Agenda


Sunday, April 6, 2014

Sunday, April 6, 2014

7:15 a.m. – 10:00 am.
PDA 8th Annual Walk/Run

10:00 a.m. – 1:00 p.m.
Science Advisory Board (Invitation Only)

12:30 p.m. – 1:30 p.m.
Advisory Board Mix & Mingle (Invitation Only)

1:00 p.m. – 4:00 p.m.
Regulatory Affairs & Quality Advisory Board (Invitation Only)

1:00 p.m. – 4:00 p.m.
Chapter Council Meeting (Invitation Only)

2:00 p.m. – 6:00 p.m.
Registration Open

3:00 p.m. – 6:00 p.m.
Speaker Ready Room Open

3:00 p.m. – 6:00 p.m.
Meet and Greet Reception

3:00 p.m. – 4:00 p.m.
2014 Annual Meeting Program Planning Committee (Invitation Only)

4:00 p.m. – 6:00 p.m.
Biotechnology Advisory Board Meeting (Invitation Only)

6:30 p.m. – 9:30 p.m.
PDA Awards Dinner (Invitation Only)


Monday, April 7, 2014

Monday, April 7, 2014

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

7:00 a.m. – 5:00 p.m.
Speaker Ready Room Open

7:00 a.m. – 8:30 a.m.
Continental Breakfast

7:00 a.m. – 8:00 a.m.
PCMO Steering Committee Meeting

7:00 a.m. – 8:00 a.m.
PDA Orientation Breakfast

8:30 a.m. – 8:45 a.m.
Welcome, Opening Remarks and PDA Award Announcements

8:45 a.m. – 10:30 a.m.
P1: Opening Plenary Session – Global Patient Access and Global Strategies to Medicines
Moderator: Ursula Busse, PhD, Head GxP Regulations Coordination, Novartis Group Quality

Description: The pharmaceutical industry is facing its most challenging years due to patent expirations, global competition, increasingly complex supply chains, rising regulatory requirements, and pressure to lower healthcare cost. Concurrently, we are witnessing a far-reaching change in therapeutic approaches as patient tailored treatments and personalized medicines are become the standards of care. The Opening Plenary will cover strategies developed by partakers in healthcare to strive in this context of globalization and rapid scientific innovation. Topics will address innovative drug development approaches, and how transparent health technology assessments can recognize and reward the added value of new medicines while maintaining an innovation-friendly environment.

8:45 a.m. – 9:30 a.m.
Patient Access to Treatment: How Clinical and Cost Effectiveness of Drugs can be Ensured
Mark B. McClellan, MD, Director Health Care Innovation and Value Initiative, Brookings Institute

9:30 a.m. – 10:15 a.m.
The Impact of Technology on Vaccine Manufacturing and the Downstream Impact on Human Health
Rahul Singhvi, ScD, Senior Vice President/COO, Takeda Pharmaceuticals International, Inc.

10:15 a.m. – 10:30 a.m.
Q&A

10:15 a.m. – 4:30 p.m.
Exhibit Hall Open

10:30 a.m. – 11:15 a.m.
Refreshment Break and Poster Presentations in Exhibit Hall

Poster Presentations on Monday, April 7, 2014

Integration of Microbial, Particle, RMM and Control System to Solve Monitoring Issues
Elizabeth Bennett, Microbiology Application Scientist, Particle Measuring Systems

Complexing Agents and pH Influence on Chemical Durability of Type I Moulded Glass Containers
Alberto Biavati, PhD, Group Chemical Laboratory Manager, Bormioli Rocco Glass Co., Inc.

Quality Systems for Contract Clinical Supply Operations: Using Risk Analysis to Meet Global Requirements
Karen Bossert, PhD, Vice President, Scientific Affairs, Lyophilization Technology, Inc.

Utilizing Quality by Design (QbD) Principles to Develop Plasma Coated Parenteral Containers
Brian Fitzpatrick, Program Manager, SiO2 Medical Products

Sustaining Quality and Right First Time in a 24/7 Manufacturing Organization
Robin Groen, Supervisor, Pfizer

Host Cell Residual Dna Analysis From Process Intermediates to Final Products
Michael Hantman, Associate Director, Charles River

Automated Environmental Monitoring on the Manufacturing Floor
Amy McDaniel, Associate Director, Production Operations, Pfizer

The Impact of the Single-use Revolution on Biomanufacturing From Vial to Vial
Jeff Odum, Director of Operations, IPSDB

Low Endotoxin Recovery in Biologics: Case Study – Comparison of Natural Occurring Endotoxin (NOE) and Commerically Available Standard Endotoxin
Johannes Reich,  PhD Student, University of Regensburg/Hyglos GmbH

An Audit Approach to Address Microbial Contamination in Process Equipment
Elizabeth Rivera, Technical Service Specialist, STERIS

Evaluation on Vacuum Decay Leak Test as PAT Tool for Container Closure Integrity
Shunsuke Saito, Formulation Researcher, Dainippon Sumitomo Pharma Co., Ltd.

Insulin Delivery by Pens: Effect of Needle Type
Pranshu Shrivastava, Graduate Student, Campbell University

Silicone Oil Characterization in Aging Prefilled Syringe
Ingrid Slovikova, Senior Pharm. Scientist, Abbvie

Sterilization Effects on Elastomer Characteristics and Functionality in Sterile Parenteral Drug Products
Andrea Straka, Senior Technical Specialist, West Pharmaceutical Services

11:15 a.m. – 12:45 p.m.
Concurrent Sessions

Track: Biological Sciences Track: Sterile Product Manufacturing Track: Quality Systems
A – Biosimilars B – Globalized Supply Chain C – Inspection Trends
Moderator: Morten Munk, Vice President, Business Development, CMC Biologics A/S Moderator: Ken Drost, Executive Director, Site Head, Contract Manufacturing, Amgen, Inc. Moderator: Edwin Rivera-Martinez, Vice President, U.S. Quality Liaison, Global Quality, Sanofi

Session Description: Biosimilars have to a large extent been a key driver in global pharmaceutical development over the last years.  Emerging economies as well as established small molecule players have seen the biosimilar arena as a step stone to enter the attractive biopharmaceutical market. However, the technical requirements have for many players been more challenging than initial anticipated. Concurrently, regulatory requirements have changed and increased, and are far from being harmonized from a global perspective. Thus, the introduction of biosimilar products has been slower than anticipated, and several players in the marked have either withdrawn their projects or made substantial adjustments to their development plans.  However, even though Biosimilar projects might be a challenging endeavor – it can be done!

Attend this session to get an overview of the current regulatory landscape as well as hear a case study from a company who has global approach to biosimilar development.  

Session Description: Supply Chain issues are becoming increasingly complex as the world continues to globalize.  This session will discuss the current thinking around protecting pharmaceuticals from counterfeiting and the newly drafted FDA guidance for quality agreements with contract manufactures (CMOs).

Session Description: The FDA’s pharmaceutical inspections in the U.S. and abroad continue to change.  Total GMP inspections in the U.S. decreased in Fiscal Years 2011 and 2012, while the number of FDA inspections conducted outside of the U.S. has increased significantly.  FDA officials have reported that the Agency expects to conduct more human drug inspections abroad as a result of continuing outsourcing to other countries and the passage of GDUFA.  The number of Warning Letters issued to pharmaceutical companies continues to increase while the most common FDA 483 observations remained essentially unchanged from past years. 
Also, on May 13, 2013, the U.S. Department of Justice (DOJ), together with the U.S. Food and Drug Administration and numerous other federal and state agencies, announced the conclusion of a precedent setting criminal and civil investigation of a major non-U.S. generic drug manufacturer.  This case is generating much discussion within the pharmaceutical industry. 
This session will include a presentation on the latest FDA inspection trends, both domestic and abroad, and overview on the number of regulatory actions taken by FDA and the types of deficiencies found, including data integrity, during these inspections.  The session will also include a presentation on the Ranbaxy civil and criminal investigation. 

11:15 a.m. – 11:45 a.m.
Global Approach to the Challenge of Producing Biosimilars
Morten Munk, Vice President, Business Development, CMC Biologics A/S

11:15 a.m. – 11:45 a.m.
CMOs and Quality Agreements: Contract Manufacturing and Testing
Warren Horton, Vice President, Quality, DSM

11:15 a.m. – 11:45 a.m
Data Integrity: Warning Letters
Karen Takahashi, Senior Policy Advisor, CDER, FDA

11:45 a.m. – 12:15 p.m.
Case Study: Approaches to Biosimilar Development
Lisa M. Skeens, PhD, Corporate Vice President, Global Regulatory Affairs, Hospira, Inc.

11:45 a.m. – 12:15 p.m.
Counterfeiting and Serialization
Melissa Banning, Senior Manager, Global Supply Chain Operations, Amgen, Inc.

11:45 a.m. – 12:30 p.m.
Dirty Medicine
Katherine Eban, Contributor, Fortune Magazine

 

Ranbaxy: Lessons Learned
Douglas Campbell, Senior Consultant, Interpro QRA

12:15 p.m. – 12:45 p.m.
Q&A
12:15 p.m. – 12:45 p.m.
Q&A
12:30 p.m. – 12:45 p.m.
Q&A

12:45 p.m. – 2:15 p.m.
Networking Luncheon in Exhibit Hall

2:15 p.m. – 3:45 p.m.
Concurrent Sessions

Track: Biological Sciences Track: Sterile Product Manufacturing Track: Quality Systems
D -  Advances in Analytical Testing for Large Molecules E – Facilities F – Quality System
Moderator: Jose Goin, PhD, Associate Director, Quality Control Network Operations, Genentech, Inc. Moderator: Maik Jornitz, Chief Operating Officer, G-Con Manufacturing, LLC Moderator: Susan Schniepp, Vice President – Quality and Regulatory Affairs, Allergy Laboratories, Inc. and David Cummings, Associate Director for Quality, CDER/FDA
Session Description: New types of large molecules like biospecific antibodies are being developed as new therapies.  This session will provide an update on advances in analytical methods developed to characterize these new compounds. Session Description: Key words that come to mind in today’s world of doing more with less are Innovation and Renovation.  As companies seek growth and opportunity, the development, approval and commercialization of new products produces challenges in multiproduct facilities.  Innovative engineering is necessary along with balancing risk to allow multiple manufacturing processes to coexist in the same facility.  Along with this growth, is the reality of aging facilities and the decision to renovate or re-build.  The challenge of renovating an aging facility is balanced by new technology and state of the art facility design. Management of these parameters is vital to driving success in global markets and meeting the demands of patients worldwide. This session will discuss these multi-faceted facility concepts for sterile product manufacturing. Session Description: Inadequate investigations and CAPA’s that do not address root cause continue to be one of the top regulatory citations worldwide. This session will provide participants with some important points to consider on how to scope an investigation to help ensure it gets to the true root cause of a nonconformance. Following will be a presentation of practical experience and criteria for developing an effective corrective/preventative action program for prevention of recurrence

2:15 p.m. – 2:45 p.m.
QC Testing for mAbs and Different mAb Formats
Steven L. Cockrill, PhD, Director, – Corporate Quality Control, Amgen, Inc.

2:15 p.m. – 2:45 p.m.
Multi-Product Facility Risk-Based Control Strategies
Robert Dream, Principal, HDR Company, LLC

2:15 p.m. – 2:45 p.m.
CAPA Effectiveness

Kate Gillespie, Senior Director, Quality Systems, Johnson & Johnson Consumer Products

2:45 p.m. – 3:15 p.m.
Advances in Bioassays: New Technologies and Approaches
Pin Yee Wong, Associate Director, Analytical Development & Quality Control, Genentech, Inc.

2:45 p.m. – 3:15 p.m.
Aging Facilities
George Wiker, Vice President, US Life Sciences MSL, M+W U.S., Inc.

2:45 p.m. – 3:15 p.m.
How to Avoid “Inadequate” Investigations: Scopes of an Investigation
Bryan Liptzin, Director, Quality Sciences, Amgen, Inc.

3:15 p.m. – 3:45 p.m.
Q&A
3:15 p.m. – 3:45 p.m.
Q&A
3:15 p.m. – 3:45 p.m.
Q&A

3:45 p.m. – 4:30 p.m.
Refreshment Break and Poster Presentations in Exhibit Hall

4:30 p.m. – 6:00 p.m.
Concurrent Interest Groups

IG1 – Microbiology/Environmental Monitoring

Leader:
Jeanne Moldenhauer, Vice President, Excellent Pharma Consulting

Session Description:
This IG panel session will discuss barriers to using innovation in microbiology. 

Mary Griffin, Principal, MG Quality Microbiology Consulting, LLC
Ron Smith, PhD, Boehringer Ingelheim
Brian Hubka, Vice President, Marketing, Pegasus Pharmaceuticals, Inc.
Troy Tillman, Global Marketing Manager, TSI
Andrew Bartko, PhD, Senior Research Scientist, Battelle

IG2 – Process Validation

Leader:
Vijay Chiruvolu, PhD, Director, Quality Assurance, Amgen, Inc.

Session Description:
Process Validation is embracing innovation and attempting to meet global challenges.  Having a IG session will enable PDA to:

Communicate the latest concepts from a global regulatory perspective and attempt to overcome the challenges we face today.
In April 2014 we expect the following global regulations to be issued and less than 9 months old:

  • European Medicines Agency (EMA)Guideline on process validation data for regulatory submissions (draft March 2012, comments Oct 2012; Expected before PDA Annual)
  • EMA’s Draft Guideline on Process Validation Data for Reg. Submission of Biotech Derived Drug Substances. (expected 4Q 2103 and before Annual)
  • EMA’s Annex 15 on Validation and Qualification is expected to be issued by Dec 2013, but may be later but in time for PDA Annual.
  • WHO organization- Appendix 7 – draft of by ~ Sept 2013, well before Annual.
  • Inspections: Possible update and feedback from FDA on the Jan 2011 PV Guidance.  Inspection finding shows these principles and practices are the basis for site inspections. What are the big problem areas from FDA perspective?

Pave the future for Process Validation.  The above guidance’s share a common theme of:

  • Emphasis on proper design and development, allowing innovation and advances in technology such as alternate approaches to PV for these new technologies (PAT). 
  • Maintaining a sound control strategy and quality during commercial manufacturing needs to be a focus through a continued process verification program.
  • Encouragement for drugs such as personalized medicines and breakthrough therapies, by alternative or concurrent release validation approaches.

The future is evolving to stronger emphasis on extensive development, while having a fast, responsive means of measuring and monitoring the commercial manufacturing process. This provides the best quality product for the patient.  Listen to and discuss the current problems that global companies are facing. What is hampering (if anything) implementation of process improvements and innovative technologies? Exchange and sharing amongst participants and subject experts ways they are addressing these problems.

Jana Spes, Associate Director, Ferring International Center SA

Panel:
Jason J. Orloff, Statistical & Engineering Consultant, PharmStat
Alex Viehmann, Operations Research Analyst, CDER, FDA
Karthik Iyer, PhD, Consumer Safety Officer, CDER, FDA

IG3 – Outsourced Operations

Leader:
Karen Ginsbury, CEO, PCI Pharmaceutical Consulting Israel, Ltd.

Session Description:
Continuing from previous meetings of this growing Interest Group and in the light of FDAs draft guidance on Quality Agreements, this group will discuss current issues in communication and cooperation related to outsourced operations.  A facilitated discussion led by the group co-chairs and other experts both Contract Givers and Contract Acceptors will look at managing risk assessments, regulatory inspections and batch release in the light of recent regulatory guidances on these issues.

IG4 – Blow Fill Seal

Leader:
Chuck Reed, Director, Sales  & Marketing, Weiler Engineering, Inc

Session Description:
The following initiatives will be introduced at this meeting:

  • Update from BFS Technical Report Task Force and solicitation for document reviewers.
  • Sterility Assurance levels related to autoclave and non-autoclave post processing from BFS.
  • Container closure integrity testing and current advances in leak detection.
  • Market segment penetration by BFS users and technology innovators – case studies are being solicited now from users.
  • Investigations of research related to process development for heat sensitive products.
  • Compilation of pertinent technical documents for the purpose of producing a series of protocols that can be used to support regulatory compliance.
IG5 – Lyophilization

Leader:
Edward H. Trappler, President, Lyophilization Technology, Inc.

Session Description:
This interest group provides an open forum for discussions on current topics.  As lyophilization is a constantly developing field there are always new perspectives in the science, technology and compliance realms. Topics are identified at the onset of the meeting for open discussions among participants.  The informal forum provides a unique opportunity to learn from a variety of experiences and perspectives and provides an excellent benchmark for current industry practices.  Bring current topics of interest to you for discussion with your peers.

IG6 – Visual Inspection of Parenterals

Leader:
John Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC 

Session Description:
We would have regulatory update including current activity at USP to establish a standard for visual inspection of particulates along with open discussion of hot topics of interest to those in attendance. 

IG7
Packaging Science

Leader:
Edward Smith, PhD, Packaging Science Resources, LLC

Session Description:
The PSIG plan to have a discussion on:

  • The USP Elemental Impurities chapters (232 & 233)  including a comparison with EMA (Gen Chapt 5.20)  & ICH (Q3D) requirements.
  • Patient Safety Considerations in Setting Thresholds in Extractables/Leachables Studies
  • Importance of Extractables/Leachables in Veterinary Medicines
  • Q&A and Discussion of Current Packaging Topics Selected by IG Meeting Attendees

Patty Kiang, PhD, Principal Consultant, Kiang Consulting Services

Quality Metrics Update and Proposed Definitions

Moderator:
Steven R. Mendivil,
Executive Director, International Quality External Affairs, Amgen, Inc.

Session Description:
In Dec 2013, PDA held the PDA Quality Metrics Conference and published a Points To Consider document on Pharmaceutical Quality Metrics that contained the current thinking of the PDA membership. An update on the progress made to date to develop metrics definitions will be shared in this session to include:  a report out on proposed product and site metrics definitions from the PDA Points to Consider Document; how to calculate and report metrics to FDA; and, how the culture of an organization is important to institute reliable, meaningful metrics while avoiding unintended consequences. This will be an interactive session to further dialogue on this hot topic among industry leaders.

Joyce E. Bloomfield, Executive Director, Quality Systems, Center of Excellence, Merck and Co., Inc.

6:00 p.m. – 8:30 p.m.
Gala Reception


Tuesday, April 8, 2014

Tuesday, April 8, 2014

7:30 a.m. – 5:30 p.m.
Registration Open

7:30 a.m. – 5:30 p.m.
Speaker Ready Room Open

7:15 a.m. – 8:30 a.m.
Continental Breakfast

7:15 a.m. – 8:20 a.m.
Interest Group Leaders Meeting

7:15 a.m. – 8:20 a.m.
Roundtable Breakfast Sessions

Breakfast I – Environmental Control (Bioburden and Biofilm) Breakfast II – Pharmaceutical Compounding of Sterile Drugs Breakfast III – Human Performance and Human Error Reduction
Moderator: Mike Sadowski, Director, Sterile Manufacture Support, Baxter Healthcare Moderator: Susan Schniepp, Vice President – Quality and Regulatory Affairs, Allergy Laboratories, Inc. Moderator: Miguel Nogueras, MTD, Global Manager of QA – Microbiology & Compliance, Abbott Medical Optics (AMO)
Session Description: If not properly controlled, bioburden and biofilm issues represent significant product quality risks for pharmaceutical and biopharmaceutical operations.  Accordingly, PDA has developed a technical report on this topic which presents a contemporary review of the causes, eradication measures and proactive control options for bioburden and biofilm mitigation. This session will feature a task force author’s summary of the technical report content in addition to presenting a case study which highlights the approach utilized to successfully mitigate microbial bioburden and biofilm risks.  Session Description: Almost every hospital pharmacy compounds sterile products for their patients.  Due to resource constraints, many have turned to contractors to perform the compounding tasks.  At what point does this activity cross from being pharmaceutical compounding to fill the order of a physician, to sterile manufacturing? Do these compounding pharmacies have the skills and knowledge to produce safe and effective medications?  This session will explore some of the reasons that led to widespread use of pharmacy compounded products and what role do traditional pharmaceutical manufacturers have in providing products that meet these needs Session Description:  In several meetings over the last year, regulators have highlighted the continuing occurrence of old problems. Unfortunately, these problems often contribute to inefficient production, compliance failures, or drug shortages. Human factors is an area of science that focuses on a range of different topics, including ergonomics, workplace safety, human error, product design, human capability and human-computer interaction. This session will focus on understanding our ability as humans to react to situations, while designing a process and working within given conditions, and presents key examples on how the industry is employing these techniques. 

Case Study – Redefining Cleanroom and Environmental Controls for Terminal Sterilization Operations
Edward Tidswell, PhD, Director, Sterility Assurance, Baxter Healthcare Corporation

Update on the PDA Bioburden/ Biofilm Technical Report
Kalavati Suvarna, PhD, Consumer Safety Officer, CDER, FDA

Compounding Pharmacy
Christopher Smalley, PhD,
Director, Engineering BioSterile Validation, Merck & Company, Inc.
Christina Mendat, PhD, Director, Research & Human Factors, Radius Product Development
Q&A Q&A Q&A

8:00 a.m. – 9:30 a.m.
2015 PDA Annual Meeting Exhibit Space Draw

8:30 a.m. – 10:00 a.m.
Plenary Session 2 – Science and Innovation
Moderator: Michael VanDerWerf, Director-Regulatory CMC, Shire Regenerative Medicine

Session Description: Nationally and globally, the drug industry is at a crossroads. A true need exists to apply innovative thinking in order to significantly reduce the costs of drug development and patient treatment while attaining desired patient outcomes. This session features leaders experienced in identifying and implementing innovations to enable improved quality and lower costs.

8:30 a.m. – 9:00 a.m.
Stronger not Sicker
David Shanahan, President Emeritus, Mary Crowley Research Center and Founder & Chairman, Gradalis, Inc.

9:00 a.m. – 9:30 a.m.
Cell and Gene Therapy
Wilfried Dalemans, PhD, Chief Technology Officer, TiGenix

9:30 a.m. – 10:00 a.m.
Q&A

9:45 a.m. – 4:00 p.m.
Exhibit Hall Open

10:00 a.m. – 10:45 a.m.
Refreshment Break and Poster Presentations in Exhibit Hall

Poster Presentations on Tuesday, April 8, 2014

Adopting Single-Use Technologies to Improve Speed to Clinic – A Leachables Case Study
Janmeet Anant, Regulatory Advocate, Global Product Manager, EMD Millipore

Evaluation of the Milliflex® Quantum System for the Detection of Microbial Contaminants in Water Samples
Beth Brescia, Application Scientist, EMD Millipore Corporation

Cost Benchmarking
John Costalas, Project Executive,  Integrated Project Services

The Importance of Accurate Microorganism Identification in Microbial Challenge Tests of Membrane Filters
Gerhard Haake, Laboratory Manager, Sartorius Stedim Biotech GmbH

Innovative Outsourcing Approaches – Mastering the challenges of injectable drug development
Frank-Michael Hans, Project Manager, Vetter Pharma-Fertigung GmbH & Co. KG

The Use of CDC Biofilm Reactor to Test Cleaning Agents
Paul Lopolito, Technical Service Manager, STERIS Corporation

Particle Investigations: Addressing Product Recalls and Quarantines
Mary Miller, Executive Director,  MVA Scientific Consultants

Fungal Spore Contamination Control and Residue Removal in Cleanrooms
Jim Polarine, Technical Services Specialist,  STERIS Corporation

Blow/Fill/Seal System Decontamination and Depyrogenation
Chuck Reed, Director, Sales & Marketing, Weiler Engineering Inc.

Efficient Mycoplasma Concentration Technique For Increasing Real-Time PCR Sensitivity in Large Sample Volumes
Alexandra Scholz, PhD Student, Sartorius Stedim Biotech GmbH

Compatibility Assessment of Model Monoclonal Antibody Formulation in Glass and Plastic Vial Delivery Formats.
Dipesh Shah, PhD, Senior Development Engineer, Catalent

Comparing HPLC and UPLC Methods for the Determination of Related Compounds in a Sterile Adrenaline Injection Product
Nicolas Thurin, PhD, NPI&D Team Leader, Catalent Pharma Solutions

Development of Sensitive QC Friendly Container Closure Integrity TestinG (CCIT) Methods for Stability Testing
Casey Tyrrel-Pawlowic, Research Scientist, Bristol-Myers Squibb Co.

On-line TOC Monitoring in GMP Parts Washers
Oliver Van Houtte, Associate Product Manager, STERIS Canada Corporation

Implementation of the EndoSafe Rapid Endotoxin Testing Platform at Pfizer
Jeffrey Weber, Senior Scientist, PAT Projects, Pfizer

Challenges in Sterile Manufacturing of Multiple Product Lines on A Single Process Configuration, Case Study
Joseph Wojcik, Development Engineer, Catalent

Systematic Approach of Developing a Terminally Sterilized, Ready-To-Use Ibuprofen Premix in a Suitable Flexible Container
Joseph Wong, PhD, Principal Scientist, Baxter Healthcare

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

Track: Biological Sciences Track: Sterile Product Manufacturing Track: Quality Systems
G  –  Protection Strategies for Biologics H – Sterile Processing I – Process Validation / Lifecycle Approach and FDA Guidance
Moderator:  Michele Creech, Quality Operations Manager, Grifols, Inc. Moderator: Miguel Nogueras, MTD, Global Manager of QA – Microbiology & Compliance, Abbott Medical Optics (AMO) Moderator:  Hal Baseman, Chief Operating Officer, ValSource, LLC
Session Description: Product protection strategies are important in reducing the potential for contamination, risk, and consequences from two very different perspectives – product and people. This session will delve into these two concepts and incorporate case studies, technical report updates and current industry trends.  The first presentation will cover protecting product from people, environment and equipment.  Do you have a clean room or a cleanroom?  What is the difference?  And how do you achieve the cleanliness standards necessary for sterile drug product manufacturing?  Key strategies reduce the potential for product contamination from external sources.  The second presentation will cover protecting people from highly toxic compounds, such as Anti-body Drug Conjugates (ADCs).  How do you manufacture these highly toxic compounds while maintaining a safe environment?  How do you balance the lifesaving therapeutic benefits of a drug with its potential risks for patients? Product control and containment are examples of strategies that are critical to maintaining robust, reproducible processes that ensure a safe, effective drug product.  Session Description:  In today’s pharmaceutical world, the regulatory scrutiny has increased to ensure patient safety as we continue to become a global organization.  The industry has a responsibility of ensuring supply chain, product safety and efficacy.  When evaluating all of these factors together it may be a little challenging to meet requirements around the world as many regions have different requirements however the one common element is to provide a sterile product.  Hence why PDA continues to develop new standards and guidance documents to ensure the industry is enabled to meet global regulatory requirements as well as patients’ expectations.  During this session you will have the opportunity to learn about the newly released Technical Report 62 (TR 62) Manual Aseptic Processing.  In addition we will discuss novel sterilization practices when dealing with combination products.  Session Description:  New Guidance on Process Validation Lifecycle approach was introduced by the US FDA in January of 2011, with additional final guidance from European regulators expected soon.  In 2013 the PDA published further guidance on implementation of process validation lifecycle approach with PCMO TR 60.   An important part of these approaches is the use of scientifically based sampling plans and data interpretation.  This session will present discussion of and methods for the design of workable sampling plans and the analysis of results, to validate processes consistent with the lifecycle approach.

10:45 a.m. – 11:15 a.m.
How Clean is Clean in Drug Product Manufacturing
Igor Gorsky, Senior Consultant, ConcordiaValsource, LLC

10:45 a.m. – 11:15 a.m.
Manual Aseptic Processes (TR 62)
Carol Lampe, Consultant

10:45 a.m. – 11:15 a.m.
Statistical Process Control (SPC) Data: How it is Used in Process Validation and Manufacturing
Jason J. Orloff, Statistical & Engineering Consultant, PharmStat

11:15 a.m. – 11:45 a.m.
Product Containment, Highly Toxic Compounds (ADC)
Hank Rahe, Director, Containment Technologies Group, Inc.

11:15 a.m. – 11:45 a.m.
Novel Sterilization Practices (e.g. E-Beam Terminal Sterilization)
Byron Lambert, PhD, Senior Associate Fellow, Sterilization Science Director, Preclinical Research & Biocompatibility, Abbott Vascular

11:15 a.m. – 11:45 a.m.
Process Validation: Statistical Based Sampling and Testing – Process Performance Qualification
Alex Viehmann, Operations Research Analyst, CDER, FDA

Karthik Iyer, PhD, Consumer Safety Officer, CDER, FDA

11:45 a.m. – 12:15 p.m.
Q&A
11:45 a.m. – 12:15 p.m.
Q&A
11:45 a.m. – 12:15 p.m.
Q&A

11:00 a.m. – 12:00 p.m.
Exhibit Committee Meeting

12:15 p.m. – 1:45 p.m.
Networking Luncheon in Exhibit Hall

12:15 p.m. – 1:30 p.m.
PDA Publishing Luncheon

1:45 p.m. – 3:15 p.m.
Concurrent Sessions

Track: Biological Sciences Track: Sterile Product Manufacturing Track: Quality Systems
J -  Balancing Quality and Productivity in Biopharmaceutical Drug Substance Manufacturing Processes K  – Process and Product Quality – Control and Detection of Particulates L  – Process Analytics Technology (PAT)
Moderator: Mike DeFelippis, PhD, Senior Research Fellow, Eli Lilly and Company Moderator: Jeffrey Hartman, Director, Divisional Validation Quality Assurance, Merck and Company, Inc. Moderator: Morten Munk, Vice President, Business Development, CMC Biologics A/S
Session Description: The biopharmaceutical industry is continually challenged with increasing expectations from worldwide regulatory bodies to achieve the highest and most consistent product quality possible.  Simultaneously, economic considerations continue to drive the need to boost productivity of cell culture processes to increase titers from bioreactors to meet global supply demands for lower cost medicines.  Both factors heavily influence cell culture process development strategies for biopharmaceutical drug substances.  It is well understood that raw materials, media composition and culture processing conditions influence the final product profile and overall production output. This session examines compliance and scientific aspects associated with cell culture processes with a focus on raw materials and selection of media composition.   The first presentation discusses raw materials and the associated control strategies for testing and maintenance of supply chain.  A case study describing implementation of a chemically defined media strategy is the subject of the second presentation and details how the approach improves quality and contributes to gains in cellular productivity. Session Description: Control of particulates during processing and ensuring “essentially no visible particulates” in the final product is a critical and challenging attribute to achieve for all sterile processes.  In this session, case studies will be provided for how particulates can be proactively controlled during processing by applying a Quality by Design strategy.  Following this presentation, an update will be provided on all of the new developments and advances that have been made in the area of control and detection of particulates. Session Description: It is the 10 years anniversary for FDA’s guideline on PAT. This guideline can be viewed as the starting point for the paradigm shift the industry has experienced over the last 10 years. This includes increased emphasis on flexibility in pharmaceutical manufacturing, supported by increased focus and revisions on how the industry applies Statistical tools, risk assessment and data analysis during development, validation and manufacturing of pharmaceutical products.  Additionally, PAT is an integrated part of Quality by Design, as applying PAT is a key tool to monitor and adjust for the variations in the manufacturing process, to ensure manufacturing of high quality products.  
This session will include presentations from PAT pioneers, who will discuss the development of PAT over the years as well as future prospects for how PAT may affect and support pharmaceutical manufacturing.
 

1:45 p.m. – 2:15 p.m.
Raw Material Quality Control Strategies for Cell Culture Processes
Annemarie Möritz, PhD, Quality Expert,
Novartis Pharma AG

1:45 p.m. – 2:15 p.m.
Control of Foreign Particulate Matter – Using Forensics in QbD
Julianne Wolfe, Manager, Biotechnology & Pharmaceutical Services, RJ Lee Group, Inc.

1:45 p.m. – 2:15 p.m.
The PAT Concept: A Regulatory Perspective
Ali Afnan, PhD, President, Step Change Pharma, Inc.

2:15 p.m. – 2:45 p.m.
Case Study: Implementing Chemically Defined Media in Cell Culture Processes
Tongtong Wang, PhD, Senior Director, Bioprocess Research, Development and Optimization, Eli Lilly and Company

2:15 p.m. – 2:45 p.m.
Detection of Particulates
John Shabushnig, PhD,Principal Consultant, Insight Pharma Consulting, LLC

2:15 p.m. – 2:45 p.m.
PAT in Action – Experiences from Industrial Implementation
Chris Watts, PhD, Principal/Owner, VolPal

 

2:45 p.m – 3:15 p.m.
Q&A
2:45 p.m – 3:15 p.m.
Q&A
2:45 p.m – 3:15 p.m.
Q&A

3:15 p.m. – 4:00 p.m.
Refreshment Break, Poster Presentations and Passport Raffle Drawing in Exhibit Hall

4:00 p.m. – 5:30 p.m.
Concurrent Interest Groups

IG8 - Inspection Trends

Leader:
Stephan Roenninger, PhD, Head External Affairs Europe, International Quality, Amgen (Europe) GmbH

Session Description:
This Interest Group will review the organizational changes in the Pharmaceutical Inspection Cooperation Scheme (PIC/S), where FDA is an active member. We will expense experience during inspections by US-FDA as well as share experience on inspections performed by other inspectorates. Recent trends will be presented from EU and US as well as on technical topics.

Brian Laskowski, Site Quality Director, Hospira, Inc.

IG9 – Quality Systems

Leader:
Jennifer Magnani, Associate Director, Global Quality Systems, Genentech, Inc.

Session Description:
The PDA Quality System Interest Group is a network of quality professionals.  This session is open to any industry professional interested in discussing and/or listening to ICH Q10 related topics ICHQ10 and feedback on the Technical Report.

IG10 – Filtration

Leader:
Maik Jornitz, Chief Operating Officer, G-Con Manufacturing, LLC

Session Description:
0.1 micron membrane filtration is widely used within the biopharmaceutical industry, especially to separate mycoplasma species from cell culture media. In the past, 0.1 micron filter ratings were assigned without any standardized bacteria challenge test, the only one which was established, ASTM 838-05, was for 0.2 micron sterilizing grade filters. The PDA Task Force on Mycoplasma is working on the establishment of a bacteria challenge test standard, which will make the performance of 0.1 micron filters comparable. In this session, we will hear an up-date on the progress of this Task Force and have the chance to ask a filtration expert panel questions about the challenge test and other filtration topics.

Barbara Potts, PhD, PDA Mycoplasma Task Force Leader

Expert Panel:
Ross Acucena,
Regulatory Consultant, EMD Millipore
Mandar Dixit, Director, Field Marketing, Filtration Technology, Sartorius Stedim North America
Martha Folmsbee, PhD, Principal Scientist, Pall Life Sciences
A. Mark Trotter, Marketing Development Manager, 3M Purification Inc.

IG11 – Prefilled Syringes

Leader:
Olivia Henderson, Principal Scientist, Biogen Idec, Inc.

Session Description:
The session should give insights to the extensive work done by the  pharmaceutical industry as it relates to the numerous cases reported regarding imperfect alignment of drug delivery container characteristics and injection devices capabilities and requirements.

Hear from industry experts’ and participate in the knowledge exchange. This session is open to anyone interested in this topic.

Hans Lee, PhD, Principal Scientist, Amgen
Aaron Kemp, R&D Manager, BD Medical, Pharmaceutical Systems

IG12 – Vaccines

Leader:
John Finkbohner, PhD, Senior Director, Regulatory Affairs, MedImmune, Inc.

Session Description:
The Vaccines IG will be a review of hot topics in vaccines and will be followed by open discussion and a brainstorming session to identify new group goals to pursue in 2014

IG13 – Quality Risk Management

Leader:
Jeffrey Hartman, Director, Divisional Validation Quality Assurance, Merck and Company, Inc. and Michael Long, PhD, Director & Principal Consultant, ConcordiaValSource, LLC

Session Description:
For this IG, we are planning an interactive session on applying risk principles to Stage 3 Continued Process Verification (CPV) activities.  Discussion points would include:

  • Re-qualification of equipment and utilities, including establishing the frequency of reviews.  Additionally, we will share concepts on setting action and alert limits to trigger re-qualification.
  • Using risk and statistics to establish effective CPV programs for manufacturing processes.
  • Open discussion on other hot topics and issues that have surfaced when applying risk to CPV.

6:30 p.m. – 9:00 p.m.
PDA Dine Around

6:00 p.m. – 9:30 p.m.
Chairs Reception (Invitation Only)


Wednesday, April 9, 2014

Wednesday, April 9, 2014

7:00 a.m. – 1:00 p.m.
Registration Open

7:00 a.m. – 11:15 a.m.
Speaker Ready Room Open

7:15 a.m. – 8:30 a.m.
Continental Breakfast

7:15 a.m. – 8:20 a.m.
Roundtable Breakfast Sessions

Breakfast IV – Career Development Breakfast V – Fundamentals: LAL Testing
Session Sponsored by Associates of Cape Cod
Breakfast VI – Fundamentals: Drug Product Shipping Breakfast VII – Drug Shortages
Moderator: Ursula Busse, PhD, Head GxP Regulations Coordination, Novartis Group Quality Moderator: Michele Creech, Quality Operations Manager, Grifols, Inc. Moderator: Maik Jornitz, Chief Operating Officer, G-Con Manufacturing, LLC Moderator: Anders Vinther, PhD, Vice President, Quality Biologics, Genentech, Inc.
Session Description: Don’t miss this opportunity to understand today’s challenging job market and advance your career and leadership development! Strategies and tips for professional development will be discussed by respected and highly experienced senior leaders in our industry, who will be available to answer all your questions. Session Description: The innovative, breakthrough development of the LAL reagent in 1964 has led to the three principle methods of LAL testing that are in use today:  Gel-Clot, Turbidimetric, and Chromogenic.  Based on the physiological reactions of a biological entity – Limulus polyphemus – to the presence of endotoxin, the LAL test is an excellent example of how basic research can have a significant impact.  This session will review the fundamentals of the test that transformed our industry, examine new, novel approaches to endotoxin research, testing and knowledge and discuss current trends, issues and hot topics related to endotoxin and LAL testing. Session Description: This session will cover the expectations for shipping validation, particularly as it relates to bio products. 

Session Description: The topic on managing drug shortages is becoming an increasing area of focus for health authorities, manufacturers and patients. The growing complexity of global supply chains coupled with manufacturing and quality issues, can contribute to pronounced supply disruptions and drug shortages. While responding to drug shortage events to ensure reliable supply to patients is critical, it is even more important to understand and mitigate potential triggers to prevent drug shortages, especially given today’s reality of leaner manufacturing and supply chains. 

This session on risk based approaches for managing drug shortages will explore proactive application of risk and knowledge management to build in preventive controls such as redundant capacity, better supply planning, manufacturing site metrics and quality status for potential manufacturing partners and suppliers. Attendees will also have an opportunity to share their perspectives on elements such as establishing a proactive drug shortage plan for key products, understanding underlying economics and managing the risk-benefit balance associated with upfront planning and prevention of drug shortages.

Winston Brown, Global Head, Quality R&D – Pharmaceuticals,  Alcon/Novartis

Jennifer Magnani, Head of Global Quality System & Processes, Genentech, Inc.

Lisa Skeens, PhD, Corporate VP, Global Regulatory Affairs, Hospira, Inc.

LAL Testing
Jack Levin, MD, Professor of Laboratory Medicine, Professor of Medicine, Univ. of California School of Medicine, San Francisco
San Francisco

Expectations for Shipping Validation
Karl Kussow, Manager, Quality and Validation, FedEx Custom Critical
Risk Based Approaches for Managing Drug Shortages
Emma Ramnarine, Head, Global Biologics Quality Control, F. Hoffmann-La Roche Ltd
Q&A Q&A Q&A Q&A

8:30 a.m. – 10:00 a.m.
Concurrent Sessions

Track: Biological Sciences Track: Sterile Product Manufacturing Track: Quality Systems
M – Combination Products (i.e. Pre-Filled Syringes) & Container Closure Integrity N – Technology Transfer O – Parametric Release
Moderator: Miguel Nogueras, MTD, Global Manager of QA – Microbiology & Compliance, Abbott Medical Optics (AMO) Moderator:  Jean-Marie Geoffroy, PhD, Vice President, Quality Pharma Engineering & Analytical Services, Hospira, Inc. Moderator: Mike Sadowski, Director, Sterile Manufacture Support, Baxter Healthcare
Session Description:  FDA expects to receive large numbers of combination products for review as technological advances continue to merge product types.  Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products.  Fortunately the industry has been preparing for such technological advances and has provided harmonization activities as reflected in ISO standard ISO 11040-4: 2007, Prefilled syringes — Part 4: Glass barrels for injectables.  This session will focus on new developments related to the ISO standard as well as advances in testing combination devices to ensure product quality including their delivery system(s).  Session Description: Successful and timely tech transfers are paramount to product launches. Due to their complexity with materials and processes, the tech transfer of biological processes can be very challenging, oftentimes having to perform additional studies, leading to significant delays. Any approaches or tools which may enhance the probability of success for a tech transfer is of value. This session addresses some of the key issues of a tech transfer for biologic processes and how risk management of the tech transfer process can be utilized to enhance the probability of success.  Session Description: Parametric release is a sterility release program that is founded upon effective control, monitoring and documentation of a validated sterile product manufacturing process where sterile product release is based upon demonstrated achievement of critical parameters in lieu of end product sterility testing (PDA TR No. 30-2012).  Real time product release is similar in concept to parametric release except this approach is applied to physical, chemical or functional finished product attributes.  This session will highlight the current state of practice for parametric and real time release and will include a case study to highlight the application of these advanced release programs. 

8:30 a.m. – 9:00 a.m.
New Guidance on Standards in Addition to ISO in Combination Products
Lee Leichter, President, P/L Biomedical

8:30 a.m. – 9:00 a.m.
Case Studies: Integrating Risk Management to Tech Transfer
Chris Watts, PhD, Principal/Owner, VolPal 

8:30 a.m. – 9:00 a.m.
Sterilization of a Combination Biologic/Device Product Using Multiple Technologies in a Parametric Release Program
Bob Tomaselli, Principal, RPT Medical Products Consulting, Inc.

9:00 a.m. – 9:30 a.m.
Tools for Evaluating the Robustness of Integral Container Closure Systems
Andrea Straka, Sr. Technical Specialist, West Pharmaceutical Services

Roger Asselta, Vice President, Technical Affairs, Genesis Packaging Technologies

9:00 a.m. – 9:30 a.m.
Best Practices for Technology Transfer of Biologic Drug Products
Willow DiLuzio, PhD, Associate Director, Pre-formulation and Formulation, Takeda Pharmaceuticals International Co.

9:00 a.m. – 9:30 a.m.
Real Time Release Case Study
Jeffrey Weber, Senior Scientist, PAT Projects, Pfizer, Inc.

9:30 a.m. – 10:00 a.m.
Q&A
9:30 a.m. – 10:00 a.m.
Q&A
9:30 a.m. – 10:00 a.m.
Q&A

10:00 a.m. – 10:30 a.m.
Refreshment Break

10:30 a.m. – 12:15 p.m.
Closing Plenary Session: Emerging Technologies and Markets
Moderator: Jose Goin, PhD, Associate Director, Quality Control Network Operations, Genentech, Inc.

Session Description: New technologies are being rapidly developed. While some are ready to be utilized today, others innovations will be emerging within the next 5 years and are in the "infant" stage of development. This session focuses on how several of these future technologies may shape our industry beyond our current understanding and practice.

10:30 a.m. – 11:00 a.m.
Innovation of Today, Leading to Treatments of Tomorrow
J. Christopher Love, PhD, Professor of Chemical Engineering, MIT Koch Institute

11:00 a.m. – 11:30 a.m.
Emerging Markets
Martin VanTrieste, Senior Vice President, Quality, Amgen, Inc.

11:30 a.m. – 12:15 p.m.
Q&A

12:15 p.m.
Closing Remarks and Adjournment