3rd Annual MarketsandMarkets High Potent Medicines Conference

28 - 29 May 2019 | Novotel Milano Linate Aeroporto Hotel, Milan, Italy
CONFERENCE SPEAKERS
Advisors
Ester Lovsin Barle
Ester Lovsin Barle
Head, Product Stewardship and Health,
Takeda, Switzerland


Ester Lovsin Barle, DVM, MSc, PhD, MScTox is the Head of Product Stewardship and Health at Takeda, reporting to the Corporate head of Environmental Health and Safety, Deborah Donovan. She is in Zurich, Switzerland. Her responsibilities include Safety Data Sheet process, maintaining article and material regulatory complaince and scientific development and cross-organizational implementation of health based exposure limits (HBEL) in support of research and manufacturing in Takeda globally, as well as global implementation of occupational hygiene. Previously she has held corporate positions at Lonza and Novartis. She received her PhD in veterinary sciences from University of Ljubljana, Slovenia and a second masters degree in toxicology and risk assessment from Medical University in Vienna.


Richard Denk
Richard Denk
Head Containment,
SKAN AG, Switzerland


Richard Denk is working at the company SKAN AG, headquartered in Allschwil in the position Head Containment. Mr. Denk founded 10 years ago the expert Containment group of the ISPE D / A / CH. The Containment Group published the ISPE Containment Manual Mr. Denk was responsible for in September 2015. He is Member of the ISPE SIG Biotech Group in Europe and Steering Committee Member of the ISPE SPP CoP. Mr. Denk is co Autor of the ISPE OSD Baseline Guide Volume 2 and Volume 3. Mr. Denk has spent nearly 20 years with the subject production of highly active / highly hazardous substances and has developed the containment pyramid.


Speakers
Dean Calhoun
Dean Calhoun
President, CEO,
Affygility Soultions, USA


Dean Calhoun is an American Board of Industrial Hygiene Certified Industrial Hygienist (CIH). He has been an environmental health and safety professional for over 33 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 EH&S guidelines, implementation and coordination of an executive management EH&S Steering Committee, establishment of occupational exposure limits for pharmaceutical active ingredients, industrial hygiene program management, and EHS auditing of research, manufacturing and contract manufacturing facilities.

Dean has performed high potency API safety audits at facilities throughout the world, including the United Kingdom, China, Saudi Arabia, and the United States.

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. He is a member of AIHA, ISPE, BOHS, and NAEM.


Kenneth Farrugia
Kenneth Farrugia
Quality Assurance Manager ,
Natrix Sciences, Malta


Kenneth Farrugia is a Subject Matter Expert in Cleaning Validation and the Prevention of Cross-Contamination. Working with big names within the Generics Pharmaceutical sector such as Teva, Allergan, Actavis and Watson Pharmaceuticals, Kenneth has gained invaluable experience in this field. He is currently working for Natrix Sciences®, an emerging company with great potential based in Malta. In the past five years Kenneth was the leading brain behind the harmonization and implementation of the cleaning validation lifecycle approach within the global structure of the companies. Having a drive for continuous improvement, he was the founder and chairman of the Community of Practice for the Prevention of Cross-Contamination within Teva Pharmaceuticals. Incorporating the best quality assurance principles possible within a cost effective, efficient and sustainable system is always the main goal behind each project. On a more personal level, Kenneth is the President of the Shotokan Karate-DO Association in Malta and a committed Karate practitioner for the past twenty years. Preserving very strong family values, Kenneth is also a very dedicated family person and a proud father of one. Well… life becomes boring without adding that spice here and there!


Jennifer O'Leary
Jennifer O'Leary
EHS Director ,
SK biotek Ireland


Jennifer graduated University College Dublin with a BSc in Chemistry and the University of Sheffield with a Masters in Chemical Engineering. Jennifer has worked with the team at Swords Campus for over 27 years. She is responsible for the Environment, Health and Safety of the Site.


Matthias Angelmaier
Matthias Angelmaier
Product Manager Isolator Technology,
Bosch


Matthias Angelmaier has a bachelor’s degree in industrial and mechanical engineering as
well as a master’s degree in business development. He joined Robert Bosch GmbH in 2009.
During his first 3 years, he was a project manager for handling complex customer projects.
Since 2012, he is the globally responsible product manager for barrier systems and isolator
technology. His expertise includes process engineering, sterilization, bio-decontamination,
aseptic and high-potent Isolator applications, glove testing systems as well as topics related
to advanced aseptic processing.


Sean Codling
Sean Codling
Managing Director ,
CTS Europe


Sean Codling is the Managing Director and Owner of CTS Europe Ltd. CTS was formed in 2010 by Sean to focus on building containment solutions for Pharmaceutical laboratories. Sean studied as a Mechanical Engineer and has over the past 20 years has been involved in the design and Fabrication of Enclosure systems in the Pharmaceutical industry. Sean has some good knowledge on how laboratory equipment works and how the users need to use them, this knowledge is used to find the best overall solution to meet laboratory scale containment needs.


Fabio Zenobi
Fabio Zenobi
EHS Director, QP ,
BSP Pharma


Fabio is responsible of Environment, Health and Safety at BSP Pharmaceuticals S.p.A., Latina Italy, a Contract Development and Manufacturing Organization focused on anticancer product, small molecules and ADC compounds. He is a Pharmaceutical Chemist and has over 20 years of experience in pharmaceutical industries as Serono, Bristol-Myers Squibb and Intervet, in Manufacturing, Quality Assurance, Technical Operations and EHS.


Nicola Giubellina
Nicola Giubellina
Head, CRAMS Sales ,
Dishman Europe Ltd.


Nicola holds an MBA degree in International Management and a PhD in chemical synthesis.

He has over 15 years of industry experience as a sales director and in project management for CMO and Pharma companies, with a short tenure as a research associate at University of Ghent (Belgium).

Nicola currently leads the sales activities of Customer Research and Manufacturing Services (CRAMS) for Dishman Carbogen Amcis, a leading provider of custom manufacturing solutions for pharmaceutical companies. Over the past three years, he has implemented successful strategies that have driven business growth in Europe and the United States, with the acquisition of new customers and the growth of existing accounts.


Andrea Messori
Andrea Messori
Lead Process Engineer-Project & Engineering Manager,
Process Service


Andrea Messori is leading process engineering design activities for Pharmaceutical and Fine Chemicals in Process Service – Italian Engineering Company. He has more than 20 years of expertise in APIs production facilities design starting from feasibility and conceptual design, basic design development and complete detailed engineering project management. He joined Process Service in 1997 and in those years, he increased his knowledge developing many projects for Pharma (APIs production facilities, HPAPIs, Fermentation and DSP Biotechnologies, utility systems) and Fine Chemicals. In the last 8 years he has managed HPAPIs projects for more than six different main Pharma Companies in Italy and abroad dealing with High Potent APIs up to few tens of nanograms CPT with investments ranging from few millions to many tens of millions, achieving a significant expertise in High Potent APIs facility design and containment strategies. Andrea Messori graduated in Chemical Engineering in 1995 at Politecnico di Milano.


Pascal Michoux
Pascal Michoux
Vice President, TAPI and BIO Global EHS,
TEVA (TAPI and BIO division)


Pascal Michoux is Vice President Global EHS TAPI & Biologics, reporting to the Senior Vice President Head of Technical Support group for TGO (Teva Global Operations), and to the CEO and President of TAPI & Biologics Operations. Over than 32 years of experience in the Pharma Industry including API Manufacturing, Quality, Engineering and Biology. Establish EHS priorities and pilot EHS programs with more than 20 facilities (China, Croatia, Czech rep., Israel, India, Italy, Germany, Hungary, Lithuania, Mexico, USA). Lead the implementation and installation of TEVA EHS management system to achieve corporate EHS excellence goals and Target ZERO Objectives.


David O’Connell
David O’Connell
Director, Scientific Affairs,
PCI Services, UK


David O’Connell is the Director of Scientific Affairs at PCI Pharma Services, an integrated full-service provider expertly delivering a seamless transition from development to commercialization. After graduating from Glasgow Caledonian University with a Bachelor of Science degree in applied bioscience David spent seven years as a Supervisory Scientist working for Aptuit in Edinburgh before moving to Penn Pharma as Head of Formulation Development in 2009. Here he played a vital part in the design of the potent Contained Manufacturing Facility (CMF), which won the ISPE Facility of the Year award for Facility Integration (2014). In 2013 David took on the role of Director, Pharmaceutical Development at the PCI site in Tredegar and in 2017 became PCIs Director of Scientific Affairs.


Shailendra Singh (Shelly)
Shailendra Singh (Shelly)
Board Member,
MarketsandMarkets


Shailendra Singh (Shelly) is a member of MarketsandMarket's board. He focuses on global sales and client services functions, as well as commercial optimization at MarketsandMarkets. He has years of expe¬rience in global delivery and outsourcing sector in the IT/ Consulting/Analytics/Big Data sectors. Prior to MnM, he was leading the global sales, client services and commercial ef¬fectiveness functions for Mu Sigma, a unicorn company and a leading global provider of Decision Sciences and Big Data analytics solutions.


Rudolf Bechter
Rudolf Bechter
Managing Director ,
Bechter Consulting GmbH, Switzerland


Dr. Rudolf Bechter has 35 years of experience and intimate knowledge in the management of the drug discovery, development and manufacturing processes. He retired 2014 as Head Occupational Health from Novartis Global HSE & BCM. As a EUROTOX registered toxicologist, his expertise in his position included Occupational Toxicology, Hazard and Risk Assessments and Auditing in Novartis internal as well as 3rd party development and manufacturing.  He also provided his expertise in acquisitions/divestments, new constructions as well as decommissioning/demolitions of plants with special emphasis on highly active/highly toxic substances. He recently founded his own company and is currently consulting as occupational toxicologist and HSE specialist.


Andrew Walsh
Andrew Walsh
President ,
Centre for Pharmaceutical Cleaning Innovation, USA


Andrew Walsh is an experienced Cleaning Validation SME with 38 years of Manufacturing experience with 28 years in Validation working for Johnson & Johnson, Schering-Plough and Hoffmann-La Roche.
Andrew also worked for 10 years at the Colgate-Palmolive and Clorox companies as an Analytical Chemist and Microbiologist. Andrew was an Industry Professor in the Pharmaceutical Manufacturing and Engineering Graduate Program at Stevens Institute of Technology (2008 to 2015) where he created and taught courses in Pharmaceutical Validation and Lean Six Sigma. Andrew is President of the Center for Pharmaceutical Cleaning Innovation (CPCI) a not-for-profit research and educational organization.
Andrew was co-author of ISPE’s Risk-MaPP Guide and led the global team that authored the new ASTM E3106 "Standard Guide on Science-Based and Risk-Based Cleaning Process Development and Validation". Andrew has a B.S. and M.S. in Biology (Microbiology) and is a certified Lean Six Sigma Black Belt and an accredited Lean Six Sigma Trainer.


Chris Seaman
Chris Seaman
Managing Toxicologist,
SafeBridge, UK


Chris Seaman is a European Registered toxicologist with over 40-years of experience in the pharmaceutical industry. Providing services for toxicological hazard assessment and communication, particularly with respect toxicological risk assessment contributing to articles on derivation of Occupational Exposure Limits (OELs) and Occupational Exposure Bands (OEBs), Acceptable Daily Exposure (ADE)/Permissible Daily Exposure (PDE) values for cross-contamination. With considerable experience in classification and labelling, SDS production and toxicity testing including replacement, reduction and refinement of animal tests.


Stefano Butti
Stefano Butti
Sales Director,
Food Pharma Systems, Italy


Stefano Butti has studied Mechanical Enineering at university of Milan and graduated in 2000. ISPE member since 2002 he partecipated as speaker to different congress and seminar on Containment and Micronisation topic both for HPAPI and Sterile application as well as published different articles on technical newspaper.

He worked as project and process manager in the Chemical and Pharmaceutical business following Containment and Micronisation system installation worldwide. He also took direct role in the definition of containment system upgrade and optimisation for the handling of products with OEL down to ng level with successful results. Also few projects where combination of sterile and toxic compound handling were succesfully coordinated during the nearly 19 years spent in this business. He Joined FPS company in 2008 starting as Technical Sales Manager and he is now head of the Sales group for the company Containment and Micronisation system provided worldwide.


Michel Crevoisier
Michel Crevoisier
Consultant,
Ex-Novartis Consultant, Switzerland


Michel Crevoisier holds a Ph.D. in Chemistry from the University of Berne in Switzerland. He has thirty years of experience in manufacturing of intermediates and API in pharmaceutical and in custom manufacturing companies. In his last position he was senior quality expert for cleaning validation with chemical manufacturing at Novartis Pharma in Switzerland. He retired from Novartis in summer of 2015 and works as a freelance QA specialist


Andreas Schreiner
Andreas Schreiner
Head of Validation,
Novartis, Switzerland


Andreas Schreiner graduated from the University Erlangen, Germany in 1996 in Chemical Engineering. After a Ph.D. and a scholarship at the University College London he joint Roche Vitamins as Head of Solids Processing. He moved in 2006 to Novartis and worked in various departments with increasing responsibilities from project leader to global technology platform leader. Since 2013 he is Head of Validation for Solid Dosage Forms.

Andreas Schreiner is appointed board and steering committee member at various scientific organisations (ISPE DACH Containment, EMPA Swiss Material Science Technology, School for Life Sciences) and President of the Swiss Society for Process Engineers.


Richard Denk
Richard Denk
Head Containment,
SKAN AG, Switzerland


Richard Denk is working at the company SKAN AG, headquartered in Allschwil in the position Head Containment. Mr. Denk founded 10 years ago the expert Containment group of the ISPE D / A / CH. The Containment Group published the ISPE Containment Manual Mr. Denk was responsible for in September 2015. He is Member of the ISPE SIG Biotech Group in Europe and Steering Committee Member of the ISPE SPP CoP. Mr. Denk is co Autor of the ISPE OSD Baseline Guide Volume 2 and Volume 3. Mr. Denk has spent nearly 20 years with the subject production of highly active / highly hazardous substances and has developed the containment pyramid.


Ester Lovsin Barle
Ester Lovsin Barle
Head, Product Stewardship and Health,
Takeda, Switzerland


Ester Lovsin Barle, DVM, MSc, PhD, MScTox is the Head of Product Stewardship and Health at Takeda, reporting to the Corporate head of Environmental Health and Safety, Deborah Donovan. She is in Zurich, Switzerland. Her responsibilities include Safety Data Sheet process, maintaining article and material regulatory complaince and scientific development and cross-organizational implementation of health based exposure limits (HBEL) in support of research and manufacturing in Takeda globally, as well as global implementation of occupational hygiene. Previously she has held corporate positions at Lonza and Novartis. She received her PhD in veterinary sciences from University of Ljubljana, Slovenia and a second masters degree in toxicology and risk assessment from Medical University in Vienna.