PharmaceuticalDevelopment

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1 PharmaceuticalDevelopment Activities & Timelines Agenda Factors driving development Types of product Timelines for development Factors affecting length of development Regulation of Pharma environment Cost of bringing medicine to market Special considerations for novel drug delivery 1

2 Factors Driving Development Three main factors 1. Market need for a product Real Cure for pancrea c cancer Perceived Nutri onal supplements 2. Potential solution to meet need Compound(s) with activity against target receptor Nascent technology New insights through basic research 3. Defined target market characteristics enable Product to be promoted, distributed & sold Good return on investment Type of Products New Chemical Entities New Biologicals Approved drugs New Formulations Approved Drugs New Indications Generics Biosimilars Devices Drug & Device Combinations Gene Therapies Theranostics Cell Therapies 2

3 Definitions & Examples NCE = small molecules (typically < 500 MW) Biologicals insulin, monoclonal antibodies Approved drug/new formulation Abraxane (paciltaxol), Bydureon (exenatide) Approved drug/new indication BVA-501 (antibiotic being tested in cancer) Thalidomide (erythema nodosum leprosum & multiple myeloma) Biosimilars Copies of off-patent biopharmaceuticals Not exact copy complex structure Generics Copies of off-patent small molecule drugs Parenteral Across the Skin Oral Route of Admin Nasal Buccal Sublingual Inhalation 3

4 Timeline for Development -NCE Basic Research Understand disease & identify target Drug Discovery 5000 to 1000 compounds Preclinical Studies 250 compounds Phase I 5 compounds ,000 molecules at discovery stage but only 1-2 will reach market Drug development process takes 10 to 15 years average 12 to 13 Drug discovery to end of pre-clinical 3 to 6 years PhRMA website Pathway to Market (NCE) Select candidate from preclinical studies & file IMPD/IND Phase I: Volunteers -Evaluate Safety & Dosage Phase II: patients - Evaluate Efficacy & Side Effects 6 7 years Beginning Phase I to End Phase III Phase III: 100s-5000 patients - Against Gold Standard File Dossier & Obtain Regulatory Approval 0.5 to 2 years Pricing, Reimbursement, Phase IV, Pharmacovigilance 4

5 Clinical Factors Affecting Development Disease characteristics Incidence of disease affect clinical trial recruitment Chronic or non-chronic affects length of clinical trials Severity of disease fast-tracking for breakthrough therapy Route of administration/dosage form Genetic factors develop diagnos c test to select trial subjects Aim of therapy & potential for side-effects Ideal plasma levels dosage form design Dose & frequency of administration dosage form design Point of treatment Hospital/Clinic/Home Physiological & Physicochemical Dose & safety of handling during manufacture Solubility & permeability of drug at site of absorption Metabolism (liver, tissue) & excretion Pharmacokinetic parameters & pharmacodynamics Chemical & physical stability Size, shape & appearance Patient must be able to swallow dosage form Injections volume constraints Need to be able to identify product Marketing considerations 5

6 Regulation of Pharma Environment Most pharmaceuticals sold globally Regulatory Requirements European Medicines Agency (EMA) Food & Drug Administration (FDA) Japanese Ministry of Health, Labour & Welfare Other agencies Pharmacopeial requirements ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use GMP/GLP/GCP Cost of Bringing Medicine to Market 1,172 million ($ 1,506 million in year 2011 dollars)* Includes cost of failures Allocation of R&D investments by function (%) Stage % Investment ** Preclinical/Prehuman 21.5% Phase I 8.7% Phase II 12.5% Phase III 35.7% Approval 8.3% Pharmacovigilance/Phase IV 9.8% Uncatagorized 3.5% *Mestre-Ferrandiz et al, Office of Health Economics, December 2012 **PhRMA, Annual Membership Survey 2013 (% calculated from 2011 data) 6

7 Acceptable Excipients Pharmacopoeial USP/NF, Ph. Eur., JP GRAS (Generally Regarded as Safe) (FDA) Scientific procedures or substance used in food before 1958 Requires a substantial history of consumption by a significant number of consumers Same quantity and quality of scientific evidence as is required to obtain approval of the substance as a food additive Inactive Ingredients in Approved Products Database (FDA) Lists route & dosage form & maximum potency Japanese Pharmaceutical Excipients Directory Novel Excipients Non-clinical studies required Existing data -humans or from GRAS or as food additive Can add groups of animals to normal drug testing Safety should be determined early on Requirements depends on treatment duration & route Short-term use 14 days Intermediate use > 14 days but 3 months Long-term use > 3 months Parenteral, topical, opthalmic, otic, rectal, vaginal, intra-oral, intranasal - additional requirements Photosafetytesting 7

8 Nanoparticles Preclinical & toxicology requirements on a product-by-product basis EU s Scientific Committee on Emerging & Newly Identified Health Risks Scientific Basis for the Definition of the Term nanomaterial EMA 4 papers Reflection paper on non-clinical studies for generic nanoparticle iron medicinal product applications Reflection paper on surface coatings: general issues for consideration regarding parenteral administration of coated nanomedicine products FDA s Nanotechnology Task Force Draft Guidances Safety of Nanomaterials in Cosmetic Products Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology Draft Guidance 8

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