pHase pharma
pHase is a boutique pharma company established to develop new and/or better pharmaceutical therapies.
About Us
pHase was founded by our three principals who have over 100 years of combined experience in drug development and 5 successful FDA approvals. The core of their mission is a commitment to unraveling unique and misidentified therapeutic conditions, paving the way for groundbreaking solutions. With a passion for pushing the boundaries of medical understanding and a relentless focus on efficiency, we strive to develop products that address unmet needs and redefine possibilities in healthcare.
Development focus
P2-101
pHase's current focus is a patented sublingual epinephrine formulation for the treatment of anaphylaxis; a severe, life-threatening allergic reaction.
ANAPHYLAXIS
Anaphylaxis is a severe, potentially life-threatening allergic reaction with a rapid onset from exposure to various triggers, including certain foods, medications, insect venom and latex, causing respiratory distress and circulatory collapse. If not treated immediately, anaphylaxis can result in death. The flood of chemicals released by the immune system during anaphylaxis causes shock: a sudden drop in blood pressure, swelling and a narrowing of the airways that blocks normal breathing. Signs and symptoms of anaphylaxis include a rapid weak pulse, skin rash, tongue swelling, airway restriction, nausea and vomiting.
According to a 2011 study conducted by Epocrates, the “At-Risk” population for anaphylaxis in the U.S. was 28 million, of which only 2 million (7%) carried an EpiPen®. Worse yet, even those who do carry their emergency medication may not live to talk about it.
Until now, there were no solutions to address the barriers to use, clinical inconsistency, inconvenience and instability associated with the use of epinephrine in liquid form delivered through an auto-injector or other painful injectable devices.
Epinephrine and DESI
pHase Pharmaceuticals is developing P2-101, a sub-lingual epinephrine formulation to treat the 28 million+ patients in the US alone dealing with life-threatening anaphylaxis simply by placing a tablet under their tongue. Epinephrine, a hormone, and neurotransmitter, is a compound that stimulates the nervous system. Through this action, epinephrine is the primary compound recommended and prescribed, through various forms of dosage delivery mechanisms, to ameliorate Anaphylaxis. In its history, Epinephrine was classified as effective through the FDA's Drug Efficacy Study Implementation ("DESI") process, which served to classify all known drugs on the market during the 1960s-80s, whether efficacy data had been submitted or not, based purely on safety.
The original Epi-Pen, and all subsequent devices (approved and pending approval), were not required to complete clinical efficacy studies as a condition for approval. They produced bioequivalent blood levels (PK) that the FDA set as the endpoint for basis of approval.
The principals at pHase, while working on a sublingual tablet formulation, were focused on efficacy instead of mere bioequivalence as they were concerned about the underlying mechanism and process of resolving anaphylaxis. While initially filing for a 505(b)(2) and bioequivalence, the principals discovered a novel, neural pathway and underlying mechanism of action. This new science is evident in pHase's studies and shows that pHase's patented sublingual formulation is more effective, safer and achieves better results than other delivery mechanisms. Additionally, in advanced states of anaphylaxis with a marked drop in blood pressure, other delivery mechanisms’ efficacy is called into question by pHase's studies and published literature.
who we are - CEO/cfo
Lynn Howard, B.S. MT (ASCP), M.D. | Chief Executive Officer & Chief Financial Officer
Dr. Howard defines her CEO role as the effective overall management of the business and affairs of pHase based on strategy and policies agreed upon by the Partners. Additionally, she is serving as CFO for the firm. She provides a unique combination of scientific, technical, business, and financial management expertise to the table allowing her to wear many hats in the overall business as well as compound identification and development process. In her off time, she and her husband are high-level Men's Rugby 7's coaches for a Nationally top 10 ranked Rugby Club and a mother of two.
She earned a BS in Medical Technology and Clinical Laboratory Science and an MD focusing on Infectious Disease. Spending 2 years in West Africa studying tropical medicine, she returned to the US in December 1997. The following year she entered the finance world earning a Series 7, 55, 63 and later a series 24. She spent 15 years as equity market maker/ trader, then managing director of institutional and equity trading activities at Spear Leeds & Kellogg, Goldman Sachs, in New York City, then Knight Capital Group in Jersey City, NJ. At Knight Capital Group as Managing Director, she oversaw a staff of 42 traders and 50 assistants in addition to personally generating $18+ million in annual revenues for five straight years. Since January 2006, she has been President of LandSea Ventures, Inc., a subchapter S Corp that provides consulting to virtual, small, and moderately sized pharmaceutical companies in the evaluation and selection of outsourcing vendors related to clinical operations as well as nutraceutical R&D. Since inception, in 2011, she has lead pHase Pharma's accomplishments, from proof of concept and non-clinical animal studies to 4 human trials and the granting of its 2 current patents in the space.
who we are - COO
Chris Howard | Chief Operations Officer
Mr. Howard is responsible for managing the overall day-to-day activities of the organization. Reporting directly to the CEO, he provides leadership and direction for the organization and specifically for the study design and the execution of action plans in all areas of the business, including clinical development and operations (IT, HR, and Legal). This position also oversees all clinical data and implementation of proper protocol and adherence to study design as is outlined by the FDA. It should be noted that due to the intense concentration of resources in the clinical study design, management and implementation, the CEO and COO will offer redundancies to the Chief Research and Safety Officer (“CRSO”) in order to provide internal quality assurance of all clinical data and processes. This includes constant interaction with investigative sites to ensure they are receiving the necessary support required for success and to make sure they are providing all information required of them.
Mr. Howard holds a B.S. degree in Biochemistry, He has over 30 years of experience in global program and project management, strategic outsourcing, clinical study design, and operations in medium and large pharmaceutical companies. from a role as Director of Clinical Operations at Andrx Pharmaceuticals to Global Head of Operations at Esai Pharmaceuticals. His skills and expertise are centered in clinical operations, including outsourced vendor evaluations, selections, contract negotiations, site visit, monitoring, vendor management, drug packaging, and protocol generation and review.
Dr. Farina’s responsibilities include ensuring that the Company follows appropriate licensing, marketing, and legal compliance for pharmaceutical and medical products. This position combines the knowledge of scientific, legal, and business issues to enable products that are developed, manufactured, or distributed to meet required legislation. The CRMO will advise on and coordinate the approval and registration of the chemical entities that the Company engages in. This position acts as the crucial link between the Company, its products, and regulatory authorities, including, but not limited to, the Food and Drug Administration. This position also oversees and determines all formulations, drug packaging, investigator brochure Pre-IND briefing with the CRSO, and decisions regarding drug formulation and manufacturing while working directly with the manufacturing facility and its employees, which includes close supervision throughout the entire manufacturing process.
who we are - Crmo
Nicholas J. Farina, Ph.D. | Chief Regulatory and Manufacturing Officer
Dr. Farina has over 50 years of extensive experience and expertise in both manufacturing and regulatory submissions. He began his career as a senior clinical scientist and was promoted to positions of increasing responsibility, ultimately rising to the position of Vice President of Regulatory Affairs at Andrx Labs (a subsidiary of Andrx Corp) in Hackensack NJ. During his career, he also worked for Warner- Lambert Company, NJ, Schering-Plough Corp, NJ, and Eisai, Inc., NJ. His skills and expertise are centered in the formulation of protocols, evaluating new pharmacological agents for licensing and marketing, managing projects through the FDA approval process, and managing third-party outsourced vendor-manufacturing processes. For the past six years, he has managed his own consulting company, Regulatory Warriors, LLC. Regulatory Warriors provides outsourced regulatory services to pharmaceutical companies.
Dr. Farina received his Ph.D. degree in 1981 and his M.S. degree in 1976, majoring in both degrees in Pharmacology and Toxicology from Temple University in Philadelphia, PA. He also received his B.S. degree from Temple University in 1973, majoring in Pharmacy.