©2013 IDSC, LLC10/25/2013 WWW.IDSCBIOTECHNETWORK.COM 1
IDSCFrom Hit to the Clinic…Your Drug
Discovery & Development Partner
Capabilities ● Expertise ● Services
Mark CreswellPresident and [email protected]: 734.433.9670Cell: 734.476.4097
©2013 IDSC, LLC
Mission
IDSC's mission is to add significant value to our client's organization by providing drug discovery, development, and outsourcing leadership and expertise to assist our clients in delivering innovative medicines to the clinic and on to the market faster, while minimizing attrition.
IDSC’s scientists have delivered many drugs to the clinic & to the market
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©2013 IDSC, LLC
Stages of Drug Discovery & Development
Hit to LeadLead
Optimization
Preclinical Development to IND Filing
Clinical Development
DevelopmentDiscovery
IDSC’s Services Span:
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Identify Clinical
Candidate
Draft & Submit
IND
Draft & Submit
NDA
FDAPre-IND Meeting
FDAPhase 2 Meeting
Evaluate HTS Hits or SBDD
Results
Select lead compounds
©2013 IDSC, LLC
Why Clients Come to IDSC
Interim Leadership
• Filling the gaps
• Most major therapeutic areas
• All line disciplines
• Small molecules, biologics, stem cells, diagnostics, devices, nutraceuticals
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Due Diligence
• Investment opportunities
• Program reviews
• SWOT analyses
•Venture capitalists
• Pharma companies
•Academics
Molecular Modeling
• Structure based design
• Pharmacophore modeling
•Homology models
•Docking, etc.
• Small molecules or biologicals
Outsourcing Management
•Medchem, API/ biological, pharmacology, toxicology, ADME, etc.
• Identify CROs & CMOs
•Manage CROs & CMOs
Consulting
•Most major therapeutic areas
•All line disciplines
• Small molecules, biologics, stem cells, diagnostics, devices, nutraceuticals
Fully Integrated Collaborations
• IDSC supplies a full project team to our client.
•All discovery, preclinical development, or clinical development line discipline experts.
©2013 IDSC, LLC
Interim Leadership
Filling gaps in our client’s scientific leadership and project teams
Leadership, program & project management
Med-chem, pharmacology, molecular modeling, chemical development, API management, CMC, formulation, ADME, toxicology, regulatory, clinical study design, clinical operations, clinical pharmacology, outsourcing management (chemistry, API, pharmacology, ADME, toxicology, some pieces of clinical)
Small molecules, biologicals, stem cells, devices, diagnostics, nutraceuticals
• CNS, CV, dermatology, infectious diseases, inflammation, immunology, metabolic diseases, oncology, pain
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©2013 IDSC, LLC
Examples of What Our Leaders Do
Medicinal Chemists• Therapeutic area expert
• Evaluates SAR & decides what compounds to make
• Know ADME & design targets to improve ADME, potency, & efficacy
•Designs synthesis and manages outsourcing
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API & CMC Managers•Manage CMOs
• Chemistry, biologicals, cell lines…
•Optimize chemistry process
• Troubleshoot biologicals
• Submit regulatory registrations
Clinicians• Support preclinical
development plan
•Draft clinical protocols
• Participate in and/or lead clinical advisory boards
•Oversee clinical trials
•Advise client, preclinical, and clinical project teams
TA Experts and Project Leaders
• Advise client on therapeutic area
• Prepare program reviews
• Lead teams in preparation of gap analyses and development plans
• Serve as project leader for project teams
Regulatory Experts• Guide client and IDSC team on
and assure regulatory guidelines are met
• Assist client with preparation for and accompany client to FDA meetings
• Assist client with preparation of and submission of regulatory documents
ADME, Toxicologists, Pharmacologists
• Design in vitro and in vivo studies
• Identify vendors and manage outsourcing
• Evaluate study data and write INDsubmission study reports
• Make decisions based on study results
©2013 IDSC, LLC
• Small molecules, biologics, nutraceuticals, devices, diagnostics
• Medchem, pharmacology, ADME, toxicology, regulatory, CMC, Process development, clinical, formulation, fill/finish, commercial assessment
• Most major therapeutic areas (slide 10)
• Due diligence - Evaluation of investment and in-licensing opportunities
• SWOT analyses: Strengths, Weaknesses, Opportunities, Threats
• Program reviews, gap analyses, & development plans– Discovery, preclinical development, and clinical development
• Writing & evaluating patents & IP space
• How: Ad hoc consulting, retainers, to partial FTEs
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Strategic & Technical Consulting
©2013 IDSC, LLC
Fully Integrated Collaborations
• Drug discovery, pre-clinical development & clinical development collaborations
• For virtual biotechs; universities; foundations; small, medium, & large Pharmas expanding bandwidth…
• IDSC supplies most of or the entire project team (all of the line discipline experts; slides 11 & 12)
• Progress our client’s program from its current state to the next desired milestone: spinout, funding, partnering, licensing…
• IDSC provides the leadership, therapeutic area expertise, line discipline expertise, outsourcing expertise, outsourcing management
• Chemistry, biologics production, cell line production, assays, studies, API manufacturing, and depending on size, pieces of clinical trials are outsourced.
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©2013 IDSC, LLC
Rhetorical Question…
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Could an interdisciplinary group of 40 pharmaexperts with a combined >1,000 years of drug discovery, preclinical, & clinical development experience make a difference in YOUR drug discovery & development program?
©2013 IDSC, LLC
Therapeutic Area Focus
• Cardiovascular
• CNS
• Dermatology
• Immunology
• Infectious diseases
• Inflammation
• Metabolic diseases
• Oncology
• Pain
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Back to Slide 7
©2013 IDSC, LLC
Discovery Expertise
• Medicinal Chemistry
• Molecular Modeling
• Pharmacology
– in vitro
– in vivo
• ADME
Small
Molecules
&
Biologics
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Back to Slide 8
©2013 IDSC, LLC
Development ExpertisePreclinical & Clinical
• ADME / Toxicology / Pathology
• PK/PD/TK Modeling
• Process Chemistry/ API Mgmt / CMC
• Regulatory Compliance
• Clinical Study Design
• FDA Meetings
• BLA/IND/NDA Prep & Submission
• Commercialization Strategy
• Product Assessment & Valuation
• Competitive Intelligence
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Small
Molecules
●
Biologics
●
Stem Cells
●
Devices
●
Nutraceuticals
Back to Slide 8
©2013 IDSC, LLC
Broad Outsourcing Expertise:
• Med-Chem, Custom Synthesis• API Supply & Raw Materials– Small Molecules, Biologics
• Pharmacology (In Vitro/In Vivo)• ADME (In Vitro/In Vivo)• Toxicology/Safety• IDSC manages clinical trials internally
while outsourcing non core activities as well as large trials– PhI, II, III Clinical Trials– US & International
Vendor Management
& Project Management
Database of Vendors
…………..
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©2013 IDSC, LLC
MEDICAL DEVICES
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©2013 IDSC, LLC
IDSC Medical Device Services
Regulatory Compliance•Determine the correct regulatory strategy
• Ensure actives and goals are aligned with the regulatory strategy
•Write regulatory documentation
•Make regulatory submissions
• Prepare client for meeting with regulatory agencies
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Strategic Planning•Guide company strategy
•We help our client:
–Establish a business plan
–Set company goals, timelines, budgets, and milestones
–Generate an exit strategy
• Identify and oversee external vendors
Clinical Development• Establish and run clinical advisory board
• Identify and utilize KOLs
•Determine clinical pathway
•Write clinical protocols
• Ensure nonclinical studies & other development activities align with clinical plan & regulatory requirements
• Clinical operations
Market Assessment•Asset valuation
•Determine market size and potential market penetration
• Competitive intelligence
• Position client to manage negotiations with investors and partners by receiving the highest value for their asset
• Performing product valuations are not just in the domain of “big-pharma”
©2013 IDSC, LLC
DIAGNOSTICS
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©2013 IDSC, LLC
IDSC Diagnostics Services
Regulatory Compliance
•Determine the correct regulatory strategy
• Ensure actives and goals are aligned with the regulatory strategy
•Write regulatory documentation
•Make regulatory submissions
• Prepare client for meeting with regulatory agencies.
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Strategic Planning•Guide company strategy
•We help our client:
–Establish a business plan
–Set company goals, timelines, budgets, and milestones
–Generate an exit strategy
• Identify and oversee external vendors
Clinical Development• Establish and run clinical advisory board
• Identify and utilize KOL
•Determine clinical pathway
•Write clinical protocols
• Ensure nonclinical studies & other development activities align with clinical plan & regulatory requirements
• Clinical operations
Market Assessment•Asset valuation•Determine market size and potential market
penetration• Competitive intelligence• Position client to manage negotiations with
investors and partners by receiving the highest value for their asset• Performing product valuations are not just in
the domain of “big-pharma”
©2013 IDSC, LLC
NUTRACEUTICALS
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©2013 IDSC, LLC
IDSC Nutraceutical Services
Regulatory Compliance
•Determine the correct regulatory strategy
• Ensure actives and goals are aligned with the regulatory strategy
•Write regulatory documentation
•Make regulatory submissions
• Prepare client for meeting with regulatory agencies.
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Strategic Planning•Guide company strategy
•We help our client:
–Establish a business plan
–Set company goals, timelines, budgets, and milestones
–Generate an exit strategy
• Identify and oversee external vendors
Market Assessment•Asset valuation•Determine market size and potential market
penetration• Competitive intelligence• Position client to manage negotiations with
investors and partners by receiving the highest value for their asset• Performing product valuations are not just in
the domain of “big-pharma”.
©2013 IDSC, LLC
IDSC Nutraceutical Services
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Training•Ensure Pharmaceutical companies moving into nutraceuticals gain the needed knowledge to be successful
•Ensure an appropriate understanding of the risks, benefits, and regulations around nutraceuticals
©2013 IDSC, LLC
STEM CELL THERAPIES
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©2013 IDSC, LLC
• Somatic (adult), embryonic, pluri-/multi-potent cells
• Non-embryonic sources: Peripheral blood, marrow, adipose tissue, organ tissue, cord blood, amniotic fluid…
• General types: Hematopoietic, mesenchymal, endothelial, neural, cardiac, ….
• Autologous, allogeneic
• Differing regulatory environments worldwide
• At least 17 companies active in heart disease alone
~ Many combinations currently in R&D
and even more to come, with time. ~
Rapidly Evolving Science
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©2013 IDSC, LLC
Stem Cells: Clinical Development
Regulatory Compliance•Optimize regulatory strategy
• Ensure activities and goals are aligned with regulatory strategy
• Prepare regulatory documentation
• Create and deliver regulatory submissions
• Prepare client for meeting with regulatory agencies
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Strategic Planning•Guide development of company strategy
–Establish a business plan integrated across R&D, manufacturing and clinical lines
–Set and track company goals, timelines, budgets, and milestones
–Generate an exit strategy
• Identify and oversee external vendors
Clinical Development• Establish and manage clinical advisory board
• Identify and utilize KOLs
•Determine clinical pathway to registration
•Design clinical protocols
• Ensure nonclinical studies & other activities align with clinical plan & regulatory requirements
•Manage clinical program and trial execution
Market Assessment• Evaluate client asset
•Determine market size and potential market penetration
•Gather competitive intelligence
• Position client to manage negotiations with investors/ partners in order to receive highest value for their asset
• Performing product valuations are not just in the domain of “big-pharma”
©2013 IDSC, LLC
Summary
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IDSC’s clients come to us for Discovery, Preclinical Development, Clinical Development, and Project Management expertise
Expertise
IDSC offers the academic, biotech,
pharma, and VC community a fully
integrated drug discovery and
development partner
Discovery Development
Interim Leadership ● Consulting ● Fully Integrated Collaborations ● Outsourcing Management
Discovery
CommercialAssessment
ClinicalDevelopment
ProjectLeadership
RegulatoryCompliance
PreclinicalDevelopment
CROsClient
Small Molecules ● Biologics ● Stem Cells
Therapeutic Area Expertise• CNS• Cardiovascular• Dermatology• Infectious Diseases• Inflammation• Immunology• Metabolic diseases• Oncology• Pain
Discovery Expertise• Medicinal Chemistry• Molecular Modeling• Pharmacology• Outsourcing Management• ADME
Development Expertise• ADME & PK/PD/TK Modeling• Toxicology & Pathology• API management & CMC• Formulation, Fill & Finish• Regulatory Compliance• FDA meetings, IND/NDA prep &
submission• Clinical Study Design• Commercial Assessment &
Valuation
Hit to LeadLead
Optimization
PreclinicalDevelopmentTo IND Filing
ClinicalDevelopment
Therapeutics . Stem Cells . Nutraceuticals . Devices . Diagnostics
IDSC
©2013 IDSC, LLC
CASE STUDIESIDSC
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©2013 IDSC, LLC
• Client was downsizing– Came to IDSC to contract head of med-chem and manage chemistry CROs
• IDSC performed a program & budget review – Performed by IDSC’s experienced oncology med-chemist and pharmacologist
• Based on data and remaining budget - IDSC recommended the client stop med chem activity and focus in vivo efforts on select compounds already in the portfolio.
• The implementation of this recommendation saved the company– They now have a clinical candidate and have scaled material & have begun an IND enabling Tox
Study.
– Had they continued with med-chem, IDSC would have profited, and the client would have burned their budget without getting a candidate.
– IDSC continues in a multi-disciplinary consulting role with this client
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To The Rescue (Receptor Antagonist For Oncology)
©2013 IDSC, LLC
From Target to Pre-Candidates
• Client had a biological target based platform• IDSC helped client establish its goals• IDSC trained client in drug discovery strategy & budget• IDSC serves in an overarching discovery role that includes heads of
medicinal chemistry and molecular modeling• Began with mass screen of commercial compounds and analogs of
literature compounds• Lead to multiple novel series & rapid SAR expansion and lead
optimization in best series• IDSC manages 5 CRO chemistry FTEs• IDSC manages in vivo biology, PK/PD, tox, formulation, etc…• Several potential clinical candidates have been identified• Timeline – 9 months
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©2013 IDSC, LLC
Relationships Grow: Oncology Development (International Client)
• Web Inquiry led to a gap analysis
• Gap analysis led to ad hoc consulting
• Ad hoc consulting led to CAB (clinical advisory board)
• CAB: Clinical advisory board preparation, attendance, management, summary
• CAB led to a fully integrated 8-member IDSC development team engaged to develop the asset
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©2013 IDSC, LLC
Molecular Modeling
• In-House full service molecular modeling supports all appropriate med chem projects (We use the MOE integrated suite)
• IDSC currently serves as the molecular modeling department for several pharmaceutical and biotech companies
• IDSC modeling directors conducted computational fragment-based design studies that led directly to two clinical candidates and three additional chemical leads for a nuclear hormone receptor program
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©2013 IDSC, LLC
Program Reviews
• University– Started with 6 programs for relevance of
biological target and quality of lead chemical matter
–Based on results this relationship continues to grow
– Six different IDSC Directors have written program reviews for client
– Trained client on IND process
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©2013 IDSC, LLC
40 Consultants – One Roof
• IDSC received a phone call – Client needed a preclinical & phase I development plan & budget to be delivered within 35 days.
• A team of 7 IDSC directors (toxicology, clinical pharmacology, ADME, CMC, API, regulatory, project management) met the ambitious deadline.
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©2013 IDSC, LLC
DISCOVERY & DEVELOPMENT TEAMS
IDSC
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©2013 IDSC, LLC
Client
IDSCMed Chemist &
PM, POC
ChemistryCRO
In Vivo Pharmacology
CRO
In Vitro Screening
CRO
IDSCDMPK Director
DMPK /ADMECRO
Keys To Success Team can make key decisions
Good communication
Good project management
Significant TA expertise
Goal oriented team
Manage streamlined logistics process
Management:
Information & DataSample logistics
Decision treeCROs
IDSC Pharmacologist
SampleSample
(Bulk to client)
PM – Project Manager
POC – Point of Contact
DISCOVERY
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©2013 IDSC, LLC
PRECLINICALDEVELOPMENT Client
IDSCTA Expert &
PM, POC
In Vivo Pharmacology
CRO
API Scale up and Synthesis
CRO
Toxicology Studies
CRO
DMPK /ADMECRO
Keys To Success Team can make key
decisions Good communication Good project management
Significant TA expertise Goal oriented team Manage streamlined
logistics process
Management:
Information & Data Sample logistics
Decision treeCROs
IDSC Toxicology Director
Sample
(Bulk to client)
PM – Project ManagerPOC – Point of Contact
IDSCClinician
IDSCAPI & CMC
Director
IDSC Regulatory Director
IDSC DMPK/ADME
Director
IDSCClinical
Pharmacologist
FDA
IDSC In-vivo
pharmacology Director
IDSC In-vitro
pharmacology Director
In Vitro Pharmacology
CRO
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©2013 IDSC, LLC
Client
IDSCPM, POC
Data mgmt, CRFs,
programming
Supporting Preclinical Studies
CRO
Keys To Success Team can make key
decisions Good communication Good project management Significant TA expertise Goal oriented team Manage streamlined
logistics processIDSC
preclinical Directors PM – Project Manager
POC – Point of Contact
IDSC Clinicians/MDs
IDSCAPI & CMC
Director
IDSCRegulatory Director
IDSCClinical
Pharmacologist
IDSCClinical-Ops
(CRAs/monitors)
FDA
Statistics, IVRS, Med Writing
CRO
CLINICALDEVELOPMENT
Study Sites
API GMP Manufacture
CRO
Clinical PK Analysis CRO
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©2013 IDSC, LLC
U of Iowa
U of Michigan
WARF
NVF
Nektar
CRL
Arsenal Cap
U of Louisville
KFSYSCC
Partial Client List
Pfizer
Cubist
Profectus
Lycera
Deciphera
AKI
Altiris
ShaunaRx
Nymirum
Biolytx
Biota
Glenmark
Maxthera
Mazorx
MBI
NAEJA
ReGenX
ApiGenesis
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©2013 IDSC, LLC
IDSC
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©2013 IDSC, LLC
Leadership
• IDSC’s 40 discovery and development directors have a career averaging 25 years each with high level management expertise.
• Our directors have taken programs from discovery to the clinic and from phase I to market.
• IDSC’s leaders have proven discovery and development track records within big pharma and consultancy having developed their careers and skills at large pharma organizations like Abbott, J&J, Novartis, and Pfizer among others & having led or participated in teams responsible for the development or commercialization of products like Zoloft®, Lyrica®, Nexterone®, Cerebyx®, Linezolid®, and Plazomicin® just to name a few.
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©2013 IDSC, LLC
Science & Consulting
• IDSC brings its clients an interdisciplinary leadership team with career expertise in all of the major therapeutic areas (We are especially strong in antibacterials, CNS, CV, oncology, and inflammation).
• The team remains at the cutting edge of their fields by:
– Progressing state of the art programs
– Reviewing current market reports and review articles
– Attending key therapeutic area conferences
– Reading the current literature
• As respected leaders in their field our directors provide insight to the industry by giving conference presentations.
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©2013 IDSC, LLC
Outsourcing
• IDSC was founded by leaders who built a $35M global discovery outsourcing program within big Pharma
• We bring the highest value vendors to our fully integrated collaborations
• Fully integrated collaborations bring new insights into our client’s organization in addition to more shots on goal through a very flexible & cost effective business model
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• Alex Bridges, PhD: 25 years big pharma, 6 years Academics, 5 yrs biotech; oncology, metabolic disease; medicinal chemistry.
• Brent Blumenstein, PhD: 30+ years academia, industry; FDA advisory committees; biostatistics; clinical trials; oncology, urology, epidemiology.
• Mukund Chorghade, PhD: 26 big pharma; regulatory filings; tech transfer; CMC, and API management.
• Lauren Costantini, PhD: 20+ yrs biotech & academia; multiple vice president roles; nutraceuticals, medical foods, devices; neurodegenerative diseases, research, clinical, regulatory, commercialization strategy.
• John Domagala, PhD: 30 years big pharma, global head, infectious diseases, med-chem, 30 clinical candidates, 8 compounds to the clinic.
• Joe Fix, PhD, MBA: 30+ years big pharma, biotech; formulation, fill & finish, product development; CRO management; drug delivery technologies.
• Shelly Glase, PhD: 17 years big pharma; CNS; med-chem; outsourcing management, project management; 5 clinical candidates.
• Richard Kavoussi, MD: 28 years of academia, pharma, consulting expertise. Board certified psychiatrist. Extensive experience in the design, execution, and analysis of clinical psychopharmacology trials.
• Joan Keiser, PhD: 30 years big pharma; cardiovascular, metabolic diseases; pharmacology; global therapeutic area head; portfolio management; idea to POC.
• Francie Kivel: 26 years big pharma & small biotech, clinical development & corporate strategy, program management, clinical operations, stem cell therapies, CV, CNS, oncology, women’s health, inflammation.
• Bill Kenney, PhD: 24 years big pharma; CNS, oncology, antiviral; medicinal chemistry.
• Brad Martin, PhD: 15 years big pharma, CV physiology and regenerative medicine, stem cell therapies, translational research.
• David Moreland, PhD: 24 years big pharma; molecular modeling; CNS, cardiovascular, infectious diseases; 3 clinical candidates.
• Anne Norment, MD, PhD: 20 years biotech; immunology, inflammation; pharmacology; translational research.
Brief BIOs (Partial List)
©2013 IDSC, LLC
• Ron Shebuski, PhD: 20+ year academia, & pharma, cardiovascular, pharmacology, therapeutics, devices, diagnostics.
• Bob Sigler, DVM, PhD: 21 years big pharma; toxicology, pathology; study design; IND support.
• Jeff Simpson, BS: 28 years big pharma, consulting; commercial strategy, product assessment, valuation, lifecycle planning, advisory boards.
• Richard Stead, MD: 24 years experience, clinical and regulatory strategy for development of biotechnology products, including oncology and hematology products; academic experience in hematology & coagulation.
• Ken Tack, MD: 26 years big pharma, Internal medicine, clinical trial design, 3 marketed drugs in infectious disease.
• Charlie Taylor, PhD: 27 years big pharma; CNS; pharmacology; neurological disorders, psychiatric disorders, pain; gabapentin, pregabalin.
• Jim Thomson, PhD: 30 years biotech; biologics; process development, formulation, analytical development, CMC, lyophilization, and stability.
• Howard Welgus, MD: 30 years academia & pharma, global head, dermatology, inflammation, clinician, CMO, medical affairs.
• Lloyd Whitfield, PhD: 30 years big pharma, population PK and PK/PD, dose selection, allometric scaling, and modeling and simulation support.
• Jim Zeller, PhD: 22 years big pharma, 6 years API consultant, chemical development of API processes, API cost analysis, CMO identification and management.
• Bob Zimmerman, PhD: 25 years big-pharma, biotech; oncology pharmacology; large and small species; recombinant proteins, monoclonal antibodies, vaccines, and engineered proteins.
• Mary Zimmerman, MS: 25 years biotech; SVP; regulatory affairs & strategy; IND, CTA, INPD, CTD submissions.
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Brief BIOs (Partial List)
©2013 IDSC, LLC
THANK YOUMark Creswell
President & CEO
310 N. Main St.204
Chelsea, MI 48118 USA
Phone: 734.433.9670Fax: 734.433.9671Cell: 734.476.4097
From hit to the clinic:Your drug discovery & development partner
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©2013 IDSC, LLC
SUPPLEMENTAL SLIDES
IDSC
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©2013 IDSC, LLC
Gene Family Expertise
• GPCRs
• Kinases
• Cytokines
• Ion channels
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• Proteases
• Nuclear receptors
• Transporters
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