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to the pharma and specialty chemical
industries’ most influential thought
leaders and innovators.
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FEATURED SESSIONS:
FEATURED SESSIONS:
• Innovative Breakthrough Technologies for Drug
Targets and Emerging Pathways
• Formulation Trends for Topical Dosage Forms
• Regulatory Update on US Toxic Substances Control
Act-Current Interpretations and the Impact on
Business
• Case Studies in API Continuous Processing
• Discover the Latest Innovations in Green Chemistry
• Economies of Capability vs. Economies of
Scale – Advancing CMO Decisions
• How to Create a Start-Up Environment in a
Traditional Company
• Utilizing Novel Technology to Improve Drug R&D
Productivity and Accelerate the Development of Drug
Delivery and Formulation
• Plant Operations to Efficiently Meet Regulatory
Requirements for Multiple Markets
• The Latest Developments in Chiral Chemistry
HEAR SPEAKER PERSPECTIVES FROM:
AbbVie • BASF Pharma Solutions • BioSpectra • Capsugel • Codexis • Deloitte Consulting • Eli Lilly • GSK •
InnoSyn • Lonza Ltd • Merck • Catalent Pharma Solutions • MIT • Pfizer Center One • Provivi • Sandoz • Seattle
Genetics • And more!
CPhI Connect Keynote Speaker
Ronald T. Piervincenzi, Ph.D.
Chief Executive Officer, U.S. Pharmacopeial
Convention
CPhI Connect Keynote Speaker
Magid Abou-Gharbia, Ph.D., FRSC
Associate Dean for Research, Director
Moulder Center for Drug Discovery
Research, School of Pharmacy,Temple
University
May 16-18 2017
Pennsylvania Convention Center
Philadelphia, PA, USA
Powered By:
InformEx Connect Keynote Speaker
John Foley
CEO, ORG Chemicals Holding, LLC
(KMCO LLC, KMTEX LLC)
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Sponsored By:
Platinum Media Partner:
Advancing Development & Manufacturing
INTERNATIONAL
PharmTech.com
The Science & Business of Biopharmaceuticals
One pass. Two conferences. Three days.
80+ hours of industry-leading educational content.
Introducing the Connect
Conferences! Featuring
two complete programs,
CPhI Connect and InformEx
Connect, these forwardthinking sessions help industry
professionals navigate a rapidly
evolving regulatory, strategic
and technological landscape.
Registering for one program
includes access to all eight
tracks - 44+ sessions in total!
Coming to Philadelphia in May 2017 is the only event which offers
you access to the complete North American pharmaceutical supply
chain – CPhI North America – alongside the leading fine & specialty
chemical event – InformEx.
Source business solutions from 450+ exhibitors
Network with 6,000+ attendees
See the latest innovative products and services
earn from the industry’s most forward-thinking movers
L
and shakers – on the show floor or at one of the 44+
Connect Conference sessions!
Where the Industry Meets to Foster Transformative
Innovation in Drug Development, Manufacturing and
Outsourcing
TRACKS INCLUDE:
Drug Development
Quality / Regulatory
Drug Manufacturing
Outsourcing
Who Should Attend?
Mingle with key stakeholders across drug development, drug
manufacturing, outsourcing and specialty chemical sectors including:
C-Level Executives, VPs, Directors, and Managers responsible for:
• Manufacturing • Drug Development • Procurement
• Outsourcing • Formulation
• Regulatory Affairs
• Quality
• Sourcing
• Process Analytical
Technology
As well as:
• CROs • CMOs
• Regulatory Consultants
The Future for Growth and Innovation in the Fine
and Specialty Chemicals Industry
TRACKS INCLUDE:
The Business of
Chemicals
AgroChem Spotlight
Regulatory Spotlight
ChemInnovation
Who Should Attend?
Meet key stakeholders from the fine and specialty chemicals markets
including agrochemicals, pharmaceutical, energy and personal care
including:
C-Level Executives, VPs, Directors, and Managers responsible for:
• Manufacturing • R&D
• Tolling
• Procurement • Purchasing
• Research
• Sourcing
• Outsourcing
• Quality
Connect Conferences: Two market-leading
educational programs focused on innovation and trends in
the North American pharmaceutical and specialty chemicals
markets.
Agenda at a Glance
TUESDAY MAY 16, 2017
8:00 AM - 9:00 AM Join your colleagues for breakfast, included with all Connect Conference Passes!
9:00 AM – 12:00 PM
CPhI Connect Opening Keynote
InformEx Connect Opening Keynote
CPhI Opening Keynote: Discovery of Innovative
InformEx Opening Keynote: Accelerating Value
Therapeutics: Today’s Realities
Creation via Innovation and Transformation: Opportunity
and Tomorrow’s Vision
beyond the Laboratory Beaker
12:00 PM – 2:00 PM Join your colleagues for lunch, included with all Connect Conference Passes!
2:00 PM – 3:30 PM
CPhI Connect
InformEx Connect
CHEMINNOVATION
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DRUG DEVELOPMENT
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How to Create a Start-Up Environment in a Traditional
Innovative Breakthrough Technologies for Drug Targets
Company
and Emerging Pathways
DRUG MANUFACTURING
Powered by
A Case Study in API Continuous Processing (Part I)
DRUG DEVELOPMENT
Sponsored by
Accelerating Your Product’s Development: Practical
Considerations from Pre-Clinical through Commercial
4:00 PM – 5:30 PM
CPhI Connect
DRUG DEVELOPMENT
Sponsored by
Formulation Trends for Topical Dosage Forms
DRUG MANUFACTURING
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A Case Study in API Continuous Processing (Part II)
InformEx Connect
CHEMINNOVATION
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The Latest Developments in Chiral Chemistry
REGULATORY SPOTLIGHT
Chemical Regulation in the US - Toxic Substances
Control Act (“TSCA”) Reform – Current Interpretations and
the Impact on Business
QUALITY / REGULATORY
Navigating GDUFA – Reduce Cost and Accelerate
Delivery
6:00 PM – 8:00 PM Mix and mingle with your peers at the Welcome Reception, taking place at the
Pennsylvania Academy of the Fine Arts (PAFA), a National Historic Landmark and an important part of
Philadelphia’s architectural heritage.
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WEDNESDAY MAY 17, 2017
7:30 AM - 8:30 AM Join your colleagues for breakfast, included with all Connect Conference Passes! 8:30 AM – 10:00 AM
CPhI Connect
InformEx Connect
CHEMINNOVATION
Powered by
DRUG DEVELOPMENT
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Discover the Latest Innovations in Green Chemistry
Advances in Solubility and Bioavailability
DRUG MANUFACTURING
Economies of Capability vs. Economies of Scale –
Advancing CMO Decisions
AGROCHEM SPOTLIGHT
Food Sustainability Trends and Outlook
OUTSOURCING
Supply by Design – Global Good Supply Practices (GSPs)
for Your Success
DRUG MANUFACTURING Powered by
Packaging Innovation
10:30 AM – 12:00 PM
CPhI Connect
DRUG DEVELOPMENT
Legal and Policy Strategies for Drug Companies in
Today’s Global Market
InformEx Connect
THE BUSINESS OF CHEMICALS
The Changing Dynamics of Outsourcing: Strategies,
Essential Elements, Advantages and Limitations
DRUG MANUFACTURING
The Latest Developments on Global Serialization
Requirements and Implementation
AGROCHEM SPOTLIGHT
Help Wanted! Herbicide and GM Herbicide Trait
Treadmills are Too Slow
OUTSOURCING
Technology Transfer Risk Mitigation Practices
DRUG MANUFACTURING
Process Development and Quality by Design Case Study
12:00 PM – 2:00 PM Join your colleagues for lunch, included with all Connect Conference Passes!
2:00 PM – 3:30 PM
CPhI Connect
InformEx Connect
THE BUSINESS OF CHEMICALS
DRUG DEVELOPMENT
Making the Business Case for Occupational Health &
Utilizing Novel Technology to Improve Drug R&D
Safety
Productivity and Accelerate the
Development of Drug Delivery and Formulation
CHEMINNOVATION
DRUG DEVELOPMENT
Drug Product Development and Biophysical
Characterization of Protein Therapeutics
OUTSOURCING
Sponsored by
Determining the Value of Re-Shoring Drug Ingredient
Manufacturing
DRUG MANUFACTURING
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Drug Manufacturing: Quality Risk Assessment
Management and Supply Chain Sourcing Strategies for
APIs and Excipients
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Continuous Manufacturing of Fine Chemicals
WEDNESDAY MAY 17, 2017 CONT.
4:00 PM – 5:30 PM
CPhI Connect
DRUG DEVELOPMENT
Understanding Critical Excipient Properties to Ensure
Consistent Quality of Amorphous Solid Dispersion and
Extended-Release Products
InformEx Connect
THE BUSINESS OF CHEMICALS
Catalyzing Innovation in the Chemicals Industry by
Maximizing R&D Tax Credits
DRUG MANUFACTURING
Continuous Solid Dose Manufacturing – Analytics to
Support the Supply Chain
DRUG DEVELOPMENT
Pediatric Formulation Development Innovation
DRUG MANUFACTURING
Continuous Manufacturing of (Bio)Pharmaceuticals
THURSDAY MAY 18, 2017
7:30 AM - 8:30 AM Join your colleagues for breakfast, included with all Connect Conference Passes! 8:30 AM – 10:00 AM
CPhI Connect
InformEx Connect
THE BUSINESS OF CHEMICALS
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DRUG DEVELOPMENT
USP <232> Elemental Impurities -Limit chapter
Implement Novel Container/Closure Technologies
Requirements Update - Best Practices and Standardized
DRUG MANUFACTURING
Methods for Metals Testing
Applied Biocatalysis for the Synthesis of Industrial
CHEMINNOVATION
Relevant Pharma Compounds
Nanotechnology
DRUG DEVELOPMENT
Discover the Latest in Inhalation Product Development
and Regulatory Standards
10:30 AM – 12:00 PM
CPhI Connect
InformEx Connect
THE BUSINESS OF CHEMICALS
DRUG DEVELOPMENT
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Circular
Economy
Bioconjugate and Biotherapeutics: Present and Future
DRUG MANUFACTURING
Pharmaceutical Impurities
THE BUSINESS OF CHEMICALS
NDAs - Legal Strategies to Mitigate Risk
QUALITY / REGULATORY
The World of Quality Metrics – Yesterday, Today and
Tomorrow
12:00 PM – 2:00 PM Join your colleagues for lunch, included with all Connect Conference Passes!
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CONF20 by May 8.
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Drug Development Track
Innovative Breakthrough Technologies for Drug Targets and
Emerging Pathways
Tuesday, May 16, 2017, 2:00 PM – 3:30 PM
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Peter D. Senter, Ph.D., Vice President, Chemistry and Senior
Distinguished Fellow, Seattle Genetics
A review of innovative technologies for drug targets
including gene editing/CRISPR, immunotherapy, gene
therapy and antibody drug conjugates.
Accelerating Your Product’s Development: Practical
Considerations from Pre-Clinical through Commercial
Tuesday, May 16, 2017, 2:00 PM – 3:30 PM
Sponsored by
Ron Vladyka, Director of Research & Development, Catalent
Pharma Solutions
Stephen Tindal, Director of Science & Technology, Catalent
Pharma Solutions
Kunal Jaiswal, Vice President, Global Strategic Development
Solutions, Catalent Pharma Solutions
I. DEVELOP: Getting your product to Phase I quickly and
efficiently (30 min)
• Overcoming challenges facing developers: molecule,
money, market approvability
• Biggest known challenges for drug formulation
• Best practices for optimizing your API for formulation
• Latest thinking on strategies for poorly soluble
molecules
• Utilizing an integrated, parallel screening approach for
preclinical development
II.DELIVER: Keeping your Clinical Trial on Track from Phases
to Finish (30 min)
• Scrutinizing partner selection: what capabilities do you
need?
• Managing products with special needs: potent and
cold-chain handling
• Improving efficiency with demand-led clinical supply
III.SUPPLY: Tools and Technologies to Get to Dose Form and
Scaled for Launch (30 min)
• Scale up for success
• Flexible manufacturing – technologies, potency,
volumes
• New Product Introduction Excellence – best practices
for product launch
For the most up-to-date program, go to schedule.
cphinorthamerica.com or schedule.informex.com.
Formulation Trends for Topical Dosage Forms
Tuesday, May 16, 2017, 4:00 PM – 5:30 PM
Sponsored by
Norman Richardson, Global Technical Development and
Marketing Manager, Skin Delivery, BASF Pharma Solutions
Amy Ethier, PhD, Formulation Scientist, Skin Delivery, BASF
Pharma Solutions
In topical drug formulations the selection of excipients, the
amount of each excipient and the complexes and phases
that they form in the formulation are collectively responsible
for all of the performance attributes of the final product. By
their physicochemical nature different classes of topical
excipients (e.g. high melting point lipidic materials, oils,
hydrophilic fluids, linear and globular polymers, nonionic
and anionic and cationic emulsifiers, etc.) perform different
functions in the topical dosage form.
Excipients contribute to or influence viscosity, spreadability,
aesthetic properties, API solubilization and/or solid state, as
well as the physical and chemical stability of the formulation,
dermal drug permeation and many other attributes.
Formulators seek to leverage excipient functionalities to
develop products with specific performance attributes
that (1) allow for aesthetically acceptable application to
the treatment area, (2) deliver the active to the appropriate
location (e.g. surface of the skin, epidermis, dermis,
systemic, etc.), (3) enable the active to permeate the stratum
corneum barrier, when necessary, (4) prevent irritation and
maintain mildness throughout the use of the product and
(5) maintain chemical and physical stability of the product
throughout its shelf life.
To achieve these objectives a variety of dosage forms are
available to the topical drug formulator (e.g. emulsions, gels,
ointments, foams, solid sticks and balms, sprays, patches,
etc.). How excipients are chosen to achieve various dosage
forms will be discussed. A hands-on, interactive session will
explore the different dosage forms that are available in the
market place. Some examples from the BASF Global Skin
Delivery Lab will also be available for evaluation.
Learn how and why to select a specific dosage form
including:
I. What are the design criteria for your topical formulation
• Ease of application
• Good sensory properties
• Drug delivery options
• Retain on surface of skin
• Deposit into epidermis, scalp, nail or mucosal
membrane
Drug Development Track
• Penetrate skin for systemic delivery
• Controlled release
• Mildness, impurities and support of healing of
compromised skin
• API solubility, stability and compatibility and dosage
strength
II.What dosage forms are available and which one should you
use?
• Emulsions (biphasic creams and lotions)
• Gels (single phase aqueous semi-solid)
• Foams (aerosol and non-aerosol, aqueous and
anhydrous)
between capitalism, good economics, corporate interests,
and altruism? Do these paradigms apply to both established
and emerging markets? What are the legal frameworks
surrounding these decisions? What are the ethical
debates underpinning these decisions? What are the legal
ramifications of approaching it incorrectly?
I. Drug pricing:
• How is it set?
• Is it set accurately?
• Is it set appropriately?
• What do those even mean?
II.Why does levothyroxine matter? Reimbursement.
• Ointments (hydrophobic and hydrophilic)
• What’s happening with reimbursement in 2017?
• Solid sticks and balms (hydrophobic and hydrophilic)
• What does a new presidential administration mean for
drug prices?
• Film forming topicals
•Sprays
•Patches
III.Interactive Session
Participants will observe, touch, feel and evaluate the
application and performance of products from the market
place and placebo dosage forms from the lab. In some
cases systematic sensory evaluations may be employed.
III.The Heinz Dilemma
• Separating ethics and morals from business, enterprise,
and economics
IV.Interactive Exercise
• Develop regionally-specific pricing models to create a
visual worldwide market that encourages competition,
growth, and sustainability.
Advances in Solubility and Bioavailability
Utilizing Novel Technology to Improve Drug R&D Productivity and
Accelerate the Development of Drug Delivery and Formulation
Wednesday, May 17, 2017, 8:30 AM – 10:00 AM
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Wednesday, May 17, 2017, 2:00 PM – 3:30 PM
Moderator: Sunny Bhardwaj, Senior Scientist, Merck
Panelists:
Elanor Pinto-Cocozza, NA Technical Specialist, Science and
Technology for DDS & OFSS, Catalent Pharma Solutions
Rodney Ketner, Director, Pharmaceutical Business Development
- Global Accounts, Capsugel
D. Jeffery Liu, PhD, MBA, MS, Director/Clinical Development
Head, ID/IIDPH, RD, GSK
I. Explore and apply new technology to accelerate drug
development pipeline and develop a novel formulation
II.Delivering benefit to the patient while creating novel
formulations
III.Translating the technology from use in R&D to clinical output
Discussion to include the following topics:
Legal and Policy Strategies for Drug Companies in Today’s
Global Market
• Drug delivery and formulation for the future - challenges
and opportunities
Wednesday, May 17, 2017, 10:30 AM – 12:00 PM
• Preparing for new drug delivery strategies
Thomas Fox, Principal, Advanced Compliance Solutions
Ben Locwin, PhD, MBA, MS, President, Healthcare Science
Advisors & Former Director, Biogen
This session is centered directly on the diametricallyopposed viewpoints of strategic drug pricing. How are
prices set? How should they be set? What’s the balance
For the most up-to-date program, go to schedule.
cphinorthamerica.com or schedule.informex.com.
• The evolution of formulation challenges for improved
optimum outcome
Drug Development Track
Drug Product Development and Biophysical Characterization of
Protein Therapeutics
Wednesday, May 17, 2017, 2:00 PM – 3:30 PM
Haripada Maity, Ph.D., Research Advisor, Eli Lilly and Company
Arvind Srivastava, Ph.D., Research Advisor, Formulation
Development, CMC Development, Eli Lilly and Company
Protein instability may occur at different stages of
development, including bioprocessing, purification,
formulation, and during storage and delivery. Enthalpyentropy compensation makes protein structure to be
marginally stable and it is stabilized by higher enthalpic
contribution to the free energy of unfolding.
A major physical degradation pathway of a therapeutic
protein during its life cycle is aggregation which strongly
depends on both conformational (thermodynamic)
and colloidal stabilities. Higher free energy of unfolding
corresponds to higher conformational stability and higher
colloidal stability of a protein solution corresponds to higher
protein-protein repulsive electrostatic interactions compared
to attractive interactions (Derjaguin-Landau-VerweyOverbeek theory).
The primary objective of a robust formulation development
is to reduce the rate of change of both physical and
chemical degradation of a protein by optimizing
conformational and colloidal stabilities. Uncluttered
experimental strategy using both biophysical and analytical
methods and correct understanding of complex data
are critical for optimal formulation development and
characterization of proteins. In addition, dosage form
selection, container closure integrity, and in-use stability
are critical for the overall drug product development. This
presentation will address the following:
• Stability challenges in protein therapeutics
• Rational formulation development strategy
• Selection of biophysical and analytical methods
• Utility of these multidimensional approaches and the
connectivity of these data in terms of thermodynamic/
conformational stability and kinetic stability of protein.
• Characterization of Higher Order Structure (HOS) and
its effect on protein stability
• Dosage form selection
• Container closure selection and drug wastage
• Temperature excursion
• In-use stability
Understanding Critical Excipient Properties to Ensure Consistent
Quality of Amorphous Solid Dispersion and Extended-Release
Products
Wednesday, May 17, 2017, 4:00 PM – 5:30 PM
Yihong Qiu, Oral Drug Products, Manufacturing Science &
Technology, AbbVie, Inc.
Assessing variation of critical excipients properties is an
essential element in:
I. Developing a product of consistent quality,
II.Establishing appropriate specifications to assure quality
and,
III.Building robustness into manufacturing process,
especially for dosage forms based on more
sophisticated drug delivery technologies, such as
extended-release and amorphous solid dispersion
systems.
This presentation intends to examine the crucial role
excipients and their “natural” variability may play in
affecting product quality and highlight the importance of
understanding variability of key functional excipients and
continuous learning & improvement through application of
the new knowledge to ensure consistent product quality
and performance and minimize patient risks in commercial
manufacturing.
An overview of the basic principles and key functional
excipients of extended-release and amorphous solid
dispersion systems will be provided. Case studies will be
shared to demonstrate:
• How critical material properties and variation within and
outside of compendial and/or supplier’s specifications
can influence product quality and performance, such
as in vitro dissolution, stability and in vivo absorption,
during manufacture of marketed products; and,
• Continuous monitoring, accumulating knowledge of
raw materials, product and process are imperative in
maintaining production consistency.
It is also shown that the susceptibility of a particular quality
attribute to variation of excipient properties and extent
of the impact often depend on the API, product design
and operating principles, manufacturing process and test
method. Therefore, it is important to apply systematic
approach in evaluating material properties on product
quality and performance via an integrated evaluation of
drug substance, formulation, process, test method and their
interactions.
Drug Development Track
Pediatric Formulation Development Innovation
Wednesday, May 17, 2017, 4:00 PM – 5:30PM
Implement Novel Container/Closure Technologies
Thursday, May 18, 2017, 8:30 AM – 10:00 AM
Satish K Singh, Drug Product Services. Lonza Pharma and
Biotech, Lonza Ltd
Delivery systems are being increasingly used for parenteral
products as a way to add value in terms of convenience,
patient compliance as well as product differentiation. These
systems, oftentimes encompassing the primary container/
closure system, must be considered an integral part of
parenteral products and not an afterthought. The choice of
the system and the assessment of its suitability, functionality
and manufacturability are key aspects of the development
process. A range of technologies are available for selection,
depending on the user requirements. This session will
cover container/closure requirements in general, address
the requirements for qualification of such systems including
compatibility, integrity testing (in the context of the new USP
requirements) and manufacturability.
The session will cover the major systems with a focus
on pre-filled syringes which are by far the most common
system being used after vials. Beyond the primary
packaging, the secondary packaging may also have
functional requirements in specific application. Examples of
such systems will be discussed.
Discover the Latest in Inhalation Product Development and
Regulatory Standards
Thursday, May 18, 2017, 8:30 AM – 10:00 AM
Jennifer Yaping Zhu, Ph.D., Executive Director, Inhalation Product
Development, Sandoz Inc.
Overview of inhalation therapies
• What are the US regulatory pathways for inhaled
products
• Why we like 505(b)(2) and 505(j) inhaled products
• Latest cGMP requirements for combination products
II.Development of generic inhaled products:
• How to select formulations and devices
• What analytical methods are typically required for
development and quality control
• How to qualify packaging components
• Challenges with in-vitro and in-vivo bioequivalence
studies for US filing
III.Interactive Exercise:
For the most up-to-date program, go to schedule.
cphinorthamerica.com or schedule.informex.com.
Compounds with known toxicity can potentially be
leached from packaging components into an MDI,
leading to a great concern to regulators. Routine
testing for component extractables is typically required
on those MDI components which contact either the
drug product and/or the patient’s mucosa. We’ll
discuss how to effectively deal with extractables and
leachables in MDIs to ensure consistency and safety of
the container closure system.
Bioconjugate and Biotherapeutics: Present and Future
Thursday, May 18, 2017, 10:30 AM – 12:00 PM
Powered by
Moderator: Richard Silva (full title and company to be provided
by ACS – waiting to hear from team )
Robert Garbaccio, Executive Director, Merck
Jagath Reddy Junutula, Cellerant Therapeutics
David Rabuka, PhD, Global Head of R&D, Chemical Biology,
Catalent Biologics - West (formerly Redwood Bioscience),
Catalent Pharma Solutions
I. An Antibody-Drug Conjugate Approach to Tissue-Selective
Glucocorticoids
• Investigation of the targeted delivery of glucocorticoids
using the ADC modality
• Discovery of a novel linker design that provided optimal
properties for payload conjugation & delivery
• Lessons learned from investigation of novel linkerpayload combinations
II.Engineering Antibody Based Designer Drugs for Cancer
Therapy
Antibody therapeutics has revolutionized the treatment
of a number of diseases including cancer and
inflammation. Antibody engineering methods have
been used to improve the efficacy, safety, and half-life
of antibody-based drugs to ensure the clinical success.
There are about 470 antibody-based therapeutic
molecules are currently in the clinical testing, which is
a testimony to the applications of antibody engineering
that played a major role in expanding this family of large
of molecule therapeutics over the past two decades.
Several applications of antibody engineering will be
presented and discussed on how these tools are
applied to further expand in developing next generation
antibody therapeutics, such as site-specific Antibody
Drug Conjugates (ADCs), Bi-specific ADCs, Bi-specific
T-cell Engagers (BITE), Immune mobilising monoclonal
Drug Development Track
TCRs Against Cancer (ImmTACs), Chimeric Antigen
Receptors (CARs). Oncology drug development
recently witnessed an unprecedented improvement
in overall survival of patients with the certain type
of cancer indications upon treatment with immunooncology (IO) molecules, such as anti-PD-1 or antiPD-L1 antibodies.
such as antibody-drug conjugates (ADCs), where the
proteins are chemically elaborated. The application of
these chemistries to generate site-specifically modified
bioconjugates with improved efficacy and safety
profiles will be highlighted.
The presentation highlights the rapidly evolving IO
combo trials in conjunction with above described next
generation antibody therapeutic molecules that may
further raise the bar of overall survival, thus benefiting
the cancer patients.
III.Novel Bioconjugation Strategies Used in Biotherapeutic
Development
This is an overview of chemical methodologies that are
currently used in the development of bioetherapeutics,
Drug Manufacturing Track
A Case Study in API Continuous Processing (Part I)
Tuesday, May 16, 2017, 2:00 PM – 3:30 PM
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Economies of Capability vs. Economies of Scale – Advancing
CMO Decisions
Wednesday, May 17, 2017, 8:30 AM – 10:00 AM
Moderator: David Conlon, Senior Principal Scientist, BristolMyers Squibb
Pete Stevenson, Vice President and General Manager, Pfizer
CentreOne
Panelists:
Tom Wilson, Vice President, Contract Manufacturing Operations,
Pfizer Global Supply & Pfizer CentreOne
Klavs F. Jensen, Warren K. Lewis Professor of Chemical
Engineering, and Professor of Materials Science and Engineering,
MIT
Timothy Braden, Research Scientist, Eli Lilly
A Case Study in API Continuous Processing (Part II)
Tuesday, May 16, 2017, 4:00 PM – 5:30 PM
Powered by
Moderator: David Conlon, Senior Principal Scientist, BristolMyers Squibb
Panelists:
Ian W. Davies, Department of Process and Analytical Chemistry,
Merck Research Laboratories, Merck and Co. Inc.
Christian Oliver Kappe, Professor of Chemistry, University Of Graz
• Defining ‘economies of capability’ and the drivers of its
increased importance
• A look at challenging market conditions; increased
regulatory scrutiny and industry consolidation
• How evolving product and market trends are changing CMO
partner selection considerations
• Matching your compound’s unique needs and business
strategy with the specialized strengths of the right CMO
• Analyzing the criteria for selecting potential CMO partners in
an evolving supply environment
• How to ensure supply chain reliability
Packaging Innovation
Wednesday, May 17, 2017, 8:30 AM – 10:00 AM
Powered by
Save an extra 20% off when you use Promo Code
CONF20 by May 8.
Go to cphinorthamerica.com/register to save today!
For the most up-to-date program, go to schedule.
cphinorthamerica.com or schedule.informex.com.
Drug Manufacturing Track
The Role of Track and Trace in a Post-Serialized World
Wednesday, May 17, 2017, 10:30 AM – 12:00 PM
Brad Pedrow, Manager, S&O Supply Chain Strategy, Deloitte
Consulting
Rajesh Singh, Senior Manager, Supply Chain Technology, Life
Sciences, Deloitte Consulting
I. Recognizing the Changes and Impact
• Current global snapshot; US current situation and
implementation challenges
• Current technology developments; preparing for the
next round
• Forward thinking to leverage value from investments
II.Driving Value
• Recognize the progression from product security to
value-driving capabilities
• Recognize the relative value of returns processing,
chargeback accuracy and recall management
• Chart out the evolutionary journey
III.Interactive Exercises
Audience polling to occur throughout Sections I and II.
The session concludes with Q&A and audience crossfertilization of ideas.
Process Development and Quality by Design Case Study
Wednesday, May 18, 2017, 10:30 AM – 12:00 PM
Drug Manufacturing: Quality Risk Assessment Management and
Supply Chain Sourcing Strategies for APIs and Excipients
Wednesday, May 17, 2017, 2:00 PM – 3:30 PM
Powered by
Stephen Andruski – Verification Manager, USP
Pharmaceutical companies are required by FDA to
control the supply chain for all of the ingredients used in
their products. Often, this translates into pharmaceutical
companies conducting numerous and redundant GMP
audits of their suppliers. Recently, several third-party GMP
certification programs have introduced business models
designed to help reduce the number and frequency of these
audits. New proposals and guidelines suggest a dedicated
risk assessment strategy can further help to improve
efficiencies in resources and activities. This is an approach
currently employed by FDA to determine the audit frequency
and urgency in many regulated industries.
This presentation will provide an overview of the advantages
of different Certification business models, including the
USP Verification program and how inclusion of Quality risk
assessment management strategies can be used to help
focus resources to the most critical ingredients in the supply
chain.
Continuous Solid Dose Manufacturing – Analytics to Support the
Supply Chain
Wednesday, May 17, 2017, 4:00 PM – 5:30 PM
Stephen V. Hammond, Senior Director/ Team Leader of the
Process Analytical Sciences Group, Pfizer Global Technology
To be an effective contributor to a transformed “low
inventory - pull” medical products supply chain,
manufacturing of pharmaceuticals must also transform. The
large scale batch processing, in centralized facilities does
not serve the new supply chain well. The need for flexibility
and localization of manufacturing in Emerging Markets is
becoming a primary objective for the development of new
processing technologies in the pharmaceutical industry.
This paper will describe some of the efforts that Pfizer and
the industry in general, are putting into the concepts of
continuous manufacturing, married together with integrated
analytics and Advanced Control Systems. The combined
technologies allow for rapid response to demand, through
flexible low inventory supply streams that occupy a small
footprint, and can be rapidly deployed to markets anywhere
in the world.
Interfacing PAT’s into a continuous manufacturing system
requires consideration of patient safety, compliance to
existing standards but also supply flexibility and reliability.
This paper will describe the on-going efforts to develop
analytics and controls to respond to these considerations.
Emphasis will be placed on the need for a measurement and
control system that is based on the business need, as well
as satisfying the need for patient safety and compliance.
Continuous Manufacturing of (Bio)Pharmaceuticals
Wednesday, May 17, 2017, 4:00 PM – 5:30 PM
Richard D. Braatz, Ph.D., Edwin R. Gilliland Professor of
Chemical Engineering, Massachusetts Institute of Technology
I. Comparison of Batch and Continuous Unit Operations
• What are the advantages of batch operations
• What are the advantages of continuous operations
• Learn about specific processes that are operated more
effectively in continuous flow
• Learn how to achieve tighter control of product
characteristics using continuous manufacturing
• Learn how continuous operations can streamline process
development
Drug Manufacturing Track
II.Plant-wide Control Approach
• Learn about requirements to run a successful
bioprocess (e.g. regulatory)
• Build first-principles dynamic models for each unit operation
• Design control systems for each unit operation to meet local
material attributes
• Exploit the potential of biocatalysis in the industry
III.Interactive Exercise
• Evaluate performance in simulations and proposed design
modifications as needed
Discuss how to accelerate application of biocatalysis in
the future. Hear the perspective of leading researchers
from industry what the biggest hurdles to develop
industrial bioprocesses are. Increase your biocatalysis
network by meeting colleagues working in the different
fields applying biocatalysis (large pharma, technology
providers, CROs and CMOs).
• Implement and verify the control system for each unit
operation
• Design and verify plant-wide control system to ensure that
the product quality specifications are met
III.Interactive Exercise
Using a real-life example of a continuous drug
manufacturing plant, participants will study how material
attributes during continuous operations are affected by
design changes.
Pharmaceutical Impurities
Thursday, May 18, 2017, 10:30 AM – 12:00 PM
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Antonio Hernandez-Cardoso, Senior Scientific Liaison, USP
Applied Biocatalysis for the Synthesis of Industrial Relevant
Pharma Compounds
Thursday, May 18, 2017, 8:30 AM – 10:00 AM
Kahkashan Zaidi, Principal Scientific Liaison, USP
I. USP Chapters <232> and <233> -- Key changes,
Harmonization and Implementation Strategy
Moderator: Iwona Kaluzna, Ph.D., NBD Manager InnosynTM
Route Scouting Services, InnoSyn
• An update on chapter <232> and where we are with its
harmonization with ICH-Q3D
Panelists:
• Impact of <232> on other USP chapters and how it will
be addressed
Jim Lalonde, SVP of R&D, Codexis Inc.
David Rozzell, SVP, Provivi, Inc
Matthew Truppo, Executive Director, Head of Chemical
Biotechnologies and Head of Global Structural Sciences at
Merck
The aim is to promote developments in applied biocatalysis
through science and engineering of useful biological
catalysts and their commercial applications in the
production of small molecule pharma products.
I. How to identify, optimize and develop biocatalysts and
biocatalytic processes
• Biocatalyst discovery, optimization and design of new
processes
• Elemental impurities implementation plans
II.
Modernization of Organic Impurities testing in Drug
Substances and Drug Products
• Justification for modernization of organic impurities
testing
• Industry survey results and Stimuli article content
• Proposed content of the new chapter <476> and
revised chapter <1086>
• Proposal for introduction of cross references in
monographs, in a case-by-case basis
• Next steps and implementation plan
• Emerging strategies for improving the characteristics of
biocatalysts in industrial setting
• Reaction engineering for enzyme catalyzed reactions
• Pragmatic downstream processing technologies
• Biocatalyst production and formulation
II.Application of biocatalysts in industrial processes
• Demonstration of diversity of reactions enabled by
enzyme catalysis
• Understanding of the boundaries for application of
enzymes in chemical process
• Recent advances and current trends in industrial
biocatalysis
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Outsourcing Track
Supply by Design – Global Good Supply Practices (GSPs) for Your
Success
Determining the Value of Re-Shoring Drug Ingredient
Manufacturing
Wednesday, May 17, 2017, 8:30 AM – 10:00 AM
Wednesday, May 17, 2017, 2:00PM – 3:30PM
Sponsored by
Marla Phillips, Director, Xavier Health, Xavier University
Jack Solomon, Practice Leader – Supply Chain, Core Risks, Ltd.
(A JLT Company)
I. Understand the Root Causes of Supply Chain Failure
• What actionable steps did the gap analysis reveal?
• What can you do in your organization to reduce risk?
II.
Richard Mutchler, President, BioSpectra, Inc.
Dora Meissner, Director of Regulatory Affairs, BioSpectra, Inc.
Sarah DeMaio, General Manager, BioSpectra, Inc.
I. Knowing when to consider Re-Shoring drug ingredient
manufacturing
• What can you implement across organizations to
partner for supply chain success?
• Pros and cons of investing to improve your existing
manufacturer
Solutions You Can Implement Today
• Pros and cons of qualifying a new manufacturer
• Supplier-Qualification vs. Self-Qualification
II.Selecting the safest and most sustainable drug
ingredient manufacturing source
• Relationship Risk
• Business Smart Transparency – how to decide
• Right-First-Time Supplier Selection
III. Interactive Exercises
• Ensuring your decision actually improves your supply
chain
• The surprising financial impact of Re-Shoring your drug
ingredient
• Work with your colleagues to uncover hidden gaps in
your supply chain practices.
III.Ensuring your supply chain decision is beneficial to end
patients and shareholders
• Table discussions to put your learning into action before
you return to your organization
• Clearly communicating Regulatory and Quality benefits
• Quantifying short term and long term Return on Investmen
Technology Transfer Risk Mitigation Practices
Wednesday, May 17, 2017, 10:30 AM – 12:00 PM
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For the most up-to-date program, go to schedule.
cphinorthamerica.com or schedule.informex.com.
Quality / Regulatory Track
Navigating GDUFA – Reduce Cost and Accelerate Delivery
The World of Quality Metrics – Yesterday, Today and Tomorrow
Tuesday, May 16, 2017, 4:00 PM – 5:30 PM
Thursday, May 18, 2017, 10:30 AM – 12:00 PM
Jonathan S. Helfgott, Adjunct Professor, Johns Hopkins
University Graduate Program in Regulatory Science & Former
Acting Associate Director, Office of Scientific Investigations,
CDER, FDA
In this session, our expert explores the role of FDA CDER’s
Office of Generic Drugs (OGD) in its review and approval
of Abbreviated New Drug Applications (ANDAs). Topics
covered include:
• Tips for a successful ANDA submission
Marla Phillips, Director, Xavier Health, Xavier University
I. Why is there so much attention on metrics?
• How does the FDA want to use metrics and why?
• How does industry NOT want FDA to use metrics and
why?
• What is driving the need for metrics for FDA and
industry?
II.What are the metrics FDA is considering?
• FDA’s focus during an ANDA review
• CDER’s approach to metrics and what they are
• The role of GDUFA and it’s impact on reviews and timelines
of ANDAs
• CDRH’s approach to metrics and what they are
• When a Bioequivalence study is required to support an
ANDA
• Conducting a high-quality Bioequivalence study
• FDA site inspections of Bioequivalence studies
• Role of technologies used to support Bioequivalence
studies
• Why is there a difference across CDER and CDRH?
• How can industry use the metrics to inform decision
and trigger action?
III.How to quantitate a commitment to quality
• The role of Culture in an organization’s commitment to
quality
• How to quantitate the commitment to quality
• How to improve the reliability of your product
IV.Interactive Exercises
• Work with your colleagues to explore successful
practices on metrics
• Table discussions to articulate cultural impact
AgroChem Spotlight Track
Food Sustainability Trends and Outlook
Wednesday May 17, 2017, 8:30 AM – 10:00 AM
Help Wanted! Herbicide and GM Herbicide Trait Treadmills are
Too Slow
Wednesday May 17, 2017, 10:30 AM – 12:00 PM
Jerry Green, President, Green Ways Consulting
Glyphosate and glyphosate-tolerant crops had a
revolutionary impact on weed management and new
combinations of herbicides and traits will help continue
their utility. However, the epidemic of herbicide-resistant
weeds is rapidly decreasing their value and threatening high
production agriculture. The chemical company solution is to
combine glyphosate with other herbicides, while the seed
company solution is to combine glyphosate resistance with
other traits to enable more herbicide options.
Unfortunately, no new commercial mode-of-action for over
30 years and current herbicide types all have problems with
For the most up-to-date program, go to schedule.
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weed resistance. New traits for glufosinate, auxin, HPPDinhibiting and PPO-inhibiting herbicide traits will help when
combined with glyphosate resistance, but are temporary
solutions.
The process to develop new herbicides and their associated
traits is too slow and expensive to support what critics call
the chemical and transgenic treadmills. The lack of new
herbicide types and the epidemic of multiple herbicideresistant weeds is forcing growers to spend more money
to manage weeds, creating a best of times, worst of times
predicament for the crop protection industry. New research
efforts have already produced some results, but much more
technology wanted!
AgroChem Spotlight Track
Food Sustainability Trends and Outlook
Wednesday May 17, 2017, 8:30 AM – 10:00 AM
Help Wanted! Herbicide and GM Herbicide Trait Treadmills are
Too Slow
Wednesday May 17, 2017, 10:30 AM – 12:00 PM
Jerry Green, President, Green Ways Consulting
Glyphosate and glyphosate-tolerant crops had a
revolutionary impact on weed management and new
combinations of herbicides and traits will help continue
their utility. However, the epidemic of herbicide-resistant
weeds is rapidly decreasing their value and threatening high
production agriculture. The chemical company solution is to
combine glyphosate with other herbicides, while the seed
company solution is to combine glyphosate resistance with
other traits to enable more herbicide options.
weed resistance. New traits for glufosinate, auxin, HPPDinhibiting and PPO-inhibiting herbicide traits will help when
combined with glyphosate resistance, but are temporary
solutions.
The process to develop new herbicides and their associated
traits is too slow and expensive to support what critics call
the chemical and transgenic treadmills. The lack of new
herbicide types and the epidemic of multiple herbicideresistant weeds is forcing growers to spend more money
to manage weeds, creating a best of times, worst of times
predicament for the crop protection industry. New research
efforts have already produced some results, but much more
technology wanted!
Unfortunately, no new commercial mode-of-action for over
30 years and current herbicide types all have problems with
ChemInnovation Track
How to Create a Start-Up Environment in a Traditional Company
Tuesday, May 16, 2017, 2:00 PM – 3:30 PM
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The Latest Developments in Chiral Chemistry
Tuesday, May 16, 2017, 4:00 PM – 5:30 PM
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• Hardware; Existing & New developments; Mixing
devices
II.Applying continuous flow for the manufacturing of fine
chemicals
• Chemistries particularly suitable for continuous
manufacturing
• Hazardous chemistry and reagents
• Highly exothermic reactions
Discover the Latest Innovations in Green Chemistry
• Showcasing real life examples
Wednesday May 17, 2017, 8:30 AM – 10:00 AM Powered by
• On-line analysis and in-process controls
Continuous Manufacturing of Fine Chemicals
Wednesday May 17, 2017, 2:00 PM – 3:30 PM
André H.M. de Vries, PhD, Business Director, Innosyn
I. How to decide between continuous and batch wise
manufacturing
• Advantages and disadvantages of both types of
operation
• Defining parameters, such as safety, control, quality
and cost
• Environmental advantages
• License to operate
For the most up-to-date program, go to schedule.
cphinorthamerica.com or schedule.informex.com.
III.Interactive Exercise
Plenary discussion between panelists and attendees on how
to accelerate implementation of continuous manufacturing
of fine chemicals, especially if one can gain advantages in
safety and environment. Are non-competitive collaborations
possible? Sharing best practices of other industries.
Nanotechnology
Thursday, May 18, 2017, 8:30 AM – 10:00 AM
Regulatory Spotlight Track
Manufacturing Plant Operations to Efficiently Meet Food and
Drug Regulatory Requirements for Multiple Markets
Tuesday, May 16, 2017, 2:00 PM – 3:30 PM
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Chemical manufacturers are faced with operating their
plants in a quality environment driven by a multitude of
governmental regulations, voluntary industry programs
and customer requirements. Because they serve a
variety of market segments, it often seems each segment
has different, and in some cases incompatible and/or
redundant, requirements that drive up complexity and cost.
Some manufacturers choose to abandon niche markets,
forgoing high margin markets for what are perceived to
be less complex quality regulatory requirements. Some
choose to operate at a very high level of quality such as
Pharmaceutical GMP regulatory requirements, believing
such a level will inherently meet all requirements. Others
choose to operate in smaller, batch style production,
applying specific GMPs regulatory requirements on a batch
by batch basis.
This session seeks to provide a unified view of how to meet
regulatory requirements across multiple end user markets,
hopefully minimizing complexity and cost. Topics will
include:
• Legal requirements to operate a plant that
simultaneously serves the Industrial, Food, Dietary
Supplements and Pharmaceutical markets
• How a commodity plant can operate to satisfy multiple
markets
• Advantages and challenges to meeting multiple
markets using a batch style production plan
Chemical Regulation in the US - Toxic Substances Control Act
(“TSCA”) Reform – Current Interpretations and the Impact on
Business
Tuesday, May 16, 2017, 4:00 PM – 5:30 PM
Brendan K. Collins, Partner, Ballard Spahr
I. Overview of the Lautenberg Act (30 minutes)
• The presentation will provide a brief overview of TSCA
and the Frank R. Lautenberg Chemical Safety for the
21st Century Act (“Lautenberg Act”), adopted in 2016.
• Learn how r the Lautenberg Act will affect your
business.
For the most up-to-date program, go to schedule.
cphinorthamerica.com or schedule.informex.com.
• Understand the calendar: the Lautenberg Act imposes
strict deadlines for EPA rulemaking affecting new and
existing chemicals in the marketplace.
• Discover the Loopholes: Important provisions of the
Lautenberg Act are subject to different interpretations
that can dramatically affect impacts on business.
II.Roundtable Discussion
• The Most Wanted List - EPA Selects the First Ten
Chemicals for Risk Evaluation
• On November 30, 2016, EPA announced the initial
list of 10 “high priority” chemicals subject to its risk
evaluation as required by the Lautenberg Act.
• Learn about EPA’s risk evaluation process and the
progress of EPA’s ongoing review.
• Panelists will share their insights on the risk evaluation
prospects of other chemicals listed in the EPA TSCA
Work Plan.
• Casting Call - EPA’s Proposal to Reset the TSCA
Chemical Inventory
• On January 13, 2017, EPA proposed to subdivide the
TSCA Chemical Substance Inventory into “active” and
“inactive” substances.
• Learn how EPA intends to approach the notification
process.
• Panelists will share their insights on preparing for the
notification rule, discuss key issues that emerged
during the public comment process.
• Keeping Secrets - EPA’s Guidance on the New
Substantiation Requirements for Confidential Business
Information (“CBI”) Claims
• On January 19, 2017, EPA published a guidance
document interpreting the new substantiation
requirements for CBI claims submitted under section
14 of TSCA.
• Learn strategies for complying with the new
requirements.
• Panelists will share their experience in submitting CBI
claims and thoughts on the possibility of change in the
guidance under the new Administration.
III.Q&A with the Audience
The Business of Chemicals Track
The Changing Dynamics of Outsourcing: Strategies, Essential
Elements, Advantages and Limitations
Wednesday May 17, 2017, 10:30 AM – 12:00 PM
Lalit Baregama, PhD, General Manager-Global Business
Development, Cadila Pharmaceuticals Ltd
I. Outsourcing - Current scenario
• Transformational shifts of Pharma/Chemical industry
• Mergers and acquisition
• Reshaping of development strategy
• Core sectors become the growth strategy
II.Essential elements for successful partnership
• Strategic intent of outsourcing
• Nature of business
• Risk tolerance
• Mode of partnership: single transduction or long term
III.Advantages, Challenges and Limitations
• Partner selection: Location, opportunities, risk and cost
• Preference advantages
• Challenges and Limitations: competition, policies,
pricing, EHS
IV.Future Perspective
2.Grassroots Awareness Programs – Multiple “off the shelf”
programs exist that industry professionals can utilize both
within their companies and in their local communities.
Attendees will learn about these initiatives and how they can
implement them immediately.
• NIOSH Safety Matters Campaign – This new program
aims to raise awareness among young people
about workplace safety and health and to provide
an understanding of the skills they need to become
active participants in creating safe and healthy
work environments. Chemical and other industry
professionals are already taking these materials to
classrooms across the country.
• OSHA Safe and Sound – This new program focuses
on the three pillars of all safety and health programs:
management commitment, employee involvement, and
a systematic method for finding and fixing hazards.
Attendees will learn how they can participate in a
nationwide event planned for the 2nd week of June
(6/12 – 6/16).
• #IamIH -- Sponsored by AIHA, this new public
awareness campaign kicked off last fall and strives to
educate industry stakeholders and students alike about
the integral role professionals engaged in the field of
environmental and worker health and safety play in
corporations and the communities in which we live.
Making the Business Case for Occupational Health & Safety
Catalyzing Innovation in the Chemicals Industry by Maximizing
R&D Tax Credits
Wednesday May 17, 2017, 2:00 PM – 3:30 PM
Wednesday May 17, 2017, 4:00 PM – 5:30 PM
Lawrence Sloan, CAE Chief Executive Officer, AIHA
Steven Lacey, PhD, CIH, CSP President, AIHA, Associate
Professor and Chair Dept. of Environmental Health Science,
Indiana University Fairbanks School of Public Health
The purpose of this presentation is to draw awareness
about compelling business case that can and should be
made for ensuring a company is committed to a structured
comprehensive worker health and safety program,
recognized from the C-suite down. A brief introduction to
AIHA and our affiliate group, Product Stewardship Society,
will be followed by a review of two main strategic areas:
1.Center for Safety & Health Sustainability -- Launched in
2011, CSHS is a 501(c)3 nonprofit organization committed
to advancing the safety, health and sustainability of the
global workplace. Unfortunately, when an organization
considers the “social” aspect of its own sustainability
picture, occupational safety and health receives very little
attention, if any at all. Yet more than 2 million people die
from occupational accidents or work-related diseases each
year. Attendees will learn about the Center’s initiatives and
hear results from an insightful new Harvard University study
on Human Capital, worker health and safety, and its impact
on a company’s capital valuation.
For the most up-to-date program, go to schedule.
cphinorthamerica.com or schedule.informex.com.
Yair Holtzman, CPA, MBA, MS, CGMA, Partner, R&D Tax Credits
Practice Leader, Global Chemicals & Life Sciences Practice
Groups Leader, Anchin, Block & Anchin LLP Accountants and
Advisors
Has your company developed new or improved compounds
or other chemical products recently? Have you experienced
failed batch trials or experimented with scale-up processes?
Have your employees modified product formulations and/
or production techniques and processes to increase yields,
reduce waste, improve product performance, or made
other improvements to the efficiency of your manufacturing
operation? If so, your company may qualify for Research
and Development (R&D) Tax Credits, often an overlooked
and misunderstood opportunity for taxpayers.
Our expert shares specific industry examples that are
common to the chemicals industry, and helps participants
understand the qualification process, and discuss the
four-part test including how different activities qualify for the
credit.
The Business of Chemicals Track
USP 232 Heavy Metals Mandate Update – Compliance Best
Practices and Standardized Methods for Testing for Metals
Thursday, May 18, 2017, 8:30 AM – 10:00 AM
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Gain the latest insights into regulatory changes on the
horizon for elemental impurities standards and what you
need to know in order to be prepared for the implementation
deadline.
Circular Economy
Thursday, May 18, 2017, 8:30 AM – 10:00 AM
Julie B. Manley, President, Guiding Green LLC
NDAs - Legal Strategies to Mitigate Risk
Thursday, May 18, 2017, 10:30 AM – 12:00 PM
NDAs and supplier agreements are getting more complex.
Hear from legal experts on how contractors and toll
manufacturers can build in protections to mitigate risk. Vet
sample NDA scenarios from both sides of the negotiating
table during this interactive session.
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Promo Code CONF20 by May 8.
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For the most up-to-date program, go to schedule.
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