IMPROVING PATIENT LIVES by consistently delivering high-quality biopharmaceutical products

The Difficult Decision – Identifying What’s Important for CDMO Selection

William Leonardi, Ph.D.Project Manager Wednesday, February 13, 2019

Avid Bioservices: A Dedicated Commercial CDMO

Avid is an experienced biologics CDMO with over 13 years of commercial

manufacturing history and an exemplary regulatory track record for

biotherapeutics approved and marketed in 18 countries. We partner with our

clients and take pride in the success of each product as if it were our own.

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Facilities Overview Located in Heart of West Coast Biotech Hub

Avid Bioservices Snapshot

Southern California

Avid HQ

Strategically located ~5 miles from John Wayne Airport

San Diego

Los Angeles

• Located in Orange County (Tustin, CA)

• 200 employees (164 operational, 36 SG&A)

• 182,000 ft2 of leased space in five adjacent buildings⎯ Two operational commercial manufacturing

facilities

⎯ Existing 42,000 ft2 shell space set aside for a new manufacturing facility for up to 6 x 2,000L bioreactors to support additional revenue growth

Single Use

Infrastructure Aligned with Industry Trends

Stainless Steel

1,000L

300L

100L

Avid is Well Positioned to Meet Growing Market Demand Given its Investment in Single-Use, Smaller-Scale Bioreactors

3 x 1,000L

3 x 2,000L

6 x 200L

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Agenda

CDMO Overview

What is CDMO?CDMO Service OfferingHow a CDMO becomes an important partner for industries?

How do you select a CDMO that suits your needs?

Process Flow of CDMO selectionAttributes and Questions to Consider selecting CDMOScore Card and Case Studies for CDMO selection

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CDMO Overview

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What is CDMO?

• Contract Development Manufacturing Organization– Provide services ranging from drug development through drug manufacturing

(commercial supply) that complies with GMP and Regulatory standard

• The growth of CDMO’s are attributed to dynamic of biopharmaceuticalindustries due to:– Drug losing patent– Reduction need of “in-house” manufacturing

• Current Biologics CDMO Market = $5.3 Billion

• Expected to grow by 8.3% YoY– Outpacing the growth of pharma industries(huge opportunities in CDMO biologics landscape)

Source:• The Pharmaceutical CDMO Industry is Consolidating. EY Report. Sept 2017• Review of Outsourced Manufacturing. Results Healthcare Report. 2017• Market Insight CDMOs. Bourne Partners. May 2018

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CDMO Service Offering

Source: The Pharmaceutical CDMO Industry is Consolidating. EY Report. Sept 2017

• A CDMO provides more service offerings and larger scale production than a CRO• New trend of One Stop Shop, where companies offers both CRO and CDMO services

CRO CDMO

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How a CDMO Becomes an Important Partner for Biopharmaceutical Industries

• Biologics and Biosimilar show a faster pacedgrowth than among other sectors (22.2%market share in 2021 vs 16.6% in 2015)

• 220 New Drugs are expected to be introducedin 2021 (biologics products lead the growth) –Demand for biologics manufacturing will increase

• Manufacturing biologic products would requireheavy investment, technology, manufacturingexpertise, long lead time, and more expenseto build a good reputation and track records –High overhead cost

• Externalizing manufacturing of biologicproducts to CDMO is highly desirable toreduce time to market and operationalexpense - pharma and biotech companies canfocus on its core capabilities and strengths

Source:• Review of Outsourced Manufacturing. Results Healthcare Report. 2017• Outlook of Global Medicines through 2021. QuintilesIMS

CDMO is an important partner to biopharmaceutical industries to help advancing its product from development to manufacturing and eventually commercialization stage

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How Do You Select The CDMO That Suits Your Needs

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How Do You Select The CDMO That Suits Your Needs?Process Flow of CDMO Selection (Request for Proposal)

Request for Proposal (RFP)

Short List the CDMO

Contract Awarded

Critical Questions that each companies need to ask themselves before approaching a CDMOwith RFP:

1. Understand your projects (Any special technologies required, scale of the productionfacilities, etc.)

2. Understand risk level (Risk factors often center around several areas: time, budget,experience, available capacity, and region/location)

3. Clear level involvement with future project management (clear line of communicationand expectation)

Developing a Clear and Focused Direction before Approaching a CDMOs will maximize the chance of successful partnership

Source: Selecting a CDMO: Strategies to ensure successful partnership. 14 Nov 2017 10

How Do You Select The CDMO That Suits Your Needs?Process Flow of CDMO Selection (Shortlist the CDMO)

Source: Selecting a CDMO: Strategies to ensure successful partnership. 14 Nov 2017

Reference

• Recommendation from Peers (Consultant, Industry Partners, CRO, etc.)

• Having objective references will help to short list the CDMOs that you want to partner with

Shotgun

• Look at the company directories during conferences and in catalogs

• Send CDAs and send out the RFPs to multiple companies

Match Capabilities with Criteria

• Combination of Reference and Shotgun Approach

• More experience and relationship working with multiple CDMOs

• Evaluate CDMOs based on the key criteria of Quality system, Capacity, and Technology

There is NO Right or Wrong Answer on the Approach above. The key to success in building a successful relationship is by understanding your focused directions and expectations

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Company Name Location

Size (# of Employee

)

Financial Status Technology Regulatory

ApprovedCommercial

ProductDisposables

UsedCell Line

DevelopmentProcess

Development

Pilot Scale Plant

Scale (Largest Brx Vessels) Cost Scheduling

Avid Bioservices Tustin, CA Small

(<250) Good All Yes Yes Yes Yes Yes Yes Large >1000L $$Med

(Between 9-12 Months)

Company B Boston, MA Large (>500) Good All Yes Yes Yes Yes Yes Yes Large >1000L $$$

Med (Between 9-12 Months)

Company C Manchester UK

Small (<250) Loss All Yes No Yes No Yes Yes Mid 100-

1000L $ Fast ( < 9 Months)

Company D Singapore Small (<250) Good All Yes Yes Yes No Yes Yes Mid 100-

1000L $$ Fast ( < 9 Months)

How Do You Select The CDMO That Suits Your Needs?Process Flow of the CDMO Selection (Awarding the Contract)

Additional Qualification can be altered based on the company needs

Snap shot of CDMO Score Card selection:

Qualification

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How Do You Select The CDMO That Suits Your Needs?Process Flow of the CDMO Selection (Awarding the Contract – Case Study 1)

• Headquarter/CMC Team Located in San Francisco, CA• Tech transfer process to CDMO• Process development and analytical development work required• 200L bioreactor scale to supply phase I studies• IND filing within 18 months from today

Company Name Location

Size (# of Employee

)

Financial Status Technology Regulatory

ApprovedCommercial

ProductDisposables

UsedCell Line

DevelopmentProcess

Development

Pilot Scale Plant

Scale (Largest Brx Vessels) Cost Scheduling

Avid Bioservices Tustin, CA Small

(<250) Good All Yes Yes Yes Yes Yes Yes Large >1000L $$Med

(Between 9-12 Months)

Company B Boston, MA Large (>500) Good All Yes Yes Yes Yes Yes Yes Large >1000L $$$

Med (Between 9-12 Months)

Company C Manchester UK

Small (<250) Loss All Yes No Yes No Yes Yes Mid 100-

1000L $ Fast ( < 9 Months)

Company D Singapore Small (<250) Good All Yes Yes Yes No Yes Yes Mid 100-

1000L $$ Fast ( < 9 Months)

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How Do You Select the CDMO That Suits Your Needs?Process Flow of the CDMO Selection (Awarding the Contract – Case Study 2)

• Headquarter/CMC Team Located in Chicago, IL• Looking for backup CDMO for its commercial products (process has been validated)• Production demand = 3 - 4 Lots per month• Minimum scale in 2,000L single use bioreactor • Process validation for new site required to be finalized 9 months from today

Company Name Location

Size (# of Employee

)

Financial Status Technology Regulatory

ApprovedCommercial

ProductDisposables

UsedCell Line

DevelopmentProcess

Development

Pilot Scale Plant

Scale (Largest Brx Vessels) Cost Scheduling

Avid Bioservices Tustin, CA Small

(<250) Good All Yes Yes Yes Yes Yes Yes Large >1000L $$Med

(Between 9-12 Months)

Company B Boston, MA Large (>500) Good All Yes Yes Yes Yes Yes Yes Large >1000L $$$

Med (Between 9-12 Months)

Company C Manchester UK

Small (<250) Loss All Yes No Yes No Yes Yes Mid 100-

1000L $ Fast ( < 9 Months)

Company D Singapore Small (<250) Good All Yes Yes Yes No Yes Yes Mid 100-

1000L $$ Fast ( < 9 Months)

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IMPROVING PATIENT LIVES by consistently delivering high-quality biopharmaceutical products

Thank You and Questions

William Leonardi, Ph.D.Project Manager Wednesday, February 13, 2019

Partnering with Avid

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Established Track Record

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Flexible Manufacturing Facilities: Current and Future Expansion

Franklin Facility• 12,000 ft2 facility

• cGMP manufacturing since 1993

• Inspected by multiple regulatory agencies

Commercial manufacturing since 2005 Fully disposable manufacturing process

Myford 1 Facility• 42,000 ft2 facility

• Commissioned in 2016

• Integrated QC labs for in-process samples, final release, & environmental monitoring

200L

1,000L

Single-useStainless Steel

1,000L300L

100L4 x 200L

2 x 1,000L

3 x 2,000L

Single-use

Faci

lity

Ove

rvie

wC

apac

ity

Future Expansion

Myford 2 Expansion• 42,000 ft2 open space

• Facility Design with twice the capacity as Myford 1

4 x 200L

6 x 2,000L

Single-use

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Collaborative approach with clients enables rapid responses to changing production requirements, client satisfaction and retention;

availability of multiple manufacturing platforms offers flexibility

Full Service Capabilities and Strengths

End-to End Solutions

Development, Analytical and Manufacturing Services

Exceptional Regulatory Track Record

Areas of Competitive Differentiation

Industry-LeadingRegulatory Track

Record

Flexible Manufacturing

and Development

Cost Effective and Timeliness

Customer Centric Approach &

Communications

Single use bioreactor technologies and state-of the-art facility enhances manufacturing efficiency, lowers costs, reduces space requirements, time-in-plant and eliminates cleaning

requirements; one campus centralizes activities for speed and timeliness

Customer focused from start to completion, provides tailored strategies across all stages, smaller organization enables high responsiveness;

Strong project management team focused on the client & communication

Demonstrated track record of strong regulatory compliance with global agencies; 13+ year history of commercial manufacturing

Commercial Supply

Early & Late Phase Clinical SupplyProcess Development Pilot Scale

ProductionProcess

Characterization & Validation

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Dedicated Project Management Teams

• Single point of contact throughout the project(s) & back up PM support• Bi-weekly status calls to maintain open & direct communication• Optional routine functional calls to expedite project activities• Detailed and transparent project contracts and status updates• Focused on expediting manufacturing to meet customer and patient

needs• Highest standards of quality and integrity—outstanding customer service

• Project management team all come from a scientific background• Drug development, quality or manufacturing experience

• Established core project team & joint steering committee for each project• Timely and solution based responses to client requests• Functional project activities completed in parallel to expedite timelines• Defined meeting types and escalation approach

SUCCESS DRIVEN

BROAD INDUSTRY

EXPERIENCE

RAPID RESPONSE

Avid maintains a strong reputation for providing flexible, client-focused project management

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Your Trusted Partner for Quality Solutions & Reliable Results

Fully Integrated & Experienced CDMO Partner—from cell line development to commercial drug supply✔

Robust Quality Systems—exemplary regulatory inspection history, delivering quality biotherapeutics to improve patients’ lives✔

World-Class Capabilities & Flexible Facilities—to meet your most demanding biomanufacturing challenges and timelines✔

Cost Effective and Timeliness—Strength across single use platforms and all services centralized in one location translate to cost and time savings for you and speed to market and patients✔

✔

✔

Customer Centric Approach—a collaborative partner with expertise to deliver tailored services & creative solutions when needed

Empathy—former in-house product development experience brings a unique perspective, understanding & passion for your molecule

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