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AMERICAN BIOMANUFACTURING SUMMIT 2019

JUNE 18-19, 2019

HYATT REGENCY SAN FRANCISCO AIRPORT • SAN FRANCISCO, CA

biomanamerica.com

+1-416-298-7005

[email protected]

TOMORROW’S CONNECTION TODAY

Designing a new future for manufacturing, quality and supply chain leaders

PROGRAM

American Biomanufacturing Summit 2019 Program • Page 1

DELEGATE REGISTRATION AND BREAKFAST

CHAIR’S WELCOME AND OPENING REMARKS

RAJ K. PURI, M.D., PH.D.

Director, Division of Cellular and Gene Therapies Office of Tissues and Advanced Therapies

PLENARY ADVANCING MANUFACTURING FOR ADVANCED THERAPIES

• Examining examples of cell and gene therapies

• Discussing the need for consistent manufacturing and characterization processes

• Reviewing the challenges of logistics and manufacturing for autologous cells

• Solutions on the horizon for cell and gene therapy manufacturing

• Simplifying agency interactions for gene therapy products

• Plans for CBER laboratory research programs and collaborations with academic and public-private partners to advance the field

6:15 am – 7:15 am

7:20 am – 7:30 am

8:05 am – 8:40 am

PROGRAM DAY ONE

PAUL DALY, PH.D.

Corporate VP and Head,

Global Quality

MANUFACTURING AND TECHNOLOGY CHAIR

7:30 am – 8:05 am

* JOIN US FOR THE PRE-EVENT HAPPY HOUR ON JUNE 17, 2019 AT 6:00 PM – 7:00 PM

KEYNOTE ATTRIBUTES OF GREAT LEADERS TO CREATE A GAME-CHANGING CULTURE

• Setting clear expectations of where we need to be in one, five, 10 years from now

• Ability to connect with others and motivate people to do what is important

• Engaging and empowering teammates to help address the skills gap

• Discussing how culture informs new products and process from R&D to the patient

• Examining the right mindset and culture needed to drive productivity and ingenuity

• Focusing on the future: What’s next to drive continuous improvement and innovation in the industry?

RON BRANNING

SVP, Quality

QUALITY AND COMPLIANCE CHAIR SUPPLY CHAIN AND LOGISTICS CHAIR

Sponsored By:

TIM MOORE

EVP, Technical Operations

VIMAL GANDHI

Director, Global BioVentures

Supply Operations and Strategy


PLENARY LEVERAGING GLOBAL CHANGE TO TRANSFORM OPERATIONS AND DESIGN A NEW FUTURE

• Designing a new future for manufacturing and supply chain leaders

• Examining the state of the bioproduction industry and its impact on global operations:

• Evolution of medicines

• CMO/CDMO consolidation

• Capacity and complexity

• Cost Pressures

• How is Teva taking a leading role in shaping this new future?

• Discussing capabilities needed to drive business performance

HERMANN ALLGAIER, PH.D.

Managing Director and Executive Board Member

PRE-ARRANGED 1-2-1 BUSINESS MEETINGS AND REFRESHMENTS

8:40 am – 9:15 am

10:00 am – 11:40 am

9:20 am – 9:55 am

ROOM 2 USING RISK-BASED TOOLS FOR A SEAMLESS AND

EXPEDITED TRANSITION FROM CLINICAL

MANUFACTURING TO PROCESS PERFORMANCE

QUALIFICATION (PPQ) READINESS

• Discussing the latest tools to drive process

improvement and process characterization

• Exploring the benefits of systematic process

mapping

• Examining risk-based methods for bioburden

verification

• Case study: Lessons learned from expediting

breakthrough designation molecules and

biosimilars

ROOM 1 INTEGRATED SOLUTIONS FOR EFFICIENT PROCESS

SCALE-UP AND SINGLE-USE FACILITY START-UP AND

PROJECT EXECUTION

• Leveraging of standard platforms

• Sizing and selection of optimal process

equipment

• Harmonization and simplification of project

execution

• Scale-up and material generation services to

reduce time to facility start-up

• Considerations for design of consumables for

complete process

MATT NILOFF

Director, Integrated Solutions

ROOM 3 ENSURING SAFE AND SECURE HANDLING OF

BIOLOGICS IN YOUR SUPPLY CHAIN

• Why talent and innovation should be at the

heart of a supply chain and logistics strategy

• Understanding the needs of specific, time-critical

shipping requirements and the differences

needed for clinical trials vs. commercialization

• Importance of inventory management and full

integration with technology platforms

• Delivering on an unmatched level of customer

service and superior handling

• Ensuring just-in-time delivery of products

OLGA KOPER

Senior Director,

Business Development ABEL HASTINGS

Director, Process Sciences

ERIN SUMMERS

VP, Strategic Marketing


MANUFACTURING AND TECHNOLOGY INDUSTRY 4.0: TAKING THE STEPS TO CREATE A

“DIGITAL FACTORY” AND SHAPING THE FUTURE OF

VACCINE MANUFACTURING

• Discussing the impact of digitization on people,

process and production

• Defining the capabilities you need for success

• Understanding the technology landscape and

your digital maturity

• Focusing on the projects that will bring the most

value

• AI and Machine Learning: Further integrating

these into your operations

• Getting started on a digital journey with small

pilot projects

• Case study: Implementing a digital strategy at

Takeda

• Providing truly revolutionary differentiation for

vaccine manufacturers

QUALITY AND COMPLIANCE QUALITY CULTURE AND QUALITY LEADERSHIP:

WHERE ARE WE NOW AND WHERE ARE WE HEADED

IN THE NEXT 5 YEARS?

• Exploring three crucial questions we need to ask:

• What are we trying to achieve with

Quality Metrics?

• What would we want quality culture

in our industry to look like?

• How effective is your process

capability program in driving product

quality?

• Examining different approaches to create a

quality culture within an organization

• Creating a quality ecosystem as an agent of

change

• Engaging and motivating teams to strive for

Continuous Improvement

SUPPLY CHAIN AND LOGISTICS UTILIZING JOINT AUDIT PROGRAMS TO ENSURE THE

QUALITY OF RAW MATERIALS USED IN PRODUCTION

• Establishing strong operational control and

quality processes to drive supply chain

transparency

• Mitigating supply chain risk through the

application of regulatory guidance and

independent best practices

• Building a better culture of quality across

complex global supply chains

• Case study: Improving supply chain reliability

through the standards and mechanisms of Rx-

360 in conjunction with the regulatory guidance

ANDERS VINTHER, PH.D.

VP, Global Quality

and Engagement

12:25 pm – 1:00 pm

11:45 am – 12:20 pm

JIM FRIES

CEO

RAHUL SINGHVI, PH.D.

Chief Operating Officer, Takeda

Vaccines

ERIC BERG

Director, Quality

PLENARY LEVERAGING TECHNOLOGY AND ARTIFICIAL INTELLIGENCE TO ACCELERATE IMPROVEMENTS IN EFFECTIVENESS AND PRODUCTIVITY IN THE SUPPLY CHAIN

• What are the best investments in tools and technology for improving supply chain performance?

• Understanding normal supply variability, demand patterns and drivers of variability

• Connecting data across multiple systems to improve root cause analysis

• Planning, scheduling, and prioritizing processes based on the new understanding of supply and demand variability

• Transitioning to demand-driven production with simplified status visibility across the supply chain

• Case study: Demonstrating a quantum leap in performance through a new supply chain management approach

JAIME VELEZ

Partner


1:05 pm – 2:05 pm

ACHIEVING GLOBAL CONTRACT MANUFACTURING

EXCELLENCE

HELPFUL STRATEGIES FOR A SUCCESSFUL PHASE I-II

RELATIONSHIP WITH YOUR CDMO

LUNCH AND LEARN ROUNDTABLE DISCUSSIONS

Benefit from additional learning by joining a moderated roundtable discussion on pressing issues in the industry. Choose from:

Seating is limited, so please sign up early. Sessions start at 12:45 pm and run for one hour. More seating will be provided if you would prefer to discuss other topics.

IMPROVING COST SAVINGS IN YOUR COLD CHAIN

OPERATIONS THROUGH THE REUSE OF

TEMPERATURE ASSURANCE PACKAGING

EXPLORING INNOVATIVE APPROACHES FOR SINGLE-

USE, FLEXIBLE, AND SMALL-SCALE GMP

MANUFACTURING

STORAGE AND DISTRIBUTION OF TEMPERATURE

SENSITIVE BIOLOGICS: HOW DO YOU KNOW WHAT’S

HAPPENING TO YOUR PRODUCT AFTER IT’S LEFT

YOUR FACILITY?

OPTIMIZATION OF A COMMERCIALIZED DRUG

SUBSTANCE MANUFACTURING PROCESS

DISCUSSION AND INTERACTION BETWEEN END-

USERS, INTEGRATORS AND DISTRIBUTORS DURING

THE PROCESS OF QUOTING SINGLE-USE PROJECTS

ADVANCING QUALITY BIOTHERAPEUTICS FROM

CONCEPT TO COMMERCIALIZATION

UTILIZING DIAGNOSTIC TOOLS THAT ACCELERATES

MEDICAL DISCOVERIES THROUGH A NOVEL

APPROACH TO CELL ANALYSIS AND SORTING

EMPLOYEE JOB SATISFACTION OR EMPLOYEE

ENGAGEMENT: WHICH HAS THE GREATER IMPACT

ON CREATING A CULTURE OF ORGANIZATIONAL

EXCELLENCE?

FINDING YOUR ORGANIZATION’S ROAD MAP TO

SUCCESS FOR QUALITY AND REGULATORY MATTERS

BUILDING TOMORROW’S ADVANCED THERAPY

MEDICINAL PRODUCTS (ATMP) FACILITY TODAY

DANIEL MARTINEZ

Senior Vice President

SPEAKER TBA

DEREK UNG

Associate, Bioprocess Specialist

DYLAN T. LINCOLN

OEM BioProcess Manager

SEAN J. HART, PH.D.

Chief Executive Officer and

Chief Scientific Officer

NIKKI NOGAL, PH.D.

Senior Consultant HUA TU, PH.D.

CEO and Chairman

BRUCE FRAZIER

Director, Business and

Contracts

ARYO NIKOPOUR

SVP, Scientific and Technical

Services and Supply ANDREW SINNEN

Director, Sales

JEFFREY GUTKIND

Senior Business Development

Manager

PATRICK HALEY

Director, Project Management

BRINGING PRECISION MEDICINE TO MARKET:

DIVERSE THERAPIES CREATING COMPLEXITY AND

DIGITAL INNOVATIONS DRIVING MODERNIZATION

AMIT BHATIA

Senior Director


2:10 pm – 2:45 pm

ROOM 3 LEGAL AND REGULATORY ISSUES IMPACTING THE

SUPPLY CHAIN AND COMMERCIAL TRANSACTIONS,

RISK MANAGEMENT AND BEST PRACTICES

• Discussing the importance of experts in litigation

and government investigations

• Lowering litigation risk

• Conduct risk assessments and counsel clients on

risk mitigation.

ROOM 1 THE IMPACT OF INNOVATION ON BUILDING THE

FACILITIES OF THE FUTURE

• How to maintain flexibility and adaptability

during a facility build in the midst of constant

changes

• Creating a modern facility using emerging

technologies and cutting-edge equipment

• Adapting quickly and overcome challenges while

not losing sight of the envisioned goal

• Case study: Overcoming challenges and changes

encountered during an innovative cell therapy

facility build

• Discussing engineering and quality principles

used to overcome obstacles

JOHN W. JONES, JR.

Partner and Chair, Health Care

Transactions and Regulatory

ROOM 2 PROJECTING QUALITY: ASSURING CULTURE AND

COMPLIANCE IN THE BIOMANUFACTURING SUPPLY

CHAIN

• Examining common supply chain challenges that

require a sharper, deeper view of the global

supply landscape

• Understanding the current environment of

emerging standards, corporate churn, new risks

and finite resources

• Three key areas of supply chain evaluation and

monitoring that represent best practice, and

maximize the effectiveness of internal and

external resources

• Identifying and addressing supply chain

vulnerabilities. Staging for success – the pre- and

post-audit process

• Following-up, closing the loop, and adapting the

process

• Using data analytics to make your team and

your supply chain better

GERARD PEARCE

Executive Vice President

2:50 pm – 3:25 pm

QUALITY AND COMPLIANCE BUILDING A QUALITY CULTURE: KEY ELEMENTS IN

IDENTIFYING GAPS AND BUILDING A PLATFORM

FOR CONTINUOUS IMPROVEMENT

• Reviewing universal key elements to ensure a

quality culture

• Discussing ICH Q10 Pharmaceutical Quality

System (QS) Elements

• What are the FDA’s current Quality Metrics and

what you need to be aware of?

• Identifying gaps and implement a platform for

continuous improvement

MANUFACTURING AND TECHNOLOGY DISCUSSING THE IMPORTANCE OF ARTIFICIAL

INTELLIGENCE AND MACHINE LEARNING IN

BIOMANUFACTURING INFRASTRUCTURE PLANNING,

FACILITIES OPERATIONS AND STRATEGY

• What are the top leaders in global industries

doing to improve efficiencies in their product

supply chain?

• Examining where technology is in the

biomanufacturing industry and projecting where

we're headed

• Exploring tools and approaches that greatly

increase your ability to create value faster and

within the most difficult situations

• Driving technology in your supply chain: AI and

machine learning

• Using data-driven techniques to ensure on-time,

on-quality biologics

• Creating a results-oriented global supply chain

and operations workforce

• What's next?: Making a roadmap ready for the

Age of Disruption

SUPPLY CHAIN AND LOGISTICS CASE STUDY: DEVELOPING RELATIONSHIPS AND

USING EFFECTIVE GOVERNANCE MODELS WITH

SUPPLIERS TO ENSURE RELIABLE END-TO-END

MANUFACTURING COMPLIANCE

• How does Bayer’s External Relationship

Governance model value to the business?

• Techniques for ensuring a sustainable and

reliable partnership

• Examining common roadblocks of operating in

Brazil that affect the supply

• Establishing relationships and building trust with

CMOs to guarantee the security of supply

• Concepts and tips that can be implemented to

improve relationships analysis

LUIZ ALBERTO BARBERINI

Head, External Manufacturing,

Latin America

RON BRANNING

SVP, Quality

JOYDEEP GANGULY

SVP, Operations

CHRISTOPHER MCDONALD

VP, Manufacturing

JOHN KHOURY

VP, Operations


FIRESIDE CHAT EVOLVING EXTERNAL COLLABORATION MODELS: HOW OUR INDUSTRY’S BUSINESS PARTNERSHIPS HAVE CHANGED OVER TIME AND HOW TRENDS WILL CONTINUE

IN THE FUTURE

• Assessing and address issues of over- or under-capacity in today’s industry

• Examining how our industry’s business partnerships have changed over time

• What does the current state of partnerships say about the future?

• Having an external partner that can absorb projects in times of internal under-capacity

• Utilizing a combination of internal and external expertise and technology to propel innovation

• What's next: Where are we headed and what collaboration models will help get us there?

KELVIN H. LEE

Director

5:35 pm – 6:10 pm

3:30 pm – 4:05 pm

ROOM 1 BEST PRACTICES AND IMPORTANT

CONSIDERATIONS IN THE PROCUREMENT OF

UPSTREAM BIOPROCESS EQUIPMENT

• How does the total cost of ownership of

upstream equipment tie into with the complexity

of a system?

• Maintaining a high level of flexibility of

equipment while still dealing with many process

unknowns

• Reviewing control systems and their implications

on different scale equipment

• Looking forward: Increasing robustness and

reliability of systems

ROOM 3 ACHIEVING DIGITAL TRANSFORMATION: CRITICAL

DRIVERS FOR THE “NEW WAY OF WORKING”

• Why is digital transformation one of the most

complex and disruptive initiatives an

organization can experience?

• Understanding the drivers of successful digital

transformation

• Examining the 4 Essentials for Strategy

Execution, and 6 Qualities of a Digital Culture

• Learning why behavior change is required at all

levels of the organization

ANN RAI

Sales Engineer

KIM HUGGINS

Partner

ROOM 2 CASE STUDY: REDUCING CLEANING AND CROSS-

CONTAMINATION RISK IN SINGLE-USE POWDER

HANDLING

• How cleaning validation is getting more difficult

as the industry gets better at detecting dust and

particles

• Enabling rapid turnover of campaigns to get you

to market faster

• Understanding how powder handling is a bigger

challenge than liquid handling and why it is

often overlooked as a potential source of

contamination

• Improving and simplifying both the

manufacturing of the biologics and Antibody-

Drug Conjugates (ADCs) with on-demand media

and buffer prep and contained HPAPI handling

JOANNE BECK, PH.D.

EVP, Global Pharmaceutical Development and Operations

4:10 pm – 5:30 pm

HAPPY HOUR AND PRE-ARRANGED 1-2-1 BUSINESS MEETINGS


TIM MOORE


NETWORKING DRINKS RECEPTION

7:00 pm – 8:00 pm

Sponsored By:

6:10 pm – 6:55 pm

PANEL DISCUSSION DRIVING MODERN DAY QUALITY THINKING AND OPERATIONAL APPROACHES

• Exploring the historical role of quality and what's needed to be successful in the future

• How can quality be of greater benefit to an organization beyond compliance?

• What motivations do both quality and operations teams need have to modernize?

• Discussing examples of how quality is helping take organizations to a new modern state

• Learning from successful quality activities that propel change

CHAIR’S SUMMARY AND CLOSING REMARKS

6:55 pm – 7:00 pm

CHRISTOPHER BELL

VP, Quality Systems and

Compliance

TINA SELF

VP, Quality, Supply Center

Berkeley

ANDY RAMELMEIER, PH.D.

SVP, Chief Manufacturing and

Quality Officer

PAUL DALY, PH.D.


Global Quality


RON BRANNING

SVP, Quality


VIMAL GANDHI



ZHI XU TAN

Regional Director,

New York Off


CHAIR’S OPENING REMARKS

KEYNOTE TECHNICAL OPERATIONS: FOCUSED ON THE FUTURE

• How does the industry best plan for the future of personalized therapeutics and new modalities?

• Discussing the right mindset to drive strategy product development success

• Keys to driving productivity:

• Manufacturing: Building a flexible manufacturing environment

• Quality: Improving capabilities for CMC and analytical chemistry

• Logistics: Disruptive supply chain models

• What's next?: Discussing the next generation of biomanufacturing on the horizon

• Bringing down the cost of goods and creating a second revolution in bioprocessing

• Increased competitiveness by reducing cost and increasing market access

8:10 am – 8:45 am

PROGRAM DAY TWO

ROBERT A. BAFFI, PH.D.


NETWORKING BREAKFAST

WOMEN IN LEADERSHIP ROUNDTABLE

Enjoy breakfast refreshments and informal networking in the Exhibition Hall. We also invite our attendees to network at a Women in Leadership Roundtable with

discussion from inspirational leaders in manufacturing, quality and supply chain. Seating is limited, so please sign up early.

8:05 am – 8:10 am

7:00 am – 8:00 am

DIANE BLUMENTHAL

Head, Technical Operations NEVADA BLAIR

Director, Supply Chain

RAN ZHENG

Chief Technical Officer

RUBY GULATI

Head, Supplier Collaborations

and Quality Management

PAUL DALY, PH.D.


Global Quality


RON BRANNING

SVP, Quality


VIMAL GANDHI



GARGI MAHESHWARI, PH.D.

AVP, Biologics Process Develop-

ment and Commercialization

JILL ZUNSHINE

SVP and Head, Global Real

Estate, Facilities,

and Procurement


9:55 am – 10:30 am

PLENARY CONTINUOUS PROCESS VERIFICATION OF NEXT GENERATION PROCESSES UTILIZING ADVANCED PROCESS CONTROL

• Minimizing process input variability through better raw material control

• Achieving greater process understanding and control through real-time analytics

• Reviewing examples of robust process design and advanced process control

• Applying tools to assure process and product quality consistency

• Discussing elements of a predictive model development strategy:

• Data acquisition and population

• Data pre-treatment and exploratory analysis

• Model optimization and validation

• Seeing adaptive control as a critical element of process consistency

ROHIN MHATRE, PH.D.

SVP, Pharmaceutical Development, Engineering and Technology

PLENARY NAVIGATING THE UNIQUE MANUFACTURING CHALLENGES IN CELL AND GENE THERAPY AND WHAT WE CAN LEARN FROM OUR PAST EXPERIENCES

• What are the unique challenges to the gene and cell therapy manufacturing processes?

• Why supply chain needs a lot of attention, from starting materials, vector banking, frozen vial to chain of custody and how to build it robustly

• How does cell and gene therapy capacity planning compare to products in the past?

• Re-thinking the capacity dilemma: CDMO, build our own facilities or partnership strategies for facility build, space sharing and co-control?

• Highlighting Sangamo’s approach to addressing these challenges

8:45 am – 9:20 am

ANDY RAMELMEIER, PH.D.

SVP, Chief Manufacturing and Quality Officer

PLENARY DISCUSSING THE TOP 5 TECHNOLOGY TRENDS TO GIVE YOUR BIOPHARMACEUTICAL PROCUREMENT FUNCTION A COMPETITIVE EDGE

• Examining how are other industries are leveraging technology to innovate their business

• Applying these innovative technologies to the bio/pharma industry, and examining the productivity pay-off

• How automation will disrupt the industry

• Exploring key elements to building a future-proof procurement strategy?

• A new learning culture: Preparing your teams for new technology adoption and more experimental innovative techniques

JILL ZUNSHINE

SVP and Head, Global Real Estate, Facilities, and Procurement

9:20 am – 9:55 am

10:35 am – 11:55 am

PRE-ARRANGED 1-2-1 BUSINESS MEETINGS AND REFRESHMENTS


ROOM 2 CASE STUDY: EXPLORING THE IMPLEMENTATION OF

A MULTI-PROCESS, LARGE-SCALE, END-TO-END AND

REAL-TIME MODELING SYSTEM

• Understanding the requirements and strategic

fit of the project

• Establishing planning and scheduling processes

scope

• Examining concept feasibility, real-time

scheduling implementation, etc.

• MES Interface management: Gaining easy and

reliable data

• Debottlenecking capacity issues through staffing

forecasts and simulations

12:00 am – 12:35 am

ROOM 1 DISCUSSING THE EVOLUTION INTO A DIGITAL

BIOPHAMA ENVIRONMENT AND POTENTIAL

EFFICIENCY GAINS

• What is your organization doing with

unstructured data for compliance and quality

assurance purposes? a

• How to leverage this data for process

optimization

• Examining data sets that can provide insights

into potential efficiency gains

• Developing requirements needed to get to a

desired future state

• Case study: Comparing high yield batches of

biopharmaceuticals with low yield batches to

determine cell-culture media quality

• Adapting to the need for deeper knowledge of

bioproduction methods to produce better

therapeutics

ROOM 3 BUYER AND SELLERS PERSPECTIVES: STREAMLINING

TECHNICAL OPERATIONS AND QUALITY

INTEGRATION DURING M&A

• How to ensure operating models are effectively

designed and implemented

• Discussing acquisition diligence and post-merger

integration

• Best techniques for managing digital technology

adoption and Big Data across a global network.

• Case study: Seeing bottom-line results from an

enhanced manufacturing and supply strategy

DAVID ZHANG

CEO

CHRIS KOPINSKI

Global Product Leader, Analytics

12:40 pm – 1:15 pm

QUALITY AND COMPLIANCE ACCELERATING DEVELOPMENT AND INNOVATION:

MANAGING INCREASED QUALITY DEMANDS, TIME

TO MARKET AND THE NEED FOR FLEXIBILITY

• Discussing the constraints and complexities of

vaccine product development and manufacture

• Examining the evolution of bioprocess and

analytics technologies to accelerate and

overcome these challenges

• Leveraging innovation and technology for rapid

product development to shorten time to clinical

trials

• Case study: Accelerating process and analytical

development

• Exploring potential technologies that could play

a role in accelerating product development in

the future

SUPPLY CHAIN AND LOGISTICS APPLYING LEAN CONCEPTS TO DRIVE INNOVATION

IN BIOPHARMACEUTICAL DEVELOPMENT AND

MANUFACTURING

• How is Roche/Genentech applying lean concepts

to pilot manufacturing operations and facilities?

• Determining the best way to make medicines

faster and at larger scales

• Overcoming challenges in going from small-scale

to large-scale production

• Examining processes and equipment that can

help improve cost savings and efficiencies

MANUFACTURING AND TECHNOLOGY CASE STUDY: CREATING A FUTURE-FOCUSED

BIOMANUFACTURING FACILITY AND PORTFOLIO

• What does the current clinical and commercial

capacity look like at Chugai, and what's next?

• Examining the importance of creating a modular

facility for commercial biologics manufacturing

• Exploring recent design and technology trends

new directions in modular manufacturing.

• Using enabling technologies and innovative

thinking to ensure the right strategy for the

future

HIROSHI MURATA, PH.D.

VP and General Manager,

Pharmaceutical Technology

JEFF DAVIS

Head, Operations and

Engineering, US Biologics

Process Development

JEAN MARIE BOUVIER


and Digitalization

ZHOU YU, PH.D.

Director, Global Bioprocess

Expert, Bioprocess R&D


INNOVATION SPOTLIGHT MAKING GENE THERAPY A REALITY – CMC CONSIDERATIONS FOR FAST-PACED

PRODUCT DEVELOPMENT AND SPEED-TO-MARKET

• What are the challenges of taking a product from clinical to commercial?

• Conducting a technology transfer to external partners, and getting it right

the first time

• Developing a robust CMC program that meets regulatory requirements

• Ensuring the rapid delivery of quality product to the patients

DIANE BLUMENTHAL

Head, Technical Operations

1:20 pm – 2:20 pm

ENHANCING YOUR SUPPLIER RELATION

MANAGEMENT (SRM) PROGRAM TO CREATE

MOMENTUM FOR TECHNOLOGY INNOVATION AND

API PLANT MANAGEMENT AND QUALITY

OPERATIONS: ENHANCING YOUR EH&S AUDITS TO

ENSURE QUALITY AND REGULATORY COMPLIANCE

ENSURING A SUCCESSFUL COMPANY-CMO

RELATIONSHIP THOUGH GOAL ALIGNMENT,

COLLABORATION AND COMMUNICATION

LUNCH AND LEARN ROUNDTABLE DISCUSSIONS

Benefit from additional learning by joining a moderated roundtable discussion on pressing issues in the industry. Choose from:

BUILDING A BETTER BIOASSAY: PRACTICAL

APPROACHES TO UNDERSTANDING THE

BEST PRACTICES FOR CREATING WELL-DEFINED

MASTER SERVICE AND QUALITY AGREEMENTS WITH

CMOS

HOPE MUELLER

VP, Quality

MANAGING COMMERCIAL MANUFACTURING

LIFECYCLE STRATEGIES THAT LOWER THE COST OF

GOODS

MICHAEL MERGES

Director, Analytical

Sciences and Technology

NIAMH MALONEY

Senior Director, Chemical

Development and

Manufacturing

TAD THOMAS, PH.D.

AVP, Technical Operations

NATHALIE FRAU, PH.D.

Head, Biologics Technology

Innovation and Strategy,

Downstream Processing

PAUL HANSON, PH.D.

Senior Director,

Technical Operations, Global

Manufacturing and Supply

2:25 pm – 3:00 pm

DIRK SCHRADER, PH.D.

EVP and Head, Global Technical Operations

INNOVATION SPOTLIGHT INCREASING EFFICIENCY THROUGH AUGMENTED REALITY I

N REAL SHOP FLOOR

• Examining new technology that helps reduce setup times and increase

efficiency, productivity and quality

• Case study: Vifor Pharma AG's first realized shop floor application of a

system using Augmented Reality:

• Augmented Reality brought to the pharma shop floor

• First insights from Proof-of-Concept to day-to-day use

• Discussing improvements to performance, quality and employee

engagement

• What's next: Packaging line and other applications

CREATING A PATIENT-CENTRIC SUPPLY CHAIN IN

CELL THERAPY

DAVID KIM


MANAGING A COMPLEX GLOBAL SUPPLY CHAIN:

STRIKING THE BALANCE BETWEEN RISK, FLEXIBILITY

AND COST

BRIAN MCREE

Senior Director, Global Supply

Chain Management


3:40 pm – 4:25 pm

3:05 am – 3:40 am

PLENARY VISIONARY PLANNING AND INNOVATIVE THINKING PAY OFF

• What are the key opportunities and threats shaping the biologics industry today?

• How to strategically respond to those trends, and prepare for where the industry is heading over the next 5-10 years

• The Innovation Imperative: Examining critical success factors in biomanufacturing, including strategic outsourcing and partnering

• Examining technology and facility investments to create a dynamic flexible network

• Case study: Exploring future-focused advancements in Boehringer Ingelheim's bioproduction network

JENS H. VOGEL, PH.D.

President and CEO

PANEL DISCUSSION ADDRESSING CHALLENGES IN MEETING GLOBAL CAPACITY

• What are companies thinking about when building new capacities?

• How to best invest in capacity, contract manufacturers, emerging markets and technology

• Seeking partnerships and alliance models to help overcome production challenges

• Increasing the agility of your organization in a global markets

VIMAL GANDHI



TOMMY FANNING

Head, Biopharmaceuticals

and Food

CHAIR’S REMARKS AND DELEGATE SURVEY PRIZE DRAW

4:25 pm – 4:30 pm

PAUL DALY, PH.D.


Global Quality


RON BRANNING

SVP, Quality


VIMAL GANDHI



JOANNE BECK, PH.D.

EVP, Global Pharmaceutical

Development and Operations

BRIAN MCREE

Senior Director, Global Supply

Chain Management

TOM SPITZNAGEL, PH.D.

SVP, BioPharmaceutical Devel-

opment and Manufacturing

HEATHER ERICKSON

VP, Supply Chain Management

and Business Operations

american biomanufacturing summit 2019 - generis · american biomanufacturing summit 2019 program...

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