Company Presentation

company presentation

08 April 2015

Copyright Triveritas Limited © 2015All rights reserved 2011 20072013 2013

who

are we?

team

services

a global

company


Animal Health contract product development consultancy

over 450 years Animal Health R&D and regulatory experience

industry and CRO backgrounds

covering all species and product types

5 offices worldwide:

UK – head office

Germany

France

USA

Poland

who are we?

Copyright Triveritas Limited ©All rights reserved 2015 4

who are we?

breadth of Animal Health industry experience gained from working in:

more than 15 Animal Health companies including:

Grampian Pharmaceuticals, Merial, Novartis, Pfizer, Virbac, Schering Plough, SmithKline Beecham, Smith & Nephew, Mallinckrodt Veterinary, Vétoquinol, Elanco, AstraZeneca, Boehringer Ingelheim Vetmedica, Bioniche

contract research organisations including:

Charles River Laboratories, Inveresk, Ridgeway

experience


who are we?

expertise in Animal Health

team includes 10 veterinarians, science graduates, MSc, and PhDs with expertise in:

biochemistry, chemistry, immunology, pharmacology, parasitology, toxicology, agricultural science, aquahealth, veterinary statistics, microbiology

covering all quality, safety and efficacy aspects of:

pharmaceuticals

biologicals

expertise


who are we?

projects conducted in a wide range of species

companion animals

• cats

• dogs

• horses

food producing species

• cattle

• sheep

• pigs

• chickens

• turkeys

• fish

species

52%48%

projects up to October 2014

companion animals

food producing species


who are we?

Triveritas can add value to your development

adding value

specialist expert knowledge to complement your in-house skills

support your in-house activities when resources become overstretched

build long lasting relationships

TIME

QUALITY COST


who are we?

since foundation…

expanded from 3 to over 35 staff

over 1500 projects since 2000 across the EU, USA, Australasia, Africa, South America and Japan

built a large customer base of over 150 international Animal Health companies (30% sales to SMEs)

proven track record (re-order rate of ca. 95%)

won 2007 Animal Pharm Excellence Award - Best Supporting Role

won 2011 Global Business Excellence Award - Outstanding Service

won 2013 Queen’s Award for Enterprise - International Trade

won 2013 CN Group Business Awards - Exporter of the Year

achievements


who are we?

ANAESTHETICS, ANALGESICS & NSAIDS: injectables, topicals, sedatives

ANTIBACTERIALS: tablets, topicals, injectables, in-feeds, intramammaries, water solubles,

ANTI-INFECTIVES: antiparasitics, anticoccidials, biocides, antiprotozoals, antifungals, teat dips

BIOLOGICALS: live, inactivated, combination, genetically modified, serum, monoclonal antibodies, hormones

CANCER TREATMENTS

CARDIOVASCULAR:diuretics

breadth of experience

DERMATOLOGICALS: therapeutic shampoos, anti-inflammatories

GASTROINTESTINAL: antiulcer

GENITOURINARY: uterine products, contraceptives, renal

LIFESTYLE PRODUCTS: anti-obesity, oral health

NUTRITIONAL: feed additives, vitamins, trace elements, performance enhancers

NEUROMUSCULAR SYSTEM:behaviour modifiers, anti-convulsives

RESPIRATORY


who are we?

who

are we?

team

services

a global

company


a growing company

Triveritas founded by 3 directors within the UK2000

2001 located to a rented office

2002 first member of staff joined

2003 first Start-to-Finish project began113 clinical site study and pan-EU DCP


a global company

Triveritas head office opens

Northern England - (North Lakes)

rural environment

19th century barn converted to a modern office

2004

Triveritas Germany

key EU regulatory driving force (PEI and BVL)

network of small animal clinics, specialist vets; large pig and dairy farms, horses, etc.

links with key research institutes: BfR, Freie Universität Berlin, Robert Koch-Institut

a growing company

2005


a global company

2006 Triveritas France

French veterinary product market is reportedly the largest in Europe

strong links to key EU regulatory agencies: EMA and ANSES - ANMV

a growing company

Animal Pharm Excellence Awards Best Supporting Role

2007

2008 30% growth in scale of operations in previous 12 months

2009 identified as a high growth business by a Regional Development Agency


a global company

Triveritas USA

support joint EU and USA development projects and offering access to more than two thirds of the world Animal Health market

expertise in regulatory affairs and clinical trials in USA and Canada

2010

Triveritas Poland

access to cost effective Investigators for clinical trials

expertise in regulatory affairs with local agencies

Global Business Excellence Award Outstanding Service

a growing company

2011

2012


a global company

head office extension almost doubles capacity

USA office strengths global programmes in and from the USA

a growing company


a global company

Queen’s Award for Enterprise International Trade

UK’s highest accolade for business success

overseas sales increased by 219% from 2010 to 2012

US largest overseas market, 46%

2013

2014 clinical development and regulatory affairs teams strengthen their global capacities

two new specialists in biologicals and pharmaceuticals regulatory affairs

two new Monitors in EU and USA

a global company


a global company

your expert partner in Animal Health

UK GERMANY FRANCE USA POLAND

who

are we?

team

services

a global

company


Triveritas

from veterinary practice to managing Triveritas, more than 25 years experience within the industry

• R&D and regulatory affairs in 5 Animal Health companies

• R&D Director before starting Triveritas

• managed clinical trials, regulatory groups, experimental sites and laboratories

• global experience: Europe, North America, Asia, New Zealand and Australia

• novel products and generics

• worked on a wide range of speciesJulian BraidwoodBVSc (Hons) MRCVSManaging Director

our expert team


team

Triveritas

over 25 years in AH industry developing quality systems and promoting compliance

extensive experience in:

• veterinary diagnostics and analyses

• pharmaceuticals formulation, manufacturing, QC

• pre-clinical and laboratory GLP studies

• QA auditing and implementing quality systems – GMP, GLP, GCP

managing and developing Triveritas operations, systems and procedures since its foundationSue Lester

BSc (Hons) FRQADirector

our expert team


team

Triveritas Germany

more than 15 years of experience in Animal Health industry

• extensive knowledge of German veterinary market

• product development, study monitoring and marketing

• rapid trial clearance in Bundesländern and BVL (average 2 to 3 weeks)

connections to specialist vets, farmers, laboratories and opinion leaders at veterinary universities in Germany and AustriaRoland-G Ludwig

VeterinarianDirector Triveritas Germany

our expert team


team

Triveritas France

over 15 years within the industry in top-10 AH companies including Pfizer and Merial

R&D and regulatory affairs

• monitoring

• extensive international GCP and GLP experience

• regulatory expertise - centralised route, MRL, quality aspects and expert reports

• data management

local understanding of French systemsPascale Sierra

Dr. VétérinaireDirector Triveritas France

our expert team


team

Triveritas USA

qualified veterinarian and lawyer

over 30 years in Animal Health drug development

previously Senior Director of Worldwide Regulatory Affairs at Schering Plough AH

an experienced regulatory negotiator with FDA, USDA and EPA in the USA and EMA in the EU

trainer in all aspects of USA Animal Health drug development

Dave PetrickBA VMD JD

Regulatory Director USA

our expert team


team

Triveritas USA

experienced entomologist focused on pest control technologies and development of parasiticides for food and companion animals

9 years in academia

over 20 years of experience in Animal Health product development in the USA and abroad

led USA and global R&D projects at Boehringer Ingelheim Vetmedica and Elanco

Jeffrey MeyerPhD

Technical and Business

Development Director USA

our expert team


team

Pharmaceuticals Regulatory Affairs

our expert team


team

Dr Mel Munro BSc (Hons) PhD MTOPRAMs Juliet Greenslade BSc (Hons) MSc MTOPRA

Ms Donna Mattson BSc MSc

Dr Tamsin Dawson BSc (Hons) PhD

Dr Andrew Hewitt BVMS MRCVS

Ms Melanie Anderson HNDDr Karolina Figiel DVM

Dr Pascale Sierra Dr VétDr Anne-Marie Viallet Dr Vét

Dr Dave Petrick BA VMD JD

Biologicals Regulatory Affairs

FDA - CVM

EMA – CVMP and EU National Agencies

Dr Tom Holland PhD DipABT FRCPath FRCVS

TOXICOLOGY – Part III

Dr John Banks BSc (Hons) PhDQUALITY – CMC/Part II

EMA – CVMP and EU National Agencies USDA APHIS CVB and CFIA CCVB

Mr Richard Hunter HND

Clinical Development

our expert team


team

Dr Sonja Haase Dr. med. vetDr Lynne Braidwood BVSc MRCVS

Ms Helen Cuppello HND

Dr Germán Graff DVM MBA DESCM SBR

Ms Jane Campbell BSc (Hons) MSc

Ms Sheri McCrork BSc

Dr Pascale Sierra Dr VétMs Suzanne Whiting BSc (Hons)

Dr Roland Ludwig Veterinarian

Ms Lindsey Edwards BSc (Hons)

Ms Debbie Beattie BSc (Hons)

Ms Jennifer Sayer BSc (Hons) RVN

Ms Donna Taylor BSc (Hons) Ms Jo Knipe BSc (Hons)

Quality Assurance Unit

Dr Jeffrey Meyer PhD

Dr Karolina Figiel DVM

TRIVERITAS GERMANY

TRIVERITAS FRANCE

TRIVERITAS USA

TRIVERITAS POLAND

TRIVERITAS UK

Mr Nick Gibson BSc (Hons)

who

are we?

team

services

a global

company


from proof of concept to international registrations

Triveritas manage a consortium of selected specialists to meet your project needs

• formulation

• development

• registration

• manufacturing

benefits to your company

• your R&D and regulatory teams can concentrate on fewer projects

• flexible approach tailored to each project

• regular project meetings and monitoring of project plan

• target based payments

start-to-finish service


services

Triveritas can

perform international single and multi-site VICH GCP clinical studies in all species and types of product

conduct post-marketing studies

carry out parallel scientific opinion procedures

supply Electronic Data Capture (EDC) system

contract training: Investigators and Monitors

global clinical studies 1/4


services

VICH clinical studies

expert advice on study planning and design

obtain test clearance/trial licence

set-up, monitoring and close-out

independent QA at all phases

data management – data audit, data entry and full validation

statistical analysis

final study reports



services

what is a ‘Triveritas managed study’ ?

VICH GCP study with added benefits:

• conducted by Triveritas veterinary Investigators

• blinded recordings made by Triveritas staff using validated equipment

suited for multiple sampling/data recording - where a complete dataset is critical

• vaccine studies: efficacy, field safety, serology, etc.

• Triveritas holds a UK Home Office licence allowing for sampling animals in the UK beyond standard ATC limitations



services

Triveritas managed study - near a Triveritas office

general set-up

• local practice maintains clinical service

• frequent visits by Triveritas staff

large facility database:

• companion animals

• large animals: cows, horses, sheep, pigs

• poultry

benefits to you

• excellent compliance and data



services

additional study support

other study management services

• GLP study management (Sponsor representative)

• pre-clinical studies

• screening and selection of CRO

• locating analytical CRO

information science resources

• ProQuest literature retrieval of scientific, commercial, patent, environmental data

studies support


services

pharmaceuticals and biologicals regulatory affairs teams

• over 15 years’ average experience across teams

main areas of assistance

• strategic regulatory advicequickest, most cost effective route to MA

• regulatory supportMA maintenance - popular with SMEs

discrete regulatory submissions

• variations, renewals, ATCs, batch release advice

detailed and critical summaries (DaCS)

• quality, safety and efficacy (bios and pharmas)

regulatory affairs 1/3


services

complete regulatory submissions

• full and abridged submissions

• centralised, decentralised, national and mutual recognition

• expertise in producing all parts of dossiers EU and USA formats

regulatory authorities negotiation/liaison

• anonymous enquiries to agencies

benefit : risk assessments

• new approach from regulators - no product is a ‘no-risk’ situation

• take the opportunity to highlight positive points of your product



services

gap analyses

• full consideration of current available data

• highlights regulatory issues, identifies solutions or ways to present your data effectively

compilation of DMFs/ASMFs

(Drug Master Files or Active Substance Master Files)

reports for inclusion of substances in the “Out of Scope” list

expert assistance in all CMC/Part II issues

• formulation

• stability

• manufacturing



services

tailored Standard Operating Procedures (SOPs)

compilation of Detailed Description of Pharmacovigilance System (DDPS)

compilation, review and submission of aggregate reports (e.g. PSURs)

management of serious adverse events

maintenance of safety database and paper records

compilation of data exchange contracts

EU QPPV

pharmacovigilance in clinical trials

pharmacovigilance


services

strategic project evaluation

project management

project planning and review

market surveys

due diligence

technology transfer

• manufacturing sites

• between companies

specialist services


services

publications “ghost written”

dossiers

scientific reports

presentations

Detailed and Critical Summaries (DaCS/Expert Reports)

• pharmaceuticals Part II (quality)Part III a & b (safety and residues)Part IV (efficacy)

• biologicals Part II (quality)Part III (safety)Part IV (efficacy)

scientific writing


services

specifically tailored training courses on any aspect of veterinary product development

training on site – you may include as many staff as you wish

style – tailored to suit your preferences

• formal presentation, workshop – real examples, interactive sessions

benefits

• any topic covered, clear objectives, direct relevance (use in-house examples), team development

in-house training


services

Quality Assurance (QA) at Director level

Sue Lester - FRQA

facility inspections

• GLP and GMP• contract research

GLP and VICH GCP studies

• in-phase audits, report audits, study plan and protocol reviews, Sponsor study master file audits, data audit

Sue LesterBSc (Hons) FRQA

contract QA 1/2


services

QA support

review

• independent, periodic review of QA functions and procedures

training

• QA personnel

• GLP/VICH GCP training for non-QA personnel

implementation

• GLP and VICH GCP implementation

• expertise in SOPs and policy development

contract QA 2/2


services

thank you for your attention

your expert partner in Animal Health

www.triveritas.com

GLOBAL BUSINESS

EXCELLENCE AWARDS

OUTSTANDING SERVICE

2011

ANIMAL PHARM INDUSTRY

EXCELLENCE AWARDS

BEST SUPPORTING ROLE

2007

CN GROUP

BUSINESS AWARDS

EXPORTER OF THE YEAR

2013

THE QUEEN’S AWARDS

FOR ENTERPRISE

INTERNATIONAL TRADE

2013

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