Informex USA 2013: Conference Agenda DAY 2

*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 2: Thursday, February 21, 2013
8:00 AM (concurrent sessions)
Room: Orange County 1
Track: New Chemical Trends

"Bio-based Chemicals: Going Commercial"
This presentation will analyze and review the emerging renewable chemicals technologies being commercialized, map the value chains for the different end-use products, and relate these to the incumbent routes and products.
• Responding to economic and market drivers, some of the world's largest chemical producers are investing in and pursuing projects to more profitably manufacture chemicals instead of biofuels
• This is taking place as many governments back away from carbon regulation and biofuels development funding as biofuels utilization hits numerous other obstacles, and while oil prices remain volatile
• Some bio-based commodity chemicals, like ethanol and citric acid, have long been commercial.  However, the new environment has created an exciting tipping point in strategic partnering, investment, and construction that is driving rapid growth in renewable chemicals commercialization

Speaker: Bruce Orr, Principal, Nexant Consulting
Room: Orange County 2
Track: Specialty Chemicals

"Implementing Green Chemistry Initiatives through Open Innovation"
Open Innovation is the use of knowledge transfer across traditional barriers to accelerate innovation and expand markets.
It is an effective strategy to address:
• Regulatory shifts
• Consumer interest
• Difficult market conditions and limited resources
• Adaptation or repositioning of business with new technology
• Value creation, such as better performance at lower cost

Speaker: Mike Gromacki, VP of Operations/Chief Technology Officer, Dixie Chemicals, Inc.
Room: Elite Ballroom – Salon 1
Track: Pharma

"Flow chemistry in Pharmaceutical Processing"
In recent years, there has been discussion of value manufacturing technology innovations (batch vs. continuous manufacture, PAT,QBD) for active pharmaceutical ingredients (API).  I will discuss continuous processing in the manufacture of intermediates and APIs.  Will present examples of chemical reactions and processes that can be done using continuous flow.
Speaker: Nick Petousis, PhD, Director of CMS, SK Life Science, Inc.
Room: Elite Ballroom – Salon 2
Track: General Business

"Leaders Need Real-World Crisis Training"
In 2011, Talon surveyed executives, in a variety of industries across America to find out about their organization's crisis preparedness.  The frightening thing is:  the majority are not prepared!
• If a crisis surprises your organization, are you ready to assess risk and manage a crisis?
• The Talon is a real-world simulation and immersive learning experience, placing your leadership team right into a significant, unexpected event
• Every participant leaves with not only knowledge, but practiced use of key tools to help them in crises and also in everyday life and profession

Speaker: Patrick Ropella, Chairman and CEO, The Ropella Group
Room: Elite Ballroom – Salon 3
Track: Pharmaceutical

"Innovations in Formulation and Manufacturing of Emulsions: Use of Liquid Crystals as an Effective Stability Mechanism"
Emulsion Stability by Liquid Crystals           
• Emulsions are thermodynamically unstable
• Traditional approaches to emulsion stability improve the kinetic stability but do not achieve thermodynamic stability
• Liquid crystals, a relatively new approach may potentially stabilize emulsions overcoming the inherent thermodynamic instability
• A prior knowledge of HLB may not be necessary for making stable emulsions with liquid crystals

Speaker: Mayank Bansal, Technical Director, McKenna Labs
9:00 AM (concurrent sessions)
Room: Orange County 1
Track: Regulatory and Compliance

"Market Regulations: How It Affects Your Business and How to Fight Back"
Government regulators and NGOs drive fear in the marketplace about chemicals through public relations campaigns or policy proposals. Mainstream press intentionally or unintentionally perpetuates this fear and, suddenly, downstream customers ban products that contain "blacklisted" chemicals. Why does this occur, where does it most exist, and how can you fight back?
Panel Moderator: Bill Allmond, Vice President, Government and Public Relations, SOCMA
Panel Members: John Ulrich, Co-Executive Director, Chemical Industry Council of California
Maureen Gorsen, Partner, Alston & Bird LLC (former Director of California Department of Toxic Substances Control)
Room: Orange County 2
Track: Specialty Chemicals

"Non-cGMP Manufacturing: What I Look for in a Toller"
Panel Moderator: Wendell Roth, Director, New Business Development, InChem Corp
Panel Members: Stuart Polk, Strategic Sourcing Manager, Chemtura
Brian Cunningham, Custom Manufacturing Manager, Lubrizol
Joshua Fox, Commodity Manager, Stepan Company
Room: Orange County 3 and 4
Track: Pharmaceutical

"Attn. Suppliers: This is what Keeps Me up at Night – How Rx360 Helps Me Sleep Better"
The panel will focus on the issues of most concern to senior procurement professionals, specifically as it relates to their vendors, and how the activities of Rx-360 and active involvement in the organization by both Pharmaceutical companies and their suppliers can mitigate these risks.
• The attendee will have a broader and more comprehensive understanding of the risks facing the Pharmaceutical supply chain
• The attendee will better understand the concerns of senior procurement professionals with respect to their vendors
• The attendees will explore the progress that has been made to secure the Pharmaceutical supply chain (both from the corporate and government/legislative view)

The attendees will have a greater understanding and familiarity and understanding of Rx-360
Panel Moderator: Scott Watson, Executive Director and Sales & Marketing/Membership Chair, Rx-360 
Panel Members: Tom Beil, VP of Quality and Regulatory Affairs, Sigma Aldrich/SAFC
Kim Cauchy, VP of Global Sourcing, Mylan
David McCarthy, Senior Director of Worldwide Procurement, Pfizer
William Reis, VP Global Strategic Sourcing, Amgen
Tony Weiderhold, Consultant for Development and Commercial API Sourcing, Eli Lilly and Company
Room: Elite Ballroom – Salon 1
Track: Pharmaceutical

"Lead Optimization to First in Man Studies"
By attending the Informex 2013 panel discussion, entitled "Lead Optimization to First-in-Man Studies," you will gain industry insights that focus on the dynamic and complex drug-development process. A panel of five distinguished industry speakers share more than a century of combined experience in medicinal chemistry, chemical development, formulation, safety assessment and pharmacology from several major pharmaceutical companies. These panel participants will discuss the myriad of options available to companies and institutions to improve this scientific process – driven by factors like budget, long-term project needs, and technical challenges – and the various pros and cons.
Panel Moderator: David Lathbury, PhD, VP Chemical Development, AMRI
Panel Members: Charles Jensen, PhD, Director of DMPK, AMRI
Bruce F. Molino, PhD, Senior Director, Medicinal Chemistry, AMRI
Nicholas A. Moore, PhD, Director, Development & Pharmacology, AMRI
10:00 AM - Special Session Time!
Room: Orange County 3 & 4
Track: Pharmaceutical

"API Manufacturing in the US is Dead. Or Is it?"
Leaders of US-based API Manufacturers Provide Their Perspectives on the Present and Future of API Manufacturing in the US.
Panel Moderator: Kate Kuhrt, Senior Director of Generics and Content Strategy, Thomson Reuters
Panel Members: Aslam Malik, PhD, President, Ampac Fine Chemicals
Stephen Munk, PhD, President & CEO, Ash Steven, Inc.
Brian Scanlan, President & CEO, Cambridge Major Laboratories
Walt Shaw, President, Avanti Polar Lipids, Inc.
Guy Steenrod, CEO & Principal, Irix Pharmaceuticals, Inc.
11:30 AM - 2:00 PM Conference Lunch
11:00 AM (concurrent sessions)
Room: Orange County 1
Track: Regulatory and Compliance

"Regulatory & Judicial Extremes: China vs CA"
In both China and California new manufacturing facilities and expansion of existing facilities can be expedited faster or delayed indefinitely by powerful but hidden forces.
While the source of this power is different in the two locations, the effect on new project initiation, completion and profitability is the same.
• Both California and China have established strict environmental laws
• In both locations, the government, public press and corporate public relations attempt to convince the populous that those laws are applied uniformly and fairly across all businesses
• In both locations, some project approvals get preferential treatment or weakened enforcement of environmental standards yet other projects can be delayed indefinitely without a clear, transparent and equitable process
• In this presentation we will explore the differences between the sources of power in China and California and how they are applied to create similar inequities

Speaker: Len Keck, President, Westfield Consulting LLC
Room: Orange County 2
Track: New Chemical Trends

"Hedge Your Bets! Add Market Research to your New Product Development Process"
Small and medium size enterprises (SMEs) in the fine and specialty chemicals industry need to adapt to the new realities of the globalized markets by embracing market-driven processes. Marketing research provides an affordable and reliable screen for the choice of new products development (NPD). This presentation will tell why an R&D project should be regarded as an investment decision. Several examples will illustrate how this change in optics can increase the success rate for your R&D portfolio.  Learn how to:
• Introduce market-driven processes in your NPD decisions
• Use databases in market size determination
• Make reasonable assumptions on market penetration rate
• Position your offering for success
• Estimate ROI potential on new products
• Accept/reject R&D projects upfront based on the hurdle rate

Speaker: Bogdan Comanita, PhD, President, MarketChemica Inc.
Room: Elite Ballroom – Salon 1
Track: Pharmaceutical

"Monitoring the BioPharmaceutical Raw Material Supply"
This talk will discuss the relationship between manufacturing and markets and availability of various raw materials for biopharmaceutical companies. Doe & Ingalls has developed a systematic process to monitor the markets for key raw materials used in biotech production to anticipate potential interruptions. Doe & Ingalls will present case studies on their approach to mitigate the risks posed by a complex market space.
Speaker: Charlotte Hicks, Management of Risk Program Manager, Doe & Ingalls
Room: Elite Ballroom – Salon 2
Track: General Business

"Business Valuation and the Exit Planning and Sale-of-Business Process"
Part 1 (45 minutes): "Business Valuation and the Exit Planning Process.

• Learn how to value your business and how to increase value in the future
• Learn how to substantiate the Goodwill of the business and how to enhance the     Financial, Marketing and Organizational areas in order to increase value
• Determine how to transfer the equity of the business to family and employees in a favorable manner
• Learn about the steps involved in the Sale-of-Business Process for future planning.

Speaker: Allen Oppenheimer, President, O.M. Oppenheimer
Part 2 (45 minutes):  "Mergers and Acquisitions Basics – Pharmaceutical Industry Trends"
This presentation is best for CEOs, CFOs and owners of pharmaceutical businesses who are considering the sale of their business, as well as senior executives who are responsible for acquisition strategy and corporate development.  Merger and Acquisitions Basics will discuss the strategy, preparation and process of selling a pharmaceutical services business, including:
• When is the "right time" to sell your business, and current trends and valuation parameters in the Pharma Services market
• Selling to a Financial Buyer or an Industry Buyer – which one is best for you and your business, and why
• Preparing for a Transaction – what to do, and what to avoid, to get the highest price and have the smoothest transition
• How to run a process that will find you the best buyer for you and your business – how to find best cultural fit and highest price in one package

Speaker: Neal McCarthy, Managing Director, Fairmount Partners
12:00 PM (concurrent sessions)
Room: Orange County 1
Track: Regulatory and Compliance

"REACh - Preparing for May 30, 2013 and Beyond"
REACh lessons learned and preparing for 2013 and beyond….
• How to budget for compliance
• Purchasing a LOA (Letter of Access)
• Is it a substance or an intermediate
• Handling materials on the CoRAP (Community Rolling Action Plan) list
• How to deal with your "OR"

Speaker: Jim DeLisi, CEO, Fanwood Chemical
Room: Orange County 2
Track: General Business

"The Secret Language of Influence: Your Passport to Powerful Persuasion"
GOT INFLUENCE? How well do your words and phrases motivate others? Language training is the most neglected area of any management, leadership or business development program. Recent research from the world of psychology can help us increase the potency of our conversations. Useful for leading, managing, motivating and most critically, selling your ideas. This fun, interactive program will leave you wiser in your role as an executive, manager, salesperson and (most importantly) within your personal relationships.
Speaker: Dan Seidman, CEO, GOT INFLUENCE?
Room: Elite Ballroom – Salon 1
Track: Pharmaceutical

"Meeting the Challenge of Phase 1 Development of APIs"
In exceedingly few instances can an API be dispensed directly to human patients for Phase 1 clinical trials.  The requirements of accurate doses are dependent on the physicochemical properties and stability of that API, which frequently are not amenable to ready-to-go formats.  This discussion will cover:
• Typical challenges faced by Phase 1 investigators
• How to handle well-behaved and problematic APIs
• Formulation options for solid and injectable platforms
• Several cases studies of successful formulation for Phase 1 clinical studies

 Speaker: Kevin Kane, PhD, Technical BD, Patheon
Room: Elite Ballroom – Salon 3
Track: New Chemical Trends

"Leading Edge Ophthalmic Sensor Technologies for Diabetes Management"
Angelika Domschke, Ph.D., will highlight advanced technologies and applied chemistry in her field of her expertise:  Ophthalmic Sensors in Diabetes Management. The presentation will provide insight into:
• The perpetual hot topic in diabetes research:  Continuous glucose monitoring devices ( CGMD)
• A high potential niche for CGMDs: Ophthalmic glucose monitoring
• The latest technologies in ophthalmic glucose monitoring
• Future technologies for ophthalmic monitoring devices

Speaker: Angelika Domschke PhD, President, Angelika Domschke Consulting
1:00 PM (concurrent sessions)
Room: Orange County 1
Track: Regulatory & Compliance

"Regulatory challenges and trends in finished dosage manufacturing: A CMO perspective"
Perhaps one of the most pertinent questions for our industry, as the rate of official action by regulatory agencies and the rate of outsourcing are increasing at dramatic rates, is where do the responsibilities begin and end for both drug application holder and CMO?  Join us as we examine:
• Trends in regulatory actions and outsourcing
• 483 Examples
• Where is the line in CMO-Applicant Holder responsibilities
• Who pays?

Speaker: Milton Boyer, President, Oso BioPharmaceuticals
Room: Orange County 2
Track: Pharmaceutical

"Market and Technology Trends in BioPharmaceutical Contract Manufacturing"
Contract manufacturing trends for the production of large-molecule drug substances and drug products
• Major market segments for bioPharmaceutical contract manufacturing
• Past and expected  market growth rates and the major factors affecting growth
• Disruptive technologies being adopted by contract manufacturing organizations
• BioPharmaceutical fill-and-finish pricing trends
• Key liability elements in supply contracts

Speaker: William Downey, President, HighTech Business Decisions
Room: Elite Ballroom – Salon 1
Track: Pharmaceutical

"Enhancing Process Economics by Combining Unit Operations – A global approach to the purification" problem"
With the increasing pressure to reduce cost, engineers and chemists are trying to implement new solutions to optimize the manufacturing process.  Using a more global approach to a process optimization, significant improvements can be achieved.  By the introduction of a chromatographic step – batch on continuous - in the synthesis route we will show that several objectives can be achieved – simpler downstream process, lower raw material consumption, greener process, overall yield improvement and finally lower manufacturing costs.  After a short comprehensive introduction to continuous chromatography, we will present real case studies and provide information about the implementation of continuous purification processes in a synthesis route at commercial scale that result in significant cost reduction of the final API.
Speakers: Olivier Dapremont, PhD, Director of Process Technologies, Ampac Fine Chemicals
Ashley Fung PhD, Process Scientist, Ampac Fine Chemicals
Room: Elite Ballroom – Salon 2
Track: General Business

"Accelerating Innovation through Strategic Outsourcing"
• Laboratory outsourcing to a trusted partner results in a fixed cost becoming a variable cost for the parent company outsourcing their laboratory.
• A realignment of resources to concentrate on core activities results in accelerated time to market.
• Examples and learning from ongoing laboratory outsourcing contracts will be provided. 

Speaker: Ruud Overbeek, PhD, Vice President of Global Health, Environmental, & Regulatory Services, Intertek
Room: Elite Ballroom – Salon 3
Track: Pharmaceutical

"Structure-Based Sourcing of Research Chemicals"
Chemists searching the ChemACX database of available chemicals by structure and substructure save time and money while exploring novel chemistry
• Find starting materials, reagents and catalysts to speed up synthesis and control costs
• Search catalogs from over 600 suppliers for 3.5 million diverse structures online or direct from electronic lab notebooks
• Search by name, CAS Registry Number, structure, and substructure
• No fees for chemical suppliers to be included in ChemACX

Speaker: Phil McHale, PhD, Executive Director, PerkinElmer Informatics