Biopharmaceutical Good Distribution Practices Summit Agenda

Monday, March 18, 2013 – Pre-conference Workshop

12:00 p.m. – 1:00 p.m.

Registration

1:00 p.m. – 5:00 p.m.

Developing a Controlled-Environment Logistics Validation Master Plan
Nearly 40 countries have GDP regulations that include a mind-numbing array of unique temperature control demands. If you want to enter emerging markets or leverage the growing controlled-room temperature segment, you have to understand the individual climate in each location.  But you can't break the bank in your quest to improve the bottomline. In this extensive half-day seminar, you'll learn:

  • How you can uncover new profits in the Middle East, China, Brazil and North Africa
  • How to understand what temperatures you can maintain by product and location
  • Why it’s critical to understand your design space from a product point of view BEFORE you begin your cold chain management design
  • How to develop product characterization, understand your product lanes, packaging qualification, and create a validation master plan
  • How to produce a plan that regulators will bless and understand
  • How to understand and benefit from the latest technologies, including automated change control tools, cell phones and satellite GPS

Tuesday, March 19, 2013 – Summit Day 1

8:00 a.m. – 9:00 a.m.

Registration and Continental Break

9:00 a.m. – 9:15 p.m.

Chairperson Welcoming Remarks, Gary Hutchinson, President, Modality Solutions LLC, formerly Director of Global Transportation, Amgen

9:15 a.m. – 10:00 a.m.

FDA’s Perspective on GDP:  Harness and Harmonize Your Operations & Quality Teams
You have to make your operations and quality teams understand they are accountable for systems or products — or face the consequences of a mess in both areas. Leverage an intelligent and effective quality system management review, coupled with tracking and trending the right metrics, to improve effectiveness and efficiency across your GDP cold-temperature-control supply chain security system program. In thid session straight from a leading FDA expert, you'll get a handle on:

  • How you can translate specific industry examples into new workable solutions in your own shops
  • Helping senior management drive the PQS
  • Proven tactics to bring the sometimes conflicting operations and quality teams together as one smooth unit

10:00 a.m. – 10:45 a.m.

Without True Distribution Validation Integrity, You're in for a World of (Global) Hurt
How does a manufacturer ensure the integrity of its temperature sensitive supply chain while moving towards more user and environmentally friendly solutions?  This becomes even more challenging when the manufacturer is operating a virtual or fully outsourced supply chain. In this session, you'll learn how to:

  • Describe procedures to maintain proper storage environments for individual products to ensure a drug’s integrity is maintained until the end
  • Review appropriate product maintenance achieved in transit — and not just distribution to prevent neglecting at any stage throughout the chain
  • Move from traditional management of “frozen” cold chain to more user and environmentally friendly systems
  • Manage the end-to-end cold chain through robust qualification systems
  • Partner with 3PLs and packaging solution providers to provide the most effective approach to protecting your products

10:45 a.m. – 11:00 a.m.

Refreshment Break

11:00 a.m. – 12:30 p.m

Panel Discussion:  Strengthening the Distribution Chain – How to Protect Your Product From Crooked Employees, Pirates, Warehouse Warriors and Other Miscreants
Recently, federal authorities arrested 11 South Florida men in connection to multi-million dollar drug thefts at the warehouses of Eli Lilly in Connecticut, GlaxoSmithKline (GSK) in Virginia and others.  The largest theft came from Lilly’s Enfield, Conn., facility, where criminals cut a hole in the roof to enter the warehouse and disable the security system.  They were also charged with the cargo theft of prescription drugs from a truck stop in Ohio and selling products stolen from a trailer at a Tennessee truck stop.  Similar thefts have occurred within airline terminals and other transportation hubs.  Attendees will learn:

  • How to educate transportation and distribution employees on hijacking and theft awareness, prevention, rapid reporting of incidents and good data gathering
  • Tips to remind drivers and distribution workers of corporate policies and emergency contact numbers should an emergency occur
  • Best practices for communications between drivers and corporate contacts while drivers are on the road and when stopped
  • The importance of reporting all cargo thefts to the FDA, EMA and/or appropriate regulatory agency

12:30 p.m. – 1:30 p.m.

Lunch Break

1:30 p.m. – 2:15 p.m.

Stability Testing to Support Distribution of New Drug Products
There's a growing consensus when it comes to the use of stability and other key data to support the secure distribution of temperature-sensitive pharmaceuticals.  In this important session, you'll benefit from shared industry wisdom and best practices from an acknowledged industry expert.  You'll learn:

  • The most effective stability approach as outlined in PDA Technical Report 53
  • How to effectively assess the risks of humidity exposure during distribution
  • New techniques for improving truck validation

2:15 p.m. – 3:00 p.m.

Maybe the World Isn’t Coming to an End, But It Sure Seems Like That on Some Days — Contingency Planning Best Practices for Biopharmaceuticals GDPs
Risk is your enemy. Risk assessment can be your best friend. Expert Andrew Mills will guide you through the importance of a robust risk assessment program, and offer a case study analysis of how getting it wrong can damage your company's business plan — and how to fix it before a crisis hits.
Learn how to find and fix your company's biggest weaknesses with a triage approach that is prioritized and budget-conscious.

  • Learn about the most common problems companies overlook in their risk assessment — and how to find long-term solutions, not just a "patch."
  • Get up-to-the-minute tools and strategies that will keep you ahead of looming risk challenges

3:00 p.m. – 3:45 p.m.

You Are Your Brand, Your Brand Is You — Combating Counterfeiting
It just takes a single tampering or counterfeiting crisis to set your supply chain and your broader reputation back years. So why do so few pharma companies have a strong anti-counterfeiting program in place? In this session, you will learn how to fight back and keep the crooks away. You'll learn:

  • How to develop a continuously updated program that manages new risks and preemptively adjusts to avoid fraud
  • How to get a firm grip on your supply chain, whether it is domestic or global
  • What's working and what's not when it comes to protecting patient and product integrity

3:45 p.m. – 4:30 p.m.

Cubist Pharmaceutical Case Study:  Managing a Virtual Supply Chain
Sometimes you don’t have the luxury of studying a problem for years, finally making a decision and then implementing a plan, particularly if you’re involved with a virtual supply chain.  Unfortunately, you've got no choice but to get it right.  Success comes from quickly understanding the needs of and impact on your distribution centers, 3PL providers and other important players in your supply chain.  Also key is utilizing the expertise of a package solution provider.  From an expert out there on the frontlines with a proven track record of success, you’ll learn about:

  • Development and verification of proposed design for the intended use  (e.g., 2-8 C for a 48-hour period, must meet both winter and summer conditions)
  • Best practices for simulation of test protocol in a temperature-controlled chamber
  • How to conduct simulation tests of distribution method (nontemperature studies) to ensure package integrity
  • Verification of pack-out performance through “live” shipments of product or equivalent payload

4:30 p.m. – 4:45 p.m.

Refreshment Break

4:45 p.m. – 6:00 p.m.

Panel: Good Distribution Practice Quality Agreements — Can’t We Just All Get Along? Understanding Where Industry Has Consensus and Differences
Featuring a roundtable full of successful industry experts, Barbara Falco, former QA Director at Abbott Laboratories, guides you through the maze of identifying the kind of QA agreements your organization needs — and how to develop them with a minimum of heartache. Key to success is securing buy-in from top brass that may not fully understand QA for GDP. You'll hear case studies and firsthand experience covering:

  • Lessons learned from QA agreement pioneers: what they wish they knew then but learned the hard way
  • How to present QA to senior executives in a way that educates and motivates them with an effective call to action
  • How Abbott's innovative QA agreement approach boosted the bottom line almost immediately

6:00 p.m. – 7:00 p.m.

Adjournment and Networking Cocktail Reception

Wednesday, March 20, 2013 – Summit Day 2

8:00 a.m. – 9:00 a.m.

Continental Breakfast

9:00 a.m. – 9:15 a.m.

Chairperson Recap of Day One Highlights

9:15 a.m. – 10:00 a.m.

A Regulator Dissects Current Track-and-Trace Strategies
Broadly applying a track-and-trace program is a big challenge, even for a smaller pharmaceutical company. For the bigger players, it can quickly degenerate into a costly failure. To avoid messy recall situations, you have to develop an intelligent and realistic program tailored to how your company does business. In this session, a leading FDA expert will:

  • Explain current and future barriers to forging and implementing an effective program
  • Offer a unique perspective on what industry is doing right, and where it's still coming up short
  • Provide the FDA's view on how to handle recalls

10:00 a.m. – 10:45 a.m.

Packaging As the First Line of Defense Against Counterfeiting
In 2008, seizures of counterfeit and black market products totaled more than $272.7 million — a spike of 38 percent in a year.  That trend has only continued upward. If you don't have brand integrity in the pharmaceutical business, you might as well find another line of work. Simply put, your company can't succeed without the rock-solid foundation of brand integrity. This session will demonstrate how easy it is to lose brand integrity, how crippling it can be for your business, and proven ways to protect yours before it's too late.

  • How to identify the products most likely to be violated, and where in your supply chain the lawbreakers are apt to strike
  • Forward-looking packaging innovations as the first line of defense against counterfeiting
  • Understanding and implementing the latest digital serialization techniques
  • Prioritizing your focus after assessing specific risks to the weak points in your supply chain

10:45 a.m. – 11:00 a.m.

Refreshment Break

11:00 a.m. – 12:30 p.m.

Panel: The Importance of Importation Security
Thieves know you have valuable property. It was thief Willie Sutton who famously said he robbed banks because that's where the money was. In today's world, your cargo is an increasingly tempting target for increasingly savvy thieves. You are already a target. Learn from a former cop and supply chain security expert how to scare thieves away, including:

  • Developing an air-tight security plan that will stymie the advances of most thieves
  • Best practices employed by narcotics intelligence units and adaptable for your organization
  • Using the art of camouflage to hide your valuable assets
  • Tools of the trade: how the FBI profiles potential thieves and can help you stop them before they strike

12:30 p.m.

Event Conclusion