Pistoia Alliance. Ramesh Durvasula, PhD. ACS CINF Webinar October 7, Board Member, Pistoia Alliance (and, Director, IT at Bristol-Myers Squibb)

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1 Pistoia Alliance Ramesh Durvasula, PhD Board Member, Pistoia Alliance (and, Director, IT at Bristol-Myers Squibb) ACS CINF Webinar October 7,

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3 Rapidly Evolving R&D Ecosystem Yesterday Today Tomorrow Big Life Science Company Innovation Model IT Yesterday Today Tomorrow Innovation inside Internal apps & data Searching for Innovation Struggling with change Security and Trust Heterogeneity of collaborations. Part of the wider ecosystem Cloud/Services Data Mostly inside Inside à Outside Distributed Portfolio Internally driven and owned Partially shared Shared portfolio

of this ecosystem CRO Regulatory authorities

4 The Role of Pistoia: Glue between Nodes Public content provider Proprietary content provider Pistoia s strength is its diversity of members, representing substantial parts of this ecosystem CRO Regulatory authorities Service provider Software vendor Academic group 4

5 Pistoia Alliance Mission Lowering the barriers to innovation in life science R&D by improving inter-operability of business processes through pre-competitive collaboration 5

6 Pistoia Alliance A Very Short History Founded in 2009 Strategic Review in 2013 Opening Next Chapter in

7 Pistoia Alliance Recent Successes HELM CSCS transmart 7

8 The HELM Project: Hierarchical Editing Language For Macromolecules PISTOIA ALLIANCE MISSION 8

9 HELM: Fit-for-Purpose Structure Representation Enable the representation, manipulation and visualization of each macromolecule type in a way that is appropriate for its size and complexity

10 Biomolecules: Stuck in the middle

11 HELM is available: openhelm.org

12 HELM - Summary Phase I complete: HELM released BioIT Best Practices Award 2014 Phase II: Exchangable HELM in the works Participating in upcoming InChI/ IUPAC workgroup meeting in Oct

13 The CSCS Project: Controlled Substances Compliance Service PISTOIA ALLIANCE MISSION 13

CSCS Business Challenge The global nature of externalisation - including outsourcing and collaboration - is increasingly prevalent in today s pharmaceutical industry.

14 CSCS Business Challenge The global nature of externalisation - including outsourcing and collaboration - is increasingly prevalent in today s pharmaceutical industry. Businesses need to know the international, regional and local laws wherever they operate United Nations Single Convention on Narcotic Drugs 1961 United Nations Convention on Psychotropic Substances 1971 United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances 1988 United Kingdom Misuse of Drugs Act 1971 United States Controlled Substances Act 1970 United States CHEMICAL DIVERSION AND TRAFFICKING ACT OF 1988 Canadian Controlled Drugs and Substances Act 1996 India - Narcotic Drugs and Psychotropic Substances Act, 1985 Singapore Misuse of Drugs Act New Zealand Misuse of Drugs Act 1975 Thailand - Psychotropic Substances Act Pakistan - Narcotic Drugs and Psychotropic Substances Act, 1985 Australia - Standard for the Uniform Scheduling of Medicines and Poisons Philippines - Comprehensive Dangerous Drugs Act of 2002 Russia - Regulations on the State Committee of Russian Federation for the control of narcotic drugs and psychotropic substances United Arab Emirates - UAE Federal Law 14 of 1995 Japan - Narcotics & Psychotropics Control Law, Stimulants Control Law, Narcotics Special Law South Africa - Drugs and Drug Trafficking Act No. 140 of 1992 Iceland - Regulation on habit-forming and narcotic substances and other controlled substances No. 233/2001 Gibraltar - Drugs (Misuse) Act 1973 Indonesia law on narcotics (Law No. 22/1997), law on psychotropics (Law No. 5/1997) European Union - Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, risk-assessment and control of new psychoactive substances European Union - REGULATION (EC) No 273/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 February 2004 on drug precursors European Union - COUNCIL REGULATION (EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the Community and third countries in drug precursors Belgium - Royal Decree of 1930 on narcotic substances and Royal Decree of 1998 on psychotropic substances Czech Republic - Law no. 167/1998, On Narcotic Drugs and Psychotropic Substances Denmark - Executive Order 698 of 1993 on Euphoric Substances Germany - Narcotics Act (BtMG) Spain - Order of 8th July 1967 and the Royal Decree 2829/1977 Ireland - Misuse of Drugs Regulations1988 France Decree Law of 22 February 1990 Netherlands - Opium Act Portugal - Decree-Law 15/93 Norway - Regulation of 1978 Poland Act on Counteracting Drug Addiction Greece - Law 3459/2006 (Codification of the Drug Legislation) Estonia - Regulation No 39 of the Minister of Social Affairs of 4 November 1997 Austria - Narcotic Substances Act (Suchtmittelgesetz, abbr. SMG) Italy - Decree 4 March 1992 Sweden - Narcotic Drugs Punishments Act (1968:64). Portugal - Decree Law 15/93, of 22 January 1993 Slovenia - Production and Trade in Illicit Drugs Act Slovakia - Act No. 139/1998 Romania - Law no. 143/2000 Malta - Medical and Kindred Professions Ordinance (Cap. 31), Dangerous Drugs Ordinance (Cap. 101) Luxembourg - Grand Ducal decrees, 4 March 1974, 20 March 1974, 26 March 1974, 8 May 1993 and 30 January 2004 Lithuania - Law on Narcotic and Psychotropic Substances Control (No.VIII-602; 1998) Bulgaria - Drugs and Precursors Control Act 1999 Croatia - Law on Combating Narcotic Drugs Abuse 2001 Cyprus - Narcotic Drugs and Psychotropic Substances Law 1977 Finland - Narcotics Act (1289/1993) Hungary - 1/1968. (V. 12., Government Decree No. 272/2001.(XII.21.), 4/1980. (VI. 24.) Latvia - Law on Procedures for the Legal Trade of the Narcotic and Psychotropic Substances, Law on Precursors Lithuania - Law on Narcotic and Psychotropic Substances Control (No.VIII-602; 1998)

15 CSCS Business Challenge Legislation is constantly evolving and becoming more complicated as it attempts to mirror developments in substance abuse mephedrone U.S. bans chemicals in "bath salts" street drug 15 methylenedioxypyrovalerone (MDPV) 15

16 CSCS - Summary Phase I completed: Two commerial solutions available Phase II Forming expert community in progress Focus on extension to China, possibly other Asian countries 16

17 The transmart Project PISTOIA ALLIANCE MISSION 17

18 transmart Another Very Short History Open source platform for management, integration and analysis of translational research data 2012 transmart released by J&J Needed care & feeding 18

19 The 2012 landscape from 30,000 feet The Big Concern:

20 The 2012 landscape from 30,000 feet

21 transmart - Summary transmart Foundation co-founded with UMich transmart Foundation is now a successful independent organization 21

22 Pistoia Alliance A Very Short History 22

23 PA Next Chapter Corner Stones Member Involvement Portfolio Generation & Transparency Pistoia Alliance Next Chapter Project Delivery Networking & Communication

Member Involvement New members meetings Quarterly (f2f or virtual) Strategic portfolio discussion Member committees/work groups PA webinar series Conference/meeting scheduling and planning Full time

24 Member Involvement New members meetings Quarterly (f2f or virtual) Strategic portfolio discussion Member committees/work groups PA webinar series Conference/meeting scheduling and planning Full time BD function John Wise Exec Director BD Europe Carmen Nitsche Exec Director BD North America Individual member updates/feedback Portfolio webinars Member Involvement Project Delivery Pistoia Alliance Next Chapter Portfolio Generation & Transparency Networking & Communication

(IP3) Well defined portfolio process Transparent portfolio Interactive Member Involvement Project

25 Portfolio Generation & Transparency New members meetings Strategic portfolio discussion Full time BD function Individual updates/feedback Portfolio webinars Interactive Project Portfolio Platform (IP3) Well defined portfolio process Transparent portfolio Interactive Member Involvement Project Delivery Pistoia Alliance Next Chapter Portfolio Generation & Transparency Networking & Communication 25

26 IP3 - Interactive Project Portfolio Platform

27 Project Delivery Member Involvement Portfolio Generation & Transparency Full time Operations function Project manager pool Project execution framework Communication strategy Project Delivery Pistoia Alliance Next Chapter Richard Holland Exec Director Operations Networking & Communication 27

Networking & Communication New members meetings Quarterly (f2f or virtual) Strategic portfolio discussion Member committees/work groups PA webinar series Conference/meeting scheduling and planning

28 Networking & Communication New members meetings Quarterly (f2f or virtual) Strategic portfolio discussion Member committees/work groups PA webinar series Conference/meeting scheduling and planning Full time Operations function Consistent communications strategy across channels (newsletters, website, social media, press releases) Full time BD function Individual updates/feedback Portfolio webinars Member Involvement Project Delivery Pistoia Alliance Next Chapter Portfolio Generation & Transparency Networking & Communication >20 new opportunities! Upcoming Webinar on Fri, Sep 26 Contact Richard Holland 28

29 Some additional thoughts Increasing number of opportunities Increasing overlap with other organizations Partnering opportunities Partner networks? Open source platforms OpenPhacts Foundation Allotrope Foundation transmart Foundation

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iclass SE multiclass SE 125kHz, 13.56MHz 125kHz, 13.56MHz Date created: 11 July 2016 Last update: 18 August 2016 READERS REGULATORY CERTIFICATION BY COUNTRY. The following table consists of the current regulatory certifications for the readers. HID Global is