Arkady Rubin, Phd

Arkady Rubin, Phd Email and Phone Number

Researcher, Innovator, Entrepreneur, Executive @ ARSTAT Pharmaceuticals Inc.
28 Colts Lane, Flemington,New Jersey 08822,United States
Arkady Rubin, Phd's Location
Flemington, New Jersey, United States, United States
Arkady Rubin, Phd's Contact Details

Arkady Rubin, Phd work email

Arkady Rubin, Phd personal email

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About Arkady Rubin, Phd

A PhD-level researcher with 30+ years of pharma industry experience, mostly in women’s health (some of my publications are listed below). In the past, I evaluated clinical data to justify the development of Ortho Tri-Cyclen Lo® and was a co-inventor of this top-selling oral contraceptive in the US. Tri-Cyclen Lo’s prescriptions share of 9% is translated into $1.8B/year in today’s market. I am the Founder, President, and Chief Scientific Officer of ARSTAT Pharmaceuticals. The specialty pharma company focuses on significant unmet needs in women’s health: contraception for women with high BMI, treatment of uterine fibroids and endometriosis, and control of painful and heavy menstrual periods. The pipeline includes four drug candidates with proven efficacy and safety, protected by fourteen U.S. patents and a European (EPO) patent. Two products are Phase III-ready (confirmed by the FDA), and two other products are ready for Phase IIb. An addressable U.S. market is approximately 50 million women, with projected peak U.S. gross sales exceeding $3.4 billion. This is arguably one of the best pharmaceutical portfolios in women’s health.Recent Roe v. Wade development makes the need for highly effective birth control more urgent than ever. ARSTAT Pharmaceuticals addresses this public health priority by developing, for the first time, an oral contraceptive for women with above-normal weight.Thirty million U.S. women search for birth control, and 20 million of these women are overweight or with obesity. By far the most popular method, oral contraceptives do not work well in this population due to poor efficacy and troublesome side effects. The company’s lead product - Nuvocept – will return the pill to these women as a trusted and safe option, greatly reducing the number of unwanted pregnancies, some of which result in abortions.The FDA has recognized the large unmet contraceptive need, accepted Nuvocept efficacy and safety projections, confirmed its Phase III-ready status, and endorsed a pathway to an unprecedented label for women with high BMI. Protected by six granted U.S. patents and an E.U. patent, Nuvocept is < $20M and 3.5 years away from FDA approval. Top experts consider Nuvocept a >$2B/year U.S. opportunity. Significant ex-US (particularly E.U.) sales are also expected. The company is raising money ahead of an appealing IPO. I am reaching out to investors, strategic partners, potential executives, and advisors. To learn more, please visit www.arstatinfo.com My contact information: email: arubin@arstatinc.com, cell phone: (347)385-0878.

Arkady Rubin, Phd's Current Company Details
ARSTAT Pharmaceuticals Inc.

Arstat Pharmaceuticals Inc.

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Researcher, Innovator, Entrepreneur, Executive
28 Colts Lane, Flemington,New Jersey 08822,United States
Website:
arstatinfo.com
Employees:
5
Arkady Rubin, Phd Work Experience Details
  • Arstat Pharmaceuticals Inc.
    Founder, President, Chief Scientific Officer
    Arstat Pharmaceuticals Inc. Mar 2021 - Present
    ARSTAT Pharmaceuticals is advancing a world-class portfolio that focuses on major areas of unmet medical needs in women’s health: contraception for overweight and obese women, uterine fibroids and endometriosis, and painful and heavy menstrual periods. Recent Roe v. Wade development makes the need for highly effective birth control more urgent than ever. ARSTAT Pharmaceuticals addresses this public health priority by developing, for the first time, an oral contraceptive for women with above-normal weight. Phase III-ready Nuvocept is designed to address a high unmet contraceptive need and a public health priority. Please visit www.arstatinfo.com for additional details.
  • Pharmaceutical Company Clients
    Clinical Research And Biostatistical Consulting (Pharmaceutical Industry)
    Pharmaceutical Company Clients Oct 2007 - Present
    - Comprehensive biometric, clinical, and regulatory support for drug development programs, including planned and exploratory data analyses, interactions with the FDA, preparation of protocols, statistical analysis plans, and study reports for Phase I – Phase IV studies, - Evaluation and management of CROs providing research data services (biostatistics, SAS programming, and data management).
  • Advanced Biomedical Research (Abr)
    Director, Biostatistics
    Advanced Biomedical Research (Abr) Jul 2007 - Apr 2008
    Us
    Coordination and management of all statistical and SAS programming activities, including supervisory responsibilities, business planning and biometric support for the analysis and reporting of clinical studies
  • Novadel Pharma Inc.
    Executive Director, Biostatistics And Clinical Operations
    Novadel Pharma Inc. 2003 - 2007
    - Responsible for the design and execution of multiple clinical studies. Coordinated all clinical, data management, SAS programming, and statistical activities.- Significant contribution to the company’s INDs, NDAs, and successful meetings with the FDA.
  • Pfizer
    Associate Director
    Pfizer Jun 1998 - Jul 2003
    New York, New York, Us
    - As a global biometric team leader, was responsible for the statistical, data management, and SAS programming support for Zoloft® (the best-selling antidepressant in the US) clinical programs and submission of NDAs, including pediatric depression, PMDD, social phobia, panic disorder, OCD and PTSD.- As a global biometric team leader, responsible for the statistical, data management, and SAS programming support for the Caduet® clinical programs. Caduet is the first drug targeting two major cardiovascular risk factors – hypertension and dyslipidemia.
  • Johnson & Johnson
    Biostatistician/Senior Biostatistician/Principal Biostatistician
    Johnson & Johnson Mar 1991 - Jun 1998
    New Brunswick, Nj, Us
    - As a lead statistician and member of the global product teams, responsible for the biometric support of the clinical programs in therapeutic areas of fertility control and anti-infectives.- Designed large-scale (6,300 subjects) Phase III program. An innovative study design substantially reduced the time of the NDA filing.- Designed global (15 countries), Phase III fertility control program for another innovative contraceptive. Defended statistical aspects of the program in front of the FDA and European regulatory authorities.- Collaborated with the marketing group by offering numerous ad-hoc analyses. These analyses contributed to the continuous leadership of the J&J contraceptive franchise in the US marketplace.- Major contribution to the Levaquin® (quinolone with a broad spectrum of antibacterial activity) clinical program. Responsible for the community-acquired pneumonia program - the most challenging and important indication and a crucial part of the NDA.

Arkady Rubin, Phd Skills

Pharmaceutical Industry Clinical Trials Clinical Development Clinical Research Fda Protocol Sas Programming Women's Health U.s. Food And Drug Administration Business Strategy Molecular Biology Clinical Data Management Biotechnology Pk/pd Studies Uterine Bleeding Genetics Science Oncology Life Sciences Cro Pharmaceutics Gcp Drug Development Management Phase Ii Iv Studies Quality Of Life Studies Non Oral Drug Delivery Protocol Development Analysis Plans Inds And Ndas Publication Development Fertility Control Acute And Chronic Pain Psychiatric Disorders Cardiovascular Studies

Arkady Rubin, Phd Education Details

  • Institute Of National Economy, Rostov, Russia
    Institute Of National Economy, Rostov, Russia
    Statistics
  • Institute Of National Economy, Odessa, Ukraine
    Institute Of National Economy, Odessa, Ukraine
    Economics

Frequently Asked Questions about Arkady Rubin, Phd

What company does Arkady Rubin, Phd work for?

Arkady Rubin, Phd works for Arstat Pharmaceuticals Inc.

What is Arkady Rubin, Phd's role at the current company?

Arkady Rubin, Phd's current role is Researcher, Innovator, Entrepreneur, Executive.

What is Arkady Rubin, Phd's email address?

Arkady Rubin, Phd's email address is ar****@****inc.com

What schools did Arkady Rubin, Phd attend?

Arkady Rubin, Phd attended Institute Of National Economy, Rostov, Russia, Institute Of National Economy, Odessa, Ukraine.

What skills is Arkady Rubin, Phd known for?

Arkady Rubin, Phd has skills like Pharmaceutical Industry, Clinical Trials, Clinical Development, Clinical Research, Fda, Protocol, Sas Programming, Women's Health, U.s. Food And Drug Administration, Business Strategy, Molecular Biology, Clinical Data Management.

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