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COMPANY PROFILE

NJ Biopharmaceuticals LLC (d/b/a NJ Bio) is a quality CRO that provides integrated chemistry and biology services to clients from the biotech and pharma sectors. Main service areas include multistep organic synthesis, medicinal chemistry, bioconjugation, antibody-drug conjugates, and flow chemistry. The company is headquartered in Princeton, NJ, with an additional chemistry facility in Bristol, PA. NJ Bio provides flow chemistry services as well as chemical process R&D in collaboration with its affiliate Amar Chemistry Pvt. Ltd. in Mumbai, India.

NJ Bio has a strong background in synthetic organic chemistry and protein-based biopharmaceuticals and is an integrated service provider with expertise in the following areas:

Antibody-drug conjugates (ADCs), bioconjugation to proteins and biomaterials, linker chemistry design for conjugations, ADC constructs, and process development for small molecules and ADCs.
Multi-step customized flow chemistry synthetic routes for drug intermediates and APIs in collaboration with Amar Chemistry Pvt. Ltd., along with a unique offering to design custom flow chemistry equipment in collaboration with experts at Amar Chemistry Pvt. Ltd.
Medicinal chemistry from lead generation via lead optimization to scale-up, with the option of engage into blended FTE services with Amar Chemistry Pvt. Ltd.
Production of research-grade proteins and antibodies.
Cell-based functional assays, including 2D & 3D cytotoxicity, ADCC (antibody-dependent cell-mediated cytotoxicity), and ELISA.

COMPANY MISSION

Our mission is to provide value-added chemistry and biopharmaceutical services to enable our clients to accelerate their product development programs and build long-lasting collaborative relationships. Our goal is to provide value through efficient, timely, and cost-effective solutions that meet our clients’ needs. NJ Bio embraces the standards of teamwork, confidentiality, and reliability with innovative solutions to our clients’ most challenging research requirements. Customer satisfaction is our highest priority.

OUR PEOPLE AND CULTURE

We have highly talented and experienced laboratory chemists and biologists with a tremendous passion for chemistry and biology resulting in unique solutions to client programs. Furthermore, our corporate culture is collaborative, communicative, and adaptable. Most importantly, our scientists strive to deliver quality services in a cost-effective and timely manner.

Our Team

Nareshkumar Jain, Ph.D. – President, CEO and Chairman

Dr. Jain is the founder and CEO of NJ Bio and co-founder of Amar Chemistry Pvt. Ltd. He is also a member of Robin Hood Ventures, a leading Mid-Atlantic investment group. Prior to founding NJ Bio in 2018, Naresh served as Global Head of Chemistry and Senior Vice-President of ADC Biomanufacturing at Abzena. In 2009, he founded the chemistry-based CRO, The Chemistry Research Solution LLC (TCRS), and served for six years as Managing Director of the company until its acquisition by Abzena in late 2015. Naresh has over ten years of medicinal chemistry experience at Johnson and Johnson, where he worked on advancing new drug molecules from early lead to lead optimization and clinical trials. He has co-authored over 60 publications, patents, and book chapters. Among his notable achievements are the total syntheses of complex natural products including the antibiotics vancomycin and rutamycin. Naresh received his Ph.D. from Boston University with Prof. James Panek, and was a Post-Doctoral Research Fellow at The Scripps Research Institute in La Jolla, California with Prof. K.C. Nicolaou. Naresh received extensive leadership training through the Advanced Management Program at The Wharton School of The University of Pennsylvania.

Ralf Mueller, Ph.D. – Chief Business Officer

Dr. Mueller is NJ Bio’s Chief Business Officer and his responsibilities include the company’s overall business development, proposal management, and marketing activities. Ralf has more than twenty years of experience working for chemistry and biopharmaceutical CROs and CDMOs, covering the fields of business development, custom synthesis, process development and cGMP manufacturing. His previous positions include Senior Executive Director of Business Management with NJ Bio, Senior Director of Business Development with Abzena, Senior VP of Chemistry & Business Development with The Chemistry Research Solution LLC as well as Director of Chemistry with Alchem Laboratories Corporation. Ralf received his doctor title in organic chemistry from the University of Freiburg, Germany, and then worked as Postdoctoral Associate with Prof. Raymond Bergeron at the University of Florida on the synthesis of a “Hypusine reagent” and polyamine analogues. He has co-authored 15 research articles on potential drugs against cancer (i.e., polyamine antiproliferatives), dyslipidemia (i.e., long hydrocarbon chain acids and diols, related to bempedoic acid), and other topics.

Libu Mathew, B.S., CPA – Chief Financial Officer

In his role as NJ Bio’s Chief Financial Officer, Libu is providing financial guidance and related executive support to NJ Bio’s administrative operations. Libu is an experienced finance professional, specialized in accounting and Generally Accepted Accounting Principles (GAAP) with more than twelve years of work experience in diverse financial positions at several companies in the healthcare manufacturing and service sectors. Libu also has a background as a financial auditor and previously headed the Accounting Department of a major car parts manufacturing company in Philadelphia. Libu obtained his bachelor’s degree in Business Administration from Drexel University, Philadelphia, and is certified as a Public Accountant in the Commonwealth of Pennsylvania.

Bram Karsten, Ph.D. – Vice President of Chemistry and Flow Sciences

Dr. Karsten is an organic chemist with 15 years of experience in the synthesis of small molecules and polymers as well as in the characterization of materials by advanced spectroscopic techniques. Bram received his Ph.D. in organic chemistry from Eindhoven University of Technology, where he investigated the synthesis of π-conjugated small molecules and polymers for organic solar cell applications. After graduation, he worked in a solar energy startup for a year, after which he joined Prof. Stephen L. Buchwald’s group at MIT for postdoctoral research. At MIT, Bram focused on the multistep flow synthesis of pharmaceuticals, which led to the development of a fully continuous flow synthesis of Imatinib (Gleevec). Before joining NJ Bio, Bram set up a synthetic chemistry laboratory at MicroChem Corp. (a subsidiary of Nippon Kayaku Co. Ltd.), where he worked on the synthesis and characterization of small molecule semiconductors. Bram’s work has been published in 11 journal articles and one patent.

Julien Dugal-Tessier, Ph.D. – Director of Innovative Chemistry and Bioconjugation

Dr. Julien Dugal-Tessier joined NJ Bio as Director of Innovative Chemistry & Bioconjugation, building off his previous experience of working for eight years in the field of Antibody-Drug Conjugates (ADCs). In his successful ADC research career at both ImmunoGen and Agensys/Astellas, Julien focused on the design of novel payloads and linkers. At ImmunoGen, he studied potent DNA damaging agents with the goal of increasing their therapeutic index. Prior to ImmunoGen at Agensys (a former affiliate of Astellas), Julien worked on a variety of different payloads and linkers which led to four product candidates, one of which (AGS62P1) is currently in a Phase 1 clinical trial. Julien was also involved in the discovery-to-scale-up activities of ADC payloads and linkers as well as in chemistry activities supporting later stage programs such as the commercially approved ADC Enfortumab Vedotin. Julien obtained his Ph.D. from the University of British Columbia in a joint project between Profs. Gregory Dake and Derek Gates on the development of metal catalysis for organic synthesis. After his Ph.D., Julien studied N-heterocyclic carbene catalysis and its application towards a total synthesis during his post-doctoral fellowship at Northwestern University with Prof. Karl Scheidt. He has published over 15 peer-reviewed research manuscripts.

David Fry, Ph.D. – Distinguished Research Leader

Dr. Fry joined NJ Bio as Distinguished Research Leader in early 2019. David has expertise in NMR analysis of proteins, peptides, and small molecules; structure elucidation and confirmation by NMR; protein analysis; ligand-binding studies by NMR; and 2D and 3D multinuclear NMR experiments. Prior to joining NJ Bio, he served for three years as Vice-President of Protein Chemistry at The Chemistry Research Solution LLC. David has 27 years of drug discovery experience as Head of Structural Chemistry at Hoffmann-La Roche and is a globally recognized expert in the use of NMR to discover small molecule drugs for protein-protein interaction (PPI) targets. David’s research highlights include pioneering work on Interleukin-2 inhibitors, the Ras-binding domain of c-Raf, design of a PYY peptidomimetic (clinical candidate), and an essential role in the discovery of the Nutlin series of MDM2-p53 inhibitors. He has directed numerous initiatives including fragment-based lead discovery and the building of PPI-targeted screening libraries. David has co-authored over 50 publications.

Thomas Markotan, M.S. – Senior Research Fellow Chemistry

Tom joined NJ Bio’s chemistry team as Senior Research Fellow. He is an organic chemist with over twenty years of industrial research experience as well as several years of academic research experience. Tom is an expert in planning and conducting multi-step organic syntheses on milligram- to multi-gram scales and has spent the last eight years working on the design and synthesis of payload-linkers for ADCs, one of which is currently advancing into clinical trials. Prior to joining NJ Bio, Tom held R&D positions with Abzena and The Chemistry Research Solution LLC (TCRS) as Associate Director of Chemistry and Senior Scientist, respectively, as well as with Johnson & Johnson Pharmaceuticals R&D and 3D Pharmaceuticals, Inc., where he was part of a team that progressed two potent, orally active thrombin (FIIa) inhibitors into clinical trials. Tom’s work at TCRS contributed significantly to the success of the company. Tom received his M.S. degree in Organic Chemistry from the University of Pittsburgh and is a co-inventor on 37 U.S. and World patents and a co-author in seven peer-reviewed journal publications.

Board of Directors

Nareshkumar Jain, Ph.D. – President, CEO and Chairman

Ronald Gold

Ronald Gold began his generic pharmaceutical career in 1988 as a sales representative for quality companies such as Par Pharmaceuticals, Hi-Tech Pharmacal, Invamed Labs and others. In 1992, he founded Rising Pharmaceuticals as President and CEO, where he quarterbacked all aspects of the business, including sales and marketing, product development, accounting, budgets, government rebates, regulatory and other functions. In 2010, he oversaw the sale of Rising to Aceto Corporation (ACET), continuing as President and COO of Rising for two and a half years before exiting and starting Leading Pharma. He is currently CEO and Chairman of the Board of Leading Pharma.

Steven M. Klosk

Steven Klosk has spent over 25 years in the pharmaceutical CDMO industry. Most recently, Steve was the CEO of Cambrex Corporation for twelve years until he retired in 2020 after leading the sale of Cambrex to Permira, a leading global private equity firm at an enterprise value of $2.5B. Under Steve’s leadership, Cambrex became a leading global, fully integrated supplier of drug substances, drug product and testing services across the entire drug life cycle to both the innovator and generic pharmaceutical markets. Through significant organic investments and M&A Cambrex grew into a network of twelve manufacturing and R&D sites in the USA and Europe with over 2,000 employees. Full year revenues in 2019 were approximately $650M. In addition to serving on the NJ Bio board he is a member of the Board of Directors of Recipharm, a leading European-based pharmaceutical CDMO and Caladrius Biosciences a publicly traded cell therapy drug development biotech company. Steve graduated with a BS degree in Industrial & Labor Relations from Cornell University and a JD from New York Law School.

Chetan Jain

Chetan Jain is the Founder and CEO of Trichem and Chemistry & Health LLP (C&H). Chetan established Trichem in 1998, as a first-generation entrepreneur. Since then, Trichem has evolved as a differentiated sourcing partner for Active Pharmaceutical Ingredients (APIs) and intermediates for global pharmaceutical companies. Trichem is the flagship company in the portfolio, with 35 Principals spanning Europe and Southeast Asia, and a customer base of over 175 companies for US, EU, and other regulated markets. Chetan’s other business interests include Trichem Health Care Pvt. Limited (distribution arm), Trichem Life Sciences Limited (domestic & ROW manufacturing, and marketing of APIs), and Chemistry & Health LLP (C&H; investments in pharmaceutical start-up companies in the US and India). Chetan has studied Commerce at the University of Mumbai.

Anjanish R. Gondalia

Anjanish is Vice President of Operations of Leading Pharma. He began his career in the pharmaceutical industry working as a business development analyst & product planning at Corepharma for finished dosage products. Later Anjanish went on to join Apicore, where he focused on business development and marketing for APIs for the US & ROW market.

Prior to Leading, Anjanish was Director of Operations at Terrene Pharmaceutical & Director of Operation at a pharmaceutical manufacturing start-up, Kalintis Healthcare. His experience working in formulations and APIs provides a unique and advantageous insight to the pharmaceutical industry.

Anjanish is a Member of the Board of Directors of NJ Biopharmaceuticals LLC d/b/a NJ Bio. In addition, he is also Managing Director & member of Board of Directors for Kalintis Healthcare, an Active Pharmaceutical Ingredient manufacturer focused on the R&D, pilot and commercial development of high-value APIs and Intermediates.

Priya Nayak, Ph.D.

Priyashri (Priya) Nayak is Director of Alliance Management at NJ Bio and Vice-President of Business Development & Alliance Management at NJ Bio’s affiliate, Amar Chemistry Pvt. Ltd in India. Priya is an angel investor with Robin Hood Ventures and has supported investment in family-owned entrepreneurship companies and sports clubs. Priya has 23 years of broad experience in global consumer healthcare companies including Glaxo SmithKline, Pfizer, Johnson & Johnson, Bayer, and Prestige Labs, as well as with a start-up company, The Chemistry Research Solution (acquired by Abzena). She has led technical teams that successfully developed and commercialized global products for brands such as Aleve PM®, Bayer® Aspirin®, Aspirin® plus C, Alka-Seltzer®, Benadryl®, Sudafed® Listerine®, Bengay®, Tums®, and Citrucel®, contributing to over a billion dollars in sales. Priya received her Ph.D. in Industrial Pharmacy from the Massachusetts College of Pharmacy & Allied Health Sciences, Boston, and a Masters in Pharmaceutical Sciences from University Department of Chemical Technology (now ICT), Mumbai.

Scientific Advisory Board

Ravi Chari, Ph.D.

Ravi Chari has over 30 years of experience in the field of Antibody-Drug Conjugates (ADCs). Following a postdoctoral fellowship at Yale Medical School, he joined the Dana-Farber Cancer Institute/Harvard Medical School in 1986 as a research scientist, where he initiated work on the targeted delivery of cytotoxic drugs to tumor cells. Subsequently he joined ImmunoGen, where he rose to the position of Vice President – Chemistry & Biochemistry. His group designed potent cytotoxic compounds for ADCs, including the maytansinoid class used in the FDA-approved ADC Kadcyla®. His group also developed the IGN and Camptothecin payload classes, and novel linkers for ADCs. Ravi was involved in several aspects of ADC development, including biological evaluation, and scale up and manufacture of payloads and linkers. Ravi is an inventor on 95 issued US patents, including the composition of matter patent for Kadcyla®, and an author on more than 60 peer-reviewed publications. He was appointed a Fellow of the American Institute for Medical and Biological Engineering (AIMBE) in 2016.

Rakesh Dixit, Ph.D., DABT

Rakesh Dixit is an accomplished executive, inventor, and scientist with over 30 years of success with top biotechnology and pharmaceutical companies including Merck, Johnson & Johnson, and Medimmune – AstraZeneca. Rakesh was selected by his biopharmaceutical peers as the 100 Most Inspiring People in the Pharmaceutical Industry by PharmaVOICE in 2015. From 2006 to 2019, Rakesh was a Global Vice President of the Biologics R&D at Medimmune – AstraZeneca, where he was a pivotal contributor to the approval of Imfinzi (anti-PD-L1 mAb) for the treatment of lung and bladder cancer, Fasenra (anti-IL-5R afucsolytated mAb) for asthma, brodalumab (anti-IL-17) in collaboration with Amgen for psoriasis and moxetumomab (anti-CD22-PEA immunotoxin) for hairy cell leukemia. His areas of expertise include discovery, early and late preclinical development, safety assessment, DMPK and translational sciences of small molecule drugs, biologics, cell and gene therapy products. Rakesh is a key opinion leader in the ADC world and recently received World ADC’s highly prestigious award for “Long Standing Contributions to the ADCs”.

Jagath Reddy Junutula, Ph.D.

Dr. Junutula is the Senior Vice President, Research & Development at ModMab Therapeutics, Inc. He has over 15 years of experience in oncology drug discovery and more than 25 years of experience in the life science research as a biochemist/molecular cell biologist. Dr. Junutula supervised and trained researchers in the antibody based discovery projects. He developed a novel THIOMAB technology platform to obtain engineered Antibody Drug Conjugates with defined number of drugs to improve therapeutic utility. Dr. Junutula contributed and collaborated with several cross-functional teams in discovery research, pre-clinical research and manufacturing to move antibody based therapeutic molecules from discovery to IND, authored over 100 patents/peer-reviewed publications, and presented work at numerous international conferences. His specialties include Target Discovery in Oncology, Antibody Discovery and Development, ADCs and Bi-specific antibodies.

Zhihua Sui, Ph.D.

Zhihua is an experienced drug hunter and a leader in drug discovery in both big pharma and biotech. He is VP, Head of Chemistry and Head of Strategic Outsourcing at Agios Pharmaceuticals in Cambridge, MA. Before joining Agios, Zhihua spent a couple decades at Janssen Pharmaceutical R&D of Johnson & Johnson, rose through the scientific and management ranks to Sr. Scientific Director/Janssen Fellow and led various medicinal chemistry teams as well as platform chemistry. Over the years, Zhihua’s teams advanced more than 20 compounds into clinical stage for treatment of cancer, rare genetic diseases, reproductive disorders (men’s and women’s health), inflammation and diabetes. Zhihua has extensive experience in drug discovery platforms such as SBDD, FBDD and mechanism-based designs and protein degradation. Zhihua is a co-author or co-inventor on more than 300 publications in peer-reviewed journals, invited lectures and patents. Zhihua is experienced in diligence of external assets and in outsourcing management. Zhihua did postdoctoral research at UCSF, received Ph.D. from Heidelberg University in Germany and MS/BS in China.