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SMi present its Inaugural Conference on…
Highly Potent Active Pharmaceutical Ingredients
CONFERENCE: 22 - 23
Finding the balance between safety, quality and cost-effectiveness
2017
and addressing containment and cross-contamination issues
COPTHORNE TARA HOTEL, KENSINGTON, LONDON, UK
WORKSHOP: 24
MAY
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
SPONSORED BY
• Hear about Teva API’s Operational Excellence and Q.C Lab Transformation A T R I N I T Y C O N S U LTA N T S C O M PA N Y
• Discuss strategies for CMO selection and solutions to better communication and transfer
PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS | WEDNESDAY 24TH MAY 2017, COPTHORNE TARA HOTEL, KENSINGTON, LONDON, UK
A: Preventing Cross Contamination & Employee Exposures in the context of HPAPIs
B: Risk assessment in HPAPIs (HAZOP)
08.30 - 12.30
Workshop Leader:
Workshop Leader: Dean Calhoun, President / CEO, Affygility Solutions
13.30 - 17.30 Yaakov Machlav, Process Safety Manager, Teva Pharmaceuticals
www.highlypotentapi.com Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 #SMiHPAPI17
Highly Potent Active Pharmaceutical Ingredients Day One | Monday 22nd May 2017
www.highlypotentapi.com
08.30 Registration & Coffee 09.00
CHALLENGES OF SCALE-UP AND COMPOUND CATEGORISATION
Chair’s Opening Remarks
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
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
TECHNOLOGY TRANSFER AND CROSS CONTAMINATION 11.00
IMPROVING CMO STRATEGIES
Morning Coffee & Networking Break 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
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
Register online at www.highlypotentapi.com SPONSORED BY
FPS Food and Pharma Systems are specialized in fine size reduction equipment and containment systems for many industrial applications. Our micronization technology considers both fluid jet mills and mechanical pin mills to assure the widest fine grinding capabilities. FPS process experts *Subject to Final Confirmation are available to define the more suitable configuration for your fine grinding needs. Containment is a general approach for FPS, allowing us to propose solutions starting from clean rooms up to isolators for sterile or HPAPI manufacturing needs. www.foodpharmasystems.com/en 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 AntibodyDrug-Conjugates our strengths is in payloads. For more details please visit our website www.heraeus-chemicals.com
A T R I N I T Y C O N S U LTA N T S C O M PA N Y
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.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:
[email protected]
Highly Potent Active Pharmaceutical Ingredients www.highlypotentapi.com
08.30
Registration & Coffee
09.00
Chair’s Opening Remarks
Day Two | Tuesday 23rd May 2017
12.20
Networking Lunch ASSESSMENT AND MANUFACTURING METHODS
Ildiko Ziegler, Distinguished Validation Expert, Gedeon Richter 13.30 PREDICTIVE MODELS AND GUIDELINE IMPLEMENTATION
Case Study: Process Equipment integration into HPAPI’s Containment systems – from R&D to Production Scale • Proper Containment strategy selection to meet product and
OPENING ADDRESS: 09.10
process specification
Navigating the EU regulatory landscape with the Small Molecule
• Project Development critical phases
Drug Conjugate (SMDC) Vintafolide
• Fully integrated R&D, Pilot and Production Unit down to
• Novel approach to containment of vintafolide during the drug
nanograms Containment Level
substance isolation process
• Conclusions and new challenges Stefano Butti, Head of Sales Group, F.P.S.
• CMC Regulatory interactions with the European Health Authorities during a centralized Marketing Authorization 14.10
Application review process
Implementation of the ICH M7 Guideline at Roche: Systematic Evaluation of in silico systems and workflow
• Guided tour of the convoluted landscape traveled to reach a positive CHMP opinion
• Short overview of the ICH M7 Guideline in the context of the in
Michael Groaning, Director of Strategic Development, Endocyte
silico assessment • In silico prediction systems
09.50
EMA Guideline on setting health based exposure limits and its
• Comparative prediction models validation
application for highly potent APIs in early development
• Process and Workflow
• EMA Guideline on setting health based exposure limits and it’s
Alessandro Brigo, Toxicology Project Leader, Pharmaceutical Sciences, Roche
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
14.50
Afternoon Tea & Networking Break
effects (e.g. developmental toxicity) Claudia Sehner, Principal Scientist, Nonclinical Drug Safety,
RISK ASSESSMENT AND SAFETY IN CHEMICAL MANUFACTURING
Boehringer Ingelheim 15.20 10.30 Morning Coffee & Networking Break
How to deal with HPAPI’s chemical manufacturing • Risk assessment with our methodology of safety requirement • How to decrease the risk to handle HPAPI
OPERATIONS AND SUPPLY CHAIN PERFORMANCE
• Our choice for containment equipment and technology Aurore Perzyna, Head, Production Plant, Oril Industrie (Servier)
11.00
Performance to Plan in the API industry 16.00
• Operations & Supply Chain as intimate friends
11.40
HPAPI Manufacturing: A Holistic, Practical Approach
• Planning process & S&OP
• Evaluation of the entire process
• Performance to plan
• Internal vs. CMO manufacturing and oversight
• Relevant KPI’s in the operation for business perspective
• Engineering controls and training
Jhon Escobar Alzate, Operations / Supply Chain Manager,
Gregory Sowell, Principal Scientific Manager, Small Molecule
Teva API
Process Chemistry, Genentech
Avibactam; a novel β-lactamase inhibitor extending the utility of
16.40
OPEX Q.C Lab Transformation
β-lactam antibiotics in life threatening infections
• Introduction to OPEX Program
• The urgent need for new antibiotics
• Overview of OPEX Transformation
• The challenges faced with the development and manufacture
• The 6 Steps of a successful OPEX
of new antibiotics
• Overview of Q.C lab transformation
• The discovery and mechanism of action of Avibactam
Shay Carmi, OPEX QC Workstream Leader Teva Tech Site,
• Future directions for the field
Teva TAPI
Gwydion Churchill, Associate Director of Chemistry, Antibiotics Business Unit, AstraZeneca
17.20
Chair’s Closing Remarks and Close of Day*Subject Two to Final Confirmation
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:
[email protected]
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: 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 09.00 09.10
Registration & Coffee Opening remarks and introductions 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 Crosscontamination 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.
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 16.00
Afternoon Tea 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.
HIGHLY POTENT ACTIVE PHARMACEUTICAL INGREDIENTS Conference: 22nd - 23rd May 2017, Copthorne Tara Hotel, Kensington, London, UK
Workshops: 24th May 2017, London
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