products and processes throughout her various leadership roles.
Maggie spent the last three years leading a team of industry experts that formed the PDA Combination Products Steering Committee, providing input and oversight into critical areas within the industry. After spending the last few years leading various start-up R&D organizations, Maggie now leads a global team for lifecycle management activities in advanced therapies at Johnson and Johnson.
Maggie holds an MBA from Rutgers University and a BS in Biomedical Engineering from UNC/NC State University. -
Edwin Bills, MEd
Principal Consultant, Edwin Bills Consultant
Presenter
Read Bio
Edwin Bills, MEd
Edwin Bills Consultant
During his over 35-year career in quality and regulatory affairs in medical devices, Edwin L Bills has held a number of positions with major manufacturers including an assignment as Corporate Director of Risk Management. He also served as Director of Quality and Regulatory Affairs with responsibilities for FDA compliance and for pre-market submissions at multiple locations. For over 24 years, Mr. Bills has acted as a United States representative on ISO TC 210 JWG1, the author of ISO 14971, the international standard for medical device risk management and is also a member of AAMI Committee CP on Combination Products. Mr. Bills presently consults in Quality Systems and Risk Management for medical devices and combination products and provides expert witness support. Throughout his career he has been adjunct faculty for courses in risk management and quality systems including the graduate health product risk management program at Virginia Tech. Currently he also teaches college courses at Pathways for Patient Health and consults and provides training in the area of medical device quality systems, regulatory affairs and risk management. -
Bettine Boltres, PhD
Director Scientific Affairs & Technical Solutions, Integrated Systems, West Pharmaceutical Services
Presenter
Read Bio
Bettine Boltres, PhD
West Pharmaceutical Services
As Director of Scientific Affairs & Technical Solutions, Glass Systems, Dr. Bettine Boltres is supporting the scientific exchange between West and the pharmaceutical industry. This complements her work as Product Manager for Schott Pharmaceutical Tubing, where she provided scientific consulting for glass primary packaging. Since 2015 Bettine has been an active member of the USP Packaging and Distribution Expert Committee as well as the ISO TC76/WG 2 on rigid container systems and WG 4 on elastomers. Additionally, in 2018 joined the European Pharmacopoeia Commission Group of Experts 16 (elastomers and plastics) and the GLS Working Party (glass). Since January 2019 she is also a member of the PDA Board of Directors, actively supporting the role of PDA in the global pharma world. She was part of the PDA Glass Handling Task Force finalizing TR 87, is actively involved in the Task Force working on an Annex to TR 73 addressing MDR GSPRs for PFS, and is part of the Pharmacopeia Interest Group. In 2015 she published the book "When Glass Meets Pharma", which builds the bridge between glass for pharmaceutical primary packaging and drug substances. -
Fran DeGrazio
President & Principal Consultant, Strategic Parenteral Solutions LLC
Presenter
Read Bio
Fran DeGrazio
Strategic Parenteral Solutions LLC
Fran DeGrazio has 35+ years in vial container closure systems and prefillable systems for combination products. Currently Fran is President & Principal Consultant for Strategic Parenteral Solutions LLC. In her role she advises executives on strategy, growth, technical and regulatory opportunities. She is also Executive Editor for Drug Delivery Leader and Chief Client Solution Advisor to GessNet , producers of QMSpace software for the industry. Prior to this she held numerous strategic & technical roles at West Pharmaceutical Services, including R&D, Quality & Regulatory, Technical Customer Support, Analytical Laboratories, Marketing and Scientific Affairs. Her final role prior to retiring from West was as Chief Scientific Officer. Fran has presented and published numerous technical articles and book chapters, the latest being a chapter within The Combination Products Handbook-A Practical Guide for Combination Products and other Combined Use Systems published in May 2023 by CRC Press. She is an active member of the PDA Combination Product steering committee, ISPE Combination Products COP, and the AFDO/RAPS Combination Products Summit Steering committee. She is the recipient of the PDA Packaging Science Award for 2021, Philadelphia Business Journal 2018 Healthcare Innovators and the Healthcare Businesswoman’s Association Luminary Award for West in 2017. -
Flora Felsovalyi, PhD
Associate Director, Lonza
Committee Member
Moderator
Read Bio
Flora Felsovalyi, PhD
Lonza
Flora Felsovalyi has 18 years of experience and a deep passion for leading combination product development in the medical device and pharmaceutical industries, specializing in parenteral drug delivery. She has contributed to various stages of the development lifecycle: from conceptualizing and inventing new subcutaneous injection devices to commercial implementation of dual chamber and ocular injection devices.
She currently works in Drug Product Services at Lonza, and holds the position of Head of Pharmaceutical Services. Her team is responsible to developing and offering device-related services offerings to customers. Prior to Lonza, Flora worked at Roche for 8 years both as an early stage formulation scientist and device team leader.
Flora holds a Bachelor’s Degree in Agricultural and Biological Engineering from Cornell University, a Master’s degree in Biomedical Engineering, and a PhD in Chemical Engineering from Columbia University in the City of New York.
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Matthew J. Huddleston, MS
Chief Commercial Officer, Enable Injections
Presenter
Read Bio
Matthew J. Huddleston, MS
Enable Injections
Mr. Matthew J. Huddleston serves as Chief Commercial Officer for Enable Injections, responsible for leading Enable’s current marketing and business development operations and expanding commercial infrastructure. He is an experienced medical device professional with more than 30 years of experience in startup environments with emphasis in project management, design, development, manufacturing, regulatory, and intellectual property. He has several issued and pending patents in the medical device field, including soft tissue and cardiovascular fixation devices and delivery instruments, histologic automated embedding systems, laparoscopic visualization devices, and automatic injection devices. He is a professional engineer and a licensed patent agent. Matt holds a Bachelor of Science in Mechanical Engineering from Purdue University and a Master of Science in Biomedical Engineering from The Ohio State University. -
Akshay R. Kamdar, PhD
Senior Director, Eli Lilly and Company
Committee Member
Moderator
Presenter
Read Bio
Akshay R. Kamdar, PhD
Eli Lilly and Company
Akshay Kamdar is the Sr. Director in the Chemistry, Manufacturing and Controls (CM&C) Project Management organization at Lilly where he is responsible for providing strategic and cross-functional leadership for drug development activities from portfolio entry to launch. Akshay joined Lilly in 2009 after receiving his Doctorate in Polymer Science and Engineering from Case Western Reserve University and his Masters in Materials Science and Engineering from Rochester Institute of Technology. Prior to his current role, he has held various technical and functional leadership roles within Lilly’s Delivery and Device organization focusing on novel container closure systems, combination product development, materials and process engineering from innovation through commercialization. He was also responsible for leading Lilly’s device and packaging sustainability efforts. -
Lee Leichter, RAC, MBA
President, P/L Biomedical
Committee Member
Moderator
Presenter
Read Bio
Lee Leichter, RAC, MBA
P/L Biomedical
Lee Leichter has close to 50 years’ experience in the health care industry, providing direct, hands-on assistance to domestic and international Pharmaceutical, Biotechnology and Medical Device companies for the last 30. Projects have encompassed a multitude of business, technical, regulatory and quality issues, primarily related to drug delivery and combination products for marketing in the USA, Europe and Canada. He has worked with large multi-national companies, as well as start-ups, successfully navigating the challenges posed during the development, testing and marketing approval of products that merge pharmaceutical substances with high-tech device systems. He has been a subject matter expert working with the ISO and AAMI committees on drug delivery devices and Combination products, and convenor for the just published ISO On-Body Delivery Systems Standard. He is currently the PDA IG Leader for Combination Products. -
Arun Mathew, EMBA
Associate Director, AbbVie
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Arun Mathew, EMBA
AbbVie
Arun is a highly skilled and experienced Risk Management professional with a wealth of knowledge and expertise in the field. He holds a master's degree from Coventry University, an executive Master of Business Administration from Quantic, and a Diploma in Electronics. Arun has led corporate-level teams in establishing robust Risk Management processes and procedures. His pioneering risk-based approaches have been implemented in design control, verification and validation, process validation, CAPA, change management and other quality management systems. Arun is an active member of the American Society for Quality and holds certifications as a CQA Certified Quality Auditor, CQE Certified Quality Engineer and Risk Management credential. Currently, Arun works as Associate Director, Quality Management Systems (Risk Management) at AbbVie. He is a co-author of the book Mastering Safety Risk Management for Medical devices and Invitro Devices released by ASQ. -
Katelyn O'Neil
Senior Manager, Device Engineering, Pfizer
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Anurag Patel, PhD
Director, Regulatory Affairs-CMC Device and Drug-Device Combinations, Merck & Co., Inc.
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Anurag Patel, PhD
Merck & Co., Inc.
Anurag Patel is a Director of Device Quality & Regulatory CMC at Merck and is currently responsible for technical leadership, people management, and cross-functional team alignment on the regulatory strategy and submission requirements for autoinjector combination products. Anurag has 28 years of diverse pharmaceutical industry experience and started in Analytical R&D. Within Regulatory Affairs he has worked on projects at various stages, clinical, new product registration, and post-approval for a variety of combination products including reconstitution kits, pre-filled syringes, mechanical autoinjectors, drug-eluting implant, transdermal delivery systems, and inhalation products. Anurag holds a BSc in Industrial Chemistry and MSc in Industrial Polymer Chemistry from Sardar patel University, India, and earned his PhD in Pharmaceutical Sciences from University of Missouri-Kansas City, USA. -
Geoffrey Wise
Medical Device Platform Lead, Genentech
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Geoffrey Wise
Genentech
Geoff wise is the Medical Device Platform Lead at Genentech’s Device and Packaging Development Group in South San Francisco. Geoff has over 18 years in the medical device industry and over 14 years developing and commercializing drug delivery systems. Previously, Geoff has held several roles over his time at Genentech including: senior manager, device team leader, and the head of product care - US (commercial products). Geoff is passionate about driving strategic direction of medical device/drug platforms, solving technical challenges, and bringing new products to market that serve unmet needs. Geoff holds a Bachelor’s degree in Mechanical Engineering with a Minor in Materials Engineering from Cal Poly Pomona University. Geoff is also a lean/six sigma black belt and has 9 issued patents with additional patents pending.
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Renaissance Phoenix Downtown (HQ)
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