Informex USA Conference: Agenda DAY 1

*Program is subject to change.  Please check back frequently for updates

8:00 AM 9:00 AM 11:00 AM 12:00 PM 1:00 PM


DAY 1: Wednesday, February 20, 2013
8:00 AM (concurrent sessions)
Room: Orange County 1 
Track: Regulatory and Compliance

"Perspectives on the Specialty Chemical Industry"
This session will give an update on the state of the US manufacturing sector and implications for the specialty chemical industry.  We will discuss:
• Current manufacturing sector business challenges and drivers for future growth in 2013
• Key federal policies are affecting the specialty chemical industry (EPA regulations/taxes, etc.)
• U.S. debt limit, sequestration and rising health care costs are among the other factors affecting the specialty chemical sector
• Primary drivers of future growth will include stronger domestic economy, sales and development of new products and increased efficiencies in the production process

Speakers: Larry Sloan, President, SOCMA
Room: Orange County 2
Track: General Business

"The One Sales Test You're Guaranteed to Fail!: Tips to Sell your Company and Yourself at a Trade Show"
World class sales professionals can answer and act on these three questions. Can you give the best answer possible? The responses and coaching tips that support them can give salespeople, managers and entrepreneurs great focus on how to best sell at trade shows.
• Who are you REALLY competing with? (no it's not yourself, good guess, though)
• What is the No. 1 PROBLEM encountered by anyone who sells anything? (solve this one and you attain selling nirvana)
• What is your RESPONSIBILITY on a sales call? (Hint: Whether it's face-to-face or on phone calls, the answer has to be correct 100 percent of  the time.)

Speaker: Dan Seidman, CEO, GOT INFLUENCE?
Room: Orange County 3
Track: Specialty Chemicals

"Differentiating Yourself from the Competition in the Green Supply Chain"
Companies are working to make their supply chains greener; going beyond simple questionnaires to requesting data about the chemicals and materials used in new products and formulations.  How well does your company use green chemistry & engineering principles when it designs new products?  Learn about metrics, best practices, and opportunities you can leverage to lead your company to the top of the pack.  
Speaker: David J. C. Constable, PhD, Director, ACS Green Chemistry Institute®
9:00 AM (concurrent sessions)
Room: Orange County 1
Track: Pharmaceutical

"The New AIA: Changes to Intellectual Property Rights"
The Leahy-Smith America Invents Act ("AIA") is the first significant overhaul of the U.S. patent system in nearly 60 years and ushers in considerable changes in how chemical and Pharmaceutical companies obtain and enforce patents in the United States.  Certain AIA patent reform measures have already been implemented, but the most significant impacts are yet to come in 2013.  This presentation will provide an overview of the AIA's impact on many important aspects of obtaining and enforcing patent rights, including the following:
• First-to-file versus first-to-invent
• AIA Implications for provisional patent applications versus utility patent applications
• Expansion in scope of potential prior art
• Due Diligence and Opinions of Counsel as aids to avoiding patent infringement
• Post-grant review process
• Expansion of prior user rights

Speaker: Paul Tully, PhD, Patent Attorney, McDonnell Boehnen Hulburt & Berghoff
Room: Orange County 2
Track: General Business

"Strategic Outsourcing Partnership: Transactional Working Relationships Versus Partnership Alliances"
• Evaluating major risks and new challenges
• Essential elements for a successful long term partnership
• Positive aspects of the development in Asia

Speaker: Lalit Baregama, PhD, CEO & President, Syngeny PharmaceuticalTech Pvt Ltd.
Room: Orange County 3
Track: Pharmaceutical

"API Sourcing in Emerging Markets"
Part 1: Sourcing in Emerging Markets- Finding the Right Supplier in India

• Emergence of India as a regulated supplier of API's
• Choice of a "pure play" or integrated supplier
• Regulatory hurdles
• How committed is your supplier?

Panel Moderator: Saharsh Rao Davuluri, President, Contract Manufacturing, Neuland Laboratories Limited
Speakers: Thomas Speace, President, Neuland Laboratories
Hui-Yin (Harry) Li, Ph.D., President, Wilmington PharmaTech Company
Room: Orange County 4
Track: Specialty Chemicals

Part 1: "Discovering the Latest Applications of Specialty Chemicals to Drive Technical Innovation"
New methodology can be used in a wide variety of product applications
• Flow chemistry is such an example and this will be illustrated
• Enzymatic transformations will be highlighted to show their general utility
Market opportunities can arise from application of existing technology and knowledge to other business areas
• This can include a new synthesis method, such as making a compound from biomass rather than being petrochemical based

Part 2: "Continuous Processing in Translational Research:  Building Applications that Drive Innovation"
New chemical processing technologies reach the market everyday.  Implementation requires significant investment  as well as the right mix of exuberance, and managed expectations.   Utilizing the help of both academic and industrial partners,  a model for  building applications in disruptive chemical technologies that have the potential to pay big dividends will be presented.  Examples for the integration of technologies that enable Real-Time Release (Integration of UPLC into continuous processing), continuous technologies that can handle fast and slow reactions,  gases, liquids, and solids will be presented along with a rational for choosing technologies that offer distinct advantages.
Speakers: Robert Tinder, PhD, Chief Scientific Officer, Proteaf Technologies
David Ager, PhD, Principal Scientist, DSM Innovations Synthesis
11:30 AM - 2:00 PM Conference Lunch
11:00 AM (concurrent sessions)
Room: Orange County 1
Track: Regulatory and Compliance

"Selling Quality Products to Quality Companies: What is Critical to Know"
For those selling into the fine chemical market, this must-see presentation will give you a rare glimpse inside your customer's mind: when, why, and especially HOW they go about qualifying new suppliers for materials in their highly-regulated industry. Most importantly, learn some of the vital secrets that might help you out serve the competition.
Speaker: Mark Silber, Director of Procurement, AMPAC Fine Chemicals
Room: Orange County 2
Track: General Business

"One Stop Shop vs. Specialty Providers, and The Possibility For An Artisan Approach"
• Big vs. small (mega one stop vs. mom & pop)
• Strengths and weaknesses of each
• When might one choose one over the other
• Would a specialty shop collaborative conglomerate be feasible (the artisan approach)
• Various business models, where they could be applied and where do they fit best

Panel Moderator: Cheryl Garr, PhD, Director BD, Pharmacore
Panel Members: Garrett Dilley, PhD, Senior Director, Business Development, Johnson Matthey  Pharmaceutical  Services
Conrad Hummel, PhD, Associate Director, Business Operations, Array Biopharma
Beth Lorsbach, PhD, Specialty Synthesis Leader, Dow AgroSciences 
Roy Ware, PhD, Director of Chemistry, Chimerix, Inc.
Scott Zook, MSc.-Director, Senior Director CMC API, Neurocrine Biosciences
Room: Orange County 3
Track: Pharmaceutical

"From Big Pharmaceutical to Virtual Biotech: What do They Really Want in a Vendor?"
The market for outsourcing API and biologics manufacturing continues to grow as Big Pharma and Virtual Biotech increasingly find contract manufacturing an effective tool for lowering costs and expediting development. But as the market for outsourcing has grown, so has the number of available vendors, and clients and suppliers alike must understand both the technical needs and business goals of the outsourcing firm to minimize risk and ensure successful project management. This panel will focus on what issues play a significant role in vendor selection, whether the client is Big Pharma or a small Virtual Biotech company.  
• Drawing on the panel's diversity and depth of experience, we will discuss a number of factors that drive the decision-making process for outsourcing: quality, technical capabilities, reputation, cost, personnel, geography, EHS, and more
• The panel will also discuss the differences in how small and mid-sized companies approach outsourcing vs. Big Pharmaceutical, the reasons that a company might choose to switch vendors, and other topics relevant to vendor selection. Input and questions from our audience will be encouraged

Panel Moderator: Hamilton Lenox, Director BD, Neuland Laboratories
Panel Members: James Davidson, PhD, Director, CMC, Ardelyx
Kevin Duffield, Senior Director, API Manufacturing, Aptuit
James Kanter, Senior Manager, Manufacturing, Gilead Sciences, Inc.
Michele Johnson, (Former) Supply Chain Advisor, Cubist Pharmaceutical
Cuong Lu, Team Leader, API Strategic Sourcing & Planning, Pfizer, Inc.
Chengzhi Zhang, PhD, Director, Chemistry & Manufacturing, Auspex Pharmaceuticals
Room: Orange County 4
Track: Pharmaceutical

"Regional vs. Global Sourcing – When Does Proximity Matter"
After decades of sending work across the world, companies are rethinking their offshoring strategies.
Companies now want to be in, or close to, each of their biggest markets, making customized products and responding quickly to changing local demand.  The panel will discuss whether this is happening in Pharma and to what extent. Is pharma still behind in this move happening in other industries?

Panel Moderator: Derek Hennecke, CEO & President, Xcelience
Panel Members: Corey Bloom, PhD, Director, Bend Research
Roger K. Harris, PhD, Associate Vice President and Director, Product Development and Repository Management, MRI Global
Neal McCarthy,  Managing Director, Fairmount Partners
Brian Scanlan, President, Cambridge Major Laboratories
12:00 PM (concurrent sessions)
Room: Orange County 1
Track: Regulatory and Compliance

"How Your EHS&S System Affects Your Bottom Line"
Many business leaders view their environmental, health, safety and security programs as a necessary evil. They don't realize how valuable they can be in differentiating themselves from their competition as well as contributing to a healthy bottom line. Dr. Jordan will discuss the business aspects of an efficient EHS&S system.
Panel Moderator: J. Holland Jordan, PhD, Director, ChemStewards
Panel Members: Mike Gromacki, VP of Operations/Chief Technology Officer, Dixie Chemicals, Inc.
Mike de la Cruz, Sales Manager, KMCO
Bob Griffith, President, Nissan Chemical
Room: Orange County 2
Track: General Business

 "Driving Sales through Research"
How to use marketing intelligence to better connect with prospects and convert them to clients
• Discover: Research as a library, not a subject
• Strategize: Use your discovery to inform your actions
• Implement: Strategically deliver to your audience
• Continue to rediscover

Speaker: Nigel Walker, Managing Director, That's Nice
Room: Orange County 3
Track: Pharmaceutical

"How does Excipient GMP Certification Protect the Patient?"
In recent years, there have been many incidents where drugs have contained sub-standard Pharmaceutical ingredients:
• Heparin contaminated with over sulfated chondroitin sulfate
• Liquid formulations contaminated with Diethylene glycol
• Gelatin capsules with elevated levels of chromium
• Povidone analogs with elevated levels of peroxide
The major Pharmaceutical companies assure the quality of their ingredients through audit all of their suppliers but what can smaller companies do? How can the FDA ensure the safety of components?

Speaker: Irwin Silverstein, PhD, Vice President and COO, IPEA, Inc.
Room: Orange County 4
Track: Pharmaceutical

"Novel High Resolution XR-Powder Diffraction Protocol for APIs Polymorph Contamination"
Novel High resolution XR-Powder Diffraction Protocol for Detection of APIs polymorph Contamination using the Synchrotron radiation will be presented.  Several studied cases will be illustrated regarding:
• Identification of phase purity of crystalline materials
• Determining small concentrations of a protected polymorph
• Detection and quantification even to 500ppm (and >> down!) of contaminants of different solid state forms in a drug substance
• Validation of seed polymorphic purity for crystallizations and enhanced control
• Enhancing the view on the polymorphic "pattern" of APIs including checking for unapproved excipients
• Detection of API solid form in finished dosage form directly
• Detect the form changes from API to dosage form, or to assess content uniformity

Speaker: Livius Cotarca, PhD, R & D Director, Zach – Zambon Chemicals
1:00 PM (concurrent sessions)
Room: Orange County 1
Track: Pharmaceutical

"High Potency API's – AFC Has Them ‘Under Control'"
High Potency API (HPAPI) is the categorization of any active drug substance that has an 8-hour weighted occupational exposure limit (OEL) of no more than 100 µg/m3.  Subsets of this classification include teratogens, mutagens, carcinogens, and cytotoxins, each of which has a significantly lower OEL.  Over the years a number of HPAPI's have fallen into one of these more-hazardous subcategories.  AMPAC Fine Chemicals (AFC) has safely produced at least one HPAPI from each of these subsets at the commercial scale in our facilities in California.  Recent trends in drug development indicate that more of the high potency NCE's will not fall into any of these subcategories, but instead will be somewhat less hazardous to process.  And, with lower levels of potency, larger volumes of the drugs are needed for treatment.  While maintaining its capability to handle HPAPI's in each of the subcategories, AFC has expanded and upgraded its assets to safely and cost-effectively produce the newer, less-potent molecules.  This allows us to meet the changing needs of the HPAPI industry while improving the overall state of isolation of materials from the environment in our facilities.
Speaker: Larry Zeagler, Executive Director Product Management, Ampac
Room: Orange County 2
Track: New Chemical Trends

"Enabling Green Chemistry and Profitability through Route Scouting"
This presentation will focus on impact of route scouting on Green Chemistry and Profitability at various stages of Pharmaceutical life cycle beginning from NCE Discovery to Generics. Following key topics will be addressed with appropriate examples.
• Role of Route Scouting in Green Chemistry by Design (GCbD)
• Relationship between Route Scouting, Green Chemistry and Economics
• Various metrics for Route Scouting and Green Chemistry
• Importance of Route Scouting in preclinical development to NCE and Generics launch

Speaker: Dhileep Krishnamurthy, PhD, Vice President and R & D Head for API Services, Piramal Enterprises
Room: Orange County 3
Track: Pharmaceutical

"Trace Impurity Control and Resolution"
When unqualified impurities exceed allowable limits they become a major issue. We will discuss why this is the case.  We will also discuss approaches that can be taken to rapidly identify these impurities and consequently allow the drug to continue its path through the development process.
Speaker: Clare Murray, PhD, Business Development Director, SCYNEXIS, Inc.
Room: Orange County 4
Track: New Chemical Trends

"Sourcing ADC Development and Manufacturing Services for a More Efficient Supply Chain"
Antibody Drug Conjugates (ADCs) consist of both highly potent drugs and biological proteins and present significant supply chain management challenges to drug developers. The rapid growth in ADC clinical programs could result in constrained development and manufacturing capacity over the coming years. This session will address how Lonza is working to manage client supply chain issues for targeting agents, cytotoxic payloads, and drug conjugation for all phases of clinical development and commercial supply. 
Speaker: Jason Brady, PhD, Head of BD, Conjugates and Cytotoxics, Lonza