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Essentials for rapid and cost‐effective 
product development
Dr. Ronald van der Geest

UMCN, June 2012
The Long Road to a New 
   Medicine...
                                                            NDA/MMA
                              Clinical Data 
                                 Analysis

Full Development                                                                              Registration
 Studies in 100‐300 
                                                                  Candidate Medicine Tested in 
 Patients (Phase II)
                                                                   3‐10,000 Patients (Phase III)
                                       Large Amounts of 
                                      Candidate Medicine                                            Extensive 
    Studies in Healthy                    Synthesized                                                Safety 
   Volunteers (Phase I)                                                                              Studies
                                                                              Formulations 
  Exploratory Development                                                      Developed             Candidate



                                                                                                     Early Safety 
                                                                                                       Studies
                          Project Team               Synthesis 
                                                                               Screening
                            and Plans             of Compounds
                                                                                                   Discovery
Creating added value
 3 Dimensions: time, cost & risk
How to get there?

      The essentials:

            IP




Capital           Expertise
Capital

• Sufficient funding
  – Simple rule of thumb: 2‐3M projects get into 
    trouble, 6‐8M projects don’t
• Based on a thought‐trough development 
  plan
  – Include scenario’s 
  – Plan for the best
  – Ask funding for the worst
  – It’s about managing expectations of 
    shareholders
Expertise
       development/business plan
• Sufficient detail for all aspects tox, CMC, 
  clinical, regulatory, etc.
• P&R… as much as possible
• CRO‐shopping: 
  – We have seen anything in the range of 70k to 
    1.5M
Expertise
development/business plan
Development plans compared…
Program I (1996)        Program II (2002)       Program III (2008)

4 phase I trials        6 phase I trials        2 phase I trials
1 phase II trial        0 phase II trials       1 phase II trial
2 phase III trials      2 phase III trials

2 open label trials



development duration:   development duration:   development duration:

Est. 5‐6 yrs            Est. 4 yrs              Est. 2 yrs
Est. budget:            Est. budget:            Budget:

105 M                   60 M                    15 M
Organisation
                            CEO


                Development management board


Protocol review committee

                                     Core development
                                           team

                                    Sub teams


                                      Collaborative teams


                                       ….
Organisation II

                                             Consultant
                       Consultant
Very  limited
in‐house staff




                 CRO                CRO      CRO          CRO   CRO

  Consultant

                                Consultant
Organisation III

                       BOD/Investors


                                       Legal counsel



SMO   CRO                   MT                   SAB




                              administration
            PROJECT TEAM
The project team...

       Who need to be in?

          Management/Planning

            Clinical operations

          Non-clinical/Toxicology

                   CMC

            Regulatory affairs
The project team...

• Core team staffing as early as possible 
  ‐ completeness
  ‐ availability
  ‐ continuity within the team
  ‐ full alignment with the company goals
  ‐ allow flexibility within the team
The project team…

• High level of ownership
• Fast and efficient
• Focus on high‐risk development

• Biggest risks:
  ‐ running out of money
  ‐ lack skills / over‐confident
  ‐ too limited number of projects / risk of 
  failure
Getting started

• Sorting out the regulatory process
• Scientific advice
  – “We are going to have a chat with FDA”
  – “Rubbish‐in – rubbish‐out” principle
  – Based on a solid plan
  – Role play
  – Negotiate
  – Regulators are not the experts
The regulatory process


                                  NCE no/yes




                    BE/hybrid 
                                               Full package
                   application




       BE study                   Hybrid study 
     development                  development 
    implications &               implications & 
        design                       design
The regulatory process

Scientific advice – 2 example questions:

“It is the sponsor’s position that the completed nonclinical 
safety studies are adequate to support a MAA in the proposed 
indication.  Does the Agency concur with the sponsor’s 
position?”

“Does the Agency agree that the proposed program of clinical 
pharmacology studies is adequate and is sufficient to support 
a MAA in the targeted indication?” 
PKPD modeling implementation
  4-way cross-over, double blind, placebo controlled

                        2.5 mg IV  
                        + placebo 




           2.5 mg  +      16          5.0 mg + 
           placebo                    placebo 
               IV       subjects         IV




                        Placebo + 
                         placebo 
                            IV
PKPD modeling implementation
Clinical Utility Index 
Balancing Efficacy  and Safety in Drug Development 
Decision Making
Contact details
Ronald van der Geest, PhD
Partner & General Manager
+31 6 523 901 30
Ronald@3d‐pxc.com




Maidstone 48A, 5026 SK Tilburg    Molenweg 50, 5349 AC Oss
Tel: +31 (0)13 534 8272           Tel: +31 (0)6 55 71 86 66
Website:www.3d‐pxc.com            Website:www.3d‐pxc.com
The Long Road to a New 
Medicine...



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