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November 4–5, 2020
posummit.com
AMERICAN PHARMA OUTSOURCING SUMMIT2020
Designing a new future for manufacturing, quality and supply chain leadersTOMORROW'S CONNECTION TODAY
PROGRAM
AMERICAN PHARMA OUTSOURCING SUMMIT 2020 · DAY 1NOVEMBER 4 , 2020th
10:30 am – 10:50 am EST
LOG-IN AND WELCOME
10:50 am – 11:00 am EST
CHAIR'S OPENING REMARKS
MARK FROMHOLD, PH.D.Sr. Director, Head, MSAT Lundbeck
11:05 am – 11:40 am EST
OPENING KEYNOTES
WALTER CHARLESSVP, Chief Procurement O�cer Allergan
USING AI AND NEXT-GEN TOOLS TO ADD MASSIVE VALUE TOPROCUREMENT SYSTEMS
Examining how businesses can power up procurement with AI and what it can mean foryour bottom lineAI and supplier evaluations: how will AI change supply chain? What are futurepossibilities?What are the next generation of tools that will help improve procurement systems?Identifying areas for improvement, solving problems and driving maximum impact in procurement processesExamining current possibilities in procurement: how to leverage the second longest leverin all business (after sales) to drive success and growth
available: Video
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BEN LOCWINSVP, Quality Lumicell
A CRITICAL LOOK AT THE FUTURE OF PHARMAExploring what the future of pharma looks like from the perspective of a FuturistHow to be a better predictor of the futureThe accuracy of the quanti�ed self and creating false conditions in peopleAs digital becomes more and more the 'now,' what does that mean for 'what's next'?Insight on “Solidarity” clinical trial for COVID-19 treatments
available: Video
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11:45 am – 12:25 pm EST
PRE-ARRANGED 1-2-1 BUSINESS MEETINGS AND NETWORKING
12:30 pm – 1:05 pm EST
WORKSHOPS
WORKSHOP
DAVE EDWARDSEVP MasterControl
PAPER PROCESSES HAVE NO PLACE IN HIGH VOLUMEMANUFACTURING
Paper-based processes are slowing you down and costing more than youthink It’s time for digital transformationDigitization gives you the power to scale quickly, meet rising demandand deliver a quality product faster than the competitionMaintain an audit-ready state to provide customers with thetransparency they need right nowEnsure remote workers throughout the country and across the globe can collaborate using the latest dataFind out how other manufacturers leveraged technology to increaserevenueLearn strategies they used and add them to your playbook
available: Video
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WORKSHOP
JOHN JACEYDigitalization Strategy Team TraceLink
JOHN BERMUDEZGeneral Manager, Digital Network Platform TraceLink
DIGITALLY TRANSFORM THE WAY YOU WORK WITH YOURSUPPLIERS
Addressing the need for better digital supply chain processes to managethe onslaught of COVID-19 issues: Why are many putting digital transformationprojects on hold?Industry research shows supply chains that are more progressed in theirtransformation journey are more likely to view the COVID-19 impact asless severe than those who have not progressed with their digital supply chain transformationLearning from a leading CMO, with a case study highlighting theirapproach to multi-enterprise collaboration with suppliers, by leveraging an industry-wide digitalsupply chain networkSeeing how network-based work management processes enable multi-discipline, multi-company teams to work together virtually to identifypotential disruptions and be more responsive to changes in demandLearning how to quickly resolve supplier incidents, approve changecontrols and conduct quality document reviewsDeveloping an actionable road map for end-to-end supply networkdigitalization to build a more agile and resilient supply chain.
available: Video
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1:10 pm – 1:40 pm EST
LUNCH & LEARN ROUNDTABLE DISCUSSIONS
TIMO TAGHIZADEH, PHDHead, Business Development andMarketing tesa Labtec GmbH
START-UP OR BIG PHARMA: CHALLENGES INDEVELOPMENT, TRANSFER AND COMMERCIALMANUFACTURING - A CDMO PERSPECTIVE
BRYAN J. COLEMANSenior Director, Pharmaceutical andMedical Device Services EAS Consulting Group
INTERNAL QUALIFICATION PROGRAMS -COMPLIANCE, AUDITING & MONITORING OFYOUR CMOS
BRITTANY HAYES, PH.D.Director, Applied Technology Recro
MANAGING TECHNOLOGY TRANSFERS TOINTERNAL AND EXTERNAL MANUFACTURINGPARTNERS
SPEAKER TBALaxai
HOW DATA CAN TRANSFORM DECISIONMAKING AND R&D
CHERI ORTHManager, Key Accounts Natoli Engineering Company
CREATING NIMBLE AND AGILE NETWORKS TOMANAGE COMPLEX SCENARIOS
ADAM SYBROWSKYBusiness Development Executive MasterControl
SUCCESSFUL AUTOMATION TO IMPROVEQUALITY, SAFETY AND DAILY OPERATIONS
Retro�t IoTBig Data & Smart AnalyticsCloud AutomationWork�ow AutomationMES and System Integration
Bene�t from additional learning by joining a moderated roundtable discussion on pressing issues in the industry. Seating is limited. Choose from:
1:45 pm – 2:25 pm EST
PRE-ARRANGED 1-2-1 BUSINESS MEETINGS AND NETWORKING
MANUFACTURING
TANYA MEZHEBOVSKY, PH.D.Head, Pharmaceutical Development Alexion
CMC AND DEVELOPMENT PROCESSES FORBIOTHERAPEUTICS: FROM PRE-FORMULATIONTO COMMERCIAL
Biotherapeutics development, bispeci�cs, fusionproteins, and/or combination productsWhat are the current best practices in end-to-endbiopharmaceutical development and commercialization?What strategies and best practices can we learn fromAlexion's CMC
QUALITY
ROBERT BERLINDivision Director, Division of Clinical Policy,O�ce of New Drug Policy FDA
ADVANCING CLINICAL AND REGULATORYPOLICY AGENDA'S TO DRIVE MEANINGFULGROWTH AND INNOVATION
Addressing how the current COVID-19 pandemic a�ectedthe movement and progress of clinical and regulatorypoliciesOutlining policies and procedures related to productapplications, digital health and diagnosticsCase study: Discussing new drug policies and high levelplans for 2021 and beyond
available: Video
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SUPPLY CHAIN MANAGEMENT
FRANCIS DUMONTSenior Director, External Drug ProductSupply Strategy P�zer, Inc.
DRUG PRODUCT DEVELOPMENT TOCOMMERCIAL STRATEGIES: THE CRITICALITYOF ROBUST SOURCING APPROACHES
Some high-level, pharma development throughcommercialization challengesConsiderations for partnering, divesting, acquiring orgoing it aloneKey steps for implementing the right make versus buyapproachesBest practices for aligning reality withoutsourcing strategic ideals
available: Video
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2:30 pm – 3:05 pm EST
SESSIONS
3:10 pm – 4:10 pm EST
EXPO HALL NETWORKING
AMERICAN PHARMA OUTSOURCING SUMMIT 2020 · DAY 2NOVEMBER 5 , 2020th
10:30 am – 10:50 am EST
LOG-IN AND WELCOME
10:50 am – 11:00 am EST
MARK FROMHOLD, PH.D.Sr. Director, Head, MSAT Lundbeck
CHAIR'S OPENING REMARKS
LUIZ ALBERTO BARBERINIHead, External Manufacturing, Latin America Bayer Consumer Care
COLLABORATING WITH CMOS TO INCREASE EFFICIENCY AND OVERCOMECAPACITY ISSUES – AND IMPACT OF A COMPLEX PANDEMIC SCENARIO
Partner with CMOs to promote innovationUtilize Lean and continuous improvement to drive e�ciency and improve operationsGet alignment with CMOs to better manage capacity and riskTake Aways and tips that can be implemented to improve relationships
available: Video
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MARCIA BARONISenior Director, Quality and Site Quality Head Emergent BioSolutions
EXPLORING VACCINE MANUFACTURING AND QUALITY OVERSIGHT INTHE COVID-19 ERA AND BEYOND
How do you maintain vaccine manufacturing, oversight and working with 3rd partymanufacturers during the current pandemic?Considerations for QA and QC in Emergent’s vaccine manufacturingWhat are the consequences of working in a resource limited virtual setting for qualitycontrol, analytical development, quality assurance and regulatory a�airs?Technical, quality, business and implementation factors for manufacturing vaccines –both Emergent’s internal oversight and oversight of work performed by CDMO’s onEmergent’s behalfHow does the COVID-19 pandemic shape the future of our Quality Unit model
available: Video
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11:05 am – 11:40 am EST
OPENING KEYNOTES
11:45 am – 12:25 pm EST
PRE-ARRANGED 1-2-1 BUSINESS MEETINGS AND NETWORKING
WORKSHOP
CHARLIE MAHERGlobal Director, Process and Manufacturing Technology CAI
TECH TRANSFER PROGRAM MANAGEMENT – BEST PRACTICESUnderstanding how technology transfer is integral to the lifecycle of virtually everypharmaceutical productEnabling a product to advance from the development lab into clinical manufacturing andthen scale-up to commercial productionMeasuring the success of a tech transfer in terms of meeting quality, regulatory, andbusiness goalsExploring why e�ective Program Management is the key to achieving all three dimensionsof success in a technology transfer project
available: Video
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WORKSHOP
JACOB JENSENAssociate Director, Head, Program Management, Process Analytics andTechnology Transfer FUJIFILM Diosynth
MANAGING AN EXTERNAL SUPPLY NETWORK TO OPTIMIZE SUPPLYCHAIN AND PRODUCTION
What does the current outsourcing landscape look like?Exploring new markets, hubs and plants across a global networkLeveraging digital and ERP platforms to meet patient demandOptimizing project management, inventory management, production scheduling, logisticsand distribution, and organizational design for consumer products
available: Video
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12:30 pm – 1:05 pm EST
WORKSHOPS
SARAH BETHUNESr. Director, Pharmaceutics and Formulation Development Cambrex
ACCELERATING YOUR SMALL MOLECULE THERAPEUTICS INTO THEMARKET
JEFFREY SPEICHERGeneral Manager, Commercial Avéma Pharma Solutions
BENEFITS OF INTEGRATED SMALL-VOLUME MANUFACTURINGCAPABILITIES
1:10 pm – 1:40 pm EST
LUNCH & LEARN ROUNDTABLE DISCUSSIONS
Bene�t from additional learning by joining a moderated roundtable discussion on pressing issues in the industry.
SPEAKER TBASmart Consulting
IDENTIFYING, EVALUATING AND ON-BOARDING PARTNERS IN CLINICALSUPPLY AND MANUFACTURING
ANNE ERTLÉSr. Director, Language Services Amplexor Life Sciences
AVOIDING LOCAL LABEL ERRORS AND ENSURING COMPLIANCE FORPHARMA COMPANIES
1:45 pm – 2:25 pm EST
PRE-ARRANGED 1-2-1 BUSINESS MEETINGS AND NETWORKING
MANUFACTURING
FRIEDA WILEYFreelance Health Writer O, The Oprah Magazine and WebMD
DETLEF BEHRENSHead, CMO Biocon
HOW CLOSE STRATEGIC PARTNERING AND THE ‘VALUE PROPOSITIONAPPROACH’ CHANGES THE RELATIONSHIP BETWEEN PHARMA CLIENTSAND THEIR CUSTOMERS
Examining in-house versus outsourced R&D, and how the decision between the two isimpacted by COVID-19Exploring changing approaches to how pharma companies’ evaluate the work of CDMOsuppliers: the value proposition approachStrategies for value proposition: open book calculations, buying of capacity, greatervisibility, and e�ective supply chain managementHow to �nd the best CDMO in the jungle of potential partners? Perspectives from bothinsourcing and outsourcing experience
available: Video
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QUALITY
LARRY PUDERBACHAssociate VP, Research Quality Merck
ADAPTING THE SUPPLIER QUALITY MODEL FOR A DYNAMIC CLINICALENVIRONMENT
Rede�ning the necessary skill-sets to keep pace with advancing science and technologyLeveraging Quality by Design (QbD) initiatives and AnalyticsExploring quality as a value propositionUsing Covid19 business adversity as a change agent
available: Video
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2:30 pm – 3:05 pm EST
SESSIONS
3:10 pm – 4:10 pm EST
EXPO HALL NETWORKING
AMERICAN PHARMA OUTSOURCING SUMMIT 2020 · DAY 3NOVEMBER 6 , 2020th
10:00 am – 10:05 am EST
LOG-IN AND WELCOME
ARLEEN PAULINOSVP, Global Manufacturing Amgen
IRENA MCGUFFYSenior Director and Head, Drug ProductOperations GlaxoSmithKline
RADHA IYERChief Quality O�cer and VP, Qualityand Scienti�c A�airs, Global DevelopedMarkets Dr. Reddy's Laboratories
RAE-ANN COOKVP, Supply Chain Culture and CapabilityDevelopment Johnson & Johnson
JENNIFER MCCAFFERTYVP, External Manufacturing Operations Merck
10:10 am – 10:50 am EST
NETWORKING BREAKFAST
WOMEN IN LEADERSHIP ROUNDTABLE
We invite our attendees to network at a Women in Leadership Roundtable with discussion from inspirational leaders in outsourcing. Seating is limited, so please sign up early.
MARK FROMHOLD, PH.D.Sr. Director, Head, MSAT Lundbeck
10:50 am – 11:00 am EST
CHAIR'S OPENING REMARKS
SANDRA AHERNHead, Biologic External Supply Quality Sano�
MANAGING GLOBAL EXTERNAL SUPPLY TO OPTIMIZE DEVELOPMENT ANDQUALITY
Technical, quality, business, and implementation factors for manufacturing drug productswith external suppliers globallyExamining the transition and integration of in-licenced drug products after they areacquired by your companyExploring how to manage demand, supply, and inventory across multiple markets andlogistics operations on a global scaleBest practices for external supply and manufacturing: suggestions for workingrelationshipsTaking a look at equity expansion, system implementation, expense control and oversight
available: Video
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MICHELE JOHNSONHead, ESO Procurement, Americas Novartis
IMPROVING SUPPLIER RELATIONSHIPS AND ENCOURAGINGTRANSPARENCY WITHIN SUPPLIER PARTNERSHIPS
How the COVID-19 pandemic has impacted how we engage with our partners andsuppliersAssessing risk exposure constantly and having contingency plans in place for various formsof disruptionDiscussing supply chain di�culties that would normally be easily resolved and how wehave been able to adapt to ensure engagement with limited interactionsDiscussing the importance of responsible risk management, relationship, cost, geography,IP and timelines in determining partner selection
11:05 am – 11:40 am EST
OPENING KEYNOTES
11:45 am – 12:25 pm EST
PRE-ARRANGED 1-2-1 BUSINESS MEETINGS AND NETWORKING
QUALITY
AMIR ZURSenior Director and Head, Product Quality and Digital Health Teva Pharmaceuticals
USING DATA AND ANALYTICS TO DRIVE MEANINGFUL GROWTH,INNOVATION, AND POSITIVE HEALTH IMPACTS
Using Data and Analytics to Drive Meaningful Growth, Innovation and Positive HealthImpactsUsing AI, data, algorithms and analytics to drive successful outcomesDeveloping analytical control strategies: examining pharma companies' shift from internalto external programs – and then back againManaging the consequences of working in a resource limited virtual setting for analyticaldevelopmentCase study: How Teva Pharmaceuticals is adding automation to the drug manufacturingprocess
available: Video
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SUPPLY CHAIN MANAGEMENT
JUNE OSOFSKYAssociate Director, Commercial Supply Planning Allakos
OPTIMIZING OUTSOURCED PHARMACEUTICAL SUPPLY PLANNING:DYNAMIC AND BROAD STRATEGIES FOR TRANSFORMING SUPPLY CHAINMANAGEMENT
Exploring strategic planning of pharmaceutical product supply chain management: whatare the biggest current trends and considerations?Taking a look at planning module within ERP systems vs excel based planning: dynamic vsstatic safety stock and promoting optimal inventory planningProactive strategies for reducing E&O in biopharmaceuticals with limited shelf life (E&O:Expiry and Obsolete)Moving away from �re�ghting to optimal supply planningMaximizing operational e�ciency in inventory management and production scheduling
available: Video
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12:30 pm – 1:05 pm EST
SESSIONS
AMNON EYLATHVIPUL GANDHI
1:10 pm – 1:40 pm EST
LUNCH & LEARN ROUNDTABLE DISCUSSIONS
VP, Quality Constellation Pharmaceuticals
CMO QUALITY OVERSIGHT AND RISKMANAGEMENT
Senior Manager, Quality Assurance, ThirdParty Operation Alvogen
DELIVERING HIGH QUALITY PRODUCTSTHROUGH CONTRACT MANUFACTURING
SCOTT DUNCANDirector, CMC Silicon Therapeutics
BEN LOCWINSVP, Quality Lumicell
MANINDER HORA, PH.D.Chief Technical Operations O�cer Amunix
SATYA KUCHIMANCHIVP, CMC Triplet Therapeutics
AMNON EYLATHVP, Quality Constellation Pharmaceuticals
ENHANCING RELATIONSHIPS WITH THIRD-PARTY PARTNERS TO DRIVE PRODUCTIVITY AND GROWTHWhat are some of today's considerations for building better relationships with contractors?Increasing communication and collaboration to avoid risks to customer service level, costs, visibility and complianceBest techniques for breaking down silos and managing the relationship through a team approachDiscussing skills that must be developed and fostered with your Supplier Relationship TeamExamining win-win examples from e�ective partnership modelsSustaining continuous improvement initiatives and taking partnerships to the next level
1:45 pm – 2:25 pm EST
PANEL DISCUSSION
2:30 pm – 2:35 pm EST
CLOSING REMARKS & PRIZE ANNOUNCEMENTS
2:40 pm – 3:40 pm EST
EXPO HALL NETWORKING
