APERTUS was founded in 2012 by Dr. Gindelberger and Dr. Ryan.  Initially, the team focused on API development, but quickly added formulation projects. After opening our doors, we obtained a DEA manufacturing registration followed by research and analytical registrations.  Our first customers were other small companies in the St. Louis area with lab support needs.  We developed analytical and manufacturing procedures for a diverse array of products from magnetic nano-particles to extended release drug products.  We then expanded our capabilities to include small scale cGMP manufacture of drug products.  We currently have the capability to manufacture tablets, capsules, creams and liquids under cGMP.  Apertus also successfully completed an FDA audit in January of 2020, and quickly responded and implemented fixes requested by the Agency.

BOARD CHAIRMAN:

Dr. Rick L. Ryan serves as the Chairman of the Board of Apertus Pharmaceuticals where he provides strategic direction to the company and its partnerships with pharmaceutical companies, venture capital firms, universities and research institutions.  Rick has over 30 years experience in the life sciences industry including business management and new business/technology development. He has held executive leadership positions in multinational corporations as well as early stage ventures.

Before joining Apertus, Rick was Vice President of the Drug Discovery & Development business unit at Millipore Corporation. He had P&L responsibility for DDD, which provided discovery and development products and services to Pharma and Biotech customers. At Millipore he also led innovation programs, such as biomarker applications for discovery, and development for companion diagnostic applications.  Rick was formerly the President of LINCO Research Inc, which was acquired by Millipore in 2007. He started his biotechnology career at Monsanto, where he held several technology and business management positions of increasing responsibility, including Dir. Commercial/Business Development, Dir. Strategic Planning and Dir. International Markets.

Rick received his PhD (Biochemistry) from the University of Illinois and his executive MBA from Washington University in St. Louis. He was an American Cancer Society post-doctoral fellow at the University of Wisconsin. He obtained his B.S. in chemistry from Central College of Iowa.

CHIEF EXECUTIVE OFFICER:

Dr. David Gindelberger serves as the Chief Executive Officer of Apertus Pharmaceuticals where he leads the API research and commercialization efforts. David has deep expertise in the manufacturing and regulatory aspects of regulated API’s including over 28 years of research, manufacturing, and management experience in the fine chemical and pharmaceutical industries. He has most recently worked as a Principal Scientist for Mallinckrodt, the controlled substance manufacturing division of Covidien.

David also has prior entrepreneurial experience, having started a successful CMO focusing on the synthesis of organic compounds which he managed as President for four years.  David established wet lab space including bench, hood and glovebox installations, and analytical capabilities including a 300MHz Bruker NMR spectrometer.  While running the CMO David initiated ongoing customer relationships with a number of entities including Sigma Aldrich, ExxonMobile, Umicore, and TCI Americas.

Previously, David was a Director of New Product Development at the Cal Tech based start-up Materia.  At Materia he focused on commercialization of Robert Grubbs’ ruthenium olefin metathesis catalysts, and efforts to use this technology in pharmaceutical production.  He has also worked as a Quality Manager at KMCO, the largest toll processor in the United States, and was a Senior Research Scientist for Exxon early in his career.  David has a total 21 patents and three pending applications spanning a wide variety of disciplines, including controlled substance manufacturing, pro-drug composition of matter, pharmaceutical and beverage formulations, and catalyst manufacturing.

David received his PhD (Organometallic Chemistry) from the University of California, Berkeley and his Bachelors (Chemistry) from Purdue University.

Patents:

• Poloxamer compositions and beverages  WO2022187295A1
• Heterogeneous catalyst and method for preparation of aromatic tricyclic pyrans WO2022182962A1 
• Organic catalyst and method for preparation of aromatic tricyclic pyrans WO2022182973A1
• Zeolite catalyst and method for preparation of aromatic tricyclic pyrans US11352337B1
• Salvinorin derivatives WO2020131689A1
• Prodrug derivatives of mesalamine EP3710423A1
• Chelating carbene ligand precursors and their use in the synthesis of metathesis catalysts US9504997B2
• Heterogeneous ruthenium metal catalyst for the production of hydrocodone, hydromorphone or a derivative thereof US8383815B2
• Preparation of 6-Keto, 3-Alkoxy Morphinans US20100261906A1
• Ruthenium Catalysts for the Production of Hydrocodone, Hydromorphone or a Derivative Thereof US20100261905A1
• Supported late transition metal catalyst systems US20040210014A1
• Catalyst system and its use in a polymerization process US20050043497A1
• Catalyst systems, method for preparing and using same in a polymerization process US20040106752A1
• Mixed transition metal catalyst systems for olefin polymerization US6492473B1
• Polymers derived from olefins useful as lubricant and fuel oil additives, processes for preparation of such polymers and additives and use thereof US6468948B1
• Polar monomer containing copolymers derived from olefins useful as lubricant and fuel oil additives, processes for preparation of such copolymers and additives and use thereof US6172015B1
• Power transmission fluids of improved viscometric and anti-shudder properties EP0988357A1
• Power transmission fluids containing alkyl phosphonates US6127323A
• Carboxylic amide-containing polymers for use as fuel or lubricating oil additives and processes for their preparation US6066605A
• Polar monomer containing copolymers derived from olefins useful as lubricant and useful as lubricant and fuel oil additivies process for preparation of such copolymers and additives and use thereof US6066603A

CHIEF QUALITY OFFICER:

Nichole DiLoretta is the Chief Quality Officer for Apertus Pharmaceuticals.  Nichole is responsible for Quality Assurance, Quality Control and Regulatory aspects of the company.  

Nichole has more than 17 years of experience in highly regulated industries including pharmaceuticals, medical device, and food.  The industry experience spans manufacturing, CRO, CMO, biologics, compounding and laboratory oversight. She has worked in start-up spaces and for large  companies such as Pfizer, bioMerieux, Infinity Laboratories, Dynalabs, and  Deibel Laboratories.  She has also served many companies as an experienced consultant for auditing, inspection remediation, process development, validation, and as a regulatory expert advising USP revisions and boards of pharmacy enforcement.

Nichole’s early career focused mostly on Microbiology in food, pharma and cosmetics and has transitioned into quality and regulatory for analytical development,  process development, production, release and post market surveillance.  She has built and maintained many quality management systems, accreditations in ISO & USDA,  and received advanced certifications in HACCP, SQF, CQA, PMP, scrum/agile frameworks, and forensic science.  She holds a Bachelor of Science from SIUE.

CHIEF DEVELOPMENT OFFICER:

Dr. Angela Sutterer is a pharmaceutical development leader with proven experience in NDA, ANDA and OTC product development and manufacturing.  Her strengths include leadership and team development, technical and regulatory aptitude, entrepreneurial drive and client relationship management.  She has more than 25 years of experience in the pharmaceutical industry with demonstrated expertise in both API and finished drug product development. 

A St. Louis native, Angela graduated from Washington University in St. Louis with a Ph.D. in Organic Chemistry.  After several years of focusing on API manufacture as a process chemist for Dow Chemical’s Pharma Division, she transitioned to developing and manufacturing finished dosage forms for Fleming Pharmaceuticals, a St. Louis based pharmaceutical company.  For the next 12 years Angela held the technical leadership position at Fleming where she designed and implemented a nasal spray development program resulting in approval and subsequent commercial launch of multiple prescription nasal spray products, developed multiple approved Rx and OTC semi-solid, suspension, and solid dose product formulations, and was credited with launching and growing Fleming’s contract development and manufacturing business. 

The seven years prior to joining Apertus Pharmaceuticals in 2021 Angela held technical leadership positions in virtual pharma companies (Lumara Health, now Amag Pharmaceuticals, Avadel, and Burke Therapeutics) where she was responsible for leading externally developed drug product pipeline activities including formulation, process, and analytical development; non-clinical, clinical, and regulatory submission strategy and preparation, along with process validation and commercial launch supply planning and execution for sterile injectable, nasal spray, topical, and controlled substance products.

GENERAL COUNSEL:

Dr. Sandra Oh joined Apertus Pharmaceuticals in February 2019 as General Counsel to meet the company’s growing need for legal and regulatory guidance. Sandra was formerly an attorney at Husch Blackwell LLP in St. Louis and brings a wide breadth of legal experience to both companies. Sandra’s legal experience includes defending one of the world’s largest agrichemical companies in multi-jurisdictional litigation and advising large multi-national manufacturer on how to successfully bring a European facility into FDA compliance. Sandra also worked in the US Attorney’s office, both in the Southern District of Illinois and the Eastern District of Missouri during her time at Washington University as a law student. 

Although Sandra did not officially join Apertus until February of 2019, she has been deeply involved in the company’s growth since its inception.  Sandra, who is married to Dr. Gindelberger, assisted with the initial business plan and regulatory research and has been an unofficial member of the Apertus team since its founding in 2011.

Prior to practicing law, Sandra was an English Professor at University of Miami where she taught American Literature.

Sandra received her J.D. from Washington University, and her Ph.D. in Rhetoric from University of California. Berkeley.