This document advertises a conference on Highly Potent Active Pharmaceutical Ingredients to be held May 22-24, 2017 in London. The conference will address containment strategies, cross contamination risks, challenges in scaling up potent compounds, improving CMO strategies, and risk assessment. Two half-day workshops will also be held on preventing cross contamination and employee exposures, and on conducting risk assessments for HPAPIs using a HAZOP methodology. The conference aims to help participants balance safety, quality and cost-effectiveness when working with highly potent compounds.

1. www.highlypotentapi.com
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
A: Preventing Cross Contamination & Employee Exposures
in the context of HPAPIs
08.30 - 12.30
Workshop Leader:
Dean Calhoun, President / CEO, Affygility Solutions
B: Risk assessment in HPAPIs (HAZOP)
13.30 - 17.30
Workshop Leader:
Yaakov Machlav, Process Safety Manager, Teva Pharmaceuticals
PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS | WEDNESDAY 24TH MAY 2017, COPTHORNE TARA HOTEL, KENSINGTON, LONDON, UK
#SMiHPAPI17
CHAIR FOR 2017:
• Ildiko Ziegler, Distinguished Validation Expert, Gedeon
Richter Hungary
FEATURED SPEAKERS:
• Andreas Flueckiger, Chief Occupational Health Officer,
Roche
• Richard Denk, Head Sales Containment, SKAN AG
• Shay Carmi, OPEX QC Workstream Leader Teva Tech Site,
Teva TAPI
• Jason Hamm, Director of Chemical Development
Operations, Bristol-Myers Squibb
• Gwydion Churchill, Associate Director of Chemistry,
Antibiotics Business Unit, AstraZeneca
• Jack Brown, Senior Principal Scientist, Boehringer
Ingelheim
• Alessandro Brigo, Toxicology Project Leader,
Pharmaceutical Sciences, Roche
HIGHLIGHTS IN 2017:
• Listen to Case Studies on steroid hormones and
cytotoxic products, as well as cross contamination
guidelines
• Introduction of the ISPE Containment Manual covering
containment issues from the PDE/OEL to Life Cycle
• Learn about Health Hazard Assessment Classifications
and the toxicological criteria of Potent Compounds
• Addressing the challenges of working with HPAPIs and
approaches to scale-up
• Hear about Teva API’s Operational Excellence and
Q.C Lab Transformation
• Discuss strategies for CMO selection and solutions to
better communication and transfer
CONFERENCE: 22 - 23
WORKSHOP: 24
MAY
2017COPTHORNE TARA HOTEL, KENSINGTON, LONDON, UK
SMi present its Inaugural Conference on…
Highly Potent Active
Pharmaceutical Ingredients
Finding the balance between safety, quality and cost-effectiveness
and addressing containment and cross-contamination issues
BOOK BY 31ST JANUARY TO SAVE £400
BOOK BY 28TH FEBRUARY TO SAVE £200
BOOK BY 31ST MARCH TO SAVE £100
SPONSORED BY

2. Highly Potent Active Pharmaceutical Ingredients
Day One | Monday 22nd May 2017 www.highlypotentapi.com
08.30 Registration & Coffee
09.00 Chair’s Opening Remarks
Ildiko Ziegler, Distinguished Validation Expert, Gedeon Richter
CONTAINMENT STRATEGIES AND FACILITY DESIGN
OPENING ADDRESS:
09.10 Containment strategies for high potency APIs
• Engineering controls utilised in API plants for HPAPI’s
• Effectively scaling up potent APIs from clinical to manufacturing
scale
• Criteria for selecting an external vendor for the manufacture of
HPAPI’s
• Development of robust process utilizing plant data systems
Jason Hamm, Director of Chemical Development Operations,
Bristol-Myers Squibb
09.50 ISPE Containment Manual
• Containment from the PDE/OEL to Life Cycle
• Full overview on Containment
• Important to consider to design a Containment Facility
Richard Denk, Head Sales Containment, SKAN AG
10.30 Morning Coffee & Networking Break
TECHNOLOGY TRANSFER AND CROSS CONTAMINATION
11.00 CMC Development Projects – Starting It Right Process Feasibility or
Process Technology Transfer
• Outsourcing of novel complex cytotoxic components is
challenging
• Misunderstandings and high risk approaches can lead to delays
and substantial cost increase
• Smart Case studies to avoid obstacles and early pitfalls
Eberhard Raemisch, Global Head Projectmanagement
Pharmaceutical Ingredients, Heraeus
11.40 Cross contamination risk assessment in multi-product facilities:
case studies on steroid hormones and cytotoxic products
• Toxicological concerns in “cross contamination” guidelines
• Complexity of cross contamination risk and technical measures
at production areas
• Case study 1: steroid hormonal API production
• Case study 2: manufacturing parenteral cytotoxic products
Ildiko Ziegler, Distinguished Validation Expert, Gedeon Richter
12.20 Networking Lunch
CHALLENGES OF SCALE-UP AND COMPOUND CATEGORISATION
13.30 Assessing Highly Hazardous Drugs within Quality Risk Management
Programs
• “Categories of concern” (cytotoxics, hormones, steroids)
are often referred to, but rarely defined for APIs requiring
segregation or dedication in manufacturing
• Characteristics of these categories are discussed to identify and
prioritize compounds requiring special attention
• Controlling airborne concentrations and the contamination of
product contact surfaces to values derived from quantitative
risk assessments is more appropriate, regardless of specific
categorical designations
• Industry movement is toward establishing compound-specific
health-based limits and performing risk assessments to determine
whether segregation and/or dedication may be required
Bob Sussman, Managing Principal – Eastern Operations,
SafeBridge Consultants
14.10 Scale-up of HPAPIs and their Unique Challenges
• Challenges with HPAPIs are very unique, in that there is typically
limited data on.
• This would include process safety data (calorimetry,
toxicological data for intermediates)
• Will discuss approaches to both and upside and down sides for each)
• There is typically limited process data as well. How do you
understand the processes and their characteristics?
Jack Brown, Senior Principal Scientist, Boehringer Ingelheim
14.50 Afternoon Tea & Networking Break
IMPROVING CMO STRATEGIES
15.20 SHE criteria for the selection of potent compound contract
manufacturers
• General SHE aspects: no undue risk for the project
• Compliance with worker health regulations in an environment
where no-one complies
• Basic understanding of occupational health risk assessments:
hazard and exposure
• Documented containment capabilities: having the data and
being able to explain them
• Project-specific tech transfer: competent and responsive
partners wanted
Andreas Flueckiger, Chief Occupational Health Officer, Roche
16.00 Outsourcing a SME pharma perspective
• Vendor Selection
• Knowledge Management
• Quality Challenges
• Project Management
James Evans, Vice President CMC, NuCana BioMed
16.40 Containment Risk Assessment of HP Drug Substance through
FMECA
• Introduction of a Drug Product
• Impact evaluation
• Operating Control
• Product Decommissioning
Fabio Zenobi, EHS Director, BSP Pharmaceuticals
17.20 Chair’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
Heraeus’ Business line Pharmaceuticals is the specialist in cytotoxic agents for nearly 30 years. We hold
globally a leading position in supply of precious metals based API as well as generic cytotoxic agents
Heraeus comprehensive custom services is focused on the synthesis of highly potent compounds (precious
metal compounds and small molecules) under high containment conditions and full GMP. In the field of
Antibody-Drug-Conjugates our strengths is in payloads. For more details please visit our website
www.heraeus-chemicals.com

3. Highly Potent Active Pharmaceutical Ingredients
www.highlypotentapi.com Day Two | Tuesday 23rd May 2017
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 Kyra Williams, SMi Marketing on
+44 (0)20 7827 6012 or email: kwilliams@smi-online.co.uk
08.30 Registration & Coffee
09.00 Chair’s Opening Remarks
Ildiko Ziegler, Distinguished Validation Expert, Gedeon Richter
PREDICTIVE MODELS AND GUIDELINE IMPLEMENTATION
OPENING ADDRESS:
09.10 Navigating the EU regulatory landscape with the Small Molecule
Drug Conjugate (SMDC) Vintafolide
• Novel approach to containment of vintafolide during the drug
substance isolation process
• CMC Regulatory interactions with the European Health
Authorities during a centralized Marketing Authorization
Application review process
• Guided tour of the convoluted landscape traveled to reach a
positive CHMP opinion
Michael Groaning, Director of Strategic Development, Endocyte
09.50 EMA Guideline on setting health based exposure limits and its
application for highly potent APIs in early development
• EMA Guideline on setting health based exposure limits and it’s
draft Q&A on implementation
• Approaches for setting PDEs/TTCs for APIs in early development
• Consideration on mode of action and it’s potential for adverse
effects (e.g. developmental toxicity)
Claudia Sehner, Principal Scientist, Nonclinical Drug Safety,
Boehringer Ingelheim
10.30 Morning Coffee & Networking Break
OPERATIONS AND SUPPLY CHAIN PERFORMANCE
11.00 Performance to Plan in the API industry
• Operations & Supply Chain as intimate friends
• Planning process & S&OP
• Performance to plan
• Relevant KPI’s in the operation for business perspective
Jhon Escobar Alzate, Operations / Supply Chain Manager,
Teva API
11.40 Avibactam; a novel β-lactamase inhibitor extending the utility of
β-lactam antibiotics in life threatening infections
• The urgent need for new antibiotics
• The challenges faced with the development and manufacture
of new antibiotics
• The discovery and mechanism of action of Avibactam
• Future directions for the field
Gwydion Churchill, Associate Director of Chemistry, Antibiotics
Business Unit, AstraZeneca
12.20 Networking Lunch
ASSESSMENT AND MANUFACTURING METHODS
13.30 Implementation of the ICH M7 Guideline at Roche: Systematic
Evaluation of in silico systems and workflow
• Short overview of the ICH M7 Guideline in the context of the in
silico assessment
• In silico prediction systems
• Comparative prediction models validation
• Process and Workflow
Alessandro Brigo, Toxicology Project Leader, Pharmaceutical
Sciences, Roche
14.10 How to deal with HPAPI’s chemical manufacturing
• Risk assessment with our methodology of safety requirement
• How to decrease the risk to handle HPAPI
• Our choice for containment equipment and technology
Aurore Perzyna, Head, Production Plant, Oril Industrie (Servier)
14.50 Afternoon Tea & Networking Break
RISK ASSESSMENT AND SAFETY IN CHEMICAL MANUFACTURING
15.20 HPAPI Manufacturing: A Holistic, Practical Approach
• Evaluation of the entire process
• Internal vs. CMO manufacturing and oversight
• Engineering controls and training
Gregory Sowell, Principal Scientific Manager, Small Molecule
Process Chemistry, Genentech
16.00 OPEX Q.C Lab Transformation
• Introduction to OPEX Program
• Overview of OPEX Transformation
• The 6 Steps of a successful OPEX
• Overview of Q.C lab transformation
Shay Carmi, OPEX QC Workstream Leader Teva Tech Site,
Teva TAPI
16.40 Chair’s Closing Remarks and Close of Day Two*Subject to Final Confirmation

4. HALF DAY POST-CONFERENCE WORKSHOP A
Wednesday 24th May 2017
Copthorne Tara Hotel, Kensington, London, UK
8.30 - 12.30
Preventing Cross Contamination
& Employee Exposures in the
context of HPAPIs
Workshop Leader:
Dean Calhoun, President / CEO, Affygility Solutions
Workshop overview:
ThisworkshopwillcoverthelegalbasisforestablishingADEs/
PDEs and for conducting risk assessment for preventing
cross-contamination in multi-product pharmaceutical
manufacturing facilities. In addition, the instructor will
cover 10 misconceptions regarding OELs/ADEs/PDEs.
Why you should attend:
If your facility handles multiple products, understanding
these requirements and how they are implemented
is a must. Facilities that have not complied with these
requirements have experienced enforcement action and
market suspensions.
Agenda
08.30 Registration & Coffee
09.00 Opening remarks and introductions
09.10 Session 1 - Regulatory Basis for ADEs/PDEs and
Preventing Cross-Contamination
Discusses the regulatory requirements in both the
U.S. and E.U.
09.50 Session 2 – Determination of ADEs and PDEs
Discusses how ADEs and PDEs are determined,
and common mistakes
10.30 Morning Coffee
11.00 Session 3 – Basic Elements of a Cross-
contamination Risk Assessment
Reviews the elements of a risk assessment
including risk identification, risk analysis, risk
evaluation, and risk reduction.
11.40 Session 4 – Ten misconceptions regarding OELs/
ADEs/PDEs
Discusses the ten most common misconceptions
regarding OELs/ADEs/PDEs
12.20 Closing Remarks
12.30 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 30
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 has spoken for a number of professional
organizations including the U.S. Environment Protection
Agency, the Colorado Safety Association, the Bay Area
Environmental Safety Group, the National Association for
Environmental Management, the National Safety Council,
the Occupational Safety and Health Administration, and
the American Industrial Hygiene Association.
About Affygility Solutions:
Since 2002, Affygility Solutions has provided environmental,
health and safety services to the biotechnology,
pharmaceutical, and medical device industry. Services
include the Affytrac EHS management tool, online training
seminars, potent compound safety and categorization,
occupational exposure limits, toxicology services and
more. Affygility Solutions has provided these services to
small, mid-size 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.

5. HALF DAY POST-CONFERENCE WORKSHOP B
Wednesday 24th May 2017
Copthorne Tara Hotel, Kensington, London, UK
13.30 - 17.30
Risk assessment in HPAPIs (HAZOP)
Workshop Leader:
Yaakov Machlav, Process Safety Manager,
Teva Pharmaceuticals
Workshop overview:
Safety workshop in Highly Potent Active Pharmaceutical
Ingredients (HPAPIs). The workshop examines production
facilities supporting infrastructure and engineering
resources for treatment and containment of HPAPIs.
Demo will be done through a typical facility wet
production of medicines containing: raw material
loading, material processing, filtering, handling, drying
and milling the final packaging. Testing will route traffic by
the materials and test each station and unit equipment
necessary protective measures. Contact person referred
to reference all work together.
Why you should attend:
• The purpose of the workshop to Understanding risk
survey process conducted by an expert
• In The workshop we will learn how to begin
implementing a risk survey of materials Highly Potent
Active Pharmaceutical Ingredients (HPAPIs)
• In the workshop we will learn how to decompose a
complex unit to basic units
• In The workshop we will learn to analyze and execute
risk survey on basic units
• In The workshop we will learn to deal with the
problems of exposure to HPAPIs
• After the workshop, each participant will be able to
understand the process of risk survey performed by an
expert
Agenda
13.30 Registration & Coffee
14.00 Opening remarks and introductions
14.10 Session 1 - Accessories
Production facilities supporting infrastructure
14.50 Session 2 – Loading
Raw material loading, material processing,
filtering
15.30 Afternoon Tea
16.00 Session 3 – Unloading Filtering, drying
16.40 Session 4 – Finishing Dry treatment
17.20 Closing Remarks
17.30 Close of workshop
About the Workshop Leader:
Yaakov Machlav - Professional Specialization
• Expert in carrying out a risk assessment survey and
answering scenarios
• Leader Risk Survey discussions in HAZOP method
expert
• Specialist in work and protection against Highly Potent
Active Pharmaceutical Ingredients (HPAPIs)
• Fire prevention expert
• Specialist in defining area classification of fire risk
• Expert in carrying out investigations and to learn
lessons
• Expert in operation of evaporation ponds
• Expert in barges operation
About Teva Pharmaceuticals:
Teva is committed to increasing access to high-quality
healthcare for people across the globe, at every stage of
life. We do this by developing, producing and marketing
affordable generic drugs as well as innovative and
specialty pharmaceuticals and active pharmaceutical
ingredients.
The company’s line of generic and specialty treatments
is backed by our impressive global development and
manufacturing capabilities, ensuring the highest quality
and accessibility to medicines while reducing costs.
Teva’s participation in a wide range of therapeutic areas
and dosage forms is empowered by a unique integration
of innovative specialty and generic research.

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HIGHLY POTENT ACTIVE PHARMACEUTICAL INGREDIENTS
Conference: 22nd - 23rd May 2017, Copthorne Tara Hotel, Kensington, London, UK Workshops: 24th May 2017, London
4 WAYS TO REGISTER
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I would like to attend: (Please tick as appropriate) Fee TOTAL
□ Conference & 2 Workshops £2697.00 + VAT £3236.40
□ Conference & 1 Workshop □ A □ B £2098.00 + VAT £2517.60
□ Conference only £1499.00 + VAT £1798.80
□ 2 Workshops only £1198.00 + VAT £1437.60
□ 1 Workshop only □ A □ B £599.00 + VAT £718.80
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the e-mail address provided during registration. Details are sent within 24 hours post
conference.
VENUE Copthorne Tara Hotel, Scarsdale Place, Kensington, London, UK
□ Please contact me to book my hotel
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□ Book By 31st January to Save £400 off the conference price
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