The Pharmaceu+cal Technology Specialists.
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1 The Pharmaceu+cal Technology Specialists
2 Mission and Vision Vision Changing Lives Through Leadership in Drug Delivery Systems Bringing Our Global Partners the Best Drug Product Solu+ons Mission 2
3 Center of Excellence Specialist in combina+on drug product development Complex formula+on design and device integra+on Deep experience in biologics drug development 30 highly experienced PhD and BS scien+sts 3
4 Experts = Efficiency, Value, Quality Leveraging a deep understanding of molecular proper+es, formula+on, and device Integra+ng delivery system R&D project into your development program Op+mizing target product profile to enhance value proposi+on Discovery Support Lead molecule profiling Clinical candidate evalua+on Biologic half-life extension Drug Product Development Formula+on design Drug product development Analy+cal methods Device Development Device iden+fica+on Integra+on with formula+on Development and selec+on 4
5 Capabili+es Pharmaceu+cal R&D Laboratory Formula+on, analy+cal, process, chemistry, device development Specialists in complex drug product development Pep+de and small molecule chemistry, conjuga+on (e.g., PEGyla+on) Lead candidate selec+on, op+mizing pharmaceu+cal proper+es Drug Product Development Strategic Partnership Strategic product development and hands-on technical support Par+cipa+on in CMC teams (analy+cal, formula+on, chemistry, device) Idea+on and transla+on of innova+ve technologies from research to clinic Partnering to Develop New Delivery Technologies Sustained release injectable delivery technology Self assembling delivery technology Oral capsule device for targeted delivery 5
6 Leadership Chris Rhodes, Ph.D., President & CEO Founded Drug Delivery Experts in 2014 a`er 20 years in biotech and drug delivery companies in both technical and execu+ve leadership roles Robert Jennings, Ph.D., COO Rob joined DDE in May 2017 with over 25 years of pharmaceu+cal development experience and was most recently site head for two startup pharmaceu+cal companies David Litzinger, Ph.D., V.P., R&D Dave joined Drug Delivery Experts in 2015 and has over 22 years of drug discovery and development experience, including technical and leadership roles in pharmaceu+cal and biotech companies Catherine H. Charles, Ph.D. Formula+on, Bioanalysis, Recombinant Protein Fu Chen, Ph.D. Analy+cal Methods Development and Formula+on Lawrence D Souza, Ph.D. Discovery, Chemical Development, Formula+on Jui-Chen Lin, Ph.D. Formula+on, Drug Product Development, Asep+c Manufacturing Shu Fen Wen, Ph.D. Drug Product Development, Manufacturing 6
7 200+ Years Industry Experience Companies Products 7
8 Project Experience Molecules Programs Protein Topical Ocular Delivery Oligo Microsphere, Liposomes, SR Pep+de Lead Selec+on Small molecule Therapeu4c Area Preformula+on Partners Cancer Infec+ous Ex-US Biotech Diabetes Alzheimer's An+-fungal Cardiovascular Ocular Metabolic Orphan Public US biotech Private US biotech 8
9 Sustained Release Formula+on Approaches Weekly Daily Quarterly Monthly Increasing Drug Potency Suspension Atrigel Liposome In Situ Gel-Forming System Microsphere Non-Aqueous Solu+on/ Suspension Implant 9
10 Sustained Exposure Conjugate Approaches Daily Weekly Monthly Increasing Drug Potency Acyla+on (albumin binder) Carbohydrate analogues HESyla+on, Glycosyla+on Poly Amino Acid Fusions PEGyla+on XTEN, ELP, PASyla+on Various including Reversible PEG Albumin or Fc Fusion (FcRn recycling) 10
11 Specialists in Biologics Lead Molecule Selec+on and Molecular Design Structural modifica+ons to improve physicochemical proper+es and extend half-life Amino acid variants for site-specific conjuga+on Muta+on series and Fc fusions Non covalent modifica+ons to alter proper+es Salts and complexes to slow dissolu+on Recombinant protein expression, pep+de and oligonucleo+de synthesis Structural characteriza+on, stability, and degrada+on products iden+fica+on PEGylated protein Insulin Hexamer Exena+de Macugen 11
12 Partnership Op+ons Project Specific Work Shorter well-defined projects (3 to 9 months) Discrete project defini+on (lead molecule profiling or preformula+on) Ini+al payment, middle of project milestone, end of lab work payment Dedicated R&D Team Longer term and broader projects (9 to 18 months) Dedicated resources for program Quarterly payments for program support Budget for R&D with 2 to 3 year project scope 12
13 Project Suppor+ng Ac+vi+es Lead Molecule Selec+on Delivery System Selec+on Drug Product Development Analy+cal Research Lead Molecule Design Development Assessment Analy+cal Development Preformula+on Delivery System Feasibility Formula+on PK Screening Formula+on Development Process Development Scale Up Analy+cal Methods Qualifica+on Device Selec+on and Development Development Stability Technology Transfer GMP Mfg Test Ar+cle Supply for Preclinical and Toxicity Studies Molecule Design Pep+de, protein variants Conjugates for half-life Delivery System Design Aqueous or non-aqueous vehicle Sustained release formula+on Triggered or targeted systems Drug Product Design Pen, auto-injector Pre-filled syringe Nasal, ocular drops or spray 13
14 How Can We Help Your Team? Combina+on Drug Product Development Pep+de and protein development Lead molecule profiling and half-life extension Subcutaneous and ocular formula+on design and development Sustained release injectable formula+ons Device design and development Transla+on from research through clinical and commercializa+on 14
15 The Pharmaceu+cal Technology Specialists
16 Advisors & Networked Resources William Vincek, Ph.D. President Pharma CMC, formerly SVP Development, Alpharma, Guilford Pharmaceu+cals, GSK, Merck Alain Baron, M.D. CEO Elcelyx and Nazura BioHealth, formerly SVP Research, Amylin Pharmaceu+cals Phil Duffy Opera+ons consultant in life sciences, previously SVP Pacira, VP at Ligand and Schein Bayer Solomon Steiner, Ph.D. CEO Perosphere Inc., previously CEO and Founder of Biodel, Mannkind, and Emisphere Technologies Donald Rindell, M.B.A. Business Strategy Will Clodfelter, M.B.A. Market & Device Development Mark Longer, Ph.D. Regulatory Strategy Nelson Lugo, M.B.A. Manufacturing Bill Van Antwerp Device and Diagnos+cs R&D Molly Holman, Ph.D., J.D. Intellectual Property, Legal James Matriano, Ph.D. Bioanaly+cal Michelle Neoh Market Research 16
17 Market Preference for Injec+on Frequency Decreasing Frequency Mul4ple Daily Inj Daily Weekly Monthly Quarterly 6 to 12 Month Inj Pa4ent Self- Common: Product Profile More Cri4cal Product Profile Parameters Complexity of product handling Ready-to-use product Needle size for injec4on (viscosity) force (viscosity) Pain on injec4on (volume) Dura4on of injec4on (volume) In-Use stability constraints Poten4al for Office Administered Product: Good Product Profile Not Cri4cal 17
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