About BSS
Affordability Access Uncompromising Quality
Biosimilar Solutions is a leading biosimilar company that develops and commercializes high-quality therapeutics for major regulated markets, lasered focus on affordability, increasing patient access with Uncompromising Quality. Biosimilar product development poses a number of scientific, regulatory and technical challenges that distinguish it from traditional, small-molecule generic product development. We believe our world class team of biologic therapeutic developers and renowned scientists gives us the critical capabilities to successfully address the complexities underlying these challenges. Our team includes industry veterans with decades of experience in pioneering biologics companies, such as Amgen and Genentech, where they were responsible for leading, and in some cases establishing, these organizations’ core capabilities in process development, protein manufacturing and analytical research and development. Senior members of our internal team have contributed to the filing of over 100 Investigational New Drug applications, or INDs, and over 40 marketing applications, including those for Enbrel, the originator product for our lead biosimilar product candidate. We have also assembled a distinguished Scientific Advisory Board of leading scientists who are acknowledged experts in their respective fields.
Experienced Scientific and Commercial Leadership
ROBERT SALCEDO
CO-FOUNDER AND CEO
•25 years experience in Biologics and Cell Therapy
•Led facility development and Technical Transfer for Amgen Puerto Rico
PROFESSIONAL EXPERIENCE:
COMMERCIALIZATION EXPERIENCE
DANIEL CHANG
CPA, MBA, CPIM, CIRM, cPMP
CO-FOUNDER, CHIEF FINANCIAL & OPERATIONS OFFICER
•20 years experience in Bio-Pharma and biosimilars as an executive
•Led product development for 30+ INDs
PROFESSIONAL EXPERIENCE:
COMMERCIALIZATION EXPERIENCE
F. DARION PETTY, MPA
SVP AND CC
•25 years experience in Bio-Pharma and biosimilar commercialization
•Led the launch and commercialization of market leading biosimliar PEG-GCSF
PROFESSIONAL EXPERIENCE:
COMMERCIALIZATION EXPERIENCE
Our Management Team
Kamali Chance, PhD, MPH, RAC
Chief Regulatory Officer (BioSciencesCorp IIc.)
She spearheads biosimilar regulatory strategy and interactions with regulators for development of biosimilars in highly regulated markets as well as emerging markets.
Dr. Chance has provided global regulatory strategy for number of biosimilar products in development including biosimilars of Enbrel, Remicade, Herceptin, Rituxin/Mabthera, Humira, Avastin, Epogen, Lucentis, Aranesp, Recombinant Insulins, Neupogen/Neulasta, among others.
In the past 10 years, her specific regulatory experience entails the following:
Spearheaded regulatory strategy to meet FDA and EMA requirements for 18biosimilar products
Spearheaded clinical development plans for 11 biosimilar products
Attended face to face meetings with FDA for 13 biosimilar products including darbepoetin, adalimumab, infliximab, bevacizumab, trastuzumab, GCSF among others
Authored or co-authored 14 articles and a book chapter on biosimilars
Regulatory oversight for briefing package preparation for 13 different biosimilar products to meet FDA/EMA requirements.
Dr. Chance has over 25 years of work experience in the healthcare industry, including the last 19 years in regulatory strategy/affairs at CRO, pharmaceutical and biotechnology industries. Dr. Chance has a Ph.D in Nutrition/Nutritional.
Dinesh Kundu, MBBS(MD), MBA
Chief Medical Officer
Dr. Kundu has over 12 years of experience in Healthcare services, Biotech Program manangement, Business Strategy & Drug Development for India, Asia-Pacific MENA and Russia market. He is a medical doctor from AFMC Pune and MBA from ISB, Hyderabad & London Business School.
His expertisee includes the following.
Leading Technical program management with 5 program managers for cytokines, hormones & monoclonal antibodies
Part of core project team for capacity assessment, conceptual designing & detailed designing of Microbial & Nammalian facility
Business Strategy expertise to take drugs-approved in India ROW/semi-regulated/regulated markets
Product due diligence for both in-licensing & out-licensing for partners in Asia Pacific, Russia, MENA
Strong Business Department expertise in APAC, MENA, Russia
Lead teams for preparation of successful EU/FDA audits
Jason Rexroad Phd
Chief Technical Officer (Sr Diractor- Technical & Analytical Operations)
Dr. Rexroad has 15+ years of experience in biotechnology with expertise in various analytical techniques for protein and peptide characterization and for biosimilars development. He can provide solutions for analytical challenges at various stages of a biosimilar development and commercialization. Jason is deep expertise in analytical method development, validation and FDA approved risk assessment methodologies.
Some highlights of his-areas of expertise include:
Development and establishing methods to support phase appropriate product development
Management of multiple FDA audits for analytical and quality control laboratories
Analytical techniques - chromatography (HPLC/UPLC), Mass spectroscopy, Capillary & Gel elecrophoresis, Glycan analysis, Spectroscopy techniques(UV, CD, Fluorescence)
Complete understanding of biologics development (from clone to product)
CQA assessment and setting up the quality criteria for product and process
Method development, qualification, and validation in line with regulatory requirements
Responding to EMA and FDA queries
Setting up analytical lab and implementation of cGMPs
Understanding of regulatory expectations, ICH guidelines and cGMP compliance
Jason has PhD in Analytical Chemistery University of Kansas
Roshan Upadhyay
Director of Analytics (Principal Scientist - Technical Operations Lead)
Roshan has 10+ years of experience in biotechnology with expertise in various analytical techniques for protein and peptide characterization and for biosimilars developement. He can provide solutions for analytical challenges at vaious stages of a biosimilar development and commercialization. Roshan led the analytical due diligence and response drafting for Peg-GCSF and ranibizumab for a Japanese client. Roshan has deep understanding in analytical method development and in product characterization. He has understanding in analytical method development and in product characterization. He has worked on multiple products such as cytokines (Erythropoietin, G-CSF, PEG-GCSF, Interferon alfa and PegIFN alfa), hormones (parathyroid hormone) and follicle stimulating hormone) and monoclonal antibodies (rituximab, bevacizumab, ranibizumab, trastuzumab, adalimumab, and cetuximab).
Some highlights of his areas of expertise include:
Analytical techniques- Chromatography(HPLC/UPLC), Mass spectroscopy, Capillary & Gel electrophoresis, Glycan analysis, Spectroscopy techniques(UV, CD, Fluorescence)
Complete understanding of biosimilar development (from clone to product)
CQA assessment and setting up the quality criteria for product and process
Method development, qualification, and validation in line with regulatory requirements
Responding to EMA and FDA queries
Setting up analytical lab and implementation of cGMPs
Understanding of regulatory expectations, ICH guidelines and cGMP compliance
Roshan has M.Sc. in Microbiology from University of Rajasthan.
Mitul Agarwal
Chief Business Strategist, QbD Biosciences Pvt. Ltd
Mitul has over 20+ years of experience in Biotech and Plasma Business Development and Licensing for US, EU and ROW market. He is a Pharmacist & Management Graduate with experience in top Global MNCs and Indian Biotech companies.
His expertise includes the following:
20+ years of experience in Global markets- leading the Sales & BD roles at Baxter, Fresenius Kabi and Intas Biopharma.
Responsible for launching top Baxter plasma products in India - including Fibrin Glue & Factor VIII
Strong connections for Corporate Hospitals & Central Tenders
Global in-licensing (Asset Acquistion) and out-licensing for top Indian Biotech company-responsible for deals worth 100 MM USD
Business Strategy expertise to take drugs apporved in India ROW/semi-regulated/regulated markets
Product due diligence for both in-licensing & out-licensing for partners in Asia Pacific, Russia, MENA
Lucas Hemandez, Ph.D.
Head of CMC (Pharmaceutical Professinal and Parenteral Inspections Expert)
Pharmacentical Quality, Validation and Scientific Professional with over 18 years of regulated industry experience in the quality, validation, technical services, manufacturing and process development environments(Parenteral Manufacturing Solid Dosage and Biotechnology DS). Fully knowledgeable of regulatory matters. EPA, OSHA, FDA, ISO. FDA Consent Decree experience and Plant Approval FDA and EMEA Audits. Dedicated, focused, and quality-oriented professional. Highly respected for consistently demonstrating hands-on process while applying best practices to critical manufacturing initiatives and product launches.
Expertise:
Strong experience in Parenteral Plant Remediation Plans managing and supervising activities for the implementation. Regulatory inspection support and response writing.
Strengths in Biotechnology Plant Start Up in Drug Substance of Biologics-Biosimilars
Expert in Documentation, APR, Training & Development, Validations (Equipment, process, cleaning), Process Development.
Review Execution of Validation Protocols and Summary Reports Provided strategies on handling issues and mentoring for corrections.
Expertise in Quality Systems (Batch Record, Investigations, Change Control and Complaints Invest.)
Pre-Approval Inspection preparation and support. Direct interaction with FDA, MHRA, INVIMA auditors.
Manager for the Remediation of Quality Manufacturing/DS/Packaging/Utilities/Facilities Materials and Production Planning. Supervisor of 7 direct reports. Direct interaction with FDA auditors for pre-approval inspection, >70% reduction on 483 observations after Quality Improvement Plan implementation.
Expert on Injectables Visual Inspection Program Creation including inspection technique design and implementation, inspectors training and certification, Defect categorization and classification SOP Generation, Process Flow, Units Handling improvement.
As Plant Manager- Co-ordinate and oversees plant activities through the planning process with departmental managers ensuring the effective allocation of resources and full utilization of assets to produce expected results in production output quality and complying with shipping schedule.
Professional Experience:
Plant Manager - GK pharmaceuticals, Guayama Site, Puerto Rico (2017-2018)
Site Remediation Manager - Intas Biopharma, India (2015)
Manufacturing Inspection Manager - Amgen (2014-2015)
Parenteral Complain Lead - Amgen (2011-2014)
Regulatory Compliance Leader - Intervet, Mexico (2010-2011)
Manufacturing Investigations Scientist - Jansen (2009-2010)
Validation Specialist - Jansen (2007-2009)
Quality Assurance Representative - Lilly del Caribe - Jansen (2003-2007)
Sr. Validation Specialist - Schering Plough Products (2000-2003)
Education:
Ph.D., Env. Sci Organic Chemistry, University of Turabo. Puerto Rico, May 2017
M.S., Biochemistry, University of Puerto Rico, Dec 2008
B.S., Chemistry, University of Puerto Rico, May 2000
Barbara Araneo, PhD, RAC
Senior Director Quality Systems
Over 25 years of work experience in the healthcare industry, including the last 5 years in Gene/Cell Therapy, pharmaceutical and biotechnology industries.
Dr.Araneo has a Ph.D. in cellular immunology from University of Rochester and Clinical trial management from UC San Diego. She has a Regulatory Affairs Certification from the Regulatory Affairs Professionals Society.
Technical Resources
Analytical and Supporting Resources
