SMi Group's Highly Potent Active Pharmaceutical ingredients USA 2019 conference takes place in Boston this October

1. www.hpapi-usa.com
Register online or fax your registration to +44 (0) 870 9090 712
or call +44 (0) 870 9090 711
ACADEMIC & GROUP DISCOUNTS AVAILABLE
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@SMiPharm
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Plus Two Interactive Half Day POST-Conference Workshops
WEDNESday 23RD OCTOBER 2019, Sheraton Boston Hotel, Boston, USA
A: The roadmap from assessing HPAPI hazards to containment
implementation along with CDMO dynamics
Workshop Leaders: Janet Gould, Senior Managing Toxicologist,
SafeBridge Consultants USA
Charlyn Reihman, Principal Occupational Health Consultant,
SafeBridge Consultants USA
08.30 - 12.30
SMi Group Proudly Presents…
Highly Potent Active
Pharmaceutical
Ingredients USA
Developing Containment, Formulation and Manufacturing Strategies
for maximum HPAPI Success
Sheraton Boston Hotel, Boston, USA
CONFERENCE:
21ST - 22ND
WORKSHOPS: 23RD
OCT
2019
B: How to sell your containment project to management:
financial justification for containment solutions
Workshop Leader:
David Eherts, Vice President, Global EHS,
Allergan
13.30 - 16.30
Chairs for 2019:
Rakesh Dixit, Vice President of RD Global Head,
MedImmune; Vice President of RD Translational Sciences
– Biologics Safety Assessment, AstraZeneca
Janet Gould, Senior Managing Toxicologist, SafeBridge
Consultants USA
Featured Speakers Include:
• David Eherts, Vice President, Global EHS, Allergan
• Keith Jensen, Owner and Consultant, Keith Jensen Consulting,
Formerly at Novartis-MIT Center for continuous Manufacturing
• Maurits Janssen, Head of Commerical Development, API
Development Manufacturing, Lonza
• Charlyn Reihman, Principal Occupational Health Consultant,
SafeBridge Consultants USA
• Tony Haight, Director of Process Chemistry, AbbVie
• Rich Arnett, Manager of Industrial Hygiene, Pharmascience
• Marc Abromovitz, Head of Industrial Hygiene, Novartis
HIGHLIGHTS FOR 2019:
• LEARN how to rationally categorise your HPAPI project into a
containment banding and implement containment solutions to
mitigate the occupational health risks
• GRASP the current landscape of HPAPI ADCs and other emerging
biologics-based therapies
• DISCOVER the emerging HPAPI manufacturing technologies
to reduce powder exposure with the possibility of continuous
manufacturing for HPAPI
• UNDERSTAND the steps involved to evolve a containment environment
to match that of the its scale of production and value of this practice
Sponsored by

2. Highly Potent Active Pharmaceutical Ingredients USA
Day One | Monday 21st October 2019 www.hpapi-usa.com
Register online at www.hpapi-usa.com
SPONSORSHIP AND EXHIBITION OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime networking
opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specific to your industry. Should you wish to join
the increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk
08.30 Registration Coffee
09.00 Chair’s Opening Remarks
Rakesh Dixit, Vice President of RD Global Head, MedImmune;
Vice President of RD Translational Sciences – Biologics Safety
Assessment, AstraZeneca
Evaluating and managing occupational risks
with HPAPI compounds
OPENING ADDRESS
09.10 Oncology Antibody-Drug Conjugates (ADC), the ongoing
developments and the containment challenges imposed
• What are the additional complications in both manufacturing
and containment of oncology ADC in contrast to small molecule
HPAPI, and gain awareness of the pitfalls to ADC HPAPI
• Discover the Medimmune/ AstraZeneca approach in managing
exposure and risk for ADC HPAPI
• Identify the implications due to insufficient data for implemented
containment efficacy validation, and learn how to use non-clinical
safety toxicology data assess risk
• Grasp the risks posed by genotoxic ADC along with the solutions
Rakesh Dixit, Vice President of RD Global Head, MedImmune;
Vice President of RD Translational Sciences – Biologics Safety
Assessment, AstraZeneca
KEYNOTE ADDRESS
09.50 Demonstrating that exposure controls are effective
• Examples of control devices and their performance
• Where does the data come from?
• ADCs – can we really measure nanogramme concentrations?
Charlyn Reihman, Principal Occupational Health Consultant,
SafeBridge Consultants USA
10.30 Morning Coffee
11.00 Preforming quantitative cost-benefit analysis of containment
technologies
• What is the most appropriate method of acquiring data to assist
in the assessment of the risk posed in a workplace and correctly
categorising the OEL and band
• Which containment banding or OEL are most relevant to you and
who’s risk standards and guidelines to follow
• Understand how the large initial investment into HPAPI
containment will return value on the long term
David Eherts, Vice President, Global EHS, Allergan
KEYNOTE ADDRESS
11.40 Requirements for fully-integrated service offerings in a HPAPI and
cytotoxic environment
The development of drug products based on potent compounds
can be quite challenging. Complications with the interface between
operations in drug substance and drug product handling can also
result in increased program complexity and cost. This presentation
will elaborate on best practices and infrastructure requirements that
facilitate accelerated timelines to clinic and market.
• A case study describing the development, rapid scaling, and
commercial production of HPAPI drug substance
• Integrated containment requirements for particle engineering and
drug products
• Impact of supporting integrated service offerings on expansion
strategies
Maurits Janssen, Head of Commerical Development,
API Development Manufacturing, Lonza
12.20 Networking Lunch
13.20 Control banding – the power of hypnosis
• The value of applying risk-based data driven making process to
your API risk management program
• Using data to identify appropriate technical solutions based on risk
vs hazard
• Eliminate waste associated with over and under engineering and
Personal Protective Equipment
Marc Abromovitz, Head of Industrial Hygiene, Novartis
KEYNOTE ADDRESS
14.00 Emergency procedures for HPAPI Disasters and how to manage
an HPAPI accident
• Gain-awareness of dangers of unforeseen circumstances and
accidents for HPAPIs and learn of the fail-safes and back-up
procedures that can be implemented to mitigate risk
• Understand the long term cost savings from planning and
implementing emergency procedures
• How to manage risks in an HPAPI workplace environment to
minimise the chance of disasters
• Learn of the best practices of disposing HPAPI waste
Aysha Ovais, EHS Professional, Taro Pharmaceuticals
14.40 Afternoon Tea
Training procedures and planning against HPAPI disasters
15.20 Industrial hygiene and potent compound containment
• Learn of the common pitfalls in industrial hygiene with highly
potent APIs and the means to avoid them
• Understand when are flexible containment more suited for
rigid containment
• Discover the advantages of externalisation, and the potential
of hastening RD
Joseph Grills, Former Associate Director EHS, Purdue Pharma
16.00 Training and managing workers with HPAPI exposure, along with the
best available techniques for cleaning and waste management
• With the constant technological innovations for containment and
transfer technologies, learn how to help your staff are sufficiently
trained and understand the equipment they are utilising
• Learn of the due diligence for management to continually assess
the HPAPI workspace and keeping your operators updated on
changes
• Understand the need to establish expectations surrounding the
safe handling of HPAPI and what value does this bring
• Recognise the best available techniques for waste management
and safe cleaning of HPAPI facilities
Patricia Weideman, President Principal, Sakari Consultants
16.40 Chair’s Closing Remarks and Close of Day One
SPONSORed by
At Lonza Pharma Biotech we provide contract development and manufacturing services that enable pharma and
biotech companies to bring medicines to patients in need. From the building blocks of life to the final drug product, our
solutions are created to simplify your outsourcing experience and provide a reliable outcome, at the time when you
expect it. Our extensive track record includes commercialization of pioneering therapies and manufacturing of a wide
variety of biological and chemical drugs. We continuously invest to solve not just the current, but also the future challenges.
Together, we can bring your next medicine to life. www.lonza.com
SafeBridge is a unique team of occupational and environmental toxicologists, industrial hygienists, chemists and safety
and environmental professionals with extensive experience inside the pharmaceutical industry. SafeBridge provides
professional consulting services and analytical support to clients across the United States and internationally including the
United Kingdom, Ireland, continental Europe, and Canada. www.safebridge.com

3. Highly Potent Active Pharmaceutical Ingredients USA
www.hpapi-usa.com Day Two | Tuesday 22nd October 2019
Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
MARKETING OPPORTUNITIES
Want to know how you can get involved? Interested in promoting your services to this market?
Contact Neill Howard, SMi Marketing on +44 (0) 207 827 6164 | Fax +44 (0) 207 827 6165 | nhoward@smi-online.co.uk
08.30 Registration Coffee
09.00 Chair’s Opening Remarks
Janet Gould, Senior Managing Toxicologist, SafeBridge Consultants USA
Scale-up, externalisation and shared facilities
OPENING ADDRESS
09.10 How to effectively plan out your plant, what are the goals you should
aim to achieve and thoroughly understand the scale-up process
• Discover the guidelines and practices for the most cost-effective
large-scale production of HPAPI products
• How to most plan a pilot plant, what are the goals that you
should strive and achieve and the purpose of these goals
• Understand what equipment, training and containment are
needed, along with the value of their implementation as
production size increases
• Recognize the tech transfers involved for scale up and their
importance
Rich Arnett, Manager of Industrial Hygiene, Pharmascience
ABBVIE SPOTLIGHT
09.50 ADC manufacturing in a multipurpose environment
• Understand the entire ADC manufacturing process
and the containment involved
• Learn of the safety requirements for cleaning standards
and how to apply them to ensure worker safety
• Discover how to use analytical techniques to validate and
establish cleaning protocols
• What scenarios are best suited for disposable containment
or fixed containment with cleaning
Tony Haight, Director of Process Chemistry, AbbVie
10.30 Morning Coffee
11.00 OH/Containment strategy and NPI at AbbVie
• OH/containment improvement targets and LRP
• Risk assessment, containment improvements and OH metrics
• Team approach – community of practice and collaboration
• Strategies, standards and technical guidance
• NPI and technology transfer
Sara Martens, Senior Manager EHS Technical Operations, AbbVie
Emerging biologics-based HPAPI therapies
and the associated occupational risks
KEYNOTE ADDRESS
11.40 Assessing and deriving the associated HPAPI related risks with
emerging technologies and therapies
• Understand the intensity of hazard imposed by emerging
biologics-based therapies that requires super-high-level band 5
containment
• Understand how to apply a level 5 banding with rational and cost-
effective containment planning that is sufficiently backed by data
• Learn of the best procedure for mitigating biologics-based HPAPI
projects
Janet Gould, Senior Managing Toxicologist, SafeBridge Consultants
USA
12.20 Networking Lunch
SPOTLIGHT PRSENTATION
13.20 Effective and safe containment solutions for biologics
based HPAPIs along with cleaning and cross contamination
requirements
• Regulatory requirements for highly potent biologics-based
Pharmaceuticals
• Requirements for aseptic manufacturing and Containment
• Cleaning and Cross Contamination Requirements
Richard Denk, Head Sales Containment, SKAN
14.00 Emerging bispecific HPAPI therapy, from development to manufacture
and multipurpose facilities
• Discover the potential of bispecific HPAPI and their latest
developments
• See the level of super high-level band 5 containment needed for
bispecific HPAPIs
• Grasp the concept of difference in manufacturing approaches
needed for bispecific HPAPI in order to gain approval international
market approval
• Understand the challenges and solutions to the manufacture of
bispecific antibodies in a shared facility
Jean Lord, Senior Scientific Manager, Product Quality
Occupational Toxicology, Genentech
14.40 Afternoon Tea
Emerging HPAPI manufacturing technologies
15.20 Alternative HPAPI manufacturing technologies to reduce powder
exposure and improving safety along with enabling continuous
manufacturing
• Discover alternative drug manufacture through nanocrystal
formulations, thin films and hot-melt extrusion/injection molding
that reduces HPAPI powder exposure and improve safety
• Detailing step-by-step process along with the equipment needed
to achieve these alternative HPAPI manufacturing techniques
• Learn of the advantages of continuous manufacturing and how to
achieve this via alternative manufacturing technologies
Keith Jensen, Owner and Consultant, Keith Jensen Consulting,
Formerly at Novartis-MIT Center for continuous Manufacturing
16.00 Respiratory HPAPIs: development, formulation and delivery
• Find the advantages and targets of a respiratory HPAPI
• Learn of the equipment and analytical instruments that are the
most suitable for respiratory HPAPI containment and safe handling
• Grasp the strategy for the development and industrialisation
process to ensure your respiratory HPAPI thrives
• Gain awareness of the current trends in respiratory HPAPIs
Speaker to be confirmed
16.40 Chair’s Closing Remarks and Close of Day Two
Media Partner Supported by

4. The roadmap from assessing HPAPI
hazards to containment implementation
along with CDMO dynamics
Workshop Leaders: Janet Gould, Senior Managing
Toxicologist, SafeBridge Consultants USA
Charlyn Reihman, Principal Occupational Health
Consultant, SafeBridge Consultants USA
Overview of the workshop:
Pharmaceutical companies embody application of the
scientific method to identify and deliver new patient
therapies in an environment that increasingly relies on
outsourcing much of the RD and production of HPAPIs.
The same systematic, scientific principles should be used to
develop and deliver research, development and production
facilities that are fit for purpose and protect healthy workers.
This workshop will explore key steps in rolling out an HPAPI
program while partnering with a CDMO, helping to define
and deliver HPAPI projects that are technically sound,
based on justifiable data which can underpin robust and
defensible investment.
Why you should attend?
• Learn key HPAPI project elements
• Understand key drivers from an innovator and
CDMO perspective
• Assess what factors are important and how to build
information designed to underpin HPAPI project
investments
• Providing a pathway to systematic and scientific
project design
Agenda
08.30 Registration and Coffee
08.45 Strategic HPAPI Project Considerations:
Roles of Innovator and CDMO
09.15 Hazard Assessment – It All Starts with the Hazard
09.45 Process is Primary
10.10 Real Risk Assessment – Risk to Product and
Risk to Workers
10.30 Morning Coffee
10.50 Facility Design Features
11.20 Containment for Higher Risk Activities and Control
for Lower Risk Activities
11.40 Verification of Control/Containment Performance
12.00 Occupational Health and Safety Management
Systems
12.30 Workshop Leader’s Closing Remarks
About the workshop leader:
Dr. Janet Gould, PhD, DABT, CIH is a Principal
Toxicologist at SafeBridge Consultants based in
New York, NY. She has over 20 years of experience
in occupational toxicology including 14 years
at Bristol-Myers Squibb, which also included general EHS
support for RD. In addition, she has experience with
chemical industry product safety and regulatory toxicology
support. She has numerous presentations, trainings and
publications including topics of occupational exposure
limits, banding, sensitization, biologics, ADCs, and structure
activity relationship. She is a member of the Workplace
Environmental Exposure Level (WEEL) Committee,
Occupational Toxicology Roundtable, Society of Toxicology,
AIHA and the NIOSH Hazardous Drug Alert Committee.
Charlyn Reihman, MPH, CIH is a Principal
Occupational Health Consultant for SafeBridge
Consultants, Inc. based in Exton, Pennsylvania.
She has over 30 years of safety and health
experience in pharmaceutical/vaccine manufacturing
and research development, including 28 years at Merck.
Her experience includes pharmaceutical industrial hygiene
and exposure control, biosafety, ADC handling and
controls, program development, training, management
system implementation, remediation, and conducting EHS
compliance and pharmaceutical supply chain audits.
She also has experience providing safety and industrial
hygiene support to other industries include the lead industry,
medical device manufacturing, construction, chemical
manufacturing, and academic research and development.
Charlyn has a wealth of experience providing regulatory and
best practice recommendations for improving performance
and minimizing risk.
About the company:
SafeBridge is a unique team of occupational and
environmental toxicologists, industrial hygienists, chemists
and safety and environmental professionals with extensive
experience inside the pharmaceutical industry. SafeBridge
provides professional consulting services and analytical
support to clients across the United States and internationally
including the United Kingdom, Ireland, continental Europe,
and Canada.
HALF-DAY POST-CONFERENCE WORKSHOP
Wednesday 23rd October 2019
08.30 - 12.30
Sheraton Boston Hotel, Boston, USA

5. How to sell your containment project to
management: financial justification for
containment solutions
Workshop Leader:
David Eherts, Vice President, Global EHS, Allergan
Workshop overview
Dr. Eherts will teach you how to convince your management
of the value that your containment project will bring to the
company, their employees and their stakeholders. He will
describe successful techniques including strategic and
tactical approaches to demonstrating value that have served
him well in his 35 year career in safety and toxicology.
Why should you attend:
• Understanding the financial terminology used by CFOs;
how to speak their language
• Use of software tool to calculate Net Present Value,
Return on Investment, Internal Rate of Return,
Discounted Payback Period, Impact on Unit Cost…
• Applying these learnings to decisions around most
cost-effective solutions
• Using all this to get positive decisions of
Containment Proposals
Agenda:
13.30 Registration Coffee
13.50 Opening remarks and Introduction to The Business
Value of Safety
14.00 Qualitative, Strategic and Tactical Benefits of
Containment Explained
15.00 Afternoon Tea
15.30 Introduction to Quantitative Cost-Benefit Analysis
16.00 Multiple Case Studies Presented and Discussed
16.30 Closing Remarks and End of Workshop
About the workshop leader:
Dr. Eherts joined Allergan (then Actavis)
Pharmaceuticals in March of 2014 as Vice President
of Global EHS. Allergan is a global, integrated
specialty pharmaceutical company focused
on developing, manufacturing and distributing generic,
brand and biosimilar products. They market products and
have RD and manufacturing operations in more than 60
countries worldwide. Allergan is a leader in a new segment
called “Growth Pharma” and Forbes has ranked Allergan #1
in its list of the top 17 global large cap ($50+ billion market
capitalization) pharmaceutical companies. Dave holds
Bachelor’s degrees in Chemistry and Biology and a Masters
and PhD in Environmental Toxicology from Drexel University.
He’s served on various boards and committees including
an appointment by the US Secretary of Labor under the
Obama administration to serve on the Federal Whistleblower
Protection Advisory Committee. More conventionally, he’s
served on advisory boards for ORCHSE’s Executive Business
Issues Forum, CAE Flight Training and the Board of Directors
for Occupational Knowledge International (an NGO
dedicated to preventing overexposures to toxic chemicals
in developing countries) and SoundWaters (protecting the
environment of Long Island Sound). In his spare time, he’s
an adjunct professor at New York Medical College and
Tulane University where he teaches courses in Finance, EHS
Management, Environmental Toxicology, Industrial Hygiene
and Occupational Health.
About the organisation
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland,
is a bold, global pharmaceutical leader. Allergan is focused
on developing, manufacturing and commercializing branded
pharmaceutical, device, biologic, surgical and regenerative
medicine products for patients around the world. Allergan
markets a portfolio of leading brands and best-in-class
products primarily focused on four key therapeutic areas
including medical aesthetics, eye care, central nervous
system and gastroenterology. Allergan’s success is powered
by our global colleagues’ commitment to being Bold for Life.
Together, we build bridges, power ideas, act fast and drive
results for our customers and patients around the world by
always doing what is right. With commercial operations in
approximately 100 countries, Allergan is committed to working
with physicians, healthcare providers and patients to deliver
innovative and meaningful treatments that help people
around the world live longer, healthier lives every day.
For more information, visit www.Allergan.com
HALF-DAY POST-CONFERENCE WORKSHOP
Wednesday 23rd October 2019
13.30 - 16.30
Sheraton Boston Hotel, Boston, USA

6. Highly Potent Active Pharmaceutical Ingredients USA 2019
Conference: Monday 21st Tuesday 22nd October 2019, Sheraton Boston Hotel, Boston, USA
Workshops: Wednesday 23rd October 2019, Sheraton Boston Hotel, Boston, USA
4 WAYS TO REGISTER
ONLINE at www.hpapi-usa.com
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