Rochester BioVenture Center November 14th

Transcription

1 Rochester BioVenture Center November 14th

2 Calvert Holdings, Inc. Established in 1996 Parent company for several subsidiaries Focus: health care services and investments Corporate HQ located in Cary, NC 2

3 Calvert Holdings Companies Calvert Labs (Scranton, PA) Preclinical CRO Acquired in 2000 by Calvert Holdings Calvert Creative (Cary, NC) Marketing agency Identity design & rebranding Website design and rebranding 3

4 Executive Management Team R. C. McLauchlan Chairman & Chief Executive Officer Charles B. Spainhour, V.M.D, Ph.D., D.A.B.T President & Chief Scientific Officer, Calvert Labs, Chief Scientific Officer, Calvert Holdings David Morgan Executive VP and Chief Operating Officer Michael Recny, Ph.D. Executive VP Investment Strategies Andy Burch Vice President, Business Development 4

5 Calvert Labs History Founded in 1969 by Dr. Richard Matthews (Pharmakon) Developed out of one of the first CROs in the pharma industry First CRO to offer services in pharmacology 40 years of experience operating in FDA regulated industry Comprehensive record of submissions globally (FDA, Health Canada, MHLW & PMDA (Japan), EU, EPA, SFDA (China)) 5

6 Calvert Labs Overview Fully GLP compliant 150+ collective years of experience No study ever rejected for reasons of design or technical performance FDA inspections occurred in 2004, 2006, 2009 and 2010; no 483s issued Averages 18 to 24 full IND-enabling programs and 8 to 12 BLA programs completed each year Serve on average 400 hundred clients each year researching technologies in a variety of therapeutic areas. 6

7 Scientific Services Discovery services Efficacy testing, autoimmune / inflammation assays and models, anti-cancer models, anti-infective models, immunomodulation Pharmacology Discovery pharmacology, Safety pharmacology, Toxicology Acute tox, subchronic / chronic, carcinogenicity, reproductive/ developmental, immunotoxicology PK / ADME Pharmacokinetics / toxicokinetics, screening services Telemetry, pathology, bioanalytical services 7

8 Support Services Regulatory guidance Clinical pathology Hematology, coagulation, clinical chemistry, urinalysis Lab animal medicine AALAC, AALAS, IACUC Pathology/histology Archiving services SBIR grant support Potential service-for-equity partnerships 8

9 Our Clients Small to mid-size biotech/pharma Big pharma Medical Device companies Chemical companies Personal care companies Academic R&D ~ 85% of our business is repeat business 9

10 The Calvert Difference Customized Tailored individual study designs Adjust quickly to changing needs Responsive Ongoing personal communication with your study director Streamlined data collection and entry with Xybion (Pristima TM software) Proven 150+ collective years of experience in design and submission of INDenabling studies No study ever rejected for reasons of design or technical performance 10

11 Client Testimonial Thanks to a strong IND filed with the FDA, we are now initiating our first-in-man studies for our current lead drug candidate. Our internal team with the help of excellent work conducted by our partners like Calvert, the Agency cleared our IND package with no questions or concerns raised. Calvertʼs team was also critical to completing several key IND enabling studies for a lead compound at my previous company. It is always great to work with this partner on key non-clinical studies. - President and Chief Scientific Officer, Altheos, Inc. 11

12 Thank you! 12

13 Appendix 13

14 Preclinical Capabilities Toxicology Acute, subchronic, chronic Carcinogenicity Developmental Reproductive Multi-generation Pharmacokinetics/toxicokin etics and ADME Telemetry Dog and primate Immunology/immunotoxicol ogy Safety pharmacology Discovery pharmacology General pharmacology Bioanalytical analysis 14

15 Areas of Expertise Vaccine safety testing Gene therapy safety assessment Human and vet product safety evaluation Biologics safety testing Ocular studies Wound healing studies Dermal studies Customized rodent surgical models for novel drug development Novel studies; client-tailored studies Infusion Development of novel routes Telemetry (canine & primate) Immunoassays (design, validation and analysis) Screening programs Cardiovascular pharmacology In vivo QT prolongation studies bioassay Radioisotopic work Contract archiving services Bioanalytical support 15

16 Toxicology Services Regulatory (FDA, EPA, EU, ICH, MHW, OECD) Acute toxicology Subchronic/chronic toxicology Carcinogenicity Local hamster tolerance Reproductive/developmental toxicology Dermal toxicology Immunotoxicology 16

17 Pharmacokinetics/Toxicokinetics Preclinical pharmacokinetics from study design to report Toxicokinetics study and prediction of human exposure Flexible and customized reports C max, T max, AUC, AUMC, K e, T 1/2, e, MRT, Cls, Vdss, Cl/F, Vd/F, F 17

18 In Vivo and In Vitro ADME Mass balance and excretion In vivo metabolism-radiolabeled and non-radiolabeled studies In vitro metabolic stability in S9, microsomes and hepatocytes a Intrinsic clearance studies a In vitro metabolic profiling and metabolite Characterization by LC-MS/MS a Protein binding and blood cell partitioning a Subcontracted to third party 18

19 Bioanalytical Services Small molecules and proteins LC-MS/MS a Method development/validation Custom analytical method development and validation UV-HPLC and spectrophotometry Rapid turnaround, data conform to clientʼs database requirements Analytical trouble-shooting and consultancy Licensed for a wide range of radionuclides a Subcontracted to third party 19

20 Safety Pharmacology Services Core studies Neuropharmacological Profile in Mice or Rats herg Channel (subcontracted) Ancillary studies (included but not limited to): Diuretic Assay in Rats Isolated Guinea Pig Ileum GI Propulsion Assay in Mice and Rats Barbiturate Sleep Time in Mice or Rats Action Potential in Canine or Rabbit Purkinje Fiber herg (subcontracted) Cardiovascular (QT/QTc) Assay in Dogs (in vivo) 20

21 Discovery Pharmacology Services Anti-inflammatory/analgesia Cardiovascular Diabetes/obesity Other Diuretic assay in rats Renal function in dogs In vivo hair growth model in mice Ulcerogenic study in rats 21

22 Immunology Services Autoimmune/inflammatory disease models Tumor studies Anti-infective models ELISA and RIA assays Antigenicity/hypersensitivity studies Immunomodulation studies Blood compatibility assays Immunotoxicology 22

23 Animal Models We routinely perform all of the previously mentioned studies in all conventional species including: Rats, cotton rats, mice Guinea pigs, hamsters Rabbits Dogs Minipigs Nonhuman primates (cynamolgus) 23

24 Dose Administration Routes Parenteral Intraarterial Injection Intraarticular injection Intracystic instillation Intradermal injection Intraglandular injection Intramuscular injection Intraperitoneal injection Intravenous injection Intravitreal injection Enteral Oral Intraesophageal Intrarectal Topical Epicutaneous Intranasal Ocular Other Intravaginal 24