Aptuit Consulting Inc., an Aptuit company, is an independent, global, pharmaceutical, medical device and intellectual property consultancy that supports product development needs of clients. Aptuit’s consultants have the expertise required to support all of development for emerging pharmaceutical and medical device companies or to fill in the gaps for medium to large companies. Practice areas include: Strategic Planning, CMC, Preclinical, Clinical, Legal/IP and Regulatory Strategy and Submissions.
William Mackin PhD RAC
Dr. William Mackin joins the Lexington, Massachusetts Development Consulting Group. Dr. Mackin brings more than 20 years of diverse experience in the development of drugs, devices, biologics, and cell/tissue therapies in large pharmaceutical and small to mid-size biopharmaceutical companies. Prior to Aptuit, Dr. Mackin was the president of Mackin & Associates and has held numerous senior management positions in R&D and Preclinical Development at several companies including Alpha Beta Technology, ViaCell, Inc. and Total ReCord, Inc. Dr. Mackin also spent 12 years at DuPont Pharmaceuticals working in the discovery and development of novel small molecules for treating inflammation, cancer, and cardiovascular disease.
Areas of Expertise:
Regulatory documentation to support INDs and IDEs
CMC of drugs, biologics, and cell/tissue therapeutics
Regulatory strategy development and execution
Medical device and combination product development
GMP manufacturing development, support, and audits
Education:
Ph.D from the University of Illinois Medical Center in Chicago, IL
Postdoctoral training at the University of Connecticut Health Center in Farmington, CT
Accreditations and Memberships:
Regulatory Affairs Certified
“Dr. Mackin brings strong experience in the drug and device development and the biologics arena and his experience and leadership with the FDA and other regulatory authorities will be of particular value to our clients” commented Dr. William Kerns, Managing Director.
Aeri Park PhD
Dr. Aeri Park joins the West Lafayette, Indiana Legal Consulting Group. Before joining Aptuit Consulting, Dr. Park worked as a Research Director at SSCI for over ten years. During this time, she managed a number of groups involving client projects that ranged from polymorph screening, to salt selection, and finding solutions to problems encountered during the pharmaceutical development process. A number of these projects lead to new intellectual property that was filed as patent applications on behalf of the client. In addition, Dr. Park was involved with a number of patent litigation projects.
Areas of Expertise:
Polymorph, salt and cocrystal screen and selection
Solid-state characterization of API and drug products
Crystallization method development
Patent prosecution support
Education:
B.S. in Chemistry from Pusan National University in South Korea
M.S. in Organic Chemistry from the University of Hawaii
Ph.D in Organic Chemistry from the University of Oklahoma.
Accreditations and Memberships:
Registered patent agent with the United States Patent and Trademark Office
Member of the American Chemical Society and the American Association of Pharmaceutical Scientists
“Dr. Park will serve as a scientific consultant and expert witness to attorneys representing pharmaceutical companies involved in patent prosecution and infringement cases,” noted Dr. David E. Bugay, Managing Director and Legal Consulting Practice Leader. “Her addition will expand the capabilities of our team to further serve our clients important intellectual property protection needs.”
Lori Dostal PhD DABT
Dr. Lori Dostal joins the Lexington, MA Development Consulting Group and is based in Michigan. Dr Dostal brings 20 years of experience in Pharmaceutical Research and Development to Aptuit Consulting. During her pharmaceutical career, Dr. Dostal held many senior management positions in Drug Safety Research & Development at Parke-Davis/Warner Lambert and Pfizer Global Research and Development. She is an expert in Reproductive and Development Toxicology and most recently was the Therapeutic Area Drug Safety Leader for antibacterials. Dr. Dostal has contributed to nonclincial safety assessments for many therapeutic areas including CNS, cardiovascular, anti-infective, endocrine, and oncology.
Areas of Expertise:
Reproductive and development toxicology, including juveniles
Male reproduction and lactation
Electronic INDs, exploratory INDs
General and genetic toxicology studies to support antibacterials from IND through NDA
Education:
B.S. in Microbiology from the University of Michigan
Ph.D. in Pharmacology from the University of North Carolina at Chapel Hill
Postdoctoral fellowship in drug metabolism at NIEHS and a staff fellowship at the National Toxicology Program in Research Triangle Park, NC
Accreditations and Memberships:
Diplomat, American Board of Toxicology (1995)
Society of Toxicology – SOT Nominating Committee and Vice President of Reproductive and Developmental Toxicology Specialty Section
Author of 21 full publications and numerous abstracts
“Dr Dostal possesses a strong toxicology background that combined with her regulatory experience with antibacterials will provide significant value to our clients” noted Dr. Kerns.
Mr. Ping Chen joins the West Lafayette, Indiana Legal Consulting Group. Mr. Chen is recognized for his expertise in chemometrics and multivariate data analysis. Prior to joining Aptuit Consulting, Mr. Chen worked as a chemical engineer in the power industry where he gained expertise in power control, process optimization, and quality control.
Areas of Expertise:
Techniques such as vibrational spectroscopy, gas chromatography, ion chromatography, voltammetry, mass spectrometry, ion mobility spectrometry, multivariate data analysis, and chemometrics.
Education:
B.S. and M.S. in Chemistry from Wuhan University in China
Ph.D.candidate in Analytical Chemistry, Ohio University
Accreditations and Membership:
Member of the American Chemical Society, the International Chemometrics Society, the American Society for Mass Spectrometry, and Sigma Xi
“In his new role, Mr. Chen will concentrate on assisting in patent litigation and patent infringement investigations,” said Dr. Bugay. “His experience and expertise in chemometrics and multivariate data analysis will provide a welcome complement to the existing Legal Consulting team.”
“Since many of our customers are smaller biotechnology companies with promising prospects but may be lacking the internal resources and capabilities to execute development of their drug candidates,” commented Dr. Burford, “we look forward to the contributions from our newest colleagues that will further enhance the scope of services and value that Aptuit Consulting can provide across the full drug development and Legal/IP protection process to our customers.”
