Management

joe-good-pic

Dr. Joseph Sinkule

Ms. Rita Kelley

Ms. Rita Kelley

Dr. Phil Lavin

Dr. Phil Lavin

Dr. Bruce Mackler

Dr. Bruce Mackler

Anew Biotechnology, Inc. has established a pipeline of follow-on biologic products with multiple therapeutic indications. The expert management team has advanced two Phase III-ready biologic candidates. Anew has been working with select, world-class biopharmaceutical partners, and has significantly expanded the company’s commercial reach to the emerging and major drug markets. All of this was accomplished in less than two years, which has been a major success.

The Board of Directors

Anew Biotechnology, Inc. has appointed a highly experienced, knowledgeable and active Board of Directors focused on representing and creating value for the shareholders;

  • Joseph Sinkule (Founder, CEO and Chairman),
  • Bruce Mackler (President, Regulatory Operations),
  • Jon McGarity (Independent),
  • Phil Lavin (President, Development Operations)
  • Mark Godsy (Independent)

The Board is actively recruiting two additional Independent Board members.

The Operations Team

Anew is managed by a group of industry veterans who were involved with the development of the first generation of biologic drugs. The management team is responsible for over 75 regulatory approvals and launched over 25 “breakthrough” pharmaceutical products worldwide. The management team and part-time consultants each have an average of 25-30 years or more of experience in oncology drug development in the pharmaceutical and/or biotechnology industry. All have had success in start-ups or in a big pharma environment – many with both. They have launched products internationally, established branded and generic sales & marketing systems, executed drug distribution agreements, got drug listings in formularies, and obtained approvals for reimbursement from private Governmental payer systems. Anew has an abundance of knowledge and hands-on experience in GMP manufacturing, QC testing, product development, launch, marketing and sales of pharmaceuticals and biopharmaceuticals that is unmatched in any young, start-up biotechnology company at a similar stage. The management team acquires products in a late-stage of development and uses its combined expertise to guide the products through the final stages of development and then commercialization.

Dr. Joseph Sinkule, Founder, CEO and Chairman. Dr. Joseph Sinkule is a serial entrepreneur and oncology drug development expert with a 34 year career (8 years in cancer research academics, 9 years in the CRO industry and 17 years in the biopharmaceutical industry) which includes executive management, strategic and product planning, business development and general senior management positions. After leading academic research and development programs at St. Jude’s Children’s Research Hospital, University of Chicago and University of Michigan, Dr. Sinkule’s career in industry included management positions at recombinant protein and antibody companies like NeoRx Corporation, Immunex Corportion, Techniclone, gene therapy companies like Inex and Introgen, CROs like EER Medical Systems, Medelis, and Quintiles, and early start-ups like Apthera. Dr. Sinkule founded Apthera in 2005, obtained a Phase III SPA for NeuVax and sold the Company in 2009, and the successor company has a market cap of approximately $300 million. Dr. Sinkule, with extensive experience in biopharmaceuticals, pharmaceuticals and the CRO industry, ushered five drug product approvals and three biotechnology drug approvals through the FDA during his tenue in industry. Dr. Sinkule will oversee all activities and will rely on his keen out-sourcing expertise and his talented senior team to manage activities (business development, finance/accounting, manufacturing oversight and project management) and our expert international consulting groups during the next 12-24 months of operations. Dr. Sinkule received undergraduate (B.S. Chemistry) and graduate (Doctor of Pharmacy) degrees at University of Nebraska.

Ms. Rita Kelley, President, Global Commercial Operations. Rita Kelley has over 25+ years in the pharmaceutical and biotech industry with 15 years directly in the oncology/hematology space. Ms. Kelley has experience in Sales, Sales Management, New Product Planning, US and Global Marketing, Regional Operations, and International Business Development. Ms. Kelley was VP of Marketing for Oncogenerix (Privately Held), and was key in securing $7M in A Round funding prior to the merger with Dara Biosciences (NASDAQ: DARA). While at Millennium Pharmaceuticals: The Takeda Oncology Company (Nikkei: TYO: JP:4502) Ms. Kelley was responsible for the successful launch of Adcentris® (brentuximab- vedotin) for Non-Hodgkins Lymphoma, and CLL, which accounted for $138M in sales in 2012, an increase of 300% since launch. Additionally, Ms. Kelley has led the launch of 3 products with Pfizer (NYSE: PFE) that have each achieved over $1B in sales since launch, ReFacto (rhFVIII), BeneFix( RhFIX) and Sutent® (sunitinib malate) and Novartis Oncology (NYSE: NVS) for Zometa (zoledronic acid). Additionally, she has significant experience in clinical development, and global regulatory, having made presentations to health authorities in the US, Japan and China. Ms. Kelley started her own strategic consulting agency, Shoreline Consulting, LLC, specializing in aiding start up pharmaceutical and biologics oncology companies to develop their strategic commercialization and operational plans. Rita will continue this function along with program management, financial management in her territories, and product launch planning in North American markets for Anew. Ms. Kelley holds a BA from the University of Mississippi, and diplomas from both Harvard Business School and Wharton Business School as part of Novartis and Wyeth Executive Management Training.

Dr. Phil Lavin, President, Development Operations. Dr. Lavin is a well-known biostatistician and drug development expert with a long history supporting clinical trials, outcomes, and reimbursement. Dr. Lavin has developed successful clinical and regulatory strategies leading to 54 regulatory market approvals on an international basis for drugs, biologics, and medical devices (40 PMAs, 12 NDAs, 1 BLA, and 1 HDE). Having authored nearly 180 peer-reviewed medical and scientific publications and book chapters, Phil is an industry leader and an advisor to FDA and other regulatory agencies regarding biostatistical methods and study endpoints. Dr. Lavin was a member of the Biostatistics faculty at the Harvard School of Public Health and a member of the Department of Surgery at Harvard Medical School where he was affiliated for over 25 years. He co-founded Boston Biostatistics which became Aptiv Solutions before being acquired by the CRO, ICON plc. He has developed solutions for optimum timing of interim analysis, extending labeling for multiple endpoints as well as devising composite endpoints and adaptive models. As the Lead Biostatistician for 54 major FDA approvals (to date), this total is more than any other biostatistician. Phil received his PhD in Applied Mathematics at Brown University in 1972. He is a member of Who’s Who in the World as well as multiple professional societies. He is the only person to be elected a Fellow of the American Statistical Association and the Regulatory Affairs Professional Society reflecting his many pioneering contributions to statistics, regulatory approvals, and medicine. He has served as a Special Government Employee for 30 years where he has advised FDA on complex statistical and policy issues. He has won multiple awards from professional societies. He remains hands on and available for study design, complex statistical matters, and regulatory strategy consulting inclusive of agency representation, reimbursement modeling, biostatistics, clinical trials design, combination products, and adaptive designs.

Dr. Bruce Mackler, President, Regulatory Operations. Dr. Mackler is a seasoned veteran of the biotechnology industry. Dr. Mackler’s 28 years of FDA legal/regulatory experience in biomedical products includes biologics, drugs, nutraceuticals, medical and in vitro diagnostic devices, food and cosmetics manufactured by traditional and biotechnology processes (recombinant proteins, genomics, cell and gene therapy). Dr. Mackler has advised financial groups on integrated FDA, technical and business issues, when performing due diligence assessments on biomedical opportunities prior to their making initial investments and during bridging. These due diligence activities integrate his business acumen from working in sales/manufacturing in a family business, owning and managing several bioservice businesses and being a researcher for 15 years (graduate, fellow, NIH and University), followed by 28 years in a FDA legal / regulatory practice with premier law firms, and now as a resource for numerous financial groups. Dr. Mackler received his J.D. from the South Texas College of Law (magna cum laude, 1979), his Ph.D. (Immunology/Microbiology) from the University of Oregon Medical School (1970), his M.S. (Immunology/Microbiology) from the Pennsylvania State University (1965), and his B.A. (Biology) from Temple University (1964). Dr. Mackler has authored more than 100 published scientific papers and abstracts in immunology, immunopathology, and various disease models, as well as numerous additional articles and briefing papers on FDA and FDA-related legal and regulatory issues. Dr. Mackler advises biomedical companies and venture capital groups on FDA regulatory approval strategies, pre-INDs, on problems regarding manufacturing, QA/QC facilities, and how to effectively interact with FDA. He has assisted companies in developing regulatory approval strategies for US and global markets, pre-clinical and clinical study strategies to facilitate clinical studies and market entry.

Other Key Employees include:

Dr. John Grous, Chief Medical Officer. A licensed and Board-certified Medical Oncologist trained at Sloan-Kettering, worked as chief medical officer at Alkermes, Allos Therapeutics, and Calydon, and as Medical Director of Oncology at AstraZeneca. Worked for several CROs as consultant and will oversee all clinical development activities, and will Chair the Medical Oncology Advisory Board.

Dr. Stephen Schmitz, Vice President, Pharmacovigilence. Physician and post-marketing pharmacovigilence expert having worked for Biogen-Idec, Stryker, Shire and other companies in post-marketing safety and REMS programs and in CROs managing such post-approval safety reporting.

Bonnie Robbins, Vice President, Global Program Management. Ms. Robbins is based in the US and is a highly experienced pharmaceutical development project manager. Bonnie has set up management plans and budgets for multi-million dollar programs and will track and report progress and risk mitigations strategies for all of our pipeline products.

Anew draws upon CROs – a dedicated team of people within the CRO – and a global team of clinical and regulatory experts who are brought in to serve advisory and hands-on work functions and providing “deliverables” on an “as needed” basis. Our international team of consultants include senior advisors in Regulatory Affairs – FDA, EMA, Japan, Israel, Latin America, Australia and others; Clinical Trials – medical and pediatric oncology, radiation oncology, autoimmune diseases, and ocular diseases; Non-Clinical Animal Studies – design and implementation of GLP studies required for full BLA submissions; and Manufacturing, Stability and Analytical Testing – former FDA inspectors, process development and manufacturing experts retired from Amgen and Genentech.

Photo of Scans being analyzed Doctor