Domestic Mo-99 ProductionA look at efforts to secure a U.S. supply

Roy W. Brown

Sr. Director, Strategic Alliances

Mallinckrodt Pharmaceuticals

September 11, 2015

Background on Nuclear Medicine

Nuclear Medicine & Radiopharmaceuticals• Radiopharmaceuticals are FDA approved

drugs which are labeled with small quantities of radionuclides.

• The radiopharmaceutical concentrates in the area of the body to be examined where special cameras capture the nuclear particles or photons emitted by the radiopharmaceutical producing a visual image of the body system, organ or tissue

• Globally 30 million patients benefit from these procedures each year.

Tc-99m MDP Whole Body Scan

Tc-99m Sestimibi Cardiac Stress Test

The Importance of Mo-99/Tc-99m• Today, over 100 different nuclear medicine

applications exist, such as diagnosing heart disease, brain disorders, infections and treating cancer

• More than 80% of these applications (procedures) use Tc-99m from Mo-99/Tc-99m generators

• These procedures are one of the most accurate methods of combating cardiovascular disease

• This technique makes early diagnosis possible, thereby saving patients and the health industry millions of dollars every year

IMAGING THE LUNGSFOR BLOOD CLOTS

DIAGNOSING BRAIN DISORDERS

ACCURATELY DIAGNOSING CORONARY ARTERY DISEASE

EXPOSING THE SPREADOF CANCER

DIAGNOSING THYROID CANCER

SCANNING BONESFOR INFECTION

The Importance of Mo-99 & Tc-99m• Vital part of diagnostic and therapeutic

management of patients

– Nuclear cardiology represents 60%– Bone Imaging represents 17%

– Other imaging of brain, endocrine system, lungs, GI & GU tract, infection, and others.

• There are also a number of therapeutic nuclear medicine treatments for bone pain palliation related to Prostate Cancer, Non-Hodgkin’s Lymphoma and Thyroid Cancer

Breakdown of Tc-99m Nuclear Medicine Studies

Mo-99/Tc-99m Generators

• Tc-99m is a very effective radionuclide to image patients, but it’s 6 hour half-life creates delivery challenges.

• A generator provides a supply of Tc-99m that effectively decays with the half-life of the Mo-99 (~3 days) rather than the half–life of the Tc-99m (6 hours)

• Generators are typically used for two weeks, but can be used longer

Ultra-Technekow™ DTE Technetium Tc 99m Generator

Mo-99/Tc-99m Generator Operation

• The conventional Tc-99m generator utilizes a chromatographic column to selectively bind the Mo-99 to the substrate (aluminum oxide)

• The sodium molybdate (Mo-99) is chemically bound to the aluminum oxide in the column

• Saline solution is passed across the column to elute the sodium pertechnetate (Tc-99m)

Mo-99 Market Demand*

*Sources: Internal data. OECD report “The Supply of Medical Isotopes”, June 2011, with total demand revised.

Global Mo-99 Demand Approximately: 9,000 Ci / week

58%

25%

3%

8%2%

4%

Global Mo-99 Demand by Geography

North AmericaEMEALatin AmericaJapanChinaOther Asia

Production of Mo-99

The Eight Main Reactors for Irradiating Mo-99 Targets

OSIRIS ReactorThe OSIRIS reactor is scheduled to shut down at the end of 2015.

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High Flux Reactor (HFR)The HFR is property of the European Commission and is operated by the Nuclear Research and Consultancy Group (NRG).

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National Research Universal (NRU)Chalk River Laboratories are situated on the banks of the Ottawa River, in the upper Ottawa valley, Ontario.

Nuclear Research Centre (BR2)Belgian Reactor 2

Maria Research ReactorPoland

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South African Fundamental Atomic Research Installation (SAFARI-1)

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LVR-15 REZ ReactorCzech Republic

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OPAL ReactorAustralia

• Most of these reactors are 50-60 years old

• None are located close to the largest Mo-99/Tc-99m market (U.S.)

• A domestic supply would help with the security of supply

The Current U.S. Mo-99/Tc-99m Generator Supply ChainReactor Mo-99

ExtractionMo-99

Purification

HFR

BR2

OSIRIS

NRU

Safari

OPAL

Maria

MallinckrodtNetherlands

IREBelgium

NTP

AECL Nordion

ANSTO

MallinckrodtU.S.

Lantheus

LVR-15

Mo-99Processing

10/28/201512 |

13

RADWASTE SUMMIT

SEPTEMBER 11, 2015

Presented by:

Carolyn Haass, Chief Operating Officer

14

Organization

Irradiation Services

University Reactors

Radioisotope Production Facility Technology Demonstration

Engineering Design

Licensing and Environmental Permitting

Criticality, Shielding, and Safety Analysis

Transportation

ATKINS3rd Reactor

15

Primary Assumptions Single Radioisotope Production Facility (RPF)

– 99Mo produced using a fission based-method – “Gold Standard”

– Nominal capacity 3,500 6-day Ci; surge capacity of 1,500 6-day Ci

– Use low-enriched uranium (LEU)

– Recover 99Mo from LEU targets using standard chemical processes

Utilize network of University Reactors

– Utilize same target design for all reactors

Recycling processed LEU for reuse as target material

Fission product releases will comply with environmental release criteria and WOSMIP guidelines

Generate Class A, B, and C wastes; no GTCC waste

Uranium processing and storage will meet all required Safeguards & Security Requirements

Target

Dissolution

Irradiated LEU

Targets from

Reactor

Mo Recovery

& Purification

LEU Recovery

& Recycle

Decay

Storage

Waste

ManagementRadioisotope

Distributor

Mo99

I2, Kr, Xe

Removal

or Capture

Recycled LEU

back to LEU

Target Production

System

Accumulation Beds

(e.g., carbon, others)

16

NWMI Project Status and Schedule

Status

– Construction Permit (CP)

Application submitted

– RPF preliminary design completed;

Final design initiated

– Regularly producing Ci (6-day) of 99Mo from proof of concept

demonstrations

– Technology optimization currently

being performed

– Siting Decision Taken; Option

formalized– Network of irradiation suppliers

complete

Summary Schedule

– NRC CP approval anticipated early

2016

– Construction of RPF 2016 into 2017

– Initiation of production mid-2017

17

Technology

LEU target material is

fabricated (both fresh LEU

and recycled U)

LEU Target material

encapsulated using metal

cladding LEU Target

LEU Targets are

packaged and shipped to

university reactors for

irradiation

After irradiation, targets

are shipped back to RPF

Irradiated LEU targets

disassembled

Irradiated LEU targets

dissolved into a solution for

processing

18

Facility Description 1st Level footprint ~52,000 ft2

– Target Fabrication Area

– Hot Cell Processing area (Dissolution, 99Mo and 235U recovery)

– Waste Management, Laboratory and Utility Areas

Basement ~2,000 ft2 (tank hot cell, decay vault)

2nd Level ~17,000 ft2 (Utility, Ventilation, Off-Gas Equipment)

WM Out Building ~1,200 ft2

Administration Building (outside of secured RPF area) ~10,000 ft2

High bay roof – 65 ft

Mechanical area, 2nd Floor – 46 ft

Top of exhaust stack – 75 ft

Loading dock (back) roof – 20 ft

Support & Admin (front) roof – 12 ft

Depth below grade for Hot Cell/HIC storage – 15 ft

19

NRC Licensing Strategy

Combine several license activities and submit one application that covers all applicable

regulations for construction/operation of RPF under 10 CFR 50

University Reactor(s) and Cask Licensee(s) will amend their current operating license’s

10 CFR 50 Activities

– Irradiated Target receipt

– Irradiated target disassembly

– Target dissolution

– 99Mo separations, purification and packaging

– LEU reclamation and purification

– Waste management

– Associated laboratory and support

10 CFR 70 Activities

– Receipt of LEU (from DOE)

– Production of LEU microspheres

– Target fabrication and testing

– Shipping/loading of fabricated targets

– Llaboratory and support areas

10 CFR 30 Activities

– Handling of byproduct material

20

Radioisotope Production Facility Layout

NWMI-040132r01

Target fabrication area

Waste management area

Laboratory area

Tank

hot cell

Irradiated target

receipt area

10 CFR 70

Utility area

Administration and

support area

10 CFR 50

21

NWMI Challenges and Advantages

Advantages

NWMI 99Mo indistinguishable from

existing supply

– No change to generators

– No change to diagnostic modality

Network of existing University

irradiation suppliers

– Assurance of supply

– Surge capacity

Target Design

– Reactor safety

– No dissolution of metal cladding

Novel process extraction and

purification chemistry

– Proven Efficient

– 235U reclamation

Challenges

Heavily regulated industry with significant

review processes that are critical path to

production

National laboratory capability to support

optimization testing

Uranium lease take back

– T&C for both lease and take back

– Need of R&D LEU quantities not

integrated

– Receipt of LEU for commercial

production when required

– Requirements for LEU take back

Micro-porous Sorbent for 99Mo/99mTc Generator using (n,) 99Mo

L.F. Centofanti

Perma-Fix Environmental Services, Inc.

Isotope Production

23

Fission vs. Neutron Activation Process

24

235U(n, f)99Mo 98Mo(n,)99Mo

Requires enriched 235U target Requires high purity molybdenum

Produces high specific activity of 99Mo Produce low specific activity of 99Mo

Generates high level radioactive waste Generates minimal waste

Great concern about secondary fission

product

No fission product

Export of highly controlled material

required

Non-fissile material.

No proliferation concerns.

Medical Isotope ManufacturePerma-Fix Approach• Perma-Fix Environmental Services, Inc. has completed initial development

of a prototype 99mTc generator using a patent pending micro-porous composite (MPCM) resin

– MPCM can adsorb commercially significant amounts of low specific activity 99Mo produced by neutron activation

– MPCM based 99Mo/99mTc generator has the potential to allow neutron activated 99Mo to contribute significantly to the supply chain

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MPCM at a glance• MPCM was prepared using phase inversion technique

• The surface area of MPCM is very high - 15 m2/g with a pore volume of 0.012 cc/g

• MPCM is amorphous in nature

• Temperatures up to 100 °C do not adversely affect the adsorption capacity of MPCM

• MPCM resin is found to be resistant to extreme pH conditions

• The structure of MPCM has been demonstrated to maintain its integrity when exposed to 50,000 Krad Co-60 gamma radiation

26

MPCM Key Properties• MPCM has the capacity to adsorb up to 700 mg of Mo per dry gram

compared to alumina that holds approximately 20 mg/g

• The elution efficiency of a MPCM based generator exceeds 80% of the 99mTc generated

• Cost effective to prepare

• Adsorbs 99Mo quickly and efficiently

• Handling and hydraulic properties similar to alumina facilitate generator manufacture

27

MPCM based 99Mo/99mTc Generator• MPCM high adsorption capacity allows the use of neutron activated 99Mo

within a footprint similar to current generator designs

• Creates US Supply Chain

• Internationally creates local supply chain

• Does not require the use of uranium targets

• No “orphan” waste generated

• Cost competitive at existing price structure

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Successful Technology Validation

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• First set of independent tests conducted at POLATOM, the national center for nuclear research in Warsaw, Poland

– Reaffirmed previous testing

• Second set of tests conducted at the Missouri University Research Reactor (MURR) in Columbia, Missouri, USA

• Demonstrated 6.0 Ci Mo-99 in a column– Natural Molybdenum

– 1.5Ci Mo-99/g of Proprietary MPCM resin

– higher elution efficiency (80%+)

Katrina PitasVice President Business Development,

SHINE Medical Technologies

Modern, LEU-based, domestic

Mo-99 production

SHINE Technology Overview

• Integrated production and refining

• SHINE irradiation unit is a hybrid

– Accelerator-based D-T neutron generator acts as “spark plug”

– Neutrons multiply in subcritical uranium sulfate solution, allowing for very high yield

• Plant capacity around two-thirds U.S. demand (4000 6-day Ci/week)

• Fission Mo allows use of existing supply chain, no changes to pharmacy practices

• Cost effective approach

• Fission process ensures access to other isotopes, including I-131 and Xe-133

Neutron Generator

Subcritical Assembly

A modernized approach to making Mo-99

Facility Design

• Preliminary design completed early 2013

• Approximately 55,000 sq. ft. hardened production facility

• 8 irradiation units – ensures high reliability, flexible production schedule

• Independent hot cell chains further increase reliability and flexibility

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Major facility design and community integration effort has taken place

Regulatory

• Primary regulatory authority is the Nuclear Regulatory Commission (NRC)

• Submitted construction permit application in 2013

– Approximately 4000 pages– First application of its type to be docketed since the

1960s

• Have moved rapidly through application process• Draft Environmental Impact Statement was

issued in May• On track for construction permit issuance late

2015/early 2016

SHINE noted as model applicant and moving “at the speed of light” by NRC

“The Commission has approved publication of a Direct Final Rule as one step … addressing the construction permit application from SHINE. Others are not as far along in the process.”

-- Allison M. Macfarlane, NRC Chairman, August 27, 2014

NRC Construction Permitting ProcessMilestone Date Status

Receipt of Construction Permit Application

(Part 1of 2)March 2013 Complete

Receipt of Construction Permit Application

(Part 2 of 2)May 2013 Complete

Docketing of Construction Permit Application

(Part 1 of 2)July 2013 Complete

Environmental Scoping Meeting July 2013 Complete

Environmental SiteAudit August 2013 Complete

Issuance of Request for Additional

Information on Environmental ReportAugust 2013 Complete

Docketing of Construction Permit Application

(Part 2 of 2)

December

2013Complete

Issuance of Request for AdditionalInformation on Preliminary Safety

Analysis Report and Environmental Report

September

2014Complete

Milestone Date Status

Issuance of Supplemental Requests for

Additional Information on Preliminary

Safety Analysis Report and

Environmental Report

January 2015

March 2015

Complete

Pending

Completion of Draft Environmental Impact

StatementMay 2015 Complete

Completion of Safety Evaluation Report with

Open ItemsJuly 2015 Complete

Advisory Committee on Reactor Safeguards

Subcommittee MeetingsJune 2015 Underway

Advisory Committee on Reactor

Safeguards Full Committee MeetingOctober 2015 Pending

Publication of Safety Evaluation Report October 2015 Pending

Publication of Environmental Impact

StatementOctober 2015 Pending

Mandatory Hearing on Construction Permit

ApplicationTBD Pending

Strategic Progress

• Supply agreements signed with GE Healthcare and

Lantheus Medical Imaging in 2014

– First agreements with a U.S.-based producer

– First supply agreements with a non-government producer

• Additional supply agreements under negotiation

• SHINE market entry coincides with NRU shutdown in 2018 and the end of Canadian emergency production

Market conditions continue to provide a unique opportunity for SHINE

In Conclusion…SHINE technology and process has several clear competitive advantages

• U.S.-based, will avoid significant decay loss

• Operating costs much lower than reactor

• Substantially reduced material costs

• Product fits seamlessly into the existing supply chain

• Utilizes existing technetium generators

• Market validation – supply agreements executed with two of the largest Mo-99 buyers

• Proven accelerator technology replaces nuclear reactor

• Avoids the use of weapons-grade HEU completely

Superior EconomicsDemonstrated,

Patented TechnologyCompatible with Existing Market

Jim HarveySr. VP & Chief Science Officer,

Northstar

NorthStar’s Technologies for Producing Mo-99

10/28/2015 39

• Near Term Solution (1H2016)o Missouri University Research Reactor (MURR)

Contract in place effective March 2011, extended thru 2019 in 2014

o Will have the capability to produce >50% of the US requirement

o Developing ORC and redundancy with Westinghouse Electric Company

• Long Term Solution (2017/2018)o NorthStar’s electron accelerator methodology for the production of Molybdenum-99

o Will have the capability to produce >50% of the US requirement

• Once up and running both solutions will be used to supply not only the US market but also ROW

• These two approaches utilize NorthStar’s RadioGenix™ technology in order to guarantee success

Near Term and Long Term Solutions

10/28/2015 40

10/28/2015 41

Production of Mo99• NorthStar has been active in this option since 2009

o MURR originally produced Mo99 with nat-Mo up until mid-1980’s

• NorthStar/MURR capable of producing up to 3,000+ 6D Ci per week o One target set; one or more irradiation cans, per week (60 6D Ci – 3,000+ 6D Ci

Mo99; nat or enriched Mo dependent) processed

o Steady weekly production, and

o Dedicated shipping to client pharmacies from Columbia, MO; with return of

spent Mo99 solutions to Beloit, WI for recycle if enriched Mo98 used; otherwise

dispose of after DNS

• Production start upon FDA approval of the RadioGenix system

• No licensing issues; within scope of MURR’s current license

• No technical challenges

10/28/2015 42

Production of Mo99 via Reactor at MURR

10/28/2015 43

MURR NorthStar Dispensing Line #1

10/28/2015 44

MURR NorthStar Dispensing Line #2

10/28/2015 45

NorthStar Successful Integrated Production Run

• Announced May 5, 2015 that we successfully completed a full

scale production run of 100 6D Ci that included:o Target preparation

o Target irradiation

o Mo99 extraction/preparation

o Transfer to dispensing line

o Fill NorthStar Type A shipping vessels

o Ship overnight with receipt at facility within 8 hours

Mount and run RGX successfully to produce Tc99m

All microbiology and sterility data favorable

Successful completion and validation critical to FDA approval

Production of Mo99 via Electron Accelerator

10/28/2015 46

• NorthStar has been active in this field since Nov 2007o NorthStar funded effort at RPI in early 2008 to validate the 1999 INL publication

o Produced small quantities of Mo99 in that study and validated calculated estimates and

experimental results were comparable

• NorthStar facility will house electron linear accelerators capable of producing

>3,000 6D Ci per weeko steady, redundant production on a daily basis

o Have completed 4 x 24hr irradiations at ANL with targets processed and resulting Mo99 shipped

to NorthStar overnight for processing with RGX

o 6.5 day irradiation scheduled in Sept 2015

o No major remaining technical challenges; optimizing the full process

• Facility location - Beloit, WIo Located immediately adjacent to a new power substation being built with NorthStar requirements

incorporated in the design including redundant power from two separate transmission line sources

RadioGenix™

47

RadioGenix™ FDA Timeline

• October 2010 NorthStar met with the FDA to outline a path to NDA submission

• MURR submitted DMF for production via neutron capture in September 2012

• NorthStar submitted RadioGenix™ (TechneGen) DMF in October 2012

• January 2013 NorthStar submitted its NDA

• NorthStar received its Complete Response letter from the FDA on November 4, 2013 outlining deficiencies primarily in two areas

o Microbiological Control

o User Manuals

• NorthStar met with the FDA on February 27, 2014 to gain clarity on the CR letter

o NorthStar has submitted to FDA its revised Microbiological Test Plan (MTP) for comment

o Met with the FDA July 2, 2014 to MTP; “appears to answer our questions”

• NorthStar added ozone sterilization to the system and made other enhancements as a result

• NorthStar now generating data to support Amendment 11 to the NDA; to be submitted 4QTR15

10/28/2015 48

NorthStar Beloit Facility

49

Occupancy May 2015

Waste Profile

10/28/2015 52

• No uranium use (no Class C, GTCC or transuranic waste) thus all waste is Class A

waste providing major technical and cost advantages

o Tc99g requires monitoring in our waste profile 55 gal drum at 90 days decay will be <10% of limit

o Other isotopes at disposal time (nat-Mo targets):

Initial 90d

µCi/Ci Mo99 µCi/Ci Mo99

Sb-124 (↓) 3.96E-06 1.41E-06

Nb-92m (↓) 7.00E-06 1.48E-08

Nb-95 (↑) 2.13E-07 3.59E-08

Zr-95 (↑) 2.67E-08 1.01E-08

Cs-134 (↓) 6.67E-09 6.14E-09

Selective Gaseous Extraction:A transformational Molybdenum-99production technology

Tom Burnett

President, Medical Isotopes, Nordion

Sept 11, 2015

About Nordion

Nordion is a health science company that provides market-

leading products used for the prevention, diagnosis and

treatment of disease.

We’ve been delivering safe, high-quality products to

global customers for more than 60 years.

To best serve the diversity of our customers’ requirements,

we are organized into two business units–Sterilization

Technologies and Medical Isotopes.

APPROXIMATELY

375 EMPLOYEESSUPPLY OVER

500 CUSTOMERS

AROUND

30 PRODUCTSACROSS MORE THAN

40 COUNTRIES

Nordion: Experts in the Critical Supply Chain (Mo-99)

• Established, reliable facilities providing high-quality isotopes to global customers• Specialty skills in operations, regulatory affairs and global logistics• Manufacturing Mo-99 for 40 years

Irradiation of

HEU targets to

produce crude

isotopes

NUCLEAR

REACTORS

Purification of

Mo-99 and

distribution to global

radiopharmaceutical

manufacturers

MEDICAL ISOTOPE

PROCESSORS

Tc-99m

Generator

manufacturing

and distribution to

radiopharmacies

RADIOPHARMACEUTICAL

MANUFACTURERS

Unit dose

compounding and

distribution to

hospital/departments

RADIOPHARMACIES

AND HOSPITALS

Critical physiological

diagnosis enabling

informed therapeutic

decisions

PHYSICIANS

AND PATIENTS

Nordion Future Mo-99 Supply Options

Since 2008 Over 50 worldwide files/projects have been evaluated• Both Reactor and Accelerator-Based

Supply Selection Criteria1. Non HEU-based technology/targets2. Credible Partners3. Leverages existing infrastructure/capabilities to drive efficiency4. Commercial feasibility – for Nordion and partners5. Timeline - potential for commercialization in the near term

Nordion Current Mo-99 Supply• Nordion’s current supply chain utilizes the National Research

Universal (NRU) reactor operated by Canadian Nuclear Laboratories (CNL)

• The NRU is scheduled to cease routine production of Mo-99 in November 2016.

• Government of Canada announced on February 6, 2015 its support of the extension of the NRU operations until March 31, 2018 to help support global medical isotope demand in the unexpected circumstances of shortages during this time.

• Nordion will maintain standby capability for processing Mo-99 from the NRU from Nov 1, 2016 to Mar 31, 2018 to mitigate potential global shortages and ensure processing capacity during a period of increased supply risk.

Nordion Announcement – Feb 20, 2015

Partnership with General Atomics and the Missouri University Research Reactor (MURR)

• Mo-99 supply utilizing proprietary Selective Gaseous Extraction (SGE) technology

• Leverages existing reactor, processing facility and licensed shipping container infrastructure and capabilities

• Commercial production by the end of 2017

Highly Credible PartnersGeneral Atomics

Target and reactor systems design and manufacturing

• Trusted resource of high-technology systems

• Experts in nuclear fuel cycle, including uranium mining and processing

• Experts in reactor design: GA TRIGA® research reactors in operations around the world for over 50 years

• Developer of LEU technology utilizing novel reusable target design

Missouri University Research Reactor (MURR)

Premium Reactor Operator and Research Center

• 10-megawatt facility; the largest university research reactor

• Operates 52 weeks a year• 25-year history of successful and

innovative radiopharmaceutical R&D and collaborations with industry

• Strong record of regulatory compliance (US NRC, US FDA)

• Experts in volume radiochemical processing and international shipping

• Nordion’s partner in production of TheraSphere for over 20 years

Nordion

Premier Isotope Producer and Distributor

• Experts in Mo-99 purification into medical grade product since 1975

• Strong record of regulatory compliance (US FDA, EMEA, Health Canada)

• cGMP/GLP - licensed facility• Global leading supplier of Mo-

99 with extensive marketing, sales & distribution expertise

• Global licensed transport container fleet

Missouri University Research Reactor:• Proven Reliability• Robust and Modular Design

Source: MURR

Selective Gas Extraction: Reusable LEU Targets

Mo-99 – Solid

Other solid products

Step 1

Reusable LEU targetirradiated; forms new radioisotopes

Step 2

Gas introduced to target in-situ; desired isotopes are converted to volatile compounds

Step 3

Gas extracted with desired isotopes and transported to collection system

Reusable LEU target

Isotope – Gas

• Uranium waste and liquid waste greatly reduced (less than 10% of current process)

• High volume production – up to 4,200Ci per week

• 52 weeks per year availability

• Mo-99 production flexibility – production can be tailored to market demand

• 100% Compatible with existing Tc-99m generators and established distribution infrastructure

• North America based – proximity to largest market

Key Advantages of SGE Technology

Mo-99 production by SGE process is highly efficient relative to

current and other proposed methods of Mo-99 production

Thank you

Find out more at

www.nordion.com

Follow us at http://twitter.com/NordionInc

DOMESTIC MOLLY-99 PRODUCTION

• Moderator: Roy Brown, Sr. Director, Strategic Alliances, Mallinckrodt Pharmaceuticals

Speakers:– Carolyn Haass, Technical Program Director, Northwest Medical Isotopes– Lou Centrofanti, President and CEO, Perma-Fix Environmental Services– Katrina Pitas, Vice President Business Development, SHINE Medical Technologies– Jim Harvey, Sr. VP & Chief Science Officer, Northstar– Tom Burnett, President Medical Isotopes, Nordion