2017 PDA Container Closure Workshop

2017 PDA Container Closure, Devices PAGE TITLE and Delivery Systems: Compatibility and Material Safety Workshop

Exhibition: October 2-3

October 2-3, 2017 | Washington, DC Omni Shoreham Hotel

#2017CC

Co-sponsored by

Exhibition: October 2-3

#2017CC

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Exploring Regulatory Expectations and Patient Considerations for the Future

pda.org/2017CC This preliminary agenda is current as of July 11, 2017

RECORDINGS ARE PROHIBITED AT ALL PDA EVENTS

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2017 PDA CONTAINER CLOSURE, DEVICES AND DELIVERY SYSTEMS: COMPATIBILITY AND MATERIAL SAFETY WORKSHOP – GENERAL INFORMATION

2017 PDA Container Closure, Devices and Delivery Systems: Compatibility and Material Safety Workshop October 2-3, 2017 | Omni Shoreham Hotel | Washington, DC

The Parenteral Drug Association presents the...

2017 PDA CONTAINER CLOSURE, DEVICES AND DELIVERY SYSTEMS: COMPATIBILITY AND MATERIAL SAFETY WORKSHOP – GENERAL INFORMATION

Connecting People, Science and Regulation®

PROGRAM PLANNING COMMITTEE

A MESSAGE FROM THE PROGRAM CO-CHAIRS Dear Friends, Colleagues and Peers:

Program Co-Chairs:

On behalf of the Program Planning Committee, we would like to invite you to attend the 2017 PDA Container Closure, Devices and Delivery Systems: Compatibility and Material Safety Workshop taking place in Washington, DC, Oct. 2-3.

Ronald G. Iacocca, PhD Eli Lilly and Company Diane Paskiet West Pharmaceutical Services

Kim Li, PhD, DABT, MPH Amgen Inc. Nazia F. Rahman Center for Devices and Radiological Health, U.S. FDA M. Isabel Tejero del Rio, MD, PhD Center for Devices and Radiological Health, U.S. FDA Richard V. Levy, PhD PDA Molly O’Neill Moir, CMP PDA Planning Committee Liaison Brooke Schneider, CMP PDA Planning Committee Liaison

Ronald G. Iacocca, PhD Eli Lilly and Company

Diane Paskiet West Pharmaceutical Services

Although the Workshop title is long, the subject matter is critical to the development of new devices and delivery systems that are being considered for use with advanced

therapeutic treatments.

Delivery devices are becoming an increasingly important part of the patient experience, raising new challenges for companies developing novel device delivery systems. In addition, as more biologic therapies are being developed, many therapies are using combination product delivery systems. Technology advances are moving more quickly than traditional drug development approaches can accommodate. New products/devices/therapeutics must be developed with a much clearer vision of the final product in mind as the demand for these new technologies is high.

How does one keep up with these increasing demands? The key is to have a much deeper understanding of the entire landscape, requiring both breadth and depth of the required information. This Workshop will bring some of these topics to the surface, allowing participants to interact directly with industry and regulatory thought leaders on the crucial topic of compatibility and safety of drugs utilizing devices and advanced delivery systems.

We have also provided the opportunity to learn about ongoing initiatives to improve product quality by understanding limits on leachables, particle generation in the manufacturing environment and the steps suppliers are taking for continuous product improvement. Never has the supplier/customer relationship been so crucial.

While at this exciting Workshop, be sure to visit the vendors in the Exhibit Area, who will be showcasing the latest technologies, and meet and mingle with colleagues and other industry professionals during refreshment breaks and the Networking Luncheon.

We hope you attend this Workshop and maximize the opportunity to immerse yourself in these cutting-edge conversations. Don’t miss this unique opportunity to delve deeper into issues related to material compatibility and safety for container closure for devices and delivery systems.

We look forward to seeing you in DC!

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Exhibition: October 2-3

#2017CC

GENERAL INFORMATION, REGISTRATION LEARNING OBJECTIVES FOUR WAYS TO REGISTER 1. Click 2. Fax 3. Mail

4. Phone

pda.org/2017CC +1 (301) 986-1093 PDA Global Headquarters Bethesda Towers 4350 East West Highway, Suite 600 Bethesda, MD 20814 USA (301) 656-5900 ext. 115

VENUE Omni Shoreham Hotel 2500 Calvert St., NW Washington, DC 20008 USA Phone: +1 (202) 234-0700 Website: www.omnihotels.com/hotels/washington-dc-shoreham Rate: Single: $259, plus applicable state and local taxes.

Cut-Off Date: Monday, September 4, 2017 (Rooms must be secured by this date in order to receive the PDA rate). Rates are guaranteed until the PDA block of rooms are sold out on a first come basis.

CONTINUING EDUCATION CREDITS PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits.

To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive CPE credit.

ALERT: ACPE and the National Association of Boards of Pharmacy developed the Continuing Pharmacy Education (CPE) Monitor that allows pharmacists to electronically track their CPE credits.

Upon completion of this workshop, you will be able to: • Describe the complexity around safety and compatibility for combination products • Explain the FDA interpretation of combination product testing to ensure patient safety and efficacy • Distinguish the approaches being employed in the pharmaceutical and biotech industry for testing and evaluating combination products • Discuss the importance of ongoing industry initiatives such as PQRI, PDA, and others • Summarize the rationale for required testing of combination products • Identify available resources for combination product testing

WHO SHOULD ATTEND Job Function: Biotech | Clinical Trial Materials | Combination Products | Flexible Container | Packaging Science | Quality Risk Management | Sterile Processing Departments: Biochemistry | Biology | Chemistry | Compliance | Engineering | Manufacturing | Development | Quality | Regulatory Affairs | Research

WORKSHOP REGISTRATION HOURS Monday, Oct. 2: 7:00 a.m. – 2:00 p.m.

Tuesday, Oct. 3: 7:00 a.m. – 5:30 p.m.

DRESS/ATTIRE Business casual attire is recommended for the 2017 PDA Container Closure, Devices and Delivery Systems: Compatibility and Material Safety Workshop. Since the temperature in meeting rooms tends to be cool, please bring a jacket or sweater for your comfort.

SPECIAL REQUIREMENTS If you require special accommodations to fully participate, please attach a written description of your needs with your registration form. Specific questions can be directed to registration@pda.org.

The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE accredited activity. Always submit CPE activity claims as soon as possible and by the deadline specified on the CPE credit request form.

CONTACT INFORMATION

2017 PDA Container Closure, Devices and Delivery Systems: Compatibility and Material Safety Workshop ACPE # 0116-0000-17-018-L04-P | 1.175 CEUs Type of Activity: Knowledge

Workshop Inquiries Brooke Schneider, CMP Manager, Programs Tel: +1 (301) 656-5900 ext. 111 Email: schneider@pda.org

Exhibition/Sponsorship Inquiries David Hall Vice President, Sales Tel: +1 (240) 688-4405 Email: hall@pda.org

Registration Customer Care Tel: +1 (301) 656-5900 ext. 115 Email: registration@pda.org

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2017 PDA CONTAINER CLOSURE, DEVICES AND DELIVERY SYSTEMS: COMPATIBILITY AND MATERIAL SAFETY WORKSHOP – GENERAL INFORMATION

2017 PDA Container Closure, Devices and Delivery Systems: Compatibility and Material Safety Workshop October 2-3, 2017 | Omni Shoreham Hotel | Washington, DC

2017 PDA CONTAINER CLOSURE, DEVICES AND DELIVERY SYSTEMS: COMPATIBILITY AND MATERIAL SAFETY WORKSHOP – AGENDA

Connecting People, Science and Regulation®

MONDAY, OCTOBER 2 AGENDA 7:00 a.m. – 5:30 p.m.

Registration Open

7:00 a.m. – 8:30 a.m.

Continental Breakfast 8:15 a.m. – 8:30 a.m.

Welcome and Opening Remarks Diane Paskiet, Director, Scientific Affairs, West Pharmaceutical Services, and Co-Chair, 2017 PDA Container Closure, Devices and Delivery Systems: Compatibility and Material Safety Workshop Program Planning Committee 8:30 a.m. – 10:00 a.m.

P1: Opening Plenary: The Future of Drug Delivery Moderator: Diane Paskiet, Director, Scientific Affairs, West Pharmaceutical Services Session Description: The product quality of drugs relies on the safety and compatibility of their container closure and delivery system.

As the complexity of delivery systems and drug device combination products increases, the task of qualifying components fit for use becomes especially challenging. This session will give insight on how drug development is transforming the way primary packaging and delivery systems are viewed during development and throughout the product lifecycle.

8:30 a.m. – 9:00 a.m.

Considerations for Early Drug-Device Development Didier Pertuy, MS, Vice President, Global Head Drug Device Integrated Development, Sanofi 9:00 a.m. – 9:30 a.m.

Expediting Approval for Innovative Delivery Systems Regulatory Representative Invited 9:30 a.m. – 10:00 a.m.

Questions and Answers/Discussion 9:45 a.m. – 6:30 p.m.

Exhibit Area Open 10:00 a.m. – 10:45 a.m.

Refreshment Break in Exhibit Area

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Exhibition: October 2-3

MONDAY, OCTOBER 2 AGENDA (CONTINUED)

#2017CC

10:45 a.m. – 12:15 p.m.

P2: Strategies for Safety Evaluation Moderator: Ronald G. Iacocca, PhD, Research Fellow, Device and Delivery Research & Development, Eli Lilly and Company Session Description: Biocompatibility testing is a growing area of interest in the development and registration of combination products. This session will focus on the basic concepts of biocompatibility testing for device platforms, as well as the strategies to execute them in a meaningful way such that excessive animal testing is not required.

10:45 a.m. – 11:15 a.m.

Approaches to Biocompatibility Evaluation of Combination Products Kathleen Lin, PhD, Associate Senior Consultant Engineer, Eli Lilly and Company 11:15 a.m. – 11:45 p.m.

Industry Perspective on Strategies for Safety Evaluation Industry Representative Invited 11:45 p.m. – 12:15 p.m.

Questions and Answers/Discussion 12:15 p.m. – 1:30 p.m.

Networking Luncheon 1:30 p.m. – 3:15 p.m.

P3: Leachables and Extractables for Combination Products that Include Both Drugs and Devices Moderator: Kim Li, PhD, DABT, MPH, Senior Manager, Amgen Inc. Session Description: Chemical characterization is important for device-drug combination products. Risk of leachables and interaction products guides the analytical testing strategy. Extractables and leachables profiles are critical to qualifying these types of combination products, but the regulatory approaches can vary depending on the lead U.S. FDA center. There is one common purpose for leachables and extractables testing – to protect drug product quality and inform patient safety. This session will examine some of the different approaches to acquiring data and describes the PQRI strategy for safety thresholds and best practices.

1:30 p.m. – 1:50 p.m.

PQRI Strategy for Thresholds and Best Practices for Extractables and Leachables Christopher T. Houston, PhD, Director of Analytical Chemistry, iuvo BioScience 1:50 p.m. – 2:15 p.m.

Biocompatibility Assessment of Medical Devices Jennifer L. Goode, Biocompatibility Program Advisor, CDRH, FDA 2:15 p.m. – 2:45 p.m.

Chemical Characterizations Materials Considerations of Extraction for Devices Matthew Woods, Group Leader/Senior Chemist, Eurofins Lancaster Laboratories Considerations of Extraction for Drug Packaging Piet Christiaens, PhD, Scientific Director, Toxicon Europe 2:45 p.m. – 3:15 p.m.

Panel Discussion Piet Christiaens, PhD, Scientific Director, Toxicon Europe Jennifer L. Goode, Biocompatibility Program Advisor, CDRH, FDA Christopher T. Houston, PhD, Director of Analytical Chemistry, iuvo BioScience M. Isabel Tejero del Rio, MD, PhD, Lead Consumer Safety Officer, CDRH, FDA Matthew Woods, Group Leader/Senior Chemist, Eurofins Lancaster Laboratories

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2017 PDA CONTAINER CLOSURE, DEVICES AND DELIVERY SYSTEMS: COMPATIBILITY AND MATERIAL SAFETY WORKSHOP – AGENDA

2017 PDA Container Closure, Devices and Delivery Systems: Compatibility and Material Safety Workshop October 2-3, 2017 | Omni Shoreham Hotel | Washington, DC

2017 PDA CONTAINER CLOSURE, DEVICES AND DELIVERY SYSTEMS: COMPATIBILITY AND MATERIAL SAFETY WORKSHOP – AGENDA

Connecting People, Science and Regulation®

MONDAY, OCTOBER 2 – TUESDAY, OCTOBER 3 AGENDA 3:15 p.m. – 4:00 p.m.

Refreshment Break in Exhibit Area 4:00 p.m. – 5:30 p.m.

P4: Holistic Safety & Quality Assessment Moderator: Ronald G. Iacocca, PhD, Research Fellow, Device and Delivery Research & Development, Eli Lilly and Company Session Description: Safety assessment (i.e., toxicological evaluation) of leachables is a cornerstone of any pharmaceutical development program in which the issue of extractables/leachables is a concern. The session will begin with a discussion of background on the potential for safety concerns related to leachable substances, risk assessment considerations for human safety evaluation purposes and current initiatives/proposals for safety assessment of leachables. These recommendations provided toxicologists with a process to qualify extractables in parenteral products.

4:00 p.m. – 4:25 p.m.

Current Progress in Approaches for the Safety Assessment of Extractables and Leachables Kim Li, PhD, DABT, MPH, Senior Manager, Amgen Inc. 4:25 p.m. – 4:50 p.m.

Review of the Extractables and Leachables Studies by the U.S. FDA: Practical Advice Dan Mellon, PhD, Pharmacology Toxicolology Supervisor, CDER, FDA 4:50 p.m. – 5:30 p.m.

Questions and Answers/Discussion

5:30 p.m. – 6:30 p.m.

Networking Reception in Exhibit Area

TUESDAY, OCTOBER 3 7:00 a.m. – 2:00 p.m.

Registration Open 7:00 a.m. – 8:30 a.m.

Continental Breakfast 7:15 a.m. – 8:15 a.m.

Breakfast Session: Packaging Science Interest Group Moderator: Roger Asselta, Vice President, Technical Affairs, Genesis Packaging Technologies Session Description: This session will provide updates on current activities in the area of parenteral packaging, including Technical Reports, Tasks Forces and regulatory issues. It will provide an open forum for further discussion on this issue and additional topics of interest.

7:15 a.m. – 7:30 a.m.

Packaging Science Update 7:30 a.m. – 8:15 a.m.

Questions and Answers/Discussion

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Exhibition: October 2-3

TUESDAY, OCTOBER 3 AGENDA (CONTINUED)

#2017CC

8:30 a.m. – 10:00 a.m.

P5: Particle Challenges Associated with Delivery Systems and Devices Moderator: M. Isabel Tejero del Rio, MD, PhD, Lead Consumer Safety Officer, CDRH, FDA Session Description: There is great a concern for contributions of particles from packaging components resulting in greater scrutiny of individual components. Understanding the sensitivity and uniqueness of particulate assessments will allow for an improved industry alignment on the subject. This session will focus current challenges associated industry initiatives for particulate evaluations and contributions from packaging components.

8:30 a.m. – 9:00 a.m.

Industry Initiatives for Visible Particulates Specifications: Pharmaceutical Manufacturers Forum Paolo Golfetto, Business Development Director, Ompi 9:00 a.m. – 9:30 a.m.

Impact and Consideration of Pharmaceutical Packaging on Particulates Fran DeGrazio, Vice President, Scientific Affairs & Technical Services, West Pharmaceutical Services 9:30 a.m. – 10:00 a.m.

Questions and Answers/Discussion 9:45 a.m. – 1:45 p.m.

Exhibit Area Open

10:00 a.m. – 10:45 a.m.

Refreshment Break in Exhibit Area 10:45 a.m. – 12:45 p.m.

P6: Compatibility of Delivery Systems with Biologics Moderator: Nazia F. Rahman, Biomedical Engineer, CDRH, FDA Session Description: A product formulation and its container closure must be chemically or biochemically stable to maintain the system’s integrity to be considered compatible. This session will explore correlation of biologic product quality with containment and delivery systems. This is a dynamic process that involves understanding suitability of delivery systems to preserve protein stability throughout the product lifecycle.

10:45 a.m. – 11:15 a.m.

Understanding Particulates from Formulation and Container Closure: Choosing the Right Techniques to Properly Assess Particle Profiles Amber Haynes Fradkin, PhD, Director, Particle Characterization Core Facility, KBI Biopharma 11:15 a.m. – 11:45 a.m.

Qualifying Delivery System Platforms and Lifecycle Management Regulatory Representative Invited 11:45 a.m. – 12:15 p.m.

Product Formulation-Package Interactions: Impact on Container Closure Evaluation and Risk Mitigation Approaches for Combination Products Lei Li, PhD, Associate Senior Consultant Engineer, Eli Lilly and Company 12:15 p.m. – 12:45 p.m.

Questions and Answers/Discussion 12:45 p.m. – 2:00 p.m.

Networking Luncheon

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2017 PDA CONTAINER CLOSURE, DEVICES AND DELIVERY SYSTEMS: COMPATIBILITY AND MATERIAL SAFETY WORKSHOP – AGENDA

2017 PDA Container Closure, Devices and Delivery Systems: Compatibility and Material Safety Workshop October 2-3, 2017 | Omni Shoreham Hotel | Washington, DC

2017 PDA CONTAINER CLOSURE, DEVICES AND DELIVERY SYSTEMS: COMPATIBILITY AND MATERIAL SAFETY WORKSHOP – AGENDA

Connecting People, Science and Regulation®

TUESDAY, OCTOBER 3 AGENDA (CONTINUED) 2:00 p.m. – 4:00 p.m.

P7: Closing Plenary: Quality Considerations for Combination Products and Device Moderator: Richard V. Levy, PhD, Senior Vice President, Scientific and Regulatory Affairs, PDA Session Description: Specialty applications for drug delivery systems and devices continue to evolve and providing fit for use criteria is a challenge for suppliers. Compliance with national and international standards is a starting point but cannot encompass all uses.

A set of baseline requirements can support suitability studies along with insight on quality expectations. This session will present the rationale, development and content of the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) baseline requirements for materials quality, discussing engagement with suppliers, lifecycle implications and relationship to risk-based concepts.

2:00 p.m. – 2:30 p.m.

A Device Perspective: Change Control for Marketed Combination Products Kesley Gallagher, MS, Senior Regulatory Affairs Manager, Amgen Inc. 2:30 p.m. – 3:00 p.m.

Partnering across the Supply Chain to Develop and Communicate Risk-Based Requirements for Materials Quality Lee Mia Nagao, PhD, Science Advisor, Drinker Biddle 3:00 p.m. – 3:30 p.m.

Regulatory Insight on Supplier Controls Regarding Quality of Delivery Systems Nazia F. Rahman, Biomedical Engineer, CDRH, FDA M. Isabel Tejero del Rio, MD, PhD, Lead Consumer Safety Officer, CDRH, FDA 3:30 p.m. – 4:00 p.m.

Questions and Answers/Discussion 4:00 p.m.

Closing Remarks Ronald G. Iacocca, PhD, Research Fellow, Delivery and Device Research and Development, Eli Lilly and Company, and Co-Chair, 2017 PDA Container Closure, Devices and Delivery Systems: Compatibility and Material Safety Workshop Program Planning Committee

2017 PDA CONTAINER CLOSURE, DEVICES AND DELIVERY SYSTEMS: COMPATIBILITY AND MATERIAL SAFETY WORKSHOP

Sponsorship and Exhibit Opportunities are Available!

The 2017 PDA Container Closure, Devices and Delivery Systems: Compatibility and Material Safety Workshop offers exciting and unique sponsorship and exhibition packages designed to strengthen brand image, increase visibility and help you connect with industry leaders. This Workshop will bring together industry experts from product development, process validation, quality control, product testing, biocompatibility testing, manufacturing and engineering.

At this Workshop, you will have access to engaged and interested attendees from a variety of manufacturing companies – making this a must-attend meeting. In addition, high-profile sponsorships are available for lanyards, notepads, audience response systems, tote bags, pens, Refreshment Breaks, luncheons and the evening Networking Reception. We’ll create a customized sponsorship to fit your unique needs and budget.

For more information about exhibit and sponsorship opportunities, please contact: David Hall, Vice President, Sales Cell: +1 (240) 688-4405 | Email: hall@pda.org

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2017 PDA Container Closure, Devices and Delivery Systems: Compatibility and Material Safety Workshop October 2-3, 2017 | Washington, DC

Four easy ways to register – Click: www.pda.org/2017CC Fax: +1 (301) 986-1093 (USA) Mail: PDA Global Headquarters

4350 East West Highway, Suite 600

Bethesda, MD 20814 USA Call: +1 (301) 656-5900 ext. 115

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Omni Shoreham Hotel Exhibition: October 2-3

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 Check here to become a member and receive the member price for this event. (Add $279 to your total.)

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CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancelation notice is not received by August 3, 2017, your credit card will be charged the prevailing rate. SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including on-site at the prevailing rate. If you are a non-member substituting for a member, you will be required to pay the difference in the non-member fee. If you are pre-registering as a subsitute attendee, indicate this on the registration form. REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). Refunds for Workshop/Event: If your written request is received on or before August 3, 2017, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. Onsite registrants are not guaranteed to receive Workshop materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice or to cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancelation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900. PLEASE NOTE THAT PHOTO ID WILL BE REQUIRED IN ORDER TO PICK UP BADGE MATERIALS ON-SITE. THIS IMPORTANT SECURITY PROCEDURE WILL PREVENT ANYONE OTHER THAN THE REGISTRANT FROM PICKING UP THEIR BADGES AND MATERIALS. RECORDING/PHOTO RELEASE: By registering for these events, I authorize PDA to record and photograph me and to use the recordings/photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the recordings/photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership. Tape recordings are prohibited at all PDA events.

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