Mark J. Kontny, Ph.D.                                    President, PDS & CSO     Partnership Opportunities in Drug Delive...
Objectives             • Provide an understanding of the critical decision               points and timing in the developm...
The Drug Product Development Process   Clinical & Early Development CMC                                 Early Clinical   L...
The Drug Product Development Process              Clinical and Full Development CMC    nology                             ...
Develop Product DevelopmentDiscovery    Preclinical                       Clinical                     Review   Product   ...
Key PDS Drug Product Deliverables1. Physical chemical characterization of the drug substance (technology   development & r...
Product Alert                Key CMC decision criteria to evaluate                in h                i humans            ...
Proof of Concept            Key CMC decision criteria to              proceed t clinical Phase IIb                    d to...
Decision to Register              Key CMC decision criteria to produce Phase III              supplies and i iti t registr...
Decision to Launch            Key CMC decision criteria to launch            1. Process validation complete?            2....
Selecting a Partner – MUST HAVES             • Technical depth and breadth – formulation, process,               packaging...
Cost of Transition of Service Providers               Time               • 3 - 6 months               Quality & regulatory...
Summary          • Delivering a drug product through the development            process and into the market place is akin ...
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Podd slide deck mark kontny

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Podd slide deck mark kontny

  1. 1. Mark J. Kontny, Ph.D. President, PDS & CSO Partnership Opportunities in Drug Delivery Conference Boston, MATransforming a New Drug or Technology g g gy into a Marketed Product
  2. 2. Objectives • Provide an understanding of the critical decision points and timing in the development process to i t d ti i i th d l t t speed the product to market • Emphasize the interplay between physical and chemical characteristics of the drug, the h i l h t i ti f th d th formulation, the manufacturing process, the analytical methodology, the packaging, and clinical trial materials • Establish criteria for selecting a vendor that can help bring a product across the finish line and into the market2l
  3. 3. The Drug Product Development Process Clinical & Early Development CMC Early Clinical Late Clinical Discovery Preclinical Registration Validation Commercial Ph I / II h Ph II / IIIProduct Proof of Alert Early Development Concept Formulation Preformulation Development / CTM / Salt Selection l l i Analytical l i l Manufacturing f i Development 3l
  4. 4. The Drug Product Development Process Clinical and Full Development CMC nology Early Clinical Late Clinical Discovery Preclinical Registration Validation CommercialChron Ph I / II h Ph II / III Decision Decision to Register Full Development to Launch tions Final Process Formulation & Development / CTM RegistrationFunct Analytical Scale-up & Manufacturing Stability Method Final Process 4l
  5. 5. Develop Product DevelopmentDiscovery Preclinical Clinical Review Product Physical-Chemical Characterization Develop the Formulation Develop the Process Validate the Process Develop the Package Manufacture, Package, Label Clinical Supplies Analytical Methods & Stability Technical Reports, IND & NDA Documentation Improve the Technology Phase I Phase II Phase III IND ICH NDA Approved EOP Product Proof of Decision Decision Alert Concept to Register to Launch 5l
  6. 6. Key PDS Drug Product Deliverables1. Physical chemical characterization of the drug substance (technology development & regulatory) d l t l t )2. Technology development (Commercial operations) – Formulation – Manufacturing process – Packaging – Analytical methods3. Clinical trial materials – CTM (Clinical)4. Stability (Regulatory)5. CMC sections of regulatory submissions (INDs, NDAs and BLAs)6. Intellectual Property6l
  7. 7. Product Alert Key CMC decision criteria to evaluate in h i humans 1. Biologic properties? – Dose – Half-life 2. Acceptable physical & chemical properties for development? – P it Purity – Solid form – Chemical Stability – Solubility Assessment – Impurities & Degradants 3. Acceptable level and variability of bioavailability? 4. Formulatable? 4 F l t bl ?7l
  8. 8. Proof of Concept Key CMC decision criteria to proceed t clinical Phase IIb d to li i l Ph 1. API? 4. Analytical? – Purity – Robust methods – Impurity profile 5. Package? – Solid Form 6. Quality? – Stability (physical and chemical) 7. 7 QbD Ri k Assessment Risk A e ment 2. Formulation? – Excipient compatibility – Stability / degradants – Bioavailability / bioequivalence 3. Process? – Reproducibility – Scalable8l
  9. 9. Decision to Register Key CMC decision criteria to produce Phase III supplies and i iti t registration stability li d initiate i t ti t bilit 1. Final API? 2. Final formulation? 3. Final process? 4. Final analytical methods? 5. Commercial manufacturing site selected? 6. Suitable registration stability protocol?9l
  10. 10. Decision to Launch Key CMC decision criteria to launch 1. Process validation complete? 2. Robust and characterized process? 3. PAI? Actions implemented? l d 4. Adequate commercial manufacturing volume to support market demand? 5. Stability to support desired expiration date?10 l
  11. 11. Selecting a Partner – MUST HAVES • Technical depth and breadth – formulation, process, packaging development, analytical k i d l t l ti l • Quality system and track record • Manufacturing scale – seamless scale-up from lab, scale up to pilot, to intermediate, to commercial scale • Customer service & agility • B i Business plan – f f service, royalties, terms l fee for i li & conditions • Fair pricing11 l
  12. 12. Cost of Transition of Service Providers Time • 3 - 6 months Quality & regulatory • More audits, greater complexity of submission and review Cost • Additional technology transfer expense Knowledge loss !!12 l
  13. 13. Summary • Delivering a drug product through the development process and into the market place is akin to d i t th k t l i ki t preparing for and running a marathon • Key drug product CMC deliverables – Clinical trial supplies – Regulatory documentation – Robust technology • Development must be managed carefully to control costs, yet deliver a registered product and robust manufacturing technology • Partnering with the right drug development partner can save time and cost throughout the process13 l

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