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Biopharma & Lifesciences Connected Live
January 25th 2023
Radisson Blu Hotel & Spa, Cork




Register Free
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   * Partners
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BioPharma & Lifesciences Connected Live
January 25th 2023 | Radisson Blu Hotel & Spa, Cork
REGISTER
 

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Book you place at the Biopharma & Lifesciences Connected conference and
exhibition to hear from leading national and international experts in
pharmaceutical manufacturing. The biopharma sector in Ireland is experiencing
significant challenges around supply chain issues, digital transformation,
automation, carbon reduction and regulatory changes..

The central theme of this event is to hear directly from industry leaders and
stakeholders who are willing to share challenges and solutions in practice. That
means, the spotlight in presentations will be on case studies from
pharmaceutical companies - allowing you to benefit from the speakers' experience
in their everyday practice.

Over 15 leading speakers involved in the development & manufacturing of
biopharmaceutical & biotech products & technology will participate in a full
day's schedule of keynote talks & panels on the topics shaping the sector.

Why Attend

 * Listen to over 15 expert talks and panel debates on the latest industry
   issues facing the biopharma & biotech sector.
 * Avail of the excellent networking opportunities with peers throughout the day
 * Network with over 30 exhibitors displaying the latest technology and research
 * Meet with government support agencies and associations
 * Join our Q&A with industry thought leaders

Key Topics Include

 * Research & Innovation
 * Automation
 * Vaccine Manufacturing
 * Process Optimization
 * Tech Transfer
 * Digitalization
 * IoT & Industry 4.0
 * Covid 19 – Impact to the market
 * Hybrid Systems – Single Use and/or Stainless Steel
 * Biosimilars – Best-Practice
 * Ultrafast Project Execution
 * Turnkey
 * HVAC & Cleanroom Engineering
 * Cell & Gene Therapy

Call for Speakers

To speak, sponsor and or exhibit at the event please email
info@biotransformationevent.com

SPEAKERS CONFIRMED

SIOBHAN FLEMING

COLLABORATIONS MANAGER - BIOPHARMA DATA ANALYTICS - SIEMENS

Speaker Bio



Working in regulated industry for over 20 years, Siobhan has supported the
implementation of new technologies across the pharmaceutical organisation. With
Siemens Digital Industries she leads the BioMAC initiative between Siemens,
NIBRT and industrial partners, using advanced data analytics to improve
operations at all stages of the biopharmaceutical manufacturing lifecycle.


CONOR MCALONAN

SUPPLIER QUALITY ENGINEER -

Speaker Bio



Conor is a Supplier Quality Engineer focused on Single-Use Technology and
vaccine manufacturing. He has received a Bbus. (Hons.) in Global Supply Chain
Management from MTU and holds certifications in Medical Device Manufacturing,
cGMP Validation and Chemistry, and Lean/Six Sigma. Prior to holding a role in
the pharmaceutical industry, he was a Paratrooper in the US Army and had a
20-year career in the hospitality industry as a chef. He is passionate about
digital transformation in supply chain and has spoken on topics covering both
change management and diversity and inclusion.


MATT MORAN

DIRECTOR - BIOPHARMACHEM IRELAND

"MAKE IRELAND THE GLOBAL LEADER IN SUSTAINABLE BIOPHARMACEUTICAL AND CHEMICAL
MANUFACTURING – A STRATEGY FOR THE SECTOR 2023-27"

Speaker Bio



Matthew Moran is Director of BioPharmaChem Ireland. He graduated in Chemistry at
Trinity College Dublin in 1980 and in Chemical Engineering at University College
Dublin in 1981; he holds an MBA also from University College Dublin (Smurfit
School of Business). He worked for over ten years in the pharmaceutical industry
where he held a number of management positions both in active ingredient and
dosage form manufacture. He is a member the European Chemical Industry Council
(CEFIC). Matthew Moran is a Board member of the Active Pharmaceuticals
Ingredients (API) Committee of CEFIC (CEFIC/APIC) and The European Association
for Bioindustries (Europabio) BioPharmaChem Ireland represents the interests of
the biopharmachem sector in Ireland. CEFIC/APIC represents the European API
Industry. Europabio represents the European Biotech Sector.


GERARD CARTON

CEO & CO-FOUNDER - PLANTQUEST

"DIGITAL TRANSFORMATION - FROM THE BOARDROOM TO THE PLANTROOM"

Speaker Bio Synopsis



Ger Carton is the co-founder and CEO of PlantQuest, a software company enabling
some of the world’s largest BioPharma & Lifesciences companies to digitally
transform their asset management operations. Prior to this Ger gained over two
decades of experience working across a range of disciplines within the leading
pharmaceutical, med devices, and oil & gas companies. No stranger to the
challenges and opportunities faced in digitising process intensive facilities,
Ger shares his learnings and experiences in the matter from both the perspective
of the buyer and the vendor.





In this talk Ger will focus on the challenge of transferring products and
services as they are sold in the boardroom, to the real world use cases out in
the Plant. Key points Ger will touch on are: The disconnect between new products
and technologies, and the availability of the datasets needed to make them work.
The managing of expectations around digital transformation in terms of
technology, timelines and outcomes. How to plan for success in facility digital
transformation


PATRICK O'SULLIVAN

DIRECTOR OF DATA & ANALYTICS - LIFE SCIENCE - EY

"LEVERAGING DIGITAL CAPABILITIES TO CONNECT TO YOUR EXTERNAL SUPPLY CHAIN &
CMOS"

Speaker Bio



Patrick is the Director of Life Science Data & Analytics at EY where he leads a
dedicated team in supporting clients deliver value through data driven decision
making and artificial intelligence. Patrick’s team works across all key areas of
Life Science organisations such as Advanced Internal & External Manufacturing,
Supply Chain, Procurement and Commercial Operations. Prior to joining EY Patrick
worked at Johnson and Johnsons Pharmaceutical company Janssen where he
supported, built and lead many of the recent global digital successes in their
pharmaceutical business impacting a number of areas such as supply chain,
manufacturing and procurement. Patrick’s work at J&J included defining common
data strategies and enterprise deployment, integrating analytics and emerging
technologies into manufacturing sites to stabilize/optimize the process leading
to multi million euro savings through increased productivity and defining plant
data strategies that supported achieving World Economic Forum Lighthouse status
at two international sites. In addition, Patrick’s key work related to the rapid
scaling up of the covid-19 vaccine by leading a team to enable live data
connectivity with real time analytics from Contract Manufacturers. This critical
work enabled live manufacturing visibility, inventory levels and product
movement in which Patrick continued to scale this capability across J&Js Small
and Large Molecule business to shift the external supply chain from a reactive
to proactive approach.


DARREN WOODS

MANAGING DIRECTOR - WD EXCELLENCE

"INSPIRE YOUR TEAM TO ACHIEVE OPERATIONAL EXCELLENCE"

Speaker Bio



Darren Woods is the Managing Director and co-founder of WD Excellence.
Specialising in the Pharma and Biotech industry, WD Excellence is an energetic
consulting company with a mission to guide organisations to new levels of
performance. Darren is very focused on continuous learning, holding an MBS in
Business Practice, an honours degree in Manufacturing Engineering, 3 post
graduate diplomas and a Lean Six Sigma Black belt. Darren is passionate about
all things Operational Excellence and has delivered significant transformations
for manufacturing and R&D companies over the past 2 decades. Darren has had the
pleasure of working with companies including MSD, Wuxi, Astellas, APC, VLE
therapeutics, and Aerie Pharmaceuticals .


ELÉONORE ASSAS

SENIOR MSAT BIOMANUFACTURING ENGINEER - MERCK LIFE SCIENCE

"CURRENT PRODUCT BEHAVIOUR TRENDS, IMPACT AND MITIGATION MEASURES FOR VIRAL
FILTRATION AND VALIDATION"

Speaker Bio



Eléonore Assas is a Merck Senior Biomanufacturing Engineer (BME) based in
Copenhagen (Denmark).

She holds a Masters degree in Industrial and Mechanical Engineering and a
Masters of Science in Biomedical Engineering from Arts et Metiers ParisTech in
Paris, France.

Initially coming from membrane manufacturing she then joined the Merck MSAT
(Manufacturing Science And Technology) team and has a strong focus on viral
filtration processes


OWEN BUCKLEY

HEAD OF CORPORATE PARTNERSHIPS - UNICEF IRELAND

"UNICEF: LARGEST SINGLE VACCINE BUYER IN THE WORLD"

TANER CHAKAR

PRODUCT MANAGER - SKYCELL

"COMPLEXITIES OF END-TO-END VISIBILITY OF YOUR SUPPLY CHAIN: WHY BOTH S-DATA AND
O-DATA ARE NEEDED"

Speaker Bio Synopsis



Tanre is a product manager at SkyCell with more than 15 years in supply chain
solutions. Together with his colleagues at SkyCell, they strive for only one
thing: to provide sustainable solutions to pharma organizations to deliver
medicines without any product loss.





During the past two decades, the value of pharmaceutical goods traded globally
has grown sixfold, from $113 billion in 2000 to $629 billion in 2019¹. As a
result of this growth, supply chains have become increasingly global and
complex. With $35B still lost annually as a result of failures in
temperature-controlled logistics worldwide, it’s clear that there is room for
improvement. In this talk, we would like to introduce a new definition of
end-to-end visibility and discuss why simulation data (S-data) and operational
data (O-data) are mandatory for making data-driven decisions.


JOHN COBB

GROUP MICROBIOLOGIST - PMT (UK) LTD

"ANNEX 1 VIABLE MONITORING: CLASSICAL VERSUS REAL-TIME METHOD"

Speaker Bio



John is a GMP qualified Microbiologist with over 30 years of experience in
Environmental Monitoring.

He was part of an MHRA group selected to develop and validate the first
irradiated agar plates to be used in Grade A GMP facilities.

John has also been involved in the Design, Promotion and Validation of
slit-to-agar active air samplers since 1985.

He is a strong advocate of viable monitoring over an entire production run by
classical agar based methods and real time methods.


CLAIRE DALY

TRAINING MANAGER - JANSSEN SCIENCES IRELAND

PATRICK FALVEY

PRINCIPAL CONSULTANT - LATHAM BIOPHARM GROUP

"CDMO SELECTION STRATEGY AND PROCESS"

Speaker Bio



Patrick Falvey has over 30 years of research, managerial and technical
experience in the Pharmaceutical and Biotechnology Industries. He has enjoyed
various positions of responsibility and leadership in Operations, Quality
Assurance, and Compliance and believes in collaboration among individuals and
groups to effect positive change and improvement.



Patrick has previously been a Senior Team Lead for Pfizer with responsibility
for the manufacture of Prevnar 13 vaccine, (prevention of pneumococcal
meningitis) one of the world’s most successful vaccines. He has hosted and
responded to various agency audits including FDA, EMA, SFDA (China) and was
responsible for overall Department Inspection Readiness program. He has led and
been responsible for a team of Investigation and Compliance specialists that
closed hundreds of investigations and commitments to maintain state of
compliance. He has onboarded & designed GMP training programs for new college
graduates for introduction to Aseptic & Cleaning Qualification programs to
support multiple aseptic manufacturing lines and has managed site GMP
Training/Safety programs. Patrick has worked with a variety of companies ranging
from large pharmaceutical companies to start-up ventures.



Patrick received his Bachelor of Science in Biochemistry from University College
Cork in Ireland, Masters of Science (Industrial Pharmacy) from Long Island
University in Brooklyn, and his Master of Business Administration from Iona
College in New Rochelle NY.


MARGOT HOLLAND

SUPPLY CHAIN ANALYTICS SITE LEAD - JANSSEN SCIENCES IRELAND

Speaker Bio



Site Lead for Supply Chain Analytics in Janssen Sciences Ireland, Ringaskiddy
and a core team member for the global Johnson & Johnson Analytics Team. Margot
has over 24 years of experience across the Finance, Engineering, Pharmaceutical
and IT industries. Prior to joining Janssen, Margot held technical and
leadership roles in IBM, UCC, Motorola and Financial Services. In her current
role she is focused on data science and analytics including predictive
modelling, digital twins, natural language processing and decision optimisation.


JP KELLY

HEAD OF DEPARTMENT - CORK - MURPHY GEOSPATIAL

"EFFECTIVE GEOSPATIAL STRATEGY TO REDUCE RISK AND DELAYS IN BIOPHARMA PROJECTS"

Speaker Bio



JP Kelly is Department Head at Murphy Geospatial Cork office. He qualified as a
Geomatics Surveyor at TU Dublin in 1999 and later returned to TU Dublin in 2010
to add another degree to his name, this time in Quantity Surveying and
Construction Economics. He started his career as a surveyor with Murphy
Geospatial (formerly Murphy Surveys Ltd.) and then moved into the construction
sector working as a project manager on a variety of civil and building projects
in Ireland and the UK. JP returned to his Geospatial roots in 2012 when he
re-joined Murphy Geospatial. Over the last 10 years, JP has successfully
introduced cutting-edge BIM workflows and Geospatial Management plans on
numerous prestigious high-tech and Pharmaceutical projects. By leading and
enabling our brilliant Geospatial team in Cork, JP takes great pride in
delivering industry-leading geospatial and surveying services to all of our
valued customers in Cork, Munster and Europe.


NIELS-ERIK KONGSTE

VICE PRESIDENT SALES HIGH PURITY EUROPE - AAF EUROPE

"MEMBRANE HEPA FILTRATION TO LIFE SCIENCE: HISTORY, PRESENT AND THE FUTURE"

Speaker Bio Synopsis



MSc Mechanical Engineer
30 years experience in the global HVAC and Air Filtration industry
Specialist in HEPA filtration in especially the cleanroom & lifescience
industry.
Recent years additional focus on optimization related to energy savings and
predictive maintenance programs.





Membrane HEPA filtration or ePTFE (expanded PolyTetrafluoroEthylene) media which
is the technically description of the material used in the membrane filter media
has been on the market since the mid 1980 ́s. ePTFE fine fibers was initially
developed by Daikin as part of their chemical division. This presentation will
describe the early progress of the fine fiber technology and the development
process of manufacturing commercially available filters throughout the 90 ́s
until today where modern PTFE membrane HEPA filters are replacing the
traditional microglass HEPA filters in the LifeSCience industry. ePTFE HEPA and
especially ULPA (U15-U17) filters were quickly adopted by the semiconductors
industry due to the superior mechanical stability and super low outgassing
behavior and proven chemical compatibility compared to traditional microglass
HEPA/ULPA filters. Today ePTFE membrane ULPA filters is the industry standard in
the most critical process steps in the semiconductor industry.


TERRI LOVE

SENIOR MSAT BIOMANUFACTURING ENGINEER - MERCK LIFE SCIENCE

"CURRENT PRODUCT BEHAVIOUR TRENDS, IMPACT AND MITIGATION MEASURES FOR VIRAL
FILTRATION AND VALIDATION"

Speaker Bio



Terri Love is a Senior Biomanufacturing Engineer within the Manufacturing and
Sciences Technology team at Merck KGaA, based in Ireland. Following a BSc degree
in Industrial Biochemistry from the University of Limerick, Terri worked for
Lonza Biologics in the UK before returning to Ireland to work with Merck.

Terri has been employed within the biopharma industry for the past 21 years, and
she has been working for 18 years as a field-based Biomanufacturing Engineer at
Merck in Ireland. During her time at Merck, Terri has been collaborating with
Irish biopharma customers on their technology transfers, scale-up and
implementation


DR. TRISH O'CONNELL

LECTURER IN BIOPHARMACEUTICAL & MEDICAL MATHEMATICS & STATISTICS - ATLANTIC
TECHNOLOGICAL UNIVERSITY

"LEAN SIGMA AND ITS APPLICATION TO THE BIOPHARMA & LIFESCIENCES SECTOR."

Speaker Bio



Dr. Trish O’Connell is the academic coordinator of the Master of Science in
Biopharmaceutical Manufacturing run by the Atlantic Technological University
Galway city campus. Having come to academia from industry, she has extensive
industrial experience at both senior and consulting engineer level in the
application and use of statistical tools for manufacturing. Trish holds a Lean
Six Sigma Black Belt and currently lectures to final year students on the BSc
(Hons) in Applied Biology and Biopharmaceutical Science. She also lectures and
supervises students on the level 9 Masters.


MUKUNTH VENKATESAN

FOUNDER, DIRECTOR & CEO - AGARAM TECHNOLOGIES

"PAPERLESS SOLUTIONS FOR DATA INTEGRITY & COMPLIANCE IN BIOPHARMA"

Speaker Bio



Mukunth Venkatesan is the Founder, Director & CEO of Agaram Technologies. Agaram
technologies is a leading provider of enterprise class laboratory solutions to
regulated & non-regulated industries across the globe. Mukunth has a strong
background in Applied Sciences & Biomedical instrumentation. He started his
career as a Biomedical instrumentation engineer in 1990 following which, he
joined the Agaram group in 1992 to lead the analytical instrumentation and R&D
division for developing and manufacturing HPLCs in India.

He then moved on to establish a software development team focused on solutions
for analytical instrumentation. This move laid the foundation for the
development of in-house Laboratory Informatics software products such as Qualis
LIMS, Logilab ELN and Logilab SDMS that are now established solutions being used
by Pharmaceutical and Life Sciences organisations across the globe. Mukunth has
worked along with ASTM committee members for the development of the latest LIMS
standard, delivered solutions for regulatory bodies and other reputed regulated
organisations.

Over the past 25 years , Agaram Technologies under the leadership of Mukunth has
helped organizations involved in QC and R&D processes in laboratories to meet
cGMP, Data Integrity, GxP, Regulatory Compliances such as US FDA 21 CFR Part 11,
EudraLex annex 11, ISO 17025 and other industry standards.


CHRISTIAN WITZ

CEO & FOUNDER - SIMVANTAGE

"ACCELERATING SCALE-UP WITH A NEXT-GENERATION SIMULATION SOFTWARE"

Speaker Bio Synopsis



Christian Witz did his Ph.D. in the group of Prof. Khinast at the Institute of
Process and Particle Engineering on the topic of multiphase reactor simulation
using the lattice Boltzmann method. He then established the Computational
Bioprocess Engineering group at the institute to find, test, validate, and
interconnect highly efficient algorithms for graphic processing units (GPUs) to
simulate the physical process inside devices like the bioreactor. This in-house
codebase is the basis for the spin-off SimVantage, which provides cloud-based
simulation software and consulting for stirred and/or aerated reactors.





With new numerical algorithms and powerful computer hardware, the first
physical-principle simulation of (bio-)reactors in production sizes is now
possible. With the lifelines concept, different reactor sizes or geometries can
be compared based on the experience of the cells or microorganisms in the
reactor, thus providing a scientifically sound way for scale-up and reactor
characterization based on validated simulations. The presented approach can lead
to a reduced time-to-market and the experimental load during scale-up and
process transfer.




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