Company Presentation. Speed up Development as Competitive Advantage

Transcription

1 Company Presentation Speed up Development as Competitive Advantage

2 Agenda PharmDev Innovations in brief Three elements principle Vision Mission Founder and professional background Location Client portfolio Business Units in brief VirtuPharm Alliances PharmLink Consultants PharmGMP Qualifying PharmLearning Concepts PharmQP Contractors

3 Three elements principle Pharmaceutical research & development is mostly based on three elements which are each indispensable to get to success: In the CMC-area: Compound, dosage form, processes In the reg Affairs area: CMC, pre-clinical, clinical In the clinical area: Money, Patients, IMPs In the strategic area: Money, quality, time

4 Vision PharmDev s virtual pharmaceutical development approach benefits clients, patients and health systems by supporting the highest achievable level of efficiency for industrial drug development projects. We want to be first: first in new business model, first in getting ready with development projects, first in enabling industrial client s development strategy. It s time for a new paradigm!

5 Mission reduce overall cycle-times of this industry s pharmaceutical development activities to the minimum achievable level by professional management of standardised, parallelised and distributed processes in a virtual environment based on experience, competence and established provider networks develop competence- and value based world-class Pharmaceutical Technology into all entrusted projects to benefit patients, clients and their stakeholders and shareholders for new and existing molecules today... for tomorrow apply most current technological, organisational and regulatory standards to reach our clients developmental milestones at the earliest possible time without delaying the schedules by any loops Ensure an appealing working environment to attract the most competent and experienced people for achieving demanding business objectives

6 Founder and his professional background Dr. Rango Dietrich Pharmacist (University of Würzburg) PhD in Pharmaceutical Technology (University of Hamburg) Studied information science (Informatik) (University of Hamburg) MBA from Henley Management College (University of West London) Further specialisation in Pharmaceutical Technology (Fachapotheker Pharmazeutische Technologie) Pharmaceutical Analytics (Fachapotheker Pharmazeutische Analytik)

7 Founder and his professional background > 25 years experience in Pharmaceutical Industry in development, manufacturing and quality assurance functions > 20 years experience as international business consultant to pharmaceutical industry in above-mentioned areas several technology innovation awards

8 Founder and his professional background some 140 patents / patent applications

9 Founder and his professional background Internationally acknowledged speaker on PharmDev, CMC, QP, GMP and Clinical Supplies related topics some 100 papers and presentations Invited lectures presented on (selection):

10 Experienced Co-Workers Flexibly available Focussed Reliable Responsive Covering a wide range of expertise (selection): Pharmaceutical technology, Analytics, Quality Control Quality management, GMP Training, Training Organisation document (eg SOPs) generation, control Webhosting of project portal and data-bases (ie Training documentation) open for customers Contractor management Project management

11 Location Konstanz, Germany Easily accessible from Zurich airport

12 Client portfolio Small start-ups in virtual environment Medium-size pharmaceutical companies Some of the global top 20 Generic manufacturers Importers and exporters CMOs (Contract Manufacturing organisations) CROs (Contract Research Organisations) Equipment providers IT providers to pharmaceutical industry Patent attorneys Investors Headhunters / HR consultants Event organisers Architects

13 (selected) clients up to present (Fisher Clinical Services)

14 Time for a new Paradigm Newly defining the speed paradigm: (most decisive current criterion in competitive environment) Beware of hectic actionism Avoid unnecessary loops Do it right first time Time Action: gain speed and reliable planning ground through standardisation of processes along regulatory needs and and project targets and by parallelising activities By far the fastest processes seem to be the well structured ones! Money (result from quality requirements) Action: invest money to gain competitive speed (ie infrastructure & strategy) Quality (given by regulatory requirements and competition) Action: set up quality to adequate level (no over-engineering!)

15 Time for a new Paradigm Be fast or be food It s not the BIG that eats the SMALL it s the FAST that eats the SLOW Significantly reduce complexity: Don t make things more difficult than they are Keep things as simple as possible but not simpler

16 Toolset of 5 Business Units adressing speed in pharmaceutical development adressing speed in business processes and clinical supplies related areas adressing speed in qualifying GxP environment (people & infrastructure) adressing speed in learning processes by efficient and innovative learning concepts adressing speed by pragmatism and competence when releasing drugs for patient s use

17 Toolset of 5 Business Units adressing speed in pharmaceutical development adressing speed in business processes and clinical supplies related areas adressing speed in qualifying GxP environment (people & infrastructure) adressing speed in learning processes by efficient and innovative learning concepts adressing speed by pragmatism and competence when releasing drugs for patient s use

18 adressing speed in pharmaceutical development by virtual pharmaceutical development means: Pharmaceutical development without binding own resources on both sides (client s and PharmDev s) Based on networks of service providers established over years Comprehensive project management with accountability for deadlines and results Under certain circumstances we can take over liability for time, cost and results Since complexity of successful outsourcing is frequently underestimated, we offer Outsourcing of Outsourcing

19 Service offering: Development of Target Product Profiles / Pharmaceutical Target Specifications und Development Plans ICH Q8 familiarisation virtual contract development virtual clinical supplies department based on respective international guidelines (eg EU- GMP Annex 13) quality control of development products Pharmaceutical IP generation & strategy contract due diligence assessments

20 Toolset of 5 Business Units adressing speed in pharmaceutical development adressing speed in business processes and clinical supplies related areas adressing speed in qualifying GxP environment (people & infrastructure) adressing speed in learning processes by efficient and innovative learning concepts adressing speed by pragmatism and competence when releasing drugs for patient s use

21 adressing speed in business processes PharmLink Consultants has been offering (as the oldest business unit in PharmDev) already since 1989 results oriented and competence based consulting services in the area of Investigational Medicinal Products (Clinical Supplies), Pharmaceutical development, GMP Compliance und all topics related to these fields Service offering is thus both multifaceted (as covering all aspects of clinical supplies preparation) and focussed (as always related to clinical supplies) at the same time Our approach ist somewhat different from current standards which makes us unique in this field

22 Situation in pharmaceutical industry s drug development business has become more and more difficult since 1989: Challenges of "Time to market" have continuously grown Communication between IMP- customers (eg clinical research/operations) and IMP- providers has become more difficult (not only due to increasing internationalisation of clinical studies) Regulatory framework has been increasingly tightened (eg childsafety regulations, GCP-Directive, GCP Regulation, Annex 13, Import, AMG Novelle, GCP-Verordnung, AMWHV) More and more people are claiming for increased percentages of IMP related activities to be sourced out. Opportunities, consequences, impact and risks of such outsourcing attempts are mostly misperceived Importance of interfaces between the different units involved in preparation of clinical trials has dramatically grown. This is why this business unit (PharmLink Consultants) will benefit from synergies from the other business units in particular

23 PharmLink Consultants have always been following their initial vision statement which also at present is relevant more than ever: To be a world-class competence- and value based Pharmaceutical Consultancy, specialising in Clinical Supplies, offering Clients the opportunity to maximise operational effectiveness thus enabling time to market improvements to benefit their patients, stakeholders and shareholders

24 Service Offerings Strategic Consulting Strategy Technology Process Optimisation / Process Improvement Operational Consulting Training and Coaching of staff Specialised Service Functions Project Management GxP Compliance Training on GxP Guidelines and Regulations (together with ) Auditing (together with ) Advisory Expert Opinions Comparator Sourcing beyond normal complexity Based on own manufacturing/import authorisation and wholesaler s license Benefitting from personal network of contacts matured over years Also covering exotic enquiries

25 Strategic Consulting Business process re-engineering / optimisation / improvement Strategic site assessments Make or buy decisions Outsourcing strategies Strategic IT investments, e.g. evaluation of MES (manufacturing execution systems) to support the clinical supply chain Introduction of performance measurement, balanced scorecard methodology, KPIs

26 Process Optimisation / Process Improvement Analysis Interviews to identify issues and initial improvement opportunities As-Is Analysis & target setting Opportunities discovery & visioning Improvement and Standardisation Opportunities Strategy setting Detailed process mapping Identify standardisation and/or re-engineering potential Address potential organisational changes Address potential IT systems to support process Implementation Business process re-engineering

27 Some further reading: Selected Projects US headquartered, major multinational pharmaceutical company evaluation, selection and pilot facilitation of an MES system to support the global clinical supply chain US headquartered, major multinational pharmaceutical company long-term strategic analysis of manufacturing and sourcing activities to support clinical operations at their three global sites Germany headquartered, global pharmaceutical company evaluation of potential scenarios for the selection and implementation of a MES system to support the clinical supply chain Germany headquartered, global pharmaceutical company analysis and documentation of current As-Is processes in pharmaceutical development, clinical trial supplies and the quality control unit to identify areas for standardisation and/or re-engineering, and introduction of performance measurement by defining and implementing appropriate KPIs according to the balanced scorecard approach US headquartered, globally active clinical trial supplies contract packager market survey on the future outsourcing practices of major pharmaceutical companies IT systems for investigational medicinal products evaluation of different software vendors providing MES systems for the IMP market

28 Selected Projects (cont d) Decision support on business strategies of an equipment manufacturer: becoming a pharmaceutical contract manufacturer or not Decision support for a clinical supplies service provider: strategic site assessment for further acquisition Decision support for a clinical supplies service provider outside EU: strategies for acquiring EU customers including planning of a completely new facility within EU Workflow optimisation with a clinical supplies service provider Alignment of structure with a clinical supplies service provider in order to better comply with international GxP regulations GxP compliance audits on contract basis Supporting an IT service provider to get familiar with GMP regulations for software validation and acting as an expert interface between a big international customer and the IT service provider during negotiations about functionalities and validation requirements for a customized MES for clinical supplies preparation (RFPs etc.) Advising a big international excipients manufacturer about potentials and pitfalls when entering the business area of pharmaceutical contract manufacturers

29 Selected Projects (cont d) Clinical trial medication management of several big multinational long term clinical trials Development of IT supported barcode-controlled labelling system Optimisation of the clinical supply process (Quality, Time and Cost) Integrated QA system to support and improve the clinical supply process Installation of a planning and co-operation concept between clinical and pharmaceutical development Training of clinical monitors and CRA`s to understand the details and necessities of the clinical supply chain, forecast, planning, communication and co-operation

30 Toolset of 5 Business Units adressing speed in pharmaceutical development adressing speed in business processes and clinical supplies related areas adressing speed in qualifying GxP environment (people & infrastructure) adressing speed in learning processes by efficient and innovative learning concepts adressing speed by pragmatism and competence when releasing drugs for patient s use

31 adressing speed in qualifying GxP environment (people & infrastructure) PharmGMP Qualifying is offering services in the non-product related area of GMP and GxP Compliance

32 GMP Audits active (ie acting as auditor at third parties like CMOs). Audits are requested as per respective regulations but fail in frequent cases due to lack of capacity and qualifications passive (ie preparing and accompanying audits from third parties like authorities at client s site) Training of personnel at PharmDev s premises or on client s site according to the respective GMP regulations Documentation of training, gap monitoring, qualification profiling, monitoring of repeated and regular trainings in a web-hosted external database SOPs: authoring, editing, revisions, maintenance and training Branded:

33 Trainings (in part in cooperation with other providers) provided to participants (selection) from

34 Innovative Training Concept (based on own experiences as organiser, participant and decision maker) Intensive Coaching Principle Take place guarantee Flexible Timely Small groups (max 6) Standardized Web-based seminar booking All inclusive (Transfers etc.) Unique (design protected & patented) file folder for seminar handouts Branded:

35 Toolset of 5 Business Units adressing speed in pharmaceutical development adressing speed in business processes and clinical supplies related areas adressing speed in qualifying GxP environment (people & infrastructure) adressing speed in learning processes by efficient and innovative learning concepts adressing speed by pragmatism and competence when releasing drugs for patient s use

36 Web-based GMP Training Concept (based on own experiences as organiser, participant and decision maker) Competitive Costs Starting at 49 Principle Flexible (learning whereever and whenever possible and meaningful) Timely Location independent Standardized Web-based booking Two levels (Basic & Advanced) Rapid development of further topics Unique set of topics (a lot of them not covered elsewhere)

37 Pharmaceutical Technology Training (based on own experiences as organiser, participant and decision maker) Particular Knowledge in Pharmaceutical Technology Solid Dosage Forms Granulation Tabletting Coating Other dosage forms on request

38 Pharmaceutical, Organisational & Regulatory Know-How Training (based on own experiences as organiser, participant and decision maker) Examples: Surviving Regulatory Inspections Application of Design of Experiments Establishing efficient SOP Structures Organisation of Training Infrastructures Application of MS-Office Software in Developmental and/or GMP Environment

39 Toolset of 5 Business Units adressing speed in pharmaceutical development adressing speed in business processes and clinical supplies related areas adressing speed in qualifying GxP environment (people & infrastructure) adressing speed in learning processes by efficient and innovative learning concepts adressing speed by pragmatism and competence when releasing drugs for patient s use

40 adressing speed by pragmatism and competence when releasing drugs for patient s use EU GMP-Directive 2003/94 allows that the Qualified Person does not necessarily have to be an employee of the holder of the marketing authorisation. This constellation was transferred into german legislation by the revised version ( 14. AMG Novelle ) of the german medicines act (AMG = Arzneimittelgesetz) in 2005 Regulators and legislators wanted to take account of the situation with small start-up companies and such companies lacking from respective structures, qualifications, know-how and money to invest in a respective infrastructure of the Qualified Person as such Keeping this background in mind, PharmQP Contractors offers the service of a Qualified Person for product release not only for marketed products but also for IMPs (which is an even higher challenge due to additional qualification requirements as per Annex 13 of the european GMP guideline)

41 The named Qualified Person has to meet the regulatory requirements with regard to his qualification. Responsible authority (RP Tübingen) has officially confirmed Dr. Dietrich s respective qualification in writing.

42 Service offering: a) Audit of all areas related to manufacture, quality control and quality assurance at the client s site as basis for assessment of client s quality assurance system b) Demarcation of own responsibilities against those of other Qualified Persons involved in the process according to Annex 16 of EU GMP Guideline c) Liable release / certification of drugs based on in-depth knowledge of the product, the client s site and processes and the respective documentation as laid down in the Quality Agreement to be signed in advance with the client. d) Support of client in all questions related to regulatory and GMPcompliance issues and those related to release and quality assessments of drugs.

43 Conclusion PharmDev Innovations provide a comprehensive service offering for Pharmaceutical Industry in Development and Manufacturing related areas Why not to join the long list of satisfied clients NOW? Thank you very much for your interest and please feel free to question any of the statements made in this presentation

44 Contact PharmDev Innovations Dr. R. Dietrich Im Tiergarten 16 D Konstanz Germany Phone Fax Mobile Xing: LinkedIn: