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Imran Ahmed, Ph.D.

Imran Ahmed, Ph.D.

Dr. Imran Ahmed is Senior Director and Head of Formulation Development at Alcami. He has a Bachelor of Science in Pharmacy from the University of Michigan and his M.S. and Ph.D. in Pharmaceutical Chemistry from the University of Kansas. Dr. Ahmed has 30+ years of experience in pharmaceutical product development for small and large molecules with subject matter expertise in sterile injectables, ophthalmics, and oral controlled release dosage forms. He has over 30 scientific publications in peer reviewed journals, authored 3 book chapters, and has 6 granted patents.

Recent Posts by Imran Ahmed, Ph.D.:

The Changing R&D Landscape: Emerging Technology Needs and Value Proposition for Strategic Partnerships with Contract Development and Manufacturing Organizations (CDMOs)

The pharmaceutical product landscape is rapidly and fundamentally changing with profound impact on research and development strategy and technology needs. After a precipitous fall in new drug approvals during the last two decade of the 20th century, there has been a gradual recovery going into the second decade of the 21st century.Figures 1 and 2 map drug approvals by molecule type and route, excerpted from the publication by Ouyang et al1 based on 34,673 drug products approved by the FDA over a 37-year period from 1980 through 2017. The number of biopharmaceutical products show a considerable growth accounting for nearly a quarter of the new molecular entities approved in 2017. While oral delivery route (62%) is still the most prevalent amongst marketed drug products, alternative adminstrations such as injection (22%), cutaneous, mucosal, inhalation, and others are making up a greater percentage as the industry works to improve bioavailability and subsequent efficacy.

Topics: Regulatory Compliance Editorials Development

Editorial: An Interview with Alcami Parenteral Experts

Sterile Fill Line 2Alcami parenteral experts recently contributed to an article in Pharmaceutical Outsourcing titled, "An Interview with Alcami."

As new parenteral products are introduced into the market, what are some of the challenges parenteral manufacturers have faced, and how do they solve these challenges?

If current trends hold, it is expected that new parenteral products will be increasingly complex, requiring nonstandard manufacturing technologies subjected to higher standards of regulatory scrutiny and market expectations. With the emphasis on precision medicine— an emerging approach of disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person— there will be a greater number of biologic drugs, multidrug combination products, drug device combinations, and targeted drug delivery systems introduced to the market. Parenteral manufacturing of these complex drug products will require special equipment, technologies, and control strategies. It will also require highly skilled process engineers, manufacturing operators, and quality assurance personnel. Furthermore, a greater number of new molecules will be highly potent requiring special containment facility, environmental controls, and operator training that is not commonly available in many of today’s manufacturing facilities.

Topics: Editorials Drug Product Formulations Parenteral Manufacturing