Our very successful HPAPI conference returns for its 2nd year this May in London

1. A: Practical Steps for Delivering HPAPI Projects
08.30 - 12.30
Workshop Leader:
Justin Mason-Home, Director, HPAPI Project Services Limited
B: Preventing Cross Contamination & Employee Exposures
in the context of HPAPIs – What you may not know
13.30 - 17.30
Workshop Leader:
Dean Calhoun, President/ CEO, Affygility Solutions LLC
PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS | WEDNESDAY 23RD MAY 2018, HOLIDAY INN KENSINGTON FORUM, LONDON, UK
CHAIR FOR 2018:
• Justin Mason-Home, Director, HPAPI Project
Services Limited
KEY SPEAKERS INCLUDE:
• Ildikó Zeigler, Validation Expert, Gedeon Richter
• Ulrich Ruemenapp, Head of Launch Preparation
and Coordination, Bayer
• Vincenzo De Sio, HPAPI Specialist, Cristália
• Pascal Drago, Principal Technical Manager, Roche
• Henri Motte, Head of Pilot Plant, UCB Pharma
• Jeff Parry, Senior Scientist Manufacturability,
AstraZeneca
• Greg Sowell, Principal Scientific Manager,
Genentech
HIGHLIGHTS IN 2018:
• Discover practical approaches to HPAPI
manufacturing in a controlled and efficient
manner
• Explore different containment methods and
learn about which strategy best suits your needs
• Evaluate the use of containment risk mitigation
tools in early phase development
• Learn how to manage and effectively and safely
dispose of HPAPI, post-production waste
• Discuss the most important regulations
surrounding potent ingredients
CONFERENCE: 21ST-22ND
WORKSHOPS: 23RD
MAY
2018
HOLIDAY INN KENSINGTON FORUM, LONDON, UK
SMi Presents the 2nd Annual Conference on…
Highly Potent Active
Pharmaceutical Ingredients
Finding the balance between safety, quality and cost-effectiveness
by addressing containment and cross-contamination issues
BOOK BY 31ST JANUARY AND SAVE £400
BOOK BY 28TH FEBRUARY AND SAVE £200
BOOK BY 29TH MARCH AND SAVE £100
SPONSORED BY
A TRINITY CONSULTANTS COMPANY
www.highlypotentapi.com
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
SMi Pharma
#SMiPharm

2. Highly Potent Active Pharmaceutical Ingredients
Day One | Monday 21st May 2018 www.highlypotentapi.com
8.30 Registration & Coffee
9.00 Chairman’s Opening Remarks
Justin Mason-Home, Director, HPAPI Project Services Limited
MANAGING HPAPI PROJECTS AND RISK ASSESSMENTS
9.10 Strategic Management of HPAPI projects
• Key stages of an HPAPI project
• Stakeholder Engagement and Learning for HPAPI projects
• Benefits of a Systematic and Scientific Approach
• Pot Pourri; Risk Assessment, QA and H&S conflicts, Pitfalls
and More!
Justin Mason-Home, Director, HPAPI Project Services Limited
9.50 Practical Approach to HPAPI Manufacturing in Early
Development
• Designing, building and working in a multiproduct kilo lab
environment
• Risk analysis of entire synthetic process based on factors
including process safety and industrial hygiene
• Important link between surrogate testing of equipment,
training staff and process specific equipment needs
• Ensuring proper transfer of safety information to CMOs
Gregory Sowell, Principal Scientific Manager, Small Molecule
Process Chemistry, Genentech
10.30 Morning Coffee
11.00 The manufacturing of an oncological product by a CDMO
• The different approaches via which oncological products
can be produced/ manufactured by a CDMO
• Case studies of the different approaches
• A summary, with industry perspective, of the best way
through which the manufacturing of these products should
be approached
Fabio Zenobi, EHS Director, BSP Pharmaceuticals Srl
11.40 Things about OELs and ADEs that your toxicologist never told
you
• Frequently asked questions about OELs and ADEs from
clients and end-users
• Common misconceptions on how these are applied in the
field
• Steps you can take to ensure that these values are properly
applied
Dean Calhoun, President / CEO, Affygility Solutions
12.20 Networking Lunch
CONTAINMENT STRATEGIES
13.30 Use of a containment Risk Mitigation Tool in early phase
development at UCB Pharma
• Risk Mitigation and its necessity within early development
• Leveraging of non-traditional data in order to assess risks/
hazards
• The benefits and disadvantages of using a Risk Mitigation
Tool
• Case study of application for the use of it within UCB
Pharma
Henri Motte, Head of Pilot Plant, Drug Delivery Design &
Development, UCB Pharma
14.10 Pre-reconstruction risk evaluation for an active substance
development pilot plant
• A cross contamination/containment assessment
• EU and ISPE guidelines regarding cross contamination and
containment
• Technical aspects and complexity in risk analysis
• The case study: Comparing more approaches for the
reconstruction
Ildiko Ziegler, Distinguished Validation Expert, Gedeon Richter
Plc.
14.50 Afternoon Tea
15.20 Containment design to enable existing equipment to handle
HPAPIs – a journey
• How to contain complex production equipment – solutions
considered
• Other operator considerations
• How to contain complex production equipment – solutions
trialed
• Challenges, solutions and adaptations
Jeff Parry, Senior Formulation Scientist, AstraZeneca
16.00 Levels of containment depending on equipment &
configurations
• Type of occupational measurements
• Tested configurations & equipment
• Improvement & conclusions
Elise Laperdrix Fanonnel, Manager Environmental,
Oril Industries
16.40 Chairman’s Closing Remarks and Close of Day One
Register online at www.highlypotentapi.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
*Subject to Final Confirmation
SPONSORED BY BSP is focused on the development and manufacturing of anticancer drugs with high potency and cytotoxic
characteristics for the pharmaceutical industry. With its state-of-the-art technology and highly skilled personnel,
BSP sets out to be a valuable point of reference to serve the principal actors of the pharmaceutical field involved
in research on new generation anticancer therapies. BSP has been at the forefront in the fight against cancer
since 2006. Innovation is the hallmark of BSP with investments in new technologies and production methods in a
high containment plant. The BSP industrial building covers an area of 30,000 m2 in a campus of approximately
20 hectares, 60 km to the south of Rome, ranking it in the world today as one of the most important Contract
Development and Manufacturing Organization (CDMOs) for anticancer drugs. www.bsppharmaceuticals.com
SafeBridge Consultants, Inc. is the premier resource for high level safety, health and environmental support to the
pharmaceutical and biotechnology industries. We provide services in occupational and environmental toxicology,
risk assessment, product safety, industrial hygiene and analytical chemistry to clients worldwide from offices in
California, New York and Liverpool, UK. www.safebridge.comA TRINITY CONSULTANTS COMPANY

3. Highly Potent Active Pharmaceutical Ingredients
www.highlypotentapi.com Day Two | Tuesday 22nd May 2018
Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
SUPPORTED BY
Want to know how you can get involved? Interested in promoting your services to this market?
Contact Pav Solanki, SMi Marketing on +44 (0) 20 7827 6048 or
email: psolanki@smi-online.co.uk
8.30 Registration & Coffee
9.00 Chairman’s Opening Remarks
Justin Mason-Home, Director, HPAPI Project Services Limited
WASTE MANAGEMENT AND CONTAINMENT CONSIDERATIONS
9.10 Waste management for Highly Potent APIs
• Risks after manufacturing processes: Liquid and solid
residues of HPAPIs and related risk of contamination
• Waste disposal and waste treatment: How to handle
a hazardous residue and how to avoid environmental
contaminations
• Deactivation systems and procedures: Why and how to
transform a hazardous compound in less toxic substances
Vincenzo de Sio, Especialista, Cristalia Produtos Quimicos
Farmaceuticos
9.50 Conceptual Design of new HPAPI facilities: From lab to
production scale
• How to define our target
• Which strategy of containment
• Next steps before building these new facilities
Aurore Perzyna, Head, Production Plant, Oril Industries
10.30 Morning Coffee
11.00 Demonstrating that exposure controls are effective
• Analytical and assessment procedures
• Recognising and analysing data variables
• Revision to EN689 - guidance on data interpretation
Martin Axon, Principal Occupational Hygienist, SafeBridge
Europe Ltd
11.40 High Containment Compounds and Occupational Hygiene
Long Range Targets in AbbVie
• Potent (high containment) compounds in AbbVie
• Containment targets and long-range plan
• Risk assessment and improvements projects
• New product introduction and tech transfer
• OH exposure assessment metrics
Olindo Lazarro, Director Global EHS Technical Operations,
AbbVie
12.20 Networking Lunch
REGULATION AND HPAPI APPLICATIONS
13.30 Regulatory aspects of high potency APIs
• Regulations of high potency drugs
• High potency drugs as an investigational medicinal
products and its challenges
• Guidelines for selection criteria of HPAPI manufacturing
facility
Anna Song, Director and Regulatory Manager
Pharmaceuticals, Cortex Consultancy
14.10 Verifying containment performance in pharmaceutical multi
product facilities: Providing evidence of absence of cross
contamination
• Containment concept
• Dealing with airborne particles
• Dealing with mechanical transfer
Pascal Drago, Principal Technical Manager, Roche Pharma
Research & Early Development
14.50 Afternoon Tea
15.20 The balance between regulatory quality guidelines and EHS
considerations
• The comparison between regulatory guidelines and EHS
considerations; the similarities and differences
• How to effectively balance and consider integral aspects of
both regulation and EHS considerations
• The common pitfalls and setbacks which are encountered
during attempted implementation of both
• The discrepancies which could arise as a consequence of
improper implementation of both aspects
Speaker To Be Confirmed
16.00 Antibody Drug Conjugates (ADCs) – antibodies meeting
HPAPIs for specific and efficient bio-pharmaceutical drugs
• Conjugation of small molecule toxins with antibodies
• The overlap between ADCs and HPAPIs
• In-house strategies for handling potent ingredients
• Manufacturing of ADCs using HPAPIs - challenges and
solutions
Ulrich Ruemenapp, Head of Launch Preparation and
Coordination, Bayer Pharma
16.40 Chairman’s Closing Remarks and Close of Day Two
*Subject to Final Confirmation

4. HALF DAY POST-CONFERENCE WORKSHOP A
Wednesday 23rd May 2018
Holiday Inn Kensington Forum, London, UK
8.30 - 12.30
Practical Steps for Delivering
HPAPI Projects
Workshop Leader:
Justin Mason-Home, Director, HPAPI Project Services Limited
Workshop overview:
Biopharmaceutical companies embody application of
the scientific method to identify and deliver new patient
therapies. The same systematic, scientific principles should
be used to develop and deliver research, development
and production facilities that are fit for purpose and which
protect healthy workers. This workshop will explore key
HPAPI project elements in a stepwise manner, helping
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, what factors are
important and how to build information designed
to underpin HPAPI project investments. All too often
companies and their advisors, design and deliver HPAPI
facilities based on “emotion” and guesswork. This
workshop will try to ditch the emotion and provide a
pathway to systematic and scientific project design.
The objective will be the delivery of efficient facilities
with process matters at the centre and suitable and
defensible worker protection measures integrated into
and set around the process.
Agenda
8.30 Registration and Coffee
9:00 Opening Remarks and Introductions
9.10 Strategic HPAPI Project Considerations
• Legal matters and liability
• Hazard assessment – it all starts with the
hazard
• Process is primary
9.50 Real Risk Assessment
• Risk to product
• Risk to workers
• Exposure potential and mass transport more
generally
10.30 Morning Coffee
11.00 Facility Design and Containment
• Features of facility design
• Containment for higher risk activities
• Control for lower risk activities
• Procuring control and containment solutions
• Verification of control and containment
performance
11.40 Importance of SOPs and Worker Practices
• HPAPI awareness training
• Medical surveillance
12.20 End of Workshop
About the Workshop Leader:
Justin Mason-Home is an organic chemist with extensive
health, safety, environmental and chemical engineering
experience in senior technical, legal and commercial
aspects of the pharmaceutical, biochemical, chemical
andotherindustries. Hehasheldseniorpositionsandworked
globally in potent biopharmaceutical occupational
health and safety global environmental consulting,
board level positions in a biotechnology company and
corporate environmental management. Mr Mason-Home
has worked on many HPAPI projects, contributing potent
compound project support advice for many years. He
specialises in technically complex and strategic projects,
including unique experience in managing sensitive highly
potent and toxic biopharmaceutical compound matters.
About Affygility Solutions:
HPAPI Project Services Limited is a new company formed
by Justin Mason-Home, following over 11 years heading
up the European operations of a well-known potent
compound safety consulting firm. Core objectives of the
company are to support companies design, invest and
deliver better.

5. HALF DAY POST-CONFERENCE WORKSHOP B
Wednesday 23rd May 2018
Holiday Inn Kensington Forum, London, UK
13.30 - 17.30
Preventing Cross Contamination & Employee
Exposures in the context of HPAPIs
– What you may not know
Workshop Leader:
Dean Calhoun, President/ CEO, Affygility Solutions LLC
Workshop overview:
This workshop will provide an overview of the regulatory
basis for ADEs and PDEs, will discuss how they are
determined and present the basics of preventing cross-
contamination.
Why you should attend:
Since June of 2015, the EMA’s requirements for developing
and implementing health-based exposure limits in multi-
product pharmaceutical manufacturing facilities has
been in effect. Unfortunately, there is still much confusion
and misunderstandings on how these health-based limits
are to be implemented. If your company handles multiple
products in the same facility, this workshop is for you.
Agenda
13.30 Registration & Coffee
14.00 Opening remarks and introductions
14.10 Session 1 – Regulatory factors to consider
• Basis for ADEs/PDEs
• Preventing Cross-Contamination
• Discusses the regulatory requirements in
both the U.S. and E.U.
14.50 Session 2 – Determination of ADEs and PDEs
• How ADEs and PDEs are determined
• Common mistakes
• Updates to the basic equation
15.30 Afternoon Tea
16.10 Session 3 – Basic Elements of a Cross-
contamination Risk Assessment
• Review of the elements of a risk assessment
• Risk identification and risk analysis
• Risk evaluation and risk reduction
16:50 Session 4 – Frequently asked questions
• OELs, ADEs/PDEs
• Things you may not know
16:50 Closing Remarks
17:30 Close of Workshop
About the Workshop Leader:
Dean Calhoun is an American Board of Industrial
Hygiene Certified Industrial Hygienist (CIH). He has
been an environmental health and safety professional
for over 32 years. Prior to starting Affygility Solutions,
Dean was the Associate Director of Environmental
Health and Safety for Gilead Sciences, Inc., a
biopharmaceutical company focused on developing
pharmaceuticals for infectious, viral, and oncology
applications. His experiences including development
and implementation of global EHS guidelines,
implementation and coordination of an executive
management EHS Steering Committee, establishment
of occupational exposure limits for pharmaceutical
active ingredients, industrial hygiene program
management and EH&S auditing of research,
manufacturing and contract manufacturing facilities.
Dean graduated with a B.Sc. degree in Engineering
from the University of Wyoming and has dual master
degrees in Environmental Policy and Management,
and Technology Management from the University of
Denver.
About the organisation:
Since 2002, Affygility Solutions has provided
environmental, health and safety services to the
biotechnology, pharmaceutical and medical
device industry. Our services include the Affytrac EHS
management tool, online training seminars, potent
compound safety and categorization, occupational
exposure limits, toxicology services and more. We’ve
provided these services to small, midsize and large
companies throughout the United States, Canada and
Europe. All of the environmental, health and safety
professionals at Affygility Solutions have many years
of professional and hands-on life science industry
experience. Affygility Solutions has offices in Broomfield,
Colorado, and in Dubai, United Arab Emirates.

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HIGHLY POTENT ACTIVE PHARMACEUTICAL INGREDIENTS
Conference: 21st -22nd May 2018, Holiday Inn Kensington Forum, London, UK Workshops: 23rd May 2018, London
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