Pharmaceutical advisors
This presentation is the property of its rightful owner.
Sponsored Links
1 / 29

Pharmaceutical Advisors PowerPoint PPT Presentation


  • 74 Views
  • Uploaded on
  • Presentation posted in: General

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

Download Presentation

Pharmaceutical Advisors

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript


Pharmaceutical advisors

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


The issue we address

Project

Management

The Issue We Address

Everyone can pull in the various experts needed …

Chemistry

ADME

Tox

Clinical

Manufacturing

Process

Development

Marketing

Formulation

Drug Substance

Quality

Drug Safety

Engineering

Drug Product

Clinical

Regulatory


The issue we address1

Drug Substance

Clinical

Drug Safety

Project

Management

Drug Product

Formulation

ADME

Clinical

Quality

Chemistry

Tox

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


Advisors industry focus

Advisors Industry Focus

Pharmaceuticals

Transaction

Valuation and

Licensing

Suppliers to the

Life Sciences

Animal

Health

Technology Platforms

Medical Devices

Venture Capital

Biotechnology


Advisors functional focus

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


What do we do best

What Do We Do Best?

What

+ How

= Delivery Assurance

Expert

Content

Delivery

Assurance

Efficient

Process

Professional

Management


Inverting the consulting model

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


With experienced advisors

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


Who ve run companies

Who’ve Run Companies…

  • Eli Lilly & Company

  • Environmental Toxicological, Int’l

  • 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

  • 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

  • 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


With broad functional expertise

With Broad Functional Expertise

  • 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

  • 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

  • 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

  • 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

...That is Growing


Our strengths to help you

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 what’s needed

  • We effectively deploy and integrate the RIGHT resources

    • Insight about implications on other functions and processes

    • Multiple perspectives within a specialty where needed


Some relevant case studies

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


Recent case study 1

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


The team

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.


Recent case study 2

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


The team1

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 Pfizer’s 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.


Recent case studies 3

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


The team2

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.


Other recent projects

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


Why do clients look to us

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


Pharmaceutical advisors

What is keeping you up at night?


Practical quality systems regulatory help

Practical Quality Systems& Regulatory Help

What we do and how it’s 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


Operational input to capital plans

Operational Input to Capital Plans

What we do and how it’s 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


Resolve issues and build skills

Resolve Issues and Build Skills

What we do and how it’s 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


Rapid interactive expert panels

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


Scale up and sourcing decisions

Scale-up and Sourcing Decisions

What we do and how it’s 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


Integrated development view

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


Portfolio decisions due diligence and valuation

Portfolio Decisions, Due Diligence and Valuation

What we do and how it’s 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


  • Login