AMERICANBIOMANUFACTURINGSUMMIT 2017

Presents

May 23rd & 24th, 2017

Hyatt Regency Mission Bay Spa & Marina , San Diego, CA

+1 (416) 298 7005 info@generisgp.com

biomanamerica.com

PROGRAM

Tomorrow’s Connection TodayDriving business performance through process and technological innovation

p1

7:30 am – 7:35 am

8:10 am – 8:45 am

7:00 am – 7:30 am

DELEGATE REGISTRATION AND BREAKFAST

PROGRAMDAY ONE: May 23rd, 2017

CHAIR’S WELCOME AND OPENING REMARKS

MANUFACTURING EXCELLENCEAND TECHNOLOGY CHAIR

QUALITY AND COMPLIANCECHAIR

SUPPLY CHAIN AND LOGISTICSCHAIR

PAUL DALY, PH.D.CVP and Head of Global

Quality

7:35 am – 8:10 am

KEYNOTEACHIEVING CLARITY ON GLOBAL CAPACITY IN AN EVOLVING PICTURE • What are businesses doing to build capacity into their organizations?• Addressing supply chain weaknesses early on to create better operations• Examining supply chain strategies for:

• Unfinished products in development• Finished goods locally and in different locations• Warehousing and storage

• Discussing the pros and cons of suppliers carrying extra inventory for supply chain risk mitigation• Gaining capacity through process intensification and building new facilities

ANDY SKIBOEVP, Operations, MedImmune

RVP, Supply Biologics, AstraZeneca

PHIL EVANSSales Director, North

America

MARK DIMARTINODirector, Quality

Engineering, Operations Performance Excellence

PLENARYNEXT GENERATION BIOLOGICS MANUFACTURING: PREPARING FOR THE FUTURE OF THE INDUSTRY NOW • Discussing industry transition, capacity, productivity and investments• Planning for niche environments with long-term strategies in these areas• Determining which areas to focus attention on and when to shift priorities• Developing systematic approaches to recruit and train talent to address skills gap• Managing the influx of biologics, competitive products and ever changing regulations

JOERG HEIDRICHSVP, Global Product Supply Biotech

p2

PRE-ARRANGED 1-2-1 BUSINESS MEETINGS AND REFRESHMENTS (100 MIN.)

11:15 am – 11:50 am

9:30 am – 11:10 am

INNOVATION SPOTLIGHT 1REVOLUTIONIZING MEDICINE THROUGH CAR T-CELL IMMUNOTHERAPIES • Discussing the uniqueness of cell therapies• Understanding the complexities of developing commercial cell and gene therapy products:

• Manufacturing: What does the process look like?• Quality: Best practices for quality tests and comparability studies• Supply chain: Exploring the uniqueness of the supply chain and strategies

• Navigating the regulatory pathway of the FDA or other agencies• Examining next generation technologies to meet market needs• Looking forward: Assessing trends and drivers for both personalized and broadly applicable cell-based medicines

TIM MOOREEVP, Technical Operations

8:50 am – 9:25 am

WORKSHOPBIOMANUFACTURING CAPACITY ENGINEERING: DISCUSSING THE BENEFITS AND ROI OF MODELING AND SIMULATION • Why build process models?• Discussing validation and verification of

capital expenditures• Case studies: Examining the impact of

variability when debottlenecking• Reducing risk and increasing reliability in

your operations

GARY WRIGHTVP, Business Development

WORKSHOPBUILDING CAPACITY THROUGH US MARKET EXPANSION: THE ARIZONA BUSINESS• What are companies thinking about when

selecting sites and building capacity?• Discussing recent investments in

healthcare, biologics and R&D in Arizona, East Valley, and Gilbert

• Assessing tax, logistics, skilled laborers and other benefits doing business in Arizona

DAN HENDERSONEconomic Development

Director

WORKSHOPNEXT GENERATION IN HIGH THROUGHPUT MONOCLONAL ANTIBODY PRODUCTION: MULTIPRODUCT , SINGLE-USE BALLROOM FACILITY • Discussing the importance of process

closure analysis• Closure VPP: Evaluating, documenting

and validating closure• Leveraging closure: Examining an

operational philosophy• Case study: Showing how the Saturn

mAb Facility allows for f u ll product lifecycle production

THOMAS PAGE, PH.D.VP, Engineering and Asset

Development JOAN KOERBER-WALKER

President and CEO

p3

12:35 pm – 1:35 pm

11:55 pm – 12:30 am

WORKSHOPEXAMINING THE COMPLEXITIES OF MANAGING A GLOBAL SUPPLY CHAIN: A LOGISTICS PERSPECTIVE• Discussing biomanufacturing capacity

and the impact on the supply chain• Is the global clinical/commercial supply

world flat?• New countries, new challenges• Assessing complexity of the product

temperature requirements• Are we keeping pace with EU GDP?• How the marketplace has changed and

what we can do about it

KIM ROSSALLDirector, Global Accounts

WORKSHOPLEVERAGING FUNCTIONAL AFFINITY LIGAND DIVERSITY TO DELIVER RAPID AFFINITY RESIN-BASED PURIFICATION PLATFORMS TO DIVERSE BIOPHARMACEUTICALS• Utilizing affinity capture to create

downstream manufacturing platforms from IND to commercialization

• Shaping product profile and potency through specific affinity resins that not only afford robust capture but actively select for features that confer product quality or avoid product variants

• Creating novel affinity resins compatible with legacy manufacturing infrastructure and newer next-generation manufacturing paradigms

• Case studies: Describing the use of peptide-based libraries to deliver high-selectivity affinity resins exclusively designed by bioprocess engineers with specific timelines and performance criteria

WARREN KETT, PH.D.CSO

WORKSHOPCONTINUOUS UPSTREAM BIOLOGICS PRODUCTION: FAIL FAST; FAIL SAFE; FAIL CHEAP• Overcoming difficulties of low-expressing

proteins in typical in fed-batch processes• Enabling previously cost-prohibitive

projects to enter clinical trials by establishing a cost-effective production path

• Bringing your difficult-to-express protein through clinical trials quickly, safely, and cost-effectively using an innovative, perfusion GMP platform

SCOTT WANIGERVP BioServices

LUNCH AND LEARN ROUNDTABLE DISCUSSIONS * Registration on-site required

CPV: WHY IT’S IMPORTANT AND HOW IT CAN BE IMPLEMENTED

PLANNING YOUR SUPPLY CHAIN TO ALLOW FOR A STREAMLINED TRANSITION INTO COMMERCIALIZATION

CAPITAL PROJECT DELIVERY: SORTING THROUGH LEAN INTEGRATED, AND OLD SCHOOL METHODOLOGIES

EXAMINING THE IMPACT OF RAW MATERIALS ON PRODUCT QUALITY AND DEVELOPING STRATEGIES TO MITIGATE MATERIAL RISKS

TRANSFERRING DATA AND GENERATING INTEROPERABILITY THROUGHOUT THE ENTIRE SUPPLY CHAIN: AN OUT-OF-INDUSTRY PERSPECTIVE ON IMPROVING SECURITY AND PREVENTING POTENTIAL DISRUPTIONS

VENKATESH SRINIVASAN, PH.D.

Director, Manufacturing Sciences

MARK DIMARTINODirector, Quality

Engineering RYAN SCHROEDERPresident

BRIAN FILESDirector, Pharmacy

Inventory Management

PRASHANT YADAVDirector, Healthcare

Delivery Research and Professor

EXTENDED Q&A: ACHIEVING CLARITY ON GLOBAL CAPACITY IN AN EVOLVING PICTURE

ANDY SKIBOEVP, Operations,

MedImmuneRVP, Supply Biologics,

AstraZeneca

p4

2:20 pm – 2:55 pm

1:40 pm – 2:15 pm

PLENARYUSING COLLABORATION AND ALLIANCE MODELS TO BREAK BEYOND DEVELOPMENT SILOS AND BRING NEW MEDICINES TO MARKET• Bringing stakeholders to the table early on to ensure the alignment of goals• Using manufacturing innovation to drive down the cost of goods• Creating the foundation for good will, reputation and the improvement of global health• Case study: Examining a recent collaboration between a bio business, funder and government to solve a global health priority

RAHUL SINGHVIChief Operating Officer, Takeda Vaccines

MANUFACTURING EXCELLENCE AND TECHNOLOGYESTABLISHING A ROBUST PROCESS DEVELOPMENT STRATEGY TO SUIT EVOLVING BIOMANUFACTURING NEEDS • Best practices to create robust, compliant

and efficient process development strategies

• Rolling out continuous process enhancement strategies to all pipeline products

• Maintaining quality, speed and flexibility in the replication of biologics manufacturing for new biologics

• Utilizing Continuous Process Verification (CPV) and Process Analytical Technology (PAT) data to monitor performance

• Creating a roadmap to achieve and sustain Operational Excellence and best practices from scale-up to commercialization

GARGI MAHESHWARI, PH.D.

Executive Director, Biologics Process Development and

Commercialization

QUALITY AND COMPLIANCEEXAMINING THE QUALITY OVERSIGHT OF CAR T CLINICAL MANUFACTURING AND THE CHALLENGES OF MOVING INTO COMMERCIAL OPERATIONS • Discussing quality considerations in the

CAR T-cell immunotherapies supply chain

• Understanding facility and testing requirements

• Quality and manufacturing considerations for the vector supplier

• Navigating supply chain logistics of getting in and out of countries and maintaining chain of custody

• Regulatory and quality requirements of the FDA and other agencies

PAUL DALYVP and Head of Global

Quality

SUPPLY CHAIN AND LOGISTICSEXAMINING SCIENTIFIC INTERVENTIONS TO IMPROVE THE VACCINE SUPPLY CHAIN• How to make the vaccine manufacturing

supply chain more robust• Best methods for tracking performance

and improvements along the way• Understanding which new technologies

are worth investing in• Case study: Demonstrating progress

made at Pfizer

BASAV GHOSH, PH.D.Senior Director and Team

Lead, Global Biologics Manufacturing Sciences

3:00 pm – 4:20 pm

PRE-ARRANGED 1-2-1 BUSINESS MEETINGS AND REFRESHMENTS (80 MIN.)

p5

5:05 pm – 5:40 pm

QUALITY AND COMPLIANCEESTABLISHING AN EFFECTIVE AND SUSTAINABLE QUALITY CULTURE• Examining different approaches to create

a quality culture within an organization• Building culture programs, moving them

beyond incubation stages and into long-lasting sustainable models

• Enabling the desired components of a quality culture:• Continuous Improvement• Staff accountability• Effective leadership

• Creating a culture of quality that values product integrity and risk management

• Discussing the business and regulatory benefits of a successful quality culture roll-out

MANUFACTURING EXCELLENCE AND TECHNOLOGYDEVELOPING A HIGH EFFICIENCY PROCESS TO ESTABLISH A WELL DEFINED PROCESS CONTROL STRATEGY• Overcoming challenges to achieve

manufacturing efficiency and control• Determining the best tools to identify

critical inputs and outputs for your manufacturing processes

• Assessing the implementation of DMAIC (Define, Measure, Analyze, Improve, and Control) methodology and statistical analysis for process improvement and optimization

• Applying data to get a precise direction to meet goals

CHRISTOPHER BELLVP, Quality Operations

TSU-SHUN LEE, PH.D.Director, Global

Pharmaceutical Technology - Biologics

SUPPLY CHAIN AND LOGISTICSLIFE SCIENCES IN A POST-SERIALIZATION WORLD: EXAMINING CHANGES THAT NEW U.S. INDUSTRY REGULATIONS WILL BRING ABOUT OVER THE NEXT THREE YEARS• How should you prepare and equip your

internal operations, CROs/CMOs and 3PLs?

• Examining capabilities your organization needs to be effective in a post-serialization environment

• Discussing the benefits of product traceability throughout the supply chain

• Empowering an end-to-end serialization solution with partners and teams

• Futuristic outlook: Blockchain, traceability and emerging technologies

ANGELA CARDExecutive Director, Supply Chain - Trade Compliance and Supply Chain Security

4:25 pm – 5:00 pm

QUALITY AND COMPLIANCEIDENTIFYING THE CRITICAL NEEDS OF QUALITY AND QUALITY SYSTEMS IMPLEMENTATION WITHIN YOUR ORGANIZATION• Developing a document hierarchy to

achieve a modern quality system• Improving process performance and

product quality monitoring systems• Selecting the appropriate metrics to

measure Quality System performance• Examining the implementation of ICH

Q10• Role of management review in ensuring

an effective quality system• Assuring appropriate implementation of

risk management into the Quality System

SUPPLY CHAIN AND LOGISTICSIDENTIFYING COUNTERFEIT PRODUCTS AND RAW MATERIALS IN THE SUPPLY CHAIN THROUGH ADVANCED ANALYTICS AND SYSTEMATIC APPROACHES TO MONITORING• Examining advancements in supply chain

tracking systems• Using shipment data to identify supply

chain patterns of counterfeiting and assess risk

• Making decisions to:• Sample shipment• Inspect sites

• Techniques for conducting supplier risk assessment and verification

• Gaining a deep understanding of supply chain monitoring

• Prioritizing risk at the raw material level, product level, rm level and shipment level

MANUFACTURING EXCELLENCE AND TECHNOLOGYTRANSLATIONAL CELL CULTURE TECHNIQUES FOR NEXT GENERATION DRUG DISCOVERY• Where is industry research for new

therapies going in the next 10 years?• Examining several emerging approaches

to improve cell culture technology for:• Stem cells• Artificial cells• Organs-on-chips• 3D Cultures, etc.

• Getting more relevant and more translational models for drug discovery

T. OLIVER CHAO, PH.D.Head, Emerging

Biomedical Sciences, External Innovation ANTHONY MIRE-SLUIS

Head, Global Quality

STACY L. SPRINGS, PH.D.Director, Biomanufacturing

Research Program (BioMAN) and Executive Director, MIT Consortium

on Adventitious Agent Contamination in

Biomanufacturing (CAACB), Center for Biomedical

Innovation

p6

5:45 pm – 6:20 pm

PANEL DISCUSSIONEXAMINING METHODS TO ADDRESS THE SKILLS GAP AND BUILD GLOBAL MANUFACTURING CAPACITY THROUGH TALENT DEVELOPMENT • How is the growing worldwide demand for vaccines and biologics shaping talent acquisition, management and retention practices?• Addressing the mobility of key talent across the globe• Developing talent internally and accessing a properly trained workforce• Assessing different options for developing talent:

• Job skills training grants• Government support• Partnering models• Apprentice training• University or technical school talent pools

• Best practices for sourcing talent for scale-up and commercialization, and building manufacturing capacity abroad• Looking ahead: What is the best way to mitigate risk through talent development?

ANDY RAMELMEIER, PH.D.SVP, Technical Operations

Biologics

JOYDEEP GANGULYVP and Head, Engineering,

Facilities and Operations

MELANIE TANCentre Director, Americas

JASON URBANSenior Director and Head,

Business Operational Excellence

WILBUR HODirector, Manufacturing

Support

6:30 pm – 7:30 pm

NETWORKING DRINKS RECEPTION

6:20 pm – 6:25 pm

CHAIR’S SUMMARY AND CLOSING REMARKS

Sponsored By:

DARREN DASBURGVP and Site Lead, Boulder

Manufacturing Center

p7

7:00 am – 7:55 am

NETWORKING AND BREAKFAST BRIEFS

8:05 am – 8:40 am

PROGRAMDAY TWO: May 24th, 2017

Benefit from additional learning by joining a moderated breakfast brief on pressing issues in the industry. Seating is limited, so please sign up early. Sessions will start at 7:00 AM and run for one hour. Additional seating will be provided if you would prefer to discuss other topics.

8:00 am – 8:05 am

CHAIR’S OPENING REMARKS

MANUFACTURING EXCELLENCEAND TECHNOLOGY CHAIR

QUALITY AND COMPLIANCECHAIR

SUPPLY CHAIN AND LOGISTICSCHAIR

KEYNOTEADVANCING YOUR QUALITY ORGANIZATION TO PREPARE FOR FUTURE PRODUCT PIPELINES AND BUSINESS OPPORTUNITIES • Addressing the reliability of commercial supply in the current global regulatory environment and complex international supply chain demands• Devising a manufacturing strategy for constantly changing market requirements:

• Personalized medicine concepts• Emerging markets and access requirements• Introduction of new product formats

• Supplementing large volume stainless steel equipment with disposables to enable a flexible supply of biopharmaceuticals• Managing multi-product operations to cope with an increasing number of products and more diverse manufacturing technologies

UWE BUECHELER, PH.D.Corporate SVP, Biopharmaceuticals

OPERATIONAL EXCELLENCE FOR THE QUALITY CONTROL LAB OF THE FUTURE: FROM TRANSFORMATION TO OPERATION

NIGEL SMART, PH.D.Managing Partner and

Owner

TAKE GMP DOCUMENTATION OFF THE CRITICAL PATH: PLUG-AND-PLAY BATCH RECORDS FOR ANY PRODUCT, ANY TIME

ALICIA WOODFALL-JONES

President

PAUL DALY, PH.D.CVP and Head of Global

Quality

PHIL EVANSSales Director, North

America

MARK DIMARTINODirector, Quality

Engineering, Operations Performance Excellence

OPTIMIZING VALIDATION PROCESSES IN AN EVOLUTIONARY INDUSTRY

ERIC ERICKSONPresident

p8

10:05 am – 11:05 am

PRE-ARRANGED 1-2-1 BUSINESS MEETINGS AND REFRESHMENTS (60 MIN.)

9:20 am – 9:55 am

8:40 am – 9:15 am

PLENARYADVANCING YOUR QUALITY ORGANIZATION TO PREPARE FOR FUTURE PRODUCT PIPELINES AND BUSINESS OPPORTUNITIES • How are quality teams gearing up for the next wave of products and capacity?• Embracing new technologies and automation in the progressive movement for change• Leveraging human talent to create and improve quality• Preparing staff to go beyond policy and basic compliance• Encouraging staff to make decisions that are good for quality

BRANDON VARNAUVP and Head, Operations Quality – Sanofi Specialty Care

SUPPLY CHAIN AND LOGISTICSDEVELOPING LEANER AND GREENER GLOBAL SUPPLY CHAINS • Delivering temperature assurance and supply chain profitability

with forward-thinking initiatives• Reducing waste and write-off costs through effective cloud based

data management• Discovering how an effective supply chain can improve agility and

sustainability

HANNA SÖDERSTRÖMKey Account Manager

MANUFACTURING EXCELLENCEAND TECHNOLOGYCASE STUDY: SIGNIFICANT TECHNOLOGY ADVANCES ENABLING INTEGRATED CONTINUOUS BIOPROCESSING • Developing a strategy for continuous bioprocessing• Increasing the use of innovative single-use technologies• Applying Lean thinking from batch to continuous bioprocessing• Examining how “one-piece ow” delivers higher quality and

productivity in a smaller footprint with shorter lead times• Reviewing the journey to continuous bioprocessing: Enabling unit

operations platforms• Delivering a robust platform process

IAN SELLICKDirector of Marketing, Pall Life Sciences

p9

11:45 am – 12:20 pm

11:05 am – 11:40 am

SUPPLY CHAIN AND LOGISTICSDESIGNING A COLD CHAIN NOW TO SUPPORT WHAT YOUR PRODUCTS WILL BE IN THE FUTURE• Understanding the future complexities

within your temperature controlled supply chains

• Accounting for the growth of cell therapies and other biologics

• Discussing the emergence of personalized medicine as the new normal and its nuanced distribution

• How to master a closed loop supply chain with specimens going from manufacturer to patient and back with modifications

• Assessing current industry innovations for primary and secondary packaging, and reducing vial breakage

VADIM KLYUSHNICHENKO,

PH.D. VP, Pharmaceutical

Development and Quality

QUALITY AND COMPLIANCETAKING A TOTAL COST OF QUALITY APPROACH TO RISK MANAGEMENT: ACHIEVING OPTIMAL DECISION-MAKING TO ENSURE RISK AND COST ARE IN CHECK• Unifying your decision-making process to

keep the cost/risk balance in check• Determining which shipments to focus

your limited resources is key part of the decision making process

• Moving away from a siloed organization mindset by improving collaboration between departments and partners

• Evaluate your product lines to determine where corners can be cut and where investment is needed

• Understand that price is just one dimension when developing your quality and supply chain strategy

EUGENIO FILIPPIAssociate Director, Plasma

Logistics and Analytics - Europe

MANUFACTURING EXCELLENCE AND TECHNOLOGYINNOVATION IN BIOPROCESSING AND MANUFACTURING FACILITY DESIGN – CURRENT TRENDS• Examining innovative elements on

modern bioprocessing and plant design• Discussing advancements in:

• Disposables• Closed system operations• Continuous processing

• Creating a less segregated simplified plant design

• Assessing risks associated with these technologies

BERTHOLD BOEDEKER, PH.D.

Chief Scientist, Global Biologics-Biotech

Development

PANEL DISCUSSIONADDRESSING CHALLENGES IN MEETING GLOBAL CAPACITY• What are companies thinking about when building new capacities?• How to best invest in capacity, emerging markets and technology• Seeking partnerships and alliance models to help overcome production challenges• Weighing the pros and cons of outsourcing - cost benefits, goal alignment, risk mitigation, geography, etc.• Increasing the agility of your organization in a global markets

RORY MULLENSVP

DAVID RADSPINNERGlobal Business Leader -

GE BioParks

MIKE BOYSONHead, Global Oncology

and Biologics Supply

SCOTT C. BATTISTVP, General Manager and

Site Head - Bayview

RAJESH KRISHNAN, PH.D.

Director, Biologics Process Development

NICK VROLIJK, PH.D.VP, Manufacturing

Operations

p10

12:25 pm – 1:25 pm

LUNCH AND LEARN ROUNDTABLE DISCUSSIONS * Registration on-site required

MEETING FUTURE PURIFICATION CHALLENGES BY ESTABLISHING PERFORMANCE TARGETS FOR THE DESIGN OF A PROTEIN A RESIN

LEACHABLES AND EXTRACTABLES: HOW TO REMOVE ELEMENTAL IMPURITIES FROM YOUR SIGHT GLASS?

WHAT YOU NEED TO CONSIDER WHEN CHOOSING A CDMO: TIMELINES, TECHNOLOGY AND COMMUNICATION

EMERGING SITUATIONS INCREASING THE DEMAND FOR BSL-3 MANUFACTURING

IMPROVING COST SAVINGS IN YOUR COLD CHAIN OPERATIONS THROUGH THE REUSE OF TEMPERATURE ASSURANCE PACKAGING: EXAMINING CASE STUDIES AND NEW TECHNOLOGIES

ARE YOU FORGETTING SOMETHING IN YOUR SINGLE-USE STRATEGY?

BRENDAN LUCEYMarketing Director, Pharma

and BioPharma

VISHAL KHUSHALANIDirector, Global Marketing

and Business Development

MIKE CURNUTTESales Director

PETER H. KHOURY, PH.D.

SVP and Chief Commercial Officer

SVEN LEEChief Business Officer

DEBRA HARRISVP and Site Head, San

Diego

MARTY SIWAKChief Technology Officer

QUALITY AND COMPLIANCESUPPORTING QUALITY, COMPLIANCE AND RISK MANAGEMENT THROUGH AN EFFECTIVE QUALITY METRICS PROGRAM• Health Authorities and the push to quality

and quality metrics, why it makes sense and how will it benefit all

• Making quality metrics part of your company culture with management and employees

• The “Operationalizing” of a FDA quality metrics reporting program within your organization

• Establishing and sustaining quality culture

• From development to commercial, the critical role of metric’s driven product quality surveillance

• Case study: Using informed analytics to drive decisions

JASON URBANSenior Director and Head,

Business Operational Excellence

SUPPLY CHAIN AND LOGISTICSMASTERING THE END-TO-END GLOBAL TRANSPORT AND REGULATORY LANDSCAPE OF COMMERCIAL BIOLOGICS FROM A DANGEROUS GOODS PERSPECTIVE• Examining the impact of the Dangerous

Goods regulations on your transportation modes

• Discussing best practices for:• Onboarding• Packaging/labeling• Temperature control processes

• Reviewing recent regulatory changes that affect cold chain shipments

• Selecting the best transportation mode for each destination while taking the regulations under consideration

• How to navigate the emerging market “gray area” of dangerous goods regulations

DEBBIE F. HAPEDirector, Global Dangerous

Goods Compliance

1:30 pm – 2:05 pm

MANUFACTURING EXCELLENCEAND TECHNOLOGYMANAGING QUALITY AND REGULATORY COMPLIANCE IN A GLOBAL ORGANIZATION WHILE FACING A CHANGING EXTERNAL ENVIRONMENT• Keeping up with ever-increasing volume

and constantly-raising expectations• Establishing effective systematic

approaches internally and with CMOs• Case study: Ensuring quality in process

development initiatives at the new Singapore Manufacturing Campus

• Scaling manufacturing globally to support organization-wide growth goals: What role does quality play?

DAVID G. PERKINSDirector, CMC Quality

p11

2:10 pm – 2:45 pm

INNOVATION SPOTLIGHT 2DEVELOPING A SCALABLE DISPOSABLE MANUFACTURING FACILITY FOR PRODUCING GENE THERAPIES• Examining the design and build of uniQure’s $32 million research and production facility:

• 10-month set-up time• Completing the project under budget• Beginning research and therapy production earlier than expected

• Discussing unique manufacturing features, such as critical monitoring systems, security features and data collection• Achieving flexibility through the use of singe-use and disposable systems• Getting products to clinical trials faster by producing products in-house vs. with CMOs

LANCE WEEDVP, US Operations

INNOVATION SPOTLIGHT 3EXAMINING PROGRESS IN ADCS: WHERE HAVE WE COME FROM AND WHAT DOES THE FUTURE HOLD?• Discussing robust process development for novel ADC technologies• Considerations for clinical manufacturing development in-house and with CMOs• Exploring steps for effective scale-up from clinical to commercial scale manufacturing• Overcoming challenges to managing complex supply chains• Looking forward: What new technologies and processes can help speed-up progress?

2:45 pm – 3:30 pm

3:30 pm – 3:35 pm

CHAIR’S REMARKS AND DELEGATE SURVEY PRIZE DRAW

BENJAMIN HUTCHINS, PH.D.Associate Director, Conjugation Process Development