Affinity Bio Partners (ABP) and its affiliates ensure that on a global basis that clinical research is performed safely, ethically, with high-quality so that subjects can benefit from the development of new and novel treatments and therapies. Our partners will find that ABP is dedicated to helping their clients bring efficiency, innovation and value to the clinical research process while staying on budget and pushing timelines ahead as aggressively as possible.
Founded in November 2014, in a transition from Christina DiArcangelo Puller's previous company Armonia Clinical Research (first formed in 2009), ABP represents the world’s leading cutting-edge Clinical Research Organization (CRO). Affinity Bio Partners LLC endeavors to provide integral enterprise-wide solutions that facilitate the development of drugs, biologics, natraceuticals and medical devices. ABP provides services such as, but not limited too:
Groundbreaking Medical Marijuana and Cannabinoid Clinical Research activities
Clinical Research Operations and Product Marketing
Enterprise-wide Strategic Planning Solutions
Enterprise-wide Governance Solutions
Asset Procurement and Staffing Solutions
Advance clinical outsourcing to improve the quality, efficiency and safety of biomedical research.
Conducting clinical trials in domestic and international settings while ensuring the safety of research participants.
Strengthen public understanding and confidence in clinical research, highlighting CRO expertise in all aspects of the clinical research enterprise.
Affinity Bio Partners LLC and Christina DiArcangelo Puller have been leading voices for safe and ethical clinical trials while working with stakeholders globally to promote a better and more efficient clinical trial process. Affinity Bio Partners LLC maintains an unwavering dedication to bringing efficiency, safety, innovation and value to the clinical research process. It is equally as critical to our organization that we highlight for our partners the differentiation between the value and services ABP provides as opposed to other CROs in the market. Rather than operate in the same fashion that traditional large CRO conglomerates operate their clinical trials, the ABP difference is that our clients truly matter and we believe in forming valuable cost-effective partnerships that facilitate the development of new medicines and new treatments that benefit millions of subjects worldwide.
THE AFFINITY BIO PARTNERS PROFESSIONAL TEAM
CEO - Affinity Bio Partners, Affinity BioCeuticals, Affinity Patient Advocacy, AI Health Outcomes, CannaBot
Christina DiArcangelo, CEO and Founder of Affinity Bio Partners, has forged a world-class reputation in the Biotechnology and Pharmaceutical industry for the past 21-years. Her engagements have led to numerous industry awards, keynote speaking engagements and the ultimate respect of her industry peers.
Throughout the course of Christina's career she has acted in various capacities for Global Clinical Research Organizations, Pharmaceutical Companies and Biotechnology Companies. Some of Christina's main responsibilities, but not all inclusive, include:
Strategic and Executive Oversight
Designing, Running and managing clinical trials - Domestic and Global
Global contract negotiations - Domestic and Global
Procurement - Domestic and Global
Asset Procurement - Domestic and Global
Strategic Governance - Design, Implementation and Management
Staff Recruitment - Staffing Model Creation
Process development (SOPs, Sarbanes Oxley, etc.,)
Development of Intensive Subject Recruitment plans
Budget negotiations within global Clinical Research Organizations, Pharmaceutical companies and Biotechnology companies.
Astute understanding of human resources parameters, coaching and mentoring
Christina's professional success and drive as the Founder and CEO of Affinity Bio Partners has been facilitated by her unwavering strength as a skilled negotiator, visionary entrepreneur, skilled financial expert and her ability to success to navigate the pharmaceutical industry with unparalleled success.
"My strong work ethic, coupled with my motivation and drive to keep learning, growing and pushing the limits: have helped me reach many of my professional goals. With a vast wealth of industry knowledge, I am supremely equipped to assist the organizations Affinity Bio Partners engages with in not only reaching but surpassing their goals through running efficient and highly effective clinical trials, while building a stronger brand awareness within the industry."
In addition, Christina is the Founder, President of the Board and CEO of Affinity Patient Advocacy (affinitypatientadvocacy.org) which provides cancer patients with advocates at no charge and is very active in her local community.
Recently, Christina developed with her partners an AI Cannabot, DRBot and started AI Health Outcomes.
Senior Director, Clinical Operations
Affinity Bio Partners would like to proudly welcome Gary Mantell, Sr. to our team of highly qualified professionals in the role of Director of Clinical Operations.
Gary has been involved in the Biotechnology, Pharmaceutical and Medical Device industries for the past 30 years. He has gained invaluable knowledge and insight having held positions in both Clinical Research, Sales & Marketing. His career began as a Clinical Research Associate working for Ayerst Laboratories in the Cardiovascular Group. After several years he moved over into sales & marketing and held positions with Boots Pharmaceuticals, Smith & Nephew United, Cambrex Hydrogels and Advanced Tissue Sciences.
In 1996, Gary decided to return to Clinical Research as an Independent Consultant to the Biotech/Pharmaceutical and Medical Device industries. Since that time Gary has provided his services in the capacity as Project Manager and Lead/Sr. Clinical Research Monitor to study sponsors as well as many of the top Clinical Research Organizations. He has worked on numerous projects covering various therapeutic areas, many of which allowing him to be on-site at some of the most prestigious medical centers in the country.
Throughout his career, Gary has assisted many sponsors to successful outcomes of their trials. He is skilled at working with Investigators and their research staff so that all are properly trained and understand the protocol and procedures. This is a critical component to ensure the smooth running of any clinical trial. He has also provided much needed guidance in assisting sites with the approval process both central and their local Internal Review Boards. In addition, he has had the opportunity to work in many therapeutic areas which has only served to expand his research expertise. There is additional expertise in evaluating rescue studies and determining both the needs of the sponsor as well as those of the research site.
Gary has engaged on the following type of projects, although not an all inclusive list:
1) Sponsor / Site Liaison
2) Project Management
3) Site visits: Qualification, Initiation, Interim Monitoring, Close Outs
4) Clinical Research Associate (CRA) training and mentoring
5) Site budget negotiations
6) Site training
Affinity Bio Partners is extremely excited to have Gary as part of our dynamic organization.