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Parenteral Drug Association Connecting People, Science and Regulation ®

2016 PDA Outsourcing/CMO Conference

Challenges Facing Outsourcing and Customers: Global Perspectives and Solutions
Nov 03 - Nov 04, 2016 |
Nov 04, 2016 |
Renaissance Washington, DC Hotel | Washington, DC
  • Conference
  • Western Hemisphere Events
Exhibition: November 3-4
Courses: November 2
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PDA is excited to announce its first conference in the U.S. focused on outsourcing and contract manufacturing organizations (CMO). The environment in this specialized field continues to evolve; this Conference will showcase relevant case studies that demonstrate the importance of shared goals and partnership to bring important therapies to ever wider markets. Hear from industry leaders about their experiences in driving collaborative best practices for development and commercial execution.

Learning Objectives

Participants will gain current knowledge from industry experts who represent both the client and the CMO side and will be able to:

  • Discuss and participate in effective ways to utilize outsourcing and CMO models for both large and small companies across the product lifecycle, including selection, technology transfer,manufacturing and testing.
  • Discuss latest thinking on implementing future regulatory initiatives (such as quality metrics) and technology trends (such as cell-based therapies) into the CMO, outsourcing framework.
  • Discuss lessons learned from different projects with a focus on continuous improvement from the view of different perspectives from the client and CMO side.

Who Should Attend

Personnel with experience in the following areas will find this level of direct information exchange with members from the industry and regulatory agencies useful to their specific programs: quality, manufacturing, supply chain, business development, auditing, testing and technical functions areas.

Departments: Research and Development | Regulatory Affairs | Manufacturing | Operations | Supply Chain and Business Risk Functions | Quality Assurance/Control | Business Development
Job Functions: Quality | Regulatory | Supply Chain | Executive and Corporate Management | Clinical Supply Materials Preparation | Auditing


Conference Inquiries:

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

Registration Inquiries
Tel: +1(301) 656-5900 ext. 115

Exhibition Inquiries
David Hall
Vice President, Sales
Tel: +1(301) 656-5900 ext. 160

Education Course Series Inquiries

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 ext. 151

Thursday, November , 2016

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

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

8:15 a.m. - 8:30 a.m.
Welcome & Opening Remarks
Steven Falcone, Vice President, Quality, Genzyme, and Chair, 2016 PDA Outsourcing/CMO Conference Program Planning Committee

8:30 am. - 10:00 a.m.
P1 - Quality Metrics Part I
Moderator: Steven Falcone, Vice President, Quality, Genzyme

Session Description: Are you curious how your CMO will engage with you on reporting Quality Metrics for your product or testing results or how you should engage with your customers with this information? With the advent of reporting Quality Metrics to the FDA, we want to understand how CMO’s will adapt to sharing their information with customers and sharing information with the agency. While each scenario is different we will look at a few options and their ramifications of changes to communication strategies with clients. At the same time, we want to share the current thinking and direction on the Technical Conformance Guide for metrics and understand the important role that CMO’s play in contributing to make this program successful.

8:30 a.m. – 9:00 a.m.
Metrics Implications for Contract Manufacturing and Laboratories
Nick Beaumont, Vice President, Quality Assurance & Compliance, Samsung Biologics

9:00 a.m. - 9:30 a.m.
Quality Metrics and Challenges Facing CMOs
Tara Gooen Bizjak,
Senior Advisor, CDER,FDA

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

9:45 a.m. - 6:45 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.
P2 - Identification & Selection of CMOs
Moderator: Stanley Russell, Head of Partnership Quality, Shire

Session Description: You’ve made the decision to Outsource your new product. When is the best time to do this – early stage development, right before commercial manufacturing, or somewhere in-between? What are the risks and challenges for outsourcing at the various product lifecycle stages, while always meeting quality, compliance, and business needs? Finding and acquiring the best CMO possible for your manufacturing needs has to be well-planned and with input from various groups within your company. This includes Process Development, Manufacturing, Quality, Supply Chain, Finance, and Legal. The input is converted into questions that are included in the RFPs. These are sent to a shortlist of potential CMOs. Their responses will determine who you visit for the Due Diligence. Then finally the CMO Site Selection. Case Study: Tool to use for CMO Site Selection.

10:45 a.m. - 11:15 a.m.
When to Outsource - Early Stage Development vs. Commercial Manufacturing
Lada Laenen¸ PhD, Senior Director, Allston MSAT Head,  Genzyme, A Sanofi Company 

11:15 a.m. - 11:45 a.m.
Options/Criteria for Best Fits
Robert Beall, Associate Director, Program Management, ProPharma Group

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

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

1:30 p.m. - 3:00 p.m.
P3 - Quality Agreement
Moderator: Jessica Walker, Director, Quality Assurance, Afton Scientific, LLC

Session Description: Outsourcing has created increasingly complex supply chains across the industry. The goal of any Quality Agreement is to help clearly delineate responsibilities and create open lines of communication between the parties involved. This session will discuss how to establish robust and successful Quality Agreements in a global and increasingly outsourced market. The impact that the FDA Guidance will have on how these agreements are created and managed, as well as, how to best integrate the concepts from the guidance into existing relationships will be discussed. Additionally, this session will present examples for implementing effective agreements that lead to increased product quality and safety.

1:30 p.m. - 2:00 p.m.
FDA Quality Agreement Draft Guidance
Paula Katz, Director, Manufacturing & Quality Guidance & Policy, CDER, FDA

2:00 p.m. - 2:30 p.m.
Relationships to Succeed
Scott Gunther, Vice President, Quality, Catalent Pharma Solutions

2:30 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.
P4 - Ensuring Effective Auditing
Moderator: Rich Levy, PhD, Senior Vice President, Science & Regulatory Affairs

Session Description: Guidelines for auditing management systems, an audit is a “systematic, independent and documented process for obtaining audit evidence [records, statements of fact or other information which are relevant and verifiable] and evaluating it objectively to determine the extent to which the audit criteria [set of policies, procedures or requirements] are fulfilled.” As applied to CMOs and their suppliers, the auditing process will differ from that at the license holder. Unique challenges will exist which need to be addressed. These differences can include how CAPA’s and investigations are conducted and followed up, as well as how due diligence and audits of suppliers are handled.

3:45 p.m. - 4:15 p.m.
Managing Responsibility for Observations and CAPAs Following a Regulatory Inspection
Jessica Walker, Director, Quality Assurance, Afton Scientific, LLC

4:15 p.m. - 4:45 p.m.
Exploring the differences between a Due Diligence and Supplier Audits
Dwayne Greathouse, Senior Director, Supplier Quality & Compliance, Gilead Sciences, Inc.

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

5:15 p.m. - 6:45 p.m.
Networking Reception in Exhibit Area

Friday, November 4, 2016

7:30 a.m. - 5:00 p.m.
Registration Open

7:30 a.m. - 8:30 a.m.
Continental Breakfast

8:30 a.m. - 10:00 a.m.
P5 - Regulatory Concerns
Moderator: Austin Caudle, Director, Strategic Accounts & Business Development, Metabolon, Inc.

Session Description: Outsourcing is increasing in all activities and regulatory agencies around the globe are focused on the relationship between the contract provider and drug sponsor. In addition to increased FDA scrutiny, foreign regulatory agencies have increased their inspections of contract service organizations, and with this have introduced unique interpretations of cGMP requirements and differing opinions as to how to achieve compliance. As such the cost of non-compliance is high for both sides as delay to market for the drug sponsors and decreased inflow of projects for the contract providers could prove detrimental. In this ever-evolving regulatory environment new directives and regulations are challenging even the savviest sponsors and contract providers as they navigate the complex submission management lifecycle.

8:30 a.m. - 9:00 a.m.
Managing the Inspection Life Cycle
Doug Rich, President, Fastball Consulting

9:00 a.m. - 9:30 a.m.
Contract Manufacturing Operations: Current Inspectional Issues
Patricia Frech-Baur, RP/QP & CMO Quality Management,  Amgen Europe GmbH 

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

9:45 a.m. - 4:00 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.
P6 - Tech Transfer
Moderator: Jeff Hargroves, President, ProPharma Group

Session Description: A thoughtful Technology Transfer plan with meticulous execution is critical to the utilization of a Contract Manufacturing Organization or Contract Laboratory. In this session our experts will share their experiences and insights regarding the various aspects to be considered, how to establish quantifiable and measurable expectations and specifications along the way, and proven approaches to the successful execution of the plan.

10:45 a.m. - 11:15 a.m.
Setting Specifications/Process Capabilities
Scott Bozzone, PhD, Principal, Pharm Lifecycle Validation

11:15 a.m. - 11:45 a.m.
Tech Transfer Considerations for Clinical versus Commercial Analytical Support
Wayland Rushing, PhD,Senior Scientific Advisor, EAG Laboratories

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

12:15 p.m. - 1:45 p.m.
Lunch on Your Own. Exhibit Area Closed - A listing of local restaurants is available at the PDA Registration Desk.

1:45 p.m. - 3:15 p.m.
P7 - Quality Metrics Part II
Moderator: Susan Schniepp, Distinguished Fellow, Regulatory Compliance Associates, Inc.

Session Description: A robust Quality Culture is critical in establishing, maintaining and reporting metrics that help determine the suitability, quality and safety of pharmaceutical products. The need for companies to report their quality metrics has been delineated in the FDA Guideline titledRequest for Quality Metrics. These necessary metrics must be aligned, agreed to and adhered to by all parties in the established supply chain. This session will focus on how Quality Agreements might be modified to assure that they reflect the FDA’s expectations and how a strong Quality Culture can ensure the veracity of the reported metrics.

1:45 p.m. - 2:15 p.m.
Quality Agreements 
Robert DiScipio, Chief Executive Office, Skyland Analytics, Inc. 

2:15 p.m. - 2:45 p.m.
Quality Culture
Jan Paul Zonnenberg, Principal, PricewaterhouseCoopers, LLC 

2:45 p.m. - 3:15 p.m.
Questions and Answers/Discussion

3:15 p.m. – 4:00 p.m.
Refreshment Break in Exhibit Area

4:00 p.m. - 5:30 p.m.
P8 - New Therapies
Moderator: Austin Caudle, Director, Strategic Accounts & Business Development,Metabolon, Inc.

Session Description: Are you considering using a CMO for manufacturing or testing your new gene therapy of viral vector? This session will share insights into the operation that will accommodate customer needs and questions in this space. Case studies of careful planning and execution in this space will be shared that take into consideration the latest guidance documents and needs for making this fast growing space compliant and meeting the customers and patients’ needs.

4:00 p.m. - 4:30 p.m.
How do you Upgrade an Aging Facility?
Phil DeSantis, Principal Consultant, DeSantis Consulting Associates 

4:30 p.m. - 5:00 p.m.
Personalized Medicine Manufacturing
Mark Bamforth, Founder & CEO, Brammer BioPharmaceuticals

5:00 p.m. - 5:30 p.m.
Questions and Answers/Discussion

5:30 p.m.
Closing Remarks & Adjournment
Steven Falcone, Vice President, Quality, Genzyme, and Chair, 2016 PDA Outsourcing/CMO Conference Program Planning Committee

​Conference Registration | November 3 - 4, 2016


Before August 23, 2016

August 23 - September 19, 2016

After September 19, 2016


Before August 23, 2016

August 23 - September 19, 2016

After September 19, 2016

Government/Health Authority/Academic


Before and after September 19, 2016


Before and after September 19, 2016



Before and after September 19, 2016


Before and after September 19, 2016

All prices in US dollars.

* For this member type or discounted rate, online registration is not available and 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 and course.

Group Registration Discount

Register 4 people from the same organization as a group (at the same time) for the Conference 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 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 cancelation notice is not received by September 4, 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 Conference, Workshops and Events: If your written request in received on or before September 4, 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 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. Tape recordings are prohibited at all PDA conferences.

Renaissance Washington, DC Downtown Hotel 
999 9th Street NW
Washington, DC 20001
Phone: +1 (202) 898-9000

Rate: Single: $289.00, plus applicable taxes (14.5%).

Cut Off Date: Wednesday, October 5, 2016 (Availability may be limited. Requests will be processed on a first-come, first-served basis. Attendees staying within the PDA block will receive the conference rate.

Hotel Accommodations

To make reservations at the Renaissance Washington, DC Downtown Hotel, please call the Hotel at +1 (202) 898-9000 and reference the 2016 PDA Outsourcing/CMO Conference & PDA Education to receive the PDA group rate. Check in time is 4:00 p.m., and check out time is 12:00 noon.

Individual Cancellation

Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 6 p.m. on the date of arrival otherwise specified on your reservation information.


The Renaissance Washington, DC Downtown Hotel is located in Penn Quarter; in the heart of downtown Washington DC.  Local attractions include the National Portrait Gallery, Smithsonian Institute and Air Space Museum, Washington Monument, Capitol Hill, and many more. All 794 guest rooms and suites provide high-speed Internet, upgraded Luxurious bedding, coffee makers, hair dryers, iron and an ironing board.


Area Airports
Ronald Reagan Washington National (DCA) is approximately 5 miles away. Two other airports in the vicinity are both serviced by all major carriers: Dulles International (IAD) is 28 miles away and Baltimore/Washington (BWI) is 32 miles away.

Ground Transportation
Taxi fares from Reagan National are approximately $20 one way, not including tip, and will take about 20 minutes. One way taxi fares from Dulles is approximately $75 and from BWI is about $75.

Gallery Place Metro Station is 0.5 miles away from the hotel and is approximately $2.50 one way to Reagan National.

Union Station is 1 mile away from the hotel. To book your reservation call Amtrak at 1 (800) 872-7245 or visit

Renaissance Washington, DC Downtown Hotel is located on 999 9th Street NW off of New York Avenue.

Hotel Parking
$35 / Daily Self Parking
$45 / Daily Valet Parking

Sponsorship and Exhibit Opportunities are Available!

The 2016 PDA Outsourcing/CMO Conference will be the first PDA U.S. meeting focused on outsourcing and contract manufacturing organizations (CMO). The environment in this specialized field continues to evolve; this Conference will showcase relevant case studies that demonstrate the importance of shared goals and partnership to bring important therapies to ever wider markets.

This Conference offers exciting and unique sponsorship and exhibition packages designed to strengthen brand image, increase visibility, and help you connect with industry leaders from Quality, Manufacturing, Supply Chain, Business Development, Auditing and Testing.

Good foot traffic is one thing; good leads are another. At this Conference you will be exposed to attendees from a variety of manufacturing and contract 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, lunches and networking receptions. We can even create a customized sponsorship to fit your needs and budget.

For exhibit and/or sponsorship information, please contact:

David Hall, Vice President, Sales
Tel: +1 (301) 760-7373 
Cell: +1 (240) 688-4405 

Register Now