Based on our originally designed methodology, we provide the search and verification of innovative investible projects through a full-range medical scientific, R&D and IP expertise, and market analysis for Client’s product portfolio extension and optimization:
1. Pipeline/ Portfolio Strategic Planning:
- New Therapeutic Opportunities Exploration and Evaluation:
- Tracking and analyzing the latest bioscience research advances applicable to drug discovery and development
- Scouting innovative drug candidates, products and technologies, and evaluating their therapeutic and R&D potentials (PoP/ PoM/ PoC)
- Developing innovative concepts based on off-label use, new indication detection and R&D optimization for generics
- Writing/ proofreading of preclinical and clinical modules, and toxicology part of regulatory submissions (CMC/CTD, NDA) to EMA and FDA
- New Business Development/ Licensing/ Intellectual Property* Operations:
- Identifying potential in/out-licensing opportunities for medicines and technologies in any therapeutic area (TA)
- Outlining and negotiating new license agreements with partners
- Finding new partnering opportunities with academic and private bio/pharma labs
- Product lifecycle strategic planning, SWOT and competitive landscape analysis
- Keeping up to date with changes in the national/international regulatory legislation
- IP expertise of drug candidates, products, and technologies (innovativeness/ patentability/ FTO)
- Drafting and prosecuting patent applications, including domestic and international registrations
2. Pharmacogenomics & Biomarkers Expertise:
- Providing medical scientific expertise for the verification and pre-clinical qualification of new genetic markers and
pharmacological targets in Psychiatry/CNS, Oncology, and Rare Diseases TAs, among others - Verifying patient stratification criteria, clinical assessment approach, and drawing up operations plan for pre-clinical
and clinical trials (Phase I-III) and GWAS - Providing clinical scientific evidence for rare and de novo SNPs/SNVs
- Analyzing genome/phenome datasets and repositories
3. Pharma Market Research & Ad-hoc Analysis:
- Tracking and analyzing competitor’s current R&D, regulatory and marketing strategies, hurdles and behaviors
- Auditing qualitative marketing researches, e.g. capturing additional scientific insights on innovative medicines and diagnostics
- Conducting behavioral and ethnographic studies on health and treatment practices
_______________________________________________________________
* – in close cooperation with a Senior Patent Attorney