SAMUEL RAJ SOLOMON, PhD, RAC

Principal Consultant leading Bioprecise Lifesciences Consulting, a specialized consulting firm that offers regulatory affairs services to companies in the lifesciences industry. Our primary goal is to assist lifesciences clients in obtaining USFDA EMA, India and RoW approvals for their products. Currently assisting startups with medical devices, in-vitro diagnostics, cell and gene therapy, mRNA vaccines, Biologics and Biosimilars.

• Regulatory lead for one new biologic and several biosimilars. CDMO contract projects include vaccines based on human adenoviruses and DNA COVID-19.
• Designed and implemented USFDA Scientific Advice and EMA for biosimilars
• Acquired multiple approvals, including Form 29 licenses for testing and clinical trials and CT approvals for three products.
• obtained export and import licenses for bulk drugs and products
• successfully procured Sputnik-L COVID-19 Manufacturing License for CDMO manufacturing
• CDSCO MAA approval for the first biosimilar adalimumab for SBPL increased company growth through collaboration with R&D, manufacturing, Quality, sales and marketing departments
• Identified opportunities to improve business process flows and productivity.

• Regulatory lead in approval of the first biosimilar PEG-GSCF (Pelgraz) in Europe and Canada, working in collaboration with Apotex. EMA filing, Day 120 and Day 180 query response, and post approval life cycle management USFDA PEG-GCSF and GCSF-complete Complete Response letter query responses, BLA refiling, and information request responses
• Regulatory lead in the approval of first biosimilar Teriparatide (Sondelbay) in Europe. EMA filing and query responses.
• Regulatory lead in approval of first biosimilar for Denosumab and Romiplostim (India)
• Regulatory lead for Accord Healthcare's collaboration with Henlius, product Trastuzumab – EMA approved Zercepac-EMA filing and query responses.
• Multiple clinical trial applications for biologicals (products of microbial and mammalian origin) for global development and filing
• Multiple Scientific Advice Meeting packages for biosimilars in European Medicines Agency (EMA), United States FDA (USFDA) and Rest of World (RoW) markets like Turkey, Mexico, Brazil, South Africa, South Korea etc.
• Market authorization application for EMA (3 applications), USFDA (2 applications), Canada (1 application), Australia (2 applications) and RoW markets (multiple applications)
• Extensive Product Lifecycle Management with multiple variations filed for EMA (GCSF and PEG- GCSF) and ROW
• Implemented eCTD and Regulatory Information Management System (RIMS) to streamline global regulatory operations
• Drug Delivery Device approvals- Auto-injectors and Pen injectors
• IBSC chairman for R&D portfolio
• Increased company growth through collaboration with R&D, manufacturing, Quality, sales and marketing departments.

• Regulatory and CMC consultant to multiple top global biopharma and small biotechnology companies for biologics, NCE and biosimilar development services with respect to scientific advice, BLA/MAA, MAA transfers, etc.
• Authored for clients, Module 2 and 3 dossiers for biosimilars and biologics, CTA/IND, MAA/BLA, and scientific/PIND advice packages
• Post divestment of assets, handled Market authorization transfer-related activities for top global Pharma
• Engaging global clients to deliver regulatory services remotely and onsite through gap analysis, risk assessment, and problem resolution within stipulated budget, time, and quality expectations
• Notable clients served: Amgen, Boehringer Ingelheim, Baxter, Celltrion, Samsung Bioepsis, Dong-A, Henlius, Green Cross Korea, Sun Pharma- SPARC, Zydus, etc.

• Regulatory lead (from clone to initiation of phase 3 clinical trial -2009 to 2015) for Biocon/Mylan USFDA/EMA approved biosimilar products:
• *FulphilaTM (PEG- GCSF)
• *Ogivri (Trastuzumab)
• *Abevmy (Bevacizumab) EMA approved: from clone to phase 1 clinical
• Regulatory lead for head and neck cancer orphan drug- Biomab EGFR
• Regulatory lead anti-CD20 monoclonal antibody in collaboration with Vaccinex
• Regulatory lead of novel biologics portfolios, notably fusion protein therapeutics, therapeutic vaccines, biobetter, and Itolizumab. Alzumab (Itolizumab)-world’s first-in-class novel anti CD5 monoclonal antibody
• Managed large-scale projects and introduced new systems, tools, and processes to achieve challenging objectives.
• Developed and implemented new filing systems to improve organizational efficiency and productivity.
• Increased company growth through collaboration with R&D, manufacturing, Quality, sales and marketing departments.
• Hired and managed employees to maximize productivity while training staff on best practices and protocols

Cell and Cancer research

Cell and Cancer research

Immunology : Systems Biology- B Cell Proteomics

Arthritis and Autoimmune disease/Inflammation research

Molecular Biology Project selection of HIV-I inhibiting RNA Aptamers.