IDSC is an interdisciplinary group of 40 ex-pharma leaders averaging 25-years of big-pharma, biotech, and academic experience. Our clients come to us for drug discovery and drug development interim leadership, consulting, fully integrated collaborations, due diligence, molecular modeling, and outsourcing management. Because we are a fully integrated drug discovery, preclinical development, and clinical development partner, we help our biotech, VC, academic, and pharma clients get from early discovery to IND filing and through phase I clinical trials in all major therapeutic areas and on to NDA in antibacterials, CNS, and oncology.
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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
• 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.
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?
• 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
• 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
• 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
• 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.
• 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.
• 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
• 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.
• 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.