Team2024-05-28T13:59:14-04:00

Team

SubheadEXECUTIVE LEADERSHIP
GERALD W. BRUCE2023-11-19T08:16:13-05:00

Gerald W. Bruce has spent over 30 years, including 20 years in senior leadership roles, in the Pharmaceutical and Medical Nutrition industry. He started his career at Johnson and Johnson where he was an award-winning sales representative and held leadership positions of increasing responsibility in sales and marketing ending with his role as Group Product Director of Analgesics. He then served as Vice President of Sales at Bristol-Myers Squibb where he led the Cardiovascular and Metabolic sales force responsible for over $1.2 Billion in sales. He later served as Vice President of Managed Markets where he led the team responsible for the development and implementation of the reimbursement strategy for the Bristol-Myers Squibb $7 billion US portfolio. Mr. Bruce went on to become the Senior Vice President of Commercial Operations at NitroMed where he was responsible for building the commercial strategy and led the team responsible for the development and implementation of the commercial plan for the start-up company’s first product for the treatment of Heart Failure. He also spent close to ten years in the Medical Nutrition industry where he was Vice President of Sales for Nutricia North America, Danone Medical Nutrition Division. Mr. Bruce currently serves as Chairman of the Board of Trustees for Lincoln University and serves on the executive committee of the Board for the National Sales Network. He received his bachelor’s degree in Business Administration from Lincoln University and a master’s degree in Leadership from the McDonough School of Business at Georgetown University.

VINAY SHAH, MBA, ACA2023-06-22T21:35:14-04:00

Chief Financial Officer

Mr. Shah brings more than 20 years of financial leadership experience in the medical device and biopharmaceutical industries to our company. Prior to joining our Company, Mr. Shah served as the Chief Financial Officer of Aravive, Inc (Nasdaq: ARAV) since 2018 and as the Chief Financial Officer of Aravive Biologics, Inc. since 2010, initially as a consultant and from 2017 as an employee. Aravive Biologics merged into Aravive, Inc. in October, 2018.  Prior to joining Aravive Biologics as an employee, Mr. Shah served in various financial positions of increasing responsibilities at Pacira Pharmaceuticals Inc., a specialty pharmaceutical company. Before Pacira, he worked for Cardinal Health’s medical device group in various finance management positions. The group was subsequently spun off as CareFusion and then sold to Becton, Dickinson and Company. His prior work experience includes positions at PwC and KPMG in India and the Middle East.

Mr. Shah received a Bachelor of Commerce degree from Ranchi University in India.  He is a Chartered Accountant from the Institute of Chartered Accountants in India and has an MBA from W.P. Carey School of Business at Arizona State University.

SHEILA A. MATHIAS, PhD, JD, MBA2023-01-25T18:53:15-05:00
Mathias headshot

Chief Scientific Officer

Dr. Sheila A. Mathias has more than 20 years of leadership experience in the pharmaceutical  industry accelerating drug development. She brings extensive global regulatory affairs strategic guidance and clinical development experience having worked across a range of  therapeutic areas, including pain management, addiction medicine, and dermatology. This experience has spanned across big pharma, mid-sized, to start-up biotechnology companies. Most recently, she held the position Senior Director Global Regulatory Affairs at Sun Pharma Advanced Research Company. Sheila has held increasing roles of responsibilities, entering the pharmaceutical industry at Merck US Human Health in the position of Medical Science Liaison. Dr. Mathias transitioned into Regulatory Affairs at Aventis Pharmaceuticals and has successfully  brought multiple products through regulatory approval.  Dr. Mathias received a B.S in Zoology from Howard University, a PhD in Neurophysiology from Meharry Medical College, an executive  MBA from Saint Joseph’s University, and  a JD from Northwestern California University School of Law.  Since 2018 she has served on the Advisory Board for Tennessee State University Department of Biology.

SubheadBOARD MEMBERS
ERIC FLOYD, MS, MBA, PhD2024-05-27T21:40:23-04:00

Dr. Floyd is Senior Vice President of Regulatory Affairs and Quality Assurance at Silence Therapeutics.  Eric has 26 years of pharmaceutical and biotechnology experience in Regulatory Affairs roles of increasing responsibility at Merck, Aventis, Novartis, Lundbeck, Axovant Sciences, and Neurogene Inc. Dr. Floyd has a passion for addressing the unmet medical needs of patients with few to no therapeutic options. Most recently, he served as Chief Regulatory Officer at Neurogene Inc. Neurogene is focused on developing life-changing genetic medicines for patients and their families affected by rare, devastating neurological diseases. Eric previously served as the Global Head of Regulatory Affairs at Axovant Sciences and the US Head of Regulatory Affairs at Lundbeck, where he was responsible for strategic regulatory and clinical development activities related to the company’s approvals of Sabril, Onfi, Northera (orphan approvals) as well as Anti-Depression and Schizophrenia drug approvals. Eric is the principal and CEO of Floyd Regulatory Strategic Consulting Group, LLC. Dr. Floyd serves as an adjunct faculty member in the Department of Neuroscience at Harvard Medical School and Wake Forest University School of Medicine. He serves as a board member to Virpax Pharmaceuticals, Advent Therapeutics Inc., and is also a member of the Board of Trustees of Meharry Medical College. Dr. Floyd completed his undergraduate degree in Biology from the University of Illinois, a Master’s degree in Neuroscience from Tennessee State University, a Doctorate in Neurophysiology from Meharry Medical College, an Executive MBA in Pharmaceutical Marketing from Saint Josephs’ University, and completed the Global Executive MBA in International Business from the INSEAD Business School in Fontainebleau, France. In his spare time, he enjoys mentoring high school and college students and community service projects of Alpha Phi Alpha Fraternity, Inc.

GERALD W. BRUCE2023-11-19T08:16:13-05:00

Gerald W. Bruce has spent over 30 years, including 20 years in senior leadership roles, in the Pharmaceutical and Medical Nutrition industry. He started his career at Johnson and Johnson where he was an award-winning sales representative and held leadership positions of increasing responsibility in sales and marketing ending with his role as Group Product Director of Analgesics. He then served as Vice President of Sales at Bristol-Myers Squibb where he led the Cardiovascular and Metabolic sales force responsible for over $1.2 Billion in sales. He later served as Vice President of Managed Markets where he led the team responsible for the development and implementation of the reimbursement strategy for the Bristol-Myers Squibb $7 billion US portfolio. Mr. Bruce went on to become the Senior Vice President of Commercial Operations at NitroMed where he was responsible for building the commercial strategy and led the team responsible for the development and implementation of the commercial plan for the start-up company’s first product for the treatment of Heart Failure. He also spent close to ten years in the Medical Nutrition industry where he was Vice President of Sales for Nutricia North America, Danone Medical Nutrition Division. Mr. Bruce currently serves as Chairman of the Board of Trustees for Lincoln University and serves on the executive committee of the Board for the National Sales Network. He received his bachelor’s degree in Business Administration from Lincoln University and a master’s degree in Leadership from the McDonough School of Business at Georgetown University.

JEFFREY GUDIN, MD2024-04-23T16:47:50-04:00

Director

Jeffrey Gudin completed both an anesthesiology residency and pain management fellowship at Yale University School of Medicine, and has been active in the pain management space as a clinician, consultant and researcher for more than 25 years. He is  Board Certified in Pain Medicine, Anesthesiology, Addiction Medicine and Hospice and Palliative Medicine. Dr. Gudin is on faculty at the University of Miami Miller School of Medicine in the Department of Anesthesiology, Perioperative Medicine and Pain Management. He has assisted in the development and marketing of numerous analgesics, and is currently principal investigator on an analgesic project awarded a grant through the National Center for Advancement of Translational Sciences at the NIH. He has presented at numerous national and international pain congresses, and has dedicated his career towards risk management and the development of safer, more effective pain medications.

JERROLD SENDROW, CFP2023-01-25T18:52:48-05:00
Jerry Sendrow headshot

Mr. Jerrold Sendrow has been a Certified Financial Planner since 1986, and maintains an active practice. Mr. Sendrow also served as an outside Director on the Board of Directors of SCILEX Pharmaceuticals Inc. from 2014 to 2016. In addition, up through 2014, Mr. Sendrow has more than 35 years of experience as Chief Financial Officer and Director in companies with revenues in excess of $500 million. Jerry has led these companies through start-up, survival, turnaround and growth modes. Prior to that, Mr. Sendrow was an accountant in the audit departments of Touche Ross & Co. and Peat Marwick Mitchell & Co after returning from military service of two tours in the Vietnam conflict. Mr. Sendrow holds business degrees from Bernard Baruch College of the City University of New York and Adelphi University.

THANI JAMBULINGAM, PhD2023-04-13T13:04:36-04:00
Thani Jambulingam headshot

Dr. Thani Jambulingam is a Pfizer Fellow and Professor in the Department of Pharmaceutical and Healthcare Marketing at St Joseph’s University, Erivan K. Haub School of Business, in Philadelphia, Pennsylvania, USA. He teaches in the executive MBA program for biopharmaceutical, medical device and physician executives. Dr. Jambulingam served as the chair of the department for 8 years. He is trained at Harvard in case method for teaching. Dr. Jambulingam’s research interests are in pharmaceutical and healthcare strategy, and innovation and published in marketing and management journals. Dr. Jambulingam has also served as a consultant and facilitated training sessions in innovation and strategy for senior leadership and/or brand teams within several small, mid and large pharma and healthcare firms including Alkermes, Abbott, Astra Zeneca, Inspira Health, Lancaster General, Merck, Novo Nordisk, Pfizer, and Procter & Gamble. During his sabbatical, he joined Pfizer with the Prevenar Global Commercial Team contributing to development of global Prevenar franchise positioning, healthy aging platform development, vaccine business strategy for emerging markets, pediatric expanded age strategy (life cycle management) and conducted strategy session for executive leadership within the specialty care division of Pfizer. Dr. Jambulingam is the national co-chair at the Biotechnology Industry Organization’s Bio-entrepreneurship Bootcamp. Dr. Jambulingam is a pharmacist and obtained his Ph.D. from University of Wisconsin-Madison. In 2022 he received the Tangelmann Award for commitment to excellence in teaching and outstanding contribution to scholarship. Dr. Jambulingam is a member of the Pharmaceutical Executive’s Editorial Advisory Board.

VANILA M. SINGH, MD, MACM2023-03-30T14:06:13-04:00

Director

Dr. Singh is the former Chief Medical Officer in the Federal US Department of Health and Human Services (HHS) in the senior executive services as a presidential appointee. She served as the Acting Regional Health Administrator for the western US Region 9. She served on various committees throughout the federal government and was the Chairperson of the Congressionally mandated CARA (Comprehensive Addiction and Recovery Act) HHS Pain and Opioid Task Force with the Department of Defense and the Veterans Administration. Dr. Singh is a clinical associate professor of Anesthesiology, Pain and Peri-operative Medicine at Stanford School of Medicine where she practices US guided nerve blocks, cares for complex chronic painful disease, is a teaching mentor for residents and fellows at Stanford, and is serving as a mentor at Walter Reed National Military Medical Center. She served in medical ethics as well as on scientific editorial boards, committees for the advocacy in various organizations including the California Medical Association, and the Santa Clara County Medical Association. Dr. Singh, who is double board-certified in pain and anesthesiology, focuses her practice on regional anesthesia and peri-operative, subacute, and chronic pain, with an appreciation for integrative health and traditional medicine approaches that emphasize an individualized patient-centered approach. She completed a masters in academic medicine as part of her professional development to further enhance leadership skills, educational curriculum development, and interdisciplinary work. Dr. Singh is the recipient of several awards in women’s leadership, the American Society of Interventional Pain Physicians Lifetime Award, American Academy of Pain Medicine Presidential Award, Standiford Helm Award of service, and others. She frequently speaks on local and national media on the illicit fentanyl crisis, Covid and other health topics. She serves on the boards of non-profits and corporate entities. Dr. Singh received her medical degree from George Washington University Medical School and her B.A. from U.C. Berkeley in Cell Biology/Economics.

MICHAEL F. DUBIN, CPA2023-03-29T16:07:19-04:00

Director

Michael Dubin is an accomplished senior executive, Certified Public Accountant, independent consultant, advisor, and thought leader with 40 years of experience and success in manufacturing, distribution, financial services, banking, business and professional services, pharma, technology, retail and various other industries. His areas of expertise and experience also include leading executive teams, executive leadership training, operations management, profit optimization, board governance, financial reporting, and other financial management matters. Previously, Mr. Dubin held the title of Managing Partner, PA/SNJ Offices, with RSMUS LLP (RSM), a $3.8B professional services company with over 13,000 employees. He was presented with RSM’s “National Achievement Award” in 2010 and was a finalist for the company’s “National Integrity Award.” Mr. Dubin obtained a BS in Economics (magna cum laude) from the Wharton School of Business, University of Pennsylvania. He served as a Board Member for RSM for four years, is also a board member for a privately held manufacturing business in the Philadelphia metro area, and a board member and the Risk Management Committee Chairman for a commercial bank in Pennsylvania. Mr. Dubin is professionally affiliated with the PICPA and AICPA. He was also an adjunct faculty member and course teacher for the Wharton School of Business for two years and has been a guest lecturer at the Wharton School-University of Pennsylvania, Temple University, University of Scranton, and Lehigh University. He also served as an expert witness/consultant for the Federal Deposit Insurance Corporation (FDIC) and the Resolution Trust Corporation (RTC).

BARBARA A. RUSKIN, PhD, JD2023-11-19T18:59:03-05:00

Director

Dr. Ruskin, who received her Ph.D. in Biochemistry & Molecular Biology from Harvard University, is an experienced attorney specializing in life sciences and intellectual property. Most recently she serves as the Chief Intellectual Property and Innovation Officer for Silence Therapeutics, a Nasdaq listed international biotechnology company. Prior to that role, she was the Company’s General Counsel and Chief Patent Officer. Dr. Ruskin brings over 25 years of experience in life science IP and corporate law, having served as outside counsel for pharmaceutical and biotechnology companies and their investors, including as an IP Corporate Partner at Ropes & Gray LLP and as an associate at Fish & Neave LLP, both in New York City. She has advised, managed and prosecuted worldwide patent portfolios for a number of biotech and pharmaceutical industry clients including Biogen, Stryker Biotech and Vertex Pharmaceuticals among others, and has also worked in IP litigation in both the U.S. and Europe. Dr. Ruskin previously served as Chairman and currently serves as a director on the Board of St. Jude Children’s Hospital GMP, LLC and has previously served as a director on the Board of the Burke Neurological Institute. Dr. Ruskin did her post-doctoral research at the Whitehead Institute for Biomedical Research (MIT) and at the Institute for Neuroscience (University of Oregon). She has published numerous scientific articles and given legal presentations that combine her knowledge of biochemistry and law. In addition to her Ph.D. in Biochemistry & Molecular Biology, Dr. Ruskin received a B.A. in Biochemistry from the University of California, Berkeley, and her J.D. from Fordham University School of Law.

SubheadADVISORS
EMERITUS YECHEZKEL (CHEZY) BARENHOLZ2023-05-11T15:37:58-04:00

Probudur™

Professor of Biochemistry and the head of the Liposome and Membrane Research Lab at the Hebrew University-Hadassah Medical School of Jerusalem at Hebrew University of Jerusalem. He was a visiting professor in many universities world-wide (US, UK, Japan, China, Italy, Denmark). He is on the Editorial Boards of few scientific journals. Professor Barenholz is coauthor in more than 435 publications (cited >39,000 times, h-index >98). He is in the world top 5000 scientists (among almost 1 million scientists world-wide) according to Stanford evaluation. Barenholz is a co-inventor of more than 55 allowed patents, (>50% were licensed). He is one of the key inventors of Doxil®, the first FDA approved nano-drug (November 1995), currently marketed by Baxter for a cancer treatment. On October 2021 FDA approved a generic Doxil developed by Barenholz and Ayana Pharma LTD, one of the six start-ups co-founded by Barenholz. Professor Barenholz was awarded many national and international prizes, the last one is the Israel Prime minister 2020 EMET prize in The Exact Sciences (Nanotechnology). He is married to Dr. Hanna Barenholz, together they have 4 daughters and 12 grandchildren.

IJEOMA UCHEGBU, PhD2023-09-18T11:17:10-04:00

MET • Envelta™ • NobrXiol™

Dr. Uchegbu is a multi-award winning nanotechnology scientist and Fellow of the Academy of Medical Sciences. She is the founding Chief Scientific Officer (CSO) of Nanomerics. In addition, Dr. Uchegbu holds a chair in Pharmaceutical Nanosciences at University College London. She has received a number of awards, notably the UK’s Women of Outstanding Achievement Award (2007) in Science Engineering and Technology.

PARDEEP K. GUPTA, PhD2023-05-11T15:40:38-04:00

Liposomal and Nanotechnology Delivery Platforms
Probudur™ · Envelta™ · NobrXiol™

Pardeep Gupta, Ph.D., currently serves as Professor, Burroughs Wellcome Chair, Director Industrial Pharmacy Laboratory at St. Joseph’s University. He has spent nearly 33 years teaching undergraduate and graduate courses in controlled drug delivery systems, pharmaceutical solutions, drug stability, drug diffusion and pharmaceutical rate processes. Before that, he received his doctorate degree in pharmaceutics from the University of Wisconsin-Madison.

For the past 20 years, Dr. Gupta has focused his academic research on delivery of proteins and poorly soluble drugs. Current projects in his laboratory are in the area of nanoparticle based protein delivery systems, use of amphiphilic peptides as stabilizers of nanosuspensions, and design of peptide drugs. He has served on editorial board of Remington-The Science and Practice of Pharmacy and also authored several chapters in Remington and other reference books.

Dr. Gupta is a member of several professional organizations, including the American Association for the Advancement of Science, American Chemical Society and the American Association of Pharmaceutical Scientists.

NEIL SINGLA, MD2023-05-11T15:41:01-04:00

Probudur™

Dr. Neil Singla, a board-certified anesthesiologist, is the founder and Chief Scientific Officer of Lotus Clinical Research. Since its inception in 2001, Dr. Singla has served in several roles within the organization including: Research Coordinator, Sub-Investigator, Principal Investigator, Coordinating Investigator, and Chief Scientific Officer.

Dr. Singla has published extensively and is a frequent lecturer for physicians, pharmaceutical companies, and medical research institutes throughout the country. He currently chairs the Analgesic Clinical Trials Shared/Special Interest Group at the International Association for the Study of Pain (IASP), chaired the Clinical Trials Shared Interest Group at the American Pain Society (APS) through 2019, chairs the annual Conference on Analgesic Clinical Trials, which aims to help experts advance best practices in analgesic drug development, as well as, serving on the Clinical Research Committee at Huntington Hospital.

The main focus of Dr. Singla’s academic endeavors has been to analyze and understand how the inherent variability in subjective endpoint analgesic clinical trials can be minimized. As a result, he has developed novel techniques for patient education designed to minimize variability, reduce placebo response, and increase effect size.

KENNETH SOMMERVILLE, MD2023-05-11T15:41:11-04:00

Neurologist & Epileptologist
NobrXiol™

Dr. Sommerville is a board-certified neurologist and was in private practice in Lebanon, Pennsylvania 1980-1991. He was in charge of the EEG lab and was a consultant to a local psychiatric hospital and held a clinical position at the Hersey Medical Center. He joined the pharmaceutical industry in 1991 and since that time has been in Clinical Research for drugs in epilepsy, pain (abuse-deterrent opioids), and movement disorders including Parkinson Disease and Restless Leg Syndrome. He also contributed to research on a drug for prostatic hypertrophy. He has been the Medical Director or Vice-President for over one dozen NDA filings that have achieved approval. He has also been in charge of the clinical data for several drugs for epilepsy including vigabatrin, tiagabine, divalproex, intravenous valproate, lacosamide, diazepam injection, and most recently cannabidiol which received approval after a rapid clinical program of just four years. He has been in charge of clinical data for successful submissions in Parkinson Disease (rotigotine patch) and abuse-deterrent opioids (morphine and oxycodone formulations). He worked for a number of companies including Abbott, Schwarz, UCB, Marion Merrill Dow, King, Pfizer, and lastly Greenwich Biosciences (GW Pharma). He retired in 2018 after the submission of cannabidiol for Lennox-Gastaut and Dravet Syndrome. He has extensive experience in epilepsy and development of other CNS drugs.

LAWRENCE FRIED, MD2023-05-11T15:41:19-04:00

Pediatric Neurologist & Epileptologist
NobrXiol™

Dr. Lawrence Fried’s research focuses on telemedicine, family engagement, transition of care, and increased coordination with primary care for pediatric epilepsy patients. He is also interested in healthcare disparities, especially as it pertains to telemedicine. He received his medical degree from Drexel University College of Medicine.

He currently serves as an Attending Physician in the Pediatric Regional Epilepsy Program at the Children’s Hospital of Philadelphia, as well as an Assistant Professor of Clinical Neurology at the University of Pennsylvania and is a Corporate Advisory Committee member of the American Epilepsy Society. Following medical school, he completed five years in residency positions in pediatrics and pediatric neurology, followed by a fellowship in epilepsy and pediatric neurology and has published extensively in those fields.

G. KENNETH SMITH, JD, PhD2023-03-06T15:11:56-05:00

IP Portfolio

Dr. Smith previously held the positions of Chief Intellectual Property Counsel for Alpharma, Inc. and before that Head of North American Intellectual Property for Sanofi Aventis. In both positions, Dr. Smith had global responsibility for all intellectual property issues related to multiple business units involved with various technologies including branded products, animal health products, active pharmaceutical ingredients, generic drugs, and vaccines. Dr. Smith also brings extensive background and knowledge in the area of abuse-deterrent intellectual property. Dr. Smith has a Ph.D. in Biochemistry from the University of Houston, an M.B.A from Lehigh University, and a J.D. from the University of Houston.

Our experienced executive team, board, and advisors have

PROVEN TRACK RECORDS

developing, launching, and marketing numerous FDA approved products

usaisr logo

The U.S. Army Institute of Surgical Research (USAISR)

Virpax entered into a cooperative research and development agreement (CRADA) with the U.S. Army Institute of Surgical Research (USAISR) on May 5, 2022 to evaluate Virpax’s Probudur™, an injectable long-acting liposomal bupivacaine in a formulation that is injected at the wound site. Probudur is being developed to significantly reduce or eliminate the need for opioids after surgery in approved indications. In pre-clinical trials, Probudur has shown pain control for 96 hours. The USAISR is the U.S. Department of Defense’s (DOD) primary laboratory for developing solutions for trauma and critical care challenges in combat casualties.

National Institutes of Health (NIH)/National Center for Advancing Translational Sciences (NCATS)

Virpax advances Envelta™ Development with NCATS Under CRADA Agreement to support the development and manufacturing of Envelta. The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) has awarded research and development contracts to support Good Manufacturing Practices (GMP) production of drug substance and drug product. as well as to support Good Laboratory Practices (GLP) toxicology, safety studies and preclinical efficacy studies to develop Envelta.

Envelta is Virpax’s endogenous enkephalin intranasal spray for Acute pain, including pain associated with cancer. Virpax entered into a Cooperative Research and Development Agreement (CRADA) with NCATS on August of 2020.

National Advisory Neurological Disorders and Stroke Council

Virpax entered into a cooperative research and development agreement (CRADA) with the National Institute of Neurological Disorders and Stroke (NINDS), part of the U.S. National Institutes of Health (NIH) Division of Translational Research which conducts and funds research on brain and nervous system disorders. Virpax will be partnering with the Epilepsy Therapy Screening Program (ETSP) whose mission is to identify novel agents to address unmet medical needs in epilepsy, including the identification of next generation products focused on addressing drug resistant epilepsy, disease prevention and modification. Under the CRADA, NINDS ETSP will evaluate Virpax’s NobrXiol™ product candidate that is being developed for the management of rare pediatric epilepsy. NobrXiol utilizes a unique intranasal Molecular Envelope Technology (MET) delivery platform for pharmaceutical-grade cannabidiol (CBD).

SubheadINTERNSHIPS

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