PharmAdvisors Capabilities

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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

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The Issue We Address
Everyone can pull in the various experts needed
Clinical
ADME
Tox
Chemistry
Manufacturing
Process Development
Marketing
Formulation
Drug Substance
Quality
Drug Safety
Drug Product
Engineering
Clinical
Regulatory
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The Issue We Address
linking broad and deep perspective early is key
to anticipating issues, accelerating progress,
managing risk and unlocking value!
Process Development
Marketing
Manufacturing
Engineering
Regulatory
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Advisors Industry Focus
Pharmaceuticals
Transaction Valuation and Licensing
Suppliers to the Life Sciences
Animal Health
Technology Platforms
Medical Devices
Venture Capital
Biotechnology
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Advisors Functional Focus
Integrating Research, Development Engineering and
Commercialization Expertise Click on Any Hexagon
for Examples
Practical Quality Systems Regulatory
Portfolio Decisions, Due Diligence Valuation
Rapid, Interactive Expert Panels
Integrated Development View Linking CMC, Tox,
Clinical
Operational Input to Capital Plans
Resolve Issues Build Skills Chemistry,
Formulation Drug Delivery Safety Efficacy
ADME
Scale-up Sourcing Decisions
Supporting Development, Operations, Strategy and
Portfolio Management
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What Do We Do Best?
What
How
Delivery Assurance
Expert Content
Delivery Assurance
Efficient Process
Professional Management
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Inverting the Consulting Model
Industry Experts
Experienced Consultant Managers
Unique Client Situation

• Proven Delivery
• Insight-Driven
• Customized Resourcing
• Integrated, Experienced Functional Perspective
• Hands-On Problem-Solvers
• Cost-effective, Flexible, Independent

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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 RD
• 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 RD
• 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 RD
• Senior VP, Global Drug Development
• Vice President of Business Development
• Vice President Information Technology
• Vice President of Drug Development
• Vice President of Process Development

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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

• 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

• 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

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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

• 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

• 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

• Project Implementation
• Project Management (Multi-national)
• Purchasing
• Quality Assurance
• Quality Control
• QC Strategies Assessment/QA
• Quality Systems
• RD
• Radiolabeled Antibodies
• Regulatory Affairs
• Rx to OTC Opportunities
• Safety Evaluations
• Sales and/or Marketing
• Scale-Up from RD to Manufacturing
• SOP Creation
• Start-Ups
• Supply Chain
• Synthetic Semi-Synthetic Drug Candidates

...That is Growing
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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

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Some Relevant Case Studies

• Support of Critical Manufacturing Issues for a
  Complex Biologic
• High Powered Expert Panel on a Deal- Breaker
  Issue
• Package/ Shipping Validation to Launch Key
  Products

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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
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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.

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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

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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 RD 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.

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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

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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.

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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

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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

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• What is keeping you up at night?