PharmaPro Consulting stands apart from other consultancy companies through our capacity to engage our seasoned Expert Consultants on all assignments, no matter how large or small. We can partner with you, bringing a full repertoire of functional expertise, as you take your product from discovery to market.
The PharmaPro Consulting team consists of well-tenured professionals with long-term experience in clinical pharmacology, pharmacometrics, and pharmacokinetics as well as clinical trial design, interpretation, publications, and more. We bring this wealth of experience from big and small Pharma and Biotech to bear to empower our clients to meet their aggressive timelines, make informed decisions, and save their valuable resources of time and money.
- A thought leader in the field of Clinical Pharmacology and FDA Regulatory Submissions, Dr. Dontabhaktuni has been invited to numerous national and international conferences as a Keynote Speaker and Plenary Speaker.
- Aruna serves on the Scientific Boards &and DSMBs of pharmaceutical and Biotech companies as a subject matter expert in Regulatory and Clinical Pharmacology.
- As pharmaceutical professional with 25 years of experience, she consults with Pharmaceutical and Biotech companies as a Clinical Pharmacology, DMPK and Regulatory expert, across all phases of drug development. - Working with clients like Genentech, Roche, Daiichi Sankyo, GlaxoSmithKline, Mabion S.A. (Poland), ContraFect Corporation, SK Life Sciences, and Rafael Pharmaceuticals.
- She has extensive experience in face-to-face meetings and preparing written responses to various regulatory agencies across the world including the FDA, PMDA, SFDA, EMA, and KFDA among others.
- Dr. Dontabhaktuni has broad experience in Clinical drug development for Biologics, Small molecules, and Antibody-drug conjugates both as an individual contributor and in a leadership role; in broad range of therapeutic areas including immuno-oncology, oncology, immunoscience, and rare diseases.
- Some of the assists where Aruna has supported the FDA/EMA submission include Eli Lilly’s ramucirumab (CYRAMZA®), necitumumab (PORTRAZZA™) and Breakthrough Therapy Designations application for Olaratumab (LARTRUVO™), GSK’s Tafenoquine, Daiichi Sankyo’s Mirogabalin and Edoxaban, SK life Sciences- Cenobamate; Biosimilar application of Mabion S.A.’s MabionCD20
- She has authored 45+ peer-reviewed publications and spoken at national and international Scientific conferences as a Keynote speaker on topics related clinical pharmacology and regulatory submissions.
- Michael R. Stevens, PharmD is accomplished results-oriented, science-based professional with a well-diversified career in the pharmaceutical/biotechnology industry over more than thirty years.
- Michael has served in a number of positions in “Big Pharma” and “Small Biotech” ranging from entry level to executive in the areas of Market Research, Oncology Marketing, Medical Nutritionals Marketing, Drug Discovery, New Product Development, Phase 1 through 4 Clinical Trials in HIV/AIDS and Clinical Nutrition, Medical Market Development in the hepatitis B market, and Medical Affairs. He served as the Vice President, Medical Affairs Virology for the Bristol-Myers Squibb HIV franchise.
- Dr. Stevens has served as the Bristol-Myers Squibb representative to both the NIH’s AIDS Clinical Trial Group (ACTG) and the Forum for Collaborative HIV research, gaining valuable experience in working with colleagues in academia and other pharmaceutical companies to write, field, analyze, and publish clinical trials involving products from multiple manufacturers. He has also worked to write, field, analyze, and publish clinical trials dealing with a therapeutic vaccine for HIV.
- With extensive experience in both Big Pharma and Small Biotech, Michael has consulted with companies across the full range of clinical trials from pre-clinical to Phase 4. He has authored/co-authored over 50 posters and peer-reviewed publications and has presented the data at national and international conferences. His background in both Marketing and Medical gives him a unique insight into positioning study results to provide robust labeling.
• Regulatory Strategies
• Parenteral Formulations
• Down Steam Processing
Mr. Goldstein has over 30 years of experience in biologics development including down stream development, parenteral formulation development and analytical development. Mr. Goldstein’s experience includes leadership roles for the approval of Eli Lilly’s cetuximab (ERBITUX®), ramucirumab (CYRAMZA®), necitumumab (PORTRAZZA™) and Olaratumab (LARTRUVO™).
Ms. Goldstein was formerly Vice President, Formulation Development, Lilly, NJ (formerly ImClone Systems Incorporated).
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