Marc Andersen, Ph.D.marc.andersen@aptuit.com
- API assessment, vendor RFP preparation, review, and selection
- Management of CROs
- New route design, process changes, specifications, impurities, polymorph, salt forms
- Preparation of Q7A SOPs
- Due diligence and gap analysis; ICH and FDA compliance for CMC filings
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Eyal H. Barash, J.D.eyal.barash@aptuit.com
- Hatch-Waxman
- Expert Witness Liaison
- IP Issues related to Solid Forms, Synthetic Processes and Formulations
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Simon Bates, Ph.D.simon.bates@aptuit.com
- Solid state characterization of API and drug product
- X-ray and Neutron Diffraction analysis
- Amorphous/glassy and crystalline systems
- Computation methods for data analysis
- Computational modeling for property prediction
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Brett Bobzien, B.S.brett.bobzien@aptuit.com
- Counterfeit and tamper analysis
- Experimental plan design for litigation support
- Fact witnessing bulk sampling
- Particle size analysis
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Sharon Bowen, M.S.sharon.bowen@aptuit.com
- Regulatory submission and project management
- Immunology and hematology drug discovery
- Technical writing and submission Preparation
- CRO management
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Leonard J. Chyall, Ph.D.len.chyall@aptuit.com
- Chemical reaction mechanisms
- Characterization of pharmaceutical solids
- Crystallization methods
- Synthetic chemistry
- Organic chemistry
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Paul G. Fagan, Ph.D.paul.fagan@aptuit.com
- Preformulation and formulation development
- Accelerating pathways for Phase 1 supply
- Strategies for poorly soluble compounds
- Drug product manufacture, process scale up and validation
- Analytical methods development, validation and stability programmes
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Peter Fenn,Ph.D.peter.fenn@aptuit.com
- Nonclinical development strategies
- Lead candidate pharmacokinetic optimisation
- Advice on in vitro and in vivo metabolism study design
- Strategies for early pharmacokinetic development
- Regulatory drug metabolism
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Kei-Lai Fong, Ph.D.kei-lai.fong@aptuit.com
- Drug development strategies
- Clinical and preclinical PK/PD
- Biotransformation
- Bioanalytical (LC/MS, ligand binding, antigenicity)
- Drug-drug interactions
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Peter Gaskin, Ph.D.peter.gaskin@aptuit.com
- Nonclinical development strategies
- Regulatory toxicology
- Mechanistic toxicology
- Regulatory strategies for early development
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John J. Kowalskijohn.kowalski@aptuit.com
- Preclinical toxicology/pharmacology
- DMF, IND, A/NDA preparation, submission and maintenance
- CMC Compliance
- Product development planning and tracking
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Daniel M. Linkie, Ph.Ddaniel.linkie@aptuit.com
- Regulatory filings and strategy
- Drug / biologics / device development
- CRF design and CDISC compliance
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Bill Mackin, Ph.D., RACbill.mackin@aptuit.com
- Regulatory documentation to support INDs and IDEs
- Regulatory strategy development and execution
- Medical device and combination product development
- GMP manufacturing development, support and audits
- CMC of drugs, biologics and cell/tissue therapeutics
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Linda Dellingerlinda.dellinger@aptuit.com
- Electronic publishing of regulatory documents and submissions
- Compilation and submission or regulatory documents and dossiers
- Regulatory document template development
- QA review of regulatory documents and submissions
- Experienced with electronic publishing software: Microsoft Words, Excel, Adobe Acrobat, and Docutech equipment
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Kalpana Nimkar, Ph.D.kalpana.nimkar@aptuit.com
- CMC-focused API development
- Regulatory submissions related to APIs
- Contract manufacturer management
- GMP compliance
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Kathleen Oliva-Whalen, B.S.kathy.oliva-whalen@aptuit.com
- Regulatory submission oversight, management, preparation, and maintenance
- Regulatory document review and preparation
- Regulatory authority liaison and meetings
- Regulatory strategy development, implementation, and management
- Regulatory compliance gap analysis and issue resolution
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Mary M. Sherman, Ph.D.mary.sherman@aptuit.com
- Drug discovery: lead optimization to lead selection
- DMPK: discovery through preclinical
- Analytical chemistry and preformulations
- Optimizing formulations for nonclinical studies
- General toxicology
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Aeri Park, Ph.D.
aeri.park@aptuit.com
- Polymorph, salt and cocrystal screen and selection
- Solid state characterization of API and drug products
- Crystallization method development
- Patent prosecution support
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Lori Dostal,Ph.D., DABTlori.dostal@aptuit.com
- Reproductive and development toxicology, including juveniles
- Male reproduction and lactation
- Electronic INDs, exploratory INDs
- General and genetic toxicology studies to support antibacterials from IND through NDA
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