www.highlypotentapi.comRegister 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 2017

COPTHORNE TARA HOTEL, KENSINGTON, LONDON, UK

SMi present its Inaugural Conference on…

Highly Potent Active Pharmaceutical IngredientsFinding 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

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 wantedAndreas Flueckiger, Chief Occupational Health Officer, Roche

16.00 Outsourcing a SME pharma perspective • Vendor Selection• Knowledge Management• Quality Challenges• Project ManagementJames 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 DecommissioningFabio 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 OPPORTUNITIESSMi 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 ConfirmationSPONSORED 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

Highly Potent Active Pharmaceutical Ingredientswww.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 RemarksIldiko 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

HALF DAY POST-CONFERENCE WORKSHOP AWednesday 24th May 2017

Copthorne Tara Hotel, Kensington, London, UK8.30 - 12.30

Preventing Cross Contamination & Employee Exposures in the

context of HPAPIsWorkshop Leader:

Dean Calhoun, President / CEO, Affygility Solutions

Workshop overview:This workshop will cover the legal basis for establishing ADEs/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 & Coffee09.00 Opening remarks and introductions09.10 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 mistakes10.30 Morning Coffee11.00 Session 3 – Basic Elements of a Cross-

contamination Risk AssessmentReviews 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/PDEsDiscusses the ten most common misconceptions regarding OELs/ADEs/PDEs

12.20 Closing Remarks12.30 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.

Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

SUPPORTED BY

HALF DAY POST-CONFERENCE WORKSHOP BWednesday 24th May 2017

Copthorne Tara Hotel, Kensington, London, UK13.30 - 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 Tea16.00 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.

Please complete fully and clearly in capital letters. Please photocopy for additional delegates.

Title: Forename:

Surname:

Job Title:

Department/Division:

Company/Organisation:

Email:

Company VAT Number:

Address:

Town/City:

Post/Zip Code: Country:

Direct Tel: Direct Fax:

Mobile:

Switchboard:

Signature: Date:I agree to be bound by SMi’s Terms and Conditions of Booking.

ACCOUNTS DEPT

Title: Forename:

Surname:

Email:

Address (if different from above):

Town/City:

Post/Zip Code: Country:

Direct Tel: Direct Fax:

HIGHLY POTENT ACTIVE PHARMACEUTICAL INGREDIENTSConference: 22nd - 23rd May 2017, Copthorne Tara Hotel, Kensington, London, UK Workshops: 24th May 2017, London

4 WAYS TO REGISTER

FAX your booking form to +44 (0) 870 9090 712

PHONE on +44 (0) 870 9090 711

ONLINE at www.highlypotentapi.com POST your booking form to: Events Team, SMi Group Ltd, Ground & First Floor,

1 Westminster Bridge Road London, SE1 7XW

If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at events@smi-online.co.uk

Payment: If payment is not made at the time of booking, then an invoice will be issued and must be paid immediately and prior to the start of the event. If payment has not been received then credit card details will be requested and payment taken before entry to the event. Bookings within 7 days of event require payment on booking. Access to the Document Portal will not be given until payment has been received.

Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, another delegate to take your place at any time prior to the start of the event. Two or more delegates may not ‘share’ a place at an event. Please make separate bookings for each delegate.

Cancellation: If you wish to cancel your attendance at an event and you are unable to send a substitute, then we will refund/credit 50% of the due fee less a £50 administration charge, providing that cancellation is made in writing and received at least 28 days prior to the start of the event. Regretfully cancellation after this time cannot be accepted. We will however provide the conferences documentation via the Document Portal to any delegate who has paid but is unable to attend for any reason. Due to the interactive nature of the Briefings we are not normally able to provide documentation in these circumstances. We cannot accept cancellations of orders placed for Documentation or the Document Portal as these are reproduced specifically to order. If we have to cancel the event for any reason, then we will make a full refund immediately, but disclaim any further liability.

Alterations: It may become necessary for us to make alterations to the content, speakers, timing, venue or date of the event compared to the advertised programme.

Data Protection: The SMi Group gathers personal data in accordance with the UK Data Protection Act 1998 and we may use this to contact you by telephone, fax, post or email to tell you about other products and services. Unless you tick here □ we may also share your data with third parties offering complementary products or services. If you have any queries or want to update any of the data that we hold then please contact our Database Manager databasemanager@smi-online.co.uk or visit our website www.smi-online.co.uk/updates quoting the URN as detailed above your address on the attached letter.

Unique Reference Number

Our Reference P-208

Terms and Conditions of Booking

DELEGATE DETAILS

Payment must be made to SMi Group Ltd, and received before the event, by one of the following methods quoting reference P-208 and the delegate’s name. Bookings made within 7 days of the event require payment on booking, methods of payment are below. Please indicate method of payment:□ UK BACS Sort Code 300009, Account 00936418□ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU Swift (BIC): LOYDGB21013, Account 00936418 IBAN GB48 LOYD 3000 0900 9364 18□ Cheque We can only accept Sterling cheques drawn on a UK bank.□ Credit Card □ Visa □ MasterCard □ American Express All credit card payments will be subject to standard credit card charges.

Card No: □□□□ □□□□ □□□□ □□□□Valid From □□/□□ Expiry Date □□/□□CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card Cardholder’s Name:

Signature: Date:

I agree to be bound by SMi’s Terms and Conditions of Booking.

Card Billing Address (If different from above):

DOCUMENTATIONI cannot attend but would like to Purchase access to the following Document Portal/Paper Copy documentation. Price Total□ Access to the conference documentation

on the Document Portal £499.00 + VAT £598.80□ The Conference Presentations – paper copy £499.00 - £499.00

(or only £300 if ordered with the Document Portal)

PAYMENT

VATVAT at 20% is charged on the attendance fees for all delegates. VAT is also charged on Document portal and literature distribution for all UK customers and for those EU Customers not supplying a registration number for their own country here

CONFERENCE PRICES GROUP DISCOUNTS AVAILABLE

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

PROMOTIONAL LITERATURE DISTRIBUTION □ Distribution of your company’s promotional literature to all conference attendees £999.00 + VAT £1198.80

The conference fee includes refreshments, lunch, conference papers, and access to the Document Portal. Presentations that are available for download will be subject to distribution rights by speakers. Please note that some presentations may not be available for download. Access information for the document portal will be sent to 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 hotelAlternatively call us on +44 (0) 870 9090 711, email: events@smi-online.co.uk or fax +44 (0) 870 9090 712

□ Book By 31st January to Save £400 off the conference price□ Book By 28th February to Save £200 off the conference price□ Book By 31st March to Save £100 off the conference price

EARLY BIRD DISCOUNT

Fateja Begum