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Parenteral Drug Association Connecting People, Science and Regulation ®

2016 PDA Drug Delivery Combination Products Workshop

Providing Approaches and Solutions to Help Navigate the Evolving Combination Product Environment
Oct 19 - Oct 19, 2016 |
Oct 19, 2016 |
Hyatt Regency Huntington Beach Resort and Spa | Huntington Beach, CA
  • Workshop
  • Western Hemisphere Events
Exhibition: October 19
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Listen to the real life experiences of guidance from experienced pharmaceutical and medical device professionals detailing the challenges they have, or are currently facing. Learn from their experiences and solutions they have implemented during development, approval and life-cycle management of their drug delivery combination products. Learn which activities succeeded and lessons learned. Interact with the participants in panel discussions on the issues that are important to the success of your product and company in the future.

Learning Objectives

At the completion of this Workshop, attendees will:

  • Identify and prospectively address key challenges in the development, approval and manufacture of Drug Delivery Combination Products
  • Recognize potential liabilities and opportunities within their organization
  • Benchmark their own organization against others in the area
  • Explain unique issues and challenges in the development, approval and manufacture of Drug Delivery Combination Products to peers and management

Who Should Attend

Departments
Device Development | Compliance | Operations | Regulatory Affairs | Manufacturing | Pharmaceutical Formulation and Process Development | Business Development | Marketing | Procurement | CMC | Distribution | Packaging | Quality Assurance/Control| Clinical Affairs

Job Function
Manufacture of Parenteral Products | Packaging Scientists & Engineers | Stability Coordinators | Supply Chain | Logistics | Clinical Development | Business Development | Formulators | Device Development and Engineering | Quality Engineers, Quality Professionals, Regulatory and Compliance Professionals

Workshop Inquiries

Jason E. Brown
Senior Manager, Programs & Registration Services
Tel: +1 (301) 656-5900 ext. 131
Email: brown@pda.org  

Registration Inquiries

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

Exhibition Inquiries

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

Wednesday, October, 19 2016

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

7:15 a.m. - 5:15 p.m.
Registration Open

8:15 a.m. - 8:30 a.m.
Welcome and Opening Remarks
Lee Leichter,
President, P/L Biomedical, and Chair, 2016 PDA Drug Delivery Combination Products Workshop Program Planning Committee

8:30 am. - 10:00 a.m.
P1 - Human Factors/Risk Management
Moderator: Diane Paskiet,
Senior Director, Scientific Affairs, West Pharmaceutical Services, Inc.

Session Description: The regulatory framework for combination products continues to progress with an emphasis on patient-centric drug delivery. The requirements of drug products as well as the beliefs and preferences of both the prescriber and the patient will influence choices of drug delivery options. It is essential for pharmaceutical companies to understand the patient's interaction with the delivery system to be able to incorporate features which promote adherence to treatments. Appropriate user research, characterizing their needs and good human factors engineering are all integral parts of the design and development of patient- centric drug delivery systems and will be the focus of this session.

8:30 a.m. - 9:00 a.m.
A Human Factors Road Map for Self-Injection Device Design
Chris Evans,
Vice President, Global Innovation, West Pharmaceutical Services, Inc.

9:00 a.m. - 9:30 a.m.
Risk Based Approaches to Design and Development of Drug Delivery Systems
Molly Story, PhD, Head, Global Usability Engineering & Risk Management, Sanofi

9:30 a.m. - 10:00 a.m.
Questions and Answers/Discussion

Panelists:
Chris Evans,
Vice President, Global Innovation, West Pharmaceutical Services, Inc.
Molly Story, PhD, Head, Global Usability Engineering & Risk Management, Sanofi
Regulatory Representative (Invited)

7:15 a.m. - 3:50 p.m.
Exhibit Area Open

10:00 a.m. - 10:45 a.m.
Refreshment Break in Exhibit Area

10:45 a.m. - 12:15 p.m.
Concurrent Sessions

A1 – Design Verification Testing, Critical Quality Attributes, Release & Stability Testing
Moderator: Alberto Velez,
​Consultant, ​Chimera Consulting North America, LLC 

Session Description: As design control in combination products begins to mature we begin to improve how organizations are integrating critical to quality attributes and stability testing into the design verification process. This session will share current thinking on how design verification, stability testing and critical to quality attributes.

10:45 a.m. - 11:15 a.m.
How a Center of Excellence can better Address Design Verification
Susan Neadle,
Senior Director, Design-To-Value & PQM, Janssen

11:15 a.m. - 11:45 a.m.
Integration of Essential Performance into Combination Product Control Strategies
Suzette Roan,
Associate Director, Regulatory Affairs, CMC Combination Products, Biogen

11:45 a.m. - 12:15 p.m.
Questions and Answers/Discussion

B1 – Design/Technology Transfer
Moderator: Lee Leichter,
President, P/L Biomedical

Session Description: Combination products add another layer to technology transfer for Drug Products.  In addition to standard technology transfer, the sponsor must also address Design Transfer of the Combination products.  This session will identify these challenges and methods to address both that have been successfully executed.

10:45 a.m. - 11:15 a.m.
Technology Transfer
Mark Chipperfield,
Principal Consultant & Company Director, Corvus Device Limited (Invited)

11:15 a.m. - 11:45 a.m.
Design Transfer
Amit Khanolkar,
Director, Combination Products & Emerging Technology, PQM, Janssen

11:45 a.m. - 12:15 p.m.
Questions and Answers/Discussion

12:15 p.m. - 1:30 p.m.
Lunch

1:30 p.m. - 3:00 p.m.
Concurrent Sessions

A2 - Clinical Studies/Level of Design Controls Phase I, II & III
Moderator: Lee Leichter,
President, P/L Biomedical

Session Description: This session will address the types of clinical studies that are requested, and can be performed to support NDA/BLA, ANDA and biosimilar drug delivery combination product submissions and the level of design controls necessary to be completed for type/phase of study.

1:30 p.m. - 2:00 p.m.
Device-Centric Studies for Combination Product Approval
Doug Mead,
Senior Director, Regulatory Affairs, Janssen

2:00 p.m. - 2:30 p.m.
Design Verifications and Validations Required for Clinical Supplies
Nicholas Wong,
Senior Associate III, Biogen

2:30 p.m. - 3:00 p.m.
Questions and Answers/Discussion

B2 - GMPs, Inspections and Change Management
Moderator: Manfred Maeder, PhD,
Head, Device Development & Commercialization, Novartis Pharma AG

Session Description: The regulatory framework for combination products is currently developing fast with regular updates of guidelines and increased expectations. The requirements for appropriate change management pose challenges, because it is beyond the "Pharma Change Control" system. Changes now need to consider updates to the DHF.

1:30 p.m. - 2:00 p.m.
Change Management Practices and Post Market Considerations
Paul Jansen,
Vice President, Medical Device Development, Sanofi Pasteur

2:00 p.m. - 2:45 p.m.
Current Challenges during Combination Product Inspections
Regulatory Representative (Invited)

2:45 p.m. - 3:00 p.m.
Questions and Answers/Discussion

3:00 p.m. - 3:45 p.m.
Refreshment Break in Exhibit Area

3:45 p.m. - 5:15 p.m.
P2 - Future Solutions to the Patient Experience/Challenges with Drug Delivery Devices
Moderator: Ronald Iacocca, PhD,
Research Fellow, Delivery/Device R&D, Eli Lilly & Company

Session Description: Combination products have to consider numerous factors in addition to the efficacy of the treatment. As many of the diseases treated by combination products are chronic, the patient experience must be positive such that the treatment will be used. Technology and human factors considerations are crucial to the success of the therapy. Technology, through things such as connected solutions, can provide greater information to health care providers to enable better patient care and outcomes. Human factors enable the devices are easy to use, safe, and reliable. The talks in this session will focus on these key topics, and how they promote a superior patient experience.

3:45 p.m. - 4:15 p.m.
Innovation & Emerging/New Technologies for Parental Delivery
Marie Schiller,
Vice President, Innovation, Eli Lilly & Company

4:15 p.m. - 4:45 p.m.
Human Factors and Consideration for Integration of Connected Health to Devices
Tyler Blake, PhD,
Chief Scientist, Human Factors Consulting Services, Inc.

4:45 p.m. - 5:15 p.m.
Questions and Answers/Discussion

5:15 p.m.
Closing Remarks and Adjournment
Lee Leichter,
President, P/L Biomedical, and Chair, 2016 PDA Drug Delivery Combination Products Workshop Program Planning Committee

Workshop Registration | October 19

Member | Nonmember

$800


Conference Registration | October 17-18

Member

Before August 5, 2016
$1,995

August 5- September 2, 2016
$2,395

After September 2, 2016
$2,595

Nonmember

Before August 5, 2016
$2,254

August 5- September 2, 2016
$2,654

After September 2, 2016
$2,854


Government/Health Authority/Academic

Member

Before August 5, 2016
$700

August 5- September 2, 2016
$700

After September 2, 2016
$700

Nonmember*

Before August 5, 2016
$800

August 5- September 2, 2016
$800

After September 2, 2016
$800


Student

Member

Before August 5, 2016
$280

August 5- September 2, 2016
$280

After September 2, 2016
$280

Nonmember*

Before August 5, 2016
$310

August 5- September 2, 2016
$310

After September 2, 2016
$310

All prices in US dollars.

* For this member type, online registration is not available must be faxed in.

Please note: In order to receive the prevailing registration rate, your registration(s) must be received by PDA by 5:00 p.m. ET on or before the date noted.

Please read PDA's confirmation, substitution, refund and photo release policies for this workshop.

Group Registration Discount

Register 4 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 5th registration free. Other discounts cannot be applied.

Special Dietary Requirements

Please let us know if you have any special dietary requirement we may assist you with. Please contact us at registration@pda.org for help.

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 cancellation notice is not received by August 18, 2016 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 nonmember substituting for a member, you will be required to pay the difference nonmember fee. If you are pre-registering as a substitute 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 Full Workshop/Events: If your written request in received on or beforeAugust 18, 2016, 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 conference materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice, or 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: 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 badge 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. Recordings are prohibited at all PDA conferences.

Hyatt Regency Huntington Beach Resort and Spa
21500 Pacific Coast Highway
Huntington Beach, CA 92648
Phone: +1 (714) 698-1234

They will secure the lowest available rates at the best available hotels within walking distance of The Hyatt Regency Huntington Beach & Spa Resort.

Reservations processed by A Room With A View are automatically put on a waitlist for rooms at The Hyatt Regency Huntington Beach & Spa Resort should cancellations occur within The PDA group block.

A Room with a View can be contacted at 1-800-780-4343
Monday- Friday 8am – 5pm CST
International attendees can reach them at reservations@aroomwithaview.net
This is a FREE SERVICE for all PDA attendees

Travel

Area Airports
John Wayne Orange County Airport (SNA) is approximately 10 miles from the hotel and all major carriers service this airport. One other airport in the vicinity serviced by all major carriers: Los Angeles International (LAX), 37.8 miles away.

Ground Transportation
Taxi fares from John Wayne Orange County (SNA) are approximately $28 one way, not including tip, and will take about 21 minutes. One way taxi fares from Los Angeles International (LAX) is approximately $90, not including tip, and will take about 46 minutes. 

Driving
Hyatt Regency Huntington Beach hotel is located on 21500 Pacific Coast Highway.

Hotel Parking
Valet Parking only, $35.00 overnight (car must be parked by 9:00 p.m.  Daily Valet is $20.00 for 12 hours.  Self-parking is available across street from hotel.

The 2016 PDA Drug Delivery Combination Products Workshop will provide your company with a premier opportunity to network with key decision makers in this dynamic field. Find new customers and strengthen current relationships by exhibiting at and/or sponsoring this Workshop.

The Workshop agenda will provide ample opportunity for exhibitors to have face-to-face dialogue and direct information exchange with industry professionals who are involved in development, approval and manufacturing of drug delivery combination products. Company representatives will be on hand from compliance, CMC, packaging, operations, quality, regulatory affairs, supply chain, procurement and other technical functions.

Become a sponsor and/or exhibit at the 2016 PDA Drug Delivery Combination Products Workshop to strengthen your brand image, increase your visibility and gain access to leaders and subject matter experts in the bio/pharmaceutical industry.

For more information, contact:

David Hall
Vice President, Sales
Tel: +1 (301) 760-7373
Cell: +1 (240) 688-4405
Email: hall@pda.org

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=2931

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