Meranda Parascandola - DSI InPharmatics

December 11, 2017

seven misunderstood facts about regulatory drug development consulting

Published by Meranda Parascandola at December 11, 2017

7 Reasons to Hire Regulatory Drug Development Consultants

“Why should I hire a consulting firm? I can just do it myself!” This statement is often made without a complete understanding of the real value provided by Regulatory Drug Development Consultants (RDDC). An effective consulting firm is there to supplement your business proceedings, never to imply that they know better than you do.

November 9, 2018

Published by Meranda Parascandola at November 9, 2018

5 Key Traits That Separate Subject Matter Expert Consulting Firms from the Pack

There are far too many mediocre Consultants out there. Perhaps their objective isn’t strictly to take up your time and drain your wallet, but that’s what it can feel like. Working in the pharmaceutical consulting arena requires unique expertise that can be passed on through the work performed on a daily basis.

January 6, 2019

Published by Meranda Parascandola at January 6, 2019

2019 J.P. Morgan Health Care Investor Conference

Each year, healthcare, pharmaceutical, and biotechnology executives attend the JP Morgan Healthcare Conference, some to tout recent developments, others just to bounce from session to session.

March 7, 2019

Published by Meranda Parascandola at March 7, 2019

FDA Unveils Plan for Draft CMC Guidance in 2019

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is planning to issue new draft and revised draft quality/chemistry manufacturing and controls (CMC) guidance documents spanning different categories, from biosimilars to microbiology to Pharmaceutical Quality, in 2019.

March 8, 2019

Published by Meranda Parascandola at March 8, 2019

DSI Sponsors DCAT in NYC

DCAT is the premier business development event for companies engaged in pharmaceutical development and manufacturing and related industries. Held annually in March, DCAT Week ensures that members have a forum for high-level strategic meetings with key decision makers, timely educational programs, and important networking opportunities.

March 28, 2019

Published by Meranda Parascandola at March 28, 2019

Preparing for an FDA End of Phase II (EOP2) CMC Meeting

Three rules of engagement are recommended to take place at an End of Phase II meeting, either face to face or by telephone. Each rule helps to ensure a successful negotiating strategy based on the actual discussions with the Agency.

April 10, 2019

Published by Meranda Parascandola at April 10, 2019

DSI Announces Participation in the 2019 CPhI North America Conference

DSI, the leading Chemistry, Manufacturing and Controls consulting firm, today announced its participation in CPhI North America, the only Pharmaceutical Industry Event for the North American Supply Chain. This three-day event will be held on April 30-May 2, at the Lakeside Center at McCormick Place, Chicago, Illinois.

April 16, 2019

Published by Meranda Parascandola at April 16, 2019

How a Falling Apple Inspired the Understanding of Gravitational Force

The young Isaac Newton is sitting in his garden when an apple falls on his head and, in a stroke of brilliant insight, he suddenly comes up with his theory of gravity. The story is almost certainly embellished, both by Newton and the generations of storytellers who came after him. But from today anyone with access to the internet can see for themselves the first-hand account of how a falling apple inspired the understanding of gravitational force.

May 10, 2019

Published by Meranda Parascandola at May 10, 2019

DSI announces participation in the BIO One-on-One Partnering™ at the 2019 BIO International Convention

I have never been so simultaneously energized and exhausted than during BIO Week. From the moment you arrive in the city, you’ll experience morning to evening activity. From keynote speeches with luminaries, to panels and partnering meetings with pharma CEOs, to a number of parties ranging from circus performers to whiskey tastings, to yes… Cheesesteak options!

May 22, 2019

Published by Meranda Parascandola at May 22, 2019

Helping Clients Accept A Healthy Level of Regulatory CMC Risk

Some individuals have an off-kilter sense of risk. They may play it overly safe and refuse to make even the most prudent bets on their development program. Or they may gamble willy-nilly, putting all their chips on wildly unpredictable long shot CMC strategies and preceding advice.

May 30, 2019

Published by Meranda Parascandola at May 30, 2019

Need to Know about CMC Regulatory Affairs? Consider What Makes a Great Philly Cheesesteak!

what makes a drug development program? Much like a Philly cheesesteak, the pursuit of greatness is the assurance that any given compound meets requisite technical and quality elements in each stage of development to allow for the ultimate successful commercialization of the drug.

July 19, 2019

Published by Meranda Parascandola at July 19, 2019

One Giant Leap for Mankind. The Original Moonshot.

Fifty years ago, tomorrow, astronauts walked on the moon for the first time. Apollo 11’s success—just 66 years after the Wright brothers’ first flight—showcased humankind’s moxie and ingenuity. Now the moon is in our sights again, for a generation that will test where science meets profit.