Q: What two or three drug molecules do you identify as having had the greatest impact on society? What about on the pharmaceutical industry?

Over the last century, several groundbreaking inventions in drug discovery have contributed to a remarkable increase in life expectancy. Against this backdrop, it is difficult to identify three drugs having had the greatest impact on society. I’ve identified three that changed the course of medicine.

Insulin: The discovery of insulin revolutionized both the therapy and prognosis of diabetes. This is one of the most studied diseases in the history of medicine, dating back to Egyptian medical texts in 1552 BC. Ever since the isolation of insulin from pancreas tissue in 1923, numerous efforts were made to produce fully synthetic insulin, from rDNA human insulin in 1978 to various insulin analogs in 1996, aimed at optimizing the insulin absorption, distribution, metabolism, and elimination. The dream someday is for a needle-free delivery of insulin by oral route.

Excerpted from Pharmaceutical Technology's editorial titled, "Reducing Risk with Abuse‑Deterrent Formulations."

Increasing prevalence of drug misuse and abuse is driving a heightened and more stringent approach to abuse-deterrent formulations.

Possibly the most publicized and well-documented form of drug misuse and abuse has been that of opioids—prescription pain-relief medicines. The opioid crisis, which has impacted the global health community for several years, has paved the way for increased demand in abuse-deterrent formulations.

Abuse-deterrent formulations essentially have the potential to provide an effective way of reducing the capabilities of an end-user to abuse or misuse a medical therapy, while maintaining the drug’s clinical benefit. To explore the topic of abuse-deterrent formulations in more detail, Pharmaceutical Technology spoke with Angela Moore, scientist, Analytical Development, Alcami.

Alcami announced today the appointment of Walter J. Kaczmarek III as Chief Executive Officer. Mr. Kaczmarek, who has over 30 years of experience in the pharmaceutical industry, will focus on advancing Alcami's next phase of strategic growth. 

Mr. Kaczmarek has served in executive roles at multiple pharmaceutical companies, including as President of the Multisource Pharmaceuticals division of Mallinckrodt Pharmaceuticals, COO of Aceto Corporation, and most recently, as President and CEO of Cosette Pharmaceuticals Inc. Mr. Kaczmarek is an industry veteran with a depth of experience spanning the entire value chain from development and manufacturing to sales and marketing.

WILMINGTON, NC – May 21, 2020 – Alcami, a North Carolina-based contract development and manufacturing organization (CDMO), today announced further additions to strengthen its senior leadership team. Brian Dillion has been appointed to the role of Vice President of Regulatory Affairs and Quality Assurance and Jacquelyn Uribe has been appointed to the role of Vice President of Quality Operations. “Jacque and Brian bring broad compliance expertise with a track record of success upholding the rigorous standards required by both customers and regulators in high growth environments,” commented Chief Financial Officer Eric Evans.

WILMINGTON, NC – MAY 18, 2020 – Alcami, a North Carolina-based contract development and manufacturing organization (CDMO), today announced the appointment of Ken Domagalski and Elliott Franco to their Senior Leadership Team. Ken Domagalski has been appointed to the role of Executive Vice President of Drug Product Operations and Elliott Franco has been appointed to the role of Vice President of Laboratory Operations.

Excerpted from Drug Development & Delivery's Special Feature Section titled, "Prefilled Syringes & Parenteral Manufacturing: Innovations, Challenges & Solutions."

As a contract manufacturer, Alcami provides experience in all aspects of the manufacturing process, including fill volume accuracy, plunger placement, material compatibility, and reduction in line loss. “Many of the prefilled syringe products in the contract manufacturing space are high value, low volume, so assessment of manufacturing capabilities with components selected by the client during the device design process is critical to ensuring our success during an individual manufacturing run or campaign,” says Jacquelyn Uribe, Vice President of Quality Operations at Alcami.

WILMINGTON, NC – May 8, 2020 – Alcami, a North Carolina-based contract development and manufacturing organization (CDMO), today announced the appointment of Sally Langa and Kimberly McClintock to their Senior Leadership team. Sally Langa has been appointed to the role of Senior Vice President of Sales and Kimberly McClintock has been appointed to the role of Vice President of Marketing and Client Services.  

WOODCLIFF LAKE, N.J.—April 16, 2020—Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle”), a New Jersey-based pharmaceutical company, today announced that its product RYANODEX^® (dantrolene sodium) for injectable suspension inhibited the growth of SARS-CoV-2, the virus causing the COVID-19 pandemic, in a controlled in vitro laboratory test. On Tuesday, April 14, Eagle submitted its Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for a Phase 2 clinical trial in partnership with Hackensack University Medical Center to evaluate the efficacy of RYANODEX in patients infected with SARS-CoV-2. Eagle has been in contact with the FDA’s Coronavirus Treatment Acceleration Program (“CTAP”) to request potential expedited review of the IND application and aims to begin the clinical trial as soon as possible.

Transaction Advances Alcami’s Strategic Plan by Adding Scale in Attractive and Growing Parenteral Markets

Alcami Investors Make Additional Equity Investment Alongside Ampersand Capital Partners to Fund Expansion

Durham, NC (USA) – January 17, 2020 – Alcami Corporation (“Alcami”), a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biologics industries, today announced it has acquired TriPharm Services (“TriPharm”), a new state-of-the-art sterile fill-finish manufacturing center located near Research Triangle Park, North Carolina. The acquisition of TriPharm follows the recently announced $17 million expansion of Alcami’s sterile fill-finish facility in Charleston, South Carolina.

Next Step in Alcami’s Strategic Plan to Focus its Platform on High-Growth Market Segments

Durham, NC (USA) – January 8, 2020 – Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biologics industries, today announced the sale of its preclinical and early stage active pharmaceutical ingredient (API) facility in Weert, Netherlands to MercachemSyncom, a leading mid-sized European integrated drug-discovery and development contract research organization. Terms were not disclosed.