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1. 2 Pharmaceutical Advisors –Core staff with average 20 years industry experience –Network of over 100 Advisors and growing –Covering every discipline.

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Presentation on theme: "1. 2 Pharmaceutical Advisors –Core staff with average 20 years industry experience –Network of over 100 Advisors and growing –Covering every discipline."— Presentation transcript:

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2 2 Pharmaceutical Advisors –Core staff with average 20 years industry experience –Network of over 100 Advisors and growing –Covering every discipline for pharmaceutical development and commercialization –Founded in 2001, currently more than 75 clients Small and mid-sized companies Emerging pre-clinical and clinical stage companies Top 5 pharmaceutical companies Suppliers to the Life Sciences

3 3 The Issue We Address ClinicalADMEToxChemistry Process Development Quality Manufacturing Clinical Drug Substance Drug Product Drug Safety Formulation Project Management Everyone can pull in the various experts needed … Engineering Regulatory Marketing

4 4 The Issue We Address ClinicalADMEToxChemistry Process Development Quality Manufacturing Clinical Drug Substance Drug Product Drug Safety Formulation Project Management Engineering Regulatory …linking broad and deep perspective early is key to anticipating issues, accelerating progress, managing risk and… unlocking value! Marketing

5 5 Technology Platforms Transaction Valuation and Licensing Advisors Industry Focus Venture Capital Animal Health Suppliers to the Life Sciences Medical Devices Biotechnology Pharmaceuticals

6 6 Rapid, Interactive Expert Panels Rapid, Interactive Expert Panels Practical Quality Systems & Regulatory Practical Quality Systems & Regulatory Resolve Issues Build Skills Chemistry, Formulation Drug Delivery Safety & Efficacy ADME Resolve Issues Build Skills Chemistry, Formulation Drug Delivery Safety & Efficacy ADME Integrated Development View Linking CMC, Tox, Clinical Integrated Development View Linking CMC, Tox, Clinical Portfolio Decisions, Due Diligence & Valuation Portfolio Decisions, Due Diligence & Valuation Scale-up & Sourcing Decisions Scale-up & Sourcing Decisions Operational Input to Capital Plans Operational Input to Capital Plans Advisors Functional Focus Integrating Research, Development Engineering and Commercialization Expertise Click on Any Hexagon for Examples Supporting Development, Operations, Strategy and Portfolio Management

7 7 What Do We Do Best? Expert Content Efficient Process Professional Management What+ How= Delivery Assurance Delivery Assurance

8 8 Inverting the Consulting Model… Proven Delivery Insight-Driven Customized Resourcing Integrated, Experienced Functional Perspective Hands-On Problem-Solvers Cost-effective, Flexible, Independent Industry Experts ExperiencedConsultantManagers Unique Client Situation Situation

9 9 With Experienced Advisors… Associate Director, Venture Mgmt Asst Director for Technical Affairs Chief Executive Officer Chief Operating Officer Dept. Head of Pharmaceutical Engineering Director of Fermentation and Biocatalysis Development Director of Formulation Development Director of Pharmaceutics R&D Director of Quality Control Director of Sourcing & Planning of Chemical Development Director, Clinical Operations, Medical Affairs Director, Experimental Pathology Director, Global Medical Operations Director, Planning and Business Support, U.S. Medical and Regulatory Affairs Director, Production of Therapeutic and Diagnostic Proteins Exec Director of Manufacturing Executive Vice President, Global Drug Safety, Metabolism and Safety Pharmacology Group Director of Clinical Research Group Director of Process R&D Group Director, Preclinical Safety Assessment Manager of Organizational Effectiveness Mgr, Radiopharmaceutical Manufacturing President President of Technical Operations Senior Director Operations Planning - Worldwide Pharmaceutical Group Senior Director, North American Clinical Affairs Senior Manager, Clinical Research Senior Vice-President and Chief Scientific Officer Senior Director of Process Chemistry Senior VP of Pharmaceutical R&D Senior VP, Global Drug Development Vice President of Business Development Vice President Information Technology Vice President of Drug Development Vice President of Process Development

10 10 Whove Run Companies… AAI, Inc. American Cyanamid/Lederle Labs American Home Product Amylin Pharmaceuticals Applied Immune Services Arthur D. Little Astra Pharmaceuticals Aventis Axxima Pharmaceuticals AG Baxter Healthcare Corp. Benzon Pharmaceuticals BioReliance Corporation BMS Boehringer Ingelheim Boots Pharmaceuticals Bristol-Myers Squibb BSCI, Inc. Cambrian Associates Cambrex Cancer Research Center Cardinal Health Centocor Ciba-Geigy Corporation Corixa Coulter Pharmaceutical Dentsply Discovery Partners Millennium Monsanto Napp Researche Centre National Cancer Institute Neose Norcliff-Thayer Novartis Ortho Biotech PA Consulting Group Pfizer Pharmacia Response Biomedical Richardson-Vicks Salmedix Schering Corporation Schering-Plough Searle Sepracor Inc. Sigma-Aldrich Corporation SmithKline Beecham SUGEN Tektagen The Life Sciences Group Upjohn Ltd. US Environmental Protection Agency Wyeth-Ayerst Eli Lilly & Company Environmental Toxicological, Intl US FDA Center CBER & CDER FEI Technologies Fisons Fluor Daniel Genentech Genovo GSK GX BioSystems Hoechst Marion Roussel Hybridon ICI Pharmaceuticals IMBIC Immunex Immunogenetics Immunomedics IMRE Corporation Isolation Technologies J&J Knoll Pharmaceuticals, Nottingham Matthew Hall Engineering Merck Merck, Sharpe & Dohme Mettler Toledo MicroProbe Corporation

11 11 With Broad Functional Expertise Advisory Board s Analytical Development Analytical Methods Development/Validation Analytical Operations Biologic Manufacturing Bio-Pharmaceutical Development Bulk Active Ingredients Bulk Clinical Supply Planning Bulk Drug Substance Bulk Manufacturing Business Development Capital Raising Chemical Synthesis Chemotherapeutic Agents Clinical Pharmacology Clinical Research Clinical Supplies Mgmt & Release CMC of IND/NDAs Commercial Product Profiling Corporate Inventories Cost Evaluation/Budget Prep & Control CRO, Supplier Auditing & Mgmt Diabetes & Metabolic Diseases Documentation Drug Delivery Technology Manufacturing Materials Resource Planning New Bulk Substances Novel Formulations Oncology Clinical Research Operations Operations Research & Management Organizational Analysis Parenteral/Oral Dosage Forms Patents & Procedures Performance Audits & Validation Pharmaceutical Formulation Pharmaceutics Research Pharmacodynamics Pharmacokinetics Phase III/Commercial Needs Portfolio Management Strategies (Evaluation) Preformulation Studies Preparative Chromatography Process & Lab Automation Process and/or Equipment Validation Process Development Product Development Product Launches Product Licensing Drug Development Drug Interaction Drug Metabolism Drug Product Endocrinology & Metabolism Engineering Environmental Impact Analysis Expert Reports, Dossiers, DMFs Facility Design and/or Operation FDA Regulations & Inspections (Technical Data Pkgs.) Fermentation Filling & Packaging Operations Finance Formulation Development Good Clinical Practices Hematology & Internal Medicine Immunochemistry Research In Vitro Diagnostics In-Process Control Activities Intellectual Property Management Investments Just-In-Time Methodologies Laboratory Operations Life-Cycle Strategy Lipid Consultant Long-Term Supply Agreements Project Implementation Project Management (Multi-national) Purchasing Quality Assurance Quality Control QC Strategies & Assessment/QA Quality Systems R&D Radiolabeled Antibodies Regulatory Affairs Rx to OTC Opportunities Safety Evaluations Sales and/or Marketing Scale-Up from R&D to Manufacturing SOP Creation Start-Ups Supply Chain Synthetic & Semi-Synthetic Drug Candidates Target Identification Technology Profile Technology Transfer Toxicology-Pathology Transdermal Technology...That is Growing

12 12 Our Strengths to Help You HOW we support our clients –Speed & flexibility –Content expertise & general management perspective –Business decisions & technical expertise Use our approach to solve problems and address issues –The RIGHT expertise based on client needs –We efficiently identify and involve whats needed We effectively deploy and integrate the RIGHT resources –Insight about implications on other functions and processes –Multiple perspectives within a specialty where needed

13 13 Some Relevant Case Studies 1.Support of Critical Manufacturing Issues for a Complex Biologic 2.High Powered Expert Panel on a Deal- Breaker Issue 3.Package/ Shipping Validation to Launch Key Products

14 14 Recent Case Study (1) Support Critical Manufacturing Issues for a Complex Biologic The Issue Our client is a small molecule drug discovery and development company that acquired a commercially launched biologic pharmaceutical. Process variability in the fermentation of the drug was creating N-terminal variants, preventing the product from being manufactured reliably. What We Did Assembled a cross-functional team of Bio-Analytical, Fermentation, and Bio-Manufacturing experts. We supported the client through the investigation, experimentation, and implementation phases of the project by: –Assessing the process and existing data for root cause of process variability –Selecting and directing the outsourced supplier to identify weaknesses of the existing process and analytical methods supporting the process –Identifying the most likely sources of variability –Establishing vendors for new analytical methods and fermentation development –Designing and executing an experimental protocol to definitively assign root cause –Designing cost-effective scale-up plans to manufacture the revised process at scale Providing the client with: –The root cause of variability in the face of a complex web of confounding factors –A cost-effective solution to product variability, avoiding product withdrawal Protected a key source of revenue during a critical phase of growth for a young and growing Bio-Pharmaceutical Client

15 15 The Team John Apathy, Trained in Biochemistry and Immunology. 20 years experience developing strategies and leading pharmaceutical product development teams within a major pharmaceutical company and as senior managing consultant with a major pharmaceutical consultancy. David Dodds, PhD, Former Director of Fermentation and Bio-catalysis Development with BMS Kent Iverson, formerly with Immunex and Coulter Pharmaceuticals, has led the Process Development and Materials Management departments of all products from pre-clinical development through commercialization. John McEntire, PhD Former Corporate Vice President of BioReliance, with expertise in biopharmaceutical development analytical and formulation. Tim Noonan, PhD. Trained as a medicinal chemist, and a former VP of manufacturing, Tim has broad manufacturing, operations and quality systems experience, was instrumental in the formation of a successful contract oligonucleotide manufacturing firm. Dr. Noonan also worked as a consultant to venture capital firms performing technology due diligence.

16 16 Recent Case Study (2) High Powered Expert Panel on a Deal- Breaker Issue The Issue Our client identified a degredant as a known mutagen. The client needed to understand the implications for development and the value of the compound for a partner meeting. They also needed the right regulatory strategy, as well as an understanding of the trade-offs between salt forms to pursue appropriate development programs. What We Did In less than 2 weeks assembled a team that addressed their issues –2 Gentox experts that wrote the ICH guidelines –1 Gentox expert that convinced the FDA to act favorably with a similar situation –CMC expertise with polymorph expertise –Pharmacology –Tox expertise in early and late development strategies Providing the client with: –Answers to the right questions to show their partner that they had control and a plan –Awareness of questions they had not considered –Understanding of what was NOT an issue –Insight into the right development strategies to manage risk –Confidence that they had explored all the alternatives –One place to go for follow-up and coaching No one got on a plane, stayed overnight, or was wined and dined No one had to assemble and assimilate the input

17 17 The Team Jane S. Allen, Ph.D., D.A.B.T., former Director of Toxicology, GSK, RTP with expertise in genetic toxicology. Member of US PhRMA committee that established the ICH genetic toxicology guidelines. Michael Berman, PhD, is a former biotech CEO with broad experience in pre-clinical development for Phase I studies with a focus on biologicals and peptides as well as small molecules. Dr. Berman has taken a number of novel biologicals into Phase I. Robert L. Brent, MD, Ph.D. Distinguished Professor of Pediatrics, Radiology and Pathology and Louis and Bess Stein Professor of Pediatrics, Jefferson Medical College, Philadelphia. Former advisor to Aventis for ARAVATM, with expertise in clinical medicine related to genetic toxicology. Charles E. Piper, PhD, former Executive Director, Clinical Research Strategic Partnering, Clinical Development, and former Executive Director, Product Safety Assessment, Preclinical Development, Searle. Member of US PhRMA committee that established the ICH genetic toxicology guidelines. Thomas Crawford, PhD, former Group Director of Process R&D with Pfizer where he was responsible for the development of chemical technology and the manufacture of supplies for drug candidates from nomination to transfer to Pfizer's Global Manufacturing Group. William D. Kerns DVM, MS, DACVP former Executive Vice President, Global Drug Safety, Metabolism and Safety Pharmacology, Eisai and SmithKlineBeecham. Guy Paulus, PhD. Served most recently as Senior Vice President Drug Safety Evaluation Pfizer Central Research Groton U.S. Robert Ronfeld, Ph.D. who led Pfizers Clinical Pharmacokinetics and Pharmacodynamics group with particular expertise in Drug Metabolism and Development Strategy. Richard S. Woodward, Ph.D. Biotechnology and pharmaceutical executive with multidisciplinary international experience. Formerly with Pharmacia, Ajinomoto USA, Inc. and Quality Biotech, Inc. Tim Noonan, PhD. Trained as a medicinal chemist, and a former VP of manufacturing, Tim has broad manufacturing, operations and quality systems experience, was instrumental in the formation of a successful contract oligonucleotide manufacturing firm. Dr. Noonan also worked as a consultant to venture capital firms performing technology due diligence.

18 18 Recent Case Studies (3) Complex Package/ Shipping Validation to Launch Key Products The Issue Our client is extending its growth strategy requiring an enhanced capability in packaging / package design, logistics, shipping validation, quality, and management of vendors beyond current resources and internal capabilities. What We Did Assembled a cross-functional team of Logistics, Quality, Packaging and Manufacturing / Operations experts. We are supporting the client through the investigation, planning & experimentation, and implementation phases of the project by helping to determine: –when and how to utilize engineering resources from package design and testing firms vs. independent engineering resources, –the cumulative effect of expected Time /Temp excursions in the context of stability / shelf life and possible variations in packaging and logistics –where to utilize off-the-shelf secondary packaging solutions –where custom packaging solution are appropriate, trading off cost of manufacture and design with logistics and other costs. –efficiencies anywhere in the distribution chain, based on decisions in packaging or other areas –with complex, issues such as this, any key activities or decisions not assigned or staged. Providing the client with: –Roadmap for the packaging, shipping and shipping validation project, maintaining the timeline –Key program management Enabling progress in a critical area without the need to scale-up resources

19 19 The Team John Apathy, Trained in Biochemistry and Immunology. 20 years experience developing strategies and leading pharmaceutical product development teams within a major pharmaceutical company and as senior managing consultant with a major pharmaceutical consultancy. William Gierke, former manager of Package Development with Eli Lilly and a member of the Drug & Pharmaceutical Packaging Committee Kent Iverson, former Vice President of Manufacturing & Process Development at Corixa, Coulter and Immunex. Kent has broad operational expertise and has implemented practical solutions to complex controlled temperature shipping issues for injectables and has developed successful supply plans for numerous 2-8C products. John Pock, former head of Performance Engineering & Worldwide Quality as well as manager of International Distribution at Eli Lilly.

20 20 Other Recent Projects Rapid due diligence of compounds for critical decisions Manufacturing and Outsourcing strategy including determination of number of locations and in- source / outsource mix Integrated early and full drug development plans Quality Systems planning and implementation for developing company cGMP Quality System Gap Analysis for an established company Process development to address issues on a marketed product Site Audits with regulatory and practical operations perspective Manufacturing readiness assessment Sourcing - identification of sources and review / selection Candidate nomination process and portfolio review Formulation and drug delivery choices Market studies by simulating a pharma development group Deal valuation support cGMP Supplier Management

21 21 Why do clients look to us? Trust and confidence that we will get it done We apply world-class expertise that exactly meets the need Efficiency and effectiveness of our structured approach Avoid time consuming management and coordination of challenging resources and diverse inputs to complex issues Speed of results Accountability at a single, rather than multiple points We ensure a cross-functional and downstream view Fixed predictable budget vs. multiple experts with the meters running at different rates Delivery Assurance

22 22 What is keeping you up at night?

23 23 Practical Quality Systems & Regulatory Help What we do and how its different: Operations oriented Quality perspective, not just ex-FDA… Practical approaches to regulatory compliance Helps avoid costly reactive remedial consultants Cost-effective, proactive compliance Examples of recent projects: Establishment of appropriate cGMP systems for a research based company moving to commercial development GAP Analysis and Action Plans following FDA Warning Letter Vendor Audits that strengthen the vendor / client relationship CGMP Gap Analysis and Action Plan Pre-Approval Inspection Readiness Assessment Return / Next

24 24 Operational Input to Capital Plans What we do and how its different: Application of functional operations AND engineering expertise to complement client resources Helps client identify operational implications and issues with a "downstream perspective Avoids costly change orders and feature creep, and supports sound decisions, early in the process Examples of recent projects: Development of a URS ( User requirement Specification ) for $200M Small and Large Molecule development facility Future Proofing of current pharmaceutical process through process and equipment reviews Process Validation, Equipment Qualification and Operational Efficiency input to design of new vessels for aseptic processing Development of downstream processing technology requirements to meet future development needs. Return / Next

25 25 Resolve Issues and Build Skills What we do and how its different: Focused and efficient application of functional expertise Integrated development perspective Multi-company perspectives Access to the latest thinking Integration of inputs without costly coordination Examples of Recent Projects: Expert oversight of challenging outsourced cytotoxic fermentation Dosage form strategy and action plan to obtain IP protection Dosage form strategy to overcome half life deficiency Micro Lab productivity analysis and recommendations to improve efficiency and handle greater workload without adding staff Operational Cost Model for research stage company transitioning to a product stage company Informed Tox, CMC development and risk reduction plans to accelerate progress Return / Next

26 26 Rapid & Interactive Expert Panels What we do and how it s different: Expert teams, custom assembled to address critical issues Focused assignments for panel members ensure efficient process Individual and group discussions, across-functions and within functions Interactive panel discussions via telecon with the client Real, actionable answers, action plans Completed in 1-3 weeks Examples of recent projects: A rapid due diligence review of targets Implications and path forward for gen- tox issue to support out-license Review and selection of appropriate animal models Go / No-Go review of existing efficacy data Manufacturability & scalability of synthetic routes Return / Next

27 27 Scale-up and Sourcing Decisions What we do and how its different: Capitalize on multiple advisors experience in development, sourcing, and vendor management Rapid identification of technical requirements, identification of possible vendors, screening & qualification, support development of contracting, quality agreements etc. Drug Substance/API, Intermediates, Formulation, Drug Product, Fill-Finish Examples of Recent Projects: Identified and qualified sources for hard-to-locate emulsion capability in Europe Identified and qualified US sources of peptide manufacture for a European company API Development, Scale-Up and route filing strategy Scalability / Manufacturability review Vendor Management Strategy and Process for an emerging large Biotech Identification and Qualification of Controlled Release Drug Product manufacturers for an established Biotech Return / Next

28 28 Integrated Development View The Core of Advisors Approach Leverage understanding of the interrelationship between CMC, Clinical and Safety development to create and protect value Multi-company and cross-functional perspectives Insight-driven anticipation of Advisors Functional Focus issues for improved risk management Advisors who have been accountable for all aspects of development Application to specific issues and overall program management Return / Next

29 29 Portfolio Decisions, Due Diligence and Valuation What we do and how its different: Concurrent technical and business perspective Portfolio management decision experience across a wide range of technologies and therapeutic areas Rapid inclusion of focused subject matter expertise rather than generalist research Examples of recent projects: Due Diligence of compounds in various therapeutic areas Due Diligence of company business models Valuation of compounds in support of out-licensing decision Assembly of a Virtual Pharmaceutical Company team of users to help a supplier understand the value of their technologies resulting in successful new business strategy Return / Next


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