Editorial pubs.acs.org/jmc
The Drug Annotations Series
T
synthetic route, key assays or preclinical animal model data where critical to discovery process, relevant human PK/PD profiles, and biomarkers, and if available, key clinical results should be included. In the case study story discussion section the authors have the opportunity to highlight the significance of the new agent or novel treatment relative to existing standardof-care and how it has the ability to make a difference in patient’s lives. For first time disclosures, a short experimental section should be included with the description of the synthetic pathway and key intermediates. Within the 10 journal pages, we expect to have graphics and one or more pages for the references (target maximum of 50, with flexibility). See the Guidelines for Authors for full information. We are currently extending invitations to authors and also welcome suggestions on drugs you wish to see covered. If you would like to submit a manuscript for Drug Annotations, please contact us and provide a brief summary of the molecule, disease target(s), mechanism of action, and timeline for your submission (launch Q1, 2014). We are excited to make Drug Annotations a venue for publishing drug case study series where researchers who have been directly involved in the project can describe how a new agent will significantly impact patients’ health and tell the story of the key discovery.
he Drug Annotations series in the Journal of Medicinal Chemistry is a new manuscript type that will launch in the first quarter of 2014. A successful article will cover a new approved drug or phase I, II, or III clinical candidate that is likely to provide or has provided a new treatment modality or significant patient benefit over existing therapy. The authors should outline a case study of a synthetic molecule (including structure) or biological (e.g., monoclonal antibody drug conjugate or oligonucleotides), disease target(s), mechanism of action, and scientific rational for bringing the candidate to clinical trial (for example, first-in-class or highlight improvement over previous clinical candidates). We envision the authors will showcase the medicinal chemistry and use the available clinical data to support the significance of the compound. In addition, when appropriate, it will be important to illustrate how any target engagement or safety biomarker was used to guide human dosing strategies. The availability of pharmacokinetic or efficacy clinical data provides an opportunity for the authors to discuss the predictability of the bioassays or preclinical models used to select the development candidate. The structure−activity relationship (SAR) leading to the choice of the clinical candidate should be shown along with key challenges with regard to biological activity and selectivity profiles; absorption, distribution, metabolism, and excretion (ADME) optimization; and any toxicology issues that needed to be overcome. The Drug Annotations article can also report original research relevant for first time disclosures where medicinal chemistry strategy and SAR data, synthetic routes, and relevant preclinical data are described along with early pharmacokinetics/pharmacodynamics (PK/PD) clinical data. In this case, authors should emphasize the promise for the new therapy based on efficacy in preclinical models or potential therapeutic advantage based on mechanism of action. For compounds in phase II/III before regulatory approval, the authors should include tolerability data and PK and PD data when possible and initial evidence of clinical activity demonstrating the potential of the new drug to benefit patient’s lives. For compounds that have been approved for marketing, more extensive clinical trial data or appropriate references should be included. The Drug Annotations manuscript covers one agent telling the drug discovery story and what interesting challenges were overcome, differentiating Drug Annotations from Perspectives where a class or field of agents is described. We are targeting approximately 10 journal pages with some flexibility on length. The format should generally have an abstract (not exceeding 150 words) and introduction section where the agent or novel treatment is shown describing the disease and highlighting key drug discovery challenges that this approach has overcome setting the stage for the significance of the findings. The body should be organized as a case study story discussion section describing the drug discovery and preclinical development process, with an emphasis on medicinal chemistry. Typical sections of the discussion section would include key drug design steps, medicinal chemistry challenges, © XXXX American Chemical Society
Jeff Zablocki,* Senior Director Gilead Sciences
Carlos Garcia-Echeverria,* Deputy Head Oncology Drug Discovery and Preclinical Development
■
Sanofi
AUTHOR INFORMATION
Corresponding Authors
*For J.Z.: e-mail,
[email protected] or jeff.zablocki@ gilead.com. J.Z. is a Senior Director at Gilead Sciences where he leads a team of scientists working on targets in multiple therapeutic areas (cardiovascular, oncology, inflammation, and antiviral). He has served as the ACS MEDI Chair and is an ACS Fellow. *For C.G.-E.: e-mail, echeverria-offi
[email protected]. C.G.-E. is Deputy Head Oncology Drug Discovery and Preclinical Development at Sanofi. He supervises the drug discovery, medicinal chemistry and in vivo pharmacology functions of the Sanofi oncology business unit. He is an ACS Fellow. Notes
The views expressed in this editorial are those of the authors and not necessarily the views of the ACS.
A
dx.doi.org/10.1021/jm401297r | J. Med. Chem. XXXX, XXX, XXX−XXX
