The Scientific, Regulatory and Medical Dream Team

Movers And Shakers

Ageless Biotech has partnered with a 28person team of PHD’s, research and development professionals and the leader in FDA Investigational New Drug Approval with over 100 IND’s, New Drug Applications and Biologic Applications (BLA’s). The team has decades of FDA regulatory and audit oversight including direct employment with the FDA as a contractor and 7 years with NIH.

 

Our scientific and research team includes  a “Best Manuscript” award winner by the American Heart Association for stem cell research targeting peripheral nerves in cardiac regeneration, former Dartmouth College and Harvard Staff Researcher(s), and Chief Scientific Officers at both well-established research based organizations and regenerative minded medical clinics.

 

Our medical board consists of top peer reviewed, industry thought leader, medical innovators, and surgeon’s 2nd to none.

 

The accomplishments listed below are the most impressive in the industry. Although some company names are listed the CV’s of the board and full patent numbers will only be disclosed after appropriate investor vetting.

 

 

  • More than 18 years as an FDA compliance auditor, regulatory affairs specialist, specializing in clinical and GMP/QSR issues with significant adverse event, non-clinical study and clinical lab experience.

  • More than 100 new-INDs for drug, biologic and combination products, 5 approved NDAs( New Drug Application), 2 BLAs( Biologics License Application), and has made several hundred FDA submissions (Investigators Brochures, Safety reports, CMC sections, Annual Reports, protocols, IND safety reports).

  • Extensive experience in medical device regulatory filings (510k and PMA) and safety monitoring. Filed 3 PMAs for medical devices, 2 PMA amendments, and four 510K applications.

  • Recruited to Harvard University to work with hematopoietic stem cells and immune cell biology 

  • More than 200 clinical trial protocols and management of more than 60 multi-national clinical trials (both under IND/IDE and non-IND trials), in the US, Canada, Europe, Latin America, Africa, and Asia.

  • More than 150 audits for GMP, GCP, GLP, and GCLP compliance in the US and about 30 countries.

  • Conducted hundreds of professional trainings in GMP, GCP, and GLP, and other regulatory and clinical trial issues such as CMC issues and clinical project management.

  • Arranged several FDA meetings for CMC/GMP/QSR, GCP and GLP issues.

  • Trained for several years as a FDA and NIH regulatory, scientific and technology transfer specialist, and in biotech business development.

  • More than 15 years of experience in developing and using software applications for drug lifecycle management, adverse event reporting, and pharmaceutical project management

  • A research scientist prior to regulatory affairs career with more than 11 years of experience in virology, gene therapy, and molecular biology.

  • Well known presenter and author for regulatory, technical and business trainings courses, workshops, and symposia. More than 500 talks, 40+ articles, and numerous workshops and conferences. Author of FDA Puran, a weekly newsletter with about 82,000 subscriptions from readers in more than 56 countries on all continents.

  • Member, Board of Editors, Regulatory Affairs Professionals Society (RAPS), USA.

                       Combined Professional Experience

Brij Strategic Consultations (FDA Consultants), Germantown, MD

 

2014 – Present

Founder and CEO, Global Regulatory Affairs and Quality Assurance

  • Lead compliance audits and training in topics in regulatory affairs and quality assurance.

  • Provide consultation to pharmaceutical, biotech and medical device companies.

  • Strategic project management, regulatory support, manufacturing, vendor management, and clinical trial support.

 

Vivacell Bio, Chicago, IL

2017 – Present

Board Member and Senior Vice-President (Acting), RA and QA

  • Lead IND submissions

  • Lead QA and manufacturing operations

  • Lead interactions with FDA and all submissions to the FDA

 

ResQ Pharma, Chicago, IL

2016 – Present

Director (Acting), RA and QA

  • Lead NDA and IND submissions

  • Lead QA and manufacturing operations

  • Lead interactions with FDA and all submissions to the FDA

  • Sold 2020 $250 million

 

Aurotech Corp, Silver Spring, MD

2015 – 2018

Chief Innovation Officer, Drug Lifecycle Tracking Application (DLTA)

  • Lead creation and management of project management solutions for clinical trials based on FDA’s internal systems

  • Lead promotion and marketing activities for DLTA

 

Amarex Clinical Research, Germantown, MD

2013 – 2016

Senior Vice-President, Regulatory Affairs & Quality Assurance

  • Manage 11 Regulatory Analysts, Auditors, Safety monitors, and Regulatory Assistants.

  • Lead submissions to FDA, EMA, HC and other regulatory bodies regarding Lead development of IND/IDE/MAA-enabling strategies for drugs, biologics and medical devices.

  • Lead submissions to FDA, EMA, HC and other regulatory bodies.

  • Lead meetings with regulators in the US and ROW

  • Supervise clinical trial projects for compliance with FDA and international regulations.

  • Lead Quality Assurance functions including internal and external audits, SOPs, and CAPA.

  • Lead GXP audits for clients and vendors.

  • Lead contractor for US NIH and FDA sponsored development projects

  • Lead corporate business development functions such as bid defense, marketing presentations, brochure development, new product development, and promotional activities.

 

2008 – 2013

Senior Director, Regulatory Affairs & Quality Assurance

  • Manage 6 Regulatory Analysts, Auditors and Regulatory Assitants.

  • Lead submissions to FDA, EMA, HC and other regulatory bodies regarding ongoing and new INDs, NDAs, ANDAs, MAA, IMPD, IDEs, PMAs, 510k, and CE dossiers.

 

  • Review new protocols and informed consent forms from regulatory perspective.

  • Prepare Clinical Study Reports/publications.

  • Supervise clinical trial projects for compliance with FDA and international regulations.

  • Training of internal, client and vendor personnel in regulatory, clinical and quality control processes.

  • Lead Quality Assurance functions including internal and external audits, SOPs, and CAPA.

  • Conduct GXP audits for clients.

  • Create, edit and review of clinical development plan for drugs (pharmaceutical, biological and botanical), and medical devices.

 

2006 -2008

Senior Analyst, Regulatory Affairs

  • Process regulatory documents to be submitted to FDA regarding ongoing and new INDs, NDAs, ANDAs, IDEs, PMAs, and 510k.

  • Review new protocols and informed consent forms from regulatory perspective.

  • Develop and write Investigator brochures, annual reports, CMC sections, pharm-tox reviews, clinical protocols, safety reports and clinical study reports.

  • Supervise clinical trial projects for compliance with FDA and international regulations.

  • Training of internal, client and vendor personnel in regulatory, clinical and quality control processes.

  • Create, edit, and review SOPs.

 

Technical Resources International, Inc. Bethesda, MD (Contractor for NIH and FDA)

2004 – 2006

Regulatory Compliance Specialist

  • Reviewed new protocols and CMC sections of the INDs from regulatory aspect for human clinical trials for HIV/AIDS drug therapies with NIH and FDA.

  • Wrote, reviewed and managed more than 30 new INDs for HIV/AIDS drugs, biologics, vaccines, diagnostic products, and combination therapies.

  • Monitored the day to day maintenance of current AIDS human clinical trial protocols and INDs.

  • Managed several HIV clinical trial-related regulatory documents (INDs, clinical protocols, Annual Reports, CMC reviews, Amendments to INDs, non-IND clinical protocols, FDA- initiated conference calls, IND safety reports, letters of amendment, investigator’s brochures, responses to FDA comments about INDs/clinical protocols, SOPs and guidelines – wrote, reviewed, implemented and quality controlled).

 

Office of Technology Transfer, National Institutes of Health (NIH), Bethesda, MD

2002- 2004

Licensing and Marketing

  • Reviewed technologies developed at NIH, CDC and FDA laboratories for commercialization.

  • Determined the commercial value of research products for licensing fee negotiations.

 

  • Made decision about and reviewed filing of patent applications for research products developed in federal laboratories.

  • Determined the regulatory pathways and development milestones applicable for available technologies

  • Marketing of Federal biological research products to commercial concerns.

  • Ensured advertisement of Federal biological research products in the Federal Register and other venues.

  • Negotiated of the terms and conditions for licensing Federal research products.

 

NICHD, National Institutes of Health, Bethesda, MD

2000- 2004

Research Fellow

  • Research scientist in the field of virology (specialization in HIV and influenza viruses) and gene therapy.

  • Trained and supervised technicians, under-graduate, doctoral and post-doctoral trainees in molecular biology, cell biology, virology, and gene therapy.

  • Wrote manuscripts based on research carried out in the laboratory for publication in peer- reviewed scientific journals.

  • Presented research seminars/posters based on self-conducted research at scientific conferences and meetings.

  • Wrote research proposals and grants.

  • Submitted research products developed in the lab for patent protection.

  • Collaborated with other research scientists and commercial concerns for research.

 

Baylor College of Medicine, Houston, TX

1999 – 2000

Research Associate

  • Researched in the field of gene therapy using HIV-derived gene transfer vectors.

  • Supervised of technician and under-graduate student in molecular biology and gene therapy.

  • Wrote manuscripts based on research carried out in the laboratory for publication in peer- reviewed scientific journals.

  • Presented research seminars/posters based on self-conducted research at scientific conferences and meetings.

 

NICHD, National Institutes of Health, Bethesda, MD

1997 – 1999

Visiting Scientist

  • Researched in the field of virology.

Dept of Biochemistry and Liposome Research Center, Univ. of Delhi, Delhi, India

1993 – 1997

National Research Fellow and PhD Scholar

Patents and Copyrights

  • Process for Producing A Targeted Gene. US Patent #568*8*6, Nov. 4, 1997.

  • A Targeted Drug Delivery Carrier. INDIAN Patent Application No. 2389/Del/95 and A Process for Producing A Targeted Gene or Drug Delivery Carrier. Patent Application No. 2390/Del/95, dt. 21..1—9-5).

  • HIV cDNA vectors. Copyright, BCM Technologies, Inc., Baylor College of Medicine, Houston, TX, OTA # 00*38, *001.

  • Process for large-scale production of HIV-based vectors.

(US patent, Appl. #**/425,8*3; Nov. 2002).

Publications Summary

  • About 50 articles in peer-reviewed scientific and professional journals

  • More than 500 presentations at scientific and professional conferences and other venues.

  • More than 1000 short articles on FDA-related topics at FDA Puran

  • A popular weekly blog in regulatory affairs with more than 125,000 reads per week.