APRIL 2021 # 74 Upfront In My View NextGen Sitting Down With The risk profile of Analyzing capsids for Unit-level traceability of Johannes Khinast – the only pharma-grade whey gene therapy glass containers science is good science 07 12 38 – 42 50 – 51 www.themedicinemaker.com Value beyond the vial When you have questions, we have answers. When evaluating your product against a reference standard, questions arise. Give yourself a cushion of confidence. When you need expert advice or are seeking a training course to help you with our reference standards, you’ll always have access to answers when you need them — with USP. Move forward with more confidence: Contact USP. 1-301-881-0666 | usp.org/chemical-medicines A Roadmap for Access We must secure sustainable markets to ensure patient Editorial access to generic and biosimilar medicines he pandemic has presented a unique challenge to healthcare systems and infrastructure, including the generic drug supply chain. Generic drug Tmanufacturers have met this challenge, ensuring a stable supply of life-saving medicines for patients throughout the pandemic. However, the long-term sustainability of the generic and emerging biosimilars medicines market faces threats. Policymakers should consider and address the unique challenges facing generics and biosimilars to maintain long-term access to cost savings for patients. In its latest paper, Securing Sustainable Markets, the Association for Accessible Medicines (AAM) announced a series of policy proposals intended to ensure patient access to lower-cost medicines (1). Generic drugs face competitive imbalances in the market, such as a highly consolidated drug purchasing system controlled by a few major organizations, combined with ill-advised government policies. These policies have historically led to high rates of price deflation and low reimbursement, sometimes driving manufacturers out of the market. For example, Medicaid imposes an inflation penalty that penalizes generic manufacturers who experience price variability due to fluctuation in purchasing patterns. And consider this: the growing categories of specialty and complex generics and biosimilars offer critical new savings Reference opportunities for patients, along with financial sustainability for 1. AAM, “Securing Sustainable Markets,” manufacturers; however, patient adoption of such new, lower-cost (2021). Available at www.secureourmeds. alternatives is unfortunately hindered by government and payer org/securing-sustainable-markets policies that perversely reward the use of high-cost brands over lower-priced generic or biosimilar competitors. Policies such as the brand drug Coverage Gap Discount Program and the use of brand drug rebate traps encourage plans to restrict patient access to generics or biosimilars in favor of higher-cost brands. Note that Medicare Part D formularies are slower in covering newly approved first generics compared with commercial health plans, in spite of the lower cost of generics. Similarly, Medicare Part B reimbursement policies discourage biosimilar adoption, even though biosimilars are 30 percent less expensive (on average) than reference brand-name biologics. As more FDA-authorized COVID-19 vaccines are distributed and administered, we’ll all be hoping for a speedy rebound from the pandemic. Certainly, generics will have played a key role as a bridge to those vaccines. AAM calls for updated government policies that value generic and biosimilar competition, do not penalize continued production of older commoditized generics, and create opportunities for future patient savings. Craig Burton Vice President, Policy at the Association for Accessible Medicines www.themedicinemaker.com Contents 48 09 In My View 20 12 We need better analytical techniques that can tell us what is happening inside our capsids for gene therapy, says 03 Guest Editorial Upfront Lori Stansberry A Roadmap for Access, by Craig Burton 06 The latest news, views and 14 According to Jason Lacombe, research – including guidance secure digital technology is more on whey and lactose-derived essential than ever before in On The Cover Cover excipients, a technique for today’s world of remote working lowering chromatography costs Celebrating The Medicine Maker in bioprocessing, and the true 16 Karen Fallen believes that DNA 2021 Power List effectiveness of traditional manufacturers need to pick up medicine the pace if they want to take part in the genetic medicine revolution ISSUE 74 - APRIL 2021 Feel free to contact any one of us: 38 [email protected] Content Team Editor - Stephanie Sutton James Strachan (Deputy Editor) Maryam Mahdi (Associate Editor) Commercial Team Publisher - Helen Conyngham Stacy Gaines (Business Development Manager, North America) Design Team Head of Design - Marc Bird Hannah Ennis (Senior Designer) Charlotte Brittain (Designer) Digital Team Digital Team Lead - David Roberts Peter Bartley (Digital Producer Web/Email) Abygail Bradley (Digital Producer Web/App) Audience Team Audience Growth Strategy Manager – Brice Agamemnon CRM & Compliance CRM & Compliance Manager - Tracey Nicholls Hayley Atiz (CRM Assistant) Commercial Support Team Internal Systems Manager - Jody Fryett Dan Marr (Campaign Reporting Analyst) Commercial Services Commercial Service and Social Media Manager - Matt Everett Kevin O’Donnell (Marketing Executive) Alice Daniels-Wright (Video Project Manager) Jess Lines (Video and Project Support Coordinator) Lindsey Vickers (Sales Support Project Manager) FeatureFeature Marketing Team Marketing Manager - Katy Pearson Jo Baylay (Marketing Executive) 20 The 22021021 P owoPowererr L isiListt Accounts Team We celebratecelebbratee thethe toptop Kerri Benson (Accounts Assistant) inspirationalinspirationan l anandd iniinfluentialfluuential Emily Scragg (Accounts Apprentice) professionals across three Human Resources categories of medicine 48 Hello World! Human Resource Manager - Tara Higby Management Team making: small molecules, We round up the hottest topics Chief Executive Officer - Andy Davies biopharmaceuticals, and that have been seen in the cell Chief Operating Officer- Tracey Peers Senior Vice President (North America) advanced medicine and gene therapy field over the - Fedra Pavlou Financial Director - Phil Dale course of the last month Commercial Director - Richard Hodson Content Director - Rich Whitworth NextGen Report 38 Raising the Bar(code) Change of address [email protected] Stevanato’s Tod Urquhart has 18 Filling: How to Find the Hayley Atiz, The Medicine Maker, Texere Publishing Limited, Booths Park 1, Chelford Road, Knutsford, Cheshire, WA16 8GS, UK taken a lead role in a draft ISPE Right Setup General enquiries Discussion Paper on traceability www.texerepublishing.com | [email protected] +44 (0) 1565 745 200 | [email protected] of glass containers; he tells us Distribution: The Medicine Maker (ISSN 2055-8201), why it is so important is published monthly by Texere Publishing Limited, Booths Park 1, Chelford Road, Knutsford, Cheshire, WA16 8GS, Sitting Down With UK. Single copy sales £15 (plus postage, cost available on request [email protected]). Non-qualified annual 44 A Smaller Piece of PiE subscription cost is £110 plus postage There are growing concerns 50 Johannes Khinast, CEO Reprints & Permissions – [email protected] The copyright in the materials contained in this publication and the about API levels in wastewater, and Scientific Director of the typographical arrangement of this publication belongs to Texere Publishing Limited. No person may copy, modify, transmit, distribute, display, but pharma manufacturers can Research Center for reproduce, publish, licence or create works from any part of this material or typographical arrangement, or otherwise use it, for any public or commercial manage these – with the right Pharmaceutical Engineering use without the prior written consent of Texere Publishing Limited. The names, publication titles, logos, images and presentation style appearing processes in place (RCPE), Graz, Austria in this publication which identify Texere Publishing Limited and/or its products and services, including but without limitation Texere and The Medicine Maker are proprietary marks of Texere Publishing Limited. Nothing contained in this publication shall be deemed to confer on any person any licence or right on the part of Texere Publishing Limited with respect to any such name, title, logo, image or style. 6 Upfront Upfront Research Trends A Little Less Innovation Conventional Researchers prove the effectiveness of traditional herbal medicines against neglected tropical diseases Can traditional medicines be standardized to help create affordable drug access in low- and middle- income countries? Dorcas Osei-Safo Researchers at the University of Ghana, certainly think so and have published data that indicates how herbal preparations are thought to have few adverse effects. So far, only one active extract has can be successfully used for the treatment With the aim of improving access, Osei- been subject to complete bioassay of neglected diseases (NTDs) like Safo and her colleagues decided to explore fractionation. The remaining identified schistosomiasis (snail fever), onchocerciasis whether these plant-based medicines could active extracts are currently under (river blindness), and lymphatic filariasis make a difference to patient care. investigation. “We hope to come up (elephantiasis) (1). After screening multiple plant and solvent with a couple