Management

Randy Milby, MBA

Founder, President and Chief Executive Officer

Before founding Hillstream BioPharma, Randy Milby was chief executive officer of CorMedix, Inc. (NYSE American: CRMD). Prior to CorMedix, Mr. Milby was co-founder and a managing director of WaterStone Bridge, LLC, a healthcare consulting services firm. In his 11-year tenure at DuPont Company and DuPont-Merck Pharmaceuticals, he held several management positions, ultimately, global business director, Applied Biosciences. From 1998 through 1999, Mr. Milby was a Healthcare Analyst at Goldman Sachs & Company. Mr. Milby received his Pharmacy degree at the University of Kansas and his MBA from Washington University, St. Louis.

Surender Kharbanda

Surender Kharbanda, Ph.D.

President, Research and Development

Dr. Kharbanda received his Ph.D. in cell biology from the All India Institute of Medical Sciences [AIIMS], New Delhi. Following his doctorate, he joined the Dana-Farber Cancer Institute, Harvard Medical School as a research fellow and undertook extensive work in the area of oncology drug discovery and development. Shortly thereafter, he was promoted to Assistant Professor at Harvard Medical School where he worked as a faculty member for 15 years.

Dr. Kharbanda is a co-author on more than 180 papers published in peer-reviewed scientific journals and holds more than 20 patents and patent applications in the area of oncology drug discovery. He has served as vice president and head of R&D at Ilex Oncology Inc., an oncology-driven pharmaceutical company where his responsibilities included development of novel drugs for cancer. Dr. Kharbanda was a member of the team which successfully advanced three oncology drug candidates to human clinical trials. Following the acquisition of Ilex Oncology by Genzyme Corporation, Dr. Kharbanda founded several early stage oncology companies including Genus Oncology, Linus Oncology and, most recently, NanoProteagen where the QUATRAMER platform was developed.

Bruce Wallin, M.D.

Chief Medical Officer

Dr. Wallin has developed drugs across multiple therapeutic areas, both small molecules and biologics. He has demonstrated proven technical and management skills in small and large pharmaceutical companies with a track record of innovative success in bringing drugs to market quickly and efficiently. He has proven adept at rapid assessment, streamlined development, creative problem-solving, and focused team leadership, focusing on clinical and pre-clinical drug development, global regulatory submissions (INDs, NDAs, MAAs), FDA Advisory Committee presentations, and organizing multiple boards of Opinion Leaders across a variety of therapeutic areas. His therapeutic areas of expertise include oncology, rheumatoid arthritis, and pain medicine (opioid-induced constipation; mu opioid antagonist; kappa opioid agonist; delta opioid agonist; sterile lidocaine patch). He possesses executive experience in a variety of treatment areas at Morphotek, Neose Technologies, Adolor Corp., Abbott Laboratories, and SmithKline&French.

Grace M. Furman, Ph.D., D.A.B.T.

Head of Toxicology

Grace received her Ph.D. in Biomedical Sciences with a specialization in toxicology from Northeastern University. She also holds a B.S. in toxicology) and is a Diplomate of the American Board of Toxicology. Dr. Furman is an active member of the American College of Toxicology (ACT) and has served ACT as a 2-term Council member, a member of the Nominating Committee, as secretary, and as co-chair and chair of the Education Committee. She is also an active member of the Society of Toxicology and the Southern California Chapter of the Society of Toxicology and has held several Executive Council positions, including president, within the Regional Chapter. Dr. Furman is chair emeritus of the San Diego Biotechnology Discussion Group and a founding member of San Diego's Women in Biosciences. Additionally, she designed and instructed the "Toxicology" classroom and distance-learning courses offered through University of California/San Diego Extension's Drug Discovery and Development and AMDET Process Certificate Programs (2005-2014). She has held leadership roles at Agouron Pharmaceuticals, Pacira, and Pfizer.

Barry Rosenblatt, Ph.D.

CMC & Technical Support

Dr. Rosenblatt is a subject matter expert in the chemistry and manufacturing controls (CMC) of biotherapeutics with a proven 35+ year track record in biotechnology and the pharmaceutical industry. He has developed, transferred and validated purification processes and assays for multiple new molecular entities through all stages of drug development, including licensure and served as CMC Team leader with dotted line reports exceeding 500 individuals. He is currently serving as a consultant to the industry as president/sole proprietor of SME Biotech Consulting. Dr. Rosenblatt previously served as associate director of Process Development for Centocor/JNJ (18 years) and spent eight years as head of Analytics, Process Evaluation, Contract Manufacturing, and Sterile Services at Charles River Laboratories, Malvern, Penn. He is a proven presenter who has served as an instructor and presenter, as well as serving as chairperson for conferences and courses. His academic credentials include a BA in biochemistry from Columbia University (NY) and a Ph.D. in cell biology/immunology/microbiology from the Albert Einstein College of Medicine, Bronx, NY.

Robert Niecestro, Ph.D.

Regulatory Affairs

Robert is a regulatory strategist in the biotechnology and pharmaceutical industries. He has served on the board of directors for the Collaborative Study Group (an academic research group in nephrology based at Vanderbilt University) since 2014 and is on the Advisory Board for Oncolix. Dr. Niecestro also acts as an advisor to ThinkEquity (a private investment bank) in the biopharmaceuticals, medical device and medical equipment/diagnostic areas.  in addition to his work at Hillstream Biopharma, Dr. Niecestro currently serves as a strategic regulatory-development consultant to Altius Pharma, ArunaBio, Auris Medical, Avenue Therapeutics, BioVie, BioXcel, Checkpoint Therapeutics, Citius Pharmaceuticals, Cyprium Therapeutics, Fortress Biotech, Micelle Pharma, Oncolix, and RDD Pharma. 

Dr. Niecestro was a founder and served as the vice president of Clinical and Regulatory Affairs for Axsome Therapeutics as well as founding and serving as the executive vice president of Clinical and Regulatory Affairs for TG Therapeutics.  He has also served in numerous senior management positions in the pharmaceutical industry at Keryx Pharmaceuticals, Andrx Laboratories, Eisai Inc. and Organon Inc. Dr. Niecestro has been involved in the filing of over 60 INDs, the approval of 13 NDAs or BLAs, authored more than 60 peer-reviewed scientific presentations, abstracts and/or publications, and holds 3 patents. Dr. Niecestro completed his graduate and post-graduate work at the University of Illinois at Chicago.

Trinh Le, MBA

Head of Clinical Operations/Program Management

Ms. Le is a clinical professional with over 25 years of broad operational and industry experience across the biotechnology, pharmaceuticals and contract research organization industries. Her expertise ranges from Pre-IND to Phase 1-3 trial set up and execution. She currently serves as a Principal at Collaborative Clinical Research Consulting, Inc. She has held senior level positions at Intellikine (acquired by Takeda), SGX Pharmaceuticals (acquired by Eli Lilly), Metabasis Therapeutics (acquired by Ligand) and Chiltern International. She earned an MBA from University of Redlands and a B.A. with a focus in biology and chemistry from University of California, San Diego.

Hillstream is this Month’s Recipient of BioNJ's Emerging Company in the Spotlight