Articles by Anna Rose Welch

41. Top 5 Biosimilar Developments Of 2017 12/29/2017

    These top five events reflect the steps the numerous industry stakeholders are taking to build what they hope will be a biosimilar friendly framework in the U.S. Though a number of these developments could bring positive implications for the biosimilar industry moving forward, several of these have raised a number of questions and concerns.

42. Biosimilar Evolutions To Watch For In The New Year 12/21/2017

    Experts from Adello Biologics, PA Consulting Group, Momenta Pharmaceuticals, and Avalere Health, share which trends and challenges they’re watching closely, along with how the industry could “break from tradition” in the next few years.

43. What U.S. Biosimilar “Traditions” Need To Be Broken In 2018? 12/19/2017

    You may feel “tradition” is not yet a realized concept in the biosimilar industry — and I would agree with you. But this didn’t stop me from asking several experts which areas they felt could stand more attention or redirection in the future. And they left no stone unturned.

44. DIA Biosimilars Conference Reveals “More Questions Than Answers” 10/31/2017

    During the DIA Biosimilars 2017 conference, there were three topics of discussion that, arguably, could remove barriers to biosimilar development and advance it. But a phrase that was regularly used over the two days highlights one of the biggest issues standing in front of this industry: “There are more questions than answers.”

45. Pfizer's Cultural Evolution To “Tell The Biosimilar Story” 10/26/2017

    Pfizer's Tracy Dianis presents a candid look into the cognitive and cultural transition that needed to occur in her own mindset, as well as within Pfizer, in order to embrace biosimilar development.

46. Could 96 Percent FDA Drug Approval Rate Harm Biosimilar Market? 9/1/2015

    Last week, Matthew Herper of Forbes published an eye-opening article providing a closer look at FDA approvals in recent years, coming to the conclusion that the industry is facing what could be a dangerously high approval rate for new drugs. But how could high approval rates be a bad thing?

47. New Teva, AstraZeneca Deals To Bolster Emerging Biosimilars Market 7/29/2015

    After this week, it looks like there will be a few big players advancing in the biosimilar market. For those concerned about what a Teva-Mylan acquisition deal would do to the generics industry, recent action on behalf of Teva finally put those fears to bed.

48. FDA News Roundup: Otsuka, AstraZeneca, Ipsen, And More 7/17/2015

    What FDA decisions have you missed recently?

49. Human Error: What Pharma Should Know And Do About It — Part One 7/16/2015

    When it comes to determining the underlying cause of a breach in good manufacturing practices, industry often falls back on human error and looks no farther into the matter. However, as Life Science Training Institute’s expert Joanna Gallant describes, retraining employees is only going to go so far and, more often than not, will not even be the appropriate CAPA for the issue. In part one of this four-part series, Gallant discusses where the industry currently stands in identifying the root cause of a problem, as well as the extent to which industry turns to human errors as an explanation.

50. Venture Philanthropy: Is It Really Promoting Patient Centric Drug Development? 7/14/2015

    Within the last 10 years, a number of nonprofit groups, including the Michael J. Fox Foundation and the Multiple Myeloma Research Foundation, have taken a similar approach to ensuring that their targeted patient populations are being well represented in pharma R&D.