Jayant Aphale Email & Phone Number

Specializing in executive advisory services for pre-IPO through late stage clinical companies in operationalizing and monetizing complex therapeutics, with a clear line of sight to commercialization. Apex Global Advisors, LLC provides technology, quality and CMC regulatory due diligence, gap analysis and remediation, as well operational strategy development for cost effective, manufacturable, scalable and globally fileable clinical processes. Specialization includes COGS reduction, personalized and rare disease supply chain development & implementation, cGMP facility design, build out & commissioning, build vs buy decision counsel, and program & portfolio management. Experienced in viral vector and cell culture, LNPs, mRNA, oligos, vaccines and biologics in the immuno-oncology, gene therapy, rare disease and infectious disease areas. Client profile includes VC firms, C-level executives and other senior executives from pre-IPO to late stage clinical organizations.

Emeryville, California, Us

Cambridge, Ma, Us

• Provided integrated operations, quality and regulatory advise to a start up biotech; CMC operations, quality & compliance strategy for an European early stage vaccines company; manufacturing quality and compliance risk mitigation (recommendation was implemented) as well fill/finish contamination control training (including RFT/HEP) at one of the Big 5 vaccine manufacturer; and CMC tech ops consulting for one of the Big 3 biotech companies to assess global supply chain quality compliance, processes and supply continuity.

Brentford, Middlesex, Gb

• Structuring business processes for timely delivery of new products with robust manufacturable processes and QC methods• Streamlining handoffs between R&D and Industrialization as well Industrialization and commercial to accelerate NPI. Executive sponsor Vaccine QbD pilot and manufacturing process robustness. • Asset optimization of global manufacturing network for LCM products and anticipated NPI (bulk, fill / finish and pack assets). Global product transfer of marketed vaccines. QA / RA as major customers.• cGMP manufacturing for global Ph. 1, 2 and 3 global clinical trial material supply (CTSU). • Strong collaborative interface with clinical & commercial QA, R&D, procurement, supply chain, clinical, commercial and BD.• Steering committee member for cross functional ‘integrated vaccine development & launch’ planning and 'Vaccine Delivery Devices Of The Future’.

• Participated in FDA / MHRA meetings, QP meetings. Set up CMC regulatory compliance & CMC regulatory strategy for antibody fusion protein product commercialization. • Strategic and tactical oversight of supply chain to ensure on time delivery of clinical lots (PD / tech. transfer to 20,000 L cell culture CMO; analytics tech transfer of 12 assays and fill/finish).• Negotiated long term Manufacturing Supply and Quality agreements. Routine ongoing interaction with clinical and commercial groups.• Supported CEO for asset valuation, launch strategy and VC exit strategy.• Alignment of product development / scale up activities & product attributes with clinical trial expectations

• Re-engineered “end to end” Operations/Business model along with consultants (E&Y).• Set up business processes for enterprise resource planning and Project Management Office (PMO) with project governance methodologies, tools, templates and training.• Set up overall decision architecture, guidance and strategy road map (Stage Gate) for early stage vaccine development to launch (new product development).• Performed build / buy decision modeling for manufacturing assets in relation to portfolio mix and marketing projections over 8 – 10 years.• Managed multiple cGMP manufacturing sites to ensure on-time supply of product to the US Government. Managed overall vaccine supply chain ; hosted BARDA, CDC and FDA visits. Strong collaboration with QA during routine cGMP manufacturing.• Successful (1st cycle approval) Type C meeting with FDA regarding lyophilized aseptic viral fill/finish cGMP facility design and qualification.

New York, New York, Us

Switzerland 🇨🇭 , Ch

Mba, Strategy, Finance, Marketing

Ph. D., Molecular Biology, Fermentation Technology, Downstream Processing