Our Expertise, Your Advantage

Experienced Biotech/Pharma scientific leader and consultant (DMPK and Clin. Pharm.) who drives preclinical and clinical success with a passion for scientific excellence, enthusiasm to intelligently adopt new approaches and technologies/modalities, and an opportunistic approach to proactively influence the regulatory environment. In 25+ years across large pharma to pre-IPO Biotech, I and my teams have supported numerous programs from high throughput screening and hit identification to clinical Phase IV across a range of therapeutic areas using modalities from the traditional to the novel. I have built, sustained, and transformed project teams and scientific functional organizations while consistently increasing colleague morale and engagement while delivering to timelines with well designed and efficiently implemented strategies and crisp, informed, effectively communicated decision making.

Recognized for achieving excellent results via strong strategies, well coordinated and efficiently implemented with the highest quality fit-for-purpose data and an inclusive, coaching style. 

Recognized strengths:

•Deep and broad pharmaceutical background approached from a biochemistry and engineering perspective that marries scientific/mechanistic rigor with practical considerations to develop and implement winning strategies while rapidly and effectively driving programs forward in the context of well-balanced portfolios 

•Seamlessly inform decisions via direct data/analysis or access to/collaboration with my extensive network of pharma professionals and CRO connections  

•Coach and mentor scientists and scientific leaders to maximize their individual value/growth and that of their teams 

I welcome the opportunity to apply my broad and deep experience and my professional network to help Pharma/Biotech and Academics develop their therapeutic ideas into products

Small molecule – reversible and covalent, degraders/molecular glues 

Biologic – antibodies (traditional and bifunctional), proteins, peptides (incl. stability-modified), ASOs

Mixed modality – ADCs, bi-functionals

Emerging modality – Gene editing, LNP, RNA

Early target strategy

Candidate optimization

Candidate clinical preparation and submission (incl. GLP/non-GLP, preclinical safety strategy, 

Phase I/II study design/execution/reporting

Clin. Pharm. study design/execution/reporting and overall strategy/timing (incl. waivers)

Global regulatory documentation and interaction strategy/preparation/participation

CRO engagement (identification/contracting/study coordination, review/reporting, auditing)

Portfolio

•Specific DMPK/Clin. Pharm. focused issues/investigations incl. modality and form/formulation selection 

•Target and drugabilityassessments •Candidate stage guideline development, review/revision, and assessment 

•Project Due Diligence 

•Cross-project cost/timeline projections and resource allocation/prioritization 

•CRO engagement, management, auditing 

Project

•Specific DMPK/Clin. Pharm. focused investigations incl. modality selection 

•Integrated project team DMPK support 

•Preclinical study design, protocol writing/reviewing, and execution support 

•Target Candidate and Drug Product Profile generation and assessment 

•Project cost/timeline projections and resource allocation/prioritization 

•Project stage assessments 

•DMPK SAR design, assessment, reporting 

•Clinical study PK and Clin. Pharm. data flow, analysis, reporting, and report review/audit  

Portfolio

•Specific DMPK/Clin. Pharm. focused issues/investigations incl. platform-level formulation and cross-project route/regimen opportunities (e.g. LNP component clinical pkg expectations) 

•Target and drugability assessments 

•Project Due Diligence 

•Cross-project cost/timeline projections and resource allocation/prioritization 

•CRO engagement, management, auditing 

Project

•Specific DMPK/Clin. Pharm. focused investigations incl. formulation and dose level/route/regimen selection 

•Integrated project team DMPK/Clin. Pharm. support 

•Clinical study design, protocol writing/reviewing, and execution support 

•Clinical study PK and Clin. Pharm. data flow, analysis, reporting, and report review/audit 

•Clin. Pharm. study strategy (incl. waivers)  −Types, geographies, rationale, timing (start/duration/reporting), coordination with other efficacy/safety and clin. pharm. studies, and estimated cost  

•Project cost/timeline projections and resource allocation/prioritization 

•Project stage assessments 

•DMPK SAR design, assessment, reporting  

Discovery programs

•Drug product or candidate readiness audits/assessments and gap analysis 

•Specific DMPK/Clin. Pharm. focused issues/investigations incl. formulation and route/regimen suitability 

•Target and drugability assessments 

•Cost/timeline projections and resource allocation/prioritization 

•Documentation review/revision and audit (as appropriate) •CRO engagement, management, and auditing to address gaps 

Development programs

•Drug product stage readiness audits/assessments and gap analysis 

•Specific DMPK/Clin. Pharm. focused investigations incl. formulation and dose level/route/regimen suitability 

•Clinical study design, protocol, report suitability and gap analysis 

•Clinical study PK and Clin. Pharm. data analysis, interpretation, and reporting, suitability and gap analysis 

•Clin. Pharm. study strategy (incl. waivers) assessment −Types, geographies, rationale, timing (start/duration/reporting), coordination with other efficacy/safety and clin. pharm. studies, and estimated cost   

•Drug product or candidate readiness audits/assessments and gap analysis

•Documentation creation, editing, updating, reviewing/auditing (small molecules and biologics, US/global)

    −Submission documents; Investigators Brochures; regulatory interaction requests, background,    

       responses; drug product package inserts

•Regulatory interaction strategy; background material creation, editing, updating, reviewing/auditing; interaction preparation; and direct regulator engagement

•Medical writing CRO engagement and coordination

•Coaching/training for regulatory interaction

DBConsulting, LLC, offers 1-on-1, general, semi-custom, and fully customized training for individuals and organizations within the scope of consulting services provided.  

Below are examples of general seminars available as is or as a starting point for customized remote or on-site training.  

Audience – Chemists/biologists with 0-3 yrs of experience

Content – 

•DMPK high level strategy, general approaches, relationship to clinical pharmacology;  

•ADME components, relevance to PK and regulatory requirements, in vitro/in vivo assessment type/utility, relationship to phys. props. and SARability, result types and high-level interpretation  

•PK components (related to ADME), study species/route/regimen/type/utility, elements of study design, and result types and high-level interpretation 

•BCS relevance  

•DDI (drug-drug interaction) strategy/components/types, relevance to PK and regulatory requirements, in vitro/in vivo assessment type/utility, result types and high-level interpretation 

Time 1.5-2 h

Audience – Scientists involved in LNP Drug Development 

Content –   

•General LNP characteristics and regulatory guidances

•WHO, EMA, FDA

•Platform vs individual candidate considerations

•DMPK high level strategy, general approaches, relationship to clinical pharmacology; 

•ADME components, relevance to PK and regulatory requirements, in vitro/in vivo assessment type/utility, relationship to phys. props. and SARability, result types and high-level interpretation 

•PK components (related to ADME), study species/route/regimen/type/utility, elements of study design, and result types and high-level interpretation

DDI (drug-drug interaction) strategy/components/types, relevance to PK and regulatory requirements, in vitro/in vivo assessment type/utility, result types and high-level interpretation

Time 1.5-2 h