h.a.e.konarowski, chemrar high-teck center
TRANSCRIPT
1st International Conference on Innovative Growth for Pharmaceutical and Medical Industry in Russia.Integrating Academic and Industrial ScienceMIPT, 12 May 2011
Henrik A. E. Konarkowski
ChemRar High Tech Centerwww.chemrar.ru
The hard way to make a Medicine:Less than 1 in 100,000 compounds tested eventually reaches consumers.Only 1 of every 5 compounds that enter clinical testing reaches the market.Only 3 of 10 drugs that reach the market ever earn enough money to match or exceed the average R&D cost per new medicine.
THE COST OF A DELAY DAY(SELECT BLOCKBUSTER DRUGS)
$259$364
$499
$635
$802
$0
$250
$500
$750
$1,000
US
$ i
n M
illi
on
s
1992 1994 1996 1999 2001
$0
$5
$10
$15
Ave
rag
e D
aily
Sal
es
(US
$ i
n M
illi
on
s)
Lipitor Zocor Prilosec Zyprexa Norvasc
Note: The average drug generates $1.3 million sales daily
Source: IMS Health, 2002 and PhRMA Profile, March 2007
The Cost of Developing a Drug
DISTRIBUTION OF BIG PHARMA R&D SPENDING
Other, 12.60%
Pharmaceutical dosage formulation &
stability, 5.10%
Synthesis & extraction, 9.30%
Biological screening & pharmacological
testing, 12.10%
Clinical evaluation phase IV, 8.80%
Clinical evaluation phase I-III, 25.60%
Bioavailability, 1.50%
Toxicology & safety testing, 4.10%
Regulatory IND & NDA, 3.00%
Process development for manufacturing &
QC, 7.00%
Source: PhRMA Annual Survey, 2006
• Money• Time
Or Accessing
• Money• Time
Or Accessing
•New Technologies
Source: Contract Pharma Second Annual Outsourcing Survey, 2006
Ordering Tactical Outsourcing Strategic OutPartnering Insourcing
Catalogue / Menu
Fee for Service Preferred Fee for Service
Partner Collaboration
Alliance
Localized
Integration
Price
Trust
Independence Collaboration
•Co-investment
•Shared business objectives
Source: Modified from Price Waterhouse Coopers Am.Pharm.Outsourcing 6,01:30-32 and J. Wilmer, Prime Trials Outsourcing Clinical Trials CRO Perspective, 2004
Value
• Contracting out – fee for product business
N
NH
N
N
R3d R3b
R3e R3a
R2
R3c
R1
X
N
NH
NN
NH
R1
R2
R3
N
NH
NN
NH
R1
R2
R3
N
NH
NN
NH
R1
R2
R3
N
NH
NN
NH
OR1
R3
N
NH
NN
NH
O
R1
R3
N
NH
NN
NH
R1
R2
R3
N
NH
NN
NH
N
R1
R2
R3
N
NH N N
NH
NR1
R2
R3
• Contracting out – fee for product business• • Preferred vendor status, based on • 1) Price 2) Quality,
• Russia: since early 1990s• Asia: since early 2000s
Contracting Out by fee for service
Completion of the required data package paid for by time used
N
N
NH
R3 R1
R2
O
O
O
N
NH
R1
R2
R3
O
NS
N
NH
R1
R2
R3
O
N
O
NH R1
R2
R3a
R3b
O
NN
H
R1
R2O
NNH
R1
R2O
NON
O
H
R1
R2 NN
H
R1
R2
O
A AIn house chemistry
i.e. special Chemistry on Demand
Contracting Out by fee for service
• Preferred vendor status is based on:
1) Reliability (confidentiality, relationship, timeliness)2) Quality 3) Cost
• – drift from cost based outsourcing to quality based (value builder)
• Variety of business models in a broad partnership
ChemRar experience from mid 2000s with companies Avalon, Eli Lilly, Merck KGaA, Genentech, Solvay, Abbott
• Risk share based platform R&D– ChemRar prosecutes assets for:
• Partial R&D payment, success based development milestones. 12 Targets to generate 2 Clinical Candidates
– Solvay’s assets: • Targets, Hit series, Leads from Pharma
• Potential Deliverable– POC– Bring more later stage aassets in– Create more value for:
17
Hit series
Lead series
Leads
Clinical Candidates
2 year
FHD
POC
«We are very happy to consolidate a portion of our external research activities that are currently being outsourced to several different contract research organizations as this we believe will shorten development timeline. Moreover we are pleased to have found a partner that shares our business model approach» Frédéric Cren, Head of Research at Solvay Pharmaceuticals
4 year
ClinicalCandidate
FHD POC PII PIII NDA
• Variety of business models in a broad partnership
• Preferred vendor status is based on such competitive features as: – Long term relationship building
• Usually diversify an established “tactical” relationship• Value building for Sponsor’s R&D at “Milestones”: Lead, IND, POC(PII), PIII• Shared risk / reward element
ChemRar experience from mid 2000s with companies Avalon, Eli Lilly, Merck KGaA, Genentech, Solvay, Abbott
Передача лицензии
на территориюРоссии
Проведениедоклиники и\или
клиники в РФ
Производствоинновационногопрепарата в РФ
Передача результатовклинических
исследований
Коммерциализацияза рубежом
Руб.
Кросс-Роялти %
Финансирование От Российских партнеров
Модель трансферта разработок инновационных лекарственных средств
$$$Иностранный
партнер
Российский партнер
Иностранный партнер
Российский партнер
• Money• Time
Or Accessing
• Money• Time
Or Accessing
•New Markets
From 2008 ChemRar experts prominently participated in drafting of the “Russian Federation Innovative Development Strategy for the Pharmaceutical Industry through the year 2020” (Pharma2020).
December, 2010: Prime Minister Vladimir Putin visiting ChemRar with Ministers of Industy and Health
Bringing into Russia innovative development projects at various stages, from Biotarget stage, to clinical candidates, and developing them into Medicines
In-Partnering Development Projects Globally
20 years, more than 1200 partners 20 years, more than 1200 partners
first line
Service Research Organizations
Biotech Companies
Manufacturing &Market Access
• Moscow State University• Moscow Institute of Physics and Technology (MIPT) • D. Mendeleyev University of Chemical Technology of Russia • YSPU Yaroslavl University• State Research Center for Applied Microbiology & Biotechnology (FSIS SRCAMB)• M.M. Shemyakin and Yu.A. Ovchinnikov Institute of bioorganic chemistry of the Russian Academy of Sciences• Moscow Centre for HIV/AIDS Preventionand Treatment
7 programs funded 7 programs funded 8 in various funding 8 in various funding
stagesstages
7 programs funded 7 programs funded 8 in various funding 8 in various funding
stagesstages
15 programs suggested 15 programs suggested for fundingfor funding
250k to 2.5M for seed250k to 2.5M for seed5-30M for development5-30M for development
15 programs suggested 15 programs suggested for fundingfor funding
250k to 2.5M for seed250k to 2.5M for seed5-30M for development5-30M for development
65 programs selected 65 programs selected for evaluationfor evaluation
65 programs selected 65 programs selected for evaluationfor evaluation
200 partners identified200 partners identified200 partners identified200 partners identified
Partnering with Russia’s Scientific Institutions2007-2009
ChemRar seed funds Co-funding relationship with
• Rosnanotech ($5.5B investment bank), • Russian Venture Corporation ($1,5B fund of funds)• Ministry of Production and Trade «med-pharma»
federal program initiated Y2011 ($4B)• Russian «SBIR» ($100m per year)• SKOLKOVO
Partnership with Health Care Ventures, Celtic, Avalon Ventures, Domain, 5AM, other private equity and angel investors
Established JV for late stage co-development and market access with Pharmstandart, R-Pharm, Protek and other local players